Indiana 
  Pain 
  Society 
  Legislative 
  Report 
  on 
  Pain 
  Clinics 
  & 
  
Opioid 
  Prescribing 
  in 
  Indiana 
  2012 
   
  Final 
  7/11/12 
  

 
  
 
  
Background: 
   
  In 
  March 
  2012, 
  the 
  Indiana 
  enrolled 
  act 
  SB24 
  passed 
  the 
  legislature 
  and 
  contains 
  

section 
  1.26 
  that 
  states: 
   
   
  
(a) As 
  used 
  in 
  this 
  SECTION, 
  “pain 
  management 
  facility” 
  means 
  a 
  facility: 
  
(1) in 
  which 
  the 
  primary 
  component 
  of 
  practice 
  at 
  the 
  facility 
  is 
  the 
  treatment 
  of 
  pain; 
  or 
  
(2) that 
  advertises 
  for 
  the 
  treatment 
  of 
  pain; 
  and 
   
  
 
   
   
   
   
   
   
   
   
   
  the 
  majority 
  of 
  patients 
  at 
  the 
  facility 
  are 
  prescribed 
  controlled 
  substances 
  or 
  other 
  drugs. 
  
(b) The 
  general 
  assembly 
  urges 
  the 
  legislative 
  council 
  to 
  assign 
  to 
  a 
  study 
  committee, 
  for 
  study 
  
during 
  the 
  2012 
  legislative 
  interim, 
  the 
  topic 
  of 
  pain 
  management 
  facilities, 
  including 
  the 
  
following: 
  
(1) The 
  effectiveness 
  of 
  current 
  laws 
  and 
  rules 
  in 
  Indiana 
  to 
  regulate 
  and 
  monitor 
  pain 
  
management 
  facilities 
  and 
  prescribers 
  of 
  controlled 
  substances 
  
(2) Programs 
  and 
  regulations 
  in 
  other 
  states 
  that 
  effectively 
  regulate 
  and 
  monitor 
  pain 
  
management 
  facilities 
  and 
  prescribers 
  of 
  controlled 
  substances. 
  
(c) If 
  the 
  topic 
  of 
  pain 
  management 
  facilities 
  is 
  assigned 
  to 
  a 
  study 
  committee, 
  the 
  study 
  
committee 
  shall 
  issue 
  a 
  final 
  report 
  to 
  the 
  legislative 
  council 
  containing 
  the 
  study 
  
committee’s 
  findings 
  and 
  recommendations, 
  including 
  any 
  recommended 
  legislation 
  
concerning 
  the 
  topic, 
  not 
  later 
  than 
  November 
  1, 
  2012. 
  
(d) This 
  SECTION 
  expires 
  June 
  30, 
  2013 
  
SECTION 
  1.27. 
   
  An 
  emergency 
  is 
  declared 
  for 
  this 
  act. 
  
 
  
 
  

Key 
  Points 
  of 
  This 
  Report: 
  
 
  
• Prescription 
  drug 
  abuse 
  and 
  death 
  continue 
  to 
  be 
  a 
  major 
  health 
  problem 
  in 
  

•

•
•

•

the 
  US 
   
  and 
  in 
  Indiana, 
  that 
  is 
  ranked 
  16th 
  nationally 
  in 
  opioid 
  drug 
  deaths 
  
per 
  100,000 
  population 
  with 
  a 
  rate 
  of 
  increase 
  that 
  is 
  accelerating 
  above 
  the 
  
pace 
  of 
  the 
  national 
  average 
  
Indiana 
  did 
  not 
  develop 
  the 
  pill 
  mill 
  issues 
  of 
  Florida 
  and 
  other 
  states. 
   
  
Ownership 
  of 
  non-­‐hospital 
  based 
  pain 
  clinics 
  in 
  Indiana 
  is 
  by 
  physicians 
  
more 
  than 
  99% 
  of 
  the 
  time 
  and 
  in-­‐office 
  dispensing 
  of 
  oral 
  or 
  transdermal 
  
schedule 
  II 
  opioids 
  is 
  rare. 
   
  
The 
  major 
  source 
  of 
  prescription 
  opioids 
  in 
  Indiana 
  is 
  by 
  prescribing 
  of 
  these 
  
medications 
  by 
  physicians, 
  nurse 
  practitioners, 
  physicians 
  assistants, 
  
podiatrists, 
  and 
  dentists 
  with 
  little 
  training 
  in 
  pain 
  medicine. 
  
The 
  major 
  cause 
  of 
  substance 
  abuse 
  and 
  death 
  from 
  opioids 
  are 
  due 
  to 
  
sharing 
  the 
  medications 
  with 
  friends. 
  There 
  currently 
  exists 
  no 
  legal 
  
mechanism 
  to 
  curtail 
  this 
  type 
  of 
  behavior 
  and 
  because 
  of 
  the 
  cryptic 
  
wording 
  in 
  our 
  state 
  laws, 
  many 
  citizens 
  do 
  not 
  recognize 
  it 
  is 
  illegal. 
  
The 
  substance 
  abuse 
  rate 
  in 
  patients 
  taking 
  prescription 
  opioids 
  is 
  35%. 
   
  
Many 
  practitioners 
  prescribing 
  opioids 
  do 
  not 
  even 
  look 
  for 
  it, 
  failing 
  to 
  
incorporate 
  monitoring 
  tools 
  that 
  are 
  readily 
  available 
  such 
  as 
  INSPECT. 
   
  
Only 
  40% 
  of 
  MDs 
  with 
  Indiana 
  state 
  controlled 
  substance 
  registration 
  

 •
•

•
•
•
•
•
•
•

 
  

numbers 
  have 
  registered 
  for 
  INSPECT 
  despite 
  the 
  program 
  being 
  available 
  
for 
  several 
  years. 
  
Only 
  a 
  small 
  minority 
  of 
  state 
  and 
  federal 
  actions 
  against 
  physicians 
  in 
  
Indiana 
  for 
  inappropriate 
  prescribing 
  involve 
  pain 
  clinics 
  or 
  pain 
  physicians: 
   
  
most 
  involve 
  primary 
  care 
  or 
  other 
  specialists 
  
Substance 
  abuse 
  is 
  enhanced 
  by 
  lack 
  of 
  communication 
  between 
  
practitioners 
  and 
  physicians 
  initiating 
  opioid 
  therapy 
  and 
  prior 
  prescribers. 
   
  
Frequently 
  physicians 
  and 
  practitioners 
  starting 
  to 
  prescribe 
  opioids 
  for 
  a 
  
patient 
  will 
  not 
  communicate 
  this 
  fact 
  to 
  the 
  PCP 
  or 
  current 
  opioid 
  
prescribers 
  easily 
  discovered 
  by 
  INSPECT, 
  resulting 
  in 
  duplication 
  of 
  opioid 
  
supplies, 
  substance 
  abuse, 
  and 
  death. 
   
  
Some 
  recently 
  enacted 
  opioid 
  prescribing 
  laws, 
  as 
  enacted 
  in 
  other 
  states, 
  
will 
  not 
  necessarily 
  curtail 
  substance 
  abuse 
  and 
  death 
  in 
  Indiana 
   
   
  
Physicians 
  constitute 
  only 
  62% 
  of 
  the 
  potential 
  opioid 
  prescribers 
  in 
  the 
  
state, 
  therefore 
  enacted 
  laws 
  and 
  disciplinary 
  actions 
  must 
  equally 
  apply 
  to 
  
other 
  professions 
  
Benzodiazepines 
  are 
  found 
  in 
  the 
  majority 
  of 
  opioid 
  related 
  drug 
  deaths 
  and 
  
are 
  thought 
  to 
  increase 
  the 
  death 
  rate 
  due 
  to 
  opioids 
  by 
  8 
  times 
  those 
  not 
  
taking 
  benzodiazepines 
  
Several 
  states 
  have 
  inappropriately 
  criminalized 
  opioid 
  prescribing 
  
Improper 
  coding 
  of 
  death 
  causes 
  an 
  under-­‐rating 
  of 
  prescription 
  opioid 
  
deaths 
  in 
  Indiana 
  
High 
  risk 
  patients 
  for 
  both 
  substance 
  abuse 
  and 
  death 
  may 
  be 
  stratified 
  and 
  
measures 
  taken 
  to 
  avoid 
  poor 
  outcomes 
  
The 
  Indiana 
  Pain 
  Society 
  has 
  promulgated 
  standards 
  of 
  care 
  for 
  opioid 
  
prescribing 
  as 
  seen 
  in 
  Appendix 
  F. 
   
  These 
  standards 
  serve 
  to 
  help 
  protect 
  
patients 
  from 
  substance 
  abuse 
  and 
  overdose, 
  and 
  provide 
  a 
  framework 
  for 
  
prescribing 
  opioids. 
  

 
  

  
  
State 
  Laws 
  and 
  Regulations 
  Regarding 
  Opioid 
  Prescribing 
  
 
  

Indiana 
  remains 
  as 
  one 
  of 
  only 
  two 
  states 
  without 
  any 
  regulations/laws/or 
  medical 
  board 
  rules 
  on 
  
prescribing 
  of 
  opioids 
  according 
  to 
  the 
  Wisconsin 
  Pain 
  Policies 
  Group 
  as 
  shown 
  in 
  the 
  map 
  below. 
   
  

 
  

 
  

 
  
The 
  April 
  2012 
  list 
  of 
  state 
  by 
  state 
  regulations, 
  laws, 
  rules 
  in 
  the 
  treatment 
  of 
  chronic 
  pain 
  are 
  found 
  in 
  
appendix 
  D. 
   
  Selected 
  recent 
  state 
  pain 
  laws 
  are 
  discussed 
  below. 
  
 
  
 
  

  
  

SUMMARY 
  OF 
  STATE 
  OPIOID 
  PRESCRIBING 
  LAWS 
  ADOPTED 
  2009-­‐2012 
  

OH 
  

11 
   MB 
  

Yes 
  

WV 
  

12 
   MB 
  

No 
  

HA
O 
  
HU
CAS 
  
 
  

NY 
  

12 
    
  

 
  

 
  

Mandatory 
  
Pain 
  Board 
  
Certification 
  
 
  
Clinic 
  
 
  
Inspections 
  
 
  
 
  
 
  

Yes 
  

Mandatory 
  
Prescriber 
  
CME 
  in 
  Pain 
  

10 
   MB 
  

Clinic 
  
Ownership 
  
Limited 
  
toians 
  
Med 
   
  
Director 
  
Required 
  

FL 
  

Mandatory 
  
UDS 
  

10 
   DOH 
  

Dose 
  Limit 
  
before 
  
Mandatory 
   
  
Referral 
  
PMP 
   
  
Checks 
  

WA 
  

Yes 
  for 
  
each 
  
locatio
n 
  
No 
  

KY 
  

Excludes 
  

Pain 
  Clinic 
  
Registration 
  
Required 
  
Yes 
  

TN 
  

12 
   Boar
ds 
  
11 
   DOH 
  

State 
  

Year 
  Passed 
   
  
 
  
Rules 
  
Jurisdiction 
  

 
  

N
o 
  
N
o 
  

Q3Mo 
  

Q3mo 
  

Yes 
  

Yes 
  

No 
  

Yes*** 
  

?? 
  

Yes 
  in 
  
2013 
  
and 
  
annual 
  
Yes 
  

Q6mo
nths 
  & 
  
initial 
  

No 
  

Yes 
  
MD/DO 
  
 
  

10 
  
hrs/cycle 
  

No* 
  

Yes 
  

No 
  

No 
  

No 
  

Depends 
  

No# 
  

No 
  

No 
  

No 
  

No 
  

Yes% 
  

No 
  

No 
  

Yes 
  

No 
  

No 
  

Yes** 
  

Owner 
  

No 
  

Yes@ 
  

No 
  

No 
  

No 
  

20hrs/2y
rs 
  
No 
  

No 
  

Possib
le 
  
No 
  

Yes 
  in 
  
2013 
  

 
  

 
  

 
  

 
  

 
  

 
  

HU
AL 
  
 
  

 
  

Ye
s 
  
N
o 
  
N
o 
  
N
o 
  
 
  

 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
H=hospital 
  or 
  physicians 
  office 
  in 
  a 
  hospital 
  owned 
  facility 
  
U=universities 
  
A=Ambulatory 
  Surgery 
  Centers 
  
L=Long 
  Term 
  Facilities 
  
C=CARF 
  accredited 
  rehab 
  clinic 
  
S=Hospice 
  
O=owned 
  by 
  physicians 
  board 
  certified 
  in 
  pain 
  or 
  anesthesiology/PMR/neurology 
  or 
  primarily 
  performs 
  
procedures 
  or 
  is 
  a 
  publically 
  traded 
  corp 
  with 
  $50 
  million 
  or 
  more 
  assets 
  
 
  
* 
  Tennessee 
  Board 
  training 
  required 
   
   
  1. 
  Completion 
  of 
  residency 
  in 
  PMR, 
  Anes, 
  Addiction 
  med, 
  neurology, 
  
neurosurg, 
  family 
  practice, 
  IM, 
  preventative 
  med, 
  surgery, 
  orthopedics 
  OR 
  2. 
  Board 
  certification 
  in 
  same 
  
or 
  3. 
  Certification 
  ABMS 
  in 
  pain 
  management, 
  hospice 
  and 
  palliative 
  medicine, 
  rheumatology, 
  geriatric 
  
medicine, 
  hematology, 
  oncology, 
  infectious 
  dieseae, 
  pediatric 
  hematology-­‐oncoholy, 
  or 
  pediatric 
  
rheumatology 
  OR 
   
  4. 
  Board 
  Certification 
  by 
  American 
  Board 
  of 
  Pain 
  Medicine 
  or 
  American 
  Board 
  of 
  
Interventional 
  Pain 
  Physicians 
  
** 
  Ohio 
  board 
  requires 
  ownership 
  by 
  a 
  doctor 
  ABMS 
  pain 
  certification, 
  ABIPP, 
  or 
  AOA 
  pain 
   
  OR 
  one 
  of 
  
several 
  core 
  specialties 
  PLUS 
  have 
  your 
  pain 
  clinic 
  investigated 
  by 
  the 
  board 
  by 
  filing 
  a 
  complaint 
  on 
  
yourself. 
   
  Workers 
  in 
  the 
  clinic 
  such 
  as 
  NPs 
  do 
  not 
  have 
  to 
  be 
  board 
  certified 
  in 
  pain 
  
*** 
  KY 
  board 
  requires 
  ABMS 
  pain 
  certified, 
  ABPM, 
  ABIPP, 
   
  
% 
  Florida 
  board 
  requires 
  a 
  medical 
  director 
  practice 
  at 
  the 
  clinic 
  licensed. 
  
Florida 
  also 
  requires 
  the 
  clinic 
  engage 
  in 
  adverse 
  incident 
  tracking 
  with 
  identification 
  of 
  trends 
  or 
  patterns 
  
and 
  the 
  development 
  of 
  measures 
  to 
  reduce 
  or 
  eliminate 
  risks 
  of 
  adverse 
  events 
  
# 
  Washington 
  state 
  requires 
  a 
  pain 
  management 
  specialist 
  to 
  be 
  a 
  physician, 
   
  board 
  certified 
  or 
  eligible 
  in 
  
anesthesiology/PMR/rheumatology/neurology 
  or 
  a 
  ABMS 
  specialty 
  certificate 
  in 
  additional 
  qualifications 
  
in 
  pain 
  or 
  a 
  minimum 
  of 
  3 
  years 
  experience 
  in 
  a 
  chronic 
  pain 
  setting 
  with 
  some 
  educational 
  requirements. 
   
  
Also 
  Washington 
  recognizeds 
  NPs, 
  Dentists, 
  DPM, 
  Pas 
  may 
  be 
  pain 
  specialists. 
  
@ 
  West 
  Virginia 
  is 
  considering 
  adopting 
  emergency 
  rule 
  CSR 
  11 
  10 
  at 
  the 
  time 
  of 
  this 
  writing 
  that 
  would 
  
require 
  PMP 
  query 
  prior 
  to 
  prescribing 
  any 
  opioids 
  

  
  
Ohio 
  pain 
  licensure 
  requires 
  obtaining 
  a 
  terminal 
  licensure 
  to 
  distribute 
  drugs 
  even 
  if 
  no 
  drugs 
  are 
  kept 
  on 
  
site. 
   
  
SOURCE 
  DOCUMENTS 
  FOR 
  STATE 
  LAWS: 
  
TN 
   
  http://www.tn.gov/sos/rules/1200/1200-­‐34/1200-­‐34-­‐01.20120326.pdf 
  
OH 
  http://www.med.ohio.gov/pdf/rules/FAQ%20re%20perm%20Rule%204731-­‐29-­‐01.pdf 
  
KY 
   
  http://kbml.ky.gov/ 
  
FL 
   
  
http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-­‐
0499/0458/Sections/0458.3265.html 
  
WA 
  http://www.doh.wa.gov/Portals/1/Documents/3000/MDPAPainMgmt.pdf 
  
WV 
  http://www.wvbom.wv.gov/CSR_11_10.asp 
  
Info 
  about 
  PMPs 
   
  http://www.ama-­‐assn.org/amednews/2012/06/25/bisg0628.htm 
  
 
  
 
  
The 
  Tennessee 
  rules 
  outline 
  patient 
  medical 
  history, 
  physical, 
  treatment 
  objectives, 
  UDS, 
  treatment 
  
options, 
  medication 
  records, 
  instructions 
  and 
  agreements, 
  periodic 
  reviews, 
  and 
  PMP 
  access 
  
requirements 
  in 
  addition 
  to 
  several 
  others. 
   
  Pain 
  clinics 
  are 
  defined 
  as 
  clinics 
  where 
  more 
  than 
  half 
  the 
  
patients 
  receive 
  opioids. 
   
  However, 
  family 
  practitioners 
  may 
  prescribe 
  up 
  to 
  49% 
  of 
  their 
  patients 
  chronic 
  
opioids 
  and 
  not 
  be 
  required 
  to 
  register 
  in 
  TN 
  nor 
  have 
  to 
  follow 
  any 
  of 
  the 
  rules. 
   
   
  This 
  creates 
  a 
  huge 
  hole 
  
in 
  prescribing 
  monitoring 
  and 
  in 
  encouraging 
  substance 
  abuse. 
   
  
 
  
 
  

Discussion 
  of 
  Above 
  Laws: 
  
The 
  laws 
  adopted 
  by 
  each 
  of 
  the 
  above 
  states 
  are 
  crafted 
  with 
  response 
  to 
  the 
  individual 
  state 
  issues 
  
at 
  hand. 
   
  For 
  instance, 
  pill 
  mill 
  operations 
  in 
  several 
  states 
  with 
  businessman 
  or 
  Mafia 
  ownership 
  
have 
  caused 
  laws 
  to 
  be 
  adopted 
  that 
  limit 
  ownership 
  of 
  these 
  clinics. 
   
  Other 
  states 
  are 
  interested 
  in 
  
attacking 
  the 
  issues 
  from 
  a 
  substance 
  abuse/diversion 
  tactic 
  and 
  employ 
  mandatory 
  querying 
  of 
  
their 
  prescription 
  monitoring 
  programs. 
   
  Washington, 
  uses 
  a 
  specific 
  opioid 
  milligram 
  amount, 
  above 
  
which 
  consultation 
  with 
  a 
  pain 
  physician 
  is 
  advised. 
   
  Some 
  of 
  the 
  states 
  register 
  pain 
  clinics 
  with 
  
more 
  than 
  50% 
  of 
  the 
  patients 
  receiving 
  opioid 
  scripts. 
   
   
  
 
  
The 
  problems 
  with 
  targeting 
  “pain 
  clinics” 
  or 
  practices 
  in 
  which 
  more 
  than 
  half 
  the 
  patients 
  
receive 
  pain 
  medications 
  are 
  that: 
  
-­‐ 1. 
  Problem 
  prescribing 
  (dangerous 
  prescribing) 
  in 
  Indiana 
  does 
  not 
  originate 
  with 
  pill 
  
mills 
  as 
  in 
  Florida 
  or 
  from 
  pain 
  clinics, 
  but 
  with 
  uncontrolled 
  prescribing 
  by 
  primary 
  
care 
  physicians 
  and 
  specialists. 
   
  Some 
  of 
  these 
  prescribe 
  several 
  times 
  the 
  maximum 
  
dosages 
  that 
  board 
  certified 
  pain 
  physicians 
  would 
  prescribe. 
  Practitioners 
  (including 
  
nurse 
  practitioners 
  and 
  physicians) 
  prescribing 
  high 
  dose 
  opioids 
  with 
  insufficient 
  
patient 
  monitoring, 
  prescribing 
  multiple 
  sedative 
  drugs, 
  and 
  prescribing 
  to 
  high 
  risk 
  
patients 
  would 
  be 
  exempt 
  from 
  scrutiny 
  if 
  they 
  prescribe 
  opioids 
  to 
  less 
  than 
  50% 
  of 
  
their 
  patients 
  or 
  don’t 
  advertise 
  themselves 
  as 
  pain 
  clinics, 
  which 
  is 
  frequently 
  the 
  
case. 
   
  Some 
  primary 
  care 
  physicians 
  prescribe 
  high 
  dose 
  hydrocodone 
  for 
  well 
  over 
  a 
  
year 
  by 
  simply 
  calling 
  in 
  scripts 
  without 
  ever 
  seeing 
  the 
  patients. 
   
  It 
  is 
  these 
  practices 
  
that 
  need 
  to 
  be 
  targeted. 
   
   
  
-­‐ 2. 
  Some 
  surgical 
  practices 
  prescribe 
  opioid 
  narcotics 
  to 
  the 
  majority 
  of 
  their 
  patients 
  
following 
  surgery. 
   
  The 
  unintended 
  consequence 
  of 
  a 
  pain 
  law 
  based 
  on 
  a 
  50% 
  
threshold 
  of 
  patients 
  receiving 
  pain 
  medications 
  would 
  cause 
  surgical 
  clinics 
  to 
  
reduce 
  or 
  stop 
  prescribing 
  post-­‐operative 
  opioid 
  medications 
  to 
  avoid 
  being 
  targeted 
  
by 
  such 
  a 
  law. 
  
 
  
Some 
  of 
  the 
  states 
  employ 
  extremely 
  detailed 
  laws 
  that 
  involve 
  specific 
  history 
  and 
  physical 
  exam 
  
medical 
  requirements, 
  location 
  of 
  bathrooms 
  within 
  the 
  clinic, 
  signage 
  requirements, 
  and 
  an 
  array 
  of 
  

 rules, 
  some 
  of 
  which 
  may 
  not 
  be 
  constitutional 
  (require 
  physicians 
  accept 
  patients 
  insurance 
  instead 
  
of 
  cash 
  payments 
  if 
  they 
  are 
  not 
  part 
  of 
  that 
  plan). 
   
  The 
  Indiana 
  Pain 
  Society 
  debated 
  for 
  an 
  entire 
  
year 
  the 
  adoption 
  of 
  standards 
  of 
  care 
  that 
  encapsulate 
  the 
  needs 
  of 
  the 
  patients 
  and 
  physicians 
  in 
  
the 
  state 
  in 
  developing 
  a 
  framework 
  for 
  opioid 
  prescribing 
  applicable 
  to 
  all 
  physicians 
  and 
  non-­‐
physician 
  midlevel 
  prescribers. 
   
  The 
  Indiana 
  Pain 
  Society 
  Opioid 
  Standards 
  of 
  Care 
  as 
  summarized 
  in 
  
the 
  following 
  section 
  and 
  in 
  full 
  in 
  Appendix 
  F 
  are 
  part 
  of 
  a 
  larger 
  group 
  of 
  Pain 
  Standards 
  adopted 
  
for 
  the 
  development 
  of 
  more 
  uniform 
  pain 
  practices 
  in 
  the 
  state 
  taking 
  into 
  account 
  patient 
  safety 
  
issues 
  and 
  practitioner 
  education. 
   
  The 
  Standards 
  were 
  accepted 
  by 
  the 
  pain 
  society 
  with 
  the 
  proviso 
  
that 
  the 
  society 
  later 
  develop 
  specific 
  opioid 
  prescribing 
  guidelines 
  in 
  the 
  future. 
   
  The 
  Indiana 
  Pain 
  
Society 
  supports 
  legislative 
  adoption 
  of 
  the 
  IPS 
  opioid 
  standards 
  (Section 
  5) 
  of 
  the 
  IPS 
  Standards 
  for 
  
all 
  state 
  prescribers 
  of 
  controlled 
  substances. 
   
  
 
  
While 
  profound 
  detail 
  in 
  the 
  passage 
  of 
  laws 
  may 
  seem 
  propitious, 
  frequently 
  these 
  details 
  
may 
  contain 
  errors, 
  fail 
  to 
  adapt 
  to 
  changes 
  in 
  medicine, 
  and 
  become 
  archaic, 
  developing 
  unintended 
  
secondary 
  meanings 
  as 
  the 
  medical 
  profession 
  evolves. 
   
  The 
  laws 
  and 
  regulations 
  may 
  be 
  used 
  as 
  an 
  
unintended 
  shield 
  for 
  the 
  poor 
  prescribing 
  practices 
  by 
  practitioners 
  with 
  offices 
  in 
  hospitals 
  or 
  
university 
  affiliated 
  facilities. 
   
  At 
  the 
  same 
  time, 
  Indiana 
  and 
  other 
  states, 
  are 
  facing 
  an 
  increasing 
  
number 
  of 
  midlevel 
  providers 
  with 
  controlled 
  substance 
  prescriptive 
  authority. 
   
  The 
  simultaneous 
  
adoption 
  of 
  rules 
  by 
  each 
  professional 
  board 
  as 
  promulgated 
  from 
  the 
  passage 
  of 
  a 
  law 
  can 
  be 
  
problematic, 
  and 
  result 
  in 
  irrational 
  adoption 
  of 
  a 
  rule 
  by 
  one 
  board 
  but 
  not 
  by 
  another. 
   
  This 
  
situation 
  exists 
  in 
  the 
  Office 
  Anesthesia 
  Rule 
  in 
  Indiana 
  where 
  the 
  board 
  of 
  dentistry 
  did 
  not 
  adopt 
  a 
  
law 
  restricting 
  the 
  administration 
  of 
  an 
  anesthetic 
  agent 
  in 
  dentists 
  offices 
  but 
  the 
  medical 
  board 
  did 
  
restrict 
  physicians 
  from 
  employing 
  this 
  anesthetic 
  agent. 
   
   
  Such 
  non-­‐uniformity 
  in 
  professional 
  board 
  
adoption 
  of 
  rules 
  is 
  counterproductive, 
  and 
  in 
  the 
  case 
  of 
  opioid 
  prescribing 
  rules, 
  can 
  be 
  extremely 
  
hazardous 
  to 
  patients. 
   
  Given 
  the 
  large 
  number 
  of 
  issues 
  that 
  must 
  be 
  resolved 
  in 
  opioid 
  
prescribing 
  and 
  given 
  the 
  lack 
  of 
  an 
  executive 
  agency 
  to 
  require 
  all 
  professional 
  boards 
  comply 
  
with 
  identical 
  rule 
  adoption, 
  the 
  IPS 
  believes 
  it 
  is 
  in 
  the 
  best 
  interest 
  of 
  the 
  people 
  of 
  the 
  state 
  of 
  
Indiana 
  to 
  create 
  a 
  “Controlled 
  Substances 
  Commission” 
  (CSC) 
  that 
  would 
  have 
  representatives 
  
from 
  all 
  germane 
  professional 
  boards 
  and 
  would 
  create 
  the 
  detailed 
  opioid 
  prescribing 
  rules 
  
that 
  would 
  further 
  characterize 
  the 
  Indiana 
  Pain 
  Society 
  opioid 
  standards. 
   
  This 
  commission 
  
would 
  serve 
  as 
  an 
  proactive 
  entity 
  to 
  pre-­‐emptively 
  move 
  to 
  reduce 
  substance 
  abuse, 
  physician 
  
overprescribing, 
  and 
  create 
  guidelines 
  for 
  prescribing 
  that 
  would 
  be 
  adopted 
  by 
  reference 
  by 
  each 
  
PLA 
  board 
  rather 
  than 
  employ 
  a 
  protracted 
  and 
  expansive 
  legislative 
  or 
  professional 
  board 
  
rulemaking 
  process. 
   
  
 
  

Summary 
  of 
  IPS 
  Standards 
  of 
  Care 
  for 
  Opioids 
  (Adopted 
  November, 
  2011) 
  
STANDARD 5.1.1 Opioid treatment may be initiated in medically and psychologically
appropriate patients that have tried and failed other conservative treatments, and after a
substance abuse screening tool or substance abuse history survey result has been evaluated
for appropriateness of prescribing opioids.
STANDARD 5.1.2 Opioids should not be the only therapy employed in pain control efforts in
chronic non-malignant pain
STANDARD 5.1.3 An opioid agreement will be signed by the patient prior to the prescribing
of any opioids when long-term opioid prescribing is anticipated or in any case, after 3 months
of the patient taking opioids at least weekly. This agreement makes clear the policies of the
clinic, the responsibilities of the patient being prescribed chronic opioids, the possible
consequences of substance abuse or drug diversion, and may include the required consent
for opioid treatment.
STANDARD 5.1.4 Opioids may be prescribed only for the legitimate medical purpose of
reduction of pain or improvement of function unless addiction is being actively treated under a
Drug Enforcement Agency special license.
STANDARD 5.2.1 Referral to other specialists may be required of the patient as a part of the
continuation of opioid therapy.

 STANDARD 5.3.1 Patients receiving initiation or continuation of opioid therapy should be seen
at least every 4 weeks until the patients compliant behavior and therapeutic efficacy are
established. Subsequently, patients receiving more than 120mg a day morphine (or equivalent)
or less must be seen in follow-up at least every 8 weeks or less under normal circumstances.
Patients receiving 180mg a day or more morphine (or equivalent) must be seen in follow-up
at least every 6 weeks or less under normal circumstances.
STANDARD 5.4.1 Patients receiving chronic opioids must have an INSPECT report generated at
least every 6 months.
STANDARD 5.4.2 Urine, blood, or saliva levels of the prescribed substances and illicit
substances are a critical part of chronic opioid therapy management and for assuring patient
compliance. These tests should be employed in cases of suspected substance abuse or drug
diversion, and randomly at reasonable intervals.
STANDARD 5.5.1 Patients will be monitored by the opioid prescriber for substance abuse and
diversion, and will take decisive action to eliminate these issues in their patient population.
Identified substance abuse may include referral to an addictionologist, co-management with a
psychiatrist or psychologist, use of more frequent follow-ups, or referral to a drug treatment
center. Drug diversion must be treated with cessation of prescribing of controlled substances.
STANDARD 5.6.1 Sudden cessation of opioid prescribing should not be used in patients with
known symptomatic coronary artery disease and should not be used in general unless there is
evidence of drug diversion, use of illicit drugs, or obtaining opioids from other sources.
STANDARD 5.6.2 When opioids are no longer to be prescribed due to substance abuse or
diversion, the prescriber will offer referral to a drug rehabilitation center or addiction
treatment center. Gradual weaning may be employed if there has been substance abuse but no
drug diversion or illicit substance use.
STANDARD 5.6.3 The opioid prescriber may withdraw opioid treatment at any time for failure
to achieve adequate pain relief, excessive or life threatening side effects, substance abuse,
addiction, or drug diversion without discharging the patient from their practice. There is no
obligation of the prescriber to continue opioid treatment in such situations.
STANDARD 5.6.4 The withdrawal of opioids due to addiction, substance abuse, or diversion will
be prominently noted in the medical record and will be communicated to all known currently
treating physicians of record and those identified by INSPECT as prescribing opioids recently.
STANDARD 5.6.5 It is inappropriate to refer a patient to another opioid prescriber or back to
their primary care provider for continued opioid therapy for pain when the patient has engaged
in substance abuse, drug diversion, or exhibits signs of addiction. In such situations patients
should be withdrawn from opioids for at least 6 months prior to re-engaging opioids, and then
only under tight control with addictionology co-management if available, otherwise
with psychological counseling as an on-going part of the opioid treatment program.

 
  
 
  
 
  

IPS 
  LEGISLATIVE 
  RECOMMENDATIONS: 
  

1. Establish 
  standards 
  of 
  care 
  for 
  all 
  prescribers 
  of 
  opioids 
  as 
  adopted 
  by 
  
the 
  Indiana 
  Pain 
  Society 
  standards 
  (Appendix 
  F) 
  as 
  a 
  legal 
  framework 
  for 
  
prescribing 
  opioids 
  for 
  chronic 
  pain 
  
2. Create 
  a 
  Controlled 
  Substance 
  Commission 
  (CSC) 
  to 
  develop 
  and 
  
promulgate 
  rules 
  that 
  will 
  be 
  adopted 
  uniformly 
  by 
  all 
  stakeholder 
  
boards 
  of 
  the 
  PLA. 
   
  This 
  entity 
  will 
  also 
  develop 
  uniform 
  prescribing 
  and 
  

 3.

4.

5.

6.

7.
8.
 
  
 
  

disciplinary 
  rules 
  specifically 
  for 
  opioid 
  prescribing 
  and 
  develop 
  
communication 
  mandates 
  between 
  prescribers. 
   
   
  The 
  CSC 
  will 
  develop 
  
tracking 
  and 
  quality 
  improvement 
  rules 
  regarding 
  controlled 
  substance 
  
related 
  deaths 
  
Mandatory 
  controlled 
  substance 
  provider 
  participation 
  in 
  INSPECT 
  with 
  
anyone 
  that 
  has 
  a 
  state 
  CSR. 
   
  INSPECT 
  would 
  be 
  funded 
  perpetually 
  
through 
  imposition 
  of 
  a 
  25 
  cent 
  per 
  prescription 
  filled 
  fee 
  collected 
  from 
  
pharmacies 
  at 
  the 
  point 
  of 
  filling. 
   
  INSPECT 
  will 
  provide 
  the 
  CSC 
  requested 
  
data 
  for 
  research 
  purposes 
  or 
  to 
  agencies 
  or 
  researchers 
  as 
  authorized 
  
by 
  the 
  attorney 
  general 
  or 
  governor 
  and 
  the 
  CSC 
  will 
  have 
  access 
  to 
  
INSPECT 
  data 
  during 
  queries 
  involving 
  individual 
  prescribers. 
   
  INSPECT 
  
will 
  permit 
  saving 
  a 
  generated 
  INSPECT 
  report 
  to 
  the 
  patient’s 
  chart 
  
The 
  admitting 
  physician, 
  discharging 
  physician, 
  or 
  the 
  hospital 
  
pharmacist 
  (as 
  established 
  by 
  hospital 
  bylaws) 
  must 
  query 
  INSPECT 
  and 
  
send 
  a 
  hospital 
  discharge 
  note 
  to 
  all 
  physicians 
  and 
  midlevels 
  who 
  have 
  
prescribed 
  controlled 
  substances 
  over 
  the 
  past 
  3 
  months 
  in 
  cases 
  of 
  
admission 
  for 
  respiratory 
  arrest, 
  drug 
  toxicity, 
  or 
  suspected 
  opioid 
  
overdose 
  
Coroners 
  are 
  directed 
  to 
  investigate 
  all 
  suspected 
  drug 
  overdose 
  cases 
  
with 
  toxicology 
  studies. 
   
  INSPECT 
  will 
  be 
  queried 
  by 
  the 
  coroner 
  and 
  the 
  
CSC 
  and 
  all 
  physicians 
  prescribing 
  controlled 
  substances 
  over 
  the 
  past 
  3 
  
months 
  will 
  receive 
  notification 
  of 
  a 
  drug 
  overdose 
  death. 
   
   
  The 
  CSC 
  will 
  
devise 
  a 
  standard 
  operating 
  protocol 
  to 
  be 
  used 
  by 
  coroners 
  in 
  accurately 
  
coding 
  poisoning 
  deaths 
  due 
  to 
  controlled 
  substances. 
   
   
  
In 
  the 
  absence 
  of 
  clarity 
  in 
  Indiana 
  state 
  law 
  regarding 
  opioids, 
  the 
  CSC 
  is 
  
given 
  the 
  authority 
  to 
  create 
  a 
  one 
  page 
  publication 
  of 
  plain 
  English 
  
summary 
  of 
  the 
  law 
  regarding 
  what 
  patients 
  can 
  and 
  cannot 
  do 
  with 
  
opioids, 
  and 
  these 
  are 
  to 
  be 
  distributed 
  yearly 
  by 
  the 
  prescribing 
  
physician 
  to 
  every 
  patient 
  receiving 
  opioids. 
  
Authorization 
  of 
  the 
  CSC 
  to 
  develop 
  a 
  databank 
  of 
  high 
  risk 
  patients 
  that 
  
have 
  engaged 
  in 
  substance 
  abuse 
  or 
  diversion 
  with 
  the 
  same 
  provider 
  
access 
  as 
  INSPECT 
  
Create 
  a 
  law 
  protecting 
  physicians 
  for 
  being 
  charged 
  with 
  homicide 
  or 
  
manslaughter 
  for 
  drug 
  overdoses 
  if 
  they 
  use 
  the 
  ISP 
  standards 
  and 
  CSC 
  
guidelines. 
   
  
 
  

 IPS 
  RESEARCH 
  ON 
  OPIOID 
  PRESCRIBING 
  IN 
  THE 
  US 
  AND 
  INDIANA 
  
 
  
Executive 
  Summary: 
   
  Recently 
  several 
  states 
  adopted 
  laws 
  to 
  curtail 
  opioid 
  prescribing 
  in 
  an 
  

effort 
  to 
  reduce 
  the 
  epidemic 
  of 
  substance 
  abuse, 
  drug 
  diversion, 
  and 
  prescription 
  drug 
  related 
  death. 
   
  
While 
  the 
  overall 
  death 
  rate 
  from 
  these 
  medications 
  constitutes 
  less 
  than 
  0.6% 
  of 
  the 
  number 
  of 
  
deaths 
  in 
  the 
  US, 
  there 
  has 
  been 
  significant 
  attention 
  brought 
  to 
  escalating 
  death 
  rates. 
   
  Indiana, 
  
ranked 
  16th 
  in 
  prescription 
  drug 
  deaths 
  per 
  100,000 
  population, 
  has 
  largely 
  escaped 
  the 
  type 
  of 
  
situations 
  seen 
  in 
  other 
  states 
  with 
  drug 
  epidemics 
  in 
  which 
  pill 
  mills 
  posing 
  as 
  “pain 
  clinics” 
  were 
  
prescribing 
  opioids 
  en 
  masse 
  for 
  non 
  medical 
  purposes 
  then 
  dispensed 
  directly 
  from 
  the 
  pain 
  clinic, 
  
patients 
  were 
  drawn 
  into 
  the 
  state 
  in 
  large 
  numbers 
  from 
  surrounding 
  states 
  or 
  across 
  the 
  country 
  
for 
  opioid 
  medications, 
  and 
  criminal 
  enterprises 
  were 
  owned 
  by 
  non-­‐physicians 
  developed 
  for 
  the 
  
sole 
  purpose 
  of 
  pumping 
  out 
  opioid 
  medications 
  for 
  cash. 
   
  The 
  enormous 
  quantities 
  of 
  opioids 
  being 
  
prescribed 
  by 
  these 
  pseudo-­‐pain 
  clinics 
  with 
  coupled 
  increases 
  in 
  death 
  and 
  substance 
  abuse 
  rates 
  in 
  
Florida, 
  Kentucky, 
  Ohio, 
  Tennessee, 
  and 
  several 
  other 
  states 
  instigated 
  legislative 
  action. 
   
  But 
  in 
  
Indiana, 
  the 
  vast 
  majority 
  of 
  medical 
  board, 
  DEA, 
  and 
  state 
  police 
  actions 
  against 
  physicians 
  for 
  
inappropriate 
  opioid 
  prescribing 
  over 
  the 
  past 
  10 
  years 
  did 
  not 
  involve 
  pain 
  physicians 
  but 
  rather 
  
mainly 
  family 
  physicians 
  and 
  other 
  specialists 
  without 
  training 
  in 
  a 
  pain 
  related 
  specialty. 
   
  Generally, 
  
the 
  new 
  laws 
  adopted 
  by 
  several 
  states 
  call 
  for 
  registration 
  of 
  pain 
  clinics 
  with 
  the 
  state, 
  but 
  do 
  
nothing 
  to 
  curtail 
  errant 
  prescribing 
  by 
  family 
  physicians, 
  nurse 
  practitioners, 
   
  or 
  any 
  other 
  medical 
  
specialty 
  that 
  does 
  not 
  advertise 
  themselves 
  as 
  a 
  pain 
  clinic. 
   
  The 
  determination 
  of 
  death 
  rates 
  and 
  
cause 
  of 
  death 
  is 
  problematic 
  in 
  that 
  Indiana 
  coroners 
  and 
  physicians 
  inappropriately 
  miscode 
  opioid 
  
related 
  deaths 
  into 
  an 
  “unknown” 
  or 
  “other” 
  category 
  rather 
  than 
  the 
  designated 
  ICD-­‐10 
  code 
  for 
  
opioid 
  deaths. 
   
  For 
  instance, 
  opioid 
  death 
  coding 
  would 
  rank 
  Indiana 
  at 
  39th 
  in 
  death 
  rates 
  nationally 
  
but 
  when 
  combining 
  “other” 
  and 
  opioid 
  deaths, 
  Indiana 
  ranks 
  16th. 
   
  This 
  may 
  portend 
  a 
  need 
  for 
  
education 
  of 
  our 
  elected 
  coroners 
  and 
  physicians 
  encoding 
  death 
  certificates 
  since 
  the 
  degree 
  of 
  
miscoding 
  is 
  far 
  higher 
  in 
  Indiana 
  than 
  is 
  the 
  national 
  average. 
   
  
Direct 
  prescribing 
  of 
  opioids 
  to 
  patients 
  is 
  responsible 
  for 
  90% 
  of 
  the 
  total 
  supply 
  of 
  opioids 
  
in 
  our 
  society 
  with 
  the 
  remainder 
  obtained 
  via 
  the 
  internet 
  or 
  by 
  theft 
  from 
  pharmacies. 
   
  The 
  single 
  
major 
  issue 
  surrounding 
  opioid 
  substance 
  abuse 
  however 
  is 
  sharing 
  of 
  drugs 
  among 
  patients 
  with 
  
their 
  friends 
  and 
  families. 
   
  Once 
  the 
  medication 
  is 
  prescribed, 
  physicians 
  have 
  acted 
  on 
  good 
  faith 
  
that 
  the 
  patient 
  will 
  take 
  the 
  medication 
  for 
  their 
  own 
  use, 
  yet 
  it 
  is 
  now 
  clear 
  they 
  fail 
  to 
  do 
  so 
  
regardless 
  of 
  pain 
  agreements 
  or 
  state/federal 
  laws 
  prohibiting 
  such 
  behavior. 
   
  70% 
  of 
  initial 
  and 
  
65% 
  of 
  occasional 
  substance 
  abusers 
  of 
  prescription 
  opioids 
  obtain 
  the 
  medications 
  from 
  a 
  friend. 
   
  
Chronic 
  opioid 
  abuse 
  has 
  a 
  higher 
  incidence 
  of 
  doctor 
  shopping 
  for 
  prescription 
  opioids 
  but 
  this 
  is 
  
responsible 
  for 
  only 
  26% 
  of 
  the 
  source 
  of 
  the 
  medications. 
   
  Therefore 
  societal 
  permissiveness 
  in 
  the 
  
sharing 
  of 
  drugs 
  is 
  the 
  main 
  source 
  of 
  substance 
  abuse. 
   
   
  Patients 
  receiving 
  chronic 
  opioid 
  treatment 
  
for 
  non-­‐malignant 
  pain 
  have 
  substance 
  abuse 
  rates 
  of 
  35% 
  with 
  12% 
  having 
  severe 
  substance 
  abuse 
  
issues. 
   
  Frequently 
  they 
  migrate 
  from 
  one 
  doctor 
  to 
  another 
  once 
  they 
  are 
  dismissed 
  from 
  the 
  
medical 
  practice 
  due 
  to 
  substance 
  abuse 
  or 
  drug 
  diversion. 
   
  Referring 
  physicians 
  may 
  know 
  about 
  
this 
  behavior 
  but 
  due 
  to 
  lack 
  of 
  education 
  about 
  substance 
  abuse, 
  continue 
  to 
  refer 
  the 
  patient 
  to 
  one 
  
pain 
  clinic 
  after 
  another 
  until 
  they 
  are 
  accepted 
  for 
  opioid 
  prescribing. 
   
  Physicians 
  seeing 
  these 
  
patients 
  for 
  the 
  first 
  time 
  may 
  accept 
  records 
  directly 
  from 
  the 
  patient 
  (damaging 
  entries 
  may 
  be 
  
removed 
  by 
  the 
  patient) 
  or 
  not 
  check 
  the 
  INSPECT 
  to 
  note 
  other 
  recent 
  prescribers, 
  and 
  the 
  cycle 
  of 
  
opioid 
  prescribing/substance 
  abuse 
  begins 
  again. 
   
  A 
  particular 
  problematic 
  practice 
  is 
  that 
  of 
  
accepting 
  patients 
  and 
  prescribing 
  opioids 
  without 
  checking 
  any 
  past 
  patient 
  records 
  from 
  other 
  
physicians. 
   
  This 
  may 
  happen 
  when 
  patients 
  prevaricate 
  about 
  the 
  records 
  from 
  their 
  prior 
  physician 
  
no 
  longer 
  being 
  available. 
   
  
All 
  opioid 
  medications 
  should 
  be 
  prescribed 
  only 
  for 
  a 
  legitimate 
  medical 
  purpose, 
  but 
  the 
  
degree 
  of 
  proof 
  of 
  a 
  chronically 
  painful 
  condition 
  that 
  is 
  necessary 
  for 
  opioid 
  prescribing 
  is 
  
controversial 
  given 
  the 
  limitations 
  of 
  current 
  medical 
  science 
  to 
  determine 
  a 
  subjective 
  measure 
  or 
  
indicator 
  of 
  pain. 
   
  Chronic 
  pain 
  is 
  a 
  neurological 
  disease 
  that 
  results 
  in 
  changing 
  physiology 
  of 
  
neurons 
  at 
  the 
  spinal 
  and 
  brain 
  level, 
  yet 
  these 
  changes 
  are 
  currently 
  not 
  detectable 
  with 
  typically 
  
available 
  technologies. 
   
  Opioids 
  of 
  any 
  kind 
  may 
  be 
  abused 
  by 
  patients. 
   
  Although 
  there 
  are 
  less 
  
abusable 
  opioid 
  medications 
  (tamper 
  resistant), 
  most 
  insurers 
  cover 
  these 
  only 
  at 
  a 
  very 
  high 
  copay 
  

 cost 
  to 
  the 
  patient, 
  thereby 
  making 
  them 
  unaffordable. 
   
  State 
  insurance 
  plans 
  such 
  as 
  Medicaid 
  have 
  
rules 
  that 
  actually 
  force 
  patients 
  and 
  doctors 
  into 
  using 
  drugs 
  with 
  much 
  higher 
  abuse 
  potential 
  due 
  
to 
  arcane 
  rules 
  and 
  absurd 
  regulations 
  such 
  as 
  the 
  Indiana 
  Medicaid 
  rule 
  that 
  transdermal 
  fentanyl 
  
patches 
  are 
  covered 
  for 
  chronic 
  non-­‐malignant 
  pain 
  only 
  if 
  the 
  patient 
  cannot 
  take 
  anything 
  by 
  
mouth. 
   
  Doctors 
  are 
  forced 
  into 
  prescribing 
  short 
  acting 
  opioids 
  in 
  high 
  quantities 
  instead 
  of 
  a 
  much 
  
less 
  abusable 
  transdermal 
  patch. 
   
  The 
  high 
  quantities 
  of 
  pills 
  make 
  drug 
  sharing 
  easier 
  since 
  patients 
  
can 
  readily 
  share 
  2 
  out 
  of 
  their 
  8 
  tablets 
  per 
  day 
  whereas 
  they 
  cannot 
  easily 
  share 
  a 
  once 
  every 
  three 
  
day 
  patch. 
   
  This 
  produces 
  a 
  society 
  that 
  has 
  not 
  only 
  enough 
  medication 
  for 
  their 
  own 
  usage, 
  but 
  has 
  
plenty 
  to 
  spare 
  to 
  give 
  to 
  others 
  that 
  have 
  not 
  seen 
  physicians 
  for 
  their 
  pain 
  issues. 
   
   
  
Other 
  states 
  have 
  adopted 
  laws 
  targeting 
  clinics 
  in 
  which 
  50% 
  or 
  more 
  of 
  their 
  patients 
  
receive 
  opioids, 
  however 
  non-­‐pain 
  clinic 
  physicians, 
  PA, 
  NPs, 
  etc. 
  under 
  these 
  new 
  laws 
  may 
  continue 
  
to 
  prescribe 
  opioids 
  inappropriately 
  and 
  in 
  large 
  quantities. 
   
  Therefore 
  Indiana 
  needs 
  laws 
  that 
  
address 
  the 
  prescribing 
  of 
  opioids 
  by 
  all 
  physicians 
  and 
  non-­‐physicians 
  (now 
  constituting 
  a 
  growing 
  
38% 
  of 
  potential 
  DEA 
  registrants) 
  in 
  a 
  uniform 
  fashion 
  with 
  uniform 
  penalties 
  imposed 
  across 
  
professions. 
   
   
   
  Indiana 
  medical 
  board 
  actions 
  and 
  police 
  actions 
  regarding 
  excessive 
  or 
  inappropriate 
  
opioid 
  prescribing 
  only 
  uncommonly 
  involve 
  pain 
  physicians, 
  and 
  most 
  often 
  involved 
  family 
  
practitioners. 
   
  Yet, 
  Indiana 
  remains 
  as 
  one 
  of 
  only 
  2 
  states 
  in 
  the 
  union 
  without 
  any 
  kind 
  of 
  rules, 
  
laws, 
  or 
  regulations 
  regarding 
  opioid 
  prescribing. 
   
  We 
  are 
  in 
  need 
  of 
  these 
  rules 
  but 
  they 
  should 
  be 
  
inclusive 
  of 
  all 
  physicians 
  prescribing 
  opioids. 
   
   
  
There 
  are 
  patients 
  that 
  pose 
  particularly 
  high 
  risks 
  for 
  opioid 
  prescribing 
  such 
  as 
  those 
  
taking 
  benzodiazepines 
  (Valium, 
  Klonopin, 
  Xanax, 
  etc). 
   
  Many 
  doctors 
  fail 
  to 
  recognize 
  the 
  profound 
  
elevation 
  of 
  risk 
  that 
  comes 
  from 
  prescribing 
  these 
  drugs 
  in 
  combination 
  with 
  opioids 
  at 
  moderate 
  to 
  
high 
  doses. 
   
  Patients 
  with 
  sleep 
  apnea, 
  obesity, 
  liver 
  or 
  kidney 
  dysfunction, 
  COPD, 
  prior 
  substance 
  
abuse 
  history, 
  presence 
  of 
  illicit 
  drugs, 
  etc 
  are 
  at 
  much 
  higher 
  risk 
  of 
  overdose 
  and 
  death 
  compared 
  
to 
  those 
  without 
  these 
  features. 
   
  Yet 
  many 
  physicians 
  do 
  not 
  take 
  these 
  conditions 
  into 
  account 
  when 
  
prescribing. 
  
Patients 
  receiving 
  opioid 
  medications 
  must 
  be 
  held 
  accountable 
  for 
  securing 
  the 
  medications 
  
for 
  their 
  personal 
  use 
  only 
  and 
  following 
  the 
  laws 
  of 
  the 
  state. 
   
  Yet 
  the 
  Indiana 
  laws 
  regarding 
  
substance 
  abuse 
  and 
  diversion 
  are 
  so 
  cryptic 
  and 
  surreptitious 
  that 
  they 
  are 
  incomprehensible 
  to 
  
patients 
  and 
  prescribers 
  alike. 
   
  Crystal 
  clarity 
  on 
  these 
  laws 
  must 
  be 
  promulgated 
  to 
  patients 
  at 
  the 
  
time 
  of 
  prescribing 
  of 
  controlled 
  substances. 
  
The 
  Indiana 
  Pain 
  Society 
  has 
  many 
  recommendations 
  regarding 
  adoptions 
  of 
  potentially 
  
useful 
  laws 
  that 
  will 
  help 
  reduce 
  substance 
  abuse 
  and 
  mortality 
  yet 
  will 
  fairly 
  continue 
  to 
  permit 
  
access 
  to 
  opioid 
  prescribing 
  where 
  appropriate 
   
  The 
  Indiana 
  Pain 
  Society 
  Standards 
  for 
  Opioid 
  
Prescribing 
  are 
  listed 
  in 
  Appendix 
  F 
  and 
  these 
  are 
  suggested 
  to 
  be 
  adopted 
  as 
  the 
  fundamental 
  
framework 
  for 
  controlled 
  substance 
  prescribing 
  in 
  Indiana. 
   
   
   
  

 
  
Preamble: 
   
  The 
  use 
  of 
  opioids 
  (painkillers 
  with 
  effects 
  on 
  the 
  body 
  similar 
  to 
  opium) 
  for 
  chronic 
  
pain 
  treatment 
  is 
  common 
  in 
  the 
  US 
  and 
  in 
  Indiana, 
  yet 
  remains 
  controversial. 
   
   
  Chronic 
  pain 
  is 
  a 
  
neurobiological 
  disease 
  that 
  regardless 
  of 
  the 
  initiating 
  cause, 
  occurs 
  after 
  3-­‐6 
  months 
  of 
  daily 
  
unrelenting 
  pain 
  ultimately 
  resulting 
  in 
  changes 
  in 
  spinal 
  cord 
  neuron 
  function 
  and 
  neural 
  pathways, 
  
and 
  changes 
  to 
  the 
  brain 
  as 
  demonstrated 
  on 
  fNMR 
  and 
  PET 
  scans. 
   
  (1). 
   
   
   
  It 
  is 
  related 
  to, 
  but 
  differs 
  
significantly 
  from 
  acute 
  pain 
  that 
  serves 
  as 
  a 
  warning 
  signal 
  to 
  the 
  body 
  to 
  take 
  steps 
  to 
  avoid 
  tissue 
  
damage. 
   
  The 
  2011 
  Institute 
  of 
  Medicine 
  Report: 
  Relieving 
  Pain 
  in 
  America: 
  A 
  Blueprint 
  for 
  
Transforming 
  Prevention, 
  Care, 
  Education, 
  and 
  Research 
  notes 
  that 
  there 
  are 
  100,000,000 
  Americans 
  
affected 
  by 
  chronic 
  pain-­‐ 
  more 
  than 
  heart 
  disease, 
  cancer, 
  and 
  diabetes 
  combined. 
   
  This 
  is 
  the 
  largest 
  
single 
  health 
  issue 
  in 
  the 
  country 
  costing 
  the 
  nation 
  $635 
  billion 
  each 
  year. 
   
  There 
  are 
  many 
  
imperfect 
  methods 
  used 
  to 
  treat 
  chronic 
  pain 
  including 
  multidisciplinary 
  approaches 
  with 
  physical 
  
therapy, 
  massage, 
  psychotherapy, 
  surgery, 
  several 
  classes 
  of 
  medications, 
  acupuncture, 
  chiropractic, 
  
injection 
  therapies, 
  nerve 
  ablation, 
  spinal 
  cord 
  stimulation, 
  intrathecal 
  pump 
  medication 
  
administration, 
  and 
  a 
  variety 
  of 
  others. 
   
  Increasingly, 
  state 
  and 
  federal 
  government 
  social 
  insurance 
  
health 
  programs 
  and 
  commercial 
  insurers 
  are 
  placing 
  more 
  restrictions 
  on 
  the 
  treatment 
  of 
  chronic 
  
pain 
  that 
  are 
  not 
  supported 
  by 
  an 
  array 
  of 
  double 
  blind 
  placebo 
  controlled 
  trials, 
  even 
  in 
  the 
  absence 
  
of 
  the 
  same 
  type 
  of 
  trials 
  that 
  would 
  refute 
  their 
  effectiveness. 
   
  Evidence 
  based 
  medicine 
  processes 
  

 state 
  in 
  such 
  cases, 
  the 
  next 
  highest 
  level 
  of 
  evidence 
  is 
  to 
  be 
  evaluated, 
  however 
  commercial 
  
insurers 
  in 
  particular 
  conclude 
  incorrectly 
  that 
  without 
  double 
  blind 
  placebo 
  controlled 
  results, 
  there 
  
is 
  no 
  credible 
  evidence 
  of 
  effectiveness 
  of 
  a 
  treatment. 
  It 
  appears 
  many 
  of 
  the 
  non-­‐coverage 
  decisions 
  
on 
  therapies 
  that 
  could 
  benefit 
  millions 
  are 
  largely 
  financial 
  driven 
  by 
  stock 
  issuing 
  health 
  insurance 
  
companies, 
  rather 
  than 
  being 
  sound 
  evidence 
  based 
  medicine 
  decisions. 
   
  These 
  restrictions 
  on 
  
treatments, 
  particularly 
  new 
  treatments 
  made 
  available 
  within 
  the 
  past 
  5 
  years, 
  have 
  forced 
  more 
  
and 
  more 
  patients 
  with 
  chronic 
  pain 
  into 
  options 
  of 
  very 
  limited 
  physical 
  therapy, 
  spine 
  surgery, 
  
limited 
  injections/ablations, 
  and 
  medication 
  management. 
   
  Although 
  many 
  non-­‐opioid 
  medications 
  
and 
  treatments 
  have 
  been 
  shown 
  to 
  be 
  partially 
  effective 
  for 
  chronic 
  pain 
  treatment, 
  frequently 
  these 
  
are 
  either 
  not 
  covered 
  or 
  require 
  an 
  application 
  for 
  each 
  medicine 
  be 
  made 
  to 
  the 
  insurer 
  who 
  will 
  
then 
  decide 
  whether 
  a 
  person 
  meets 
  their 
  specific 
  criteria 
  or 
  not. 
   
  The 
  cumulative 
  effect 
  of 
  these 
  
limitations 
  on 
  care 
  have 
  actually 
  pushed 
  increasing 
  numbers 
  of 
  patients 
  into 
  opioid 
  treatments 
  as 
  
one 
  of 
  the 
  few 
  options 
  remaining 
  due 
  to 
  insurance 
  coverage 
  and 
  affordability 
  concerns. 
   
  There 
  are 
  
many 
  studies 
  demonstrating 
  short 
  term 
  effectiveness 
  of 
  opioid 
  pain 
  medications 
  in 
  the 
  treatment 
  of 
  
chronic 
  pain 
  and 
  6 
  long 
  term 
  studies, 
  although 
  none 
  are 
  randomized 
  controlled 
  trials. 
   
  Some 
  financial 
  
coverage 
  decisions 
  such 
  as 
  the 
  Medicaid 
  programs 
  restrictions 
  on 
  the 
  use 
  of 
  tamper 
  resistant 
  and 
  
abuse 
  deterrent 
  opioid 
  medications 
  that 
  are 
  either 
  not 
  covered 
  or 
  require 
  a 
  protracted 
  step 
  therapy 
  
with 
  a 
  lengthy 
  insurance 
  intermediary 
  preauthorization 
  for 
  each 
  therapy 
  have 
  actually 
  jeopardized 
  
patient 
  safety 
  through 
  forcing 
  them 
  into 
  using 
  more 
  abusable 
  and 
  dangerous 
  drugs. 
   
  
 
   
   
   
  One 
  of 
  the 
  main 
  purposes 
  of 
  medicine 
  is 
  to 
  relieve 
  suffering 
  by 
  balancing 
  the 
  risk 
  of 
  treatment 
  with 
  
the 
  risk 
  of 
  serious 
  side 
  effects. 
   
  Virtually 
  all 
  medications 
  have 
  some 
  significant 
  side 
  effects, 
  and 
  
physicians 
  prescribing 
  of 
  a 
  particular 
  medication 
  takes 
  into 
  account 
  the 
  likelihood 
  of 
  significant 
  side 
  
effects 
  based 
  on 
  the 
  patient’s 
  health 
  and 
  organ 
  function. 
   
  The 
  risk 
  is 
  a 
  shared 
  one 
  between 
  the 
  
physician 
  that 
  is 
  assumed 
  to 
  be 
  informed 
  about 
  the 
  contraindications 
  for 
  use 
  of 
  a 
  drug 
  and 
  the 
  
patient, 
  who 
  after 
  receiving 
  information 
  from 
  both 
  the 
  physician 
  and 
  pharmacist 
  about 
  the 
  
medication, 
  elects 
  to 
  take 
  it. 
   
  However 
  unlike 
  most 
  other 
  medications, 
  controlled 
  substances 
  have 
  the 
  
potential 
  for 
  substance 
  abuse, 
  overuse, 
  use 
  in 
  a 
  non-­‐medical 
  manner 
  (snorting 
  or 
  IV 
  injection 
  of 
  a 
  
pill), 
  and 
  drug 
  diversion 
  (selling 
  or 
  giving 
  away 
  the 
  medication). 
   
   
  Opioids, 
  as 
  several 
  other 
  drug 
  
classes, 
  may 
  induce 
  drug 
  overdose 
  with 
  resultant 
  respiratory 
  depression, 
  sedation, 
  disorientation, 
  
and 
  death. 
   
   
  Opioids 
  in 
  particular 
  are 
  used 
  as 
  a 
  substitute 
  for 
  illicit 
  drugs 
  and 
  have 
  a 
  particularly 
  high 
  
rate 
  of 
  abuse 
  and 
  overdose 
  death, 
  especially 
  when 
  combined 
  with 
  other 
  controlled 
  substances 
  such 
  
as 
  benzodiazepines 
  (Xanax, 
  Valium, 
  Klonopin, 
  etc). 
   
   
  It 
  is 
  acknowledged 
  the 
  increasing 
  abuse 
  of 
  opioid 
  
medications 
  results 
  in 
  significant 
  morbidity 
  and 
  mortality 
  to 
  Americans, 
  but 
  as 
  will 
  be 
  seen 
  in 
  this 
  
report, 
  most 
  of 
  the 
  substance 
  abuse 
  and 
  death 
  is 
  due 
  to 
  those 
  without 
  prescriptions 
  for 
  the 
  
medications. 
   
  Our 
  society 
  has 
  since 
  the 
  1970s 
  adopted 
  an 
  increased 
  permissiveness 
  for 
  sharing 
  of 
  
medications 
  or 
  medicating 
  others 
  with 
  their 
  own 
  medications. 
   
  Informed 
  consent 
  to 
  patients 
  may 
  
help 
  educate 
  patients, 
  but 
  in 
  and 
  of 
  itself 
  cannot 
  stop 
  the 
  free 
  wheeling 
  drug 
  sharing 
  in 
  our 
  society. 
   
  
Much 
  tighter 
  controls 
  on 
  what 
  happens 
  to 
  the 
  medications 
  after 
  prescribing 
  is 
  necessary 
  given 
  that 
  
the 
  latest 
  national 
  data 
  presented 
  in 
  this 
  report 
  show 
  39% 
  of 
  patients 
  receiving 
  medications 
  for 
  pain 
  
control 
  do 
  not 
  have 
  them 
  in 
  their 
  urine, 
  showing 
  they 
  have 
  not 
  taken 
  the 
  medications 
  for 
  many 
  days. 
   
  
This 
  is 
  a 
  cardinal 
  sign 
  of 
  substance 
  abuse, 
  overuse, 
  or 
  drug 
  diversion 
  by 
  sharing 
  or 
  giving 
  away 
  their 
  
medications. 
   
   
  Frequently 
  when 
  a 
  patient 
  with 
  such 
  a 
  drug 
  screen 
  has 
  their 
  medications 
  stopped 
  by 
  
the 
  prescribing 
  physician, 
  they 
  simply 
  move 
  on 
  to 
  the 
  next 
  family 
  doctor 
  or 
  nurse 
  practitioner 
  or 
  
pain 
  physician 
  who 
  may 
  not 
  check 
  the 
  state 
  INSPECT 
  report 
  to 
  seek 
  past 
  prescribers 
  or 
  may 
  not 
  ask 
  
for 
  past 
  medical 
  records 
  from 
  prescribers. 
   
   
  The 
  lack 
  of 
  physician 
  and 
  other 
  opioid 
  prescriber 
  
monitoring 
  (urine 
  drug 
  screens, 
  failure 
  of 
  physicians 
  to 
  require 
  past 
  medical 
  records 
  from 
  
prescribers 
  of 
  record 
  or 
  require 
  pill 
  counts 
  on 
  their 
  patients, 
  failure 
  to 
  check 
  INSPECT) 
  is 
  a 
  
contributing 
  factor 
  to 
  the 
  increased 
  availability 
  of 
  the 
  medications 
  to 
  those 
  patients 
  who 
  would 
  
abuse 
  them 
  or 
  to 
  those 
  who 
  are 
  given 
  the 
  medications 
  by 
  friends. 
   
   
  Therefore 
  a 
  higher 
  level 
  of 
  
scrutiny 
  of 
  patients, 
  control 
  of 
  medication 
  access, 
  and 
  informed 
  consent 
  is 
  necessary 
  given 
  the 
  
increased 
  risk 
  of 
  these 
  medications 
  to 
  both 
  the 
  patient 
  and 
  to 
  society. 
   
  As 
  is 
  also 
  shown 
  in 
  this 
  study, 
  
there 
  are 
  many 
  other 
  licensed 
  prescribers 
  of 
  opioid 
  medications, 
  each 
  with 
  their 
  own 
  professional 
  
board, 
  and 
  none 
  have 
  adopted 
  rules 
  on 
  opioid 
  prescribing. 
   
  Given 
  the 
  increasing 
  overlap 
  of 
  patients 
  
seeing 
  midlevel 
  providers 
  and 
  physicians, 
  it 
  is 
  necessary 
  to 
  create 
  an 
  overseeing 
  law 
  or 
  commission 
  
that 
  would 
  monitor 
  prescribing 
  by 
  all 
  entities 
  to 
  ensure 
  continuity 
  in 
  standards 
  of 
  patient 
  care. 
   
  The 
  

 Indiana 
  Pain 
  Society 
  Standards 
  are 
  found 
  in 
  Appendix 
  D 
  and 
  represent 
  the 
  most 
  comprehensive 
  
standard 
  of 
  care 
  currently 
  published 
  for 
  control 
  of 
  opioids. 
   
   
  
 
  
History 
  of 
  Opioid 
  Prescribing: 
   
  Opioids 
  (medications 
  with 
  properties 
  similar 
  to 
  opium) 
  have 
  a 
  
long 
  and 
  checkered 
  history 
  in 
  the 
  treatment 
  of 
  pain. 
   
  Opium 
  has 
  been 
  used 
  for 
  millennia 
  in 
  the 
  
treatment 
  of 
  acute 
  pain 
  and 
  was 
  readily 
  available 
  without 
  prescription 
  during 
  the 
  1700s 
  and 
  1800s 
  
in 
  the 
  US 
  in 
  the 
  form 
  of 
  the 
  opium 
  powder 
  (difficult 
  to 
  take 
  orally 
  due 
  to 
  insolubility 
  in 
  water), 
  
laudanum 
  (dissolved 
  in 
  alcohol), 
  and 
  paregoric 
  (mixed 
  with 
  camphor) 
  . 
   
  Many 
  households 
  kept 
  
opium 
  available 
  for 
  uses 
  as 
  varied 
  as 
  sedation, 
  treatment 
  of 
  diarrhea, 
  menstrual 
  cramps, 
  insomnia, 
  
and 
  of 
  course 
  pain. 
   
  Morphine, 
  one 
  of 
  the 
  constituents 
  of 
  opium 
  comprising 
  5-­‐21% 
  of 
  the 
  opium 
  latex, 
  
was 
  first 
  isolated 
  in 
  1804 
  however 
  significant 
  commercial 
  availability 
  did 
  not 
  occur 
  until 
  the 
  1827 
  
when 
  Merck 
  began 
  sales 
  of 
  the 
  drug. 
   
  It 
  was 
  used 
  only 
  orally 
  until 
  the 
  Civil 
  War, 
  during 
  which 
  time 
  it 
  
was 
  injected 
  intramuscularly 
  and 
  subcutaneous. 
   
  After 
  the 
  Civil 
  War, 
  over 
  400,000 
  soldiers 
  were 
  
dependent 
  on 
  opioids 
  and 
  returned 
  home 
  to 
  continue 
  use 
  of 
  laudanum 
  and 
  morphine, 
  both 
  of 
  which 
  
were 
  readily 
  available. 
   
   
  In 
  the 
  1880s 
  patent 
  medicines 
  became 
  very 
  popular 
  (as 
  a 
  treatment 
  for 
  
everything 
  from 
  the 
  common 
  cold 
  to 
  cardiac 
  disease-­‐ 
  most 
  contained 
  a 
  large 
  amount 
  of 
  alcohol 
  and 
  
frequently 
  morphine 
  and 
  some 
  quite 
  toxic 
  substances), 
  and 
  many 
  contained 
  opium 
  or 
  morphine, 
  but 
  
the 
  contents 
  were 
  not 
  disclosed. 
   
  The 
  patent 
  medicines 
  were 
  frequently 
  elixirs, 
  sold 
  by 
  traveling 
  
salesmen, 
  gypsies, 
  and 
  at 
  carnivals/fairs. 
   
  But 
  many 
  households 
  had 
  a 
  large 
  family 
  supply 
  of 
  
morphine 
  or 
  laudanum 
  used 
  to 
  treat 
  teething 
  children 
  or 
  even 
  hunger 
  of 
  children 
  during 
  the 
  
Industrial 
  Revolution 
  when 
  morphine 
  was 
  less 
  expensive 
  than 
  food 
  and 
  caused 
  the 
  hunger 
  pangs 
  to 
  
lessen. 
   
   
  The 
  book 
  confessions 
  of 
  an 
  Opium 
  Eater 
  brought 
  to 
  light 
  the 
  addictiveness 
  of 
  the 
  drug, 
  and 
  
morphine 
  was 
  touted 
  as 
  a 
  way 
  to 
  eradicate 
  opium 
  addiction, 
  and 
  indeed 
  was 
  very 
  successful 
  at 
  that. 
   
  
The 
  medical 
  community 
  became 
  increasingly 
  concerned 
  about 
  the 
  prospect 
  of 
  addiction 
  to 
  morphine 
  
in 
  the 
  1870s 
  and 
  1880s 
  but 
  due 
  to 
  the 
  rise 
  of 
  patent 
  medicines 
  and 
  continued 
  widely 
  available 
  
opioids, 
  the 
  medical 
  community’s 
  protests 
  had 
  little 
  effect. 
   
  Morphine 
  and 
  opium 
  were 
  sold 
  in 
  drug 
  
stores 
  without 
  a 
  prescription, 
  by 
  doctor’s 
  prescription, 
  via 
  mail 
  without 
  prescription, 
  or 
  in 
  patent 
  
medicines 
  that 
  became 
  available 
  in 
  grocery 
  stores 
  in 
  the 
  1880s. 
  Heroin 
  was 
  first 
  synthesized 
  in 
  1874 
  
but 
  was 
  not 
  sold 
  commercially 
  until 
  1898. 
   
  It 
  was 
  touted 
  by 
  Bayer 
  as 
  a 
  non-­‐addictive 
  substitute 
  for 
  
morphine 
  and 
  was 
  sold 
  in 
  Sears 
  catalogs. 
   
   
  Since 
  heroin 
  much 
  more 
  rapidly 
  crosses 
  the 
  blood 
  brain 
  
barrier 
  than 
  does 
  morphine, 
  it 
  became 
  rapidly 
  addictive, 
  and 
  sales 
  of 
  heroin 
  skyrocketed, 
  as 
  did 
  the 
  
addiction 
  rate. 
   
  It 
  was 
  estimated 
  5% 
  of 
  the 
  population 
  of 
  the 
  US 
  was 
  addicted 
  to 
  opioids 
  by 
  1900. 
   
  The 
  
temperance 
  movements 
  of 
  the 
  1880s-­‐1920 
  (targeting 
  alcohol 
  being 
  perceived 
  as 
  a 
  much 
  greater 
  
threat) 
  largely 
  left 
  opium 
  and 
  morphine 
  untouched 
  since 
  the 
  medicinal 
  properties 
  were 
  thought 
  to 
  
be 
  more 
  beneficial 
  than 
  the 
  side 
  effects 
  of 
  addiction 
  that 
  occurred 
  in 
  the 
  minority. 
   
  However 
  social 
  
changes 
  prompted 
  by 
  an 
  expose 
  on 
  patent 
  medicines 
  by 
  Samuel 
  Collins 
  Adams 
  in 
  the 
  influential 
  
Collier’s 
  Magazine 
  and 
  the 
  publication 
  of 
  “The 
  Jungle” 
  by 
  Upton 
  Sinclair 
  caused 
  Theodore 
  Roosevelt 
  
to 
  push 
  through 
  Congress 
  the 
  very 
  controversial 
  Pure 
  Food 
  and 
  Drug 
  Act 
  in 
  1906. 
   
  This 
  law 
  was 
  
created 
  " 
  For 
  preventing 
  the 
  manufacture, 
  sale, 
  or 
  transportation 
  of 
  adulterated 
  or 
  misbranded 
  or 
  
poisonous 
  or 
  deleterious 
  foods, 
  drugs, 
  medicines, 
  and 
  liquors, 
  and 
  for 
  regulating 
  traffic 
  therein, 
  and 
  for 
  
other 
  purposes." 
  and 
  established 
  the 
  Bureau 
  of 
  Chemistry 
  Department 
  of 
  Agriculture 
  as 
  the 
  
mechanism 
  to 
  determine 
  whether 
  adulteration 
  or 
  misbranding 
  of 
  patent 
  medications 
  had 
  
occurred. 
   
  Adulteration 
  was 
  defined 
  as 
  when 
  "standard 
  of 
  strength, 
  quality, 
  or 
  purity" 
  of 
  the 
  active 
  
ingredient 
  was 
  not 
  either 
  stated 
  clearly 
  on 
  the 
  label 
  or 
  listed 
  in 
  the 
  United 
  States 
  Pharmacopoeia 
  or 
  the 
  
National 
  Formulary". 
   
   
  In 
  1910 
  the 
  US 
  was 
  a 
  signatory 
  to 
  the 
  Hague 
  Opium 
  Convention 
  Treaty 
  to 
  ban 
  
the 
  spread 
  of 
  dangerous 
  narcotics 
  throughout 
  the 
  world 
  in 
  response 
  to 
  the 
  rapid 
  rise 
  of 
  heroin 
  use 
  
globally. 
   
  In 
  1912, 
  the 
  1906 
  Pure 
  Food 
  and 
  Drug 
  Act 
  was 
  strengthened 
  by 
  requiring 
  the 
  labeling 
  of 
  
drugs 
  and 
  patent 
  medicine 
  dangerous 
  ingredients. 
   
  Most 
  patent 
  medicines 
  were 
  eliminated 
  by 
  this 
  
act 
  or 
  changed 
  their 
  ingredients 
  to 
  non-­‐dangerous 
  drugs. 
  The 
  US 
  government 
  passed 
  the 
  Harrison 
  
Tax 
  Act 
  in 
  1914 
  that 
  intended 
  to 
  further 
  control 
  the 
  sale 
  of 
  narcotics 
  through 
  taxation. 
  There 
  were 
  
two 
  taxes 
  imposed: 
  one 
  on 
  physicians 
  to 
  provide 
  them 
  with 
  a 
  stamp 
  that 
  permitted 
  them 
  to 
  write 
  
prescriptions 
  as 
  long 
  as 
  they 
  stayed 
  within 
  the 
  statute 
  requirements 
  and 
  a 
  tax 
  on 
  non-­‐medical 
  use 
  of 
  
drugs. 
   
  In 
  1919 
  two 
  landmark 
  US 
  court 
  cases 
  limited 
  the 
  prescribing 
  of 
  narcotics 
  to 
  physicians 
  and 
  
permitted 
  regulation 
  of 
  narcotics 
  that 
  they 
  cannot 
  be 
  prescribed 
  to 
  addicts 
  and 
  in 
  1930 
  the 
  Bureau 
  of 
  
Narcotics 
  and 
  Dangerous 
  Drugs 
  (BNDD) 
  was 
  formed. 
   
  The 
  cumulative 
  effect 
  of 
  these 
  laws 
  caused 
  a 
  

 reduction 
  in 
  the 
  availability 
  of 
  opioids 
  throughout 
  the 
  1920s 
  and 
  1930s 
  until 
  the 
  repeal 
  of 
  
prohibition 
  in 
  1933. 
   
  At 
  that 
  time, 
  former 
  bootleggers 
  turned 
  to 
  running 
  narcotics 
  since 
  their 
  services 
  
were 
  no 
  longer 
  needed 
  in 
  the 
  alcohol 
  industry. 
   
  Thus, 
  in 
  the 
  mid 
  1930s, 
  illicit 
  sale 
  of 
  opioids 
  spiked 
  
and 
  lasted 
  until 
  World 
  War 
  II. 
   
  In 
  1946, 
  federal 
  prisoners 
  volunteered 
  for 
  a 
  morphine 
  addiction 
  study 
  
that 
  demonstrated 
  rapid 
  addiction 
  with 
  morphine 
  over 
  6 
  weeks 
  (Miami 
  News 
  Jan 
  18, 
  1946 
  page 
  
14a). 
   
   
  The 
  medical 
  community 
  severely 
  curtailed 
  the 
  usage 
  of 
  opioids 
  in 
  all 
  except 
  acute 
  pain 
  or 
  
cancer 
  pain 
  from 
  this 
  point 
  on 
  until 
  the 
  late 
  1970s 
  largely 
  due 
  to 
  these 
  observations. 
   
  The 
  Dangerous 
  
Substance 
  Act 
  was 
  passed 
  in 
  1969 
  and 
  had 
  the 
  effect 
  to 
  initiate 
  the 
  “Schedules” 
  of 
  how 
  addictive 
  
drugs 
  are, 
  determined 
  if 
  they 
  are 
  for 
  non-­‐medical 
  use, 
  and 
  separated 
  out 
  the 
  criminal 
  penalties 
  based 
  
on 
  the 
  schedule 
  or 
  drug. 
   
  Heroin 
  use 
  spiked 
  in 
  the 
  mid 
  60s 
  through 
  the 
  late 
  1970s 
  with 
  many 
  Viet 
  
Nam 
  vets 
  becoming 
  addicted 
  to 
  it 
  while 
  in 
  Indochina. 
   
  The 
  rise 
  of 
  the 
  drug 
  culture 
  in 
  the 
  US 
  in 
  the 
  mid 
  
1970s 
  paralleled 
  an 
  increase 
  in 
  permissiveness 
  with 
  drug 
  experimentation, 
  however 
  the 
  medical 
  
community 
  continued 
  to 
  hold 
  firm 
  against 
  widespread 
  use 
  of 
  opioids 
  for 
  chronic 
  non-­‐malignant 
  pain, 
  
and 
  in 
  many 
  cases, 
  malignant 
  pain. 
   
  MS 
  Contin, 
  a 
  potent 
  form 
  of 
  sustained 
  release 
  morphine 
  was 
  
introduced 
  in 
  1984 
  by 
  Purdue 
  Frederick 
  and 
  became 
  very 
  popular 
  for 
  the 
  treatment 
  of 
  cancer 
  pain 
  
bolstered 
  by 
  the 
  World 
  Health 
  Organization 
  development 
  of 
  a 
  cancer 
  pain 
  treatment 
  ladder 
  in 
  1986. 
   
  
Sales 
  of 
  the 
  drug 
  exceeded 
  $475 
  million 
  over 
  the 
  next 
  decade. 
   
  Pain 
  clinics 
  of 
  the 
  1980s 
  were 
  rare, 
  
and 
  were 
  mostly 
  multidisciplinary 
  employing 
  epidural 
  steroids, 
  trigger 
  point 
  injections, 
  and 
  only 
  
occasionally 
  high 
  dose 
  opioids. 
   
  Pain 
  education 
  advanced 
  with 
  the 
  development 
  of 
  pain 
  fellowships 
  in 
  
1991 
  and 
  board 
  certifications 
  in 
  pain 
  by 
  1994. 
   
  In 
  1995 
  Oxycontin 
  was 
  approved 
  by 
  the 
  FDA 
  and 
  in 
  
1996, 
  the 
  American 
  Pain 
  Society 
  and 
  American 
  Academy 
  of 
  Pain 
  Medicine 
  developed 
  a 
  joint 
  
statement 
  condoning 
  the 
  use 
  of 
  opioids 
  for 
  chronic 
  non-­‐malignant 
  pain. 
   
   
  In 
  1997 
  the 
  American 
  
Society 
  of 
  Anesthesiology 
  published 
  “Practice 
  Guidelines 
  for 
  Chronic 
  Pain 
  Management”. 
   
   
   
  Oxycontin 
  
after 
  this 
  point 
  was 
  marketed 
  very 
  heavily 
  for 
  use 
  in 
  the 
  treatment 
  of 
  non-­‐malignant 
  pain. 
   
  Part 
  of 
  the 
  
company’s 
  education 
  strategy 
  included 
  luxury 
  junkets 
  for 
  doctors 
  that 
  minimalized 
  the 
  addictiveness 
  
of 
  the 
  drug 
  (a 
  1998 
  promotional 
  video 
  by 
  Purdue 
  stated 
  the 
  addictiveness 
  was 
  much 
  less 
  than 
  1%) 
  
(3) 
  and 
  promoted 
  the 
  concept 
  of 
  “pseudoaddiction”, 
  and 
  the 
  lack 
  of 
  a 
  ceiling 
  on 
  opioid 
  prescribing. 
   
  
Pseudoaddiction 
  was 
  a 
  concept 
  based 
  on 
  a 
  literature 
  report 
  of 
  a 
  single 
  patient 
  in 
  1989 
  with 
  leukemia 
  
that 
  seemed 
  to 
  have 
  substance 
  abuse 
  issues 
  that 
  were 
  solved 
  by 
  increasing 
  the 
  dosages 
  of 
  opioid. 
   
  
One 
  of 
  the 
  authors 
  later 
  became 
  the 
  senior 
  medical 
  director 
  for 
  Purdue, 
  the 
  manufacturer 
  of 
  
Oxycontin. 
   
  Marketing 
  of 
  Oxycontin 
  was 
  not 
  confined 
  to 
  pain 
  physicians 
  but 
  was 
  also 
  marketed 
  to 
  
surgeons 
  for 
  use 
  in 
  post 
  operative 
  pain 
  control 
  and 
  to 
  general 
  family 
  practice 
  physicians/internists 
  
for 
  treatment 
  of 
  chronic 
  non-­‐malignant 
  pain. 
   
  By 
  2000, 
  half 
  the 
  physicians 
  prescribing 
  the 
  drug 
  were 
  
family 
  physicians, 
  with 
  little 
  or 
  no 
  training 
  in 
  pain 
  management. 
   
  Purdue 
  manipulated 
  the 
  graphs 
  of 
  
blood 
  level 
  vs 
  time 
  and 
  presented 
  these 
  in 
  a 
  different 
  way 
  than 
  any 
  other 
  opioid 
  manufacturer 
  and 
  
different 
  than 
  its 
  own 
  graphs 
  of 
  the 
  same 
  values 
  for 
  MS 
  Contin. 
   
  Purdue 
  used 
  a 
  log 
  scale 
  of 
  blood 
  level 
  
vs 
  time 
  presentation 
  that 
  flattened 
  the 
  curves 
  significantly, 
  making 
  it 
  appear 
  as 
  though 
  the 
  drug 
  
worked 
  for 
  12 
  hours. 
   
  When 
  it 
  became 
  apparent 
  the 
  drug 
  only 
  worked 
  8 
  hours, 
  Purdue’s 
  solution 
  was 
  
to 
  increase 
  the 
  dosage 
  (since 
  they 
  were 
  locked 
  into 
  a 
  set 
  prescribing 
  frequency 
  as 
  specified 
  as 
  every 
  
12 
  hours 
  in 
  their 
  IND 
  application 
  to 
  the 
  FDA) 
  rather 
  than 
  the 
  frequency 
  as 
  is 
  recommended 
  with 
  
other 
  drugs, 
  thereby 
  resulting 
  in 
  higher 
  peak 
  blood 
  levels 
  of 
  the 
  drug. 
  As 
  drug 
  sales 
  soared, 
  so 
  did 
  the 
  
per 
  capita 
  death 
  rate, 
  number 
  of 
  ER 
  visits 
  and 
  hospital 
  admissions 
  due 
  to 
  overdose, 
  rehabilitation 
  
center 
  admissions, 
  pharmacy 
  robberies, 
  and 
  theft. 
  Oxycontin 
  sales 
  in 
  the 
  US 
  increased 
  from 
  a 
  recent 
  
low 
  of 
  680 
  million 
  dollars 
  in 
  2006 
  during 
  a 
  federal 
  investigation 
  of 
  Purdue 
  to 
  3.55 
  billion 
  dollars 
  in 
  
2010. 
   
  Ironically, 
  the 
  sales 
  of 
  suboxone, 
  a 
  drug 
  used 
  to 
  treat 
  addiction 
  in 
  part 
  due 
  to 
  Oxycontin 
  has 
  
increased 
  820% 
  during 
  the 
  same 
  period 
  to 
  1.16 
  billion 
  dollars. 
   
  The 
  increase 
  in 
  use 
  of 
  prescription 
  
opioid 
  abuse 
  and 
  death 
  is 
  clearly 
  linked 
  to 
  prescribing 
  of 
  these 
  opioids, 
  but 
  as 
  will 
  be 
  shown 
  below 
  is 
  
mainly 
  due 
  to 
  a 
  stunning 
  increase 
  in 
  permissiveness 
  of 
  society 
  with 
  respect 
  to 
  drug 
  sharing. 
   
   
  
 
  

Cause 
  of 
  Death 
  Determination: 
   
  Statistics 
  on 
  escalating 
  numbers 
  of 
  deaths 
  from 
  opioids 
  have 
  
been 
  sensationally 
  trumpeted 
  in 
  the 
  press 
  by 
  the 
  CDC, 
  state 
  attorney 
  generals, 
  law 
  enforcement, 
  and 
  
the 
  medical 
  community, 
  however 
  frequently 
  these 
  statistics 
  are 
  neither 
  well 
  explained 
  nor 
  are 
  
relevant 
  to 
  opioid 
  induced 
  deaths 
  from 
  prescription 
  drugs. 
   
  Many 
  of 
  the 
  quoted 
  statistics 
  by 
  CDC 
  
publications 
  frequently 
  mix 
  several 
  types 
  of 
  incongruent 
  data 
  within 
  the 
  same 
  publication 
  in 
  order 
  to 
  
amplify 
  their 
  points 
  about 
  prescription 
  drug 
  abuse 
  due 
  to 
  opioids. 
   
  There 
  exists 
  a 
  dizzying 
  array 
  of 
  

 CDC 
  metrics 
  to 
  measure 
  death 
  rates 
  that 
  have 
  several 
  definitions, 
  and 
  to 
  make 
  matters 
  worse, 
  the 
  
definitions 
  have 
  changed 
  over 
  time. 
   
  Until 
  1999, 
  the 
  CDC 
  and 
  National 
  Vital 
  Statistics 
  Bureau 
  of 
  the 
  
CDC 
  used 
  ICD-­‐9 
  E 
  code 
   
  definitions 
  for 
  mortality. 
   
  The 
  codes 
  and 
  definitions 
  changed 
  in 
  1999 
  with 
  the 
  
adoption 
  of 
  ICD-­‐10 
  codes 
  X 
  and 
  Y. 
   
   
  For 
  example: 
   
  
 
  
Prescription 
  Drug 
  Death 
  Codes 
  used 
  by 
  the 
  CDC 
  and 
  National 
  Vital 
  Statistics 
  System 
  
 
  
Prescription 
  Drug 
  
Unintentional 
  
Suicide 
  
Indeterminate 
  
Deaths 
  
ICD 
  9 
  (used 
  before 
  
E850-­‐858 
  
E950.0-­‐950.5 
  
E980.0-­‐980.5 
  
1999) 
  
ICD 
  10 
  (used 
  1999 
  and 
  
X40-­‐44 
  
X60-­‐64 
  
Y10-­‐14 
  
thereafter 
  
 
  
Current ICD 10 Accidental Poisoning Codes: X40-44 Accidental Drug
Poisoning
X40: 
  Accidental 
  poisoning 
  by 
  and 
  exposure 
  to 
  nonopioid 
  analgesics, 
  antipyretics 
  and 
  antirheumatics 
  
X41: 
  Accidental 
  poisoning 
  by 
  and 
  exposure 
  to 
  antiepileptic, 
  sedative-­‐hypnotic, 
  antiparkinsonism 
  and 
  
psychotropic 
  drugs, 
  not 
  elsewhere 
  classified 
  (includes 
  antidepressants, 
  barbituates, 
  hydantoin 
  drugs, 
  
neuroleptics, 
  psychostimulants, 
  tranquillizers) 
  
X42: 
  Accidental 
  poisoning 
  by 
  and 
  exposure 
  to 
  narcotics 
  and 
  psychodysleptics 
  [hallucinogens], 
  not 
  
elsewhere 
  classified 
  (includes 
  codeine, 
  morphine, 
  heroin, 
  cocaine, 
  LSD, 
   
  
X43: 
  Accidental 
  poisoning 
  by 
  and 
  exposure 
  to 
  other 
  drugs 
  acting 
  on 
  the 
  autonomic 
  nervous 
  system 
  
X44: 
  Accidental 
  poisoning 
  by 
  and 
  exposure 
  to 
  other 
  and 
  unspecified 
  drugs, 
  medicaments 
  and 
  
biological 
  substances 
  
There 
  are 
  additional 
  codes 
  used 
  for 
  non-­‐prescription 
  accidental 
  drug 
  related 
  deaths 
  in 
  all 
  three 
  
categories 
  for 
  instance 
  accidental 
  alcohol 
  poisoning 
  (X45), 
  accidental 
  death 
  due 
  to 
  organic 
  solvents 
  
and 
  halogenated 
  hydrocarbons 
  and 
  their 
  vapors 
  (X46 
  benzene, 
  chlorofluorocarbons), 
  accidental 
  
poisoning 
  due 
  to 
  exposure 
  to 
  other 
  gases 
  and 
  vapors 
  (X47 
  carbon 
  monoxide, 
  tear 
  gas, 
  nitrogen 
  
oxides), 
  accidental 
  exposure 
  due 
  to 
  pesticides 
  (X48), 
  accidental 
  poisoning 
  by 
  other 
  and 
  unspecified 
  
chemicals 
  and 
  noxious 
  substances 
  (X49 
  glues, 
  adhesives, 
  paints, 
  acids 
  and 
  alkali, 
  metals). 
   
  Finally 
  
there 
  specific 
  drugs 
  involved 
  in 
  death 
  using 
  T 
  codes 
  (T40.0 
  opium, 
  T40.1 
  heroin, 
  T40.2 
  other 
  opioids, 
  
T40.3 
  methadone, 
  T40.4 
  synthetic 
  opioids 
  excluding 
  methadone, 
  T40.5 
  cocaine, 
  T40.6 
  unspecified 
  
narcotics, 
  T40.7 
  cannibis, 
  T40.8 
  LSD, 
  T40.9 
  unspecified 
  psychodysleptics 
  and 
  hallucinogens). 
   
  The 
  
T40.2 
  include 
  semisynthetics 
  (oxycodone, 
  hydrocodone, 
  oxymorphone, 
  hydromorphone) 
  and 
  
morphine/codeine. 
   
  The 
  T40.3 
  is 
  methadone 
  and 
  T40.4 
  includes 
  buprenorphine, 
  meperidine, 
  
fentanyl, 
  etc. 
   
  
 
  

UNDERLYING 
  CAUSE 
  OF 
  DEATH 
  TERMS 
  

CDC 
  TERM 
  POISONING: 
   
  includes 
  codes 
  X40-­‐49 
  (accidental) 
  plus 
  X60-­‐69 
  (suicide) 
  plus 
  Y10-­‐19 
  
(indeterminate) 
  plus 
  assault 
  with 
  a 
  drug 
  causing 
  death 
  (X85). 
   
  
CDC 
  TERM 
  ACCIDENTAL 
  (Unintentional) 
  POISONING: 
  includes 
  codes 
  X40-­‐49 
  
CDC 
  TERM 
  PRESCRIPTION 
  DRUG 
  POISONING: 
  includes 
  codes 
  X40-­‐44, 
  X60-­‐64, 
  and 
  Y10-­‐14 
  
CDC 
  TERM 
  ACCIDENTAL 
  (Unintentional) 
  PRESCRIPTION 
  DRUG 
  POISONING: 
  includes 
  codes 
  X40-­‐44 
  
CDC 
  TERM 
  ACCIDENTAL 
  (Unintentional) 
  NARCOTIC 
  OR 
  PSYCHODYSLEPTIC 
  POISONING: 
  code 
  X42 
  
(includes 
  illicit 
  drugs) 
  
CDC 
  TERM 
  ACCIDENTAL 
  (Unintentional) 
  OPIOID 
  POISONING: 
  code 
  T40.0, 
  T40.1, 
  T40.2, 
  T40.4, 
  T40.4 
  
CDC 
  TERM 
  ACCIDENTAL 
  (Unintentional) 
  PRESCRIPTION 
  OPIOID 
  POISONING: 
  code 
  T40.2, 
  T40.3, 
  T40.4 
  
 
  
There 
  are 
  many 
  different 
  accidental 
  deaths 
  and 
  total 
  drug 
  death 
  descriptions 
  as 
  above. 
   
   
  The 
  accuracy 
  
of 
  the 
  encoding 
  of 
  this 
  data 
  depends 
  both 
  on 
  the 
  physician 
  of 
  records 
  signing 
  the 
  death 
  certificate 
  and 
  
any 
  coroner’s 
  evaluation 
  of 
  the 
  cause 
  of 
  death. 
   
  Inaccurate 
  encoding 
  appears 
  to 
  be 
  a 
  huge 
  problem 
  

 nationwide, 
  whether 
  it 
  is 
  due 
  to 
  a 
  coroner 
  or 
  physician. 
   
   
  The 
  X42 
  code 
  is 
  used 
  for 
  opioid 
  narcotic 
  
deaths 
  and 
  should 
  include 
  prescription 
  opioids. 
   
  However, 
  many 
  encoders 
  on 
  death 
  certificates 
  
inappropriately 
  use 
  X44 
  that 
  means 
  “Other 
  and 
  unspecified” 
  when 
  there 
  are 
  opioid 
  narcotic 
  deaths. 
   
   
  
This 
  inappropriate 
  coding 
  means 
  the 
  true 
  number 
  of 
  opioid 
  narcotic 
  deaths 
  are 
  unknown. 
   
  Specific 
  T 
  
codes 
  may 
  not 
  be 
  available 
  or 
  lab 
  testing 
  not 
  performed 
  to 
  determine 
  a 
  class 
  of 
  agents 
  as 
  a 
  causation 
  
of 
  death. 
   
   
  The 
  use 
  of 
  the 
  X44 
  codes 
  by 
  physicians 
  signing 
  the 
  death 
  certificates 
  and 
  by 
  coroners 
  
varies 
  widely 
  throughout 
  the 
  country 
  and 
  averages 
  50% 
  of 
  the 
  total 
  number 
  of 
  X40-­‐44 
  codes 
  
nationwide 
  for 
  the 
  year 
  2009. 
   
  In 
  North 
  Carolina, 
  that 
  uses 
  a 
  medical 
  examiner 
  system 
  rather 
  than 
  an 
  
elected 
  coroner 
  system, 
  the 
  inappropriate 
  coding 
  is 
  only 
  19%, 
  Illinois 
  is 
  22%, 
  Oregon 
  23%, 
  and 
  
Massachusetts 
  is 
  24%. 
   
  At 
  the 
  other 
  end 
  of 
  the 
  spectrum 
  is 
  Arkansas 
  79%, 
  New 
  Jersey 
  79%, 
  Louisiana 
  
75%, 
  and 
  Kentucky 
  at 
  74%. 
   
   
   
  Over 
  the 
  past 
  decade 
  North 
  Carolina 
  is 
  the 
  lowest 
  in 
  inappropriate 
  
coding 
  at 
  16.7% 
  while 
  Mississippi 
  tops 
  the 
  list 
  at 
  71.9%. 
   
  This 
  nearly 
  5 
  fold 
  difference 
  in 
  
inappropriate 
  coding 
  may 
  be 
  due 
  to 
  differences 
  in 
  laws 
  requiring 
  coroner 
  interventions 
  in 
  drug 
  
poisonings, 
  lack 
  of 
  available 
  education 
  in 
  appropriate 
  poison 
  coding 
  by 
  coroners 
  and 
  physicians, 
  
unavailability 
  of 
  lab 
  access, 
  inappropriate 
  coding 
  of 
  suicides 
  as 
  accidental 
  deaths, 
  inappropriate 
  
interpretation 
  of 
  lab 
  data, 
  lack 
  of 
  funding 
  for 
  lab 
  analysis 
  or 
  autopsies, 
  or 
  insouciance 
  of 
  physicians 
  
and 
  coroners 
  with 
  the 
  lack 
  of 
  a 
  meaningful 
  effort 
  to 
  discover 
  the 
  cause 
  of 
  death. 
   
  For 
  the 
  years 
  1999-­‐
2009, 
  Indiana 
  ranks 
  7th 
  worst 
  in 
  the 
  US 
  in 
  miscoding 
  at 
  70.4%. 
   
   
  In 
  Bartholomew 
  county 
  Indiana, 
  
during 
  the 
  same 
  period 
  inappropriate 
  coding 
  occurred 
  over 
  90% 
  of 
  the 
  time 
  making 
  it 
  one 
  of 
  the 
  
highest 
  in 
  the 
  country. 
   
  Discussions 
  with 
  the 
  assistant 
  coroner 
  made 
  it 
  clear 
  when 
  there 
  is 
  any 
  doubt, 
  
the 
  X44 
  code 
  is 
  preferentially 
  used, 
  and 
  that 
  there 
  is 
  no 
  standard 
  or 
  guideline 
  for 
  this 
  coding. 
   
  Indiana 
  
ranks 
   
  The 
  entire 
  list 
  of 
  states 
  coding 
  appropriateness 
  is 
  included 
  in 
  appendix 
  E. 
   
  Regardless 
  of 
  the 
  
reason 
  of 
  inappropriate 
  coding, 
  it 
  makes 
  data 
  interpretation 
  less 
  accurate, 
  however 
  one 
  may 
  draw 
  
some 
  inferences 
  based 
  on 
  statistical 
  analysis. 
  
• The 
  average 
  X40, 
  41,and 
  43 
  values 
  are 
  only 
  4% 
  of 
  the 
  total 
  of 
  the 
  X40-­‐44 
  group. 
  
• It 
  is 
  likely 
  that 
  given 
  these 
  values 
  are 
  so 
  small 
  that 
  the 
  opioids 
  indeed 
  are 
  the 
  major 
  
contributing 
  cause 
  of 
  death 
  in 
  the 
  X40-­‐44 
  group 
  since 
  cocaine 
  death 
  and 
  heroin 
  death 
  rates 
  
(included 
  in 
  X42) 
  have 
  been 
  stable 
  or 
  declining 
  over 
  the 
  past 
  several 
  years 
   
  
 
  
To 
  make 
  matters 
  even 
  worse, 
  a 
  few 
  states, 
  namely 
  Maryland 
  and 
  Utah, 
  lack 
  the 
  ability 
  to 
  determine 
  
which 
  deaths 
  are 
  accidental 
  and 
  which 
  are 
  intentional. 
   
  More 
  than 
  85% 
  of 
  the 
  time, 
  Maryland 
  codes 
  
the 
  deaths 
  as 
  of 
  unknown 
  intent 
  compared 
  to 
  15% 
  for 
  the 
  national 
  average. 
   
  However, 
  most 
  coroners 
  
and 
  medical 
  examiners 
  throughout 
  the 
  US 
  (including 
  Indiana) 
  are 
  indeed 
  competent 
  enough 
  to 
  
determine 
  the 
  intent 
  of 
  the 
  death 
  (accidental, 
  suicide) 
  in 
  that 
  vast 
  majority 
  of 
  drug 
  poisoning 
  death. 
   
  
 
  

OPIOID 
  DRUG 
  OVERDOSE 
  MORTALITY 
  AND 
  MORBIDITY 
  
 
  
US 
  Drug 
  Related 
  Mortality: 
   
   
  
Poisoning 
  is 
  the 
  CDC 
  and 
  National 
  Vital 
  Statistics 
  System 
  term 
  used 
  to 
  describe 
  any 
  drug, 
  chemical, 
  
gas, 
  or 
  biological 
  agent 
  resulting 
  in 
  death. 
   
  Poisonings 
  are 
  typically 
  accidental 
  (76%), 
  suicide 
  (15%), 
  
indeterminant 
  9%, 
  and 
  homicide/assault 
  (<1/2 
  of 
  1%). 
   
   
  Drug 
  poisoning 
  refers 
  to 
  poisoning 
  death 
  by 
  
all 
  types 
  of 
  prescription 
  drugs, 
  OTC 
  drugs, 
  and 
  illicit 
  drugs. 
   
  These 
  are 
  derived 
  directly 
  from 
  CDC 
  data. 
   
  
The 
  prescription 
  opioid 
  deaths 
  are 
  not 
  available 
  nationally 
  via 
  the 
  CDC 
  system 
  and 
  are 
  estimated 
  
based 
  on 
  state 
  system 
  searches. 
   
   
  Accidental 
  prescription 
  drug 
  overdose 
  deaths 
  constitute 
  
approximately 
  39% 
  of 
  all 
  drug 
  poisoning 
  deaths 
  in 
  the 
  US. 
   
  The 
  estimated 
  poisonings 
  are 
  derived 
  
from 
  CDC 
  T 
  code 
  data. 
  

  
  
 
  
The 
  death 
  rates 
  have 
  escalated 
  significantly 
  beginning 
  in 
  1990 
  per 
  100,000 
  population 
  for 
  
poisonings, 
  drug 
  poisonings, 
  and 
  narcotics. 
   
   
  In 
  the 
  graph 
  below, 
  the 
  lower 
  graph 
  of 
  Unintentional 
  
Narcotic 
  and 
  Psychodysleptic 
  Poisonings 
  closely 
  approximates 
  the 
  number 
  of 
  prescription 
  opioid 
  
deaths 
  in 
  a 
  correlation 
  study 
  conducted 
  by 
  IPS. 
   
  Specific 
  drug 
  death 
  numbers 
  for 
  individual 
  opioids 
  
are 
  also 
  rising 
  with 
  most 
  opioid 
  deaths 
  rising 
  3 
  fold 
  between 
  1999 
  and 
  2008 
  and 
  methadone 
  rising 
  6 
  
fold 
  during 
  the 
  same 
  time 
  period. 
   
  Oxycodone 
  is 
  associated 
  with 
  the 
  highest 
  number 
  of 
  deaths 
  
currently. 
  In 
  the 
  figure 
  below, 
  Poisonings 
  include 
  suicides, 
  homicides, 
  and 
  unintentional 
  from 
  drugs, 
  
chemicals, 
  gases, 
  biologics, 
  and 
  alcohol. 
   
  Drug 
  Poisonings 
  include 
  suicides, 
  homicides, 
  and 
  
unintentional 
  (accidental) 
  from 
  the 
  use 
  of 
  illicit 
  and 
  prescription 
  drugs. 
   
  Unintentional 
  Drug 
  
Poisoning 
  includes 
  prescription 
  drugs 
  and 
  illicits 
  with 
  exclusion 
  of 
  suicide 
  and 
  homicide. 
   
  As 
  can 
  be 
  
seen 
  above, 
  the 
  unintentional 
  opioid 
  death 
  rate 
  is 
  only 
  a 
  fraction 
  of 
  the 
  prescription 
  drug 
  deaths 
  or 
  
poisonings. 
   
  However, 
  this 
  fraction 
  is 
  most 
  likely 
  artificially 
  low 
  due 
  to 
  coroners 
  use 
  of 
  the 
  X44 
  code 
  
(unspecified 
  accidental 
  drug 
  death). 
   
  When 
  the 
  data 
  is 
  analyzed 
  in 
  detail, 
  most 
  of 
  these 
  drug 
  deaths 
  
probably 
  belong 
  in 
  the 
  opioid 
  prescription 
  drug 
  death 
  column 
  but 
  are 
  miscoded 
  due 
  to 
  either 
  lack 
  of 
  
lab 
  data, 
  inability 
  of 
  coroners 
  to 
  interpret 
  the 
  data, 
  or 
  lack 
  of 
  training 
  of 
  coroners. 
  The 
  prescription 
  
opioid 
  death 
  rate 
  has 
  increased 
  by 
  1300% 
  since 
  1990 
  and 
  overall 
  prescription 
  drug 
  death 
  rate 
  by 
  
1000% 
  since 
  that 
  time. 
   
   
  Although 
  the 
  rates 
  for 
  all 
  measures 
  appear 
  to 
  be 
  on 
  the 
  decline 
  since 
  2008 
  
(based 
  on 
  final 
  2009 
  data 
  and 
  preliminary 
  2010 
  data), 
  the 
  overall 
  death 
  rate 
  from 
  opioids 
  is 
  still 
  
significant. 
   
   
   
  The 
  suicide 
  rates 
  from 
  drugs 
  (included 
  in 
  rates 
  reflected 
  in 
  the 
  blue 
  and 
  red 
  graph) 
  have 
  
been 
  relatively 
  constant, 
  ranging 
  from 
  1.7-­‐2.1 
  per 
  100,000 
  over 
  the 
  past 
  two 
  decades, 
  so 
  the 
  suicide 
  
overdose 
  rate 
  has 
  not 
  significantly 
  increased 
  due 
  to 
  the 
  availability 
  of 
  prescription 
  opioids. 
   
   
   
  
 
  
The 
  figure 
  below 
  depicts 
  US 
  poisoning 
  death 
  rates 
  from 
  different 
  causes 
  as 
  constructed 
  by 
  the 
  
Indiana 
  Pain 
  Society, 
  using 
  the 
  best 
  available 
  data 
  from 
  WONDER 
  system 
  CDC 
  database 
  searches, 
  
print 
  publications, 
  and 
  estimates 
  for 
  2010 
  data 
  based 
  on 
  preliminary 
  data 
  published 
  by 
  the 
  CDC. 
   
  
 
  

 
  

  
  
 
  
 
  
However, 
  one 
  must 
  keep 
  the 
  mortality 
  rates 
  in 
  perspective 
  to 
  the 
  impact 
  on 
  overall 
  mortality 
  in 
  the 
  
US. 
   
  The 
  chart 
  below 
  shows 
  US 
  Causes 
  of 
  Death 
  by 
  Percentage 
  for 
  2010 
  for 
  various 
  causes 
  obtained 
  
from 
  the 
  National 
  Vital 
  Statistics 
  Data. 
   
  The 
   
  ICD10 
  X42 
  (unintentional 
  opioid 
  and 
  psychodysleptics 
  ) 
  
death 
  rate 
  (includes 
  prescription 
  drugs, 
  heroin, 
  hallucinogens) 
  is 
  0.54% 
  of 
  the 
  total 
  death 
  causes 
  in 
  
the 
  US, 
  and 
  if 
  prescription 
  opioids 
  alone 
  are 
  used, 
  that 
  figure 
  drops 
  even 
  lower. 
   
  The 
  ICD10 
  X42 
  death 
  
rate 
  (unintentional 
  opioids 
  and 
  psychodysleptic 
  deaths) 
  per 
  100,000 
  people 
  is 
  4.0 
  for 
  the 
  US 
  while 
  
the 
  motor 
  vehicle 
  accident 
  rate 
  is 
  12.9/100,000, 
  alcohol 
  caused 
  deaths 
  are 
  7.4/100,000, 
  and 
  
cigarettes 
  kill 
  146/100,000. 
   
  
 
  
 
  

 
  

  
  
 
  
 
  

Indiana 
  Drug 
  Mortality 
  Rates 
  
 
  
On 
  first 
  glance 
  of 
  the 
  data 
  regarding 
  state 
  by 
  state 
  mortality 
  rates 
  using 
  the 
  CDC 
  ICD10 
  code 
  X42 
  
(accidental 
  poisoning 
  deaths 
  due 
  to 
  narcotics 
  and 
  psychodysleptics) 
  Indiana 
  fares 
  very 
  well 
  
compared 
  to 
  other 
  states. 
   
  Using 
  that 
  metric, 
  Indiana 
  ranks 
  39th 
  in 
  narcotic 
  and 
  psychodysleptic 
  
mortality 
  per 
  100,000 
  population 
  for 
  2009 
  (as 
  seen 
  in 
  the 
  graph 
  below). 
   
  This 
  was 
  obtained 
  from 
  an 
  
Indiana 
  Pain 
  Society 
  CDC 
  Wonder 
  search 
  calculation 
  for 
  2009, 
  the 
  last 
  year 
  complete 
  data 
  is 
  available 
  
using 
  the 
  search 
  parameter 
  ICD10 
  code 
  X42, 
  “Accidental 
  Poisoning 
  Deaths 
  Narcotics 
  and 
  
psychodysleptics”. 
   
  
 
  
 
  
 
  

 
  

  
  
 
  
 
  

However, 
  due 
  to 
  a 
  high 
  rate 
  of 
  improper 
  coding 
  of 
  X42 
  deaths 
  by 
  Indiana 
  physicians 
  and 
  coroners 
  as 
  
the 
  more 
  generalized 
  unspecified 
  code 
  X44, 
   
  the 
  true 
  death 
  rate 
  due 
  to 
  prescription 
  opioids 
  is 
  much 
  
higher 
  than 
  in 
  the 
  graph 
  above. 
   
  When 
  one 
  evaluates 
  the 
  accidental 
  drug 
  poisonings 
  that 
  includes 
  the 
  
X40-­‐44 
  code, 
  a 
  different 
  picture 
  emerges 
  as 
  shown 
  in 
  the 
  graph 
  below. 
   
  Using 
  this 
  metric, 
  Indiana 
  is 
  
ranked 
  19th 
  in 
  the 
  US 
  with 
  the 
  latest 
  data 
  available 
  show 
  Indiana 
  now 
  surpasses 
  the 
  national 
  average 
  
death 
  rate 
  due 
  to 
  accidental 
  poisoning. 
   
   
  

 
  

  
  

 
  

The 
  various 
  poisoning 
  death 
  rate 
  metrics 
  as 
  applied 
  to 
  Indiana 
  are 
  shown 
  below: 
   
  Poison 
  Death 
  Rates 
  
(from 
  all 
  chemicals, 
  unintentional+suicide+homicide), 
  Drug 
  Death 
  Rates 
  (from 
  all 
  drugs, 
  
unintentional+suicide+homicide), 
  Unintentional 
  Poison 
  Rates 
  (chemicals 
  and 
  drugs), 
  Opioids 
  and 
  
Psychodysleptics 
  X42 
  (opioid 
  narcotics+heroin+hallucinogens), 
   
  Semisynthetic 
  Opioid 
  Deaths 
  T40.2 
  
(oxycodone, 
  hydrocodone, 
  oxymorphone, 
  hydromorphone,+morphine). 
   
   
  It 
  is 
  clear 
  that 
   
  by 
  any 
  
measure, 
  there 
  has 
  been 
  a 
  significant 
  increase 
  in 
  death 
  rates 
  since 
  1999 
  with 
  over 
  a 
  6 
  times 
  increase 
  
in 
  unintentional 
  (accidental) 
  poisoning 
  death 
  rates 
  in 
  Indiana. 
   
  The 
  X42 
  code 
  data 
  listed 
  as 
  opioids 
  
and 
  psychodysleptics 
  are 
  the 
  accidental 
  poisoning 
  due 
  to 
  these 
  substances, 
  but 
  pale 
  in 
  comparison 
  to 
  
the 
  overall 
  accidental 
  death 
  rate 
  from 
  poisoning 
   
  (listed 
  in 
  green). 
   
   
  Part 
  of 
  the 
  difference 
  in 
  the 
  two 
  
may 
  be 
  due 
  to 
  miscoding 
  of 
  X42 
  codes 
  (purple 
  graph) 
  as 
  X44 
  codes 
  (accidental 
  non-­‐specific). 
   
  

 
  

 
  

  
  
When 
  the 
  same 
  data 
  is 
  plotted 
  (the 
  graph 
  below) 
  including 
  the 
  X44 
  deaths 
  (accidental 
  death 
  due 
  to 
  
unspecified 
  medicants), 
  it 
  becomes 
  clear 
  that 
  the 
  majority 
  of 
  the 
  unintentional 
  poison 
  rates 
  
(X40_41+42+43+44) 
  is 
  due 
  to 
  a 
  combination 
  of 
  the 
  X44 
  plus 
  X42. 
   
  Given 
  that 
  other 
  states 
  with 
  better 
  
coding 
  of 
  the 
  death 
  rates 
  (eg 
  Maryland) 
  find 
  the 
  majority 
  of 
  the 
  unintentional 
  poison 
  rates 
  to 
  be 
  due 
  
to 
  prescription 
  opioids, 
  it 
  is 
  likely 
  the 
  same 
  is 
  true 
  in 
  Indiana, 
  but 
  due 
  to 
  improper 
  coding 
  it 
  is 
  
impossible 
  to 
  determine 
  the 
  actual 
  percentage 
  of 
  deaths 
  in 
  Indiana 
  due 
  to 
  prescription 
  opioid 
  drugs. 
   
  
 
  

 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
The 
  prescription 
  opioids 
  plus 
  illicit 
  drug 
  death 
  rates 
  by 
  county 
  is 
  depicted 
  in 
  the 
  figure 
  below. 
   
  The 
  
death 
  rates 
  were 
  calculated 
  from 
  a 
  Wonder 
  search 
  CDC 
  for 
  the 
  1999-­‐2009 
  years 
  and 
  are 
  calculated 
  
per 
  10,000 
  population. 
   
  Parameters 
  included 
  are 
  the 
  X42 
  (opioid 
  plus 
  illicit 
  drugs) 
  plus 
  X44 
  
(unspecified 
  medicants). 
   
  The 
  brown 
  shaded 
  counties 
  have 
  the 
  highest 
  death 
  rate 
  and 
  the 
  blue 
  is 
  the 
  
lowest. 
   
  White 
  are 
  counties 
  without 
  data 
  available 
  from 
  the 
  CDC. 
   
   
  There 
  seems 
  to 
  be 
  no 
  apparent 
  
pattern 
  to 
  the 
  distribution 
  of 
  deaths 
  throughout 
  the 
  state 
  with 
  highest 
  death 
  rates 
  involving 
  both 
  
large 
  and 
  small 
  counties, 
  both 
  urban 
  and 
  rural. 
   
   
  The 
  county 
  with 
  the 
  greatest 
  population 
  (Marion) 
  
has 
  the 
  greatest 
  number 
  of 
  deaths 
  but 
  also 
  has 
  one 
  of 
  the 
  lowest 
  death 
  rates 
  per 
  10,000 
  population. 
   
  

  
  

 
  
Opioid 
  Dose 
  and 
  Mortality 
   
  Several 
  studies 
  have 
  examined 
  this 
  issue 
  and 
  uniformly 
  have 
  found 
  
there 
  is 
  a 
  correlation 
  between 
  increasing 
  opioid 
  doses 
  prescribed 
  and 
  death. 
   
  However 
  the 
  validity 
  of 
  
these 
  studies 
  is 
  compromised 
  due 
  to 
  the 
  facts 
  that 
  patients 
  succumbing 
  to 
  opioid 
  deaths 
  may 
  have 
  
actually 
  been 
  taking 
  more 
  drug 
  than 
  prescribed 
  resulting 
  in 
  overdose, 
  have 
  other 
  sources 
  for 
  opioids 
  
or 
  other 
  sedative 
  hypnotics 
  that 
  were 
  not 
  known 
  to 
  the 
  researchers, 
  or 
  be 
  taking 
  other 
  drugs 
  that 
  
were 
  not 
  directly 
  attributed 
  to 
  death 
  in 
  coroner’s 
  data 
  submission 
  but 
  could 
  have 
  contributed 
  to 
  
death. 
   
  Therefore 
  the 
  assumed 
  quantity 
  of 
  opioids 
  taken 
  may 
  be 
  artificially 
  low 
  in 
  these 
  studies 
  with 
  
the 
  amount 
  needed 
  to 
  cause 
  death 
  actually 
  being 
  much 
  higher 
  or 
  co-­‐drugs 
  were 
  not 
  appreciated 
  as 
  
causes 
  of 
  death. 
   
   
  There 
  is 
  also 
  no 
  way 
  to 
  know 
  if 
  the 
  medications 
  resulting 
  in 
  death 
  in 
  these 
  studies 
  
were 
  being 
  used 
  non-­‐medically 
  (eg. 
  excessive 
  binge 
  usage, 
  snorting, 
  diverting 
  to 
  IV 
  use) 
  or 
  were 
  
associated 
  with 
  co-­‐drug 
  poisoning 
  (eg. 
  benzodiazepines). 
   
   
  
A 
  Canadian 
  study 
   
  tracking 
  socioeconomically 
  disadvantaged 
  patients 
  receiving 
  government 
  
sponsored 
  drug 
  assistance 
  programs 
  contained 
  the 
  highest 
  doses 
  prescribed 
  in 
  all 
  studies 
  and 
  found 
  

 that 
  in 
  patients 
  receiving 
  high 
  dose 
  opioids 
  averaging 
  a 
  morphine 
  equivalent 
  of 
   
  75mg/day 
  have 
  a 
  2 
  
year 
  opioid 
  related 
  mortality 
  rate 
  of 
  1.6 
  per 
  1000 
  patients. 
   
  Those 
  that 
  are 
  receiving 
  an 
  average 
  of 
  
270mg 
  per 
  day 
  had 
  a 
  2 
  year 
  mortality 
  rate 
  of 
  7.9/1000 
  patients 
  while 
  those 
  receiving 
  615mg/day 
  
have 
  a 
  2 
  year 
  mortality 
  of 
  9.9 
  per 
  1000 
  patients. 
   
  However, 
  the 
  overall 
  death 
  rate 
  (not 
  limited 
  to 
  
opioid 
  induced 
  deaths) 
  for 
  those 
  taking 
  high 
  or 
  very 
  high 
  doses 
  of 
  opioids 
  were 
  40 
  per 
  1000 
  patients, 
  
that 
  is 
  4-­‐5 
  times 
  the 
  death 
  rate 
  attributed 
  to 
  opioids 
  alone. 
   
  This 
  suggests 
  lifestyle, 
  overall 
  poor 
  
health, 
  or 
  behavioral 
  issues 
  in 
  this 
  low 
  income 
  population 
  were 
  more 
  of 
  an 
  issue 
  than 
  the 
  opioid 
  itself 
  
leading 
  to 
  their 
  demise. 
  (6) 
   
   
  
Another 
  study 
  employed 
  much 
  lower 
  doses 
  of 
  prescribed 
  opioids 
  and 
  also 
  found 
  VA 
  patients 
  
receiving 
  more 
  than 
  100mg/day 
  morphine 
  equivalency 
  and 
  a 
  substance 
  abuse 
  disorder 
  had 
  a 
  4.5 
  
hazard 
  risk 
  compared 
  to 
   
  those 
  receiving 
  1-­‐20mg 
  morphine 
  equivalency. 
   
  For 
  those 
  with 
  chronic 
  
pain, 
  the 
  hazard 
  ratio 
  for 
  overdose 
  was 
  4.2 
  at 
  the 
  higher 
  compared 
  to 
  lower 
  dosage 
  while 
  cancer 
  
patients 
  had 
  a 
  12 
  times 
  hazard 
  ratio 
  for 
  overdose 
  with 
  the 
  higher 
  vs 
  lower 
  dosage. 
  (7) 
   
   
  However 
  the 
  
study 
  was 
  limited 
  in 
  impact 
  since 
  there 
  was 
  a 
  significant 
  prescription 
  overdose 
  rate 
  among 
  veterans 
  
that 
  had 
  no 
  prescription 
  at 
  all, 
  implying 
  the 
  prescribing 
  system 
  inside 
  the 
  veterans 
  administration 
  is 
  
not 
  closed 
  thereby 
  permitting 
  narcotics 
  being 
  acquired 
  from 
  private 
  physicians 
  outside 
  the 
  VA. 
   
  
Therefore 
  the 
  actual 
  amount 
  of 
  opioids 
  VA 
  patients 
  were 
  taking 
  is 
  unknown, 
  and 
  could 
  have 
  been 
  
much 
  higher 
  than 
  reported 
  in 
  this 
  study. 
   
   
   
   
   
   
  
A 
  third 
  study 
  found 
  that 
  the 
  odds 
  ratio 
  of 
  death 
  was 
  dose 
  related 
  to 
  the 
  amount 
  of 
  opioid 
  
prescribed 
  with 
  intermediate 
  dose 
  (50-­‐99mg 
  morphine 
  equivalents) 
  being 
  associated 
  with 
  a 
  1.92 
  
odds 
  ratio 
  of 
  death 
  compared 
  to 
  <20mg 
  dose, 
  and 
  100-­‐200mg 
  daily 
  dosage 
  associated 
  with 
  and 
  odds 
  
ratio 
  of 
  2.08, 
  and 
  >200mg 
  per 
  day 
  being 
  associated 
  with 
  an 
  odds 
  ratio 
  of 
  2.88. 
  (8) 
   
   
  Clearly 
  drug 
  
overdose 
  is 
  causally 
  linked 
  to 
  amount 
  prescribed, 
  however 
  this 
  is 
  not 
  a 
  linear 
  relationship, 
  and 
  other 
  
factors 
  may 
  be 
  involved. 
   
  
Substance 
  abuse 
  may 
  lead 
  to 
  a 
  higher 
  proclivity 
  for 
  overdose 
  and 
  death 
  when 
  patients 
  reach 
  
relatively 
  high 
  doses 
  of 
  opioids. 
   
  Patients 
  that 
  double 
  hydrocodone 
  dosing 
  from 
  3 
  to 
  6 
  per 
  day 
  
without 
  prescriber 
  authorization 
  will 
  probably 
  have 
  no 
  significant 
  increase 
  in 
  risk 
  of 
  death 
  from 
  the 
  
dose 
  escalation. 
   
  However 
  patients 
  that 
  double 
  oxycontin 
  80mg 
  from 
  3 
  to 
  6 
  a 
  day 
  may 
  result 
  in 
  death. 
   
  
Therefore 
  it 
  is 
  extremely 
  important 
  prescribers 
  keep 
  tight 
  controls 
  on 
  patient 
  use 
  of 
  medications 
  and 
  
not 
  permit 
  unauthorized 
  usage 
  of 
  the 
  medications 
  without 
  there 
  being 
  consequences 
  for 
  the 
  patient. 
   
  
Patients 
  that 
  feel 
  it 
  is 
  ok 
  to 
  double 
  hydrocodone 
  if 
  their 
  physician 
  is 
  passive 
  about 
  this 
  will 
  
undoubtedly 
  engage 
  in 
  dose 
  escalations 
  of 
  more 
  potent 
  medications. 
   
   
  
 
   
   
   
   
   
  
The 
  CDC, 
  in 
  their 
  enthusiasm 
  to 
  show 
  the 
  severity 
  of 
  death 
  related 
  to 
  the 
  amounts 
  of 
  drug 
  
prescribed 
  online 
  published 
  “Policy 
  Impact: 
  Prescription 
  Painkiller 
  Overdose” 
  in 
  2011. 
   
  The 
  table 
  and 
  
text 
  imply 
  as 
  the 
  amount 
  of 
  opioid 
  sold 
  per 
  state 
  rises, 
  there 
  is 
  a 
  corresponding 
  rise 
  in 
  death 
  rate. 
   
  A 
  
state 
  overdose 
  rate 
  correlated 
  with 
  kilograms 
  of 
  opioid 
  sold 
  in 
  each 
  state 
  is 
  referenced 
  in 
  a 
  table 
  in 
  
the 
  publication. 
   
  However, 
  when 
  this 
  data 
  is 
  plotted 
  out 
  using 
  a 
  least 
  squares 
  analysis, 
  that 
  there 
  is 
  
not 
  a 
  good 
  relationship 
  between 
  these 
  two 
  variables 
  with 
  a 
  correlation 
  coefficient 
  of 
  only 
  0.53 
  (weak 
  
correlation). 
   
   
   
   
   
  
 
  

  
  
 
  
 
  
However, 
   
  using 
  data 
  obtained 
  from 
  ARCOS 
  and 
  from 
  the 
  Indiana 
  State 
  Department 
  of 
  Health, 
  there 
  is 
  
a 
  demonstrated 
  correlation 
  of 
  retail 
  sales 
  with 
  death 
  rates 
  associated 
  with 
  a 
  particular 
  opioid 
  
medication 
  or 
  group 
  as 
  shown 
  in 
  the 
  graphs 
  below. 
   
  

  
  

Note 
  the 
  much 
  more 
  rapid 
  increase 
  in 
  methadone 
  death 
  and 
  sales 
  rates 
  compared 
  to 
  the 
  
semisynthetics 
  + 
  morphine 
  in 
  the 
  graph 
  above. 
  In 
  2006 
  there 
  were 
  an 
  equal 
  number 
  of 
  deaths 
  

 
  

 associated 
  with 
  methadone 
  compared 
  with 
  the 
  semisynthetics+morphine 
  group 
  although 
  the 
  retail 
  
sales 
  of 
  methadone 
  were 
  only 
  8% 
  of 
  the 
  total 
  of 
  the 
  two 
  groups. 
   
  However, 
  by 
  2009, 
  the 
  number 
  of 
  
deaths 
  due 
  to 
  the 
  semisynthetic+morphine 
  group 
  were 
  twice 
  the 
  number 
  of 
  methadone 
  deaths. 
   
  The 
  
difference 
  between 
  the 
  death 
  rate 
  curve 
  and 
  the 
  methadone 
  sales 
  curve 
  may 
  be 
  thought 
  of 
  as 
  excess 
  
deaths 
  primarily 
  due 
  to 
  drug 
  sharing 
  in 
  those 
  not 
  being 
  prescribed 
  the 
  medications. 
   
  The 
  US 
  
government 
  stopped 
  publishing 
  opioid 
  retail 
  sales 
  data 
  after 
  the 
  2006 
  year 
  without 
  explanation 
  and 
  
a 
  freedom 
  of 
  information 
  act 
  request 
  for 
  the 
  years 
  2007-­‐2010 
  has 
  been 
  submitted 
  to 
  the 
  DEA 
  at 
  the 
  
time 
  of 
  this 
  writing. 
   
  Data 
  for 
  the 
  above 
  Indiana 
  graphs 
  was 
  derived 
  from 
  the 
  Indiana 
  State 
  
Department 
  of 
  Heath 
  request 
  made 
  by 
  IPS 
  (kindly 
  provided 
  by 
  Brian 
  Carnes) 
  for 
  T40.2, 
  T40.3, 
  and 
  
T40.4 
  ICD 
  10 
  data, 
  and 
  the 
  ARCOS 
  retail 
  sales 
  publications 
  by 
  the 
  DEA 
  for 
  years 
  1999-­‐2006. 
   
  
 
  
The 
  sales 
  of 
  most 
  opioids 
  also 
  rapidly 
  increased 
  over 
  the 
  past 
  decade 
  with 
  hydrocodone 
  sales 
  having 
  
more 
  than 
  doubled 
  between 
  1997 
  and 
  2006 
  while 
  oxycodone 
  increased 
  by 
  nearly 
  10 
  fold. 
   
   
  Such 
  sales 
  
depict 
  a 
  changing 
  attitude 
  by 
  physicians 
  and 
  other 
  practitioners 
  in 
  their 
  proclivity 
  to 
  prescribe 
  
opioids. 
   
   
  The 
  DEA 
  stopped 
  making 
  sales 
  data 
  available 
  publically 
  after 
  2006 
  claiming 
  that 
  it 
  is 
  data 
  
for 
  internal 
  and 
  law 
  enforcement 
  use. 
   
  Currently 
  the 
  IPS 
  has 
  a 
  FOI 
  act 
  request 
  for 
  further 
  data 
  but 
  this 
  
has 
  yet 
  to 
  be 
  answered 
  by 
  the 
  US 
  government. 
   
  It 
  is 
  likely 
  given 
  the 
  correlation 
  between 
  death 
  and 
  
sales 
  of 
  opioids 
  that 
  the 
  opioid 
  sales 
  exploded 
  after 
  2006 
  both 
  in 
  Indiana 
  and 
  across 
  the 
  country. 
   
  
 
  

 
  

 
  
 
  
 
  
Multiple 
  Drug 
  Use 
  Mortality: 
  A 
  major 
  factor 
  in 
  drug 
  overdose 
  deaths 
  associated 
  with 
  opioid 
  
use 
  is 
  the 
  use 
  of 
  other 
  prescription 
  and 
  non-­‐ 
  prescription 
  drugs, 
  especially 
  those 
  drugs 
  with 
  sedative 
  
properties. 
   
  Certain 
  combinations 
  of 
  prescribed 
  drugs 
  by 
  “pill 
  mills” 
  around 
  the 
  country 
  are 
  known 
  to 
  
be 
  lethal 
  such 
  as 
  “the 
  holy 
  trinity” 
  consisting 
  of 
  hydrocodone/Soma/Xanax 
  or 
  an 
  
oxycodone/Soma/Xanax. 
   
  However, 
  many 
  patients 
  not 
  seeking 
  care 
  in 
  “pill 
  mills” 
  across 
  the 
  nation 
  
end 
  up 
  getting 
  the 
  same 
  drugs 
  through 
  the 
  use 
  of 
  multiple 
  specialists. 
   
  A 
  psychiatrist 
  may 
  prescribe 
  
Xanax 
  for 
  anxiety, 
  a 
  family 
  physician 
  prescribing 
  Oxycontin 
  for 
  low 
  back 
  pain, 
  and 
  a 
  rheumatologist 
  
prescribing 
  Soma 
  for 
  muscle 
  spasms 
  associated 
  with 
  fibromyalgia. 
   
  The 
  lack 
  of 
  coordination 
  of 
  care 
  
among 
  different 
  prescribers 
  regarding 
  prescribing 
  of 
  sedatives 
  and 
  opioids, 
  and 
  lack 
  of 
  recognition 
  
by 
  prescribers 
  that 
  certain 
  drug 
  combinations 
  are 
  far 
  more 
  lethal 
  than 
  opioids 
  alone 
  are 
  major 
  
problems 
  that 
  contribute 
  strongly 
  to 
  mortality 
  rates. 
   
  Sedative 
  drugs 
  may 
  cause 
  suppression 
  of 
  

 respiration. 
   
  Obesity 
  (endemic 
  in 
  the 
  chronic 
  pain 
  population 
  due 
  to 
  inactivity), 
  obstructive 
  lung 
  
diseases 
  (common 
  in 
  the 
  smoking 
  population), 
  and 
  sleep 
  apnea 
  are 
  all 
  factors 
  that 
  amplify 
  the 
  
respiratory 
  depressant 
  effects 
  of 
  the 
  sedatives 
  and 
  opioids. 
   
  There 
  are 
  many 
  drug 
  classes 
  with 
  
sedative 
  properties 
  including 
  sleeping 
  aids, 
  benzodiazepines, 
  tricyclic 
  antidepressants, 
  
antihistamines, 
  restless 
  leg 
  syndrome 
  treatments, 
  most 
  muscle 
  relaxants 
  (especially 
  carisoprodol), 
  
and 
  a 
  variety 
  of 
  others. 
   
   
  
 
  
The 
  Marion 
  County 
  metro 
  area 
  DAWN 
  data 
  (reporting 
  represents 
  1/6 
  of 
  the 
  state’s 
  
population) 
  is 
  seen 
  in 
  the 
  next 
  two 
  graphs 
  below. 
   
  The 
  overall 
  drug 
  death 
  rate 
  (suicide, 
  accidental, 
  
illicits, 
  and 
  prescription 
  combined) 
  is 
  generally 
  rising 
  during 
  the 
  reporting 
  periods 
  available 
  at 
  this 
  
time 
  2003-­‐2009, 
  and 
  the 
  vast 
  majority 
  of 
  deaths 
  have 
  opioids 
  found 
  in 
  the 
  blood. 
   
  The 
  opioids 
  may 
  
not 
  necessarily 
  be 
  the 
  causation 
  of 
  death 
  but 
  are 
  present 
  in 
  measurable 
  amounts. 
   
  Of 
  note 
  are 
  all 
  the 
  
other 
  drugs 
  found 
  used 
  in 
  conjunction 
  with 
  opioids, 
  especially 
  the 
  high 
  numbers 
  of 
  alcohol, 
  cocaine, 
  
and 
  benzodiazepines. 
   
   
  In 
  the 
  year 
  2009 
  there 
  were 
  logged 
  152 
  drug 
  related 
  deaths, 
  75% 
  of 
  which 
  
were 
  ruled 
  accidental. 
   
  Of 
  the 
  152 
  drug 
  deaths, 
  134 
  were 
  accidental, 
  7 
  were 
  due 
  to 
  opioids 
  alone 
  and 
  
134 
  had 
  opioids 
  combined 
  with 
  other 
  drugs. 
   
  68 
  had 
  benzodiazepines 
  (half 
  of 
  all 
  opioid 
  related 
  
deaths), 
  47 
  involved 
  alcohol, 
  36 
  involved 
  cocaine, 
  22 
  involved 
  marijuana, 
  14 
  involved 
  
antidepressants, 
  9 
  involved 
  anticonvulsants, 
  6 
  muscle 
  relaxants, 
  5 
  antipsychotics, 
  and 
  4 
  
sedatives/hypnotics. 
   
   
  There 
  were 
  no 
  club 
  drugs, 
  hallucinogens, 
  or 
  inhalants 
  involved, 
  and 
  the 
  
stimulants 
  (including 
  methamphetamine) 
  were 
  less 
  than 
  4 
   
   
  None 
  of 
  the 
  benzodiazepine 
  deaths 
  
occurred 
  solely 
  due 
  to 
  benzodiazepines: 
  all 
  involved 
  other 
  drugs. 
   
  Of 
  the 
  opioid 
  deaths, 
  heroin 
  was 
  
involved 
  in 
  26, 
  methadone 
  in 
  27, 
  and 
  other 
  opioids 
  in 
  131. 
   
   
  
 
  
This 
  data 
  shows 
  single 
  drug 
  use 
  deaths 
  are 
  uncommon, 
  with 
  12% 
  of 
  accidental 
  drug 
  deaths 
  
being 
  due 
  to 
  a 
  single 
  drug 
  as 
  seen 
  in 
  the 
  graph 
  below. 
   
  
 
  

 
  
 
  
 
  The 
  most 
  common 
  drug 
  used 
  in 
  single 
  drug 
  use 
  deaths 
  in 
  the 
  Marion 
  County 
  metro 
  area 
  is 
  opioids 
  
constituting 
  42% 
  of 
  single 
  drug 
  overdoses. 
   
  95.7% 
  are 
  these 
  prescription 
  opioids. 
   
  The 
  second 
  most 
  
common 
  drug 
  type 
  involved 
  in 
  single 
  drug 
  deaths 
  is 
  cocaine 
  at 
  38%. 
   
  The 
  remainder 
  of 
  the 
  drugs 
  are 
  
all 
  prescription 
  benzodiazepines, 
  antidepressants, 
  and 
  a 
  small 
  variety 
  of 
  others. 
   
   
  However, 
  as 
  seen 
  in 
  

 the 
  next 
  graph, 
  88% 
  of 
  drug 
  deaths 
  involve 
  multiple 
  drugs 
  with 
  opioids 
  found 
  in 
  82% 
  and 
  
benzodiazepines 
  found 
  in 
  42% 
  of 
  all 
  accidental 
  drug 
  deaths. 
   
   
  
 
  

 
  

 
  

Other 
  areas 
  of 
  the 
  country 
  have 
  similar 
  findings. 
   
  The 
  state 
  of 
  Florida 
  has 
  a 
  complete 
  
electronic 
  coroner’s 
  database 
  and 
  in 
  an 
  analysis 
  of 
  this 
  data 
  from 
  2009, 
  it 
  can 
  be 
  seen 
  in 
  the 
  blue 
  bars 
  
(figure 
  below), 
  benzodiazepines 
  account 
  for 
  a 
  co-­‐drug 
  found 
  in 
  death 
  in 
  72% 
  of 
  the 
  cases 
  associated 
  
with 
  oxycodone. 
   
  Benzodiazepines 
  include 
  the 
  drugs 
  Xanax 
  (alprazolam), 
  Valium 
  (diazepam), 
  
Klonopin 
  (clonazepam), 
  Ativan 
  (lorazepam), 
  Restoril 
  (temazepam), 
  etc. 
  and 
  these 
  drugs 
  are 
  used 
  for 
  
the 
  treatment 
  of 
  anxiety 
  disorders, 
  muscle 
  spasticity, 
  sleep 
  aids, 
  restless 
  leg 
  syndrome, 
  seizures, 
  and 
  
a 
  variety 
  of 
  other 
  maladies. 
   
  There 
  are 
  substitute 
  drugs 
  that 
  do 
  not 
  have 
  the 
  extreme 
  sedating 
  and 
  
respiratory 
  depression 
  properties 
  of 
  the 
  benzodiazepines, 
  however 
  patients 
  strongly 
  prefer 
  the 
  
much 
  more 
  addictive 
  benzodiazepines 
  to 
  these 
  substitutes. 
   
   
  It 
  is 
  the 
  combination 
  of 
  the 
  
benzodiazepines 
  (frequently 
  prescribed 
  in 
  the 
  US 
  by 
  family 
  doctors 
  and 
  specialists 
  alike) 
  and 
  opioids 
  
that 
  may 
  lead 
  to 
  profound 
  respiratory 
  depression, 
  anoxic 
  brain 
  injury, 
  and 
  death. 
   
   
  Soma 
  
(carisoprodol) 
  is 
  found 
  in 
  12% 
  of 
  cases 
  in 
  this 
  study. 
   
  Soma 
  is 
  metabolized 
  by 
  the 
  body 
  into 
  a 
  major 
  
tranquilizer 
  (meprobamate) 
  that 
  may 
  still 
  be 
  prescribed 
  in 
  the 
  US, 
  but 
  only 
  uncommonly 
  is 
  due 
  to 
  the 
  
sedating 
  and 
  addictive 
  properties. 
   
   
  Other 
  opioids 
  are 
  found 
  in 
  42% 
  of 
  the 
  drug 
  overdoses 
  in 
  this 
  
study 
  (designated 
  as 
  “opioid” 
  in 
  the 
  graph 
  below). 
   
   
  A 
  second 
  opioid 
  is 
  frequently 
  prescribed 
  in 
  pain 
  
medicine 
  as 
  a 
  breakthrough 
  medication 
  in 
  conjunction 
  with 
  a 
  long 
  acting 
  opioid 
  for 
  base 
  pain 
  control. 
   
  
The 
  rationale 
  behind 
  this 
  comes 
  from 
  the 
  fact 
  that 
  pain 
  is 
  frequently 
  activity 
  related, 
  and 
  while 
  long 
  
acting 
  basal 
  pain 
  medications 
  may 
  control 
  pain 
  at 
  rest, 
  such 
  may 
  be 
  insufficient 
  for 
  activity 
  related 
  
increase 
  in 
  pain. 
   
  Also, 
  Milner 
  and 
  others 
  have 
  produced 
  data 
  to 
  suggest 
  the 
  short 
  acting 
  medications 
  
are 
  abused 
  more 
  than 
  the 
  long 
  acting 
  medications, 
  therefore 
  in 
  order 
  to 
  provide 
  some 
  balance 
  
between 
  substance 
  abuse 
  proclivity 
  and 
  pain 
  control, 
  a 
  combination 
  of 
  long 
  and 
  short 
  acting 
  pain 
  
medications 
  are 
  frequently 
  used. 
   
   
  According 
  to 
  an 
  IPS 
  CDC 
  Wonder 
  query 
  of 
  X41 
  code 
  ICD10, 
  
sedatives/hypnotics 
  and 
  other 
  non-­‐opioid 
  drugs 
  including 
  benzodiazepines 
  (Antiepileptic, 
  sedative-­‐

 hypnotic, 
  antiparkinsonism 
  and 
  psychotropic 
  drugs) 
  are 
  responsible 
  for 
  only 
  a 
  small 
  fraction 
  of 
  the 
  
drug 
  death 
  rates 
  in 
  2009. 
   
  The 
  drugs 
  in 
  these 
  classes 
  caused 
  a 
  death 
  rate 
  of 
  0.2/100,000 
  in 
  1999 
  that 
  
gradually 
  rose 
  to 
  0.5/100,000 
  by 
  2009. 
   
  This 
  compares 
  with 
  4.0 
  for 
  opioid 
  induced 
  death 
  and 
  14.4 
  for 
  
the 
  overall 
  drug 
  death 
  rates 
  during 
  the 
  same 
  year. 
   
  Therefore, 
  sedatives 
  alone 
  are 
  not 
  responsible 
  for 
  
a 
  significant 
  number 
  of 
  deaths, 
  but 
  in 
  concert 
  with 
  opioids 
  have 
  a 
  significant 
  impact 
  on 
  the 
  death 
  
rates. 
   
  
 
  
 
   
  
 
  
 
  

 
  
Polypharmacy 
  deaths 
  (those 
  involving 
  more 
  than 
  one 
  drug) 
  are 
  the 
  rule 
  rather 
  than 
  the 
  exception. 
   
  In 
  
Florida 
  in 
  2009, 
  92% 
  of 
  oxycodone 
  deaths 
  were 
  associated 
  with 
  other 
  drugs, 
  90% 
  of 
  methadone 
  deaths, 
  
87% 
  of 
  hydrocodone 
  deaths, 
  and 
  82% 
  of 
  morphine 
  deaths 
  had 
  significant 
  other 
  prescription 
  drugs 
  found, 
  
most 
  often 
  benzodiazepines. 
   
  
 
  
 
  

 
  

  
  
A 
  West 
  Virginia 
  study 
  (21) 
  of 
  drug 
  deaths 
  from 
  2006 
  demonstrated 
  the 
  following 
  findings: 
  
Contributory 
  Prescription 
   % 
  Deaths 
   % 
  With 
  
% 
  with 
  
% 
  with 
  
% 
  with 
  
% 
  No 
  
Drug 
  
with 
  Drug 
   Prescription 
   Other 
  
Illicit 
  
Alcohol 
  
Other 
  
Found 
  
Prescription 
   Drugs 
  
Drugs 
  
Drug 
  Found 
  
Found 
  
93 
  
44 
  
63 
  
16 
  
14 
  
22 
  
Opioids
Methadone 
  
40 
  
32 
  
63 
  
13 
  
10 
  
26 
  
Hydrocodone 
  
23 
  
85 
  
84 
  
9 
  
11 
  
8 
  
Oxycodone 
  
21 
  
61 
  
71 
  
15 
  
10 
  
18 
  
Morphine 
  
16 
  
22 
  
54 
  
28 
  
28 
  
21 
  
Fentanyl 
  
11 
  
42 
  
77 
  
19 
  
10 
  
13 
  
55 
  
94 
  
8 
  
21 
  
0.7 
  
Psychotherapeutics 49 
  
Diazepam 
  
22 
  
46 
  
92 
  
8 
  
20 
  
0 
  
Alprazolam 
  
18 
  
65 
  
100 
  
6 
  
11 
  
0 
  
Antidepressants 
  
17 
  
71 
  
94 
  
10 
  
20 
  
2 
  
Other 
  Prescription 
  Drug 
  
11 
  
60 
  
97 
  
9 
  
12 
  
3 
  
All 
  Decedents 
  
100 
  
37 
  
62 
  
16 
  
17 
  
21 
  
Clearly 
  multiple 
  drug 
  use 
  is 
  common, 
  especially 
  with 
  other 
  prescription 
  drugs, 
  and 
  particularly 
  
benzodiazepines 
  that 
  were 
  found 
  in 
  49% 
  of 
  decedents. 
   
  Only 
  22% 
  of 
  the 
  overdose 
  deaths 
  involved 
  a 
  
single 
  drug. 
   
  The 
  number 
  of 
  decedents 
  that 
  had 
  prescriptions 
  for 
  all 
  the 
  drugs 
  taken 
  is 
  surprisingly 
  
low, 
  suggesting 
  that 
  it 
  is 
  more 
  common 
  to 
  overdose 
  with 
  drugs 
  or 
  co-­‐drugs 
  being 
  obtained 
  from 
  
others 
  than 
  from 
  taking 
  the 
  prescriptions 
  as 
  written 
  by 
  physicians. 
   
  
 
  
Other 
  studies 
  show 
  the 
  following 
  findings. 
   
   
   
  
-­‐One 
  US 
  study 
  found 
  75% 
  of 
  those 
  taking 
  opioids 
  are 
  also 
  taking 
  benzodiazepines 
  and/or 
  
antidepressants 
  (23) 
  
-­‐Methadone 
  taken 
  with 
  other 
  drugs, 
  particularly 
  benzodiazepines, 
  results 
  in 
  mortality 
  that 
  is 
  much 
  
higher 
  than 
  taking 
  methadone 
  alone 
  (16). 
   
   
  
-­‐In 
  several 
  studies 
  of 
  opioid 
  related 
  death, 
  the 
  concurrent 
  use 
  of 
  benzodiazepines 
  with 
  methadone 
  is 
  
32-­‐39% 
  but 
  tricyclic 
  antidepressants 
  are 
  also 
  frequently 
  found 
  in 
  30-­‐45%. 
   
  The 
  risk 
  of 
  death 
  with 
  
methadone 
  when 
  taking 
  both 
  a 
  tricyclic 
  antidepressant 
  and 
  benzodiazepine 
  is 
  4.3 
  times 
  that 
  of 
  taking 
  
methadone 
  alone 
  (11). 
   
   
   
  
-­‐Another 
  study 
  of 
  methadone 
  found 
  the 
  increased 
  risk 
  of 
  death 
  rate 
  adding 
  benzodiazepines 
  to 
  
methadone 
  was 
  4.8. 
  (12) 
   
  
-­‐Indiana 
  Pain 
  Society 
  calculations 
  based 
  on 
  the 
  2009 
  Marion 
  County 
  Area 
  mortality 
  data 
  demonstrate 
  
a 
  relative 
  risk 
  of 
  death 
  of 
  7.98 
  when 
  taking 
  prescription 
  opioids 
  plus 
  benzodiazepines 
  vs 
  the 
  risk 
  of 
  
death 
  from 
  prescription 
  opioids 
  alone 
  
-­‐The 
  drug 
  levels 
  of 
  opioids 
  required 
  for 
  overdose 
  death 
  are 
  much 
  less 
  when 
  other 
  drugs 
  are 
  found 
  as 
  
co-­‐mortality 
  drugs, 
  particularly 
  benzodiazepines. 
   
  A 
  Swedish 
  study 
  showed 
  the 
  blood 
  levels 
  of 
  
methadone 
  involved 
  in 
  overdose 
  death 
  were 
  60% 
  lower 
  when 
  other 
  drugs 
  such 
  as 
  benzodiazepines 
  
were 
  also 
  found 
  (15). 
   
   
  Therefore 
  taking 
  even 
  usual 
  prescribed 
  doses 
  of 
  opioid 
  drugs 
  may 
  cause 
  
overdose 
  death 
  when 
  benzodiazepines 
  and 
  other 
  drugs 
  are 
  added. 
   
  
Alcohol 
  as 
  a 
  co-­‐drug 
  is 
  also 
  found 
  in 
  many 
  overdose 
  deaths 
  typically 
  15-­‐25% 
  of 
  deaths. 
   
  
 
  
Yet 
  there 
  are 
  many 
  other 
  non-­‐sedating 
  drugs 
  that 
  can 
  also 
  lead 
  to 
  increased 
  opioid 
  drug 
  levels 
  due 
  to 
  
drug-­‐drug 
  interactions 
  via 
  inhibition 
  of 
  the 
  Cytochrome 
  P450 
  metabolic 
  pathways. 
   
   
  Polasek 
  et 
  al 
  
created 
  an 
  evidence 
  based 
  list 
  of 
  such 
  drugs 
  and 
  the 
  Indiana 
  Pain 
  Society 
  combined 
  this 
  research 
  
with 
  the 
  glucuronyl 
  transferase 
  metabolic 
  pathways 
  into 
  a 
  chart 
  with 
  specific 
  opioid 
  medications 
  
known 
  metabolic 
  pathways 
  in 
  Appendix 
  B. 
   
   
   
   
  

 
  

 
  

  
  
Specific 
  Opioids 
  Found 
  in 
  Overdose 
  Deaths 
  

Trends 
  in 
  specific 
  drugs 
  found 
  in 
  decedents 
  may 
  be 
  useful. 
   
   
  This 
  data 
  was 
  derived 
  from 
  T 
  code 
  
analysis 
  of 
  specific 
  drug 
  groups. 
   
  

 
  

 
  

 
   
  

  
  
 
  
 
  
-­‐ 
   
   
   
  Methadone. 
   
   
  This 
  drug 
  is 
  used 
  in 
  the 
  US 
  for 
  pain 
  management 
  (due 
  to 
  it 
  being 
  extremely 
  
inexpensive, 
  having 
  a 
  moderate 
  duration 
  of 
  pain 
  relief, 
  and 
  being 
  covered 
  under 
  both 
  private 
  
insurance 
  and 
  social 
  service 
  insurances 
  (Medicaid/Medicare) 
  when 
  other 
  more 
  expensive 
  drugs 
  may 
  
not 
  be 
  covered. 
   
   
  The 
  drug 
  is 
  also 
  used 
  in 
  opioid 
  treatment 
  centers 
  (methadone 
  clinics) 
  for 
  addiction. 
   
  
The 
  doses 
  used 
  are 
  typically 
  much 
  higher 
  in 
  the 
  methadone 
  clinics 
  ranging 
  in 
  the 
  120-­‐300mg 
  dosage 
  
range 
  per 
  day 
  whereas 
  most 
  physicians 
  using 
  it 
  for 
  pain 
  treatment 
  range 
  between 
  30 
  and 
  80mg 
  a 
  
day. 
   
  It 
  is 
  a 
  completely 
  synthetic 
  drug 
  (not 
  related 
  to 
  morphine 
  or 
  derived 
  from 
  thebaine) 
  first 
  made 
  
in 
  Germany 
  in 
  1938 
  and 
  introduced 
  into 
  the 
  US 
  in 
  1947 
  as 
  Dolophine. 
   
  The 
  drug 
  has 
  particularly 
  
unusual 
  pharmacokinetics 
  (uptake, 
  distribution, 
  and 
  elimination) 
  from 
  the 
  body 
  compared 
  to 
  all 
  
other 
  opioids, 
  and 
  therein 
  lies 
  much 
  of 
  the 
  danger 
  of 
  usage. 
   
  There 
  exist 
  conversion 
  tables 
  published 
  
in 
  books 
  and 
  on 
  the 
  internet 
  that 
  would 
  result 
  in 
  overdose 
  and 
  death 
  if 
  the 
  drug 
  were 
  administered 
  
by 
  these 
  tables 
  given 
  the 
  very 
  long 
  half 
  life 
  of 
  the 
  drug 
  in 
  the 
  body 
  (variable 
  from 
  8 
  to 
  130 
  hours), 
  an 
  
exponential 
  increase 
  in 
  potency 
  at 
  higher 
  doses, 
  and 
  the 
  fact 
  that 
  many 
  common 
  drugs 
  (including 
  
benzodiazepines, 
  some 
  antibiotics, 
  some 
  over 
  the 
  counter 
  drugs) 
  cause 
  inhibition 
  of 
  liver 
  metabolism 
  
of 
  the 
  drug 
  thereby 
  resulting 
  in 
  very 
  high 
  blood 
  levels 
  of 
  the 
  drug. 
   
   
  Age 
  strongly 
  affects 
  the 
  
metabolism 
  and 
  effectiveness 
  of 
  the 
  drug, 
  and 
  the 
  elderly 
  may 
  overdose 
  on 
  as 
  little 
  as 
  5mg 
  a 
  day. 
   
   
   
  
1/3 
  of 
  all 
  opioid 
  overdose 
  deaths 
  in 
  the 
  US 
  are 
  due 
  to 
  methadone 
  even 
  though 
  it 
  constitutes 
  only 
  5% 
  
of 
  the 
  prescribed 
  opioids 
  (16). 
   
  Most 
  overdose 
  symptoms 
  begin 
  late, 
  typically 
  not 
  until 
  6 
  hours 
  after 
  
the 
  drug 
  was 
  taken 
  (12), 
  and 
  half 
  of 
  all 
  overdose 
  deaths 
  with 
  the 
  medication 
  are 
  during 
  the 
  first 
  2 
  
weeks 
  of 
  use 
  with 
  the 
  other 
  50% 
  over 
  the 
  next 
  several 
  months. 
  (35) 
   
   
  Methadone 
  has 
  been 
  shown 
  to 
  
cause 
  significant 
  respiratory 
  depression 
  (CO2 
  response 
  curve 
  blunted) 
  even 
  when 
  taken 
  long 
  term. 
  
(36). 
   
  This 
  is 
  important 
  because 
  many 
  physicians 
  were 
  led 
  to 
  believe 
  (via 
  opioid 
  manufacturer 
  
propaganda) 
  that 
  opioid 
  depression 
  would 
  partially 
  or 
  completely 
  resolve 
  due 
  to 
  tolerance 
  to 
  this 
  
effect. 
   
   
  Without 
  adequate 
  explanation 
  to 
  the 
  patient 
  about 
  the 
  importance 
  of 
  taking 
  the 
  drug 
  exactly 
  
as 
  prescribed 
  and 
  because 
  of 
  physicians 
  attempting 
  to 
  convert 
  from 
  another 
  drug 
  to 
  methadone 
  
directly 
  at 
  full 
  maintenance 
  doses 
  (training 
  in 
  appropriate 
  prescribing 
  of 
  methadone 
  is 
  neither 
  
required 
  nor 
  readily 
  available), 
  overdose 
  deaths 
  are 
  not 
  uncommon. 
   
  Methadone 
  overdose 
  deaths 
  
may 
  occur 
  due 
  to 
  the 
  addition 
  of 
  other 
  prescription 
  drugs 
  (especially 
  benzodiazepines) 
  or 
  several 
  

 over 
  the 
  counter 
  non-­‐prescription 
  drugs 
  or 
  supplements. 
   
  There 
  is 
  also 
  an 
  unusual 
  cardiac 
  
dysrhythmia 
  induced 
  by 
  methadone 
  (torsade 
  de 
  points) 
  that 
  is 
  dose 
  dependent 
  and 
  may 
  be 
  a 
  
contributing 
  factor 
  in 
  death. 
   
  The 
  FDA 
  was 
  so 
  concerned 
  about 
  methadone 
  overdoses 
  in 
  the 
  US, 
  the 
  
40mg 
  tablet 
  was 
  removed 
  from 
  use 
  unless 
  the 
  patient 
  is 
  being 
  treated 
  in 
  a 
  methadone 
  clinic. 
   
   
  A 
  
unique 
  problematic 
  feature 
  with 
  this 
  drug 
  is 
  that 
  methadone 
  clinics 
  dispense 
  high 
  doses 
  of 
  the 
  drug 
  
directly 
  to 
  patients 
  at 
  the 
  clinic, 
  and 
  are 
  prohibited 
  by 
  federal 
  law 
  from 
  entering 
  this 
  information 
  in 
  
any 
  prescription 
  drug 
  monitoring 
  database 
  including 
  INSPECT. 
   
  The 
  methadone 
  clinics 
  are 
  not 
  
required 
  to 
  check 
  prescription 
  monitoring 
  programs 
  such 
  as 
  INSPECT 
  for 
  other 
  physician 
  prescribing 
  
of 
  controlled 
  substances 
  and 
  many 
  do 
  not 
  according 
  to 
  data 
  obtained 
  from 
  a 
  Sermo 
  query 
  online. 
   
  
This 
  creates 
  a 
  situation 
  whereby 
  a 
  person 
  may 
  be 
  obtaining 
  methadone 
  treatment 
  at 
  a 
  methadone 
  
clinic 
  and 
  additional 
  methadone 
  from 
  a 
  private 
  physician, 
  and 
  the 
  patient 
  may 
  either 
  overdose 
  from 
  
the 
  combined 
  methadone 
  dosages 
  or 
  be 
  selling 
  the 
  methadone 
  obtained 
  for 
  treatment 
  of 
  pain, 
  and 
  
there 
  is 
  simply 
  no 
  mechanism 
  for 
  non-­‐methadone 
  clinic 
  physicians 
  to 
  obtain 
  this 
  information. 
   
   
   
  
 
  
The 
  graph 
  below 
  links 
  drug 
  sales 
  to 
  death 
  rates 
  using 
  the 
  T-­‐codes 
  in 
  Indiana 
  deaths. 
   
  Based 
  on 
  the 
  
graph 
  below, 
  two 
  things 
  become 
  apparent: 
   
   
  1. 
  There 
  is 
  a 
  nearly 
  linear 
  relation 
  between 
  drug 
  sales 
  
and 
  death, 
  esp. 
  with 
  methadone 
   
  and 
   
  2. 
  Methadone 
  is 
  a 
  much 
  more 
  deadly 
  drug 
  than 
  the 
  group 
  
morphine+semisynthetics, 
  approximately 
  10-­‐15 
  times 
  as 
  potent 
  in 
  causing 
  death. 
   
   
  This 
  is 
  very 
  
disturbing 
  given 
  the 
  typical 
  prescribing 
  equivalent 
  of 
  1.5-­‐3 
  times 
  the 
  potency 
  for 
  analgesia 
  of 
  
methadone 
  compared 
  to 
  semisynthetics. 
   
  This 
  data 
  and 
  other 
  data 
  in 
  the 
  literature 
  suggests 
  
methadone 
  is 
  far 
  more 
  potent 
  than 
  is 
  appreciated 
  or 
  is 
  being 
  used 
  with 
  other 
  drugs 
  that 
  lead 
  to 
  
death. 
   
  Remember 
  the 
  methadone 
  sales 
  have 
  increased 
  900% 
  from 
  1999-­‐2006. 
  

 
  
 
  
 
  
 
  
 
  
 
  
The 
  CDC 
  released 
  a 
  report 
  in 
  July 
  2012 
  detailing 
  the 
  US 
  methadone 
  death 
  rates 
  from 
  all 
  causes 
  
(suicide, 
  accidental, 
  etc) 
  for 
  the 
  years 
  1999-­‐2010 
  as 
  seen 
  below. 
   
  It 
  is 
  noted 
  the 
  peak 
  death 
  rate 
  was 
  
in 
  2007 
  after 
  which 
  the 
  death 
  rate 
  decreased 
  corresponding 
  to 
  a 
  reduction 
  in 
  the 
  amount 
  prescribed 
  
for 
  pain 
  and 
  the 
  elimination 
  of 
  availability 
  of 
  the 
  40mg 
  tablet 
  of 
  methadone 
  except 
  for 
  hospitals 
  and 
  
methadone 
  treatment 
  centers. 
   
  (MMWR 
  July 
  3, 
  2012). 
   
   
  

  
  
-­‐ 
   
   
  Oxycodone. 
   
   
  Oxycodone 
  is 
  a 
  semisynthetic 
  drug 
   
  (derived 
  from 
  thebaine 
  of 
  the 
  opium 
  poppy) 
  first 
  
synthesized 
  in 
  Germany 
  in 
  1916 
  and 
  introduced 
  clinically 
  into 
  the 
  US 
  in 
  1939. 
   
  It 
  is 
  approximately 
  
1.5-­‐2 
  times 
  as 
  potent 
  as 
  morphine 
  and 
  is 
  the 
  second 
  most 
  commonly 
  used 
  opioid 
  in 
  the 
  US 
  (behind 
  
hydrocodone) 
  but 
  is 
  now 
  the 
  most 
  commonly 
  abused 
  drug 
  according 
  to 
  the 
  DEA. 
   
  The 
  US 
  uses 
  82% 
  of 
  
the 
  world’s 
  supply 
  of 
  oxycodone. 
   
  It 
  existed 
  as 
  a 
  schedule 
  II 
  drug 
  Percocet 
  (combined 
  with 
  
acetaminophen) 
  for 
  many 
  years 
  but 
  in 
  1995, 
  Oxycontin, 
  a 
  sustained 
  release 
  preparation 
  of 
  
oxycodone, 
  was 
  released 
  onto 
  the 
  market. 
   
   
  The 
  lack 
  of 
  an 
  effective 
  barrier 
  for 
  abuse 
  with 
  the 
  drug 
  
caused 
  millions 
  to 
  use 
  the 
  drug 
  inappropriately 
  since 
  merely 
  biting 
  into 
  the 
  tablet 
  would 
  release 
  up 
  
to 
  80mg 
  oxycodone 
  all 
  at 
  once 
  (equivalent 
  to 
  16 
  percocets) 
  or 
  crushing 
  the 
  drug 
  permitted 
  snorting 
  
it 
  (resulting 
  in 
  2-­‐3 
  times 
  the 
  blood 
  levels 
  compared 
  with 
  taking 
  it 
  orally) 
  or 
  banging 
  it 
  (crushing 
  it 
  
between 
  two 
  spoons, 
  adding 
  water, 
  then 
  injecting 
  it 
  intravenously-­‐ 
  resulting 
  in 
  up 
  to 
  10 
  times 
  the 
  
blood 
  levels 
  of 
  oral 
  use). 
   
  The 
  drug 
  effectively 
  became 
  a 
  substitute 
  for 
  heroin 
  in 
  the 
  US. 
   
  Pill 
  mills 
  
frequently 
  prescribed 
  this 
  drug 
  to 
  out 
  of 
  state 
  “patients” 
  and 
  the 
  drug 
  has 
  become 
  a 
  magnet 
  for 
  
pharmacy 
  robberies 
  that 
  are 
  robbed 
  not 
  for 
  money, 
  but 
  specifically 
  for 
  Oxycontin. 
   
  Many 
  pharmacies 
  
refuse 
  to 
  stock 
  the 
  drug 
  because 
  of 
  the 
  robberies. 
   
  With 
  a 
  new 
  formulation 
  of 
  Oxycontin 
  introduced 
  in 
  
2010, 
  the 
  abuse 
  potential 
  decreased 
  but 
  was 
  not 
  eliminated. 
   
  It 
  takes 
  an 
  addict 
  around 
  40 
  min 
  with 
  a 
  
razor 
  blade 
  to 
  defeat 
  the 
  delivery 
  system 
  of 
  new 
  Oxycontin 
  (called 
  Oxycontin 
  OP) 
  compared 
  with 
  a 
  
few 
  seconds 
  with 
  the 
  old 
  Oxycontin 
  OC. 
   
  Yet 
  it 
  can 
  still 
  be 
  snorted, 
  eaten 
  with 
  instant 
  release 
  of 
  all 
  the 
  
contents 
  all 
  at 
  once, 
  or 
  injected 
  IV, 
  but 
  it 
  takes 
  much 
  longer, 
  and 
  the 
  street 
  price 
  of 
  the 
  drug 
  has 
  
dropped 
  75%. 
   
  Many 
  drug 
  abusers 
  of 
  Oxycontin 
  have 
  moved 
  onto 
  the 
  short 
  acting 
  immediate 
  release 
  
products 
  Roxicodone 
  (oxycodone) 
  available 
  in 
  up 
  to 
  30mg 
  per 
  tablet 
  and 
  with 
  huge 
  abuse 
  potential. 
   
  
Some 
  patients 
  will 
  request 
  the 
  short 
  acting 
  drug 
  claiming 
  (frequently 
  correctly) 
  that 
  their 
  insurer 
  
will 
  not 
  cover 
  the 
  cost 
  of 
  oxycontin. 
   
  Even 
  state 
  programs 
  such 
  as 
  Medicaid 
  and 
  federal 
  Medicare 
  
programs 
  with 
  commercial 
  insurance 
  administrators 
  have 
  driven 
  patients 
  and 
  doctors 
  away 
  from 
  the 
  
long 
  acting 
  medications 
  with 
  drug 
  abuse 
  prevention 
  systems 
  to 
  the 
  short 
  acting 
  immediate 
  release 
  
drugs 
  because 
  of 
  cost 
  considerations 
  resulting 
  in 
  non-­‐coverage 
  decisions 
  or 
  requiring 
  appeals 
  and 
  
reams 
  of 
  paperwork 
  in 
  order 
  to 
  obtain 
  the 
  long 
  acting 
  drugs. 
   
   
   
  

 -­‐ 
   
   
  Hydrocodone. 
   
  This 
  is 
  a 
  semisynthetic 
  drug 
  (derived 
  from 
  thebaine 
  from 
  the 
  opium 
  poppy) 
  first 
  
synthesized 
  in 
  1920 
  in 
  Germany 
  and 
  introduced 
  into 
  the 
  US 
  in 
  1943 
  as 
  Hycodan. 
   
  It 
  is 
  the 
  most 
  
prescribed 
  drug 
  in 
  the 
  US 
  in 
  all 
  drug 
  classes 
  with 
  131 
  million 
  prescriptions 
  written 
  in 
  2010. 
   
  The 
  US 
  
uses 
  approximately 
  93% 
  of 
  the 
  world’s 
  supply 
  of 
  hydrocodone 
  and 
  it 
  is 
  available 
  as 
  5 
  and 
  10mg 
  
tablets 
  or 
  in 
  a 
  syrup. 
   
  The 
  use 
  of 
  hydrocodone 
  continues 
  to 
  grow 
  in 
  the 
  US 
  in 
  spite 
  of 
  the 
  existence 
  of 
  
the 
  increases 
  in 
  other 
  more 
  potent 
  drugs. 
   
  It 
  appears 
  the 
  easy 
  prescribing 
  of 
  the 
  drug 
  (being 
  a 
  
Schedule 
  III 
  drug 
  that 
  may 
  be 
  phoned 
  in 
  to 
  a 
  pharmacy, 
  unlike 
  the 
  other 
  drugs 
  in 
  this 
  list, 
  and 
  is 
  
refillable 
  for 
  up 
  to 
  6 
  months 
  on 
  a 
  single 
  prescription). 
   
  Overprescribing 
  of 
  the 
  drug 
  has 
  been 
  
encouraged 
  by 
  the 
  progressive 
  reduction 
  of 
  acetaminophen 
  included 
  as 
  a 
  co-­‐drug 
  with 
  hydrocodone 
  
permitting 
  ever 
  escalating 
  dosages 
  and 
  number 
  of 
  tablets 
  prescribed. 
   
  The 
  amount 
  of 
  acetaminophen 
  
used 
  to 
  act 
  as 
  a 
  backstop 
  to 
  prevent 
  physician 
  overprescribing 
  due 
  to 
  concerns 
  about 
  acetaminophen 
  
toxicity. 
   
  With 
  the 
  acetaminophen 
  amounts 
  dropping 
  from 
  the 
  old 
  formulation 
  500-­‐750mg 
  per 
  tablet 
  
to 
  250mg, 
  and 
  soon 
  zero 
  (approval 
  pending 
  by 
  the 
  FDA), 
  the 
  number 
  of 
  prescribed 
  pills 
  per 
  day 
  
escalated 
  from 
  4 
  to 
  10 
  or 
  more. 
   
  The 
  drug 
  is 
  up 
  to 
  90% 
  as 
  potent 
  as 
  oxycodone, 
  has 
  a 
  much 
  more 
  
variable 
  analgesic 
  effect 
  since 
  the 
  drug 
  must 
  be 
  metabolized 
  to 
  the 
  more 
  active 
  opioid 
  
hydromorphone 
  to 
  be 
  active 
  on 
  the 
  opioid 
  receptors, 
  and 
  should 
  by 
  all 
  rights 
  be 
  a 
  Schedule 
  II 
  opioid. 
   
  
Hydrocodone 
  less 
  commonly 
  results 
  in 
  death 
  compared 
  to 
  oxycodone 
  or 
  methadone, 
  but 
  it 
  is 
  
subjected 
  to 
  more 
  substance 
  abuse 
  since 
  it 
  is 
  so 
  readily 
  available. 
   
  The 
  new 
  sustained 
  release 
  
hydrocodone,that 
  may 
  soon 
  be 
  available 
  will 
  contain 
  far 
  more 
  hydrocodone 
  per 
  tablet 
  making 
  it 
  
potentially 
  an 
  abuse 
  problem. 
   
   
  In 
  1999, 
  a 
  medical 
  doctor 
  in 
  Syracuse, 
  NY, 
  and 
  director 
  of 
  an 
  
addiction 
  medicine 
  facility, 
  filed 
  a 
  citizen's 
  petition 
  with 
  the 
  DEA 
  asking 
  that 
  hydrocodone 
  products 
  
be 
  rescheduled 
  from 
  C-­‐III 
  to 
  C-­‐II. 
  Five 
  years 
  later, 
  the 
  DEA 
  requested 
  a 
  scheduling 
  recommendation 
  
from 
  the 
  FDA 
  (this 
  is 
  required 
  before 
  a 
  drug 
  can 
  be 
  scheduled 
  or 
  re-­‐scheduled). 
   
  Four 
  years 
  later, 
  
FDA 
  responded 
  but 
  did 
  not 
  recommend 
  changing 
  the 
  control 
  status 
  of 
  hydrocodone 
  products. 
  
According 
  to 
  an 
  Associated 
  Press 
  investigation 
  in 
  August 
  of 
  last 
  year, 
  when 
  queried 
  about 
  this, 
  both 
  
agencies 
  advised 
  that 
  the 
  matter 
  is 
  still 
  being 
  reviewed. 
  The 
  inertia 
  on 
  this 
  matter 
  shown 
  thus 
  far 
  by 
  
the 
  administrative 
  agencies 
  seems 
  to 
  have 
  migrated 
  to 
  the 
  Congress 
  where 
  a 
  bill 
  was 
  introduced 
  in 
  
the 
  House 
  in 
  March 
  2011 
  but 
  failed 
  to 
  gain 
  more 
  than 
  58 
  co-­‐sponsors. 
   
  In 
  2012, 
  the 
  US 
  Senate 
  took 
  up 
  
the 
  issue 
  and 
  passed 
  a 
  legislative 
  amendment 
  that 
  was 
  stripped 
  from 
  the 
  final 
  FDA 
  bill. 
   
  The 
  
hydrocodone 
  amendment 
  was 
  thwarted 
  by 
  pharmaceutical 
  industry 
  lobbyists 
  for 
  the 
  National 
  
Association 
  of 
  Chain 
  Drug 
  Stores 
  and 
  the 
  National 
  Community 
  Pharmacists 
  Association. 
   
  The 
  
objections 
  raised 
  by 
  these 
  industries 
  was 
  that 
  it 
  would 
  inconvenience 
  customers 
  that 
  had 
  severe 
  pain 
  
requiring 
  them 
  to 
  see 
  a 
  practitioner 
  before 
  the 
  drug 
  could 
  be 
  prescribed 
  (currently 
  it 
  simply 
  can 
  be 
  
phoned 
  into 
  the 
  pharmacy 
  without 
  seeing 
  the 
  patient 
  at 
  all) 
  and 
  that 
  pharmacies 
  would 
  require 
  to 
  
have 
  larger 
  secured 
  storage 
  areas 
  for 
  their 
  opioids. 
   
  But 
  one 
  cannot 
  discount 
  a 
  more 
  compelling 
  
reason: 
  sales. 
   
  In 
  2004, 
  US 
  retail 
  sales 
  of 
  hydrocodone/APAP 
  amounted 
  to 
  $93,680,000. 
  Seven 
  years 
  
later, 
  in 
  2010, 
  sales 
  of 
  this 
  formulation 
  of 
  hydrocodone 
  amounted 
  to 
  $1,905,254,710. 
   
  This 
  was 
  an 
  
increase 
  of 
  1,933.8 
  percent 
  increase 
  in 
  sales 
  revenue 
  in 
  just 
  7 
  years. 
  (NADDI 
  Newsletter 
  Vol45, 
  No 
  
17).
- Morphine. 
   
  Morphine 
  was 
  isolated 
  from 
  the 
  mixture 
  of 
  chemicals 
  in 
  the 
  opium 
  poppy 
  latex 
  by 
  
Serturner 
  in 
  1804 
  , 
  distributed 
  by 
  him 
  in 
  1817, 
  and 
  first 
  sold 
  commercially 
  by 
  Merck 
  in 
  1827. 
   
  The 
  
drug 
  continues 
  to 
  be 
  obtained 
  from 
  the 
  opium 
  poppy 
  today 
  with 
  up 
  to 
  21% 
  of 
  the 
  contents 
  of 
  the 
  
latex 
  consisting 
  of 
  morphine. 
   
  Whereas 
  opium 
  powder 
  is 
  nearly 
  insoluble 
  in 
  water, 
  the 
  salts 
  of 
  
morphine 
  are 
  readily 
  dissolvable 
  making 
  it 
  ideal 
  for 
  injection 
  during 
  the 
  civil 
  war. 
   
  It 
  was 
  touted 
  as 
  a 
  
treatment 
  for 
  opium 
  addiction 
  from 
  the 
  1840s 
  to 
  the 
  1870s, 
  but 
  a 
  skeptical 
  medical 
  profession 
  
largely 
  disputed 
  these 
  claims 
  given 
  the 
  clearly 
  addictive 
  nature 
  of 
  morphine 
  via 
  observation 
  of 
  
patients 
  behaviors. 
   
  The 
  drug 
  was 
  widely 
  available 
  in 
  patent 
  medicines, 
  over 
  the 
  counter 
  in 
  
pharmacies 
  without 
  a 
  prescription, 
  and 
  even 
  in 
  grocery 
  stores 
  until 
  around 
  1915 
  when 
  the 
  patent 
  
medicine 
  and 
  prescription 
  laws 
  made 
  it 
  available 
  only 
  via 
  physician 
  prescription. 
   
  Its 
  use 
  was 
  largely 
  
confined 
  to 
  acute 
  surgical 
  pain, 
  obstetrical 
  pain, 
  cancer, 
  and 
  major 
  trauma 
  for 
  most 
  of 
  the 
  20th 
  
century. 
   
  With 
  the 
  introduction 
  of 
  the 
  first 
  sustained 
  release 
  MS 
  Contin 
  in 
  1984 
  for 
  treatment 
  of 
  
severe 
  pain, 
  it 
  became 
  the 
  drug 
  of 
  choice 
  for 
  cancer 
  patients 
  given 
  that 
  the 
  immediate 
  release 
  
morphine 
  or 
  IV/IM 
  morphine 
  only 
  lasts 
  3-­‐4 
  hours. 
   
  The 
  drug 
  therefore 
  developed 
  a 
  reputation 
  as 
  a 
  
strong 
  opioid 
  used 
  to 
  treat 
  terminal 
  patients. 
   
  In 
  the 
  late 
  1980s 
  it 
  began 
  to 
  be 
  used 
  to 
  treat 
  chronic 
  
intractable 
  non-­‐malignant 
  pain 
  patients 
  with 
  some 
  success. 
  (40). 
   
  Once 
  the 
  patents 
  expired 
  on 
  MS 
  

 Contin, 
  the 
  pharmaceutical 
  manufacturing 
  industry 
  turned 
  their 
  attention 
  to 
  other 
  patented 
  opioid 
  
drugs 
  and 
  funded 
  a 
  series 
  of 
  research 
  papers 
  maligning 
  the 
  use 
  of 
  morphine, 
  touting 
  the 
  advantages 
  
of 
  their 
  newly 
  patented 
  drugs. 
   
  However, 
  morphine 
  use 
  for 
  chronic 
  non-­‐malignant 
  pain 
  continued 
  
and 
  several 
  other 
  manufacturers 
  in 
  the 
  1990s 
  and 
  2000s 
  developed 
  patented 
  delivery 
  systems 
  that 
  
were 
  different 
  than 
  MS 
  Contin, 
  permitting 
  the 
  sustained 
  release 
  forms 
  (Oramorph, 
  Kadian, 
  Avinza) 
  to 
  
be 
  patent 
  protected 
  once 
  again, 
  and 
  with 
  a 
  very 
  hefty 
  price 
  tag 
  per 
  pill 
  for 
  the 
  latter 
  two. 
  
Morphine 
  continues 
  to 
  be 
  problematic 
  in 
  drug 
  overdoses 
  in 
  the 
  US 
  primarily 
  because 
  the 
  short 
  acting 
  
form 
  (instant 
  release) 
  is 
  the 
  least 
  expensive 
  opioid 
  narcotic 
  prescribed 
  in 
  the 
  US. 
  Morphine 
  typically 
  
ranks 
  3rd 
  or 
  4th 
  among 
  opioids 
  involved 
  in 
  overdose 
  deaths, 
  and 
  is 
  usually 
  found 
  in 
  combination 
  with 
  
other 
  drugs 
  including 
  benzodiazepines 
  or 
  illicit 
  drugs. 
   
  Since 
  it 
  is 
  one 
  of 
  the 
  most 
  common 
  drugs 
  used 
  
for 
  cancer 
  treatments 
  (especially 
  by 
  hospice 
  programs 
  attempting 
  to 
  control 
  costs), 
  the 
  availability 
  of 
  
the 
  drug 
  is 
  widespread, 
  and 
  theft 
  of 
  the 
  drug 
   
  by 
  family 
  members 
  or 
  caregivers 
  from 
  cancer 
  patients 
  
is 
  not 
  uncommon. 
   
  The 
  instant 
  release 
  pill 
  forms 
  come 
  in 
  15 
  and 
  30mg 
  but 
  the 
  liquid 
  forms 
  have 
  5, 
  
10, 
  20mg 
  per 
  milliliter. 
   
  The 
  FDA 
  in 
  2009 
  for 
  a 
  time 
  banned 
  the 
  sale 
  of 
  liquid 
  morphine 
  due 
  to 
  the 
  fact 
  
that 
  it 
  had 
  been 
  released 
  so 
  long 
  ago 
  that 
  the 
  FDA 
  never 
  got 
  around 
  to 
  approving 
  it. 
   
  This 
  hyper-­‐
regulatory 
  activity 
  of 
  the 
  FDA 
  was 
  subsequently 
  reversed 
  later 
  in 
  2009 
  amid 
  protests 
  from 
  nearly 
  all 
  
cancer 
  groups 
  and 
  most 
  concerned 
  physician 
  groups. 
   
  The 
  sustained 
  release 
  forms 
  are 
  available 
  up 
  to 
  
200mg 
  per 
  tablet. 
   
  
-­‐ 
  Fentanyl 
   
   
  Fentanyl 
  is 
  a 
  synthetic 
  drug 
  first 
  developed 
  in 
  1959 
  and 
  released 
  in 
  1961 
  as 
  Sublimaze, 
  
the 
  injectable 
  citrate 
  salt 
  for 
  intravenous 
  use 
  in 
  surgery. 
   
  Because 
  its 
  potency 
  is 
  70 
  times 
  that 
  of 
  
morphine, 
  it 
  may 
  delivered 
  transdermally 
  or 
  transbuccal 
  in 
  addition 
  to 
  the 
  injectable 
  forms. 
   
  It 
  is 
  not 
  
a 
  good 
  oral 
  agent 
  with 
  at 
  least 
  90% 
  of 
  the 
  drug 
  being 
  metabolized 
  by 
  the 
  liver 
  on 
  first 
  pass 
  when 
  
taken 
  orally. 
   
  Although 
  it 
  is 
  very 
  difficult 
  to 
  extract 
  the 
  fentanyl 
  from 
  Duragesic, 
  one 
  of 
  the 
  
transdermal 
  patch 
  forms, 
  it 
  is 
  not 
  too 
  difficult 
  to 
  overdose 
  with 
  the 
  patches, 
  especially 
  if 
  one 
  forgets 
  
to 
  take 
  off 
  the 
  old 
  patch 
  after 
  three 
  days 
  (still 
  contains 
  about 
  1/3 
  the 
  initial 
  quantity 
  of 
  fentanyl) 
  or 
  if 
  
combined 
  with 
  benzodiazepines. 
  However, 
  the 
  transbuccal 
  forms 
  (Actiq, 
  Fentora, 
  Osalis, 
  etc) 
  that 
  are 
  
approved 
  for 
  cancer 
  use 
  only, 
  are 
  not 
  infrequently 
  stolen 
  from 
  cancer 
  patients 
  and 
  may 
  result 
  in 
  a 
  
very 
  rapid 
  overdose 
  death. 
   
  The 
  blood 
  levels 
  achieve 
  maximum 
  levels 
  within 
  10 
  minutes 
  of 
  usage 
  – 
  
not 
  too 
  dissimilar 
  to 
  intravenous 
  administration. 
   
  Therefore 
  these 
  drugs 
  are 
  highly 
  desired 
  by 
  the 
  
opioid 
  abusing 
  population. 
   
  Fortunately, 
  the 
  REMS 
  education 
  mandated 
  for 
  these 
  drugs 
  makes 
  it 
  clear 
  
to 
  physicians 
  these 
  drugs 
  are 
  for 
  cancer 
  pain 
  only 
  and 
  only 
  rarely 
  are 
  they 
  prescribed 
  for 
  non-­‐cancer 
  
pain 
  given 
  the 
  strong 
  company 
  statements 
  on 
  being 
  indicated 
  ONLY 
  for 
  cancer 
  pain 
  treatment 
  in 
  
opioid 
  tolerant 
  patients. 
   
  The 
  transdermal 
  patches, 
  prescribed 
  for 
  non-­‐malignant 
  and 
  malignant 
  pain, 
  
last 
  2-­‐4 
  days 
  with 
  steady 
  drug 
  delivery 
  during 
  that 
  time. 
   
  The 
  prescribing 
  of 
  only 
  10-­‐15 
  patches 
  per 
  
month 
  instead 
  of 
  120-­‐240 
  tablets 
  per 
  month 
  is 
  a 
  huge 
  deterrent 
  to 
  drug 
  sharing, 
  although 
  frequently 
  
patients 
  are 
  also 
  given 
  a 
  breakthrough 
  oral 
  medication. 
   
   
  The 
  patches 
  are 
  available 
  as 
  12, 
  25, 
  50, 
  75, 
  
and 
  100mcg/hour 
  delivery. 
   
  The 
  transbuccal 
  forms 
  are 
  available 
  up 
  to 
  1600mcg 
  per 
  tablet/film. 
   
   
  
-­‐ 
  Other 
  opioids 
   
  Other 
  opioids 
  that 
  are 
  involved 
  in 
  both 
  overdose 
  poisonings 
  and 
  substance 
  abuse 
  
include 
  hydromorphone 
  (Dilaudid, 
  Exalgo), 
  codeine, 
  meperidine 
  (Demerol), 
  butorphanol 
  (Stadol), 
  
and 
  buprenorphine 
  (Suboxone, 
  Subutex, 
  Butrans). 
   
  However 
  these 
  are 
  prescribed 
  much 
  less 
  than 
  the 
  
other 
  five 
  medications 
  above 
  and 
  are 
  consequently 
  less 
  available 
  for 
  substance 
  abuse/diversion. 
   
  
Suboxone 
  is 
  used 
  to 
  treat 
  opioid 
  addiction 
  and 
  has 
  a 
  ceiling 
  on 
  respiratory 
  depressant 
  effect, 
  
therefore 
  making 
  it 
  potentially 
  safer 
  than 
  the 
  other 
  opioids, 
  however 
  if 
  the 
  drug 
  is 
  mixed 
  with 
  
benzodiazepines 
  (Klonopin, 
  Xanax, 
  etc) 
  the 
  patient 
  may 
  overdose 
  and 
  die. 
   
   
  Codeine 
  is 
  prescribed 
  less 
  
and 
  less 
  due 
  to 
  gastric 
  irritation 
  and 
  the 
  fact 
  that 
  it 
  is 
  converted 
  in 
  the 
  body 
  into 
  morphine. 
   
  
Meperidine 
  (Demerol) 
  has 
  only 
  low 
  plasma 
  levels 
  attained 
  with 
  oral 
  dosing 
  therefore 
  is 
  used 
  less 
  and 
  
less, 
  whereas 
  some 
  family 
  physicians 
  continue 
  to 
  stock 
  the 
  injectable 
  drug 
  as 
  a 
  treatment 
  for 
  severe 
  
migraine 
  headaches 
  or 
  other 
  acute 
  pain 
  problems 
  to 
  keep 
  patients 
  from 
  having 
  to 
  visit 
  an 
  emergency 
  
department. 
  
 
  
 
  

 
  
 
  
 
  

 Morbidity 
  from 
  Opioid 
  Usage 
  
Whereas 
  mortality 
  represents 
  one 
  measure 
  of 
  the 
  cost 
  of 
  opioid 
  use, 
  morbidity 
  exceeds 
  mortality 
  
many 
  fold 
  in 
  cost 
  to 
  society 
  in 
  lost 
  productivity, 
  treatment 
  of 
  side 
  effects, 
  treatment 
  of 
  substance 
  
abuse, 
  drug 
  diversion, 
  pharmacy 
  and 
  personal 
  robberies 
  for 
  opioid 
  drugs, 
  etc. 
   
   
  The 
  cost 
  is 
  in 
  the 
  tens 
  
to 
  hundreds 
  of 
  billions 
  of 
  dollars 
  each 
  year. 
   
  Data 
  from 
  the 
  CDC 
  published 
  in 
  2008 
  show 
  opioid 
  usage 
  
has 
  resulted 
  in 
  in 
  massive 
  numbers 
  of 
  people 
  that 
  have 
  become 
  dependent 
  on 
  the 
  drugs 
  or 
  suffer 
  
significant 
  side 
  effects 
  resulting 
  in 
  emergency 
  treatment, 
  and 
  that 
  death 
  is 
  not 
  the 
  only 
  significant 
  
outcome 
  from 
  opioid 
  abuse/diversion. 
   
   
  
 
  

 
  
 
  

 
  
 
  
The 
  number 
  of 
  admissions 
  to 
  drug 
  rehabilitation 
  facilities 
  in 
  Indiana 
  is 
  depicted 
  in 
  the 
  next 
  two 
  
graphs 
  below. 
   
  Opioids 
  (outside 
  of 
  heroin) 
  treatment 
  ranks 
  4th 
  as 
  a 
  cause 
  of 
  treatment 
  in 
  Indiana 
  with 
  
admissions 
  showing 
  significant 
  growth 
  over 
  the 
  past 
  decade. 
   
  The 
  drugs 
  involved 
  in 
  admissions 
  
roughly 
  parallels 
  the 
  percentages 
  seen 
  nationally. 
   
  However, 
  compared 
  to 
  national 
  statistics, 
  Indiana 
  
number 
  of 
  admissions 
  as 
  of 
  2009 
  fell 
  below 
  1% 
  of 
  the 
  national 
  admissions 
  for 
  opioid 
  treatment 
  (the 
  
last 
  year 
  for 
  which 
  national 
  data 
  is 
  available 
  at 
  this 
  time). 
   
  Indiana’s 
  population 
  is 
  2% 
  of 
  the 
  US, 
  
therefore 
  Indiana’s 
  drug 
  problem 
  with 
  opioids 
  by 
  this 
  measure 
  is 
  less 
  than 
  half 
  of 
  what 
  would 
  be 
  
expected 
  based 
  on 
  population. 
   
  

 
  

  

 

Indiana Number of Admissions for
Drug Treatment 201 1 TEDS Reporting

 

 

 

 

 

System
6000 I Alcohol+secondary drug
I Marijuana
5000 -Alcohol only
4000 I Opioids other than heroin
- Other/Unknown
3000 - Heroin

2000 - I Cocaine
I Amphetamines
1000 Tranqu?uers
0 I Sedatives

 

 

 

 

 

Indiana Admissions for Drug
Treatment: Opioids Other than
Heroin (TEDS System Reporting)

 

3000

2500 

2000

 

 

1500

 

1000 

 

500

 

 

 

 

 

 
  
 
  
Substance 
  Abuse 
  and 
  Diversion 
  

 
  

Controlled 
  substance 
  prescribing, 
  to 
  a 
  greater 
  or 
  lesser 
  degree, 
  is 
  integrally 
  linked 
  to 
  substance 
  
abuse, 
  and 
  anyone 
  prescribing 
  controlled 
  substances 
  to 
  a 
  population 
  of 
  patients 
  will 
  have 
  some 
  that 
  
engage 
  in 
  substance 
  abuse 
  and 
  diversion. 
   
  
 
  
 
   
  
The 
  formal 
  terminology 
  of 
  drug 
  abuse 
  is 
  found 
  in 
  Appendix 
  C: 
  the 
  DSM 
  IV 
  explanation 
  of 
  
drug 
  dependence 
  and 
   
  abuse. 
   
  There 
  are 
  many 
  other 
  terms 
  used 
  that 
  are 
  incorrect 
  or 
  have 
  
connotations 
  of 
  nefarious 
  activities 
  or 
  are 
  derogatory. 
   
   
  The 
  most 
  common 
  term 
  is 
  “drug 
  addict”. 
   
  
This 
  is 
  not 
  a 
  DSM 
  IV 
  term 
  yet 
  is 
  widely 
  used 
  to 
  describe 
  a 
  person 
  with 
  out 
  of 
  control 
  proclivities 
  for 
  
obtaining 
  and 
  using 
  opioid 
  medications 
  for 
  the 
  euphoria 
  or 
  without 
  a 
  legitimate 
  medical 
  purpose. 
   
  
Substance 
  abuse 
  according 
  to 
  the 
  DSM-­‐IV 
  includes 
  one 
  of 
  the 
  following 
  in 
  a 
  12 
  month 
  period: 
  
Recurrent 
  use 
  resulting 
  in 
  failure 
  to 
  fulfill 
  major 
  role 
  obligation 
  at 
  work, 
  home 
  or 
  school; 
  Recurrent 
  
use 
  in 
  physically 
  hazardous 
  situations; 
  Recurrent 
  substance 
  related 
  legal 
  problems; 
  Continued 
  use 
  
despite 
  persistent 
  or 
  recurrent 
  social 
  oar 
  interpersonal 
  problems 
  caused 
  or 
  exacerbated 
  by 
  
substance. 
   
  Dependence 
  according 
  to 
  the 
  DSM-­‐IV 
  is 
  characterized 
  by 
  3 
  or 
  more 
  of 
  the 
  following 
  in 
  a 
  
12 
  month 
  period: 
  Tolerance 
  (marked 
  increase 
  in 
  amount; 
  marked 
  decrease 
  in 
  effect); 
   
  Characteristic 
  
withdrawal 
  symptoms; 
  Substance 
  taken 
  to 
  relieve 
  withdrawal; 
   
  Substance 
  taken 
  in 
  larger 
  amount 
  
and 
  for 
  longer 
  period 
  than 
  intended; 
   
  Persistent 
  desire 
  or 
  repeated 
  unsuccessful 
  attempt 
  to 
  quit; 
  
Much 
  time/activity 
  to 
  obtain, 
  use, 
  recover; 
  Important 
  social, 
  occupational, 
  or 
  recreational 
  activities 
  
given 
  up 
  or 
  reduced; 
  Use 
  continues 
  despite 
  knowledge 
  of 
  adverse 
  consequences 
  (e.g., 
  failure 
  to 
  fulfill 
  
role 
  obligation, 
  use 
  when 
  physically 
  hazardous) 
  
However, 
  the 
  term 
  dependence 
  is 
  uncommonly 
  used 
  outside 
  psychiatry. 
   
  Dependence 
  is 
  roughly 
  
equivalent 
  to 
  addiction. 
   
  Diversion 
  is 
  a 
  police 
  and 
  legal 
  term. 
   
  
 
  
Substance 
  abuse 
  and 
  drug 
  diversion 
  has 
  been 
  shown 
  in 
  several 
  studies 
  to 
  be 
  of 
  epidemic 
  
proportions 
  in 
  those 
  receiving 
  prescription 
  opioids. 
   
  Drug 
  sharing, 
  taking 
  controlled 
  substances 
  not 
  
prescribed, 
  failure 
  to 
  find 
  prescribed 
  drugs, 
  use 
  of 
  illicit 
  drugs 
  are 
  all 
  significant 
  findings 
  suggesting 
  
that 
  even 
  in 
  the 
  presence 
  of 
  opioid 
  agreements 
  and 
  clinic 
  prescribing 
  rules, 
  federal 
  and 
  state 
  laws, 
  
and 
  patient 
  education, 
  there 
  is 
  a 
  very 
  substantial 
  population 
  receiving 
  opioids 
  that 
  simply 
  do 
  not 
  care 
  

 about 
  laws 
  or 
  rules, 
  and 
  will 
  use 
  controlled 
  substances 
  in 
  whatever 
  way 
  they 
  so 
  desire. 
   
  Substance 
  
abuse 
  and 
  drug 
  diversion 
  are 
  defined 
  more 
  from 
  a 
  behavioral 
  standpoint 
  by 
  most 
  physicians. 
   
  Some 
  
of 
  these 
  are 
  listed 
  below. 
   
  
 
  
Behavior
Abuse/Diversion
Detection Method Outcome
Running 
  out 
  of 
  
May 
  be 
  either 
  abuse 
  or 
   UDS, 
  interim 
  pill 
  count, 
   May 
  result 
  in 
  death 
  of 
  
controlled 
  substances 
  
diversion 
  
self 
  reporting, 
   
  
others 
  if 
  meds 
  are 
  
early 
  
given 
  away/death 
  of 
  
patient 
  if 
  overuse 
  
Report 
  of 
  patient 
  
Diversion 
  or 
  
Interim 
  pill 
  count 
  then 
   May 
  be 
  a 
  classic 
  drug 
  
selling 
  
sometimes 
  angry 
  
check 
  INSPECT 
  and 
  
dealer 
   
  
spouse/other 
  
UDS 
  
Snorting 
  or 
  IV 
  injection 
   Diversion 
  
Track 
  marks, 
  pill 
  count 
   Death 
  due 
  to 
  several 
  
times 
  blood 
  levels 
  
achieved 
  compared 
  
with 
  oral 
  meds 
  
Illicits 
  in 
  UDS 
  
Diversion 
  
UDS 
  
Patient 
  will 
  take 
  
whatever 
  they 
  want 
  
whenever 
  they 
  want/ 
  
patient 
  may 
  be 
  trading 
  
meds 
  for 
  illicit 
  drugs 
  
Unprescribed 
  
Diversion/abuse 
  
UDS, 
  then 
  check 
  
Out 
  of 
  control 
  patient 
  
controlled 
  substance 
  in 
  
INSPECT 
   
  
may 
  result 
  in 
  death 
  
UDS 
  
No 
  prescribed 
  meds 
  in 
   Abuse/diversion 
  
UDS 
  then 
  pill 
  count 
  
Patient 
  may 
  be 
  
UDS 
  
overusing 
  the 
  meds, 
  
selling 
  the 
  meds, 
  or 
  has 
  
lost 
  physical 
  control 
  of 
  
meds 
  
INSPECT 
  multiple 
  
Abuse/diversion 
  
INSPECT/UDS 
  
Substance 
  abuse 
  with 
  
chronic 
  prescribers 
  
massive 
  use 
  of 
  drugs 
  
or 
  selling 
  drugs; 
   
  
doctor 
  shopper. 
  
Script 
  alteration 
  or 
  
Diversion 
  felony 
  
Pharmacy 
  detection 
  
Hydrocodone 
  is 
  at 
  
theft 
  of 
  scripts 
  or 
  
particularly 
  high 
  risk 
  
calling 
  in 
  own 
  meds 
  
of 
  being 
  called 
  in 
  by 
  
the 
  patient 
  
 
  
 
  Substance 
  abuse 
  is 
  frequently 
  not 
  appreciated 
  by 
  patients 
  as 
  being 
  problematic 
  nor 
  is 
  sharing 
  of 
  
drugs. 
   
  Many 
  patients 
  have 
  no 
  idea 
  it 
  is 
  a 
  crime 
  to 
  give 
  away 
  controlled 
  substances 
  to 
  another 
  person, 
  
especially 
  a 
  family 
  member. 
   
   
  Substance 
  abuse 
  (not 
  illegal) 
  includes 
  overuse 
  of 
  medications, 
  failure 
  
to 
  physically 
  control 
  medications 
  (lost, 
  stolen 
  prescriptions 
  that 
  are 
  unsecured), 
  have 
  additional 
  
unprescribed 
  controlled 
  substances 
  in 
  their 
  body, 
  binge 
  use 
  with 
  potentially 
  life 
  threatening 
  results, 
  
use 
  of 
  controlled 
  substances 
  with 
  alcohol, 
  use 
  of 
  more 
  than 
  prescribed 
  for 
  acute 
  pain 
  or 
  pain 
  
exacerbations 
  without 
  discussing 
  this 
  with 
  the 
  prescriber 
  first. 
   
   
  Drug 
  diversion 
  (illegal) 
  includes 
  
crushing 
  or 
  powderizing 
  prescription 
  controlled 
  substances 
  for 
  snorting, 
  huffing, 
  or 
  IV 
  injection; 
  
taking 
  transdermal 
  drugs 
  intravenously; 
   
  giving 
  away/selling/trading 
  prescription 
  controlled 
  
substances; 
   
  receiving 
  non-­‐prescribed 
  controlled 
  substances; 
  script 
  alteration 
  or 
  calling 
  in 
  ones 
  own 
  
medications; 
   
  failure 
  to 
  disclose 
  past 
  drug 
  abuse 
  history 
  (subterfuge) 
  or 
  being 
  prescribed 
  opioids 
  by 
  
other 
  prescriber 
  (subterfuge); 
   
  lying 
  to 
  a 
  prescriber 
  about 
  how 
  a 
  medication 
  is 
  being 
  taken 
  or 
  not 
  
disclosing 
  giving 
  away 
  or 
  sale 
  of 
  a 
  drug 
  (subterfuge); 
   
  claiming 
  lost 
  or 
  stolen 
  scripts 
  in 
  order 
  to 
  obtain 
  
more 
  controlled 
  substances 
  when 
  in 
  fact 
  the 
  controlled 
  substances 
  were 
  merely 
  overused; 
  stolen 
  
script 
  pads 
  (a 
  pad 
  of 
  controlled 
  substance 
  scripts 
  stolen 
  is 
  worth 
  $400 
  street 
  value). 
   
  Indiana 
  and 
  US 
  

 practitioners 
  do 
  not 
  have 
  available 
  at 
  this 
  time 
  the 
  tools 
  to 
  evaluate 
  past 
  substance 
  abuse 
  or 
  
diversion 
  history. 
   
  Screening 
  tests 
  completed 
  by 
  patients 
  on 
  past 
  substance 
  abuse 
  history 
  are 
  of 
  little 
  
value 
  if 
  the 
  patient 
  is 
  not 
  completely 
  truthful. 
   
  Also 
  see 
  the 
  section 
  below 
  on 
  number 
  of 
  pills 
  
prescribed 
  related 
  to 
  drug 
  diversion. 
   
  
 
  
Confirmed 
  2012 
  mass 
  spectroscopy 
  (virtually 
  100% 
  accurate) 
  nationwide 
  urine 
  drug 
  data 
  from 
  both 
  
Quest 
  and 
  AIT 
  Labs 
  confirm 
  massive 
  abuse 
  of 
  medications 
  in 
  those 
  being 
  prescribed 
  opioids. 
   
  
 
  

 
  
 
  
The 
  AIT 
  data 
  breakdown 
  shows 
  of 
  those 
  taking 
  other 
  controlled 
  substances 
  not 
  being 
  prescribed, 
  
29% 
  of 
  these 
  are 
  illicit 
  drugs 
  and 
  35% 
  are 
  taking 
  other 
  prescription 
  opioids. 
   
   
  What 
  prescribers 
  do 
  
with 
  this 
  data 
  largely 
  determines 
  whether 
  the 
  patient 
  continues 
  to 
  engage 
  in 
  substance 
  abuse. 
   
  
Whereas 
  some 
  physicians 
  will 
  stop 
  prescribing 
  opioids 
  in 
  case 
  of 
  a 
  urine 
  drug 
  screen 
  with 
  an 
  
aberrant 
  drug 
  screen, 
  many 
  will 
  simply 
  give 
  the 
  patient 
  a 
  warning, 
  and 
  may 
  not 
  test 
  again 
  for 
  a 
  year, 
  
providing 
  another 
  year 
  for 
  patients 
  to 
  overdose 
  or 
  to 
  continue 
  sharing 
  drugs 
  with 
  others 
  that 
  may 
  
overdose. 
   
  Even 
  if 
  a 
  patient 
  has 
  opioids 
  stopped 
  by 
  the 
  physician, 
  many 
  physicians 
  will 
  
inappropriately 
  try 
  to 
  refer 
  the 
  patient 
  elsewhere 
  for 
  continued 
  opioid 
  prescribing, 
  especially 
  
referral 
  to 
  pain 
  clinics. 
   
  However 
  studies 
  have 
  shown 
  in 
  populations 
  that 
  have 
  repeat 
  drug 
  screens, 
  
there 
  still 
  exists 
  substance 
  abuse 
  in 
  2/3 
  or 
  more, 
  thereby 
  confirming 
  the 
  existence 
  of 
  an 
  endemic 
  
drug 
  abusing/drug 
  diverting 
  cadre 
  that 
  is 
  being 
  perpetually 
  supported 
  by 
  physicians 
  prescribing 
  of 
  
opioids. 
   
   
  Physicians 
  that 
  continue 
  to 
  prescribe 
  opioids 
  in 
  the 
  face 
  of 
  doctor 
  shopping 
  (determined 
  by 
  
INSPECT), 
  substance 
  abuse/diversion 
  (determined 
  by 
  urine 
  drug 
  screen 
  with 
  confirmatory 
  testing), 
  
or 
  overt 
  drug 
  diversion 
  (police 
  reports/informant 
  reports 
  with 
  pill 
  counts 
  showing 
  drug 
  diversion) 
  
are 
  significantly 
  enabling 
  those 
  that 
  would 
  overdose 
  or 
  provide 
  others 
  with 
  medications 
  that 
  may 
  
result 
  in 
  overdose 
  and 
  death. 
   
   
  These 
  issues 
  are 
  complex, 
  and 
  would 
  best 
  be 
  handled 
  by 
  a 
  Controlled 
  
Substance 
  Board 
  rules 
  rather 
  than 
  by 
  legislation 
  since 
  there 
  are 
  many 
  nuances 
  and 
  judgments 
  that 
  
must 
  be 
  made 
  to 
  determine 
  the 
  type 
  of 
  misbehavior 
  in 
  which 
  patients 
  are 
  engaged. 
   
  However, 
  it 
  
would 
  be 
  useful 
  to 
  adopt 
  enhanced 
  drug 
  laws 
  that 
  specify 
  in 
  plain 
  English 
  that 
  sharing 
  drugs, 
  using 
  
controlled 
  substances 
  not 
  prescribed, 
  and 
  taking 
  drugs 
  in 
  a 
  manner 
  not 
  prescribed 
  becomes 
  a 
  
criminal 
  act 
   
  
 
  
Institutional, 
  insurance 
  company, 
  and 
  state 
  contributions 
  to 
  substance 
  abuse 
  and 
  drug 
  
diversion 
  also 
  exist. 
   
  For 
  instance, 
  the 
  veterans 
  administration 
  system 
  is 
  by 
  their 
  choice 
  completely 
  
independent 
  of 
  the 
  rest 
  of 
  the 
  state. 
   
  Opioid 
  prescriptions 
  received 
  by 
  patients 
  are 
  not 
  permitted 
  to 
  
be 
  entered 
  into 
  the 
  state 
  INSPECT 
  system, 
  thereby 
  promoting 
  substance 
  abuse 
  and 
  diversion 
  in 
  
patients 
  who 
  may 
  easily 
  see 
  physicians 
  within 
  and 
  outside 
  the 
  VA 
  simultaneously. 
   
  VA 
  physicians 
  in 
  
our 
  area 
  have 
  been 
  told 
  it 
  is 
  a 
  violation 
  of 
  patient 
  privacy 
  if 
  physicians 
  check 
  the 
  INSPECT 
  to 
  
determine 
  if 
  outside 
  physicians 
  are 
  prescribing 
  opioids, 
  and 
  the 
  VA 
  does 
  not 
  inform 
  non-­‐VA 
  
physicians 
  they 
  are 
  prescribing 
  controlled 
  substances 
  to 
  patients. 
   
  Similarly, 
  CFR 
  42 
  protects 
  those 
  
receiving 
  treatment 
  in 
  methadone 
  clinics 
  and 
  suboxone 
  clinics 
  from 
  having 
  confidential 
  psychiatric 
  
information 
  (including 
  receiving 
  methadone 
  or 
  suboxone 
  for 
  addiction 
  treatment) 
  to 
  outside 
  

 physicians 
  without 
  the 
  expressed 
  consent 
  of 
  the 
  patient. 
   
  Therefore, 
  patients 
  may 
  easily 
  be 
  receiving 
  
methadone 
  at 
  a 
  methadone 
  clinic 
  for 
  addiction 
  treatment 
  and 
  additional 
  methadone 
  from 
  a 
  private 
  
physician’s 
  office. 
   
  The 
  urine 
  drug 
  screens 
  would 
  show 
  up 
  as 
  appropriate. 
   
  The 
  federally 
  sanctioned 
  
lack 
  of 
  disclosure 
  of 
  this 
  information 
  may 
  lead 
  to 
  methadone 
  overdose 
  death 
  and 
  encourage 
  drug 
  
addiction. 
   
  Hospitals 
  that 
  admit 
  patients 
  for 
  drug 
  overdose, 
  respiratory 
  arrest 
  due 
  to 
  drug 
  overdose, 
  
or 
  other 
  complications 
  due 
  to 
  opioids 
  do 
  not 
  communicate 
  this 
  information 
  to 
  non-­‐staff 
  practitioners, 
  
and 
  unless 
  the 
  patient 
  volunteers 
  this 
  information, 
  continued 
  overprescribing 
  of 
  medications 
  may 
  
occur 
  leading 
  to 
  death. 
   
   
  Practitioners 
  instituting 
  controlled 
  substances 
  currently 
  have 
  no 
  obligation 
  
to 
  inform 
  other 
  practitioners 
  already 
  prescribing 
  controlled 
  substances 
  of 
  their 
  interventions. 
   
   
  
Coroners 
  currently 
  have 
  no 
  obligation 
  to 
  inform 
  physicians 
  about 
  a 
  patient 
  death 
  that 
  was 
  suspected 
  
or 
  proven 
  to 
  be 
  due 
  to 
  prescription 
  drugs, 
  thereby 
  perpetuating 
  physician 
  practices. 
   
  Medicaid 
  in 
  
Indiana 
  promotes 
  substance 
  abuse 
  by 
  making 
  it 
  impossible 
  to 
  use 
  tamper 
  resistant 
  drugs 
  such 
  as 
  
fentanyl 
  transdermal 
  by 
  adopting 
  policies 
  requiring 
  patients 
  to 
  not 
  be 
  able 
  to 
  take 
  anything 
  by 
  mouth 
  
in 
  order 
  to 
  be 
  eligible 
  for 
  the 
  medication. 
   
   
  Insurance 
  companies 
  also 
  have 
  instituted 
  such 
  restrictive 
  
policies 
  for 
  coverage 
  (on 
  financial 
  grounds, 
  not 
  medical 
  grounds) 
  that 
  tamper 
  resistant 
  opioids 
  and 
  
other 
  controlled 
  substances 
  are 
  not 
  approved 
  by 
  insurance 
  or 
  have 
  such 
  a 
  high 
  copay 
  so 
  as 
  to 
  make 
  
them 
  unaffordable. 
   
  These 
  policies 
  also 
  apply 
  to 
  generic 
  controlled 
  substances. 
   
   
   
  Laws 
  that 
  help 
  
control 
  some 
  of 
  these 
  institutional 
  issues 
  and 
  control 
  Medicaid’s 
  drug 
  abuse 
  perpetuating 
  policies 
  
would 
  be 
  useful. 
   
  
A 
  West 
  Virginia 
  study 
  (19) 
  found 
  that 
  of 
  those 
  that 
  died 
  from 
  overdose 
  from 
  prescription 
  
controlled 
  substances, 
  25.2% 
  were 
  doctor 
  shoppers 
  vs 
  3.6% 
  for 
  the 
  non-­‐deceased 
  population 
  and 
  
17.5% 
  were 
  pharmacy 
  shoppers 
  vs 
  1.3% 
  of 
  the 
  non-­‐deceased 
  population. 
   
  Factors 
  associated 
  with 
  
death 
  in 
  this 
  study 
  include 
  younger 
  age, 
  greater 
  number 
  of 
  prescriptions 
  dispensed, 
  exposure 
  to 
  
opioids 
  and 
  benzodiazepines 
  simultaneously, 
  and 
  doctor 
  and 
  pharmacy 
  shopping 
  . 
   
  Using 
  INSPECT, 
  
these 
  behaviors 
  are 
  readily 
  discovered 
  in 
  patients 
  receiving 
  controlled 
  substances 
  in 
  Indiana. 
   
   
  Over 
  
35,000,000 
  people 
  in 
  the 
  US 
  abused 
  drugs 
  last 
  year 
  (13% 
  of 
  the 
  over 
  age 
  12 
  population 
  according 
  to 
  
the 
  CDC). 
   
   
   
  Another 
  study 
  (21) 
  demonstrated 
  of 
  those 
  that 
  died 
  of 
  prescription 
  drugs, 
  78% 
  had 
  a 
  
history 
  of 
  substance 
  abuse 
  and 
  63% 
  had 
  diverted 
  non-­‐prescribed 
  drugs. 
   
  In 
  the 
  same 
  study, 
  22% 
  had 
  
used 
  nonmedical 
  route 
  of 
  administration 
  of 
  the 
  drug 
  (snorting, 
  IV), 
  21% 
  had 
  5 
  or 
  more 
  physicians 
  
prescribing 
  controlled 
  substances 
  in 
  the 
  year 
  prior 
  to 
  their 
  death, 
  alcohol 
  contributed 
  to 
  death 
  in 
  
17%, 
  illicit 
  drugs 
  in 
  16%, 
  and 
  17% 
  had 
  a 
  prior 
  overdose 
  history. 
   
   
   
  
 
  
The 
  National 
  Survey 
  on 
  Drug 
  Use 
  and 
  Health 
  2010 
  found 
  that 
  1/6 
  of 
  the 
  population 
  has 
  used 
  
prescription 
  pain 
  relievers 
  for 
   
  non-­‐medical 
  uses. 
   
  This 
  translates 
  to 
  nearly 
  50,000,000 
  Americans. 
   
  
The 
  most 
  commonly 
  reported 
  age 
  starting 
  to 
  use 
  prescription 
  pain 
  relievers 
  for 
  non-­‐medical 
  uses 
  is 
  
age 
  16 
  with 
  39% 
  of 
  the 
  population 
  starting 
  using 
  these 
  drugs 
  at 
  age 
  16 
  or 
  less. 
   
  50% 
  of 
  those 
  using 
  
prescription 
  pain 
  relievers 
  do 
  so 
  12 
  or 
  more 
  days 
  a 
  year 
  suggesting 
  occasional 
  use 
  is 
  common. 
   
  Of 
  
those 
  using 
  pain 
  relievers 
  in 
  the 
  past 
  12 
  months, 
  17.3% 
  spent 
  a 
  lot 
  of 
  time 
  during 
  any 
  one 
  month 
  
getting 
  our 
  using 
  pain 
  relievers. 
   
   
  22.6% 
  stated 
  they 
  often 
  use 
  more 
  pain 
  relievers 
  than 
  intended 
  and 
  
18.2% 
  said 
  they 
  needed 
  more 
  pain 
  relievers 
  that 
  they 
  used 
  in 
  order 
  to 
  get 
  the 
  desired 
  effect. 
   
   
  7.6% 
  
stated 
  using 
  the 
  same 
  amount 
  of 
  prescription 
  pain 
  relievers 
  had 
  less 
  effect 
  than 
  it 
  used 
  to. 
   
   
  34% 
  over 
  
the 
  past 
  12 
  months 
  wanted 
  to 
  try 
  to 
  cut 
  down 
  or 
  stop 
  using 
  pain 
  relievers 
  and 
  85% 
  said 
  they 
  were 
  
able 
  to 
  cut 
  down 
  or 
  stop 
  using 
  prescription 
  pain 
  relievers 
  when 
  they 
  wanted 
  or 
  tried 
  to 
  do 
  so. 
   
  10.5% 
  
said 
  they 
  had 
  problems 
  with 
  emotions, 
  nerves, 
  or 
  mental 
  health 
  that 
  were 
  probably 
  caused 
  or 
  made 
  
worse 
  by 
  their 
  use 
  of 
  prescription 
  pain 
  relievers. 
   
  6% 
  of 
  the 
  population 
  has 
  used 
  alprazolam 
  (Xanax) 
  
or 
  lorazepam 
  (Ativan) 
  non-­‐medically 
  in 
  the 
  past. 
   
  1.3% 
  of 
  the 
  entire 
  population 
  has 
  used 
  Soma 
  non-­‐
medically 
  in 
  the 
  past. 
   
  Of 
  the 
  prescription 
  opioids, 
  roughly 
  half 
  the 
  number 
  that 
  have 
  ever 
  used 
  them 
  
in 
  a 
  lifetime 
  will 
  engage 
  in 
  non-­‐medical 
  use. 
  (ratios 
  of 
  misuse/use 
  derived 
  from 
  data). 
   
   
  0.6% 
  of 
  the 
  
population 
  used 
  Oxycontin 
  non-­‐medically 
  in 
  the 
  last 
  year 
  = 
  1.8 
  million 
  Americans 
  . 
   
  5.1% 
  of 
  the 
  
population 
  has 
  used 
  hydrocodone 
  non-­‐medically 
  (lifetime) 
  and 
  1.3% 
  have 
  used 
  methadone 
  non-­‐
medically 
  (lifetime). 
   
  5.9% 
  of 
  the 
  population 
  will 
  drink 
  alcohol 
  then 
  engage 
  in 
  dangerous 
  activities 
  
each 
  year. 
   
  11.1% 
  of 
  the 
  population 
  has 
  used 
  cocaine 
  (lifetime) 
  39.6% 
  have 
  used 
  marijuana, 
  1.3% 
  
have 
  used 
  heroin, 
  6.6% 
  have 
  used 
  LSD, 
  1.5% 
  have 
  used 
  PCP, 
   
  1.5% 
  have 
  used 
  Ecstasy 
  (MDMA) 
  . 
   
  45% 
  
of 
  the 
  population 
  has 
  had 
  alcohol 
  in 
  the 
  past 
  month. 
  61% 
  of 
  the 
  population 
  has 
  used 
  alcohol 
  in 
  the 
  
past 
  year. 
   
  Of 
  those 
  that 
  have, 
  10.3% 
  use 
  it 
  288 
  days 
  or 
  more 
  each 
  year, 
  25.6% 
  use 
  alcohol 
  156 
  days 
  

 or 
  more 
  each 
  year, 
  37.4% 
  use 
  it 
  104 
  days 
  or 
  more 
  each 
  year, 
   
  53% 
  use 
  alcohol 
  over 
  52 
  days 
  a 
  year. 
   
  
30.9% 
  use 
  alcohol 
  12 
  days 
  or 
  less 
  per 
  year. 
   
  
Also 
  of 
  interest 
  from 
  this 
  national 
  survey 
  is 
  that 
  of 
  those 
  working, 
  72% 
  are 
  aware 
  of 
  a 
  written 
  policy 
  
about 
  employee 
  use 
  of 
  alcohol 
  or 
  drugs, 
  23% 
  state 
  there 
  is 
  not 
  a 
  written 
  policy, 
  and 
  5% 
  do 
  not 
  know. 
   
  
This 
  suggests 
  policies 
  about 
  drug 
  and 
  alcohol 
  use 
  and 
  misuse 
  are 
  common 
  in 
  industry 
  and 
  should 
  not 
  
be 
  a 
  surprise 
  when 
  receiving 
  pain 
  medications. 
   
   
  Also 
  42% 
  of 
  workplaces 
  test 
  its 
  employees 
  for 
  drug 
  
use 
  and 
   
  27% 
  are 
  known 
  to 
  test 
  for 
  alcohol 
  use. 
   
  The 
  majority 
  of 
  these 
  tests 
  are 
  random. 
   
  Once 
  testing 
  
positive 
  for 
  illicit 
  drugs 
  57% 
  are 
  fired, 
  18% 
  is 
  handled 
  on 
  an 
  individual 
  basis, 
  21% 
  the 
  employee 
  is 
  
referred 
  for 
  treatment 
  or 
  counseling. 
   
  This 
  suggests 
  that 
  drug 
  testing 
  is 
  common 
  in 
  the 
  workplace, 
  
and 
  getting 
  fired 
  is 
  the 
  most 
  common 
  outcome 
  of 
  use 
  of 
  illicit 
  drugs. 
   
  Physicians 
  prescribing 
  pain 
  
medications 
  therefore 
  should 
  not 
  feel 
  all 
  patients 
  are 
  oblivious 
  to 
  drug 
  testing 
  nor 
  to 
  the 
  
consequences 
  of 
  a 
  positive 
  test 
  for 
  an 
  illicit 
  drug. 
   
  
The 
  degree 
  of 
  substance 
  abuse, 
  even 
  in 
  more 
  controlled 
  circumstances 
  in 
  which 
  pain 
  
patients 
  receive 
  the 
  medications 
  directly 
  from 
  a 
  physician 
  is 
  not 
  inconsequential. 
   
  AIT 
  Laboratory 
  
national 
  data 
  (4) 
  (kindly 
  provided 
  to 
  IPS 
  on 
  request 
  from 
  AIT) 
  from 
  1/1/11-­‐4/31/12 
  show 
  41.4% 
  
are 
  taking 
  non-­‐prescribed 
  medications 
  (all 
  classes), 
  14.2% 
  are 
  taking 
  unprescribed 
  opioids, 
  and 
  
39.3% 
  tested 
  negative 
  for 
  the 
  prescribed 
  opioid. 
   
  The 
  most 
  common 
  non-­‐prescribed 
  opioid 
  was 
  
hydrocodone 
  and 
  the 
  most 
  common 
  illicit 
  drug 
  was 
  marijuana. 
  Quest 
  diagnostic 
  laboratories 
  in 
  their 
  
publication 
  “Prescription 
  Drug 
  Monitoring 
  2012” 
  (5) 
  had 
  similar 
  findings 
  in 
  patients 
  tested 
  with 
  
urine 
  drug 
  screens 
  as 
  shown 
  in 
  the 
  graph 
  below 
  from 
  2012 
  published 
  report 
  data 
  as 
  seen 
  below. 
   
   
  

 
  
Additionally, 
  Quest 
  found 
  that 
  younger 
  age 
  (18-­‐24) 
  had 
  a 
  higher 
  substance 
  abuse 
  rate 
  than 
  all 
  other 
  
ages 
  (inconsistent 
  results) 
  at 
  73% 
  and 
  decreased 
  steadily 
  to 
  59% 
  by 
  age 
  60, 
   
  however 
  all 
  ages 
  had 
  
high 
  substance 
  abuse 
  rates. 
   
  There 
  were 
  50% 
  more 
  inconsistencies 
  in 
  males 
  than 
  females. 
   
  Income 
  
level 
  did 
  not 
  significantly 
  correspond 
  to 
  inconsistency 
  rate 
  will 
  all 
  incomes 
  being 
  in 
  the 
  60-­‐70% 
  
range 
  and 
  Medicaid 
  patients 
  had 
  only 
  slightly 
  higher 
  inconsistency 
  rates 
  compared 
  to 
  private 
  
insurance 
  (72% 
  vs 
  62%). 
   
  Most 
  disturbing 
  is 
  that 
  on 
  repeat 
  testing, 
  the 
  rate 
  of 
  inconsistency 
  only 
  
decreased 
  from 
  62% 
  to 
  55% 
  suggesting 
  the 
  population 
  being 
  prescribed 
  opioids 
  simply 
  has 
  no 
  
intention 
  of 
  compliance 
  with 
  clinic 
  rules, 
  state 
  or 
  federal 
  laws, 
  prescribing 
  directions, 
  or 
  narcotic 
  
agreements 
  with 
  physicians 
  or 
  clinics. 
   
  It 
  is 
  possible 
  patients 
  receiving 
  opioids 
  around 
  the 
  country 
  
having 
  a 
  significant 
  number 
  of 
  chronic 
  substance 
  abusers 
  intermixed 
  with 
  the 
  legitimate 
  controlled 
  
pain 
  population 
  and 
  physicians 
  lack 
  the 
  tools 
  to 
  discern 
  between 
  these 
  groups. 
   
  Furthermore, 
  many 
  
primary 
  care 
  physicians 
  claim 
  they 
  do 
  not 
  have 
  time 
  for 
  compliance 
  monitoring 
  or 
  perpetuate 
  
substance 
  abuse 
  by 
  serially 
  referring 
  those 
  known 
  substance 
  abusers 
  to 
  one 
  pain 
  clinic 
  after 
  another 
  
after 
  another 
  as 
  patients 
  are 
  discharged 
  from 
  these 
  clinics 
  for 
  substance 
  abuse. 
   
  Patients 
  do 
  not 
  see 
  

 substance 
  abuse 
  as 
  a 
  violation 
  of 
  law 
  even 
  when 
  those 
  laws 
  exist 
  within 
  the 
  state, 
  speaking 
  to 
  the 
  
high 
  degree 
  of 
  permissiveness 
  associated 
  with 
  the 
  use 
  of 
  the 
  opioids 
  in 
  our 
  society. 
   
   
  
 
  
Requests 
  for 
  information 
  from 
  Ameritox, 
  one 
  of 
  the 
  largest 
  drug 
  testing 
  systems 
  in 
  America, 
  
were 
  met 
  with 
  referral 
  to 
  their 
  legal 
  department 
  and 
  refused 
  to 
  provide 
  even 
  basic 
  data. 
   
   
  
 
  
In 
  chronic 
  pain 
  patients 
  receiving 
  outpatient 
  opioid 
  therapy, 
  the 
  incidence 
  of 
  opioid 
  use 
  
disorder 
  (lifetime) 
  by 
  DSM 
  5 
  criteria 
  and 
  opioid 
  dependence 
  disorder 
  (DSM 
  4 
  criteria) 
  is 
  35% 
  and 
  is 
  
associated 
  with 
  a 
  past 
  history 
  of 
  opioid 
  abuse 
  (4.9 
  odds 
  ratio), 
  age 
  under 
  65 
  (odds 
  ratio 
  2.3), 
  and 
  
higher 
  opioid 
  withdrawal 
  symptoms 
  (odds 
  ratio 
  3.0). 
   
  Severe 
  opioid 
  use 
  disorder 
  is 
  found 
  in 
  13.2% 
  of 
  
patients 
  and 
  moderate 
  opioid 
  disuse 
  disorder 
  is 
  seen 
  in 
  21.7%. 
  (22). 
   
  This 
  study 
  strongly 
  suggests 
  
there 
  is 
  a 
  basal 
  level 
  of 
  substance 
  abusers 
  and 
  addicts 
  that 
  are 
  found 
  in 
  chronic 
  pain 
  populations. 
   
  
This 
  degree 
  of 
  substance 
  abuse 
  of 
  approximately 
  25-­‐40% 
  in 
  the 
  chronic 
  pain 
  population 
  is 
  
corroborated 
  by 
  several 
  other 
  studies. 
   
  (24-­‐31). 
   
  The 
  risk 
  to 
  these 
  patients 
  of 
  overdose 
  death 
  may 
  be 
  
much 
  higher 
  than 
  the 
  non-­‐abusing 
  population. 
  

 
  
Cost 
  of 
  Drug 
  Abuse 
  and 
  Diversion 
  
 
  
Societal 
  costs 
  for 
  substance 
  abuse 
  and 
  addiction 
  for 
  the 
  nation 
  exceeded 
  $467 
  billion 
   
  in 
  

2005 
  according 
  to 
  a 
  CASA 
  report 
  (43) 
  produced 
  by 
  the 
  National 
  Center 
  on 
  Addiction 
  and 
  Substance 
  
Abuse 
  published 
  in 
  2009. 
   
  This 
  amount 
  constituted 
  11% 
  of 
  the 
  total 
  budgets 
  of 
  the 
  federal 
  
government 
  plus 
  all 
  states 
  and 
  city 
  governments 
  combined 
  that 
  year. 
   
  By 
  now 
  the 
  cost 
  is 
  much 
  
higher. 
   
  These 
  costs 
  include 
  mainly 
  intervention 
  costs, 
  cost 
  of 
  jailing, 
  mental 
  health 
  treatment, 
  trial 
  
costs, 
  attorney 
  fees, 
  medication 
  costs, 
  and 
  other 
  interdictions. 
   
   
   
   
   
  
 
  
The 
  cost 
  of 
  drug 
  abuse 
  and 
  diversion 
  also 
  increases 
  crime 
  rates 
  including 
  violent 
  crime 
  rates. 
   
  
In 
  New 
  York 
  City, 
  6% 
  of 
  the 
  Special 
  Narcotics 
  Prosecutor’s 
  caseload 
  involved 
  prescription 
  drug 
  
related 
  arrests 
  in 
  2007 
  but 
  this 
  had 
  risen 
  to 
  15% 
  by 
  2010. 
   
  The 
  prosecutor 
  noted 
  that 
  violence 
  is 
  
becoming 
  more 
  commonly 
  associated 
  with 
  the 
  black 
  market 
  prescription 
  drug 
  trade, 
  and 
  
prescription 
  drug 
  investigations 
  have 
  involved 
  robberies, 
  gun 
  seizures, 
  and 
  in 
  some 
  cases, 
  seizures 
  of 
  
small 
  arsenals 
  (41). 
   
  Violent 
  crime 
  involving 
  direct 
  theft 
  of 
  opioids 
  from 
  pharmacies 
  have 
  increased 
  
dramatically 
  in 
  the 
  last 
  5 
  years. 
   
  NADDI, 
  the 
  national 
  association 
  of 
  drug 
  diversion 
  investigators, 
  has 
  
shown 
  an 
  escalating 
  number 
  of 
  pharmacy 
  robberies 
  at 
  gunpoint, 
  the 
  most 
  dramatic 
  involving 
  the 
  
perpetrators 
  entering 
  through 
  the 
  drive 
  in 
  window 
  of 
  the 
  pharmacy 
  while 
  the 
  pharmacy 
  was 
  open 
  
for 
  business. 
   
  Many 
  pharmacies 
  in 
  Indiana 
  have 
  been 
  robbed 
  at 
  gunpoint, 
  especially 
  for 
  oxycontin 
  
and 
  opana 
  er, 
  to 
  the 
  degree 
  that 
  some 
  pharmacists 
  have 
  stopped 
  stocking 
  these 
  medications 
  due 
  to 
  
the 
  risk 
  to 
  their 
  staff. 
   
   
  
 
  
Drug 
  addicted 
  babies 
  born 
  to 
  mothers 
  taking 
  opioids 
  have 
  increased 
  by 
  2-­‐4 
  times 
  between 
  
2003 
  and 
  2008 
  (42). 
   
  These 
  babies 
  are 
  born 
  with 
  Neonatal 
  Abstinence 
  Syndrome 
  (NAS) 
  that 
  may 
  
cause 
  seizures 
  in 
  the 
  newborn 
  along 
  with 
  other 
  physiological 
  alterations 
  requiring 
  hospitalization 
  in 
  
intensive 
  care, 
  sometimes 
  receiving 
  barbiturate 
  infusions. 
   
  This 
  results 
  in 
  not 
  only 
  increased 
  financial 
  
costs 
  to 
  society 
  (frequently 
  these 
  women 
  have 
  no 
  insurance 
  or 
  are 
  on 
  Medicaid) 
  but 
  clearly 
  induces 
  
short 
  term 
  medical 
  complications 
  in 
  the 
  unfortunate 
  offspring 
  of 
  these 
  women. 
   
  It 
  is 
  not 
  clear 
  what 
  
long 
  term 
  effects 
  may 
  result 
  but 
  it 
  has 
  been 
  proposed 
  long 
  term 
  behavioral 
  problems 
  that 
  may 
  
include 
  drug 
  addiction 
  have 
  been 
  postulated. 
   
   
  
 
  
 
  

 
  
Difficulty 
  of 
  Patients 
  and 
  Practitioners 
  Comprehending 
  Currently 
  Written 
  State 
  
Laws 
  Regarding 
  Opioids 
  
Indiana 
  State 
  laws 
  regarding 
  opioids 
  are 
  found 
  in 
  Appendix 
  F. 
   
  As 
  written 
  these 
  laws 
  are 
  cryptic 
  and 
  
incomprehensible 
  to 
  patients 
  and 
  practitioners 
  alike. 
   
   
  For 
  example, 
  the 
  law 
  that 
  prevents 
  people 
  
from 
  giving 
  away 
  or 
  sharing 
  drugs 
  is: 
  IC 
  35-­‐48-­‐4-­‐2 
   
  Dealing 
  in 
  a 
  schedule 
  I, 
  II, 
  or 
  III 
  controlled 
  
substance 
  in 
  which 
  “delivers” 
  is 
  stated 
  in 
  print 
  but 
  also 
  is 
  applied 
  to 
  sharing 
  or 
  giving 
  away 
  their 
  
medications. 
   
  Most 
  patients 
  are 
  unaware 
  of 
  this 
  law. 
  believing 
  that 
  “delivers” 
  means 
  selling 
  their 
  
medication. 
   
  Similarly, 
  receiving 
  an 
  opioid 
  even 
  if 
  it 
  is 
  given 
  to 
  a 
  person 
  for 
  free 
  is 
  made 
  illegal 
  under 
  
IC 
  35-­‐48-­‐4-­‐6 
  Possession 
  of 
  cocaine 
  or 
  narcotic 
  drug 
  that 
  discusses 
  Schedule 
  II 
  drugs 
  or 
  IC 
  35-­‐48-­‐
4-­‐7 
  Possession 
  of 
  a 
  controlled 
  substance; 
  obtaining 
  a 
  schedule 
  V 
  controlled 
  substance 
  (also 
  
includes 
  Schedule 
  II 
  controlled 
  substances). 
   
  The 
  law 
  IC 
  35-­‐48-­‐4-­‐14 
  Offenses 
  relating 
  to 
  

 registration 
  labeling 
  and 
  prescription 
  forms 
  contains 
  section 
  (c): 
  “ 
  A 
  person 
  who 
  knowingly 
  or 
  
intentionally 
  acquires 
  possession 
  of 
  a 
  controlled 
  substance 
  by 
  misrepresentation, 
  fraud, 
  forgery, 
  
deception, 
  subterfuge, 
  alteration 
  of 
  a 
  prescription 
  order, 
  concealment 
  of 
  a 
  material 
  fact, 
  or 
  use 
  of 
  a 
  
false 
  name 
  or 
  false 
  address 
  commits 
  a 
  Class 
  D 
  felony. 
  However, 
  the 
  offense 
  is 
  a 
  Class 
  C 
  felony 
  if 
  the 
  
person 
  has 
  a 
  prior 
  conviction 
  of 
  an 
  offense 
  under 
  this 
  subsection. 
  “ 
   
  This 
  is 
  the 
  section 
  of 
  the 
  law 
  used 
  
by 
  physicians 
  to 
  prevent 
  doctor 
  shopping 
  and 
  prevarication 
  in 
  order 
  to 
  obtain 
  opioids, 
  however 
  it 
  
exist 
  under 
  the 
  title 
  implying 
  registration 
  labeling 
  and 
  prescription 
  forms. 
   
  It 
  is 
  very 
  likely 
  most 
  
physicians 
  and 
  the 
  public 
  would 
  have 
  no 
  idea 
  to 
  look 
  for 
  this 
  subsection 
  that 
  specifies 
  lying 
  to 
  a 
  
physician, 
  giving 
  a 
  false 
  name, 
  address, 
  or 
  false 
  material 
  fact 
  is 
  a 
  crime. 
   
  Certainly 
  the 
  wording 
  seems 
  
not 
  to 
  apply 
  to 
  prescriptions 
  called 
  in 
  via 
  telephone 
  or 
  faxed, 
  and 
  given 
  the 
  newly 
  authorized 
  
Schedule 
  II 
  electronic 
  scripting 
  by 
  the 
  DEA, 
  this 
  law 
  would 
  not 
  necessarily 
  be 
  deemed 
  as 
  applicable 
  in 
  
those 
  situations. 
   
  In 
  any 
  case 
  the 
  way 
  the 
  law 
  is 
  written 
  does 
  little 
  to 
  make 
  it 
  clear 
  sharing 
  or 
  giving 
  
away 
  controlled 
  substances 
  or 
  lying 
  to 
  a 
  physician 
  in 
  order 
  to 
  obtain 
  controlled 
  substances 
  is 
  illegal. 
  
No 
  administrative 
  code 
  reflecting 
  these 
  crimes 
  could 
  be 
  found 
  and 
  there 
  is 
  apparently 
  not 
  a 
  specific 
  
state 
  website 
  or 
  handbook 
  that 
  explains 
  the 
  potential 
  for 
  criminal 
  acts 
  based 
  on 
  sharing, 
  giving 
  away, 
  
selling, 
  receiving, 
  or 
  trading 
  opioid 
  narcotics. 
   
  The 
  law 
  as 
  is 
  written 
  is 
  not 
  a 
  useful 
  educational 
  tool 
  for 
  
patients 
  nor 
  is 
  its 
  location 
  nor 
  meaning 
  readily 
  discoverable 
  by 
  physicians. 
   
  
 
  
 
   
  

Communication 
  Issues 
  Leading 
  to 
  Substance 
  Abuse 
  and 
  Death 
  
Many 
  patients 
  will 
  simultaneously 
  be 
  treated 
  by 
  3-­‐8 
  doctors 
  or 
  practitioners, 
  each 
  with 
  their 
  own 
  
area 
  of 
  specialization, 
  and 
  each 
  may 
  prescribe 
  a 
  medication 
  that 
  will 
  cause 
  sedation 
  or 
  impact 
  the 
   
  
metabolism 
  of 
  other 
  medications. 
   
   
  There 
  is 
  frequently 
  a 
  lack 
  of 
  communication 
  between 
  these 
  
different 
  specialists, 
  and 
  the 
  patients 
  may 
  not 
  divulge 
  they 
  are 
  receiving 
  treatment 
  from 
  several 
  
specialists. 
   
  The 
  prescribing 
  of 
  controlled 
  substances 
  by 
  more 
  than 
  one 
  physician 
  is 
  rampant 
  in 
  
Indiana, 
  especially 
  the 
  prescribing 
  of 
  opioids, 
  benzodiazepines, 
  and 
  barbituates. 
   
  Frequently 
  
physicians 
  do 
  not 
  check 
  INSPECT 
  and 
  in 
  fact, 
  only 
  40% 
  of 
  those 
  with 
  CSR 
  registrations 
  permitting 
  
prescribing 
  of 
  controlled 
  substances 
  are 
  enrolled 
  in 
  INSPECT. 
   
  Without 
  the 
  knowledge 
  of 
  other 
  
prescribing 
  physicians 
  of 
  controlled 
  substances, 
  a 
  physician 
  may 
  prescribe 
  a 
  deadly 
  concoction. 
   
  
Many 
  states 
  including 
  Texas, 
  West 
  Virgina, 
  and 
  Florida 
  have 
  found 
  the 
  combination 
  of 
  
benzodiazepines/carisoprodol 
  (Soma)/opioids 
  results 
  in 
  an 
  extraordinarily 
  high 
  death 
  rate. 
   
  But 
  
while 
  controlled 
  substances 
  represent 
  the 
  most 
  severe 
  risks, 
  many 
  other 
  drugs 
  have 
  sedating 
  
properties 
  and 
  may 
  contribute 
  to 
  death. 
   
  These 
  include 
  tricyclic 
  antidepressants, 
  muscle 
  relaxants 
  
other 
  than 
  carisoprodol, 
  antipsychotics 
  and 
  other 
  psychiatric 
  drugs, 
  Benedryl, 
  antihistamines, 
  etc. 
  
 
  
Patients 
  admitted 
  to 
  hospitals 
  due 
  to 
  drug 
  toxicity 
  or 
  overdose 
  frequently 
  do 
  not 
  have 
  this 
  
information 
  communicated 
  to 
  prescribers 
  of 
  controlled 
  substances 
  if 
  the 
  prescriber 
  is 
  not 
  in 
  the 
  
hospital 
  system, 
  does 
  not 
  have 
  privileges 
  at 
  the 
  hospital, 
  or 
  is 
  excluded 
  from 
  being 
  on 
  the 
  medical 
  or 
  
nursing 
  staff 
  due 
  to 
  exclusive 
  contracts 
  by 
  hospitals. 
   
  Patients 
  may 
  intentionally 
  withhold 
  
information 
  about 
  being 
  admitted 
  for 
  drug 
  overdose 
  in 
  order 
  to 
  continue 
  receiving 
  opioids. 
   
  Drug 
  
rehab 
  centers 
  only 
  occasionally 
  communicate 
  information 
  about 
  drug 
  treatment 
  to 
  prescribing 
  
physicians. 
   
  Methadone 
  clinics 
  never 
  communicate 
  information 
  that 
  they 
  are 
  giving 
  patients 
  
methadone 
  since 
  this 
  is 
  protected 
  by 
  federal 
  law, 
  therefore 
  patients 
  may 
  be 
  receiving 
  methadone 
  
from 
  these 
  clinics 
  and 
  from 
  the 
  pain 
  physician 
  or 
  prescriber 
  simultaneously 
  and 
  without 
  the 
  pain 
  
treatment 
  prescribers 
  knowledge 
  (methadone 
  clinics 
  are 
  excluded 
  from 
  INSPECT). 
   
  Similarly 
  the 
  VA 
  
does 
  not 
  enter 
  information 
  into 
  INSPECT 
  for 
  any 
  VA 
  patient 
  prescribed 
  a 
  controlled 
  substance, 
  nor 
  
does 
  the 
  VA 
  check 
  INSPECT 
  for 
  other 
  prescribers. 
   
  It 
  is 
  not 
  uncommon 
  for 
  pain 
  patients 
  to 
  be 
  
simultaneously 
  receiving 
  opioids 
  from 
  both 
  the 
  VA 
  and 
  non-­‐VA 
  physicians 
  with 
  the 
  increased 
  opioid 
  
load 
  sometimes 
  leading 
  to 
  death. 
   
  Coroners 
  frequently 
  do 
  not 
  communicate 
  the 
  death 
  of 
  a 
  patient 
  nor 
  
the 
  cause 
  of 
  death 
  to 
  a 
  prescriber 
  of 
  opioids 
  even 
  if 
  it 
  is 
  clear 
  the 
  opioid 
  was 
  the 
  cause 
  of 
  death. 
   
  This 
  
leads 
  to 
  an 
  insouciance 
  on 
  the 
  part 
  of 
  the 
  prescriber 
  who 
  may 
  never 
  know 
  they 
  have 
  patients 
  who 
  
have 
  died 
  due 
  to 
  a 
  drug 
  overdose 
  of 
  controlled 
  substances, 
  and 
  are 
  therefore 
  not 
  apt 
  to 
  change 
  their 
  
prescribing 
  practices. 
   
  Law 
  enforcement 
  does 
  not 
  communicate 
  the 
  arrest 
  of 
  a 
  patient 
  for 
  dealing 
  
drugs 
  to 
  the 
  physician 
  or 
  other 
  controlled 
  substance 
  prescriber. 
   
  Therefore 
  when 
  the 
  patient 
  
reappears 
  in 
  the 
  prescriber’s 
  clinic, 
  they 
  may 
  once 
  again 
  receive 
  opioids 
  from 
  the 
  unwitting 
  
physician. 
   
  Emergency 
  departments 
  often 
  see 
  chronic 
  pain 
  patients 
  and 
  will 
  deliver 
  intramuscular 
  or 
  

 intravenous 
  opioid 
  narcotics 
  as 
  a 
  treatment 
  for 
  a 
  pain 
  flair 
  up 
  in 
  those 
  receiving 
  chronic 
  opioid 
  
narcotics, 
  and 
  in 
  some 
  cases 
  will 
  initiate 
  treatment 
  with 
  high 
  potency 
  long 
  acting 
  opioids 
  or 
  will 
  
adjust 
  the 
  dosages 
  being 
  prescribed 
  upwards 
  without 
  consultation 
  with 
  the 
  prescriber 
  of 
  chronic 
  
opioid 
  therapy 
  and 
  without 
  notification 
  of 
  the 
  prescriber 
  of 
  these 
  about 
  the 
  patient 
  visit 
  to 
  the 
  
emergency 
  department. 
   
  Physicians 
  initiating 
  chronic 
  long 
  term 
  opioid 
  prescribing 
  for 
  chronic 
  pain 
  
may 
  fail 
  to 
  notify 
  the 
  primary 
  care 
  physician 
  or 
  other 
  physicians 
  of 
  this 
  therapy 
  initiation, 
  
subsequently 
  enhancing 
  the 
  chance 
  of 
  overdose 
  and 
  death 
  when 
  sedating 
  medications 
  are 
  
prescribed. 
   
   
  We 
  need 
  better 
  communication 
  between 
  all 
  entities 
  surrounding 
  the 
  use 
  of 
  patients 
  
receiving 
  opioids 
  for 
  pain 
  control 
  on 
  a 
  long 
  term 
  basis. 
   
  The 
  CSC 
  is 
  the 
  vehicle 
  proposed 
  to 
  initiate 
  
these 
  communications 
  efforts. 
   
   
  

 
  
Sources 
  of 
  Opioids 
  Contributing 
  to 
  Morbidity 
  and 
  Mortality: 
   
  The 
  US 
  has 
  a 
  closed 
  loop 
  

system 
  of 
  control 
  over 
  controlled 
  substance 
  drug 
  precursors, 
  drug 
  manufacturing 
  with 
  limits 
  placed 
  
on 
  the 
  amount 
  of 
  final 
  product 
  that 
  may 
  be 
  manufactured, 
  the 
  transport 
  and 
  storage 
  of 
  controlled 
  
substances, 
  distribution 
  to 
  wholesellers 
  and 
  retailers, 
  and 
  point 
  of 
  purchase 
  tracking 
  over 
  controlled 
  
substances. 
   
  With 
  the 
  exception 
  of 
  approximately 
  9% 
  of 
  the 
  controlled 
  substances 
  being 
  abused 
  
obtained 
  from 
  out 
  of 
  country 
  illegal 
  channels 
  and 
  the 
  small 
  amounts 
  obtained 
  via 
  theft, 
  the 
  vast 
  
majority 
  of 
  controlled 
  substances 
  used 
  in 
  the 
  US 
  are 
  prescribed 
  by 
  physicians. 
   
  Some 
  of 
  the 
  factors 
  
involved 
  in 
  inappropriate 
  prescribing 
  by 
  physicians 
  are 
  inadequate 
  physician 
  education, 
  lack 
  of 
  an 
  
appropriate 
  physician 
  office 
  monitoring 
  and 
  prescribing 
  infrastructure, 
  overprescribing 
  for 
  patients 
  
with 
  questionable 
  medical 
  conditions 
  or 
  with 
  known 
  substance 
  abuse 
  issues, 
  and 
  pill 
  mills 
   
  (see 
  the 
  
section 
  on 
  pill 
  mills 
  below). 
   
   
  However 
  the 
  crux 
  of 
  the 
  matter 
  is 
  this: 
   
  no 
  matter 
  how 
  little 
  or 
  how 
  
much 
  opioid 
  is 
  being 
  prescribed, 
  once 
  the 
  opioid 
  prescription 
  has 
  been 
  filled, 
  it 
  is 
  now 
  evident 
  from 
  
the 
  data 
  below 
  published 
  April 
  25, 
  2012 
  by 
  the 
  Office 
  of 
  National 
  Drug 
  Control 
  Policy 
  that 
  opioids 
  are 
  
freely 
  shared 
  or 
  stolen 
  from 
  those 
  individuals 
  with 
  the 
  prescriptions. 
   
  More 
  than 
  2/3 
  of 
  people 
  
abusing 
  prescription 
  opioids 
  for 
  the 
  first 
  usage 
  obtain 
  the 
  drug 
  from 
  friends 
  that 
  have 
  the 
  drug 
  
prescribed 
  to 
  them. 
   
  For 
  those 
  with 
  occasional 
  usage, 
  the 
  numbers 
  are 
  similar. 
   
  Of 
  those 
  taking 
  
opioids 
  chronically, 
  40% 
  of 
  those 
  are 
  abusing 
  these 
  drugs 
  by 
  obtaining 
  them 
  from 
  those 
  that 
  have 
  
prescriptions 
  for 
  the 
  drug 
  and 
  another 
  26% 
  are 
  doctor 
  shopping 
  to 
  multiple 
  physicians 
  in 
  order 
  to 
  
obtain 
  the 
  opioids. 
  
 
  

  
  
In 
  the 
  above 
  graph, 
  of 
  recent 
  initiate 
  abusers, 
  55% 
  had 
  the 
  prescription 
  medications 
  given 
  to 
  them 
  
for 
  free 
  while 
  15% 
  took 
  the 
  medications 
  from 
  friends 
  without 
  asking. 
   
  Similarly 
  high 
  percentages 
  are 
  
seen 
  with 
  occasional 
  abusers. 
   
  In 
  chronic 
  abusers, 
  the 
  permissiveness 
  of 
  friendship 
  has 
  waned 
  
although 
  there 
  remains 
  a 
  significant 
  number 
  of 
  abusers 
  obtaining 
  these 
  drugs 
  for 
  free 
  from 
  friends, 
  
or 
  may 
  purchase 
  the 
  drugs 
  from 
  friends. 
   
   
  Overall, 
  physicians 
  are 
  directly 
  responsible 
  for 
  17% 
  of 
  
substance 
  abuse 
  prescriptions. 
   
  They 
  are 
  indirectly 
  responsible 
  for 
  the 
  vast 
  majority 
  of 
  opioids 
  that 
  
reach 
  the 
  general 
  population 
  after 
  their 
  patients 
  divert 
  the 
  drugs 
  to 
  other 
  people. 
   
  81% 
  of 
  those 
  that 
  
obtained 
  the 
  drugs 
  from 
  friends 
  stated 
  their 
  friend 
  visits 
  only 
  one 
  doctor 
  for 
  prescription 
  narcotics. 
  
The 
  weak 
  link 
  in 
  control 
  of 
  drugs 
  in 
  the 
  system 
  is 
  after 
  patients 
  procure 
  the 
  medications 
  from 
  
physicians 
  but 
  physicians 
  clearly 
  supply 
  these 
  patients 
  with 
  the 
  drugs 
  and 
  the 
  patients 
  subsequently 
  
divert 
  the 
  medications 
  without 
  the 
  physician’s 
  knowledge. 
   
   
   
  
 
  
-­‐A 
  West 
  Virginia 
  mortality 
  study 
  in 
  2006 
  reported 
  56% 
  of 
  those 
  with 
  death 
  due 
  to 
  prescription 
  
opioids 
  had 
  no 
  prescription 
  for 
  the 
  drug. 
  (21). 
   
  
-­‐A 
  study 
  of 
  Virginia 
  methadone 
  overdose 
  deaths 
  in 
  2004 
  found 
  67% 
  did 
  not 
  have 
  a 
  prescription 
  for 
  
the 
  methadone, 
  5% 
  were 
  being 
  treated 
  in 
  Methadone 
  maintenance 
  clinics, 
  and 
  28% 
  were 
  being 
  
treated 
  in 
  pain 
  clinics. 
   
  Polysubstance 
  abuse 
  was 
  the 
  rule 
  rather 
  than 
  the 
  exception. 
  (10) 
  
-­‐A 
  Vermont 
  study 
  found 
  67% 
  of 
  overdose 
  deaths 
  due 
  to 
  methadone 
  had 
  obtained 
  the 
  drug 
  through 
  
diversion 
  and 
  only 
  33% 
  received 
  the 
  drug 
  legally 
  from 
  physicians. 
  (18) 
  
-­‐A 
  West 
  Virginia 
  study 
  found 
  nearly 
  half 
  the 
  deaths 
  in 
  the 
  state 
  occurred 
  through 
  use 
  of 
  
psychotrophic 
  drugs 
  with 
  benzodiazepines 
  found 
  in 
  37% 
  of 
  the 
  deaths. 
   
  Of 
  these, 
  46% 
  had 
  no 
  
prescription 
  for 
  the 
  drug. 
   
  (20) 
  
 
  
 
  

Relationship 
  of 
  Number 
  of 
  Pills 
  Prescribed, 
  Dosage, 
  Drug 
  Tampering, 
  and 
  Drug 
  
Diversion 
  

While 
  there 
  are 
  many 
  factors 
  that 
  go 
  into 
  the 
  determination 
  of 
  the 
  dosages 
  of 
  opioids 
  needed 
  to 
  
control 
  chronic 
  pain 
  symptoms 
  the 
  number 
  of 
  pills 
  may 
  be 
  determined 
  by 
  factors 
  outside 
  those 
  that 
  
are 
  medical. 
   
  Specifically, 
  insurance 
  companies 
  are 
  increasingly 
  shifting 
  the 
  cost 
  of 
  medications 
  to 
  

 
  

 patients 
  and 
  expensive 
  medications 
  are 
  being 
  dropped 
  in 
  lieu 
  of 
  less 
  expensive 
  medications 
  that 
  have 
  
more 
  of 
  an 
  abuse 
  potential. 
   
  Many 
  of 
  the 
  expensive 
  medications 
  are 
  no 
  longer 
  covered 
  except 
  at 
  
higher 
  tier 
  levels 
  or 
  are 
  simply 
  not 
  covered 
  at 
  all 
  by 
  insurance. 
   
  Such 
  shifts 
  in 
  costs 
  have 
  driven 
  
patients 
  into 
  taking 
  more 
  hazardous 
  pain 
  medications 
  such 
  as 
  methadone, 
  or 
  being 
  prescribing 
  
larger 
  number 
  of 
  pills 
  that 
  require 
  more 
  frequent 
  dosing. 
   
  For 
  instance, 
  a 
  patient 
  receiving 
  Oxycontin 
  
60mg 
  tablets 
  three 
  times 
  a 
  day 
  that 
  is 
  covered 
  by 
  their 
  insurance 
  will 
  have 
  a 
  sudden 
  unilateral 
  
change 
  in 
  insurance 
  coverage 
  with 
  Oxycontin 
  moved 
  to 
  a 
  very 
  high 
  tier 
  of 
  payment 
  making 
  it 
  
unaffordable. 
   
  The 
  prescribing 
  physician 
  may 
  then 
  be 
  forced 
  into 
  prescribing 
  more 
  of 
  the 
  short 
  acting 
  
equivalent 
  of 
  the 
  drug 
  that 
  is 
  still 
  covered 
  by 
  insurance 
  but 
  with 
  triple 
  or 
  quadruple 
  the 
  number 
  of 
  
pills. 
   
  Patient 
  safety 
  taking 
  many 
  short 
  acting 
  medications 
  per 
  day 
  may 
  be 
  compromised 
  due 
  to 
  the 
  
increase 
  in 
  peak 
  blood 
  levels 
  that 
  occur 
  with 
  short 
  acting 
  medications 
  compared 
  with 
  long 
  acting 
  
medications. 
   
  
 
  The 
  vast 
  number 
  of 
  pills 
  being 
  prescribed 
  because 
  of 
  medical 
  insurance 
  

carriers, 
  Medicaid, 
  and 
  Medicare 
  (outsourced 
  to 
  commercial 
  insurance 
  carriers) 
  
financial 
  decisions 
  to 
  place 
  their 
  bottom 
  line 
  above 
  patient 
  safety 
  are 
  causing 
  large 
  
numbers 
  of 
  pills 
  to 
  enter 
  the 
  supply 
  chain 
  of 
  sharing 
  of 
  drugs 
  leading 
  to 
  drug 
  abuse 
  
and 
  overdose 
  in 
  people 
  not 
  being 
  prescribed 
  these 
  medications. 
  Yet 
  physicians 
  cannot 
  force 
  

patients 
  to 
  purchase 
  expensive 
  long 
  acting 
  medications 
  when 
  they 
  are 
  completely 
  unaffordable, 
  even 
  
with 
  partial 
  coverage 
  by 
  insurance. 
   
   
  Methadone, 
  an 
  inexpensive 
  but 
  far 
  more 
  hazardous 
  opioid 
  was 
  
encouraged 
  by 
  several 
  state 
  Medicaid 
  and 
  WC 
  systems 
  as 
  an 
  alternative 
  to 
  more 
  expensive 
  drugs, 
  
especially 
  in 
  the 
  northwestern 
  US. 
   
  The 
  MMWR 
  publication 
  for 
  July 
  3, 
  2012 
  for 
  the 
  years 
  1999-­‐2010 
  
shows 
  the 
  NW 
  and 
  NE 
  US 
  having 
  a 
  much 
  higher 
  prescribing 
  rate 
  of 
  methadone 
  than 
  most 
  of 
  the 
  rest 
  
of 
  the 
  US. 
   
  
 
  
One 
  of 
  the 
  more 
  common 
  methods 
  drug 
  addicts 
  use 
  to 
  achieve 
  a 
  higher 
  drug 
  level 
  than 
  could 
  
be 
  attained 
  by 
  the 
  prescribed 
  oral 
  use 
  of 
  the 
  drugs 
  is 
  by 
  crushing 
  or 
  powderizing 
  the 
  drug, 
  then 
  
injecting 
  it 
  IV 
  (using 
  tap 
  water), 
  injecting 
  it 
  intramuscularly, 
  snorting 
  the 
  powder, 
  or 
  huffing 
  the 
  
powder 
  (inhaling 
  into 
  the 
  lungs). 
   
  Each 
  of 
  these 
  methods 
  produce 
  much 
  higher 
  doses 
  of 
  the 
  drug 
  that 
  
would 
  be 
  achieved 
  by 
  oral 
  usage 
  of 
  the 
  medication, 
  and 
  results 
  in 
  a 
  euphoric 
  “high”. 
   
  It 
  is 
  thought 
  
some 
  of 
  the 
  drug 
  overdose 
  deaths 
  seen 
  in 
  the 
  country 
  are 
  due 
  to 
  these 
  methods 
  of 
  drug 
  diversion 
  
(non 
  medical 
  use 
  in 
  a 
  manner 
  not 
  prescribed), 
  therefore 
  manufacturers 
  of 
  several 
  drugs 
  have 
  
introduced 
  tamper 
  resistant 
  (but 
  not 
  tamper 
  proof) 
  delivery 
  systems. 
   
  For 
  instance, 
  the 
  old 
  
Oxycontin 
  could 
  be 
  easily 
  abused 
  by 
  simply 
  crushing 
  it 
  by 
  biting 
  it, 
  thereby 
  releasing 
  massive 
  doses 
  
of 
  the 
  drug 
  all 
  at 
  once. 
   
  The 
  new 
  formulation 
  makes 
  it 
  turn 
  into 
  large 
  glue 
  like 
  particles 
  when 
  
smashed 
  or 
  crushed 
  and 
  these 
  are 
  not 
  snortable, 
  cannot 
  be 
  huffed, 
  and 
  are 
  very 
  difficult 
  to 
  dissolve 
  in 
  
water 
  or 
  saline 
  for 
  injection. 
   
  It 
  can 
  be 
  powderized 
  by 
  using 
  a 
  razor 
  blade 
  and 
  scraping 
  the 
  drug, 
  but 
  
this 
  takes 
  approximately 
  2 
  hours-­‐ 
  a 
  timeframe 
  that 
  is 
  not 
  well 
  tolerated 
  by 
  a 
  drug 
  abuser. 
   
  Opana 
  
similarly 
  has 
  a 
  tamper 
  resistant 
  mechanism 
  while 
  Exalgo 
  tablets 
  are 
  made 
  of 
  titanium 
  that 
  cannot 
  be 
  
crushed 
  without 
  significant 
  force 
  and 
  cannot 
  be 
  scraped. 
   
  Suboxone, 
  as 
  did 
  an 
  older 
  weak 
  opioid 
  
Talwin 
  NX, 
  incorporates 
  naloxone-­‐ 
  an 
  opioid 
  antagonist 
  that 
  reverses 
  the 
  effects 
  of 
  opioids. 
   
  The 
  
naloxone 
  is 
  active 
  only 
  if 
  injected, 
  therefore 
  drug 
  addicts 
  do 
  not 
  inject 
  suboxone 
  lest 
  they 
  go 
  into 
  
sudden 
  withdrawal. 
   
  Fentanyl 
  patches 
  contain 
  a 
  3 
  day 
  supply 
  of 
  the 
  opioid 
  and 
  it 
  is 
  difficult 
  to 
  extract 
  
the 
  fentanyl 
  from 
  the 
  patch 
  to 
  inject. 
   
  Because 
  fentanyl 
  patches 
  are 
  prescribed 
  in 
  so 
  few 
  units 
  per 
  
month 
  (10) 
  compared 
  to 
  other 
  opioids 
  and 
  because 
  of 
  the 
  difficulty 
  in 
  extracting 
  the 
  fentanyl, 
  drug 
  
sharing 
  of 
  fentanyl 
  is 
  uncommon 
  and 
  tampering 
  is 
  difficult. 
   
  Yet 
  some 
  insurers 
  have 
  eliminated 
  
fentanyl 
  from 
  their 
  formularies 
  even 
  though 
  it 
  is 
  available 
  as 
  a 
  generic 
  drug. 
   
  For 
  instance, 
  Indiana 
  
Medicaid 
  lists 
  fentanyl 
  patch 
  as 
  a 
  “preferred 
  drug” 
  yet 
  covers 
  it 
  only 
  for 
  cancer 
  or 
  for 
  people 
  that 
  
cannot 
  take 
  anything 
  by 
  mouth. 
   
  These 
  types 
  of 
  government 
  agency 
  rules 
  are 
  encouraging 
  drug 
  abuse 
  
and 
  overdose 
  by 
  eliminating 
  the 
  very 
  drugs 
  that 
  would 
  reduce 
  the 
  supply 
  of 
  shared 
  drugs 
  and 
  reduce 
  
tampering. 
   
  
Drug 
  diversion, 
  whether 
  it 
  be 
  selling 
  the 
  opioids 
  to 
  help 
  pay 
  the 
  mortgage 
  or 
  derive 
  extra 
  
spending 
  money, 
  or 
  giving 
  extra 
  pills 
  away 
  to 
  friends 
  and 
  family 
  are 
  significant 
  problems 
  associated 
  
with 
  opioids. 
   
  Of 
  note, 
  Xanax 
  is 
  also 
  an 
  extremely 
  desirable 
  street 
  drug 
  for 
  sale 
  yet 
  many 
  physicians 
  
prescribe 
  this 
  long 
  term 
  without 
  ever 
  documenting 
  effectiveness 
  of 
  treatment, 
  simply 
  filling 
  the 
  

 streets 
  with 
  these 
  drugs 
  that 
  are 
  being 
  shared 
  freely. 
   
  Selling 
  drugs 
  is 
  a 
  very 
  profitable 
  way 
  to 
  make 
  
extra 
  money, 
  especially 
  in 
  economic 
  downturns. 
   
  The 
  elderly 
  may 
  sell 
  these 
  medications 
  to 
  help 
  pay 
  
for 
  other 
  prescription 
  medications 
  needed 
  for 
  cardiac 
  medications 
  or 
  sell 
  the 
  drugs 
  for 
  food. 
   
  The 
  
Medicaid 
  population 
  is 
  at 
  very 
  high 
  risk 
  for 
  drug 
  diversion 
  given 
  their 
  relatively 
   
  penurious 
  existence 
  
and 
  the 
  loss 
  of 
  a 
  moral 
  compass 
  when 
  repeated 
  compromises 
  are 
  made 
  in 
  order 
  to 
  feed 
  their 
  
children 
  or 
  pay 
  the 
  mortgage. 
   
  Physicians 
  must 
  remain 
  ever 
  vigilant 
  for 
  this 
  behavior 
  and 
  act 
  
aggressively 
  to 
  immediately 
  stop 
  it 
  once 
  discovered, 
  no 
  matter 
  what 
  the 
  cost 
  to 
  the 
  patient. 
   
  
The 
  following 
  chart 
  is 
  a 
  comparison 
  of 
  monthly 
  scripts 
  of 
  equipotent 
  doses 
  of 
  medications 
  
and 
  their 
  costs 
  demonstrating 
  the 
  reasons 
  large 
  number 
  of 
  pills 
  are 
  being 
  prescribed. 
  These 
  figures 
  
are 
  cash 
  purchase 
  prices 
  from 
  CVS 
  for 
  a 
  one 
  month 
  supply 
  as 
  of 
  June 
  3, 
  2012 
  based 
  on 
  the 
  equipotent 
  
dosing 
  chart 
  of 
  Duragesic. 
   
  Tamper 
  resistance 
  is 
  based 
  on 
  ability 
  to 
  snort, 
  huff, 
  or 
  IV 
  inject 
  the 
  drug. 
   
  
All 
  the 
  drugs 
  below 
  may 
  be 
  abused 
  by 
  overdosing 
  or 
  taking 
  in 
  excess 
  of 
  what 
  is 
  prescribed. 
   
  Drug 
  
sharing 
  (freely 
  given 
  away) 
  proclivity 
  is 
  estimated 
  based 
  on 
  number 
  of 
  pills 
  prescribed, 
  price 
  paid 
  for 
  
the 
  pills. 
   
  Street 
  drug 
  prices 
  are 
  from 
  streetrx.com 
  and 
  bluelight.ru 
  . 
   
  The 
  profit 
  from 
  diversion 
  of 
  a 
  
script 
  is 
  calculated 
  as 
  # 
  pills 
  (units) 
  minus 
  cash 
  price 
  minus 
  physician 
  visit 
  fee 
  of 
  $75. 
   
   
  Of 
  course 
  the 
  
profit 
  will 
  be 
  greater 
  for 
  Medicaid 
  patients 
  that 
  spend 
  little 
  or 
  nothing 
  for 
  their 
  medications. 
   
  
 
  
Medication 
  

Active 
  
Ingredient 
  

Dosage 
  

Number 
  
Units 
  

CVS 
  
Cash 
  
 
  
Price 
  
($) 
  

Tamper 
  
Resistance 
  
 
  

Drug 
  
Sharing 
  

Street 
  
Drug 
  
Price 
  
per 
  Pill 
  

MS 
  IR 
  

Morphine 
  

180 
  

 
   
   
   
  68 
  

0 
  

+++ 
  

$4-­‐10 
  

MS 
  Contin 
  

Morphine 
  

90 
  

 
   
  259 
  

1 
  

++ 
  

$15-­‐36 
  

Kadian 
  

Morphine 
  

60 
  

 
   
  845 
  

2 
  

+ 
  

$30 
  

Avinza 
  

Morphine 
  

60 
  

 
   
  868 
  

2 
  

+ 
  

$30 
  

$857 
  

Oxycontin 
  

Oxycodone 
  

90 
  

1114 
  

3 
  

++ 
  

$30-­‐55 
  

Oxycodone 
  IR 
  

Oxycodone 
  

180 
  

 
   
  279 
  

0 
  

++++ 
  

Methadone 
  

Methadone 
  

360 
  

 
   
   
   
  74 
  

1 
  

++++ 
  

$10-­‐30 
  
(10mg) 
  
$5-­‐10 
  

Opana 
  ER 
  

Oxymorphone 
  

120 
  

1070 
  

3 
  

++ 
  

Oxymorphone 
  

240 
  

1106 
  

0 
  

+++ 
  

$55 
  
(40mg) 
  
$30 
  

$1511-­‐
3761 
  
$1446-­‐
5046 
  
$1651-­‐
3451 
  
$5455 
  

Opana 
  IR 
  
Fentanyl 
  patch 
  

Fentanyl 
  

10 
  

 
   
  371 
  

3 
  

+ 
  

$20-­‐60 
  

Hydrocodone 
  

Hydrocodone 
  

540 
  

 
   
  442 
  

0 
  

+++++ 
  

$4-­‐5 
  

Exalgo 
  

Hydromorphone 
  

120 
  

2673 
  

3 
  

+ 
  

?? 
  

Hydromorphone 
  

Hydromorphone 
  

240 
  

 
   
  289 
  

0 
  

+++ 
  

$10-­‐20 
  

Suboxone 
  

Buprenorphine 
  

30mg 
  
Q4H 
  
60mg 
  
Q8H 
  
100mg 
  
BID 
  
180mg 
  
QD 
  
60mg 
  
TID 
  
30mg 
  
Q4H 
  
10mg 
  3 
  
PO 
  Q6H 
  
45mg 
  
Q12H 
  
10mg 
  2 
  
PO 
  Q6H 
  
75mcg 
  
Q3D 
  
10/325 
  
3POQ4H 
  
16mg 
  4 
  
PO 
  QD 
  
8mg2PO 
  
Q6H 
  
8mg 
  BID 
  

Profit 
  
from 
  
Diversion 
  
Sale 
  of 
  
Entire 
  
Script 
  
$577-­‐
1,657 
  
$1016-­‐
2906 
  
$880 
  

60 
  

 
   
  560 
  

3 
  

+++ 
  

$5-­‐20 
  

$6019 
  
-­‐$246 
  to 
  
+$154 
  
$1643-­‐
2183 
  
 
   
   
   
  ???? 
  
$2036-­‐
$4436 
  
-­‐$335 
  to 
   
  
+$565 
  

 
  
The 
  dosage 
  per 
  day 
  for 
  most 
  chronic 
  pain 
  patients 
  is 
  less 
  than 
  300mg 
  equivalent 
  of 
  morphine 
  but 
  at 
  
the 
  upper 
  end, 
  this 
  may 
  vary. 
   
  More 
  experienced 
  physicians 
  in 
  pain 
  medicine 
  will 
  frequently 
  have 
  a 
  
cutoff 
  for 
  their 
  medical 
  practice 
  and 
  will 
  only 
  exceed 
  this 
  dosage 
  if 
  there 
  are 
  extraordinary 
  
indications. 
   
  Non-­‐pain 
  physicians 
  may 
  not 
  have 
  the 
  experience 
  with 
  limitations 
  on 
  dosing 
  and 
  will 
  

 continue 
  to 
  escalate 
  opioids 
  to 
  the 
  point 
  of 
  death. 
   
   
  The 
  profit 
  from 
  30mg 
  Roxicodone 
  (Oxycodone 
  IR) 
  
is 
  potentially 
  huge-­‐ 
  up 
  to 
  $5,000 
  per 
  month. 
   
  Opana 
  IR 
  and 
  ER 
  profits 
  are 
  even 
  higher 
  up 
  to 
  $6,000 
  
per 
  month. 
   
  Fentanyl 
  patch 
  and 
  suboxone 
  will 
  typically 
  require 
  insurance 
  coverage 
  or 
  Medicaid 
  to 
  be 
  
able 
  to 
  buy 
  the 
  drug 
  for 
  drug 
  dealers 
  in 
  order 
  to 
  make 
  a 
  profit, 
  whereas 
  all 
  the 
  others 
  (with 
  the 
  
exception 
  of 
  Exalgo 
  for 
  which 
  there 
  is 
  no 
  data) 
  may 
  garner 
  a 
  significant 
  profit 
  for 
  cash 
  payment 
  to 
  the 
  
pharmacy 
  for 
  the 
  drug. 
   
  Many 
  drug 
  dealers 
  will 
  frequently 
  ask 
  for 
  an 
  increase 
  in 
  the 
  number 
  of 
  pills 
  
prescribed 
  during 
  follow-­‐up 
  visits 
  with 
  their 
  physician 
  since 
  more 
  pills 
  equals 
  greater 
  profit 
  at 
  little 
  
extra 
  cost 
  to 
  the 
  drug 
  dealer. 
   
   
  For 
  many, 
  the 
  lure 
  of 
  easy 
  money 
  is 
  just 
  too 
  great, 
  especially 
  given 
  the 
  
profits 
  (tax 
  free) 
  over 
  one 
  year 
  may 
  exceed 
  their 
  highest 
  income 
  capable 
  from 
  working 
  by 
  500%. 
   
   
  
 
  
CLUES 
  TO 
  DRUG 
  DIVERSION 
  (SALE 
  OF 
  THE 
  PRESCRIBED 
  MEDICATION 
  FOR 
  PROFIT 
  OR 
  TRADING 
  
THE 
  MEDICATION) 
  
• The 
  patient 
  may 
  claim 
  to 
  be 
  functioning 
  at 
  a 
  high 
  level 
  with 
  little 
  pain, 
  but 
  asks 
  for 
  more 
  
opioid 
  medications 
  anyway 
  
• The 
  patient 
  may 
  have 
  vague 
  symptoms 
  of 
  pain 
  with 
  few 
  physical 
  exam 
  or 
  radiological 
  
findings 
  to 
  support 
  a 
  specific 
  diagnosis 
  
• Some 
  patients 
  may 
  claim 
  90-­‐100% 
  pain 
  control 
  all 
  the 
  time 
  with 
  the 
  current 
  medications 
  
being 
  prescribed 
  
• The 
  patient 
  may 
  be 
  self-­‐pay 
  with 
  no 
  income 
  but 
  is 
  capable 
  of 
  affording 
  more 
  expensive 
  
medications 
  and 
  specifically 
  asks 
  for 
  them 
   
   
  
• The 
  patient 
  may 
  be 
  self-­‐pay 
  or 
  have 
  Medicaid, 
  yet 
  is 
  immaculately 
  dressed 
  and 
  groomed, 
  
drives 
  a 
  new 
  car, 
  has 
  a 
  smart 
  phone, 
  and 
  frequently 
  takes 
  trips 
  around 
  the 
  country 
  or 
  buys 
  
new 
  houses 
  
• The 
  patient 
  may 
  pay 
  large 
  amounts 
  of 
  cash 
  at 
  the 
  pharmacy 
  for 
  their 
  prescriptions 
  
• Reports 
  of 
  patient 
  selling 
  their 
  medications 
  from 
  other 
  patients, 
  friends, 
  family 
  (caution: 
  
many 
  times 
  these 
  reports 
  are 
  with 
  ulterior 
  motives 
  and 
  sometimes 
  are 
  due 
  to 
  the 
  fact 
  these 
  
individuals 
  asked 
  the 
  patient 
  for 
  their 
  medications 
  but 
  were 
  refused. 
   
  Legitimate 
  reports 
  will 
  
have 
  a 
  name 
  and 
  telephone 
  number 
  by 
  the 
  reporter 
  and 
  the 
  assurance 
  the 
  person 
  is 
  also 
  
planning 
  on 
  reporting 
  the 
  patient 
  to 
  the 
  police). 
   
   
  
• Self 
  referred 
  patient 
  with 
  fabricated 
  medical 
  chart 
  or 
  a 
  doctor 
  that 
  is 
  no 
  longer 
  in 
  practice 
  in 
  
order 
  to 
  send 
  directly 
  to 
  the 
  physician 
  medical 
  records 
  
•  
  Illicit 
  drugs 
  or 
  non-­‐prescribed 
  controlled 
  substances 
  appearing 
  in 
  UDS-­‐ 
  patient 
  may 
  be 
  
trading 
  prescribed 
  opioids 
  for 
  these. 
  
• Multiple 
  physicians 
  chronic 
  prescribing 
  opioids 
  may 
  be 
  seen 
  on 
  INSPECT 
  
• Refuse 
  all 
  interventional 
  injections 
  or 
  procedures 
  due 
  to 
  vague 
  fears 
  of 
  needles 
  or 
  of 
  
anesthesia 
  used 
  for 
  sedation 
  for 
  those 
  fearful 
  of 
  needles, 
  or 
  claim 
  they 
  have 
  had 
  all 
  
interventional 
  procedures 
  without 
  success 
   
  
The 
  astute 
  drug 
  dealer 
  will 
  cover 
  all 
  their 
  tracks, 
  taking 
  some 
  of 
  the 
  medication 
  the 
  day 
  of 
  the 
  
scheduled 
  office 
  visit, 
  will 
  visit 
  only 
  one 
  physician 
  for 
  opioids, 
  and 
  are 
   
  compliant 
  with 
  urine 
  drug 
  
screens 
  (they 
  expect 
  them). 
   
   
  However 
  most 
  will 
  make 
  some 
  mistake 
  or 
  chronically 
  ask 
  for 
  more 
  
medications, 
  frequently 
  run 
  out 
  early, 
  and 
  may 
  have 
  a 
  UDS 
  without 
  explanation 
  of 
  aberrant 
  drugs 
  
showing 
  up. 
   
   
  
 
  
METHODS 
  TO 
  DETECT 
  DRUG 
  DIVERSION 
  (Sale 
  or 
  trade 
  of 
  medication) 
  
• Urine 
  drug 
  screen 
  with 
  GC/MS 
  or 
  LC/MS 
  confirmation. 
   
  Drug 
  dealers 
  may 
  have 
  the 
  parent 
  
drug 
  without 
  metabolites 
  showing 
  up 
  (means 
  they 
  have 
  not 
  been 
  chronically 
  taking 
  the 
  drug 
  
and 
  are 
  only 
  taking 
  the 
  drug 
  for 
  the 
  office 
  visit 
  in 
  case 
  of 
  a 
  UDS). 
   
  Non-­‐prescribed 
  controlled 
  
substances 
  may 
  show 
  up 
  or 
  illicit 
  drugs 
  may 
  be 
  present. 
   
  
• Pill 
  counts 
  mid 
  month. 
   
  Drug 
  dealers 
  frequently 
  have 
  buyers 
  lined 
  up 
  and 
  waiting 
  for 
  the 
  
drugs 
  or 
  may 
  sell 
  to 
  middlemen 
  who 
  know 
  exactly 
  when 
  their 
  physicians 
  appointment 
  is 
  to 
  
the 
  hour. 
   
  Mid 
  month 
  pill 
  counts 
  frequently 
  have 
  substitute 
  drugs 
  for 
  the 
  prescribed 
  drug 
  or 
  
may 
  have 
  unidentifiable 
  pills. 
   
  Pill 
  counts 
  by 
  the 
  dispensing 
  pharmacy 
  are 
  the 
  best 
  way 
  to 
  
assure 
  veracity. 
  

 •

•

•
•

Call 
  the 
  police 
  drug 
  diversion 
  unit 
  and 
  ask 
  if 
  there 
  have 
  been 
  any 
  reports 
  on 
  a 
  specific 
  
patient. 
   
  Ask 
  to 
  leave 
  your 
  office 
  number 
  and 
  have 
  the 
  police 
  call 
  you 
  back 
  at 
  your 
  office 
  
(establishes 
  the 
  legitimacy 
  of 
  the 
  query 
  and 
  identity 
  of 
  the 
  doctor) 
  
Convert 
  the 
  suspected 
  drug 
  dealer 
  to 
  a 
  drug 
  that 
  has 
  a 
  less 
  profit 
  margin 
  for 
  drug 
  dealers 
  
such 
  as 
  fentanyl 
  patches 
  or 
  suboxone, 
  especially 
  if 
  on 
  Medicaid 
  and 
  the 
  drugs 
  are 
  covered 
  
under 
  Medicaid. 
   
   
   
  
Convert 
  self 
  pay 
  patients 
  off 
  Opana, 
  Exalgo, 
  Oxycontin, 
  Kadian, 
  and 
  Avinza 
  since 
  self 
  pay 
  
cannot 
  afford 
  these 
  drugs 
  without 
  being 
  a 
  drug 
  dealer 
  in 
  many 
  cases. 
   
  
Place 
  limits 
  on 
  amount 
  of 
  pills 
  prescribed 
  and 
  avoid 
  the 
  highly 
  desired 
  drugs 
  such 
  as 
  
oxycodone 
  30mg. 
   
   
  

 
  

High 
  Risk 
  Groups 
  for 
  Drug 
  Overdose 
  

-­‐ 
  Medicaid 
  populations. 
   
  This 
  group 
  has 
  the 
  highest 
  substance 
  abuse 
  rate 
  and 
  drug 
  diversion 
  rate 
  of 
  
any 
  social 
  service 
  program 
  or 
  insured 
  patients 
  and 
  predictably 
  has 
  a 
  very 
  high 
  overdose 
  rate 
  from 
  
both 
  prescribed 
  and 
  un-­‐prescribed 
  opioids. 
   
  Drug 
  sharing 
  among 
  this 
  population 
  is 
  endemic 
  and 
  drug 
  
diversion 
  by 
  selling 
  the 
  prescriptions 
  in 
  order 
  to 
  supplement 
  meager 
  or 
  non-­‐existent 
  incomes 
  is 
  
significantly 
  problematic. 
   
  The 
  death 
  rate 
  from 
  prescription 
  opioid 
  overdoses 
  is 
  30.8/100,000 
  for 
  the 
  
Medicaid 
  population 
  compared 
  with 
  4/100,000 
  for 
  the 
  non-­‐Medicaid 
  population, 
  a 
  risk 
  factor 
  of 
  5.7 
  
(13) 
   
  In 
  Washington 
  State, 
  the 
  Medicaid 
  population 
  died 
  predominately 
  from 
  methadone 
  overdoses 
  
vs 
  other 
  opioids. 
   
  Ironically, 
  the 
  Medicaid 
  population 
  may 
  have 
  been 
  forced 
  into 
  taking 
  this 
  more 
  
dangerous 
  drug 
  by 
  restrictions 
  in 
  state 
  Medicaid 
  budgets 
  that 
  pushed 
  patients 
  into 
  using 
  this 
  very 
  
expensive 
  but 
  more 
  lethal 
  opioid. 
   
  Indiana 
  also 
  has 
  restrictions 
  on 
  the 
  usage 
  of 
  the 
  most 
  tamper 
  
resistant 
  opioids 
  that 
  force 
  physicians 
  into 
  prescribing 
  a 
  larger 
  number 
  of 
  short 
  acting 
  tablets 
  or 
  into 
  
prescribing 
  methadone, 
  a 
  much 
  more 
  hazardous 
  drug. 
   
  For 
  example, 
  fentanyl 
  patches 
  are 
  very 
  
difficult 
  to 
  abuse 
  and 
  are 
  typically 
  prescribed 
  at 
  a 
  rate 
  of 
  10 
  patches 
  per 
  month. 
   
  Indiana 
  requires 
  the 
  
Medicaid 
  population 
  to 
  have 
  tried 
  two 
  other 
  long 
  acting 
  opioids 
  and 
  there 
  is 
  a 
  requirement 
  the 
  
Medicaid 
  patient 
  is 
  incapable 
  of 
  taking 
  any 
  oral 
  medications. 
   
  This 
  effectively 
  eliminates 
  the 
  usage 
  of 
  
this 
  potentially 
  lifesaving 
  medication 
  in 
  the 
  Medicaid 
  population. 
   
  
-­‐ 
  Addiction 
  to 
  drugs 
  or 
  alcohol. 
   
  For 
  those 
  that 
  have 
  had 
  admission 
  to 
  hospitals 
  for 
  substance 
  abuse 
  
treatments, 
  those 
  with 
  a 
  dependency 
  on 
  opioids 
  had 
  a 
  5.7 
  times 
  higher 
  death 
  rate 
  than 
  non-­‐
substance 
  abusing 
  individuals. 
   
  Similarly, 
  methamphetamine 
  use 
  was 
  associated 
  with 
  a 
  4.67 
  fold 
  risk, 
  
marijuana 
  3.9 
  fold 
  risk, 
  alcohol 
  3.8 
  fold 
  risk, 
  and 
  cocaine 
  3.0 
  fold 
  risk. 
   
  These 
  deaths 
  were 
  not 
  
specifically 
  related 
  to 
  the 
  drug 
  (not 
  examined) 
  and 
  may 
  have 
  been 
  due 
  to 
  lifestyle 
  risks 
  associated 
  
with 
  drug 
  use. 
  (14) 
   
   
  Those 
  with 
  a 
  past 
  history 
  of 
  substance 
  abuse 
  with 
  smaller 
  dose 
  medications 
  
(hydrocodone) 
  frequently 
  continue 
  the 
  abuse 
  and 
  overuse 
  of 
  large 
  dose 
  medications 
  (oxycontin) 
  
with 
  sometimes 
  fatal 
  results. 
  
-­‐ 
  Sleep 
  apnea, 
  COPD, 
  obesity 
   
   
   
  Obesity 
  (Body 
  mass 
  index 
  known 
  as 
  BMI 
  >30) 
  is 
  epidemic 
  in 
  our 
  
society 
  with 
  approximately 
  the 
  same 
  number 
  of 
  obese 
  as 
  with 
  chronic 
  pain. 
   
  The 
  obesity 
  rate 
  in 
  the 
  
US 
  has 
  demonstrated 
  a 
  steady, 
  increase 
  in 
  rate 
  that 
  appears 
  to 
  be 
  accelerating. 
   
  In 
  1960, 
  the 
  obesity 
  
rate 
  was 
  12%; 
  by 
  1971-­‐75 
  it 
  was 
  16.0%; 
  by 
  1980 
  it 
  was 
  16.7%; 
  by 
  1994 
  it 
  had 
  increased 
  to 
  23.3% 
  
(NHANES 
  data) 
  and 
  today 
  27.5 
  of 
  adults 
  in 
  the 
  US 
  are 
  obese. 
   
  73.4% 
  of 
  males 
  in 
  Indiana 
  are 
  obese 
  or 
  
overweight 
  and 
  overall, 
  30.2% 
  of 
  Indianans 
  are 
  obese. 
  Indiana 
  obesity 
  has 
  increased 
  by 
  50% 
  over 
  the 
  
past 
  15 
  years 
  and 
  the 
  combined 
  overweight/morbid 
  obesity 
  levels 
  are 
  now 
  2/3 
  of 
  the 
  population 
  
according 
  to 
  the 
  CDC 
  (32). 
   
   
  Obesity 
  occurs 
  more 
  frequently 
  in 
  the 
  chronic 
  pain 
  population 
  whose 
  
activity 
  levels 
  are 
  substantially 
  lower 
  than 
  those 
  without 
  chronic 
  pain, 
  yet 
  their 
  food 
  intake 
  is 
  
unchanged. 
   
  Obesity 
  is 
  related 
  to 
  sleep 
  apnea 
  (33), 
  and 
  it 
  is 
  shown 
  2/3 
  of 
  those 
  with 
  BMI 
  of 
  35 
  or 
  
over 
  have 
  significant 
  sleep 
  apnea. 
   
  Increasing 
  weight 
  is 
  associated 
  with 
  a 
  decreased 
  functional 
  
residual 
  capacity 
  (oxygen 
  reserve 
  in 
  the 
  lungs) 
  and 
  increasing 
  upper 
  airway 
  obstruction. 
   
  Opioids 
  
and 
  benzodiazepines 
  further 
  worsen 
  these 
  conditions 
  in 
  the 
  sleeping 
  patient. 
   
  Sleep 
  apnea 
  is 
  
associated 
  with 
  greater 
  periods 
  of 
  hypoxia 
  (low 
  oxygen 
  state) 
  at 
  night 
  making 
  use 
  of 
  opioids 
  or 
  
especially 
  opioids 
  plus 
  benzodiazepines 
  far 
  more 
  hazardous. 
   
   
  

  
  
The 
  increased 
  sedentary 
  nature 
  of 
  the 
  obese 
  causes 
  reduction 
  in 
  exercise 
  capacity, 
  thereby 
  further 
  
reducing 
  cardiovascular 
  and 
  pulmonary 
  reserve. 
   
  It 
  also 
  appears 
  that 
  opioids 
  are 
  associated 
  with 
  the 
  
production 
  of 
  sleep 
  apnea. 
   
  Up 
  to 
  85% 
  of 
  patients 
  using 
  opioids 
  were 
  found 
  in 
  one 
  study 
  to 
  have 
  
sleep 
  apnea. 
  (37) 
  
-­‐Polypharmacy. 
   
  Many 
  patients 
  in 
  chronic 
  pain 
  take 
  several 
  different 
  sedative 
  or 
  respiratory 
  
depressant 
  medications 
  during 
  the 
  same 
  day. 
   
  Particularly 
  benzodiazepines 
  in 
  addition 
  to 
  opioids 
  are 
  
an 
  issue 
  causing 
  multiple 
  pathways 
  for 
  respiratory 
  depression, 
  disorientation, 
  falls, 
  etc. 
   
  In 
  DAWN 
  
2009 
  data 
  on 
  emergency 
  room 
  visits 
  for 
  drug 
  issues 
  demonstrated 
  virtually 
  the 
  same 
  number 
  taking 
  
opioids 
  as 
  benzodiazepines 
  with 
  significant 
  overlap. 
   
  Benzodiazepines 
  are 
  used 
  for 
  somewhat 
  
nebulous 
  indications 
  in 
  the 
  US, 
  particularly 
  for 
  patient 
  self 
  complaints 
  about 
  anxiety 
  without 
  any 
  
formal 
  testing, 
  documentation 
  of 
  corresponding 
  symptoms 
  and 
  signs 
  for 
  anxiety 
  disorders, 
  nor 
  any 
  
formal 
  psychiatric 
  visit. 
   
  Frequently 
  patients 
  are 
  placed 
  on 
  these 
  medications 
  for 
  profoundly 
  long 
  
time 
  periods 
  without 
  any 
  formal 
  reassessment 
  of 
  anxiety 
  or 
  attempts 
  to 
  wean 
  patients 
  from 
  these 
  
drugs. 
   
   
  Other 
  commonly 
  prescribed 
  but 
  problematic 
  drugs 
  leading 
  to 
  disorientation, 
  falls, 
  
fragmented 
  thinking, 
  etc 
  include 
  Soma 
  (carisoprodol), 
  Lyrica, 
  Neurontin, 
  and 
  Seroquel. 
  
-­‐Hepatic 
  or 
  Renal 
  Dysfunction. 
   
  The 
  levels 
  of 
  most 
  opioids 
  rise 
  significantly 
  in 
  the 
  blood 
  of 
  those 
  
with 
  liver 
  or 
  kidney 
  dysfunction. 
   
  Those 
  with 
  these 
  conditions 
  need 
  to 
  have 
  the 
  dosages 
  adjusted 
  
downward 
  or 
  switch 
  to 
  an 
  opioid 
  that 
  is 
  not 
  significantly 
  affected 
  by 
  these 
  issues 
  (buprenorphine). 
  
However 
  many 
  patients 
  will 
  develop 
  hepatic 
  or 
  renal 
  dysfunction 
  and 
  not 
  know 
  it 
  or 
  fail 
  to 
  tell 
  their 
  
physician 
  prescribing 
  opioids 
  at 
  the 
  time 
  this 
  is 
  discovered. 
   
  Overdose 
  may 
  occur 
  using 
  normal 
  or 
  
same 
  long 
  term 
  dosing 
  of 
  an 
  opioid 
  medication 
  in 
  the 
  presence 
  of 
  hepatic 
  or 
  renal 
  dysfunction. 
  
-­‐Psychological 
  disorder 
  history. 
   
   
  The 
  risk 
  of 
  substance 
  abuse 
  and 
  overdose 
  deaths 
  is 
  higher 
  for 
  
those 
  with 
  certain 
  psychiatric 
  disorders. 
   
  Clinical 
  depression 
  leads 
  to 
  an 
  increase 
  risk 
  ratio 
  of 
  1.2-­‐4.3 
  
while 
  anxiety 
  disorders 
  lead 
  to 
  a 
  risk 
  of 
  1.2-­‐3.0 
   
  (39) 
  
-­‐Other 
  factors: 
   
  use 
  of 
  illicit 
  drugs, 
  incarceration 
  for 
  sale 
  or 
  illegal 
  use 
  of 
  drugs, 
  prior 
  overdose 
  with 
  
opioids, 
  high 
  dose 
  opioid 
  use, 
  use 
  of 
  high 
  dose 
  (>80mg/day) 
  methadone 
  
 
  
All 
  these 
  issues 
  have 
  documented 
  proof 
  of 
  elevated 
  risk 
  and 
  should 
  be 
  addressed 
  by 
  prescribing 
  
physicians. 
   
   
  However, 
  the 
  complexities 
  of 
  these 
  multiple 
  issues 
  are 
  too 
  cumbersome 
  and 
  convoluted 
  
to 
  legislate 
  and 
  may 
  change 
  with 
  changing 
  scientific 
  data, 
  therefore 
  are 
  inappropriate 
  for 
  legislative 
  
control. 
   
  These 
  would 
  better 
  be 
  served 
  by 
  a 
  flexible 
  Controlled 
  Substance 
  Board. 
   
  
 
  
 
  

 Pill 
  Mills: 
   
  The 
  Scourge 
  of 
  Many 
  States, 
  Responsible 
  for 
  Significant 
  Morbidity 
  and 
  
Mortality 
  

 
  
Pill 
  mills 
  are 
  drug 
  dealers 
  with 
  a 
  physician’s 
  license, 
  and 
  the 
  Indiana 
  Pain 
  Society 
  has 
  provided 
  
criteria 
  for 
  pill 
  mills 
  in 
  Appendix 
  A. 
   
  Many 
  states 
  have 
  had 
  pill 
  mills 
  over 
  the 
  past 
  decade, 
  but 
  in 
  
Florida, 
  the 
  problem 
  became 
  epidemic 
  and 
  therefore 
  serves 
  as 
  an 
  example 
  of 
  what 
  is 
  to 
  be 
  avoided 
  
by 
  the 
  rest 
  of 
  the 
  country. 
   
  Florida, 
  until 
  2011, 
  had 
  literally 
  thousands 
  of 
  pain 
  clinics 
  that 
  prescribed 
  
opioids 
  in 
  relatively 
  high 
  quantities 
  for 
  many 
  years 
  until 
  the 
  recent 
  changes 
  in 
  state 
  law 
  required 
  
registration 
  of 
  pain 
  clinics, 
  enacted 
  rules 
  for 
  prescribing, 
  rules 
  of 
  ownership 
  of 
  these 
  clinics, 
  
developed 
  detailed 
  requirements 
  for 
  the 
  physical 
  layout 
  of 
  the 
  clinics, 
  and 
  created 
  a 
  prescription 
  
monitoring 
  program 
  for 
  controlled 
  substances. 
   
  Since 
  that 
  time, 
  the 
  number 
  of 
  pain 
  clinics 
  has 
  fallen 
  
precipitously 
  to 
  approximately 
  550, 
  down 
  from 
  over 
  1000 
  a 
  year 
  ago. 
   
  Florida, 
  had 
  pain 
  clinics 
  that 
  
were 
  frequently 
  owned 
  by 
  non-­‐physicians 
  and 
  some 
  were 
  owned 
  by 
  people 
  with 
  felony 
  
records. 
   
  Organized 
  crime 
  played 
  a 
  large 
  role 
  in 
  the 
  proliferation 
  and 
  running 
  of 
  these 
  operations 
  that 
  
fell 
  into 
  the 
  category 
  of 
  "pill 
  mill". 
   
  The 
  pill 
  mills 
  were 
  awash 
  with 
  unsavory 
  medical 
  practices 
  
including 
  the 
  use 
  of 
  parking 
  lot 
  attendants 
  to 
  direct 
  traffic, 
  security 
  guards 
  employed 
  by 
  the 
  clinic 
  
during 
  clinic 
  hours, 
  subterfuge 
  used 
  to 
  avoid 
  detection 
  of 
  nefarious 
  activities 
  by 
  law 
  enforcement, 
  5 
  
minute 
   
  or 
  less 
  visit 
  times, 
  employment 
  of 
  retired 
  physicians 
  or 
  physicians 
  with 
  no 
  training 
  in 
  pain 
  
medicine 
  or 
  any 
  relevant 
  background 
  specialty, 
  no 
  past 
  medical 
  records 
  required, 
  no 
  physical 
  exams 
  
performed, 
  frequent 
  prescribing 
  of 
  combinations 
  of 
  drugs 
  such 
  as 
  oxycontin/xanax/soma 
  or 
  
percocet/xanax/soma, 
  same 
  amounts 
  and 
  medications 
  prescribed 
  for 
  the 
  vast 
  majority 
  of 
  patients, 
  
the 
  presence 
  of 
  large 
  numbers 
  of 
  out 
  of 
  state 
  patients, 
  advertising 
  out 
  of 
  state 
  on 
  billboards 
  and 
  in 
  
out 
  of 
  state 
  newspapers, 
  pages 
  of 
  display 
  advertisements 
  in 
  the 
  back 
  of 
  many 
  newspapers 
  specifically 
  
for 
  pain 
  clinics, 
  paying 
  for 
  the 
  gasoline 
  to 
  drive 
  out 
  of 
  state 
  to 
  the 
  clinic, 
  and 
  selling 
  the 
  prescription 
  
drugs 
  at 
  inflated 
  prices 
  from 
  the 
  clinic 
  itself 
  without 
  a 
  pharmacist 
  intermediary. 
   
   
  Other 
  practices 
  
seen 
  included 
  the 
  use 
  of 
  pre-­‐signed 
  scripts 
  that 
  non-­‐physician 
  clinic 
  employees 
  could 
  use 
  to 
  write 
  
controlled 
  substances 
  for 
  patients 
  and 
  sometimes 
  for 
  themselves, 
  keeping 
  minimal 
  medical 
  records 
  
on 
  patients, 
  failure 
  to 
  employ 
  diagnostic 
  tests 
  or 
  referrals 
  to 
  other 
  physicians, 
  unusual 
  hours 
  of 
  
operation 
  running 
  up 
  to 
  16 
  hours 
  a 
  day 
  and 
  long 
  into 
  the 
  night, 
  the 
  lack 
  of 
  scheduled 
  appointments, 
  
failure 
  to 
  check 
  the 
  prescription 
  monitoring 
  program 
  once 
  it 
  became 
  available, 
  refusal 
  to 
  accept 
  any 
  
insurance 
  programs 
  (cash 
  only) 
  including 
  accepting 
  thousands 
  of 
  dollars 
  of 
  cash 
  for 
  medications 
  
being 
  purchased 
  in 
  the 
  clinic, 
  and 
  awareness 
  "drug 
  dealing" 
  was 
  occurring 
  in 
  the 
  parking 
  lots 
  and 
  in 
  
the 
  long 
  lines 
  of 
  patients 
  that 
  snaked 
  out 
  the 
  door 
  into 
  the 
  parking 
  lot. 
   
   
  Although 
  the 
  situation 
  in 
  
Florida 
  has 
  improved, 
  it 
  came 
  at 
  a 
  tremendous 
  loss 
  of 
  life 
  with 
  an 
  average 
  of 
  7 
  people 
  per 
  day 
  dying 
  
in 
  the 
  state 
  from 
  prescription 
  opioid 
  overdoses 
  and 
  untold 
  others 
  in 
  Appalacia 
  that 
  sought 
  care 
  in 
  
these 
  clinics. 
   
  What 
  is 
  clear 
  is 
  that 
  lack 
  of 
  action 
  by 
  state 
  legislators, 
  the 
  state 
  medical 
  board, 
  pain 
  
societies, 
  and 
  the 
  courts 
  over 
  a 
  decade 
  created 
  this 
  maelstrom 
  in 
  the 
  state. 
   
  It 
  is 
  also 
  clear 
  Florida 
  was 
  
a 
  significant 
  source 
  of 
  drug 
  diversion 
  for 
  millions 
  of 
  people 
  outside 
  the 
  state 
  and 
  millions 
  of 
  others 
  
inside 
  the 
  state. 
  Ultimately 
  the 
  greatest 
  harm 
  to 
  society 
  (aside 
  from 
  the 
  tens 
  of 
  thousands 
  of 
  deaths) 
  
has 
  been 
  the 
  decade 
  long 
  creation 
  of 
  a 
  pervasive 
  attitude 
  among 
  the 
  public 
  in 
  Florida 
  that 
  controlled 
  
substances 
  are 
  easy 
  to 
  obtain 
  for 
  no 
  legitimate 
  medical 
  purpose 
  and 
  may 
  be 
  shared 
  without 
  
consequence 
  since 
  many 
  of 
  the 
  pill 
  mills 
  would 
  happily 
  perform 
  early 
  refills 
  on 
  the 
  "lost 
  or 
  stolen" 
  
medications 
  or 
  would 
  treat 
  entire 
  families 
  at 
  the 
  same 
  time. 
   
   
  This 
  permissiveness 
  for 
  sharing 
  
controlled 
  substances 
  that 
  was 
  once 
  confined 
  to 
  the 
  younger 
  population 
  exists 
  among 
  all 
  age 
  and 
  
social 
  groups 
  in 
  Florida, 
  making 
  tight 
  control 
  of 
  the 
  medications 
  virtually 
  impossible. 
   
  There 
  were 
  
2,710 
  people 
  in 
  Florida 
  in 
  2010 
  that 
  died 
  of 
  accidental 
  prescription 
  drug 
  overdoses 
  compared 
  with 
  
720 
  in 
  Indiana. 
   
  Fortunately, 
  Indiana 
  never 
  developed 
  the 
  problem 
  with 
  numerous 
  pill 
  mills 
  
operating 
  throughout 
  the 
  state, 
  and 
  this 
  serves 
  as 
  a 
  testament 
  to 
  the 
  Indiana 
  Medical 
  Board’s 
  efforts 
  
to 
  control 
  excessive 
  examples 
  of 
  prescribing 
  through 
  board 
  actions. 
  
 
  

PROBLEM 
  PRESCRIBERS 
  AND 
  PILL 
  MILLS 
  IN 
  INDIANA 
  
The 
  Indiana 
  INSPECT 
  program 
  refused 
  a 
  request 
  to 
  list 
  the 
  specialties 
   
  (not 
  practitioner 
  
names) 
  of 
  the 
  top 
  10 
  prescribers 
  citing 
  restrictions 
  on 
  the 
  data 
  it 
  may 
  divulge 
  for 
  research 
  purposes. 
  
This 
  is 
  exactly 
  the 
  data 
  that 
  should 
  be 
  made 
  available 
  to 
  physician 
  groups, 
  boards 
  of 
  professions, 
  and 
  

 legislators 
  to 
  help 
  determine 
  whether 
  there 
  exists 
  out 
  of 
  control 
  prescribers 
  but 
  INSPECT 
  feels 
  
constrained 
  by 
  state 
  laws 
  to 
  not 
  provide 
  even 
  any 
  general 
  data 
  about 
  opioid 
  prescribing. 
   
  This 
  is 
  
clearly 
  counterproductive 
  to 
  drug 
  control 
  efforts 
  in 
  Indiana 
  and 
  the 
  laws 
  need 
  to 
  be 
  changed 
  to 
  
permit 
  someone 
  to 
  use 
  this 
  data 
  in 
  an 
  effective 
  manner 
  to 
  proactively 
  monitor 
  the 
  activities 
  of 
  those 
  
that 
  would 
  potentially 
  cause 
  mortality 
  in 
  the 
  population. 
  
Indiana 
  did 
  not 
  develop 
  any 
  significant 
  concentration 
  of 
  pill 
  mills 
  (massive 
  prescribing 
  of 
  
opioids 
  without 
  a 
  legitimate 
  medical 
  purpose) 
  compared 
  to 
  other 
  states 
  such 
  as 
  Florida, 
  Kentucky, 
  or 
  
Texas. 
   
  This 
  is 
  certainly 
  not 
  due 
  to 
  tight 
  regulation 
  of 
  opioid 
  prescribing 
  since 
  Indiana 
  exists 
  as 
  one 
  of 
  
only 
  two 
  states 
  in 
  the 
  US 
  without 
  any 
  opioid 
  prescribing 
  laws, 
  regulations, 
  or 
  rules. 
   
  One 
  may 
  surmise 
  
based 
  on 
  this 
  data 
  the 
  state 
  Board 
  of 
  Medicine 
  has 
  therefore 
  done 
  an 
  exemplary 
  job 
  of 
  curtailing 
  such 
  
pill 
  mill 
  activity. 
   
  The 
  IPS 
  conducted 
  several 
  studies 
  to 
  ascertain 
  the 
  degree 
  to 
  which 
  pill 
  mills 
  were 
  
operating 
  in 
   
  the 
  state. 
   
  Firstly, 
  “Pain 
  Clinics” 
  were 
  queried 
  in 
  yellow 
  pages 
  throughout 
  the 
  state 
  and 
  
revealed 
  1127 
  listings. 
   
  Pain 
  clinics 
  in 
  other 
  states 
  are 
  often 
  fronts 
  for 
  pill 
  mills 
  and 
  nefarious 
  medical 
  
practices. 
   
  In 
  Indiana, 
  only 
  84 
  of 
  these 
  listings 
  involved 
  physicians 
  and 
  the 
  remainder 
  were 
  physical 
  
therapy, 
  chiropractic, 
  and 
  massage. 
   
  Using 
  the 
  search 
  parameter 
  “Physicians 
  and 
  surgeons 
  pain 
  
management” 
  there 
  were 
  55 
  listings 
  returned 
  for 
  the 
  state. 
   
  8 
  of 
  these 
  are 
  duplicates, 
  10 
  are 
  
chiropractors 
  inappropriately 
  advertising 
  falsely, 
  1 
  is 
  a 
  podiatrist, 
  1 
  is 
  an 
  urgent 
  care 
  clinic, 
  and 
  2 
  are 
  
closed 
  clinics. 
   
  Therefore 
  of 
  the 
  33 
  physicians 
  practices 
  remaining, 
  one 
  is 
  a 
  family 
  practitioner, 
  two 
  
are 
  osteopathic 
  physicians 
  practicing 
  general 
  osteopathy. 
   
  Therefore 
  there 
  are 
  only 
  30 
  physician 
  pain 
  
practices 
  listed 
  under 
  pain 
  management 
  using 
  this 
  metric. 
   
  Next 
  every 
  hospital 
  in 
  the 
  state 
  was 
  
queried 
  for 
  pain 
  management 
  and 
  181 
  physicians 
  were 
  found 
  listed. 
   
  Many 
  of 
  these 
  are 
  primarily 
  in 
  
anesthesiology, 
  neurology, 
  and 
  PMR 
  practicing 
  pain 
  medicine 
  only 
  part 
  time 
  or 
  with 
  a 
  minority 
  of 
  
their 
  patients. 
   
  Therefore 
  the 
  number 
  of 
  active 
  pain 
  physicians 
  prescribing 
  opioids 
  is 
  between 
  30 
  and 
  
180 
  in 
  Indiana 
  compared 
  with 
  14,500 
  physicians 
  practicing 
  in 
  the 
  state. 
   
   
  The 
  IPS 
  conducted 
  a 
  study 
  
in 
  April 
  2012 
  of 
  the 
  Indiana 
  Board 
  of 
  Medicine 
  actions 
  against 
  Indiana 
  physicians 
  for 
  the 
  past 
  10 
  
years. 
   
  Of 
  the 
  80 
  petitions 
  for 
  summary 
  suspension, 
  18 
  of 
  these 
  were 
  Indiana 
  pill 
  mills. 
   
  Of 
  the 
  pill 
  
mills, 
  2 
  involved 
  pain 
  clinics 
  whereas 
  most 
  involved 
  family 
  practice. 
   
   
  
 
  

 
  
 
  

 
  

 Therefore 
  unlike 
  in 
  other 
  states 
  where 
  pain 
  management 
  clinics 
  were 
  the 
  source 
  of 
  pill 
  mill 
  
activities, 
  in 
  Indiana 
  this 
  was 
  much 
  less 
  common 
  with 
  only 
  2 
  of 
  the 
  80 
  petitions 
  for 
  summary 
  
suspension 
  involving 
  pain 
  clinics 
  but 
  with 
  16 
  others 
  involving 
  inappropriate 
  prescribing 
  by 
  non-­‐pain 
  
physicians. 
   
  Examining 
  the 
  number 
  of 
  complaints 
  filed 
  with 
  the 
  Board 
  of 
  Medicine 
  over 
  a 
  5 
  year 
  
period 
  ending 
  2012, 
  there 
  were 
  170 
  complaints 
  and 
  17 
  involved 
  pain 
  clinic 
  physicians. 
   
  
Outside 
  of 
  pill 
  mills 
  there 
  are 
  many 
  cases 
  of 
  physicians 
  prescribing 
  occasionally 
  for 
  patients 
  
in 
  massive 
  doses, 
  but 
  are 
  flying 
  under 
  the 
  radar 
  of 
  the 
  medical 
  board. 
   
  For 
  instance, 
  the 
  author 
  of 
  this 
  
paper 
  has 
  knowledge 
  of 
  a 
  gastroenterologist 
  prescribing 
  360mg 
  of 
  methadone 
  a 
  day 
  plus 
  fentanyl 
  
patches 
  for 
  chronic 
  benign 
  abdominal 
  pain, 
  and 
  has 
  not 
  performed 
  an 
  ECG 
  or 
  blood 
  work 
  for 
  many 
  
years. 
   
  Another 
  physician 
  was 
  found 
  to 
  be 
  prescribing 
  a 
  3 
  month 
  supply 
  of 
  hydrocodone 
  (over 
  a 
  
thousand 
  pills 
  per 
  prescription) 
  every 
  month 
  for 
  over 
  a 
  year. 
   
  The 
  64 
  year 
  old 
  patient 
  was 
  selling 
  
the 
  drug 
  to 
  pay 
  for 
  toys 
  for 
  her 
  grandkids 
  and 
  for 
  bills. 
   
  Another 
  family 
  physician 
  diagnosed 
  central 
  
pain 
  after 
  a 
  27 
  year 
  old 
  had 
  a 
  thalamic 
  stroke. 
   
  She 
  was 
  escalated 
  to 
  four 
  100mcg/hour 
  fentanyl 
  
patches, 
  oral 
  morphine 
  sulfate 
  100mg 
  every 
  6 
  hours, 
  and 
  was 
  receiving 
  an 
  intravenous 
  home 
  
infusion 
  of 
  morphine 
  at 
  30mg 
  IV 
  per 
  hour. 
   
  The 
  patient 
  was 
  gradually 
  withdrawn 
  from 
  all 
  these 
  
medications 
  by 
  another 
  practitioner 
  with 
  no 
  increase 
  in 
  pain 
  at 
  all, 
  but 
  the 
  patient 
  no 
  longer 
  had 
  
slurred 
  speech 
  nor 
  was 
  chronically 
  sedated. 
   
   
  Another 
  situation 
  involved 
  a 
  nurse 
  practitioner 
  taking 
  
care 
  of 
  nursing 
  home 
  patients. 
   
  One 
  was 
  receiving 
  chronic 
  opioid 
  therapy 
  by 
  a 
  pain 
  physician 
  but 
  was 
  
reported 
  by 
  staff 
  and 
  family 
  to 
  be 
  very 
  sedated 
  and 
  difficult 
  to 
  awaken 
  chronically 
  with 
  respiratory 
  
depression. 
   
  The 
  opioids 
  were 
  reduced 
  appropriately 
  by 
  the 
  pain 
  physician 
  but 
  the 
  nurse 
  practitioner 
  
rounding 
  in 
  the 
  nursing 
  home 
  elected 
  to 
  escalate 
  the 
  opioids 
  back 
  to 
  the 
  same 
  dangerous 
  level 
  
without 
  consulting 
  with 
  the 
  prescribing 
  physician. 
  And 
  in 
  another 
  case, 
  a 
  family 
  practitioner 
  took 
  
over 
  prescribing 
  from 
  a 
  pain 
  physician, 
  never 
  having 
  checked 
  INSPECT, 
  and 
  immediately 
  began 
  
prescribing 
  triple 
  the 
  amount 
  of 
  oxycodone 
  to 
  360 
  tablets 
  a 
  month 
  of 
  30mg 
  oxycodone 
  to 
  a 
  person 
  
that 
  had 
  opioids 
  halted 
  in 
  the 
  pain 
  clinic 
  due 
  to 
  documented 
  drug 
  diversion, 
  failed 
  UDS, 
  and 
  selling 
  
the 
  prescribed 
  drugs 
  on 
  the 
  street. 
   
  The 
  family 
  doctor 
  never 
  bothered 
  to 
  check 
  the 
  prior 
  physicians 
  
records 
  nor 
  requested 
  them. 
   
  It 
  is 
  these 
  issues 
  that 
  are 
  best 
  left 
  for 
  a 
  state 
  controlled 
  substance 
  board 
  
to 
  handle 
  via 
  guideline 
  development, 
  rather 
  than 
  legislation 
  that 
  cannot 
  possibly 
  cover 
  all 
  the 
  
controlled 
  substance 
  prescribing 
  issues 
  that 
  are 
  seen 
  by 
  practitioners. 
  
The 
  most 
  important 
  question 
  to 
  be 
  answered 
  is 
  who 
  is 
  supplying 
  the 
  medications 
  that 
  are 
  
being 
  used 
  in 
  overdose 
  of 
  patients. 
   
  IPS 
  attempted 
  to 
  answer 
  this 
  by 
  constructing 
  a 
  study 
  in 
  
conjunction 
  with 
  the 
  Marion 
  County 
  Coroner’s 
  office 
  and 
  the 
  state 
  attorney 
  general, 
  both 
  of 
  who 
  
were 
  very 
  supportive. 
   
  INSPECT 
  data 
  was 
  to 
  be 
  obtained 
  on 
  the 
  deceased 
  and 
  the 
  prescribing 
  
physician 
  (if 
  any) 
  was 
  to 
  be 
  identified 
  then 
  the 
  specialty 
  determined, 
  then 
  publication 
  would 
  ensue 
  
with 
  number 
  of 
  deaths 
  vs 
  specialty 
  published. 
   
  The 
  Indiana 
  INSPECT 
  attorneys 
  have 
  blocked 
  this 
  
valuable 
  study 
  based 
  on 
  implied 
  confidentiality 
  written 
  into 
  the 
  law 
  and 
  the 
  IPS 
  is 
  attempting 
  to 
  
move 
  the 
  study 
  forward 
  using 
  alternative 
  mechanisms. 
   
   
   
   
  The 
  INSPECT 
  program 
  was 
  then 
  asked 
  to 
  
provide 
  a 
  list 
  of 
  the 
  specialties 
  of 
  the 
  top 
  prescribing 
  physicians 
  for 
  opioids 
  or 
  Schedule 
  II 
  drugs 
  but 
  
the 
  officials 
  at 
  INSPECT 
  told 
  us 
  they 
  could 
  not 
  comply 
  due 
  to 
  privacy 
  arguments. 
   
  The 
  Walmart 
  and 
  
CVS 
  corporate 
  offices 
  were 
  contacted 
  about 
  obtaining 
  this 
  information 
  but 
  were 
  unable 
  to 
  offer 
  
assistance. 
   
  Finally, 
  a 
  few 
  corporate 
  data 
  mining 
  companies 
  that 
  mine 
  pharmaceutical 
  prescribing 
  
data 
  were 
  queried 
  but 
  we 
  were 
  told 
  they 
  only 
  do 
  studies 
  involving 
  5,000 
  entries 
  or 
  more. 
   
  Finally, 
  the 
  
IPS 
  constructed 
  a 
  correlation 
  study 
  of 
  accidental 
  poisoning 
  death 
  by 
  county 
  compared 
  to 
  the 
  metrics 
  
a. 
  county 
  population, 
   
  b. 
  number 
  of 
  pain 
  docs 
  per 
  highest 
  death 
  rate 
  counties, 
  c. 
  number 
  of 
  pain 
  docs 
  
in 
  the 
  county 
  and 
  surrounding 
  counties 
  (top 
  quartile 
  of 
  death 
  rates), 
  and 
  d. 
  top 
  quartile 
  death 
  rate 
  
county 
  populations. 
  The 
  highest 
  correlation 
  was 
  between 
  simply 
  the 
  number 
  of 
  deaths 
  and 
  county 
  
population 
  in 
  the 
  highest 
  death 
  rate 
  counties 
  (R 
  squared 
  = 
  0.91). 
   
  Next 
  was 
  deaths 
  vs 
  all 
  county 
  
populations 
  (R 
  squared 
  = 
  0.64). 
   
   
  The 
  least 
  correlation 
  was 
  found 
  between 
  death 
  rate 
  and 
  the 
  number 
  
of 
  pain 
  doctors 
  practicing 
  in 
  a 
  given 
  county. 
   
  These 
  data 
  suggest 
  (using 
  an 
  obtuse 
  approach 
  to 
  the 
  
question) 
  that 
  pain 
  physicians 
  are 
  not 
  the 
  cause 
  of 
  overdose 
  and 
  death 
  through 
  there 
  prescribing 
  of 
  
opioids. 
   
   
  Conversations 
  with 
  individual 
  coroners 
  in 
  Indiana 
  also 
  confirmed 
  the 
  impression 
  pain 
  
physicians 
  are 
  not 
  the 
  primary 
  source 
  of 
  opioids 
  leading 
  to 
  death, 
  and 
  that 
  PCPs 
  are 
  the 
  primary 
  
source. 
   
  
 
  

  
  

 
  
 
  
The 
  CDC 
  in 
  the 
  MMWR 
  July 
  3, 
  2012 
  edition 
  noted 
  the 
  high 
  percentage 
  of 
  deaths 
  caused 
  by 
  methadone 
  
relative 
  to 
  the 
  number 
  of 
  grams 
  being 
  prescribed 
  and 
  noted 
  “Most 
  methadone 
  prescriptions 
  were 
  
written 
  by 
  primary 
  care 
  providers 
  or 
  mid-­‐level 
  practitioners 
  (e.g., 
  nurse 
  practitioners) 
  rather 
  than 
  
pain 
  specialists. 
  Nearly 
  a 
  third 
  of 
  prescriptions 
  appear 
  to 
  have 
  been 
  dispensed 
  to 
  patients 
  with 
  no 
  
opioid 
  prescriptions 
  in 
  the 
  previous 
  month 
  (i.e., 
  opioid-­‐naïve 
  patients) 
  “. 
   
   
  This 
  further 
  bolsters 
  the 
  
evidence 
  that 
  pain 
  physicians 
  are 
  not 
  the 
  primary 
  cause 
  of 
  death 
  in 
  patients 
  taking 
  opioids 
  for 
  
chronic 
  pain. 
   
   
  
However, 
  physicians 
  are 
  no 
  longer 
  the 
  only 
  practitioners 
  that 
  may 
  prescribe 
  opioids. 
   
  Any 
  
MD, 
  DO, 
  DPM, 
  DVM, 
  DDS, 
  DMD, 
  CNM 
  (midwife), 
  NP, 
  or 
  PA 
  may 
  now 
  apply 
  for 
  a 
  DEA 
  license 
  to 
  
prescribe 
  controlled 
  substances. 
   
  There 
  exist 
  increasing 
  numbers 
  of 
  nurse 
  practitioners 
  prescribing 
  
opioids 
  and 
  some 
  have 
  actually 
  advertise 
  themselves 
  as 
  pain 
  clinics 
  (Seymour). 
   
  There 
  have 
  been 
  
conflicts 
  with 
  NPs 
  taking 
  over 
  prescribing 
  of 
  what 
  a 
  patient 
  wants 
  for 
  chronic 
  pain 
  treatment 
  (high 
  
dose 
  narcotics) 
  in 
  spite 
  of 
  significant 
  substance 
  abuse 
  or 
  significant 
  daytime 
  sedation 
  of 
  patients, 
  and 
  
contrary 
  to 
  the 
  recommendations 
  of 
  the 
  pain 
  physicians. 
  Therefore 
  any 
  laws 
  must 
  equally 
  be 
  applied 
  
to 
  all 
  practitioners 
  in 
  the 
  state 
  with 
  equal 
  disciplinary 
  actions. 
   
   
  
 
  

 Since 
  the 
  professional 
  licensing 
  agency 
  (PLA) 
  in 
  Indiana 
  does 
  not 
  have 
  an 
  executive 
  board 
  
with 
  powers 
  to 
  require 
  equal 
  application 
  of 
  regulation, 
  there 
  needs 
  to 
  be 
  a 
  controlled 
  substance 
  
board 
  established 
  to 
  promulgate 
  guidelines 
  for 
  prescribing 
  for 
  all 
  practitioners 
  and 
  to 
  provide 
  for 
  
equal 
  penalties 
  for 
  all 
  professions 
  who 
  violate 
  such 
  guidelines. 
   
  
Indiana’s 
  last 
  controlled 
  substance 
  advisory 
  group 
  was 
  dissolved 
  in 
  2010, 
  however 
  its 
  role 
  in 
  
opioid 
  prescribing 
  policy 
  development 
  was 
  minimal. 
   
   
  

 
  
 
  

Criminalization 
  of 
  Opioid 
  Prescribing 
  
Several 
  states 
  have 
  inappropriately 
  used 
  criminal 
  laws 
  to 
  target 
  physicians 
  prescribing 
  opioids 
  
resulting 
  in 
  death. 
   
  Dr 
  Gerald 
  Klein 
  of 
  Palm 
  Beach 
  County 
  Florida 
  and 
  Dr 
  Hsiu-­‐Ying 
  Tseng 
  of 
  Rowland 
  
Heights 
  California 
  were 
  charged 
  with 
  murder 
  due 
  to 
  patient 
  deaths 
  occurring 
  after 
  opioid 
  
prescribing 
  for 
  chronic 
  pain. 
   
  Board 
  actions 
  and 
  state 
  laws 
  preventing 
  excessive 
  prescribing 
  are 
  the 
  
appropriate 
  manner 
  in 
  which 
  to 
  handle 
  drug 
  overdose 
  deaths 
  since 
  once 
  the 
  physician 
  prescribes 
  an 
  
opioid, 
  there 
  is 
  no 
  guarantee 
  the 
  patient 
  will 
  not 
  use 
  excessive 
  amounts 
  of 
  the 
  drug, 
  will 
  not 
  divert 
  
the 
  drug 
  to 
  be 
  taken 
  in 
  a 
  manner 
  not 
  prescribed 
  in 
  order 
  to 
  increase 
  the 
  blood 
  levels 
  of 
  the 
  drug 
  for 
  
recreational 
  purposes 
  (snorting, 
  huffing, 
  injecting), 
  will 
  not 
  use 
  alcohol 
  or 
  illicit 
  drugs 
  in 
  combination 
  
with 
  the 
  prescription 
  opioids, 
  or 
  will 
  not 
  obtain 
  legal 
  medications 
  from 
  other 
  physicians 
  that 
  are 
  
known 
  to 
  exacerbate 
  the 
  risk 
  of 
  death 
  (benzodiazepines). 
  

 
  
IMPACT 
  OF 
  INSPECT 
  

The 
  value 
  of 
  INSPECT 
  program 
  under 
  the 
  state 
  board 
  of 
  pharmacy 
  cannot 
  be 
  overestimated. 
  
INSPECT, 
  our 
  prescription 
  monitoring 
  program 
  is 
  outstanding 
  compared 
  to 
  many 
  others 
  around 
  the 
  
country, 
  requiring 
  23 
  seconds 
  to 
  access 
  data 
  about 
  a 
  patients 
  use 
  of 
  controlled 
  substances. 
   
  The 
  
registration 
  process 
  is 
  simple, 
  and 
  it 
  would 
  be 
  logical 
  to 
  assume 
  those 
  with 
  state 
  CSR 
  licenses 
  would 
  
also 
  automatically 
  use 
  INSPECT. 
   
  However, 
  utilization 
  by 
  some 
  groups 
  is 
  actually 
  poor. 
   
  The 
  quarterly 
  
INSPECT 
  reports 
  from 
  2011Q3 
  shows 
  MD 
  Physicians 
  with 
  CSR 
  licenses 
  have 
  less 
  than 
  a 
  40% 
  rate 
  of 
  

 having 
  signed 
  up 
  for 
  INSPECT. 
   
  This 
  demonstrates 
  physicians 
  are 
  either 
  not 
  using 
  their 
  CSR 
  licenses, 
  
or 
  more 
  likely 
  are 
  simply 
  not 
  availing 
  themselves 
  of 
  the 
  invaluable 
  data 
  provided 
  by 
  INSPECT, 
  
thereby 
  promoting 
  substance 
  abuse 
  and 
  drug 
  diversion. 
   
  According 
  to 
  data 
  provided 
  by 
  Indiana 
  
INSPECT 
  to 
  IPS, 
  the 
  BJA 
  Metrics 
  reports 
  for 
  the 
  first 
  half 
  of 
  2011 
  report 
  shows 
  one 
  out 
  of 
  every 
  53 
  
people 
  prescribed 
  opioids 
  will 
  engage 
  in 
  doctor 
  shopping 
  (5-­‐9 
  different 
  doctors 
  for 
  controlled 
  
substances 
  90% 
  are 
  Schedule 
  II 
  and 
  III 
  prescription 
  opioids) 
   
  or 
  use 
  5-­‐9 
  pharmacies 
  every 
  3 
  months. 
   
   
  
This 
  data 
  suggests 
  frequently 
  checking 
  INSPECT 
  would 
  alert 
  the 
  physician 
  to 
  the 
  2% 
  of 
  the 
  general 
  
population 
  (2012 DEA report April 25) and 
  35% 
  of 
  chronic 
  pain 
  populations 
  receiving 
  opioids 
  with 
  
significant 
  abuse/diversion 
  proclivities. 
   
  Moreover, 
  INSPECT 
  is 
  also 
  used 
  to 
  serve 
  as 
  an 
  early 
  warning 
  
sign 
  of 
  patient 
  substance 
  abuse 
  and 
  diversion, 
  and 
  has 
  an 
  effect 
  on 
  patient 
  behavior 
  once 
  patients 
  
know 
  their 
  controlled 
  substance 
  prescriptions 
  filled 
  in 
  the 
  state 
  are 
  readily 
  available 
  to 
  practitioners. 
   
  
INSPECT 
  may 
  also 
  flag 
  a 
  physician 
  that 
  a 
  patient 
  is 
  obtaining 
  opioids 
  from 
  more 
  than 
  one 
  prescriber 
  
in 
  a 
  month 
  so 
  the 
  prescribers 
  may 
  stop 
  opioid 
  prescribing 
  before 
  overdose 
  occurs 
  or 
  before 
  they 
  
freely 
  share 
  excess 
  pills 
  with 
  others. 
   
   
  INSPECT 
  also 
  helps 
  physicians 
  check 
  long 
  term 
  drug 
  use 
  
history 
  before 
  ever 
  deciding 
  to 
  prescribe 
  any 
  opioids, 
  and 
  may 
  be 
  used 
  to 
  stratify 
  the 
  patient 
  as 
  high, 
  
medium, 
  or 
  low 
  risk. 
   
  Patient 
  stratification 
  may 
  help 
  prevent 
  overdose 
  and 
  death 
  due 
  to 
  different 
  
monitoring 
  of 
  patients 
  in 
  different 
  categories. 
   
  INSPECT 
  also 
  provides 
  a 
  check 
  against 
  patient 
  
prevarication 
  regarding 
  opioids 
  and 
  may 
  prevent 
  physicians 
  inadvertently 
  prescribing 
  opioids 
  to 
  
patients 
  who 
  are 
  receiving 
  non-­‐opioid 
  controlled 
  substances 
  whose 
  combination 
  could 
  prove 
  fatal. 
   
  
Finally, 
  INSPECT 
  may 
  be 
  useful 
  in 
  discovering 
  those 
  crossing 
  state 
  lines 
  to 
  obtain 
  more 
  opioids. 
   
   
  
INSPECT 
  is 
  increasingly 
  integrated 
  into 
  a 
  regional 
  network 
  of 
  states, 
  and 
  eventually 
  may 
  provide 
  
national 
  coverage. 
   
   
  Most 
  IPS 
  members 
  believe 
  INSPECT 
  is 
  an 
  extremely 
  valuable 
  method 
  of 
  curtailing 
  
substance 
  abuse/drug 
  diversion, 
  and 
  must 
  have 
  sufficient 
  funding 
  for 
  operating 
  in 
  perpetuity. 
   
  The 
  
funding 
  currently 
  available 
  for 
  INSPECT 
  will 
  run 
  out 
  in 
  2014. 
   
  Adoption 
  of 
  a 
  25 
  cent 
  per 
  controlled 
  
substance 
  prescription 
  surcharge 
  to 
  patients 
  collected 
  at 
  the 
  pharmacy 
  would 
  result 
  in 
  an 
  additional 
  
$1,000,000 
  per 
  year 
  in 
  perpetual 
  operating 
  income 
  to 
  run 
  the 
  INSPECT 
  program. 
   
   
  Both 
  registration 
  
and 
  usage 
  of 
  INSPECT 
  in 
  Indiana 
  is 
  voluntary. 
   
  The 
  IPS 
  believes 
  both 
  registration 
  and 
  usage 
  for 
  
anyone 
  prescribing 
  controlled 
  substances 
  should 
  be 
  mandatory. 
   
  

 
  
 
  
ISSUES 
  TO 
  BE 
  ADDRESSED 
  BY 
  THE 
  CONTROLLED 
  SUBSTANCE 
  COMMISSION:
 
  
1.
2.
3.
4.
5.
6.
7.
8.
9.

Limited 
  communication 
  between 
  prescribers 
  of 
  controlled 
  substances 
  or 
  sedating 
  drugs 
  
leads 
  to 
  higher 
  death 
  and 
  morbidity 
  rates. 
  
Prescribers 
  too 
  freely 
  begin 
  opioids 
  without 
  checking 
  INSPECT 
  and 
  without 
  checking 
  old 
  
patient 
  records 
  direct 
  for 
  substance 
  abuse 
  or 
  diversion 
  or 
  overuse. 
   
  (ISP 
  STANDARDS 
  
ADDRESS 
  THIS) 
  
Failure 
  to 
  recognize 
  drug 
  abusers 
  and 
  diverters 
  will 
  migrate 
  from 
  one 
  physician 
  to 
  the 
  next 
  
and 
  in 
  many 
  cases 
  are 
  inappropriately 
  referred 
  for 
  opioid 
  therapy 
  with 
  the 
  knowledge 
  of 
  
recent 
  substance 
  abuse. 
  
Coroners 
  and 
  physicians 
  pronouncing 
  death 
  do 
  not 
  communicate 
  the 
  reason 
  for 
  death 
  or 
  
contribution 
  of 
  opioids 
  to 
  death 
  to 
  the 
  prescribing 
  physician. 
  
Hospitals 
  do 
  not 
  communicate 
  with 
  prescribing 
  physicians 
  during 
  admission, 
  treatment, 
  or 
  
discharge 
  of 
  patients 
  admitted 
  for 
  overdose 
  or 
  opioid 
  complications. 
  
Law 
  enforcement 
  does 
  not 
  communicate 
  with 
  prescribing 
  physician 
  when 
  there 
  is 
  an 
  arrest 
  
made 
  for 
  drug 
  diversion 
  or 
  DUI, 
  and 
  do 
  not 
  check 
  INSPECT 
  in 
  cases 
  of 
  DUI. 
  
Prescribers 
  of 
  opioids 
  are 
  not 
  held 
  to 
  any 
  standards 
  of 
  care 
  in 
  opioid 
  prescribing 
  nor 
  are 
  
they 
  compelled 
  to 
  engage 
  in 
  examination 
  of 
  their 
  practice 
  policies 
  and 
  procedures 
  after 
  an 
  
overdose 
  or 
  admission 
  to 
  the 
  hospital 
  for 
  complications 
  of 
  opioids. 
  
Inability 
  to 
  accurately 
  assess 
  either 
  the 
  degree 
  or 
  presence 
  of 
  chronic 
  pain 
  due 
  to 
  the 
  lack 
  of 
  
technology 
  to 
  detect 
  and 
  measure 
  pain 
  
Inability 
  to 
  accurately 
  screen 
  patients 
  for 
  substance 
  abuse 
  with 
  screening 
  tests. 
   
  Anyone 
  can 
  
give 
  incorrect 
  answers 
  on 
  a 
  screening 
  test 
  especially 
  if 
  the 
  answers 
  involve 
  past 
  substance 
  

 10.

11.
12.
13.

14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.

27.
28.

29.

abuse. 
   
  Tests 
  that 
  have 
  printed 
  statements 
  attached 
  that 
  the 
  results 
  will 
  not 
  influence 
  
therapy 
  are 
  giving 
  false 
  information 
  to 
  patients 
  about 
  their 
  medical 
  care. 
   
  
Physician 
  misperception 
  that 
  there 
  develops 
  a 
  tolerance 
  to 
  side 
  effects 
  including 
  respiratory 
  
depression 
  when 
  taking 
  long 
  term 
  opioids. 
   
  This 
  creates 
  a 
  cavalier 
  attitude 
  that 
  other 
  
sedative 
  medication 
  would 
  be 
  well 
  tolerated 
  or 
  that 
  gradually 
  increasing 
  the 
  opioid 
  would 
  
mitigate 
  respiratory 
  depressant 
  effects. 
   
  However 
  it 
  has 
  been 
  shown 
  long 
  term 
  respiratory 
  
depression 
  with 
  chronic 
  opioid 
  use 
  may 
  occur. 
  (36) 
  
Avoiding 
  high 
  dose 
  systemic 
  opioids 
  in 
  those 
  with 
  substance 
  abuse 
  disorders, 
  sleep 
  apnea, 
  
severe 
  COPD, 
  hepatic 
  dysfunction, 
  or 
  taking 
  benzodiazepines 
  
Equipping 
  patients 
  with 
  naloxone 
  at 
  home 
  for 
  intranasal 
  or 
  IM 
  use 
  in 
  case 
  of 
  overdose 
   
  
(http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6106a1.htm) 
  
Coordination 
  of 
  care 
  with 
  other 
  providers 
  so 
  that 
  a 
  patient 
  never 
  has 
  a 
  combination 
  of 
  
carisoprol, 
  benzodiazepine, 
  opioid 
  and 
  will 
  have 
  their 
  opioid 
  dosing 
  reduced 
  if 
  another 
  
provider 
  prescribes 
  a 
  sedative 
  and 
  the 
  patient 
  decides 
  they 
  need 
  such 
  sedative 
  . 
   
  CSC 
  to 
  
establish 
  thresholds 
  for 
  this 
  rule. 
   
   
  
Urine 
  drug 
  screening 
  with 
  quantitation 
  of 
  dosing 
  and 
  detection 
  of 
  illicit 
  substances 
  and 
  non-­‐
prescribed 
  drugs 
  with 
  mandatory 
  action 
  taken 
  if 
  these 
  are 
  present 
  
Mandatory 
  query 
  of 
  INSPECT 
  by 
  prescribers 
  of 
  opioids 
  on 
  initiation 
  and 
  at 
  least 
  every 
  6 
  
months. 
   
  (ISP 
  Standards) 
  
Establish 
  guidelines 
  for 
  prescribing 
  opioids 
  and 
  mandatory 
  infrastructure 
  criteria 
  for 
  
monitoring. 
   
  
Drug 
  related 
  deaths 
  reported 
  to 
  a 
  state 
  opioid 
  board 
  and 
  are 
  considered 
  a 
  sentinel 
  event 
  in 
  a 
  
practice 
  that 
  would 
  trigger 
  a 
  mandatory 
  internal 
  review 
  of 
  prescribing 
  policies 
  with 
  report 
  
made 
  to 
  opioid 
  board. 
   
   
  
Establish 
  high 
  risk 
  criteria 
  for 
  opioid 
  prescribing 
  for 
  patients 
  deemed 
  high 
  risk 
  by 
  criteria 
  
and 
  mandatory 
  participation 
  in 
  the 
  high 
  risk 
  protocol 
  if 
  opioids 
  are 
  to 
  be 
  prescribed 
  
(substance 
  abuse 
  or 
  diversion) 
  
Prescribers 
  of 
  opioids 
  for 
  non-­‐emergent 
  issues 
  (eg. 
  dental, 
  surgical, 
  acute 
  pain) 
  should 
  not 
  
prescribe 
  to 
  a 
  person 
  receiving 
  long 
  term 
  opioids 
  unless 
  the 
  currently 
  prescribing 
  
physician’s 
  office 
  is 
  notified 
  and 
  care 
  transferred. 
   
   
  
Emergency 
  departments 
  may 
  only 
  prescribe 
  3 
  days 
  worth 
  of 
  pain 
  medications 
  short 
  acting 
  
and 
  no 
  initiation 
  of 
  long 
  acting 
  medications. 
  
Patients 
  receiving 
  treatment 
  at 
  VA 
  centers 
  may 
  not 
  receive 
  treatment 
  at 
  private 
  pain 
  clinics 
  
(due 
  to 
  VA 
  not 
  being 
  included 
  in 
  INSPECT) 
  
For 
  patients 
  receiving 
  methadone 
  at 
  methadone 
  clinics, 
  the 
  physician 
  at 
  the 
  clinic 
  must 
  
query 
  the 
  INSPECT 
  once 
  a 
  week 
  to 
  assure 
  compliance. 
   
  Physicians 
  not 
  compliant 
  with 
  this 
  
requirement 
  will 
  face 
  disciplinary 
  action 
  before 
  the 
  medical 
  board. 
  
Patients 
  receiving 
  suboxone 
  for 
  addiction 
  will 
  have 
  the 
  INSPECT 
  queried 
  on 
  each 
  visit 
  or 
  
once 
  a 
  week, 
  whichever 
  is 
  least. 
   
  
Mandatory 
  disposal 
  of 
  any 
  drugs 
  found 
  on 
  the 
  decedent 
  by 
  coroner, 
  medical 
  examiner, 
  or 
  
funeral 
  home 
  director-­‐ 
  families 
  are 
  not 
  to 
  have 
  access 
  to 
  these 
  medications 
  
Establish 
  dosing 
  ranges 
  with 
  physician 
  monitoring 
  responsibilities 
  and 
  mandatory 
  physician 
  
justification 
  at 
  different 
  levels 
  dependent 
  on 
  the 
  dosage 
  
Hospitals 
  admitting 
  patients 
  with 
  chronic 
  pain 
  should 
  be 
  required 
  to 
  notify 
  the 
  prescribing 
  
physician 
  (obtained 
  by 
  INSPECT) 
  about 
  an 
  admission 
  for 
  complications 
  due 
  to 
  opioids 
  
(Suggested 
  to 
  be 
  established 
  by 
  legislation 
  requiring 
  admitting 
  physician 
  to 
  implement 
  this 
  
due 
  to 
  admitting 
  physician 
  access 
  to 
  INSPECT) 
  
Consideration 
  of 
  loss 
  of 
  Medicaid 
  and 
  other 
  state 
  program 
  coverage 
  when 
  there 
  is 
  
documented 
  drug 
  diversion. 
   
  
Compliance 
  of 
  VA 
  physicians 
  and 
  methadone 
  clinic 
  physicians. 
   
  One 
  alternative 
  is 
  to 
  prevent 
  
patients 
  receiving 
  treatment 
  at 
  the 
  VA 
  from 
  receiving 
  long 
  term 
  opioid 
  therapy 
  from 
  non-­‐VA 
  
physicians 
  given 
  the 
  lack 
  of 
  ability 
  of 
  the 
  non-­‐VA 
  prescribers 
  to 
  access 
  VA 
  records 
  and 
  VA 
  
opioids 
  are 
  not 
  entered 
  into 
  the 
  INSPECT 
  program. 
   
   
  
Specification 
  of 
  the 
  minimum 
  actions 
  to 
  be 
  taken 
  for 
  failed 
  urine 
  drug 
  screens, 
  known 
  
diversion, 
  etc. 
   
  

 30. Specify 
  opioids 
  must 
  be 
  maintained 
  in 
  a 
  locked 
  location 
  as 
  safe 
  as 
  is 
  reasonably 
  achievable 
  
from 
  theft. 
   
  
 
  

 
  

REFERENCES: 
  
1 
  Pain 
  Medicine 
  Vol 
  13 
  S2, 
  2012 
  
2. 
  NY 
  Attorney 
  Generals 
  report 
  on 
  1-­‐Stop 
  2010 
  
3. 
  OxyContin: 
  Purdue 
  Pharma's 
  painful 
  medicine 
  CNN 
  Money 
  Nov 
  9, 
  2011 
   
  
4. 
  Data 
  on 
  file 
  kindly 
  provided 
  by 
  AIT 
  
5. 
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7. 
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8. 
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9. 
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13. 
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14. 
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comparative 
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18. 
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21. 
  JAMA 
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23. 
  Pain 
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25. 
   
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26. 
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27. 
   
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29. 
  the 
  National 
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  on 
  Addiction 
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  Substance 
  Abuse 
  at 
  Columbia 
  University 
  (CASA), 
  July 
  2005. 
  
www.c 
  a 
  s 
  a 
  c 
  o 
  l 
  u 
  m 
  b 
  i 
  a 
  . 
  o 
  r 
  g 
  / 
  a 
  r 
   
  t 
  i 
  c 
  l 
  e 
  f 
  i 
  l 
  e 
  s 
  / 
  3 
  8 
  0 
  -­‐U 
  n 
  d 
  e 
  r 
  % 
  2 
  0 
  t 
  h 
  e 
  % 
  2 
  0 
  C 
  o 
  u 
  n 
  t 
  e 
  r 
  % 
  2 
  
0 
  -­‐%20Diversion.pdf. 
  
30. 
   
  Office 
  of 
  Applied 
  Studies, 
  NSDUH 
  Series 
  H-­‐32, 
  DHHS 
  Publication 
  No. 
  SMA 
  07-­‐4293). 
  Rockville, 
  
MD. 
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  Drug 
   
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33. 
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34. 
   
  http://www.samhsa.gov/data/DAWN.aspx 
  
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 41. 
  Office 
  of 
  the 
  Special 
  Narcotics 
  Prosecutor 
  for 
  the 
  City 
  of 
  New 
  York, 
   
  2010 
  Annual 
  Report. 
  
Available 
  at 
   
  http://www.nysenate.gov/files/Roundtable-­‐Materials-­‐3.pdf 
  
42. 
  Colon, 
  D. 
  "Number 
  of 
  Newborns 
  Addicted 
  to 
  Painkillers 
  Rising." 
   
  National 
  Public 
  Radio. 
  Available 
  
at 
  http://www.npr.org/2011/02/16/133805289/number-­‐of-­‐newborns-­‐addicted-­‐to-­‐painkillers-­‐
rising 
  
43. 
  National 
  Center 
  on 
  Addiction 
  and 
  Substance 
  Abuse 
  (CASA). 
  Shoveling 
  Up 
  II: 
  The 
  Impact 
  of 
  
Substance 
  Abuse 
  on 
  Federal, 
  State 
  and 
  Local 
  Budgets 
  2009 
  
 
  

 
  
 
  

APPENDIX A PILL MILL ACTIVITY EVALUATION INDIANA PAIN
SOCIETY
FOR NP/PA/DDS/DMD/MD/DO Practices prescribing opioids to more than 25%
STRONG INDICATORS OF NEFARIOUS ACTIVITY
1. Long line of patients snaking out the door and around the building
2. Unusual hours of operation (eg. after 11pm and not an urgent care or ER)
3. Security guard posted at the office door
4. Cash only practice with opioids prescribed for nearly 100% of patients
5. Clinician does not keep medical records or extremely minimal medical records
6. Clinician asks patient what medication they want on initial visit
7. Clinic does not check past medical records
8. Clinic does not check PMP on anyone
9. Clinic does not perform urine drug screens in patients that are thought or known to be addicts or are
diverting drugs or are suspected of using strong illicit drugs (cocaine, methamphetamine, LSD, heroin) Sees
more than 60 patients a day per prescriber with opioid prescriptions in a non-surgical practice
10. No history/physical exam and no other clinician’s history/physical on file
11. Prescribes opioid medications over the internet or telephone without having seen the patient
12. Clinician accepting controlled substances from patients or money from patient selling controlled
substances
13. No employees present for most clinic hours of operation
14. Sex for drugs
15. Presigned blank narcotic scripts given to staff without DEA license
16. Orders large quantities of controlled substances and cannot account for significant (>5%) shortages
17. Clinician is aware of drug diversion and takes no definitive action
MODERATE INDICATORS OF NEFARIOUS ACTIVITY
18. Parking lot attendant to direct traffic (unless a parking garage)
19. Lack of set appointment times for patients (not an urgent care or ER)
20. More out of state than in state license plates for clinic more than 25 miles inside a state border
21. Sells Schedule II medications on-site without a pharmacist

 22. Fails to keep required records for controlled substances
23. Most patients paying cash or credit cards for controlled substances purchased on-site (clinician does not
accept insurance)
24. Purchases of controlled substances $500 or more in cash or credit card
25. Clinician directs patients to a specific pharmacy due to other pharmacies refusing to fill clinician written
prescriptions
INDICATORS OF INADEQUATE CLINICAL PRACTICE REQUIRING CORRECTION
26. No opioid agreement or contract and prescribes long term opioid medications
27. Clinician does not record amounts, dosage, or identity of controlled substances prescribed
28. Prescribing of controlled substances to self, immediate family, or person with which they have intimate
relationship
29. Prescribes controlled substances on first visit without checking the PMP or without reviewing past
medical records from prior physicians (unless unavailable due to state legal action or independently
verifiable
30. Fails to check PMP after the first patient visit
31. Clinician is aware of significant substance abuse issues and takes no action
32. Clinician does not obtain past medical records direct from prior clinicians and allows hand carried
records
33. Clinician prescribing controlled substances has inadequate training for prescribing long term controlled
substances
34. Inadequate record-keeping and failing to record a reason for prescribing controlled substances, lack of
significant side effects, lack of abuse or diversion indicators, degree of pain control or function, and medical
plan
35. Fails to require patient responsibility for control of the prescribed controlled substances (eg. lock box,
safe, not opening meds over a sink, not leaving meds in location that can be lost or stolen)
36. Fails to obtain random drug screens
37. Fails to take any action on random drug screens with unexplainable results suggesting drug diversion or
substance abuse
38. Use of opioids as the only means of pain control without engaging the patient in any functional
restoration, diagnostic or therapeutic interventions
39. Majority of prescriptions are for the same opioid in the same amount or are for the same combination of
controlled substances (eg soma/Xanax/hydrocodone)

 APPENDIX B Major Perpetrators of CYP-mediated drug interations based on Level A Evidence (first
three rows) and Level B Evidence (last two rows) IPS Constructed Chart Different Sources
British Journal of Clinical Pharmacology Polasek et al Vol 71 Issue 5, May 2011 pp 727-736 Perpetrators of Pharmacokinetic DrugDrug Interactions and http://www.redorbit.com/news/health/124496/medpsych_drugdrug_interactions_update/

Hepatic
Enzyme
and
opioids
metaboliz
ed by that
pathway

CYP1A2

Strong
Inhibitor
Level A
evidence

Ciprofloxin
Fluvonoxami
ne

Moderate
Inhibitor
Level A
evidence

Ethylestradio
l

Major
Inducers
Level A
evidence

Phenytoin
Rifampicin

CYP2C9
Hydromorpho
ne (Minor)

CYP2C19
Hydrocodon
e

CYP2D6
Oxycodone
(minor)
Methadone
(minor)
Hydrocodone
(major)
Hydromorpho
ne
(minor)
Oxymorphon
e
(minor)

CYP3A
Hydrocodon
e
(major)
Oxycodone
(major)
Fentanyl
Buprenorphi
ne
Alprazolam

Fluconazole
Fluvoxamine
Ticlopidine

Buproprion
Fluoxetine
Paroxetine
Perhexaline

Clarithromyci
n
Erythomycin
Grapefruit
juice
Indinavir
Itraconazole
Ketoconazol
e
Lopinavir
Saquinavir
Voriconazole

Fluconazole

Clarithromyc
in
Fluoxetine
Moclobemin
de
Moriconazol
e

Cinacalcet
Doxepin
Duloxetine
Flecainide
Moclobemide
Quinine
Terbinafine

Rifampicin

Lopinavir
Rifampicin
St John’s
wort

Apropitant
Atazanavir
Cimetidine
Cyclosporin
Diltiazem
Fluconazole
Fluvoxamine
Imatinib
Posaconazol
e
Verapamil
Bosetan
Carbamazep
ine
Efavirenz
Modafinil
Phenytoin
Rifampicin
St Johns
Wort
Amprenavir
Ciprofloxin
Delavirdine
Fosamprena
vir
Nefazodone
Paroxetine
fluoxetine
Darunavir
Dasatinib
Erlotinib
Lapatinib
Nilotinib

Likely
Inhibitor
Level B
evidence

Possible
Inhibitors
(Level C
evidence)

Amiodarone
Zafirlukast

Capecitabine
Fluoxetine

Isoniazide

Clomipramine
Haloperidol
Methadone
Metocloprami
de
Nilotinib

UGT2B7
Morphine
Hydromorpho
ne
(major)
Oxymorphon
e
(major)
Lorazepam
Temazepam
Diazepam

UGT1A1
Buprenorphine
(secondary)
Lorazepam
Temazepam
Diazepam

Codeine
Morphine
Diazepam
Probenecid
Valproate
Ketoconazole

Ketoconazole
Probenecid

UGT 1A3
Hydromorp
hone
(major)
Oxymorpho
ne
(major)

 Appendix C: DSM IV Definitions of Dependence and Abuse 
  
Dependence

Abuse

(3 or more in a 12-month period)

(1 or more in a 12-month period)
Symptoms must never have met criteria for
substance dependence for this class of
substance.

Tolerance (marked increase in amount; marked
decrease in effect)
Characteristic withdrawal symptoms;
substance taken to relieve withdrawal
Substance taken in larger amount and for
longer period than intended
Persistent desire or repeated unsuccessful
attempt to quit
Much time/activity to obtain, use, recover
Important social, occupational, or recreational
activities given up or reduced
Use continues despite knowledge of adverse
consequences (e.g., failure to fulfill role
obligation, use when physically hazardous)

Recurrent use resulting in failure to fulfill
major role obligation at work, home or school

Recurrent use in physically hazardous
situations
Recurrent substance related legal problems
Continued use despite persistent or recurrent
social oar interpersonal problems caused or
exacerbated by substance

 In using the DSM-IV criteria, one should specify whether substance dependence is with
physiologic dependence (i.e., there is evidence of tolerance or withdrawal) or without
physiologic dependence (i.e., no evidence of tolerance or withdrawal). In addition, patients may
be variously classified as currently manifesting a pattern of abuse or dependence or as in
remission. Those in remission can be divided into four subtypes -- full, early partial, sustained,
and sustained partial -- on the basis of whether any of the criteria for abuse or dependence have
been met and over what time frame. The remission category can also be used for patients
receiving agonist therapy (e.g., methadone maintenance) or for those living in a controlled drugfree environment.

 
  
 
  

APPENDIX 
  D 
  
CURRENT STATE PAIN LAWS from MEDSCAPE TODAY April 2,
2012
Introduction
Controlled substances are essential to the treatment of a myriad of disorders and represent a
wide spectrum of pharmaceutical agents. Prescribing these substances involves considering a
number of important medical, social, and cultural variables along with adherence to applicable
federal and state regulations. Physicians often stand at the crossroads of these issues and serve
as the ultimate gatekeepers of safe and effective treatment.
Physicians and others involved with prescribing controlled substances must be well-versed in the
legal requirements including knowledge of both federal and state law. The Controlled Substances
Act (CSA) is the federal law that regulates such substances. The CSA is a rather complete and
functional law and provides an operational framework the prescriber should understand. The
Drug Enforcement Administration (DEA) publishes a guide for prescribers entitled "Practitioner's
Manual, an Informational Outline of the Controlled Substances Act." This resource provides a
comprehensive overview of the Controlled Substances Act and the federal requirements for
prescribing controlled substances.
Additionally, all states have further regulations involving controlled substances. The physician
should be aware that state laws often impose additional, stricter requirements on prescribing
controlled substances. Physicians must be aware of these regulations to practice lawfully within
their local jurisdiction and in compliance with State Board of Medicine regulations.
In addition to physicians, the CSA generally authorizes dentists, podiatrists, and veterinarians to
prescribe controlled substances. Furthermore, states can authorize other licensed healthcare
professionals to prescribe controlled substances, including clinicians such as nurse practitioners
and physician assistants with proper DEA registration. In rare cases, naturopathic physicians and
optometrists can prescribe controlled substances in certain states with important limitations.
Information on nurse practitioners and their authority to prescribe can be found at Medscape's US
Nurse Practitioner Prescribing Law: A State-by-State Summary and DEA's Midlevel Practitioners
Authorized by State Website.

 The following is a summary of significant state laws involved with prescribing controlled
substances for the physician. The information provided is not intended to be completely
comprehensive and should not be exclusively relied upon for prescribing. The prescribing guide is
intended as a living document and Medscape welcome readers to submit comments and updates
to the Neurology site editor. Web links to detailed prescribing laws are provided for each state.
For additional information on prescribing controlled substances, contact the DEA or your State
Board of Medicine.
Alabama







Physician must complete medical history and physical examination and must document nature
and intensity of the pain, current and past medical treatments, history of substance abuse, etc.
before prescribing a controlled substance
Alabama Department of Public Health Prescription Monitoring Program
Prescribing or dispensing controlled substances for self or family except in emergency situations
is considered unprofessional conduct
Physicians prescribing Schedule II amphetamines must maintain an inventory, separate
dispensing record, and prescribing record for 5 years
Carisoprodol is classified as a Schedule IV controlled substance
Alabama State Board of Medical Examiners Medical Licensure Commission
Back to map
Alaska



o
o
o
o
o

Prescription Monitoring Program to monitor prescription drugs authorized but not yet
implemented.
When prescribing any controlled substance, a prescriber must create and maintain a complete,
clear, and legible written record of care that includes, at a minimum:
Patient history and evaluation sufficient to support a diagnosis;
Diagnosis and treatment plan;
Monitoring the patient for the primary condition that necessitates the drug, side effects of the
drug, and results of the drug, as appropriate; and
Record of drugs prescribed, administered, or dispensed, including the type of drug, dose, and any
authorized refills.
Alaska State Medical Board licensing information
Back to map
Arizona










The physician must maintain adequate, accurate and timely records regarding pain assessment,
treatment plan, informed consent, ongoing assessment and consultation of the patient. "Adequate
Records" indicates legible records containing, at a minimum, sufficient information to identify the
patient, support the diagnosis, and justify the treatment; adequate documentation of the results;
advice and cautionary warnings provided to the patient; and sufficient information for another
practitioner to assume continuity of the patient's care at any point in the treatment
Physicians must secure all controlled substances in a locked cabinet or room and control access
by a written procedure
Prescribing or dispensing controlled substances for oneself or family members is considered
unprofessional conduct
Prescription Monitoring Program monitors controlled substances
Arizona State Board of Pharmacy prescription monitoring information
Carisoprodol is classified as a Schedule IV controlled substance
Arizona Medical Board Website

 Back to map
Arkansas




o
o


o
o
o
o

License may be revoked or suspended for prescribing Schedule II controlled substances for
oneself or an immediate family member
Tramadol is classified as a Schedule IV controlled substance
Carisoprodol is classified as a Schedule IV controlled substance
Maintains the Intractable Pain Treatment Act (IPTA) which:
Prohibits the physician from prescribing or administering dangerous or controlled drugs intended
to manage chronic intractable pain to treat a patient for chemical dependency on drugs or
controlled substances
Prohibits the physician from prescribing or administering dangerous or controlled drugs to a
person for other than legitimate medical purposes (i.e. cause or assist in causing the suicide,
euthanasia, or mercy killing of any individual)
A physician who prescribes Schedule 2, 3, 4, and 5 narcotic agents on a long term basis (more
than 6 months) for a patient with pain not associated with malignant or terminal illness will be
considered exhibiting gross negligence or ignorant malpractice unless he or she has complied
with the following:
Keep accurate records
Periodically review the course of scheduled drug treatment
Obtain written informed consent from the patient
Arkansas State Medical Board Website
Back to map
California









Prescribers must write for all controlled substances (Schedule II-V) on tamper-resistant security
prescription forms that have at least 10 required security features
The Medical Board of California Controlled Substance Prescription Form Requirements
Prescription Monitoring Program monitors controlled substances
California Prescription Drug Monitoring Program
Prescribers cannot self-prescribe controlled substances
Medical marijuana is permitted under state law
Medical Board of California Laws and Regulations
Back to map
Colorado









Issuing a prescription on the basis of a questionnaire, Internet-based consultation, or a telephonic
consultation, without a valid preexisting patient-practitioner relationship is forbidden
A physician must not be subject to disciplinary action by the Board solely for prescribing
controlled substances for the relief of intractable pain.
Prescribing, distributing, or giving any controlled substance to oneself or family members, except
in an emergency, is considered unprofessional conduct and grounds for disciplinary action
Prescribing stimulant drugs classified as Schedule II controlled substances is not acceptable for
diet control, increasing work capacity, combating the normal fatigue associated with any
endeavor, or chemically inducing euphoria
Prescription Monitoring Program monitors controlled substances
Colorado Department of Regulatory Agencies Prescription Monitoring
Colorado Medical Board
Back to map

 Connecticut


o
o
o
o
o
o
o





Medical history and physical examination must be performed before prescribing any controlled
substance
A written prescription shall include:
The name and address of the patient
Whether the patient is an adult or a child, or his/her specific age
The compound or preparation prescribed and the amount
Directions for use of the medication
The name and address of the prescribing practitioner
The date of issuance
The Federal Registry number of the practitioner
Prescriptions for schedule II controlled substances shall contain only one drug
Prescription Monitoring Program monitors controlled substances
Connecticut Prescription Monitoring Program
Connecticut Medical Examining Board licensure information
Back to map
Delaware








Each written prescription shall have the name of the practitioner stamped, typed, or hand-printed
on it, as well as the signature of the practitioner
Prescriptions for controlled substances in schedules II and III become void unless dispensed
within 7 days of the original date of the prescription or if the original prescriber authorizes the
prescription past the seven days period.
Controlled substance prescriptions cannot be written nor dispensed for more than 100 dosage
units or a 31-day supply
Schedule II prescriptions for patients who are terminally ill or in long-term care facilities shall be
valid for a period not to exceed 60 days from the issue date unless sooner terminated by the
discontinuance of the medication
Physicians are not permitted to dispense a Schedule III or IV controlled substance for weight
reduction unless the drug has an FDA-approved indication for this purpose
Delaware Board of Medical Practice Website
Back to map
District of Columbia





Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations.
District of Columbia Health Professional Licensing Administration
Back to map
Florida




Must not prescribe drugs from different schedules or noncontrolled substances on same
prescription
Can prescribe maximum 30-day supply of a controlled substance listed in Schedule III via oral
prescription

 





o




Each written prescription prescribed by a practitioner in this state for a controlled substance listed
in Schedule II, Schedule III, or Schedule IV must include both a written and a numerical notation
of the quantity of the controlled substance prescribed on the face of the prescription and a
notation of the date, with the abbreviated month written out on the face of the prescription.
Carisoprodol is a Schedule IV controlled substance
Prescriptions or orders for any drug, synthetic compound, nutritional supplement or herbal
treatment for weight loss must be in writing and signed by the prescribing physician. Initial
prescriptions or orders of must not be called into a pharmacy by the physician or by an agent of
the physician. Even if the physician is registered as a dispensing physician, a hard copy of the
written prescription must be maintained in the patient's medical records for each time such weight
loss drugs are prescribed, ordered, dispensed, or administered
Prescription Monitoring Program to monitor controlled substances authorized but not yet
implemented.
FL§ 893.055
Self-prescribing controlled substances is prohibited
Salvia is classified as a Schedule I controlled substance
Florida Board of Medicine Laws and Rules
Back to map
Georgia




o
o
o
o
o
o
o
o
o
o
•
•
•
•
•
•
•
•

Carisoprodol is classified as a Schedule IV controlled substance
Self-prescribing controlled substances is considered unprofessional conduct
Follows "Ten-Step Policy" on the use of controlled medications to treat pain:
Medical history and physical examination must be obtained
Create treatment plan
Determine that noncontrolled drugs are not appropriate or effective for the patient's condition
Review patient's medication record and discuss chemical history before prescribing a controlled
drug
Discuss risks and benefits with the patient on the use of controlled substances
Maintain regular monitoring of the patient
Physician must keep detailed records of the type, dosage, and amount of the drug prescribed
With the patient's permission, family may be a valuable source of information on the patient's
response to the therapy regimen and the patient's functional status (ie, tolerance and
dependence)
Physician must maintain adequate records to assess and review treatment course and progress
Keep accurate and complete records including:
The medical history and physical examination
Diagnostic, therapeutic, and laboratory results
Evaluations and consultations
Treatment objectives
Medications (including date, type, dosage, and quantity prescribed)
Instructions and agreements and pain contracts (where applicable)
Georgia State Board of Medical Examiners Guidelines for Controlled Substances For the
Treatment of Pain?
Georgia Composite Medical Board Rules and Laws
Back to map
Hawaii





Self-prescribing controlled substances is only permitted in an emergency
Prescription Monitoring Program monitors controlled substances
Medical marijuana is permitted under state law

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Prescriber should use both words and figures (ie, indicate quantities both alphabetically and
numerically: five [5]) to indicate the amount of controlled substances prescribed
Carisoprodol is classified as a Schedule IV controlled substance
Hawaii Department of Commerce and Consumer Affairs Professional And Vocational Licensing
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Idaho

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When prescribing a Schedule II controlled substance, the practitioner shall indicate the desired
quantity of the drug on the prescription blank by both writing out the quantity and by indicating or
writing the quantity in numerical form
Prescription Monitoring Program monitors controlled substances
Idaho Prescription Monitoring Program
Schedule II orders for patients in properly licensed hospitals, nursing homes, or extended care
facilities that use a unit dose distribution system shall be written into the patient's record and
signed by the practitioner, with proper dating and drug information. A direct copy of this order
must be given to the pharmacist within 72 hours. These records shall be kept for 3 years and
must remain available for inspection.
Disciplinary action may be taken for prescribing or providing controlled substances for oneself,
spouse, child, or stepchild
Prescribing narcotic or hallucinogenic drugs to addicted individuals to maintain their addictions
and level of usage without attempting to treat the primary condition is considered grounds for
medical discipline
Idaho Board of Medicine
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Illinois

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Prescribers must have a state license to prescribe controlled substance
Prescription Monitoring Program monitors controlled substances
Illinois Prescription Monitoring Program
Salvia is classified as Schedule I controlled substance
Illinois Division Of Professional Regulation
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Indiana

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A physician shall not utilize, prescribe, order, dispense, administer, supply, sell, or give any
controlled substance for weight loss unless he/she conducts a thorough review and documents
that previous therapy was ineffective
A physician shall not prescribe, dispense, or otherwise provide, or cause to be provided any
controlled substance to a person who the physician has never personally physically examined
and diagnosed (except in institutional settings, on-call situations, and cross-coverage situations)
Prescription Monitoring Program monitors controlled substances
Indiana Prescription Monitoring Program
Carisoprodol is classified as a Schedule IV controlled substance
When a controlled substance is prescribed for administration to an ultimate user who is
institutionalized, it should not be prescribed or dispensed for more than 7-day supply at the same
time for Schedule II controlled substances; and no more than a 34-day supply or 100 dosage
units -- whichever is less -- at the same time for Schedule III or IV substances.
Indiana Professional Licensing Agency Statutes and Rules
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 Iowa
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o
o
o
o
o
o
o
o
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Physicians are not permitted to self-prescribe or self-dispense controlled substances
Prescription Monitoring Program monitors controlled substances
Iowa Board of Pharmacy Prescription Monitoring Program
To ensure that pain is properly and promptly assessed and treated, the physician must exercise
sound clinical judgment by establishing an effective pain management plan in accordance with
the following:
Patient evaluation
Treatment plan
Informed consent
Periodic review
Consultation/referral
Documentation
Physician-patient agreement
Termination of care
Iowa Board of Medicine Website
Back to map
Kansas

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Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
Controlled substance prescriptions in Schedules II through V shall not be issued on a prescription
blank that is preprinted with the name of a proprietary preparation or with the strength, quantity,
or directions.
Prescription Monitoring Program to monitor controlled substances was implemented on April 1,
2011.
Kansas State Board of Healing Arts Rules and Regulations
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Kentucky

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Kentucky Prescription Monitoring Program
Physicians should avoid prescribing Scheduled controlled substances for themselves, immediate
family, staff, or individuals knowingly that will abuse
Kentucky Board of Medical Licensure has issued standards of acceptable and prevailing medical
practice for prescribing controlled substances
Prescriptions for controlled substance in Schedule II are valid for only 60 days from the date
issued
Tramadol is classified as a Schedule IV controlled substance
Carisoprodol is classified as a Schedule IV controlled substance
Schedule II amphetamine or amphetamine-like controlled substance should not be prescribed to
treat obesity
Kentucky Board of Medical Licensure physician information
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Louisiana

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Louisiana Prescription Monitoring Program
The physician must see all patients treated, not to exceed every 12 weeks, and during these
interval visits must assess the efficacy of treatment, assure that controlled substance therapy
remains indicated, and must evaluate the patient's progress toward treatment objectives and any
adverse drug effects.
Carisoprodol is classified as a Schedule IV controlled substance
Louisiana State Board of Medical Examiners Laws
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Maine

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Maine Prescription Monitoring Program
Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
Medical marijuana is permitted under state law
Maine Board of Licensure in Medicine
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Maryland

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Prescriptions for a Schedule II, III, IV, or V controlled substance are valid for 120 days from the
dated issued
Prescribing of controlled substances to family members is strongly discouraged
Maryland Board of Physicians licensure regulations
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Massachusetts

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o
o
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Prescriptions must be manually signed when written. A rubber stamp signature may not be used
Separate prescription blank must be used for each controlled substance prescribed
Schedule II prescriptions valid only for 30 days after the date issued
No controlled substance in Schedule II or III shall be filled for more than a 30-day supply upon
any single filling; however, with regard to dextroamphetamine sulphate and methylphenidate
hydrochloride, a prescription may be filled for up to a 60-day supply of such substance upon any
single filling if the medication is being used for the treatment of minimal brain dysfunction or
narcolepsy
Patient contact must be maintained while prescribing controlled substances. Physicians
prescribing controlled substances over a long period of time to a patient whose disease is stable
must perform the following:
The physician sees the patient at least once every 6 months; or
The physician writes a note in his or her records explaining why it is impossible, impractical or
inappropriate to see the patient at least once every 6 months
Carisoprodol is classified as a Schedule IV controlled substance
Massachusetts Board of Registration in Medicine
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Michigan

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Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
Schedule II prescriptions are valid for 90 days from the date issued
Michigan Prescription Monitoring Program
A controlled substance prescription shall contain the quantity of the controlled substance
prescribed in both written and numerical terms
Medical marijuana is permitted under state law
Michigan Department of Community Health
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Minnesota

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Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and demonstrating compliance with controlled
substances laws and regulations
Minnesota Prescription Monitoring Program
Carisoprodol is classified as a Schedule IV controlled Substance
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Mississippi

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No physician shall prescribe, administer, or dispense any controlled substance or other drugs
having addiction-forming or addiction-sustaining liability without prior examination and medical
indication
Mississippi Prescription Monitoring Program
Schedule II prescriptions expire after 6 months from the date of issuance
No prescriptions for brand name or generic equivalents of nalbuphine HCl, carisoprodol, butalbital
compounds, or tramadol HCl shall be faxed
Mississippi State Board of Medical Licensure Laws
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Missouri

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If the prescription is for greater than a 30-day supply of a Schedule II drug, the prescriber must
write the medical reason on the prescription. A diagnosis code number is not acceptable
Physicians are prohibited from self-prescribing controlled substances except in a true medical
emergency
Schedule II prescriptions are valid for 6 months
Quantity limitations for Schedule II controlled substances is 30 days for most; prescriptions for
over 30 days require a medical reason, and the maximum is 90-day supply. Schedule III and IV
controlled substances are limited to a 90-day supply
Missouri Division of Professional Registration Rules and Statutes
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Montana

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Restricts the prescription quantity of Schedule II controlled substances to 30-day supply (may be
increased up to 6 months if medical reason is described on prescription)
Self-prescribing or prescribing controlled substances for family members may result in disciplinary
action if it does not meet the generally accepted standards of practice
Restricts the prescription quantity to initial maximum 3-month supply for CSIII-V with refills in
writing
Case law provides framework for physician assisted suicide
Medical marijuana is permitted under state law
Montana Board of Medical Examiners Website
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Nebraska

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Prescribing controlled substances for oneself or except in a medical emergency an immediate
family member is considered grounds for disciplinary action
Schedule II prescriptions expire in 6 months
Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and demonstrating compliance with controlled
substances laws and regulations
Salvia is a Schedule I substance
Nebraska Department of Health and Human Services Physician and Surgeon Regulations and
Statutes
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Nevada

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Prescribers are not permitted to self-prescribe controlled substances nor prescribe Schedule II
controlled substances to immediate family
Prescription Monitoring Program monitors controlled substances
Prescriptions for Schedule II controlled substances may include other controlled substances not
listed in Schedule II as well as other prescription drugs
Nevada State Board Of Pharmacy
All prescriptions for controlled substances expire after 6 months from the date written
Carisoprodol is a Schedule IV controlled substance
Medical marijuana is permitted under state law
Nevada Board of Medical Examiners Statutes and Regulations
Back to map
New Hampshire

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Restricts the prescription quantity of Schedule II and III controlled substances to a 34-day supply
or 100 dosage units, whichever is less (up to 60-day supply for amphetamine or methylphenidate
if for attention-deficit disorder or narcolepsy)
Schedule II prescriptions expire within 6 months
Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating patient, treatment plan, informed consent, agreement for
treatment, periodic review, consultation, medical records (accurate and complete), and
compliance with controlled substance laws and regulations
Higher controlled substance doses can be administered if the physician determines that
appropriate pain management warrants this and the benefit of the relief expected outweighs the

 

risk of the high dosage. However, the controlled substance cannot be administered for the
purpose of causing or assisting in the patient's death
New Hampshire Board of Medicine Laws and Rules
Back to map
New Jersey

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All prescriptions must be written on state authorized prescription blanks printed with the
prescriber's NPI serialized by vendor, and must include the collaborating physician's name,
license number, address, and phone number
Prescription Monitoring Program authorized, but not yet implemented
Each prescription for a controlled substance shall be written on a separate Uniform Prescription
Blank (NJPB). An NJPB that contains a prescription for only one controlled substance and
contains other prescription other than controlled substance shall be valid. But an NJPB that
contains prescriptions for 2 or more controlled substances shall be invalid
A report must be filed within 72 hours of noticing any stolen, forged, or lost NJPBs
Schedule II controlled substance prescriptions are limited to a 30-day supply
As a general rule, the State of New Jersey limits prescribing to a 34-day supply or 100 dosage
units -- whichever is less -- of controlled substance listed in schedule III or IV and dispensed at
one time (this may be exceeded under certain circumstances to achieve pain management for
patients with cancer, intractable pain or terminal illness)
The practitioner should review the patient's progress toward the treatment objectives, the course
of treatment, new information about the cause of pain at a minimum of every 3 months, if the
patient is prescribed controlled substances for greater than 3 months
All prescriptions for controlled substances expire within 30 days after the date when issued
Within 72 hours after authorizing an emergency oral prescription, the prescriber must deliver the
original prescription to the dispensing pharmacist
Medical marijuana is permitted under state law
New Jersey State Board of Medical Examiners
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New Mexico

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New Mexico Prescription Monitoring Program
Medical marijuana is permitted under state law
Carisoprodol is classified as a Schedule IV controlled substance
Physicians being treated with opiates must have medical clearance to prescribe and be under
medical care
New Mexico Medical Board Governing Statutes
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New York

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

Restricts the prescription quantity of Schedule II controlled substances to a 30-day supply, or up
to 3 months in the case of gonadotropin and up to 6 months in the case of anabolic steroids, if
used for the treatment of panic disorder (code A); ADD (code B); chronic debilitating neurological
conditions characterized as movement disorder or exhibiting seizure, convulsive or spasm activity
(code C); pain from chronic incurable conditions (code D); narcolepsy (code E); or hormone
deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic
steroids or chorionic gonadotropin, metastatic breast cancer, anemia, and angioedema (code F).
The same applies to Schedule III, IV, and V medications
Oral prescriptions for Schedule IV medications limited to 30 days or 100 dosage units, whichever
is less

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

Prescribers must submit dispensing information for all controlled substances. Prescriptions for
Schedule II medications (including anabolic steroids) and benzodiazepines must be written on
official prescription forms with no refills
The medical board recommends that physicians not self-prescribe or prescribe for family
members
Schedule II controlled substances and benzodiazepine prescriptions also require sex, age of the
patient, telephone number of the prescribing practitioner, and maximum daily dosage
New York State Prescription Monitoring Program
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North Carolina

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The patient's name and physical street address for all controlled substance prescriptions must be
readily retrievable, but is not required to be handwritten on the face of the prescription hard copy
The preprinting of or use of preprinted prescription blanks with the name of scheduled substances
is prohibited. Prescription blanks that are individually generated (aka: computer-generated
prescriptions) are permissible
Each prescription for a DEA controlled substance (2, 2N, 3, 3N, 4 and 5) should be written on
separate prescription blanks
North Carolina Prescription Monitoring Program
North Carolina Medical Board Professional Resources
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North Dakota

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Prescriptions for Schedule II controlled substances may not be filled more than 6 months after the
date they were written
Salvia is a schedule I controlled substance
Prescribing or providing a controlled substance or addictive or dangerous drug for oneself,
spouse, or child may be grounds for disciplinary action
North Dakota Prescription Monitoring Program
North Dakota State Board of Medical Examiners Medical Practice Act
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Ohio

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o

No prescription may be dispensed for the first time beyond 6 months from the date it was issued
or refilled beyond 1 year from the date it was issued
Physicians are not permitted to prescribe a Schedule II controlled substance for purposes of
weight reduction or control
A physician may utilize a schedule III or IV controlled substance that bears appropriate FDA
approved labeling for weight loss or the maintenance of weight loss, in the treatment of obesity as
an adjunct, and in a regimen of weight reduction based on caloric restriction, provided that the
scheduled drug is at all times to be considered an adjunct to diet and lifestyle changes, which are
appropriately the responsibility of the patient
The physician shall personally meet face-to-face with the patient, at a minimum, every 30 days
when controlled substances are being used for weight reduction
The total course of treatment using controlled substance shall not exceed 12 weeks.
An exception is Meridia® (sibutramine), the only controlled substance drug approved for longterm use. Its safety and efficacy, however, have not been studied beyond 2 years. Its
effectiveness in a particular patient is usually evident within the first 4 weeks of therapy. If the
patient has not lost at least 4 pounds during this period, the physician is advised to reevaluate
continued use of the drug

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Salvia is classified as a Schedule I controlled substance
Physicians are prohibited from self-prescribing or self-administering controlled substances
Physicians are permitted to prescribe controlled substances to a family member only in a medical
emergency
Ohio Prescription Monitoring Program
Ohio State Medical Board Website
Back to map
Oklahoma

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Prescriptions for Schedule II controlled substances expire 30 days after the date of issuance
Each scheduled drug must be written on a single prescription form, and no other prescriptions
(controlled or noncontrolled) can be written on the same prescription form
Refills must not be granted at the same time as the initial filling of the prescription for schedule III
or IV controlled substances
A new prescription for a specific controlled substance voids any existing refills or other
prescriptions for the same drug
Oklahoma Prescription Monitoring Program
Salvia is a Schedule I controlled substance
Carisoprodol is a Schedule IV controlled substance
Physicians are not permitted to prescribe controlled substances to oneself or family except in an
emergency when no other medical doctor is available
Oklahoma Board of Medical Licensure and Supervision laws
Back to map
Oregon

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Before initiating treatment of "intractable pain" with controlled substances, the physician must
discuss the material risks and provide written notice of said risks
Pseudoephedrine is classified as a Schedule III controlled substance
Oregon Prescription Monitoring Program
Carisoprodol is schedule IV controlled substance.
Medical marijuana is permitted under state law
Physician-assisted suicide permitted under state law using a strict protocol
Oregon Medical Board Rules and Statutes
Back to map
Pennsylvania

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o
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Schedule II prescriptions expire 6 months after the date of issuance
Patient's medical records must be kept for at least 7 years from the date of the last medical
service for which a medical record entry is required. The medical record for a minor patient must
be retained until 1 year after the minor patient reaches the majority, even if this means that the
physician retains the record for a period of more than 7 years
Prescription Monitoring Program monitors controlled substances
28 PA. Code § 25.131
Pennsylvania State Board of Medicine Website
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Rhode Island

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Physicians must perform a physical examination prior to prescribing any Schedule II, III, or IV
controlled substance
Rhode Island Prescription Monitoring Program
The State of Rhode Island finds it inappropriate to issue "do not fill before [date]" prescriptions
based on the DEA's Interim Policy Statement prohibiting this prescribing format
A schedule II controlled substance prescription (with a few exceptions) becomes void unless
dispensed within 30 days of the original date of the prescription
Prescriptions for Schedule II controlled substances -- except for amphetamine mixtures, as
specifically listed in the Rhode Island Controlled Substances Act -- may be written for up to a 30day supply, with a maximum of 250 dosage units, as determined by the prescriber's directions for
use of the medication. Amphetamines in certain forms may be written for up to a 60-day supply
with a maximum of 250 dosage units, as determined by the prescriber's directions for use of the
medication
Schedule III, IV, and V prescriptions cannot be written for more than one 100 dosage units and
not more than 100 dosage units may be dispensed at one time unless a duly licensed physician
increases, by prescription, the dosage units to a maximum of 300 dosage units for Schedule IV
and V medications to provide a patient with a 3 month supply. For purposes of this section, a
"dosage unit" shall be defined as a single capsule, tablet, or suppository, or not more than 1
teaspoon of an oral liquid.
Medical marijuana is permitted under state law
Rhode Island Board of Medical Licensure and Discipline Website
Back to map
South Carolina

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With the exception of transdermal patches, supply limitation is 31 days and must be dispensed
within 90 days of the date of issue. After 90 days, a Schedule II controlled substance prescription
is void
Self-prescribing or prescribing for family members is only permitted in an emergency
The state limits the quantity of each prescription for Schedule III through V controlled medications
to a 90-day supply. If authorized for refill, no prescription shall be refilled sooner than 48 hours
prior to the time that the prescription should be consumed if the prescribed daily dosage is
divided into the total prescribed amount
Preprinted prescriptions for controlled substances in any schedule are prohibited
South Carolina Prescription Monitoring Program
Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations.
South Carolina Board of Medical Examiners Laws and Policies
Back to map
South Dakota

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Prescribers must have a South Dakota Controlled Substance Registration
Cannot self-prescribe controlled substances. Prescribing for spouse and children is discouraged
Adopted Model Guidelines for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
South Dakota Board of Medical Examiners Laws and Policies
Back to map

 Tennessee
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Tennessee Prescription Monitoring Program
Medical and prescription orders may be transmitted to a pharmacy practice site by a facsimile
device
Prescription or medical orders transmitted electronically can be filled if they meet certain
requirements
Physician may self-prescribe Schedule IV drugs only in an emergency. Prescribing, providing, or
administering Schedule II and III drugs to oneself is prohibited
Tennessee Department of Health Legislative Updates
Texas

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Adopted the Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
Texas Prescription Monitoring Program
A practitioner may issue a prescription for a Schedule II controlled substance only on an official
Texas prescription form, which includes single or multiple copy forms. This also applies to a
prescription issued in an emergency situation
Carisoprodol is classified as a Schedule IV controlled substance
Texas Medical Board Laws, Rules, and Guidelines
Back to map
Utah

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Adopted the Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
It is considered unprofessional conduct to self-prescribe Schedule II or Schedule III controlled
substances
Age of the patient is required on controlled substance prescriptions
When writing a prescription for a controlled substance, each prescription must contain only one
controlled substance per prescription form and no other prescription drug can be listed
Unless the prescriber determines there is a valid medical reason to allow an earlier dispensing
date, the dispensing date of a second or third prescription shall be no less than 30 days from the
dispensing date of the previous prescription, to allow for receipt of the subsequent prescription
before the previous prescription runs out
Utah Prescription Monitoring Program
Utah Division of Occupational and Proffesional Licensing physician and surgeon information
Back to map
Vermont



Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with

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the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
The prescribing practitioner's signature must be hand written on prescription drug orders.
Stamped signatures are not permitted
It is considered unacceptable medical practice and unprofessional conduct to prescribe a
Schedule II through IV controlled substance for oneself, or, except in an emergency, for an
immediate family member
No prescription for a Schedule II controlled substance written to be filled at a future date may be
filled more than 90 days after the date the prescription was issued
Tamper Resistant Prescription Forms must be used for all prescriptions.
Medical marijuana is permitted under state law
Vermont Prescription Monitoring Program
Vermont Department of Health Reports, Laws, Rules and Court Cases
Back to map
Virginia

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Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations
Only allowed 1 controlled substance written per prescription order form
Virginia Prescription Monitoring Program
Self-prescribing or prescribing for family members may occur in an emergency or isolated setting
where no other physician is available
Virginia Board of Medicine Laws and Regulations
Back to map
Washington

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Washington has a triplicate prescription form program
Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, complying with controlled substances laws and
regulations.
Medical marijuana is permitted under state law Carisoprodol is classified as a Schedule IV
controlled Substance
Self-prescribing controlled substances is prohibited
Physician assisted suicide is permitted under state law under a strict protocol
Washington State Department of Health Laws
Back to map
West Virginia

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Adopted Model Policy for the Use of Controlled Substances for the Treatment of Pain. The
guidelines consist of evaluating the patient, development of a treatment plan, obtaining informed
consent and agreement for treatment, periodically reviewing the treatment plan, consulting with
the patient, maintaining good medical records, and complying with controlled substances laws
and regulations

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Each controlled substance prescription must be written on a separate prescription blank.
Controlled substances cannot be ordered on a blank with a controlled substance. Only one
prescription for a controlled substance may be written per prescription blank
A prescription for a Schedule II controlled substance can be filled up to 90 days from date of
issuance
Carisoprodol is classified as a Schedule IV controlled substance
Self-prescribing or prescribing controlled substances for family members may be grounds for
disciplinary action
West Virginia Board of Medicine Website
Back to map
Wisconsin

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Physicians are prohibited from self-prescribing controlled substances
Prescribing, ordering, dispensing, administering, supplying, selling, or giving any Schedule II
amphetamine is considered unprofessional conduct and is prohibited except for specified
conditions
Weight control is not considered an accepted indication for Schedule II stimulants in Wisconsin
No more than a 30-day supply of drugs may be prescribed or dispensed at any one time for
Schedule III-V controlled substances for weight or obesity
Medical marijuana is permitted under state law
Wisconsin Department of Regulation and Licensing physicians laws and rules
Back to map
Wyoming

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o
o
o
o
o
o
o
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Wyoming Prescription Monitoring Program
It is considered a violation of the Wyoming Medical Practice Act to repeatedly prescribe or
provide a controlled substance to one-self or a parent, spouse, or child
All controlled substance prescriptions must be issued on security paper and include the following
features:
If scanned or copied, "void" is displayed prominently throughout the front side of the document
Erasure protection on green or blue background is utilized on the front side
Clear instructions printed on the paper indicating the front and back sides
Security warning list on the blank
All suppliers of security paper must be approved by the Board
Use of preprinted prescriptions is allowed
Under no circumstance may stickers be utilized for information relating to drug, strength, quantity,
or directions.
Wyoming State Board of Medicine Web site

 
  
APPENDIX 
  E 
  
Inappropriate 
  Death 
  Coding 
  Rate 
  By 
  State 
   
   
   
  CDC 
  Wonder 
  Search 
  June 
  2012 
  
 
   X44 
  2009 
   
   X40-­‐44 
  
Ratio 
  
X44 
  1999-­‐ X40-­‐44 
  99-­‐ Ratio 
  
2009 
  
2009 
  
2009 
  
AL 
  
382 
  
537 
  
71.1 
  
2056 
  
2934 
  
AK 
  
60 
  
101 
  
59.4 
  
453 
  
704 
  
AZ 
  
353 
  
757 
  
46.6 
  
2345 
  
6038 
  
AR 
  
174 
  
220 
  
79.1 
  
772 
  
1120 
  
CA 
  
1508 
  
3236 
  
46.6 
  
11078 
  
26420 
  
CO 
  
250 
  
564 
  
44.3 
  
1549 
  
4054 
  

70.1 
  
64.3 
  
38.8 
  
68.9 
  
41.9 
  
38.2 
  

 CT 
  
DE 
  
FL 
  
GA 
  
HA 
  
ID 
  
IL 
  
IN 
  
IA 
  
KS 
  
KY 
  
LA 
  
ME 
  
MD 
  
MA 
  
MI 
  
MN 
  
MS 
  
MO 
  
MT 
  
NB 
  
NV 
  
NH 
  
NJ 
  
NM 
  
NY 
  
NC 
  
ND 
  
OH 
  
OK 
  
OR 
  
PA 
  
RI 
  
SC 
  
SD 
  
TN 
  
TX 
  
UT 
  
VT 
  
VA 
  
WA 
  
WV 
  
WI 
  

82 
  
61 
  
1499 
  
469 
  
25 
  
64 
  
251 
  
491 
  
63 
  
121 
  
466 
  
356 
  
76 
  
29 
  
165 
  
427 
  
102 
  
183 
  
281 
  
25 
  
39 
  
181 
  
43 
  
175 
  
183 
  
540 
  
179 
  
13 
  
566 
  
317 
  
83 
  
1135 
  
60 
  
345 
  
 
  
397 
  
1009 
  
95 
  
 
  
200 
  
430 
  
120 
  
223 
  

320 
  
102 
  
2509 
  
854 
  
94 
  
100 
  
1130 
  
697 
  
138 
  
229 
  
631 
  
476 
  
133 
  
73 
  
693 
  
1002 
  
291 
  
262 
  
700 
  
94 
  
81 
  
449 
  
128 
  
223 
  
352 
  
1217 
  
954 
  
23 
  
1035 
  
647 
  
360 
  
1581 
  
138 
  
539 
  
27 
  
771 
  
2004 
  
210 
  
37 
  
516 
  
804 
  
181 
  
464 
  

25.6 
  
59.8 
  
59.7 
  
54.9 
  
26.6 
  
64.0 
  
22.2 
  
70.4 
  
45.7 
  
52.8 
  
73.9 
  
74.8 
  
57.1 
  
39.7 
  
23.8 
  
42.6 
  
35.1 
  
69.8 
  
40.1 
  
26.6 
  
48.1 
  
40.3 
  
33.6 
  
78.5 
  
52.0 
  
44.4 
  
18.8 
  
56.5 
  
54.7 
  
49.0 
  
23.1 
  
71.8 
  
43.5 
  
64.0 
  
 
  
51.5 
  
50.3 
  
45.2 
  
 
  
38.8 
  
53.5 
  
66.3 
  
48.1 
  

882 
  
328 
  
9772 
  
3015 
  
225 
  
390 
  
1785 
  
2386 
  
378 
  
729 
  
3233 
  
2965 
  
423 
  
210 
  
868 
  
2849 
  
614 
  
1380 
  
1820 
  
247 
  
232 
  
1028 
  
332 
  
2848 
  
1143 
  
3801 
  
1219 
  
84 
  
4816 
  
1576 
  
568 
  
9091 
  
256 
  
1933 
  
59 
  
2856 
  
6214 
  
409 
  
146 
  
1763 
  
2999 
  
1349 
  
1425 
  

3138 
  
663 
  
18943 
  
6209 
  
688 
  
754 
  
9943 
  
3603 
  
877 
  
1501 
  
4874 
  
4329 
  
1127 
  
520 
  
3970 
  
6295 
  
1894 
  
1920 
  
4642 
  
569 
  
475 
  
3201 
  
965 
  
6164 
  
3259 
  
10609 
  
7283 
  
154 
  
9736 
  
3817 
  
2622 
  
13123 
  
608 
  
3506 
  
185 
  
5746 
  
15381 
  
995 
  
408 
  
4649 
  
6521 
  
2252 
  
3460 
  

28.1 
  
49.5 
  
51.6 
  
48.6 
  
32.7 
  
51.7 
  
18.0 
  
66.2 
  
43.1 
  
48.6 
  
66.3 
  
68.5 
  
37.5 
  
40.4 
  
21.9 
  
45.3 
  
32.4 
  
71.9 
  
39.2 
  
43.4 
  
48.8 
  
32.1 
  
34.4 
  
46.2 
  
35.1 
  
35.8 
  
16.7 
  
54.5 
  
49.5 
  
41.3 
  
21.7 
  
69.3 
  
42.1 
  
55.1 
  
31.9 
  
49.7 
  
40.4 
  
41.1 
  
35.8 
  
37.9 
  
46.0 
  
59.9 
  
41.2 
  

 WY 
  
US 
  

32 
  
14328 
  

56 
  
28740 
  

57.1 
  
49.9 
  

167 
  
99066 
  

320 
  
223168 
  

52.2 
  
44.4 
  

 
  

APPENDIX F: INDIANA PAIN SOCIETY
STANDARDS FOR OPIOID
PRESCRIBING
5. Opioid Treatment For Chronic Pain
a. Preface and Fundamental Concepts
STANDARD 5.1.1 Opioid treatment may be initiated in medically and psychologically
appropriate patients that have tried and failed other conservative treatments, and after a
substance abuse screening tool or substance abuse history survey result has been evaluated
for appropriateness of prescribing opioids.
STANDARD 5.1.2 Opioids should not be the only therapy employed in pain control efforts in
chronic non-malignant pain
STANDARD 5.1.3 An opioid agreement will be signed by the patient prior to the prescribing
of any opioids when long-term opioid prescribing is anticipated or in any case, after 3 months
of the patient taking opioids at least weekly. This agreement makes clear the policies of the
clinic, the responsibilities of the patient being prescribed chronic opioids, the possible
consequences of substance abuse or drug diversion, and may include the required consent
for opioid treatment.
STANDARD 5.1.4 Opioids may be prescribed only for the legitimate medical purpose of
reduction of pain or improvement of function unless addiction is being actively treated under a
Drug Enforcement Agency special license.

b. Referral to Other Consulting Physicians and
Psychologists
STANDARD 5.2.1 Referral to other specialists may be required of the patient as a part of the
continuation of opioid therapy.

c. Follow-up Frequency
STANDARD 5.3.1 Patients receiving initiation or continuation of opioid therapy should be seen
at least every 4 weeks until the patients compliant behavior and therapeutic efficacy are
established. Subsequently, patients receiving more than 120mg a day morphine (or equivalent)
or less must be seen in follow-up at least every 8 weeks or less under normal circumstances.
Patients receiving 180mg a day or more morphine (or equivalent) must be seen in follow-up
at least every 6 weeks or less under normal circumstances.

d. Substance Abuse Detection Tool Employment
STANDARD 5.4.1 Patients receiving chronic opioids must have an INSPECT report generated at
least every 6 months.
STANDARD 5.4.2 Urine, blood, or saliva levels of the prescribed substances and illicit
substances are a critical part of chronic opioid therapy management and for assuring patient

 compliance. These tests should be employed in cases of suspected substance abuse or drug
diversion, and randomly at reasonable intervals.

e. Drug Diversion and Substance Abuse
STANDARD 5.5.1 Patients will be monitored by the opioid prescriber for substance abuse and
diversion, and will take decisive action to eliminate these issues in their patient population.
Identified substance abuse may include referral to an addictionologist, co-management with a
psychiatrist or psychologist, use of more frequent follow-ups, or referral to a drug treatment
center. Drug diversion must be treated with cessation of prescribing of controlled substances.

f. Cessation of Prescribing Opioids
STANDARD 5.6.1 Sudden cessation of opioid prescribing should not be used in patients with
known symptomatic coronary artery disease and should not be used in general unless there is
evidence of drug diversion, use of illicit drugs, or obtaining opioids from other sources.
STANDARD 5.6.2 When opioids are no longer to be prescribed due to substance abuse or
diversion, the prescriber will offer referral to a drug rehabilitation center or addiction
treatment center. Gradual weaning may be employed if there has been substance abuse but no
drug diversion or illicit substance use.
STANDARD 5.6.3 The opioid prescriber may withdraw opioid treatment at any time for failure
to achieve adequate pain relief, excessive or life threatening side effects, substance abuse,
addiction, or drug diversion without discharging the patient from their practice. There is no
obligation of the prescriber to continue opioid treatment in such situations.
STANDARD 5.6.4 The withdrawal of opioids due to addiction, substance abuse, or diversion will
be prominently noted in the medical record and will be communicated to all known currently
treating controlled substance prescribers of record and those identified by INSPECT as
prescribing opioids recently.
STANDARD 5.6.5 It is inappropriate to refer a patient to another opioid prescriber or back to
their primary care provider for continued opioid therapy for pain when the patient has engaged
in substance abuse, drug diversion, or exhibits signs of addiction. In such situations patients
should be withdrawn from opioids for at least 6 months prior to re-engaging opioids, and then
only under tight control with addictionology co-management if available, otherwise
with psychological counseling as an on-going part of the opioid treatment program.

 
  
 
  

APPENDIX 
  G: 
  CURRENT 
  INDIANA 
  CONTROLLED 
  SUBSTANCE 
  LAWS 
  
REGARDING 
  OPIOIDS 
  
 
  
IC 35-48-4-2
Dealing in a schedule I, II, or III controlled substance
Sec. 2. (a) A person who:
(1) knowingly or intentionally:
(A) manufactures
(B) finances the manufacture of;
(C) delivers; or
(D) finances the delivery of;
a controlled substance, pure or adulterated, classified in schedule I, II, or

 III, except marijuana, hash oil, hashish, salvia, or a synthetic cannabinoid; or
(2) possesses, with intent to:
(A) manufacture;
(B) finance the manufacture of;
(C) deliver; or
(D) finance the delivery of;
a controlled substance, pure or adulterated, classified in schedule I, II, or
III, except marijuana, hash oil, hashish, salvia, or a synthetic cannabinoid;
commits dealing in a schedule I, II, or III controlled substance, a Class B
felony, except as provided in subsection (b).
(b) The offense is a Class A felony if:
(1) the person:
(A) delivered; or
(B) financed the delivery of;
the substance to a person under eighteen (18) years of age at least three (3)
years junior to the person; or
(2) the person delivered or financed the delivery of the substance:
(A) on a school bus; or
(B) in, on, or within one thousand (1,000) feet of:
(i) school property;
(ii) a public park;
(iii) a family housing complex; or
(iv) a youth program center.
The law that makes it illegal to receive an opioid drug without prescription is:
IC 35-48-4-6
Possession of cocaine or narcotic drug
Sec. 6. (a) A person who, without a valid prescription or order of a
practitioner acting in the course of the practitioner's professional practice,
knowingly or intentionally possesses cocaine (pure or adulterated) or a narcotic
drug (pure or adulterated) classified in schedule I or II, commits possession of
cocaine or a narcotic drug, a Class D felony, except as provided in subsection
(b).
(b) The offense is:
(1) a Class C felony if:
(A) the amount of the drug involved (pure or adulterated) weighs three
(3) grams or more; or
(B) the person was also in possession of a firearm (as defined in IC 3547-1-5);
(2) a Class B felony if the person in possession of the cocaine or narcotic
drug possesses less than three (3) grams of pure or adulterated cocaine or a

 narcotic drug:
(A) on a school bus; or
(B) in, on, or within one thousand (1,000) feet of:
(i) school property;
(ii) a public park;
(iii) a family housing complex; or
(iv) a youth program center; and
(3) a Class A felony if the person possesses the cocaine or narcotic drug in
an amount (pure or adulterated) weighing at least three (3) grams:
(A) on a school bus; or
(B) in, on, or within one thousand (1,000) feet of:
(i) school property;
(ii) a public park;
(iii) a family housing complex; or
(iv) a youth program center.
IC 35-48-4-7
Possession of a controlled substance; obtaining a schedule V controlled
substance
Sec. 7. (a) A person who, without a valid prescription or order of a
practitioner acting in the course of the practitioner's professional practice,
knowingly or intentionally possesses a controlled substance (pure or
adulterated) classified in schedule I, II, III, or IV, except marijuana, hashish,
salvia, or a synthetic cannabinoid, commits possession of a controlled
substance, a Class D felony. However, the offense is a Class C felony if the
person in possession of the controlled substance possesses the controlled
substance:
(1) on a school bus; or
(2) in, on, or within one thousand (1,000) feet of:
(A) school property;
(B) a public park;
(C) a family housing complex; or
(D) a youth program center.
(b) A person who, without a valid prescription or order of a practitioner
acting in the course of the practitioner's professional
practice, knowingly or intentionally obtains:
(1) more than four (4) ounces of schedule V controlled substances
containing codeine in any given forty-eight (48) hour period unless pursuant to
a prescription;
(2) a schedule V controlled substance pursuant to written or verbal

 misrepresentation; or
(3) possession of a schedule V controlled substance other than by means
of a prescription or by means of signing an exempt narcotic register maintained
by a pharmacy licensed by the Indiana state board of pharmacy;
commits a Class D felony.
IC 35-48-4-14
Offenses relating to registration labeling and prescription forms
Sec. 14. (a) A person who:
(1) is subject to IC 35-48-3 and who recklessly, knowingly, or
intentionally distributes or dispenses a controlled substance in violation of
IC 35-48-3;
(2) is a registrant and who recklessly, knowingly, or intentionally:
(A) manufactures; or
(B) finances the manufacture of;
a controlled substance not authorized by his registration or distributes or
dispenses a controlled substance not authorized by his registration to another
registrant or other authorized person;
(3) recklessly, knowingly, or intentionally fails to make, keep, or furnish a
record, a notification, an order form, a statement, an invoice, or information
required under this article; or
(4) recklessly, knowingly, or intentionally refuses entry into any premises
for an inspection authorized by this article;
commits a Class D felony.
(b) A person who knowingly or intentionally:
(1) distributes as a registrant a controlled substance classified in schedule I
or II, except under an order form as required by IC 35-48-3;
(2) uses in the course of the:
(A) manufacture of;
(B) the financing of the manufacture of; or
(C) distribution of;
a controlled substance a federal or state registration number that is
fictitious, revoked, suspended, or issued to another person;
(3) furnishes false or fraudulent material information in, or omits any
material information from, an application, report, or other document required to
be kept or filed under this article; or
(4) makes, distributes, or possesses a punch, die, plate, stone, or other
thing designed to print, imprint, or reproduce the trademark, trade name, or
other identifying mark, imprint, or device of another or a likeness of any of the
foregoing on a drug or container or labeling thereof so as to render the drug a

 counterfeit substance;
commits a Class D felony.
(c) A person who knowingly or intentionally acquires possession of a
controlled substance by misrepresentation, fraud, forgery, deception,
subterfuge, alteration of a prescription order, concealment of a material fact, or
use of a false name or false address commits a Class D felony. However, the
offense is a Class C felony if the person has a prior conviction of an offense
under this subsection.
(d) A person who knowingly or intentionally affixes any false or forged label
to a package or receptacle containing a controlled substance commits a Class D
felony. However, the offense is a Class C felony if the person has a prior
conviction of an offense under this subsection. This subsection does not apply
to law enforcement agencies or their representatives while engaged in enforcing
IC 16-42-19 or this chapter (or IC 16-6-8 before its repeal).
(e) A person who duplicates, reproduces, or prints any
prescription pads or forms without the prior written consent of a practitioner
commits a Class D felony. However, the offense is a Class C felony if the
person has a prior conviction of an offense under this subsection. This
subsection does not apply to the printing of prescription pads or forms upon a
written, signed order placed by a practitioner or pharmacist, by legitimate
printing companies.