Dear Officer of the Medical Board of California,

December 5, 2018

I am a director at the California Health Care Foundation overseeing our $5 million opioid safety
initiative, and we work closely with state leaders in public health and health services. I am reaching out
regarding the Medical Board of California’s Death Certificate Project. While I appreciate the Board’s
commitment to address the opioid epidemic, I am concerned that the approach is leading to unintended
consequences, potentially causing harm to both patients and physicians. I respectfully offer
recommendations for your consideration to address these concerns and potentially increase the
effectiveness of the Board’s project. I believe minor changes would allow the Board to continue in its
mission while adapting to the shifting epidemic in California.
The epidemic is changing: deaths in California from prescribed opioids have stabilized, but heroin and
fentanyl death rates are climbingi. While there is a clear standard of care for people with opioid
addiction, there is no clear standard of care nor consensus about how to manage the other population
harmed by opioid overprescribing: patients dependent on long-term, high-dose opioids. We do not
have enough providers to care for these patients, and I am concerned the Death Certificate Project
could exacerbate the shortage of providers.
Without clear guidelines, it is very difficult for doctors to manage patients on high-dose opioids. Both
the Medical Board and CDC guidelines are silent on the issue, other than urging caution and monitoring.
The CDC guidelines recommend voluntary tapers to lower doses, but they advise against involuntary
tapers. While the 800,000 Californians on high-dose opioids and the almost 700,000 Californiansii on
opioids and benzodiazepines are clearly at risk of harm if they stay on these regimens, they are also at
risk if tapered too quickly or tapered off altogether. Emerging data shows that stopping opioids in these
patients more than doubles their use of illicit drugsiii, and the VA found quadruple the rates of suicidal
ideation and/or self-harmiv.
These patients need high-touch management – physicians who will work with them on a safe,
individualized course of care. If the patient does not want to taper, or risks medical or psychiatric
destabilization with a taper, the best course of treatment may be to continue the regimen. This leads to
a real challenge for Medical Board oversight. A physician could be practicing safe medicine by
simultaneously prescribing high-dose opioids and benzodiazepines if the patient has been taking these
medications for years. However, if a patient on this regimen overdoses and dies, and is evaluated in the
Death Certificate project, the regimen is very likely to be judged by an expert as unsafe. This, despite
that fact that the prescriber would have been following CDC guidance to avoid involuntary tapers.v
The only way to know the true story is through the medical records. On the surface, it may seem
harmless to send out 500 letters to identify twenty-three doctors with violationsvi. However, there is

 growing concern that the letters are causing harm. I have had conversations with several physicians who
report they have changed their prescribing practice, to the detriment of patient care, either from
receiving a letter, or knowing someone who has. Recent press reports are increasing physicians’
knowledge of the project, and many clinicians have mentioned to me their growing fear that their
license could be at risk by continuing to care for complex patients on high opioid doses.
Here are examples:
Six years ago, an attending physician at a teaching program wrote a prescription, continuing the
treatment plan when covering for a resident in training -- a common practice since residents are
often on hospital rotations. The patient died shortly afterwards. In 2018, the attending received
a Medical Board letter. Since she will not know the status of her license for a year or more,vii and
she is concerned about this happening again, she has stopped writing opioid prescriptions, even
if there are no other coverage options for patients whose resident doctor is unavailable.
A medical director at community clinic told me he received a letter about a patient that died in
2012. The patient had received a methadone prescription as part of a slow taper from a higher
dose previously prescribed by a pain specialist. Since then, this physician has become fearful,
abruptly tapering several patients to lower opioid doses and telling his direct reports to do the
same. Many of his patients have subsequently left his practice. He feels guilty about the
patients but feels even more fearful about prescribing in this environment.
Two doctors working in different addiction clinics report an uptick in patients using heroin after
being “kicked off” high dose opioids, without being offered alternative treatments (e.g.
Suboxone).
I have requested data from the California Department of Public Health to understand if we can
distinguish between healthy trends (California has cut opioid prescribing almost in half since the peak in
2010)viii and unhealthy trends, that could show whether involuntary tapering is leading to bad
outcomes. Unfortunately, the analysis is complicated, and it may take several months or a year to get
these results. In the meantime, given increase in fentanyl deaths, I think we have reason to be
concerned.
The MBC Death Certificate project is quite different than it is for other types of investigations. For
example, if a cardiologist receives an investigation letter, the doctor could reasonably trust that the
reviewer has objective standards to judge good practice. Heart failure, myocardial infarction, and
arrhythmias all have large bodies of evidence to guide care. In contrast, doctors receiving letters about
overdose deaths have a real concern: in an area where no data guides practice (we do not yet have large
population studies showing tapers improve safety and outcomes), and at a time when standards are
evolving, how can clinicians be confident their practice will be judged fairly? If a death happens, the fate
of the prescriber’s license will depend on the independent judgment of one reviewer, with no clear
standard of care, no consensus about good management, and ambiguous guidelines. In that case, a
reasonable physician could decide it is safer to avoid accepting new patients on opioids, and to taper
existing patients quickly, even though emerging data suggests this practice may put patients at risk of
harm.

 I propose an alternative approach, one that could produce a higher yield of violations, lessen the impact
on appropriate prescribers and their patients, and potentially save lives. This approach involves a minor
change to the case-finding methodology: start with outlier prescribers, and then match with death data.
This approach has been studied in North Carolina: in 2012, 32-77% of the highest-volume prescribers
had written a prescription within 30 days of an overdose deathix. By starting with a recent year (e.g.
2017), the Medical Board would identify physicians doing harm at present (as opposed to harm in 2012
– before the CDC and MBC guidelines urged more cautious prescribing). Amid this epidemic, the Board
focus its resources on physicians who are currently prescribing unsafely, so we can protect patients who
may be at risk in 2018.
Attached are four recommendations, which I hope the Board will consider. The Medical Board of
California has a duty to protect the public from bad opioid practices – and the Board also has a duty to
ensure whatever action is taken does not put the same public at risk.
Best regards,

Kelly Pfeifer, MD, FAAFP
Director, High-Value Care, California Health Care Foundation
kpfeifer@chcf.org
(510) 587-3133

 RECOMMENDATIONS:
1. Publicly state that the Medical Board of California aligns with the CDC in opposing involuntary
taper policies. Work with experts to give clinicians clear guidance on how to take care of
patients on high-dose or unsafe regimens:
Clarify ambiguities in the Board’s guidelines: e.g., that risks and benefits should be reviewed
with each patient, that patients should be encouraged to taper to safer, lower doses, but that
involuntary tapers are not recommended. Tapers should be halted if the patient shows signs of
medical or psychiatric instability. Using long-acting partial agonists (e.g., buprenorphine), should
be considered for the indication of pain in patients who are at risk of overdose.
Provide educational resources on how to manage chronic pain patients with opioid and/or
benzo dependence: strategies to engage patients in tapering programs, how to mitigate risks in
patients who refuse to taper, how to manage common tapering pitfalls. Acknowledge that the
evidence is unclear, and there is room for variation.
2. Amend case-finding recommendations to allow higher yield of unsafe prescribers, and lower
yield of good clinicians.
Start with sample of clinicians in the top 1st percentile (opioid and benzo volume) and analyze
overdose deaths within this outlier cohort (consider methodology described in the Ringwalt1
paper, which showed, among the top 1% of prescribers, 32-77% had written a prescription
within 30 days of an overdose death.) These are the physicians at the most risk of doing harm.
Consider working with UC Davis (evaluators with years of experience working with CURES data)
to identify a methodology with the highest yield of potential violations. Then crosswalk these
physicians with the death data, investigating those who have both risky prescribing (by volume,
not through examining an individual patient) and overdose deaths.
3. Limit investigations to deaths after 2017.
Current deaths are more likely to reflect current unsafe prescribing. Many of the clinicians
investigated from 2012 have already changed their prescribing based on updated information
and guidelines. Working on recent deaths will detect prescribers who are currently putting
patients at risk, which could prevent overdoses before they occur.
4. Decrease turnaround time from notification to resolution of case. The current 500+-day
turnaround time could be relieved by focusing on a smaller number of physicians at a time. It
is extremely stressful for clinicians to have their license at risk for more than 16 months, and
stressed clinicians are unlikely to accept new opioid-dependent patients or continue to treat
patients on high-risk regimens. Long investigation times could harm patients.

1

Ringwalt, et al, (2015). The Use of a Prescription Drug Monitoring Program to Develop Algorithms to Identify
Providers with Unusual Prescribing Practices for Controlled Substances. The journal of primary prevention. 36.
10.1007/s10935-015-0397-0.

 END NOTES

i

From the California Opioid Surveillance Dashboard: https://discovery.cdph.ca.gov/CDIC/ODdash/
From the California Opioid Surveillance Dashboard, as of first quarter 2018.
iii
SF Department of Public Health shows patients discontinued off opioids were more than twice as likely to use
illicit drugs compared to those maintained; illicit drugs increasingly are contaminated with fentanyl.
iv
Demidenko, M., et al, Suicidal ideation and suicidal self-directed violence following clinician-initiated prescription
opioid discontinuation among long-term opioid users, Gen Hosp Psychiatry 2017 Jul; 47:2935https://www.ncbi.nlm.nih.gov/pubmed/28807135
v
The author of the CDC guidelines published recommendations to focus on slow, voluntary tapers of the willing,
and for patients too unstable (or unwilling) to taper, to continue current doses and mitigate harm (e.g. through coprescribing naloxone). Dowell, D, Annals of Internal Medicine, Vol 167 (3), 1 August 2017
vi
Personal conversation with Kim Kirchmeyer about status as of November 2018
vii
Personal conversation with Kim Kirchmeyer: average time to resolution is 505 days.
viii
From the California Opioid Surveillance Dashboard: Q12018 shows the annualized quarterly rate of morphine
milligram equivalents per resident at 360.30, compared to 760.14, the peak in 2010.
ix
Ringwalt, et al, (2015). The Use of a Prescription Drug Monitoring Program to Develop Algorithms to Identify
Providers with Unusual Prescribing Practices for Controlled Substances. The journal of primary prevention. 36.
10.1007/s10935-015-0397-0.
ii