2012 Methadone Needs Assessment Report Department of Children and Families Substance Abuse and Mental Health Program Office Methadone is regulated as a controlled substance, under federal and state laws and regulations. When methadone is used for pain management, it is regulated under federal and state laws and regulations that apply to controlled substances generally. For addiction treatment, however, federal and state laws and regulations impose additional requirements specific to the use of methadone. http://www.gao.gov/assets/290/287907.html 1 Executive Summary Section 397.497, F.S., requires the Department to conduct a Methadone Needs Assessment annually. This report contains the results of the annual assessment and is consistent with the requirements specified by statute and further clarified in Chapter 65D-30, F.A.C. In addition to those minimum requirements specified by law, the Department included additional data in its analysis that enhances the Department’s ability to assess unmet need. In order to determine the need for additional Methadone Programs, three levels of analysis were conducted. This included: 1) Fifty Mile Radius, or geographic analysis; 2) Prevalence, or rate of unwanted consequences such as arrests, deaths, and emergency room visits related to Methadone, as well as calculating a desirable census per clinic; and 3) Central Registry, which evaluated the proximity of current Methadone Clients to the location of clinics. The combined results of these analyses indicate that strategically placed Methadone Programs could be implemented in order to better meet local needs. The Department recommends up to: 3 in the Northeast Region; and 2 in the SunCoast Region) may be established. By December 31, 2012, the Department will post application materials on the Department’s website at the following web address: http://www.myflfamilies.com/service-programs/substance-abuse/treatment-and-detoxification These materials will include instructions, forms, and contact information for submission. In the interim, questions relating to this needs assessment report should be directed to Sheila Barbee, Team Leader for Substance Abuse Program, (850) 717-4400 or via email at Sheila_Barbee@dcf.state.fl.us 2 2012 Final Methadone Needs Assessment Report Figure I-Florida Department of Children and Families Regional & Circuit Map 3 2012 Final Methadone Needs Assessment Report Introduction The Department of Children and Families’ Substance Abuse and Mental Health Program Office must determine the need for Methadone medication and maintenance programs annually. This report contains the findings and recommendations of the 2012 Methadone needs assessment. In Florida, the need for new Methadone Maintenance Treatment (MMT) Programs is determined through a formal assessment process. The statutory direction for conducting needs assessments is found in Section 397.427(2) (a), Florida Statutes: “Medication-assisted treatment service providers may be established only in response to the Department’s determination and publication of need for additional medication-assisted treatment services. 1” Additionally Chapter 65D-30.014 of the Florida Administrative Code (F.A.C.) specifies the Standards for Medication and Methadone Maintenance Treatment in the State of Florida and provides direction for the annual needs assessment.2 1 2 http://www.flsenate.gov/Laws/Statutes/2012/397.427 https://www.flrules.org/gateway/ruleno.asp?id=65D-30.014 4 2012 Final Methadone Needs Assessment Report Purpose and Background The purpose of the Methadone Needs Assessment is to:  determine the prevalence of opioid dependency and related consequences;  determine the extent to which existing service capacity adequately meets the current need for treatment;  improve treatment service capacity in areas of need; and  develop additional Medicaid service capacity/indigent coverage for methadone maintenance. Historically, the Federal Narcotic Addict Treatment Act of 19743 allowed Methadone, a synthetic narcotic, to be used in the detoxification and maintenance treatment of opiate addicts. Methadone Maintenance Treatment (MMT) involves administering a constant therapeutic daily dose of Methadone, following stabilization; together with medical, rehabilitative, and counseling services. Methadone Maintenance Services provide recovering addicts support – carefully monitored support – to assist them in their successful treatment. Methadone maintenance programs across the United States and in Florida4 have historically focused on individuals addicted to heroin. In recent years, the state has seen a tremendous increase in the abuse of prescription opioid medication. Methadone, Buprenorphine, and Vivitrol are highly effective treatment options. Methadone is the most effective treatment for retaining patients in care and suppressing Heroin use. Methadone effectively reduces withdrawal symptoms, cravings, the spread of infectious diseases, and criminal activity. 5 3 4 http://www.naabt.org/documents/narcotic-addict-act-1974-public-law-93-281.pdf JOSEPH, H., STANCLIFF, S. & LANGROD, J. Methadone maintenance treatment (MMT): A review of historical and clinical issues. The Mount SINAI JOURNAL OF MEDICINE Vol. 67 Nos. 5 & 6 October/November 2000. 5 Amato, L., Davoli, M., Perucci, C. A., Ferri, M., Faggiano, F., & Mattick, R. P. (2005). An Overview of Systematic Reviews of the Effectiveness of Opiate Maintenance Therapies: Available Evidence to Inform Clinical Practice and Research. Journal of Substance Abuse Treatment, 28, 321-329. Egli, N., Pina, M., Christensen, P. S., Aebi, M., & Killias, M. (2009). Effects of Drug Substitution Programs on Offending among Drug-Addicts. Campbell Systematic Reviews, 2009:3. Gibson, A., Degenhardt, L., Mattick, R. P., Ali, R., White, J., & O’Brien, S. (2008). Exposure to Opioid Maintenance Treatment Reduces Long-term Mortality. Addiction, 103, 462–468. 5 2012 Final Methadone Needs Assessment Report Florida currently has 1,101 physicians and 67 programs6 certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) to provide Buprenorphine for the treatment of opioid addiction. However, for individuals without insurance or the financial means to self-pay, Buprenorphine is cost-prohibitive. Currently, Vivitrol, a long-acting injectable treatment, recently approved by the United States Food and Drug Administration (FDA)7 is being piloted for use in Florida. Methadone maintenance, which has been proven effective for decades, is the primary treatment regimen endorsed by the Department of Children and Families’ Substance Abuse and Mental Health Program. This needs assessment solely identifies the need for additional Methadone maintenance programs in Florida. Clausen, T., Anchersen, K., & Waal, H. (2008). Mortality Prior to, During and After Opioid Maintenance Treatment: A National Prospective Cross-registry Study. Drug and Alcohol Dependence, 94, 151–157. Lind, B., Chen, S.,Weatherburn, D., & Mattick, R. (2005). The Effectiveness of Methadone Maintenance Treatment in Controlling Crime. An Australian Aggregate-level Analysis. Journal of Criminology, 45, 201–211. 6 http://buprenorphine.samhsa.gov/pls/bwns_locator/!provider_search.process_query?alternative=CHOICEG&one_state=FL 7 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071120.pdf 6 2012 Final Methadone Needs Assessment Report Clinics and Eligibility Criteria There are two types of Methadone clinics specified in Chapter 65D-30.014,8 FAC. The eligibility criteria are outlined below: New Opioid Treatment Programs/Full Clinics (OTP) These stand-alone medication-assisted treatment programs offer Methadone induction and maintenance services for individuals who demonstrate a history of abuse/dependence on heroin or opioid medications. These programs require a new license from the Department of Children and Families, registration with the Federal Drug Enforcement Administration (DEA), and registration with the federal Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA). Limited Capacity Opioid Treatment Programs/Clinics Limited capacity medication-assisted treatment programs function under the auspice of a currently licensed Methadone Maintenance program. Existing Methadone providers establish a program at a location separate from the full clinic, provided the size of the satellite clinic does not exceed of the full clinic’s capacity up to 350 additional patients (per policy statement issued on 10/23/12). 8 https://www.flrules.org/gateway/ruleno.asp?id=65D-30.014 7 2012 Final Methadone Needs Assessment Report Approach to the Needs Assessment In order to provide a more robust statewide assessment, three methodologies were utilized to determine unmet need. The data used in this needs assessment were provided by state-licensed and accredited Methadone programs, the Florida Department of Law Enforcement (FDLE) Statistical Analysis Center, the Medical Examiners’ Commission at FDLE, and the Agency for Health Care Administration’s (AHCA) State Center for Health Statistics. The Office of Economic & Demographic Research (OEDR) of the Florida Legislature (www.edr.state.fl.us) publishes population data summaries that are prepared by the University of Florida Bureau of Economic and Business Research. Those population summaries are considered official for state agencies and are used for calculations presented in this document. Data was reviewed and analyzed for each of the Department’s six regions (Northeast, Northwest, Central, Southeast, Southern, and SunCoast). For the 2012 needs assessment, the Department remains committed to improving the geographic availability of services within each region, while considering other key factors driving the need for service capacity. Table 1 lists the factors included in the analyses. These factors include those required by Substance Abuse Rule 65D-30.014; (F.A.C.) as well as others important to the assessment: 8 2012 Final Methadone Needs Assessment Report Table 1-Data Sources for Methadone Needs Assessment PRIMARY DATA TYPE OF DATA SOURCE REQUIRED Medical Examiners 2010 Local Law Enforcement FDLE 2011 Methadone Clinic Location Central Registry 2012 Heroin & prescription drug deaths (excluding Methadone) Opiate arrests FDLE Yes FDLE Yes Geographic Location 50 mile radius DCF No Hospitals/Emergency Rooms AHCA 2010 Office Economic & Demographic Research Substance Abuse and Mental Health Information System Opiate overdoses Hospital admissions and emergency room visits AHCA Yes Florida Legislature Yes DCF No Estimates of Florida population Admissions for Opiates by County 9 2012 Final Methadone Needs Assessment Report Methodology and Results The following three analyses were conducted by Hal Johnson, These include a: 1) Fifty Mile Radius Analysis; 2) Prevalence Analysis; and a 3) Central Registry Census Mr. Johnson is an Epidemiologist with a Masters in Public Health (MPH). He has worked for a number of years with the Department’s Substance Abuse and Mental Health Program Office, Prevention Team and serves as the Chairperson of the State Behavioral Health Epidemiology Workgroup (BHEW). Fifty-Mile Radius Analysis Distance traveled to a Methadone clinic is inversely correlated with continued participation.9 Therefore, an initial spatial analysis was conducted to determine if there are any specific geographic regions in Florida that are excessively far from an existing Methadone clinic. As expected, the majority of existing clinics is in urban areas. However, there remains a need for access to clinics by residents of Florida’s rural counties as well. The address of each clinic was plotted within a 50-mile radius, and all zip codes located outside these radii were noted. All of these zip codes were concentrated in four small areas – Western Panhandle, Big Bend, South Central Florida, and the Florida Keys. The zip codes were then cross-walked with the Methadone Central Registry patient zip codes to determine the number of existing patients that have to travel more than 50 miles to an existing Methadone Clinic. Refer to Table 2 for patients traveling from outside the 50-mile radius. Figure II shows the four areas of unmet need in the state. 9 K. Beardsley et al. Journal of Substance Abuse Treatment 25 (2003) 279–285 10 2012 Final Methadone Needs Assessment Report Results and Recommendation: The results from this analysis found that out of 21,568 active patients in the Central Registry; only 107 (0.5%) travel more than 50 miles to the nearest clinic. When considering the results of 50-mile radius analysis the need for Full Capacity Opioid Treatment Programs is not clearly indicated. Table 2-Patients Traveling from Outside the 50-Mile Radius METHADONE UNMET NEED ASSESSMENT By Zip Code & 50 Mile Radius 2012 Western Panhandle 32320 32322 32328 32423 32425 32426 32431 32440 32442 32443 32445 32446 32460 32464 Big Bend 4 5 15 0 30 0 1 0 0 0 0 1 0 0 56 32340 32347 32348 32350 32356 32359 32648 South Central 2 1 0 0 0 1 1 5 33440 33471 33852 33857 33870 33875 33876 33944 33960 34974 Keys 18 1 1 0 0 1 0 0 14 0 35 33001 33036 33040 33042 33043 33050 33051 33051 0 2 6 1 1 0 0 1 11 Total 107 (0.5%)- Methadone patients statewide outside of 50 mile radius of a clinic 11 2012 Final Methadone Needs Assessment Report Figure II- Methadone Clinic Coverage Statewide The dot inside the circle represents a Methadone clinic The color green represents the areas outside the 50-mile radius 12 2012 Final Methadone Needs Assessment Report Methodology and Results (Continued) Prevalence Analysis Another method to determine need is to examine prevalence rates of opiate consequences (e.g., arrests, deaths, emergency room visits) across the state.10 Four measures of consequences of opiate abuse/misuse were used to create a scale score of need for methadone treatment clinics by DCF region. The measures used included were hospitalizations or emergency department visits for opiate poisoning, opiate-related deaths, opiate-related arrests, and substance abuse treatment admissions with opiates as the primary drug of abuse. The rate per 100,000 population was calculated for each of these measures, and regions were ranked from the highest to lowest rate. Points were assigned in a reverse-ranking order, such that the region with the highest rate on each of these measures received the most points. The hospitalization and death measures were double-weighted in relation to the other two measures, so that the region with the highest rate was assigned a point value of 12 (2 x 6 regions), and the region with the lowest rate was assigned a point value of 2. For the arrest and treatment admission data, the range was from six down to one. These “needs points” were then totaled, and an overall ranking was determined. Table 3 shows the Regional ranking of need based on prevalence rates. Results and Recommendation: The greatest need for Methadone maintenance programs was determined to be in the SunCoast and Northeast Regions; these two regions ranked first and second on three of the four measures, and first and third on the other measures. 10 https://www.flrules.org/gateway/ruleno.asp?id=65D-30.014 13 2012 Final Methadone Needs Assessment Report Methodology and Results (Continued) Table 3-Needs Ranking Based on Prevalence Rates Methadone Ranking by Prevalence Rates Total Ranking SunCoast 1 Northeast 2 Central 3 Southeast 4 Northwest 5 Southern 6 14 2012 Final Methadone Needs Assessment Report Methodology and Results (Continued) Central Registry Census Analysis After having determined where the need is the greatest, it was important to determine if that need is being met or not. The entire list of full and limited clinics and the census of active patients at each clinic as of October 22, 2012, was obtained from the Methadone Central Registry. The census of six clinics not included within the Methadone Central Registry was estimated based on the average census of the listed clinics within the region where the unlisted clinics were located. The total number of patients in each region was divided by the number of existing and approved (pending) clinics to obtain the adjusted average census per clinic. The patient rate per 100,000 regional populations and the clinic rate per 1,000,000 population were then computed. An analysis of these rates show that the Northeast and SunCoast regions, which showed the greatest need in the previous analysis, had among the highest rates of both patients and clinics, indicating that the needs for Methadone maintenance services are largely being met. See Table 4 and Figure III for regional ranking based on active patients and population. In order to assure continued capacity in the case of the closure of a facility for regulatory, natural disaster, or other reasons, an average census of 500 or fewer is ideal. A final analysis was conducted to determine the number of additional clinics needed in each region to obtain an average census of 500 patients. Results and Recommendation: The census analysis indicated that there is a need for 3 additional clinics in the Northeast Region, and 2 additional clinics in the SunCoast Region. 15 2012 Final Methadone Needs Assessment Report Table 4-Regional Ranking Based on Active Patients and Population Methadone Clinic Census by Population Unmet Need Total Need for Additional Clinics SunCoast 2 Northeast 3 Central 0 Southeast 0 Northwest 0 Southern 0 16 2012 Final Methadone Needs Assessment Report Figure III-SunCoast and Northeast Regions Highest Need for Increased Capacity 17 2012 Final Methadone Needs Assessment Report Discussion In Florida, prescription drug misuse and overdose are critical concerns for the DCF Substance Abuse and Mental Health (SAMH) Program Office. While education, safety, and monitoring efforts have been implemented to prevent Methadone abuse and Methadone-associated overdose deaths, broader efforts to prevent prescription drug misuse and deaths have been implemented by various federal agencies, states, and other organizations.11 A priority for the State Methadone Authority is to support client and public safety through the regulatory function. Since the 2010 Needs Assessment, Florida has approved the opening of 4 full programs (Circuits 5,7,15, and 20) and 3 Limited Capacity Programs (two in Circuit 12, and one in Circuit 1). The clinic in Circuit 1 has yet to receive approval from the DEA which has delayed DCF licensure. Three programs have yet to officially open; however, they have made substantial progress and are expected to open by the end of the year (2012). These additional clinics enable the State of Florida to make at least one Methadone Maintenance Treatment Program available to every citizen in the state within a 50 mile radius. In Florida, 2011 and 2012 has been a period of great change for the Department of Children and Families, Substance Abuse and Mental Health Program Office, the State Methadone Authority (SMA), and for methadone maintenance providers. According to the latest data available, opiate deaths dropped in 2011. In the case of Methadone, Hydrocodone, and Heroin, death rates dropped for more than two years in a row. 11 http://www.gao.gov/assets/290/287907.html 18 2012 Final Methadone Needs Assessment Report Summary of Recommendations This year’s Methadone Needs Assessment has been the result of a collaborative project by The Department’s Substance Abuse and Mental Health Program Office staff and is the result of 100% data-driven decision making. The utilization ion of a three dimensional analysis provides a more robust regional determination of need than a unidimensional analysis. 1. Fifty-Mile Radius Analysis - When considering the results of 50-mile radius analysis the need for Full Capacity Opioid Treatment Programs is not clearly indicated. 2. Prevalence Analysis - The greatest need for Methadone maintenance programs was determined to be in the SunCoast and Northeast Regions; these two regions ranked first and second on three of the four measures, and first and third on the other measures. 3. Central Registry Analysis - The census analysis indicated that there is a need for 3 additional clinics in the Northeast Region, and 2 additional clinics in the SunCoast Region. Recommendations included in this report is the result of a cumulative review of all three analyses as well as consideration of statewide resources, including the availability of other treatment options for persons with opiate additions. Although the first of these three analyses (Fifty-Mile Radius), did not indicate a need for additional program, the other two (Prevalence Analysis and Central Registry) identified areas of need. The data show that strategically placed Methadone Programs could be implemented in order to better meet local needs. Additional programs (up to three in the Northeast Region, and two SunCoast Region) may be needed. With these findings, the State Methadone Authority (SMA) and staff will continue to concentrate their efforts on improving options for more effective treatment services within the State’s System of Care. 19 2012 Final Methadone Needs Assessment Report How to Apply to Become a Methadone Maintenance Provider For each region of the state showing a need for expansion of opioid treatment programs, prospective providers must submit an application to the Department of Children and Families. New providers are established only when the Department has determined there is a local need for Methadone programs. Final approval is required by the State Methadone Authority prior to implementation. Upon approval, by the SMA the provider must file appropriate registrations with the Drug Enforcement Administration (DEA) and Center for Substance Abuse Treatment (CSAT) – Substance Abuse and Mental Health Services Administration (SAMHSA) and the Department of Health, Board of Pharmacy. Approvals are issued on a “first come, first serve” basis; providers are required to submit a proposal to the State Methadone Authority which identifies and justifies the need for a limited capacity program and provides a brief outline of proposed services that will meet the need of the specified population. By December 31, 2013, the Department will post application materials on the Department’s website at the following web address: http://www.myflfamilies.com/service-programs/substance-abuse These materials will include instructions, forms, and contact information for submission. In the interim, questions relating to this needs assessment report should be directed to Sheila Barbee, Team Leader for Substance Abuse Program, (850) 717-4400 or via email at Sheila_Barbee@dcf.state.fl.us This report was compiled by the Florida Department of Children and Families’, Substance Abuse and Mental Health Office Program Office and the State Methadone Authority (2012). 20 2012 Final Methadone Needs Assessment Report