The former CSAT Office of Pharmacologic & Alternative Therapies (OPAT) was
recently renamed the CSAT Division of
Pharmacologic Therapies (DPT).
Division of Pharmacologic Therapies (DPT) Director's Report (2/2003):
Opioid Treatment Programs (OTPs)
Implementation of the SAMHSA OTPs Regulations. DPT's initiative to reform the oversight of opioid treatment programs (OTPs) is in its final transition phase. More than 1,100 programs have contacted one of the approved accreditation organizations to apply for accreditation and schedule accreditation surveys. Under transitional certification regulations, OTPs must achieve accreditation before May 19. SAMHSA may extend the transitional certification of an OTP for up to one additional year. Approximately 300 programs have requested and been granted extensions of transitional certification because of the need to schedule accreditation surveys simultaneously with affiliated programs or because of extenuating circumstances.
The Joint Commission on the Accreditation of Health Care Organizations (JCAHO), the Commission on Accreditation of Rehabilitation Facilities (CARF), the Council on Accreditation for Children and Family Services (COA), the Washington State Department of Alcohol and Substance Abuse, and the State of Missouri Department of Mental Health are scheduling accreditation surveys. In addition, OTPs are obtaining technical assistance on accreditation from CSAT through an experienced contractor. Four of the five accreditation organizations have been awarded grants to provide accreditation education (up to $1,000 per OTP) and to offset some of the direct accreditation costs (up to $3,000 per OTP). The exception is the State of Missouri, which plans to conduct accreditation surveys of OTPs at no cost to the programs.
Thus far, 250 OTPs have achieved accreditation, including the OTPs which participated in the CSAT Accreditation Impact Study between 1998 and 2002. CARF has awarded accreditation to 148 OTPs; JCAHO has awarded 98 accreditation decisions and Washington State Department of Alcohol and Substance Abuse has awarded 4. The accreditation process is in progress in 6 programs being surveyed by COA. Fifteen opioid treatment programs have received non-accreditation decisions and are preparing for follow-up accreditation surveys within the next 6 to 12 months.
Accreditation Impact Evaluation. The Methadone/LAAM Treatment Program Accreditation Project Study is nearing completion. Of the original 165 participating OTPs, 130 have received accreditation surveys and 129 have become accredited; the remainder have a pending decision or dropped out of the study. To date, CARF has surveyed 88 OTPs; 77 received positive accreditation outcomes and 8 OTPs have pending decisions. CARF rendered non-accreditation decisions to three OTPs, one of which converted to a positive outcome in the next survey. Fifty-one OTPs have been surveyed by JCAHO; one received an accreditation without Type I recommendations, one of the highest ratings an organization can receive from JCAHO. Several OTPs that are control sites are receiving technical assistance to prepare them for accreditation surveys with an expected survey completion date of March.
OTP Implementation Evaluation. CSAT initiated a second evaluation study, once the new SAMHSA rules went into effect last spring, to examine the processes, costs, and administrative and clinical impacts of the accreditation process. A contract was awarded in mid-July 2002, and DPT has to date consulted with a number of OTPs, the accreditation bodies, and others toward developing an OMB package for submission.
Data Systems for Emergency Procedures Management. On a day to day basis, many patients need to be medicated somewhere other than their home OTP, for instance while traveling or because they have become ill or injured. There are many times when a patient enrolled in an opioid treatment program may need to be administered methadone or LAAM away from the patient's OTP. This might be due to natural disasters such as snowstorms or hurricanes, or--as became all too clear after September 11--emergencies related to human activities, ranging from transit strikes to bio-terrorism or a terrorist attack with the potential to cause large-scale patient dislocations. In such cases, there is no system to ensure that "guest" OTPs are able to access sufficient information to verify the patient's dosage level and "take-home" schedules for unsupervised medication.
Currently, the lack of a reliable mechanism to consistently and accurately provide such information represents a major weakness in the opioid treatment system. In response to this need, CSAT initiated a project to identify key problems, needs, and feasible data systems that could potentially address the issues while honoring patients' confidentiality. Arlene Stanton, Ph.D.,is the CSAT project officer. Results and recommendations from all the meetings will be incorporated into a report to CSAT and may provide a basis for a pilot study of the system.
Methadone Associated Deaths. There have been epidemiologic and/or medical examiner reports from Florida, Maine, and North Carolina documenting recent increases in the number of drug overdose deaths in which methadone has been found to be present, generally in combination with other drugs. There have also been reports in the lay press from other states, including Virginia and Pennsylvania, and an alarming article in the New York Times. In North Carolina, it was clear that whenever there was enough information to determine the source of the methadone associated with the overdose deaths, that it was uniformly tablet methadone diverted from prescription analgesia rather than liquid methadone diverted from OTPs. However, in Maine, there have been one to two documented deaths associated with methadone diverted from OTPs. Because of theeffects on the treatment system we regulate, CSAT has taken a leading role in convening meetings with FDA, NIDA and CDC in assessing and addressing the problem. CSAT staff is conducting an analysis of FDA Medwatch reports of deaths associated with methadone, which have more than tripled in the last two years. A meeting is scheduled for March 14, with relevant Federal agencies to plan for a two-day meeting May 8 and 9, which will bring together officials from states, along with medical examiners, toxicologists, epidemiologists, pain specialists and methadone treatment professionals, to assess the current situation and discuss short- and long-term approaches to addressing it. Alan Trachtenberg, M.D., MPH, is directing these activities.
Liver Disease in Methadone-Maintained Patients. A technical assistance publication (TAP) on the topic of Liver Disease in Methadone-Maintained Patients: Treatment and Transplant Considerations has been drafted and circulated for review to a group of hepatologists and addiction treatment researchers assembled by NIDA for a meeting in November on HIV and HCV in drug abusing populations. Early reviews have been very favorable. DPT hopes to have a near-final draft available for further field review at the upcoming American Association for the Treatment of Opioid Dependency (AATOD) meeting in Washington, D.C., in April.
Oral Fluid Testing. CSAT has received several inquiries on the appropriateness of oral fluid (saliva) testing as an alternative to urine toxicology in opioid treatment program settings. A question and answer on this matter has been posted at DPT's website www.dpt.samhsa.gov. Concurrently, DPT is supporting the development of Treatment Improvement Protocols (TIP) guidance on the use of drug testing in OTPs and general guidance on the use of drug testing in clinical addiction treatment. These TIPs will include recommendations made on oral fluid testing, consideration of other test media, as well as recommendations on the use of drug testing in office-based practice. As an interim measure, however, Dr. Lewis Baxter, a member of the CSAT National Advisory Council, was asked to chair a subcommittee of the NAC on this issue. The subcommittee met on Wednesday, November 20, 2002, with consultants and has been gathering additional information since then. The subcommittee's draft report will be presented to the National Advisory Council for discussion.
Drug Addiction Treatment Act of 2000 (DATA) Implementation. On October 8, 2002, FDA approved Subutex® and Suboxone® for the treatment of opiate addiction. This inaugurated a new era in drug addiction treatment in the Nation, making it possible for office-based physicians to address their patients' needs for opiate treatment. Since then, DPT has united with CSAT's Office of Consumer Affairs to launch a series of Community Educational Forums, ?New Paths to Recovery," in 15 cities with identified opioid abuse issues, to inform patients, providers, pharmacists and other stakeholders of the availability of this new treatment paradigm. Distribution of the medication commenced in January at pharmacies across the United States.
CSAT has continued supporting physician trainings led by the DATA mandated medical organizations. Some of these trainings have applied an innovative model involving joint trainings of physicians, pharmacists and counselors, which facilitates the implementation of this newtreatment paradigm. Two DATA qualifying organizations, the American Academy of Addiction Psychiatry (AAAP) and the American Psychiatric Association (APA) have developed and are using online trainings for busy practitioners who prefer to access the training at their own offices or homes. Also, DPT is involved in a very active schedule of presentations in many health and behavioral health related organizations' meetings, disseminating awareness of this new treatment option. As of February 21, 1,123 physicians have received DATA waivers for the use of buprenorphine products. DPT is pursuing the publication of a Buprenorphine Clinical Guidelines Treatment Improvement Protocol (TIP) and other diverse educational materials for patients and their families, pharmacists, and counselors. Through SAMHSA's website, users may link to www.buprenorphine.samhsa.gov to reach the Buprenorphine Physician Locator and obtain contact information for providers in their states and communities. On February 20, the Wall Street Journal, in an article, "New Drugs Promise Treatment for Addicts, Profits for Firms," listed the SAMHSA buprenorphine website among websites that "can help addicts and their families." Users of the SAMHSA buprenorphine website can obtain a complete copy of the Drug Addiction Treatment Act of 2000, submit an online waiver notification to prescribe Schedule III-V medications for drug dependence, including buprenorphine, obtain answers to frequently asked questions, and access information on the "New Paths to Recovery" Community Forum, among other items.
Buprenorphine/Federation of State Medical Boards (FSMB). The Federation of State Medical Boards (FSMB) and the National Association of Boards of Pharmacy (NABP) have joined with CSAT to provide training for State board members and staffs on topics relevant to the DATA of 2000, Subutex®/Suboxone® and CSAT's buprenorphine education initiative. Trainings were provided in Crystal City, Virginia, on January 10, and Dallas/Ft. Worth, Texas, on February 21. The trainings include biomedical material from CSAT's standard buprenorphine 8-hour CME curriculum, but are not intended to (by themselves) meet the training requirements for physicians under the DATA. The trainings focus on the FSMB's "Model Policy Guidelines for Opioid Addiction Treatment in the Medical Office" developed under a CSAT contract for use by State medical boards. The training (and the guidelines) also includes considerable material about Federal confidentiality regulations (42 CFR 2), as this is an area unfamiliar to most physicians and pharmacists.
Evaluation of the DATA Waivers. The primary focus of this evaluation study will be to help the Secretary, Department of Health and Human Services (DHHS), make determinations concerning whether to continue this program of waivers, considering the waiver program's impact on the availability and effectiveness of detoxification and maintenance treatment, associated adverse public health consequences and diversion, etc. As resources allow, the study will also examine issues related to the impact of this new medication on the field of treatment in general. To date, an overall evaluation plan encompassing both qualitative and quantitative methodologies has been developed. DPT has sought input from other key Federal agencies as well as a number of other stakeholders. In January, an expert panel of technical experts began meeting and will continue to meet several more times during the study to provide guidance.
Medication Assisted Treatment (MAT) Patient Education
DPT's Patient Support and Community Education Project. This project continues to involve the major national and regional MAT patient support organizations. The project convened a meeting regarding the problem reported in the media about methadone associated overdoses in Maine, and as a result, produced a poster directed at patient responsibility, introducing the concept, "Share the message, not the medicine." The poster will be sent to every OTP in the United States and will be available for the American Association for the Treatment of Opioid Dependency (AATOD) National Conference in April. Additionally, approximately 200 individuals were transported to various conferences and workshops (including AATOD and Voices and Faces in Recovery) relative to medication assisted treatments under the project.
Guidelines on the Use of LAAM. DPT circulated for field review a new draft technical assistance publication (TAP) on the prudent use of LAAM. This publication contains recommendations made by a panel convened by DPT, in cooperation with the AATOD, as well as extensive appendices on LAAM pharmacology and interactions, based on reviews of the biomedical literature by scientific experts and Alan Trachtenberg, M.D., MPH, of DPT. The document has now been submitted to DHHS for final content clearance and drafts will be made available to the upcoming AATOD meeting in Washington, D.C., in April.
Infectious Diseases and Medication Assisted Treatment
Hepatitis C Education for Opioid Treatment Programs' Staff. DPT, in conjunction with AATOD, is conducting a pilot project [in six states] for onsite education of OTP counseling and medical staff on prevention and treatment of Hepatitis C virus. The pilot project is expected to impact 60-70 programs in several states over the course of 2003. Each facility will be provided with a CD ROM and a manual with reference materials. An evaluation of the effectiveness of the training will guide future expansion of the project. Angel Gonzalez, M.D., is the DPT project officer.
Interactions with CDC and HRSA. DPT has participated in CDC's Hepatitis State Partners Conference. SAMHSA's websites have been linked with CDC and HRSA, and CSAT/DPT, CDC, and HRSA will conduct a joint workshop on integrated care models at the April AATOD Conference in Washington, D.C.
DPT participated in HRSA's HIV/AIDS Bureau Grantees meetings in August 2002, and will be supporting a Buprenorphine physician's training at HRSA's Ryan White Clinical Providers Conference in June.
National Viral Hepatitis Roundtable (NVHR). Robert Lubran, Director, DPT, was invited to participate in the development of the NVH Roundtable, modeled on a similar roundtable on colorectal cancer. The CDC is a co-founder of both roundtables. The NVHR is a coalition dedicated to the development, implementation, and maintenance of a national strategy to reduce the impact of viral hepatitis in the United States.