An NTP Affiliated Office-Based Opiate Treatment (OBOT) Program in a Public Health Setting

1. An NTP Affiliated Office-Based Opiate Treatment (OBOT) Program in a Public Health Setting Alice Gleghorn, PhD SFDPH OBOT Director

2. Heroin in San Francisco • 15,000-17,000 active heroin users (2001 HIV Consensus Report) • 2,663 methadone maintenance slots and 651 methadone detoxification slots (SF Methadone Clinic Phone Survey, 2003) • Most frequently mentioned drug involved in drug-related deaths (DAWN Report, 2002) • 59% of IDUs would accept treatment (Urban Health Study, 2001)

3. Community costs of opiate dependence • Hospital charges for treatment of IVDU abscesses are at least $20 million per year (Masson et. al.) • Every $1 invested in treatment yields up to $7 in reduced crime-related costs (CalData study) • 1/3 of treatment admissions list heroin addiction as the primary reason(CSAS database, 2003))

4. Why the Access Gap?? • Inability to expand existing, or site new, methadone treatment facilities (Prop I) • Insufficient funding for indigent clients • Stigma/mythology/misinformation regarding methadone treatment

5. San Francisco Initiatives to Close the Access Gap (1998-Present) • Increased Funding for OAT /New Initiatives San Francisco Department of Public Health Expansion of MM slots Creation of Integrated Soft Tissue Infection Clinic Buprenorphine Expansion Federal Grants (with DPH back-fill) Action-Point (HIV) Program Methadone Van (Federal/DPH) Psychopharmacology Grant OBOT (Federal/DPH) NIH-SPNS Grant for HIV/Buprenorphine

6. The San Francisco OBOT Pilot Program 1998- Board of Supervisors passes resolution directing DPH to: • “Allow physicians full discretion to treat opiate addiction through prescription methadone” • “Apply for any federal/state waivers that would allow for the development of an effective and safe program”

7. OBOT Working Group • Development of policy and operations accomplished by sub-committees including participation of: • Narcotics Treatment Program (NTP) directors and staff • Primary care physicians • Substance abuse counselors • Pharmacists • Consumers of treatment services • City and County of San Francisco • State and federal regulatory agencies (ADP, DEA, CSAT)

8. OBOT San FranciscoProgram Planning • 1998- DPH convenes interdisciplinary work group to produce a consensus statement • 1999- Three subcommittees produce recommendations (provider, pharmacy, counselor) • 2001- Grant application submitted to CSAT for pilot OBOAT program • 2002- OBOT license application submitted to CSAT, ADP, DEA • 2003- OBOT Pilot approved by CSAT, ADP, DEA

9. OBOT Guiding Principles • Expand access to effective treatment • Increase patient choice • Integrate care • Reduce stigma • Regulatory Parity for NTPs

10. San Francisco OBOT-related Legislation • Board of Supervisors Resolution - 1997 • California SB 1807 - 2000 • Drug Abuse Treatment Act - 2000 • CSAT Buprenorphine Approval - 2002

11. San Francisco OBOT Program Framework • Central administration • Multiple patient access points • Treatment team and individualized treatment plans • Training and certification for all staff • Ongoing evaluation and quality assurance

12. SFDPH OBOT Program Status • Operates as CA Pilot OBOT of SB1807 • Has specific state-approved exceptions to Title 9 • Was developed to be consistent with federal guidelines for office-based practice • Was implemented in partnership with ADP • Is licensed as an OBOT “affiliated” with SFGH Ward 93 NTP

13. San Francisco OBOT Timeline • CSAT Approval May 2003 • DADP OBOT License May 2003 • Patient enrollment begins • Dr. Leavitt July 2003 • Tom Waddell HC Sept. 2003 • Potrero Hill HC Oct. 2003 • BAART Hyde St. Clinic Dec. 2003 • Jail Health Svcs. Feb. 2004

14. OBOT Pharmacies • San Francisco General Hospital Pharmacy • Mission District • Provide methadone dispensing to 45 OBOT clients • Community Behavioral Health Services Pharmacy • South of Market Area • Provide buprenorphine dispensing to 55 OBOT clients • OBOT Buprenorphine Induction Clinic (OBIC) • Mission District • Induce/stabilize up to 55 OBOT-buprenorphine patients

15. Potrero Hill Health Center Patient capacity=30

16. Tom Waddell Health Center Patient capacity=30

17. Quality Control:Centralized Information System • A secured Internet-accessible data base is used by primary care providers, counselors, pharmacists, and administrators • Creates electronic chart on patient characteristics, treatment plans, use of treatment services, and lab results • Medication orders are transmitted by physician to pharmacy • Patients visit pharmacy for observed dosing and take-home dosing • Pharmacists record daily dosing • Facilitates quality assurance activities

18. Password-protected Online Patient Record

19. Patient Enrollment Folder

20. Quality Assurance • Staff training (didactic / practicum/ database/ logistics) • Weekly cross-site and on-site clinical review/supervision • Monthly counselor training • Weekly core, monthly cross-site implementation meeting • Database monitoring for clinical, state and Federal guideline adherence; monthly report to all providers

21. Patient Treatment Folder

22. Evaluation Goals • Document recruitment and patient demographics • Evaluate compliance with / retention in treatment • Evaluate impact on drug and alcohol use • Evaluate impact on other indicators (medical, psychiatric, employment, psychosocial functioning) • Evaluated impact on utilization of medical, psychiatric, forensic, and other city services (cost analysis) • Identify predictors of success • Solicit patient and provider satisfaction/feedback • Compare outcomes with traditional methadone clinics • Begin to assess aspects of treatment with buprenorphine

23. Methadone Track 48 total enrolled in stabilization or community 2 left community treatment 36 enrolled in community 74% male 12% homeless Mean LOS 233 (52-428) 2 currently in stabilization 8 left stabilization Buprenorphine Track 32 total enrolled 59% male 31% homeless Mean LOS 124.5 (1-361) 8 dropped out (5/8 JHS) 24 currently enrolled Mean LOS 157 (32-361) Demographics of OBOT Patients (N=80)

24. Preliminary Conclusions from OBOT Pilot • Site Staffing key to implementation • Site Logistics determine barriers • Jail-to-community transition difficult • Counselor and pharmacist play larger, on-going role in treatment • Central administration necessary for regulatory and management issues • Evidence supporting OBOT in PC, NTP satellite and Addiction Specialty settings

25. The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot ProjectClinical Corner StonesDavid Hersh, MD Program Philosophy/Guiding Principals Federal and State Regulations OBOT-Pilot Practice Guidelines Program Structure The Patients and the Providers Staff Training Continuous Quality Improvement Program Evaluation

27. The San Francisco OBOT PilotGuiding Principals • Opiate dependence is a medical condition • Opiate agonist treatment is provided in the community as part of the patient’s overall medical care • Treatment is individualized and patient-centered • The physician, counselor, and pharmacist work closely to coordinate patient care • No prior OAT treatment required for admission • Observed dosing, urine toxicology screening, and counseling are critical aspects of care • Access to higher level of care (e.g., initial stabilization and “safety net”) is critical

28. The San Francisco OBOT PilotClinical ConsiderationsFederal and State Regulations • Code of Federal Regulations- 42 CFR “Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction” • California Code of Regulations- Title 9 “Narcotic Treatment Programs”

29. The San Francisco OBOT PilotSome Basic Clinical Elements • Methadone or buprenorphine can be utilized • “Stabilization and Evaluation” tracks available at affiliated NTP/intensive buprenorphine program prior to transfer to the community or if deteriorating in the program • Medication Take-Homes • Methadone- Step levels as per Federal Regs. • Buprenorphine- As per OBOT Clinical Guidelines • Toxicology Screens- At least 8xs/year • Counseling- At least 50 minutes/month • Medication Orders- Transmitted electronically to pharmacy through OBOT database

30. The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot ProjectProgrammatic Components • Two Community Primary Care Health Centers (75 patients- 30 methadone/45 buprenorphine) • NTP Satellite Clinic (10 methadone patients) • Private Practitioner’s Office (addiction/psychiatry) (5 patients- methadone or buprenorphine) • Affiliated NTP (OTOP- “Stabilization and Evaluation” Track) • OBOT Buprenorphine Induction Clinic (OBIC) • Two Community Pharmacies

31. The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot ProjectThe Human Element • The Patients • The Providers The OBOT Physician The OBOT Counselor The OBOT Pharmacist • The OBOT Quality Assurance/Evaluation Team

32. The OBOT Patient Inclusion/Exclusion Criteria • At least 18 years old • San Francisco resident • Opiate dependent (at least 1 year) • No active, uncontrolled, serious medical, psychiatric, or behavioral condition • Willingness to continue in OAT for at least one year • Anticipated ability to comply with OBOT expectations and do well at the level of care provided through OBOT • No abuse or dependence on alcohol or sedative hypnotics • Not pregnant or planning to become pregnant • Willingness to use adequate birth control • Specifically for buprenorphine • No acute/chronic pain syndrome requiring the use of narcotic analgesics • Not currently taking greater than 35 mgs of methadone daily

33. The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot ProjectOBOT Providers- Expectations and Responsibilities • Provide services at participating OBOT sites • Posses required licenses/certifications • Attend prerequisite trainings • Provide adequate back-up capacity and referral services • Willingness to comply with Federal, State, and Pilot policies and procedures

34. The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot Project Provider Trainings • Prior to participation • At least 8-hour didactic OBOT/Buprenorphine Training • Practicum experience at OTOP • On site general trainings (addiction/recovery, OAT etc) • Other required trainings: • OBOT-specific clinical guidelines (includes review of pertinent Federal and State regulations) • ASI and treatment planning • OBOT policies/procedures • Database trainings

35. The OBOT Pilot ProgramThe Treatment Process • Patient identification • Eligibility determination • Choosing a medication • ?Need for stabilization/evaluation prior to entry? • Transfer to community site/pharmacy • Ongoing assessment of clinical course • Need for additional services? • Need for re-stabilization at any point? • Need for transfer to other level of care?

36. The Affiliated NTPRoles and Responsibilities • Program Development • Provider Training • Stabilization and Evaluation Track • Prior to entry • Safety net • Ongoing Consultation

37. The Affiliated NTPThe Stabilization and Evaluation Track • Two-to-four month maintenance track to evaluate appropriateness for OBOT • Stabilization of methadone dose • Frequent counseling and toxicology screens • Assess (address if possible) for acute medical, psychiatric, behavioral, or psychosocial problems • Remain in close communication with referring site • Facilitate transfer to OBOT or to other level of care as appropriate

38. The OBOT Buprenorphine Induction Clinic (OBIC)Roles and Responsibilities • Stabilization and Evaluation • Prior to transfer to community • As a safety net • Provider Training • Consultation

39. The OBOT DATABASE A novel, password-protected database which links the physician, counselor and pharmacist • Allows for electronic transmission of medication orders • Creates an electronic chart (patient information, clinician notes, lab results etc) • Facilitates quality assurance activities

40. THE SAN FRANCISCO OBOT PILOTContinuous Quality Improvement • Led by OBOT Clinical Coordinator and Medical Director • Assisted by Core OBOT Team and affiliated NTP • Designated QA leader at each community treatment site • Activities Include: • Staff training (didactic / practica) • “Internal” Electronic and paper chart reviews • Quarterly State audits • Case conferences • Warmline support • OBOT Core (weekly), OBOT Admission (weekly), and OBOT Implementation (monthly) mtgs

41. THE SAN FRANCISCO OBOT PILOTPreliminary Data as of September 2004 • Over 150 patients considered • 70 patients enrolled • 61 patients currently in treatment in community 36 methadone/25 buprenorphine • 16/36 methadone patients from NTP stabilization, 20/36 from maintenance • 24/25 buprenorphine patients induced at OBIC, 1/25 induced in community • 10 drop outs (9 buprenorphine*/1 methadone) *majority dropped out prior to or during “induction” at OBIC

42. THE SAN FRANCISCO OBOT PILOTPreliminary data as of June 2004 continued • Early Results • High compliance with treatment • Very few missed doses • High program retention • Little-to-no clinical deterioration • Patients extremely satisfied with program • Positive patient reports regarding buprenorphine

43. San Francisco CountyOBOT Pilot:Pharmacy Aspects Sharon Kotabe, PharmD Associate Administrator for Pharmaceutical Services Associate Clinical Professor of Pharmacy, UCSF

44. In the beginning…… • Pharmacy Subcommittee formed, November 1999 • Members represented • County Health Department • Local School of Pharmacy • State Board of Pharmacy • State Poison Control System • Local chain, independent & hospital pharmacies • Narcotic Treatment Programs (NTPs) and free clinics

45. Pharmacy Subcommittee Charge “ To develop and recommend a ‘best practices’ model to create medically appropriate and geographically-convenient dispensing of methadone in a PHARMACY-BASED SETTING in San Francisco”

46. Pharmacy Subcommittee Activities • Identified barriers to pharmacist participation in project • Pharmacists not included in “traditional” maintenance program models and in California, restricted by law from dispensing maintenance opiates to known addicts • Negative perceptions & beliefs re: addiction • Reimbursement for time necessary to provide appropriate services

47. Pharmacy Subcommittee Activities • Identified benefits of pharmacist participation in program • Expertise counseling patients on medication and drug therapy • Availability of patient’s entire drug profile for drug-drug interaction and contraindication monitoring • Increased access to treatment through local “neighborhood” pharmacies

48. Pharmacy Subcommittee Activities • Reviewed State and Federal regulations for “traditional” narcotic treatment programs • Reviewed materials training materials used to educate pharmacy students about addiction and addiction pharmacology from various schools of pharmacy

49. Pharmacy Subcommittee Activities • Met with pharmacists engaged in office-based treatment models in other States • Matched zip-codes of clients already in treatment with pharmacy locations to target potential dispensing pharmacies • Conducted focus groups with pharmacists from 10 zip-codes with highest number of current clients

50. Focus Group Comments • Support for expanding access to treatment • Participation perceived as a natural expansion of professional role and responsibilities and welcomed challenge of learning new skills • Suggestions that program start slowly with fewer initial clients, and for scheduled “appointment times”