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

2. 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. 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. 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. 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. 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. 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. 8 OBOT San Francisco Program 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. 9 OBOT Guiding Principles Expand access to effective treatment Increase patient choice Integrate care Reduce stigma Regulatory Parity for NTPs

10. 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. 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. 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. 13 San Francisco OBOT Timeline CSAT ApprovalMay 2003 DADP OBOT LicenseMay 2003 Patient enrollment begins   Dr. LeavittJuly 2003   Tom Waddell HCSept. 2003   Potrero Hill HCOct. 2003   BAART Hyde St. ClinicDec. 2003   Jail Health Svcs. Feb. 2004

14. 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. 15 Potrero Hill Health Center Patient capacity=30

16. 16 Tom Waddell Health Center Patient capacity=30

17. 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. 18 Password-protected Online Patient Record

19. 19 Patient Enrollment Folder

20. 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. 21 Patient Treatment Folder

22. 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. 23 Demographics of OBOT Patients (N=80) Methadone Track 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)

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

25. The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot Project Clinical Corner Stones David 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

26. 26

27. 27 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 The San Francisco OBOT Pilot Guiding Principals

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

29. 29 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 Medication Take-Homes  Methadone- Step levels as per Federal Regs.  Buprenorphine- As per OBOT Clinical Guidelines Toxicology Screens- At least 8xs/year Toxicology Screens- At least 8xs/year Counseling- At least 50 minutes/month Counseling- At least 50 minutes/month Medication Orders - Transmitted electronically to pharmacy through OBOT database Medication Orders - Transmitted electronically to pharmacy through OBOT database The San Francisco OBOT Pilot Some Basic Clinical Elements

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

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

32. 32 The OBOT Patient Inclusion/Exclusion Criteria At least 18 years old At least 18 years old San Francisco resident San Francisco resident Opiate dependent (at least 1 year) Opiate dependent (at least 1 year) No active, uncontrolled, serious medical, psychiatric, or behavioral condition No active, uncontrolled, serious medical, psychiatric, or behavioral condition Willingness to continue in OAT for at least one year 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 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 No abuse or dependence on alcohol or sedative hypnotics Not pregnant or planning to become pregnant Not pregnant or planning to become pregnant Willingness to use adequate birth control Willingness to use adequate birth control Specifically for buprenorphine 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. 33 The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot Project OBOT Providers- Expectations and Responsibilities Provide services at participating OBOT sites Provide services at participating OBOT sites Posses required licenses/certifications Posses required licenses/certifications Attend prerequisite trainings Attend prerequisite trainings Provide adequate back-up capacity and referral services Provide adequate back-up capacity and referral services Willingness to comply with Federal, State, and Pilot policies and procedures Willingness to comply with Federal, State, and Pilot policies and procedures

34. 34 The San Francisco Office Based Opiate Addiction Treatment (OBOT) Pilot Project Provider Trainings Prior to participation 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. 35 The OBOT Pilot Program The Treatment Process I. Patient identification II. Eligibility determination III. Choosing a medication IV. ?Need for stabilization/evaluation prior to entry? V. Transfer to community site/pharmacy VI. Ongoing assessment of clinical course I. Need for additional services? II. Need for re-stabilization at any point? III. Need for transfer to other level of care?

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

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

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

39. 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. 40 THE SAN FRANCISCO OBOT PILOT Continuous Quality Improvement Led by OBOT Clinical Coordinator and Medical Director Led by OBOT Clinical Coordinator and Medical Director Assisted by Core OBOT Team and affiliated NTP Assisted by Core OBOT Team and affiliated NTP Designated QA leader at each community treatment site 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. 41 THE SAN FRANCISCO OBOT PILOT Preliminary Data as of September 2004 Over 150 patients considered Over 150 patients considered 70 patients enrolled 70 patients enrolled 61 patients currently in treatment in community 61 patients currently in treatment in community 36 methadone/25 buprenorphine 16/36 methadone patients from NTP stabilization, 20/36 from maintenance 16/36 methadone patients from NTP stabilization, 20/36 from maintenance 24/25 buprenorphine patients induced at OBIC, 1/25 induced in community 24/25 buprenorphine patients induced at OBIC, 1/25 induced in community 10 drop outs (9 buprenorphine*/1 methadone) 10 drop outs (9 buprenorphine*/1 methadone) *majority dropped out prior to or during “induction” at OBIC

42. 42 THE SAN FRANCISCO OBOT PILOT Preliminary data as of June 2004 continued Early Results 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 County OBOT Pilot: Pharmacy Aspects Sharon Kotabe, PharmD Associate Administrator for Pharmaceutical Services Associate Clinical Professor of Pharmacy, UCSF

44. 44 In the beginning…… Pharmacy Subcommittee formed, November 1999 Pharmacy Subcommittee formed, November 1999 Members represented 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. 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. 46 Pharmacy Subcommittee Activities Identified barriers to pharmacist participation in project 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. 47 Pharmacy Subcommittee Activities Identified benefits of pharmacist participation in program 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. 48 Pharmacy Subcommittee Activities Reviewed State and Federal regulations for “traditional” narcotic treatment programs 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 Reviewed materials training materials used to educate pharmacy students about addiction and addiction pharmacology from various schools of pharmacy

49. 49 Pharmacy Subcommittee Activities Met with pharmacists engaged in office- based treatment models in other States 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 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 Conducted focus groups with pharmacists from 10 zip-codes with highest number of current clients

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

51. 51 Pharmacy Subcommittee Recommendations ( February 2001) Training Training  Integrate with training for physicians, counselors and others to foster collaborative, team-approach to care  Focus on: (1) “mechanics” of maintenance treatment and, (2) “raising consciousness” on nature of addiction

52. 52 Recommendations (continued)… Create central database for ready access to relevant client information and recording dose administration Create central database for ready access to relevant client information and recording dose administration Allow pharmacies to establish dosing “appointments” as dictated by workload Allow pharmacies to establish dosing “appointments” as dictated by workload Require establishment of dosing areas separate and private from main pharmacy counseling windows Require establishment of dosing areas separate and private from main pharmacy counseling windows

53. 53 Recommendations (continued)… Provide adequate security Provide adequate security Provide access to “on-call” system to advise pharmacists dealing with complex client issues Provide access to “on-call” system to advise pharmacists dealing with complex client issues Pharmacists provide medication counseling, counselors and physicians provide drug abuse counseling Pharmacists provide medication counseling, counselors and physicians provide drug abuse counseling Provide adequate remuneration Provide adequate remuneration

54. 54 ….. and at last! First patient enrolled, July 2003 First patient enrolled, July 2003 Community pharmacy participation Community pharmacy participation  Corporate vs. individual pharmacist views  Corporate view prevails County operated pharmacies County operated pharmacies  Hospital-based outpatient pharmacy (methadone dispensing)  Mental health clinic pharmacy (buprenorphine dispensing)

55. 55 Basic Program Components All pharmacists involved in the program undergo extensive training provided by the California Society of Addiction Medicine All pharmacists involved in the program undergo extensive training provided by the California Society of Addiction Medicine Central database with pertinent client demographic and clinical information Central database with pertinent client demographic and clinical information  Pharmacists record observed and take home dosing in database  Communication and clinical data sharing through “SOAP” notes format

56. 56 Basic Program Components Program licensure allows exemption from Board of Pharmacy prescription requirements Program licensure allows exemption from Board of Pharmacy prescription requirements “On-call” OBOT program staff to assist with problems “On-call” OBOT program staff to assist with problems Physical modifications were made to enhance security and dosing area privacy Physical modifications were made to enhance security and dosing area privacy Program uses methadone tablets (vs. liquid or diskette), or Suboxone R Program uses methadone tablets (vs. liquid or diskette), or Suboxone R

57. 57 Observations, 1 year later Establishing dosing “appointments” works! Establishing dosing “appointments” works! Estimate of pharmacist time needed for each observed dosing/take home dispensing (5 minutes) too low Estimate of pharmacist time needed for each observed dosing/take home dispensing (5 minutes) too low Regulatory agencies - e.g. DEA, state NTP licensing agency - complimentary of pharmacist record keeping, security, and professional services provided to clients Regulatory agencies - e.g. DEA, state NTP licensing agency - complimentary of pharmacist record keeping, security, and professional services provided to clients

58. 58 more observations…... Rapport between pharmacist and client quickly and easily established Rapport between pharmacist and client quickly and easily established Pharmacists enjoy client interaction and expanded responsibilities Pharmacists enjoy client interaction and expanded responsibilities Pharmacists initially reluctant to “volunteer”, later filed labor grievance to be allowed to participate Pharmacists initially reluctant to “volunteer”, later filed labor grievance to be allowed to participate Clients prefer dosing and receiving take home doses in a pharmacy setting Clients prefer dosing and receiving take home doses in a pharmacy setting

59. 59 Lessons Learned Listen to the “experts” - especially those who actually do the work Listen to the “experts” - especially those who actually do the work Local buy-in may not be enough, engage corporate decision makers if possible Local buy-in may not be enough, engage corporate decision makers if possible Initial concerns about major legal and regulatory obstacles did not materialize Initial concerns about major legal and regulatory obstacles did not materialize Flexibility, open-mindedness, and patience are required traits for anyone involved in a pilot program Flexibility, open-mindedness, and patience are required traits for anyone involved in a pilot program

60. 60 Questions? Sharon Kotabe, PharmD (415) 206-2325 sharon_kotabe@sfdph.org