The San Francisco Office Based Opiate Treatment (OBOT) Pilot Program

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1 The San Francisco Office Based Opiate Treatment (OBOT) Pilot Program Brad Shapiro, MD Medical Director And Stephen Dominy, M.D. Executive Director With Special Thanks to Dr. Alice Gleghorn and Dr. David Hersh who led the development and implementation of the SF OBOT program

2 OBOT in Context: Selected SFDPH Initiatives To Expand OAT Increased funding for traditional MMT slots for indigent individuals Creation of Integrated Soft-tissue Infection Service (ISIS) at SFGH Mobile Methadone Van Program The Office-Based Opiate Treatment (OBOT) Pilot Program A city-wide Buprenorphine treatment service (Integrated Buprenorphine Intervention Service- IBIS) Creation of the Centralized Opiate Program Evaluation (COPE) service to enhance access into existing services

3 The San Francisco DPH Mandate Board of Supervisors passes Supervisor Gavin Newsom s 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

4 OBOT San Francisco Program Planning DPH convenes interdisciplinary work group to produce a consensus statement Three subcommittees produce recommendations (provider, pharmacy, counselor) Grant application submitted to CSAT for pilot OBOAT program OBOT license application submitted to CSAT, ADP, DEA OBOT Pilot approved by CSAT, ADP, DEA

5 SB 1807 (2000) Defines OBOT in California An OBOT is affiliated or associated with an NTP Interested and knowledgeable OBOT site physicians provide addiction treatment services (max 20pts/physician) Community pharmacies supply necessary medication for distribution to patients

6 OBOT in California Differed From Previous National Models Medical Maintenance Model elsewhere with goal to increase take homes and decrease required visits for very stable patients By contrast, SB 1807 targets patients without access to service due to geographic isolation or other barriers Federal Support: Former ONDCP Chief Barry McCaffrey in 2000 on OBOTs: "Drug treatment should be available in physician's offices. Mainstreaming opiate-based treatment by offering office-based opiate therapy will help eliminate the stigma associated with addiction treatment while encouraging the inclusion of addiction education in medical school curricula.

7 The San Francisco OBOT Pilot Guiding Principles 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 patientcentered 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 7

8 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

9 Significant Program Exceptions Use of pill formulation of methadone (key for pharmacy participation) Urine Toxicology per Federal Regulations (8x/year vs 1x/month) Conformity to federal take home regulations from beginning of pilot (2003)

10 Current SF OBOT Pilot Program (NTP as the Program Hub) CBHS Pharmacy Specialty HIV Treatment (Positive Health Program) Other Potential Treatment Sites NTP (SFGH OTOP) Primary Care Clinic (Potrero Hill) Primary Care Clinic (Tom Waddell) SFGH Pharmacy

11 he San Francisco OBOT Pilot Program Programmatic Basics Few exclusion criteria ( wide-open door ) Both methadone and buprenorphine tracks Treatment occurs in the community, outside of traditional Narcotic Treatment Programs Patients may come from Methadone Maintenance, Stabilization Program, Methadone Detoxification Program, or No Treatment In most instances primary care physicians are ordering the OAT medication The physician, counselor, and pharmacist work closely together An electronic database (Methasoft) facilitates communication, documentation, and quality assurance

12 Entry Points To OBOT Methadone Transfer from OTOP MMT or another MMT program Methadone Stabilization Track at OTOP Direct from OTOP Detoxification Direct entry to program (rare)

13 Methadone Stabilization Track A MMT track within OTOP Evaluation and support of patients Assist with connection with primary care Assess suitability for OBOT level of care Stability in dosing, counseling

14 Service Delivery At The OBOT Site Integrated management of opioid use disorder and medical care Counseling services on site Medication orders are transmitted by primary care physician to pharmacy using Methasoft Patients visit pharmacy for observed dosing and take-home dosing Urine drug screens collected at OBOT site (sent to SDRL)

15 Potrero Hill Health Center

16 Tom Waddell Urban Health Center

17 Positive Health Program

18 OBOT Pharmacies San Francisco General Hospital Pharmacy Mission District Provides methadone dispensing up to 6 days/week Community Behavioral Health Services Pharmacy South of Market Area Provides methadone dispensing three days/week Pharmacist sees patient more than anyone and identifies patient needs and challenges: may have closest relationship with patient

19 CBHS Pharmacy

20 San Francisco General Hospital OTOP, Positive Health Program, and SFGH Pharmacy

21 The San Francisco OBOT Pilot Program Roles and Responsibilities of the Affiliated NTP Licensed NTP for methadone patients Program development and implementation Provider training Stabilization and Evaluation Track For new OBOT patients As safety net for enrolled OBOT patients Ongoing program monitoring and support 24/7 On-Call MD

22 Regulatory Status of Sites OBOT has remained a pilot program pending new DHCS regulations Each site has its own Drug MediCal Certification Each site has a unique NPI number CARF Accreditation in process

23 Quality Assurance Staff training (didactic / practicum/ database/ logistics) Bi-Weekly cross-site and on-site clinical review/supervision Counselors participate in all trainings at home NTP (OTOP) Database monitoring for clinical, state and Federal guideline adherence with feedback to all providers

24 Physician Training 8 hour Buprenorphine Waiver Training Practicum at NTP (and OBIC for buprenorphine) On site clinical meetings as needed by site clinical staff Warmline Support and backup by OTOP Physicians

25 San Francisco OBOT Pilot Data Produced by Drs. Alice Gleghorn and David Hersh,

26 THE SAN FRANCISCO OBOT PILOT Data as of May, 2006 Over 220 patients considered 124 patients enrolled to date 62 methadone 11 Stablilization only 24 Stabilization to methadone community OBOT* 27 Methadone maintenance transfers to community OBOT 62 buprenorphine 9 OBIC/induction only 53 OBIC to community OBOT (18 disenrolled, 35 current) 2 from methadone maintenance to OBIC 6 from methadone stabilization to OBIC 45 from street +/- methadone detox to OBIC *Two (2) patients counted twice based on two separate episodes in OBOT

27 THE SAN FRANCISCO OBOT PILOT Data as of May 2006 Demographics Methadone Bupe Combined (n=62) (n=62) (n=124) Age (avg yrs old) Gender Male 74% 68% 71% Female 26% 32% 29% Race/Ethnicity White 70% 58% 64% African American 13% 28% 21% Latina/o 12% 12% 12% Other 5% 2% 3%

28 THE SAN FRANCISCO OBOT PILOT Data as of May 2006 Baseline Demographic Data Methadone Bupe Combined % Homeless 23% 23% 23% Employed (FT+PT) 28% 15% 21% Also: Average 25+ years of heroin use 74% of sample reported IVDU in past year 37% of sample reported having been arrested in past 2 years In most all demographics, the methadone stabilization patients look like the buprenorphine patients. The methadone transfer patients look different from both groups.

29 OBOT Methadone Retention Rates are High at One Year OBOT Pilot Retention: Comparing Methadone and Buprenorphine Retention Rates Over 1 Year (For those who entered OBOT --post induction/ stabilization-- by 8/15/05) 100% 90% 80% 70% 60% 50% 100% 100% 98% 96% 96% 90% 91% 89% 86% 81% 81% 76% MM Transfers (n=26) MM Stab Grads (n=21) Bup OBOT (n=45) Months from OBOT Entry

30 LENGTH OF STAY Pre- and In-Community OBOT (2 to 31 months) Bup Induction: 0.8 (<1 to 4 months)* Average LOS for OBOT Pilot Patients Pre-OBOT MMT, Stabilization, Induction and OBOT Bup (n=57 induction; 48 OBOT) 12.5 <1 to 30 months) Total 1.2 Years Stab Grads (n=22) MM Stabilization: (1 to 8 months) (2 to 31 months) Total 1.8 Years MM Transfers (n=27) Pre-OBOT MMT: (5 to 132 months) * Mising data for 1 Bup induction LOS; n= Months (1 to 33 months) Total 4.8 Years

31 Early (Stabilization) Dropout from OBOT Methadone is Associated with Homelessness and Higher Levels of Baseline Cocaine Use Differences in Stabilization Dropouts vs. Non-Dropouts at Baseline* 100% 100% 92% 92% 80% 60% 40% 68% 58% Groups different at p=.04 42% 75% Groups different at p< % 23% 18% 9% 8% 5% 0% Unemployed Male Homeless Over 55 years Cocaine at baseline* Any alcohol at baseline* Stab Dropouts (n=12) Stab Survivors (n=21) * Self-Report per Billing Information System ** Data not available on 1 Stab Survivor

32 Dropout from OBOT Methadone is Associated with Unemployment and Higher Levels of Baseline Alcohol Use Differences in OBOT Dropouts vs. Non-Dropouts at Baseline (Post-Stabilization) 100% 90% 80% 72% p=.07 60% 60% 59% Groups different at p< % 30% 30% 30% 20% 21% 13% 10% p=.11 10% 0% 0% Male Unemployed Over 55 years Homeless Cocaine at baseline* Any alcohol at baseline* OBOT Dropouts (n=10) OBOT Survivors (n=39) * Self-Report per Billing Information System

33 OBOT Methadone Dropouts: More Cocaine Use in Treatment Mean Positive Cocaine Toxis* Survivors vs. Dropouts 50% 40% 30% 20% Groups different at p=.05 20% 44.8% n=17 Groups different at p= % Survivors p=.08 Drop Outs 27.4% 10% 0% n=9 11% 11% n=10 n=78 n=733 n=39 Avg. per Patient: Stabilization* Total OBOT UA Results** Avg. per Patient: OBOT *Based on available UA data in stabilzation **Based on total available UA results, not mean per patient

34 The San Francisco OBOT Pilot Treatment Retention Retention rate for OBOT-methadone community patients compares very favorably with rates at NTPs Retention rate for OBOT-buprenorphine patients compares very favorably with buprenorphine studies Homelessness and baseline cocaine use appear to increase the likelihood of drop out from stabilization Baseline unemployment and alcohol use are associated with reduced retention in community OBOT Cocaine use while in treatment appears to be associated with dropout from community OBOT Still, many homeless, unemployed, and/or cocaine using patients remained in treatment for at least 1 year

35 OBOT Challenges

36 Challenges: The OBOT Pharmacy Must use Methasoft database (or equivalent) Special privacy standards and methadone storage requirements per DEA Difficulty in establishing partnerships with community pharmacies intensive pharmacist role adequate reimbursement? Concerns at corporate level for pharmacy chains Additional DEA scrutiny and physical plant requirements

37 Challenges: OBOT Sites Integrating services into primary care sites (space, privacy, urine collection, stigma, education, different EHRs) Privacy Issues: Different privacy standards (HIPPA vs 42 CFR) and obstacles to information sharing and documentation Busy physicians with multiple medical problems to address (resistance to using more than one database, time, differing privacy standards

38 Challenges: NTP Balancing NTP structure and requirements with flexibility to work with different OBOT providers Effective oversight and support vs micromanagement Accreditation of OBOTs is new Need for DHCS OBOT regulations that balance safety with flexibility Providing training and backup