Transcript A Proposal for a Mobile Methadone Program in San Francisco

An NTP Affiliated Office-Based
Opiate Treatment (OBOT) Program
in a Public Health Setting
Alice Gleghorn, PhD
SFDPH OBOT Director
Heroin in San Francisco

15,000-17,000 active heroin users (2001 HIV
Consensus Report)
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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)
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59% of IDUs would accept treatment
(Urban Health Study, 2001)
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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)
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1/3 of treatment admissions list heroin
addiction as the primary reason (CSAS database, 2003))
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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

4
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
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The San Francisco OBOT Pilot
Program
1998- Board of Supervisors passes resolution
directing DPH to:
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“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”
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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)
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OBOT San Francisco
Program Planning
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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
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OBOT Guiding Principles
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Expand access to effective treatment
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Increase patient choice
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Integrate care
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Reduce stigma

Regulatory Parity for NTPs
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San Francisco OBOT-related
Legislation

Board of Supervisors Resolution - 1997
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California SB 1807 - 2000
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Drug Abuse Treatment Act - 2000
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CSAT Buprenorphine Approval - 2002
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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
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SFDPH OBOT Program Status
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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
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San Francisco OBOT Timeline

CSAT Approval
May 2003
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DADP OBOT License
May 2003

Patient enrollment begins
 Dr. Leavitt
 Tom Waddell HC
 Potrero Hill HC
 BAART Hyde St. Clinic
 Jail Health Svcs.
July 2003
Sept. 2003
Oct. 2003
Dec. 2003
Feb. 2004
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OBOT Pharmacies
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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
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Potrero Hill Health Center
Patient capacity=30
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Tom Waddell Health Center
Patient capacity=30
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Quality Control:
Centralized Information System
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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
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Password-protected Online
Patient Record
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Patient Enrollment Folder
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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
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Patient Treatment Folder
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Evaluation Goals
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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
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Demographics of OBOT Patients (N=80)

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)
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Preliminary Conclusions from
OBOT Pilot
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Site Staffing key to implementation
Site Logistics determine barriers
Jail-to-community transition difficult
Counselor and pharmacist play larger, ongoing role in treatment
Central administration necessary for
regulatory and management issues
Evidence supporting OBOT in PC, NTP
satellite and Addiction Specialty settings
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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
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The San Francisco OBOT Pilot
Guiding Principals
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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
27
The San Francisco OBOT Pilot
Clinical Considerations
Federal 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”
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The San Francisco OBOT Pilot
Some Basic Clinical Elements
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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
29
The San Francisco Office Based Opiate
Addiction Treatment (OBOT) Pilot Project
Programmatic Components
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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
30
The San Francisco Office Based Opiate
Addiction Treatment (OBOT) Pilot Project
The Human Element
The Patients
 The Providers
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The OBOT Physician
The OBOT Counselor
The OBOT Pharmacist
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The OBOT Quality
Assurance/Evaluation Team
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The OBOT Patient
Inclusion/Exclusion Criteria
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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
32
The San Francisco Office Based Opiate
Addiction Treatment (OBOT) Pilot Project
OBOT Providers- Expectations and
Responsibilities
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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
33
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
34
The OBOT Pilot Program
The Treatment Process
I.
II.
III.
IV.
V.
VI.
Patient identification
Eligibility determination
Choosing a medication
?Need for stabilization/evaluation prior to
entry?
Transfer to community site/pharmacy
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?
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The Affiliated NTP
Roles and Responsibilities
Program Development
 Provider Training
 Stabilization and Evaluation Track
 Prior to entry
 Safety net
 Ongoing Consultation
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The Affiliated NTP
The Stabilization and Evaluation
Track
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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
37
The OBOT Buprenorphine Induction
Clinic (OBIC)
Roles and Responsibilities
Stabilization and Evaluation
 Prior to transfer to community
 As a safety net
 Provider Training
 Consultation

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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
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THE SAN FRANCISCO OBOT
PILOT
Continuous Quality Improvement
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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
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THE SAN FRANCISCO OBOT
PILOT
Preliminary Data as of September 2004
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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
41
THE SAN FRANCISCO OBOT
PILOT
Preliminary data as of June 2004 continued
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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
42
San Francisco County
OBOT Pilot:
Pharmacy Aspects
Sharon Kotabe, PharmD
Associate Administrator for
Pharmaceutical Services
Associate Clinical Professor of
Pharmacy, UCSF
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

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Pharmacy Subcommittee
Charge
“ To develop and recommend a ‘best
practices’ model to create medically
appropriate and geographicallyconvenient dispensing of methadone in
a PHARMACY-BASED SETTING in
San Francisco”
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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
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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
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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
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Pharmacy Subcommittee
Activities
Met with pharmacists engaged in officebased 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
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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”
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Pharmacy Subcommittee
Recommendations
(February 2001)
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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
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Recommendations (continued)…
Create central database for ready
access to relevant client information and
recording dose administration
 Allow pharmacies to establish dosing
“appointments” as dictated by workload
 Require establishment of dosing areas
separate and private from main
pharmacy counseling windows
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Recommendations (continued)…
Provide adequate security
 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
 Provide adequate remuneration

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….. and at last!
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First patient enrolled, July 2003
Community pharmacy participation
 Corporate vs. individual pharmacist views
 Corporate view prevails
County operated pharmacies
 Hospital-based outpatient pharmacy
(methadone dispensing)
 Mental health clinic pharmacy
(buprenorphine dispensing)
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Basic Program Components
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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
Pharmacists record observed and take
home dosing in database
 Communication and clinical data sharing
through “SOAP” notes format

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Basic
Program Components
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Program licensure allows exemption from
Board of Pharmacy prescription
requirements
“On-call” OBOT program staff to assist
with problems
Physical modifications were made to
enhance security and dosing area privacy
Program uses methadone tablets (vs.
liquid or diskette), or SuboxoneR
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Observations, 1 year later
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Establishing dosing “appointments” works!
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
57
more observations…...
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Rapport between pharmacist and client
quickly and easily established
Pharmacists enjoy client interaction and
expanded responsibilities
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
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Lessons Learned
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Listen to the “experts” - especially those
who actually do the work
Local buy-in may not be enough, engage
corporate decision makers if possible
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
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Questions?
Sharon Kotabe, PharmD
(415) 206-2325
[email protected]
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