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

An NTP Affiliated Office-Based Opiate Treatment (OBOT) Program

in a Public Health Setting

Alice Gleghorn, PhDAlice Gleghorn, PhD

SFDPH OBOT DirectorSFDPH 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)

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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)

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

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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:

“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 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

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OBOT Guiding Principles

Expand access to effective treatment

Increase patient choice

Integrate care

Reduce stigma

Regulatory Parity for NTPs

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San Francisco OBOT-related Legislation

Board of Supervisors Resolution - 1997

California SB 1807 - 2000

Drug Abuse Treatment Act - 2000

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

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

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

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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

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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

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 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 TrackMethadone 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

BuprenorphineBuprenorphine Track Track 32 total enrolled32 total enrolled

59% male59% male 31% homeless31% homeless Mean LOS 124.5 Mean LOS 124.5

(1-361)(1-361) 8 dropped out (5/8 JHS)8 dropped out (5/8 JHS) 24 currently enrolled24 currently enrolled

Mean LOS 157 Mean LOS 157 (32-361)(32-361)

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Preliminary Conclusions from OBOT Pilot Site Staffing key to implementation Site Staffing key to implementation Site Logistics determine barriersSite Logistics determine barriers Jail-to-community transition difficultJail-to-community transition difficult Counselor and pharmacist play larger, on-Counselor and pharmacist play larger, on-

going role in treatmentgoing role in treatment Central administration necessary for Central administration necessary for

regulatory and management issuesregulatory and management issues Evidence supporting OBOT in PC, NTP Evidence supporting OBOT in PC, NTP

satellite and Addiction Specialty settingssatellite and Addiction Specialty settings

The San Francisco Office Based Opiate Addiction Treatment (OBOT)

Pilot ProjectClinical 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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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 PilotGuiding Principals

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The San Francisco OBOT PilotClinical Considerations

Federal and State Regulations

Code of Federal Regulations- 42 CFRCode of Federal Regulations- 42 CFR““Opioid Drugs in Maintenance and Opioid Drugs in Maintenance and

Detoxification Treatment of Opiate Detoxification Treatment of Opiate Addiction”Addiction”

California Code of Regulations- Title 9California Code of Regulations- Title 9““Narcotic Treatment Programs”Narcotic Treatment Programs”

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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-HomesMedication Take-Homes MethadoneMethadone- Step levels as per Federal Regs.- Step levels as per Federal Regs. BuprenorphineBuprenorphine- As per OBOT Clinical Guidelines- As per OBOT Clinical Guidelines

Toxicology ScreensToxicology Screens- - At least 8xs/yearAt least 8xs/year CounselingCounseling- - At least 50 minutes/monthAt least 50 minutes/month Medication OrdersMedication Orders- Transmitted electronically to - Transmitted electronically to

pharmacy through OBOT databasepharmacy through OBOT database

The San Francisco OBOT PilotSome Basic Clinical Elements

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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)(75 patients- 30 methadone/45 buprenorphine) NTP Satellite Clinic NTP Satellite Clinic (10 methadone patients)(10 methadone patients)

Private Practitioner’s Office (addiction/psychiatry)Private Practitioner’s Office (addiction/psychiatry)

(5 patients- methadone or buprenorphine)(5 patients- methadone or buprenorphine)

Affiliated NTP (OTOP- “Stabilization and Evaluation” Affiliated NTP (OTOP- “Stabilization and Evaluation” Track)Track)

OBOT Buprenorphine Induction Clinic (OBIC)OBOT Buprenorphine Induction Clinic (OBIC) Two Community PharmaciesTwo Community Pharmacies

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The Human Element

The PatientsThe Patients The ProvidersThe Providers

The OBOT PhysicianThe OBOT Physician

The OBOT CounselorThe OBOT Counselor

The OBOT PharmacistThe OBOT Pharmacist The OBOT Quality The OBOT Quality

Assurance/Evaluation TeamAssurance/Evaluation Team

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The OBOT Patient Inclusion/Exclusion Criteria

At least 18 years oldAt least 18 years old San Francisco residentSan Francisco resident Opiate dependent (at least 1 year)Opiate dependent (at least 1 year) No active, uncontrolled, serious medical, psychiatric, or behavioral No active, uncontrolled, serious medical, psychiatric, or behavioral

conditioncondition Willingness to continue in OAT for at least one yearWillingness to continue in OAT for at least one year Anticipated ability to comply with OBOT expectations and do well at the Anticipated ability to comply with OBOT expectations and do well at the

level of care provided through OBOTlevel of care provided through OBOT No abuse or dependence on alcohol or sedative hypnoticsNo abuse or dependence on alcohol or sedative hypnotics Not pregnant or planning to become pregnantNot pregnant or planning to become pregnant Willingness to use adequate birth controlWillingness to use adequate birth control Specifically for buprenorphine Specifically for buprenorphine

No acute/chronic pain syndrome requiring the use of narcotic No acute/chronic pain syndrome requiring the use of narcotic analgesicsanalgesics

Not currently taking greater than 35 mgs of methadone dailyNot currently taking greater than 35 mgs of methadone daily

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OBOT Providers- Expectations and Responsibilities

Provide services at participating OBOT sitesProvide services at participating OBOT sites Posses required licenses/certificationsPosses required licenses/certifications Attend prerequisite trainingsAttend prerequisite trainings Provide adequate back-up capacity and Provide adequate back-up capacity and

referral servicesreferral services Willingness to comply with Federal, State, Willingness to comply with Federal, State,

and Pilot policies and proceduresand Pilot policies and procedures

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Provider Trainings

Prior to participationPrior to participation At least 8-hour didactic OBOT/Buprenorphine TrainingAt least 8-hour didactic OBOT/Buprenorphine Training Practicum experience at OTOPPracticum experience at OTOP On site general trainings (addiction/recovery, OAT etc)On site general trainings (addiction/recovery, OAT etc) Other required trainings:Other required trainings:

OBOT-specific clinical guidelines (includes review OBOT-specific clinical guidelines (includes review of pertinent Federal and State regulations)of pertinent Federal and State regulations)

ASI and treatment planningASI and treatment planning OBOT policies/proceduresOBOT policies/procedures Database trainingsDatabase trainings

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The OBOT Pilot ProgramThe Treatment Process

I.I. Patient identificationPatient identificationII.II. Eligibility determinationEligibility determinationIII.III. Choosing a medicationChoosing a medicationIV.IV. ?Need for stabilization/evaluation prior to entry??Need for stabilization/evaluation prior to entry?V.V. Transfer to community site/pharmacyTransfer to community site/pharmacyVI.VI. Ongoing assessment of clinical courseOngoing assessment of clinical course

I.I. Need for additional services?Need for additional services?II.II. Need for re-stabilization at any point?Need for re-stabilization at any point?III.III. Need for transfer to other level of care?Need for transfer to other level of care?

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The Affiliated NTPRoles and Responsibilities

Program DevelopmentProgram Development Provider TrainingProvider Training Stabilization and Evaluation TrackStabilization and Evaluation Track

Prior to entryPrior to entry Safety netSafety net

Ongoing ConsultationOngoing Consultation

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The Affiliated NTPThe Stabilization and Evaluation

Track Two-to-four month maintenance track to evaluate Two-to-four month maintenance track to evaluate

appropriateness for OBOT appropriateness for OBOT Stabilization of methadone doseStabilization of methadone dose Frequent counseling and toxicology screensFrequent counseling and toxicology screens Assess (address if possible) for acute medical, Assess (address if possible) for acute medical,

psychiatric, behavioral, or psychosocial problemspsychiatric, behavioral, or psychosocial problems Remain in close communication with referring siteRemain in close communication with referring site Facilitate transfer to OBOT or to other level of care as Facilitate transfer to OBOT or to other level of care as

appropriateappropriate

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The OBOT Buprenorphine Induction Clinic (OBIC)

Roles and Responsibilities

Stabilization and EvaluationStabilization and Evaluation Prior to transfer to communityPrior to transfer to community As a safety netAs a safety net

Provider TrainingProvider Training ConsultationConsultation

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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 Led by OBOT Clinical Coordinator and Medical DirectorLed by OBOT Clinical Coordinator and Medical Director Assisted by Core OBOT Team and affiliated NTPAssisted by Core OBOT Team and affiliated NTP Designated QA leader at each community treatment siteDesignated 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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Preliminary Data as of September 2004

Over 150 patients consideredOver 150 patients considered 70 patients enrolled70 patients enrolled 61 patients currently in treatment in community61 patients currently in treatment in community

36 methadone/25 buprenorphine36 methadone/25 buprenorphine 16/36 methadone patients from NTP stabilization, 16/36 methadone patients from NTP stabilization,

20/36 from maintenance20/36 from maintenance 24/25 buprenorphine patients induced at OBIC, 1/25 24/25 buprenorphine patients induced at OBIC, 1/25

induced in communityinduced 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*majority dropped out prior to or during “induction” at OBIC

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Preliminary data as of June 2004 continued

Early ResultsEarly Results High compliance with treatmentHigh compliance with treatment Very few missed dosesVery few missed doses High program retentionHigh program retention Little-to-no clinical deterioration Little-to-no clinical deterioration Patients extremely satisfied with programPatients extremely satisfied with program Positive patient reports regarding Positive patient reports regarding

buprenorphinebuprenorphine

San Francisco CountyOBOT Pilot:

Pharmacy Aspects

Sharon Kotabe, PharmDSharon Kotabe, PharmDAssociate Administrator for Associate Administrator for

Pharmaceutical ServicesPharmaceutical Services

Associate Clinical Professor of Associate Clinical Professor of

Pharmacy, UCSFPharmacy, UCSF

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In the beginning…… Pharmacy Subcommittee formed, Pharmacy Subcommittee formed,

November 1999November 1999 Members representedMembers represented

County Health DepartmentCounty Health Department Local School of PharmacyLocal School of Pharmacy State Board of PharmacyState Board of Pharmacy State Poison Control SystemState Poison Control System Local chain, independent & hospital pharmaciesLocal chain, independent & hospital pharmacies Narcotic Treatment Programs (NTPs) and free Narcotic Treatment Programs (NTPs) and free

clinicsclinics

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Pharmacy Subcommittee Charge

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

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Pharmacy Subcommittee Activities

Identified barriers to pharmacist participation Identified barriers to pharmacist participation in projectin project Pharmacists not included in “traditional” Pharmacists not included in “traditional”

maintenance program models and in maintenance program models and in California, restricted by law from dispensing California, restricted by law from dispensing maintenance opiates to known addictsmaintenance opiates to known addicts

Negative perceptions & beliefs re: addictionNegative perceptions & beliefs re: addiction Reimbursement for time necessary to Reimbursement for time necessary to

provide appropriate servicesprovide appropriate services

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Identified benefits of pharmacist participation Identified benefits of pharmacist participation in programin program Expertise counseling patients on Expertise counseling patients on

medication and drug therapymedication and drug therapy Availability of patient’s entire drug profile Availability of patient’s entire drug profile

for drug-drug interaction and for drug-drug interaction and contraindication monitoringcontraindication monitoring

Increased access to treatment through Increased access to treatment through local “neighborhood” pharmacieslocal “neighborhood” pharmacies

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Reviewed State and Federal regulations Reviewed State and Federal regulations for “traditional” narcotic treatment for “traditional” narcotic treatment programsprograms

Reviewed materials training materials Reviewed materials training materials used to educate pharmacy students used to educate pharmacy students about addiction and addiction about addiction and addiction pharmacology from various schools of pharmacology from various schools of pharmacy pharmacy

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Met with pharmacists engaged in office-Met with pharmacists engaged in office-based treatment models in other Statesbased treatment models in other States

Matched zip-codes of clients already in Matched zip-codes of clients already in treatment with pharmacy locations to treatment with pharmacy locations to target potential dispensing pharmaciestarget potential dispensing pharmacies

Conducted focus groups with Conducted focus groups with pharmacists from 10 zip-codes with pharmacists from 10 zip-codes with highest number of current clientshighest number of current clients

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Focus Group Comments

Support for expanding access to Support for expanding access to treatmenttreatment

Participation perceived as a natural Participation perceived as a natural expansion of professional role and expansion of professional role and responsibilities and welcomed challenge responsibilities and welcomed challenge of learning new skillsof learning new skills

Suggestions that program start slowly Suggestions that program start slowly with fewer initial clients, and for with fewer initial clients, and for scheduled “appointment times”scheduled “appointment times”

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Pharmacy Subcommittee Recommendations (February 2001)

TrainingTraining Integrate with training for physicians, Integrate with training for physicians,

counselors and others to foster counselors and others to foster collaborative, team-approach to carecollaborative, team-approach to care

Focus on: (1) “mechanics” of Focus on: (1) “mechanics” of maintenance treatment and, (2) maintenance treatment and, (2) “raising consciousness” on nature of “raising consciousness” on nature of addictionaddiction

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Recommendations (continued)…

Create central database for ready Create central database for ready access to relevant client information and access to relevant client information and recording dose administrationrecording dose administration

Allow pharmacies to establish dosing Allow pharmacies to establish dosing “appointments” as dictated by workload“appointments” as dictated by workload

Require establishment of dosing areas Require establishment of dosing areas separate and private from main separate and private from main pharmacy counseling windows pharmacy counseling windows

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Recommendations (continued)…

Provide adequate securityProvide adequate security Provide access to “on-call” system to Provide access to “on-call” system to

advise pharmacists dealing with advise pharmacists dealing with complex client issuescomplex client issues

Pharmacists provide medication Pharmacists provide medication counseling, counselors and physicians counseling, counselors and physicians provide drug abuse counselingprovide drug abuse counseling

Provide adequate remunerationProvide adequate remuneration

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….. and at last!

First patient enrolled, July 2003First patient enrolled, July 2003 Community pharmacy participationCommunity pharmacy participation

Corporate vs. individual pharmacist viewsCorporate vs. individual pharmacist views Corporate view prevailsCorporate view prevails

County operated pharmaciesCounty operated pharmacies Hospital-based outpatient pharmacy Hospital-based outpatient pharmacy

(methadone dispensing)(methadone dispensing) Mental health clinic pharmacy Mental health clinic pharmacy

(buprenorphine dispensing)(buprenorphine dispensing)

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Basic Program Components

All pharmacists involved in the program All pharmacists involved in the program undergo extensive training provided by the undergo extensive training provided by the California Society of Addiction MedicineCalifornia Society of Addiction Medicine

Central database with pertinent client Central database with pertinent client demographic and clinical informationdemographic and clinical information Pharmacists record observed and take Pharmacists record observed and take

home dosing in databasehome dosing in database Communication and clinical data sharing Communication and clinical data sharing

through “SOAP” notes formatthrough “SOAP” notes format

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Basic Program Components

Program licensure allows exemption from Program licensure allows exemption from Board of Pharmacy prescription Board of Pharmacy prescription requirementsrequirements

““On-call” OBOT program staff to assist with On-call” OBOT program staff to assist with problemsproblems

Physical modifications were made to Physical modifications were made to enhance security and dosing area privacyenhance security and dosing area privacy

Program uses methadone tablets (vs. liquid Program uses methadone tablets (vs. liquid or diskette), or Suboxoneor diskette), or SuboxoneR R

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Observations, 1 year later

Establishing dosing “appointments” works!Establishing dosing “appointments” works! Estimate of pharmacist time needed for Estimate of pharmacist time needed for

each observed dosing/take home each observed dosing/take home dispensing (5 minutes) too lowdispensing (5 minutes) too low

Regulatory agencies - e.g. DEA, state NTP Regulatory agencies - e.g. DEA, state NTP licensing agency - complimentary of licensing agency - complimentary of pharmacist record keeping, security, and pharmacist record keeping, security, and professional services provided to clientsprofessional services provided to clients

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more observations…...

Rapport between pharmacist and client Rapport between pharmacist and client quickly and easily establishedquickly and easily established

Pharmacists enjoy client interaction and Pharmacists enjoy client interaction and expanded responsibilities expanded responsibilities

Pharmacists initially reluctant to Pharmacists initially reluctant to “volunteer”, later filed labor grievance to be “volunteer”, later filed labor grievance to be allowed to participateallowed to participate

Clients prefer dosing and receiving take Clients prefer dosing and receiving take home doses in a pharmacy settinghome doses in a pharmacy setting

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Lessons Learned

Listen to the “experts” - especially those Listen to the “experts” - especially those who actually do the workwho actually do the work

Local buy-in may not be enough, engage Local buy-in may not be enough, engage corporate decision makers if possiblecorporate decision makers if possible

Initial concerns about major legal and Initial concerns about major legal and regulatory obstacles did not materializeregulatory obstacles did not materialize

Flexibility, open-mindedness, and patience Flexibility, open-mindedness, and patience are required traits for anyone involved in a are required traits for anyone involved in a pilot programpilot program

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Questions?

Sharon Kotabe, PharmDSharon Kotabe, PharmD

(415) 206-2325(415) 206-2325

[email protected][email protected]

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

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