opioid risk management programs celia jaffe winchell, m.d. acting deputy division director division...

Opioid Risk Management Programs

Celia Jaffe Winchell, M.D.Acting Deputy Division Director

Division of Anesthetic, Critical Care, and Addiction Drug Products

Anesthetic and Life Support Drugs Advisory CommitteeSeptember 9, 2003

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Three Goals:

• Prevention of accidental overdose/

unintended exposure

• Proper patient selection

• Prevention of misuse/abuse

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Components of Risk Management

• Education and Outreach

• “Guiding Systems”

• Restricted Access

• Targeted Surveillance

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Education and Outreach

• Patient Package Inserts

• Public Service Campaigns

• Training Programs for Physicians

• Training/Brochures for Pharmacists

• Call center

• Website

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Physician Education Examples: Subutex/Suboxone

• “Frequently Asked Questions” Brochure – addresses qualifications, storage/recordkeeping

requirements, tips to prevent diversion

• Opiate addiction treatment seminars at professional society meetings (sponsored by SAMHSA)

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Physician Education Examples: Actiq

• CD-ROM discussing child safety, proper patient selection, prevention of diversion and abuse, product handling/storage/disposal

• Speakers’ bureau• Specialized pharmaceutical reps• Professional Information Kit: package insert,

patient leaflet, safety video, info on CD-ROM

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Physician Education Examples: OxyContin

• Anti-diversion brochure

• Special issue of medical journal on use of opioids in treatment of pain

• CD-ROM on Lawful Opioid Prescribing and Prevention of Diversion

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Pharmacist Education Examples: Subutex/Suboxone

• Pharmacist education brochure addresses pharmacology of the product, warnings/precautions, pharmacist’s role in ensuring safe use of product, confidentiality issues, safeguards against diversion

• Seminars to be sponsored at pharmacy professional meetings addressing similar topics

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Pharmacist Education Examples: Actiq

• Dear Pharmacist Letter, ads in publications targeting pharmacists

• Pharmaceutical Representative calls

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Guiding Systems

• “Tamper-resistant” prescription pads provided to physicians– OxyContin

• “Welcome Kit” for patients providing equipment for safe storage and disposal– Actiq

• Pharmacy software prompts– Actiq

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Restricted Access

• Schedule II control under CSA• Legally mandated special DEA

registration• Limited wholesale shipment size,

suspicious order monitoring• No sale directly to retail pharmacy

outlets, monitoring of high-volume wholesalers

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Targeted Surveillance, I

• Monitoring for off-label use through pharmacist survey– Actiq

• Monitoring appropriate delivery of information by pharmaceutical reps through physician survey– Actiq

• Monitoring delivery of patient education materials and “Welcome Kit” through patient survey– Actiq

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Targeted Surveillance, II

• Monitoring of usage data (e.g. IMS Health prescription data, ARCOS)– Actiq, Suboxone/Subutex, Tramadol

• Monitoring of publicly available databases, e.g. DAWN/TESS– Avinza, Suboxone/Subutex, Tramadol,

OxyContin• Monitoring of media sources, internet

– Avinza, Suboxone/Subutex, Tramadol, OxyContin

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Targeted Surveillance, II

• Surveys of entrants into drug treatment (company-sponsored/conducted or through DENS program)– Oxycontin, Tramadol, Suboxone/Subutex

• Surveys of law enforcement sources– Oxycontin

• “Key Informant” network– Tramadol, Oxycontin

• Physician survey– Suboxone/Subutex

• “Street Ethnography”– Subutex/Suboxone

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Interventions

• Retraining of pharmaceutical reps, auditing of promotional practices– Actiq, Tramadol, OxyContin

• Letters/rep visits to off-label prescribers– Actiq

• Involvement of law enforcement– OxyContin

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Summary

• Education and Outreach– lectures, websites, CD-ROMs, training programs, PPI’s, call-

centers, brochures

• “Guiding Systems”– reminders, storage equipment, special Rx pads

• Restricted Access– scheduling, marketing restraint

• Targeted Surveillance– physicians, patients, pharmacists, law enforcement, “street”

informants, addiction treatment programs, internet, media, databases