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