1. 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 Committee September 9, 2003

2. 9/9/032 Three Goals: Prevention of accidental overdose/ unintended exposure Proper patient selection Prevention of misuse/abuse

3. 9/9/033 Components of Risk Management Education and Outreach “Guiding Systems” Restricted Access Targeted Surveillance

4. 9/9/034 Education and Outreach Patient Package Inserts Public Service Campaigns Training Programs for Physicians Training/Brochures for Pharmacists Call center Website

5. 9/9/035 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)

6. 9/9/036 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

7. 9/9/037 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

8. 9/9/038 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

9. 9/9/039 Pharmacist Education Examples: Actiq Dear Pharmacist Letter, ads in publications targeting pharmacists Pharmaceutical Representative calls

10. 9/9/0310 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

11. 9/9/0311 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

12. 9/9/0312 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

13. 9/9/0313 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

14. 9/9/0314 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

15. 9/9/0315 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

16. 9/9/0316 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