Prescription Drug Abuse Sharon Hertz, M.D. Medical Officer Division of Anesthetic, Critical Care and...
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Transcript of Prescription Drug Abuse Sharon Hertz, M.D. Medical Officer Division of Anesthetic, Critical Care and...
Prescription Drug Abuse
Sharon Hertz, M.D.Medical Officer
Division of Anesthetic, Critical Care and Addiction Drug Products
Food and Drug Administration
• Scheduling under the Controlled Substances Act• Labeling• Risk Management Plan • Formulation changes• Restricted distribution
Approaches to Managing Abuse Potential
1. Key Messages• Identification of key events to monitor• Prevention of abuse and diversion• Importance of proper patient selection
Risk Management Plans
2. Identification of Risk Potential• Issues related to drug substance• Formulation issues• Prior experience
Risk Management Plans
3. Programs to identify abuse, misuse, diversion• Spontaneous reporting - hotline, MedWatch• DAWN, TESS, IMS, SAMHSA (TX centers)• State Drug Control Authorities/Boards of Pharmacy• Special registries, pediatric databases• Pharmacy surveys• Literature/Media reports
Risk Management Plans
4. Prevention/Intervention Programs• Education - Physician, Pharmacist, Patient• Tamper resistant prescription pads• Special storage needs - Physician/Patient• Child resistant packaging• Black box warnings• Restricted access to targeted populations• Expert Advisory Boards• Cooperative efforts with law enforcement
Risk Management Plans
5. Monitoring Efforts• Specific event reporting• Assessment of effects of educational efforts
Risk Management Plans
Prescription Abuse - Vignettes
1. Post-marketing surveillance followed by scheduling
2. Scheduling followed by reformulation
3. Proactive Risk Management Plan
Prescription Abuse - Vignettes
Drug A• Parenteral opioid agonist/antagonist analgesic
approved for hospital use• Abuse liability considered to be low risk• Not scheduled• Little abuse reported
Prescription Abuse - Vignettes
Drug A cont’d• Nasal spray formulation developed for outpatient use• Abuse potential revisited with FDA Advisory
Committee• Abuse potential considered low, postmarketing
surveillance program recommended
Prescription Abuse - Vignettes
Drug A cont’d• After release, concerns over abuse result in petition for
scheduling by DEA • DAWN and FDA postmarketing safety databases were
reviewed
Prescription Abuse - Vignettes
Drug A cont’d• FDA-DEA surveyed of State Authorities:
- 80% of responding state authorities confirmed cases of nonmedical use and diversion - Typical drug seeking behavior linked to the nasal spray: falsification of prescriptions, doctor shopping, requests for early refills- Reports of abuse increased
Prescription Abuse - Vignettes
Drug A cont’d• A request to DEA to place Drug A nasal spray in
Schedule IV of the CSA was granted.• Following scheduling (and dissemination of relevant
educational information) abuse-related reports began to decrease in the setting of stable numbers of Rx’s
Prescription Abuse - Vignettes
Drug B• Oral opioid agonist/antagonist• Over first decade of distribution, reports of abuse,
diversion, overdose, and death increase • Intravenous abuse of crushed tablets noted
Prescription Abuse - Vignettes
Drug B cont’d• Addition to Schedule IV of the CSA - no impact on
reports of abuse and diversion • Reformulation with naloxone, original withdrawn • Dramatic decline in reports of abuse
Prescription Abuse - Vignettes
Drug C• Novel formulation of Schedule II narcotic• Intended for narrow target pain population• Concerns of accidental exposure to non-opioid tolerant
individuals, and risk of abuse and diversion result in RMP prior to approval
Prescription Abuse - Vignettes
Drug C cont’d• Features of RMP:
- Limit to patients with labeled indication- Corrective letters to off-label prescribing physicians- Limited detailing by sponsor- Patient education materials, cabinet locks
- Surveys of participating pharmacies
Prescription Abuse - Vignettes
Drug C cont’d
Result of risk management efforts: Limited reports of misuse.
Approaches to Managing Abuse Potential
The Agency is aware of problems of abuse, misuse, and diversion of prescription narcotic analgesics and the need for adequate pain management for legitimate patients.
Approaches to Managing Abuse Potential
1. Discuss the adequacy of the available data to determine the prevalence of addiction among patients treated with opioids for chronic pain.
2. Discuss the methods for assessing and monitoring addiction in the clinical setting. Are there methods that may be extended to the Clinical Trials setting?
Approaches to Managing Abuse Potential
3. In the context of increasing awareness of the problems of diversion and addiction to prescription opioids among patients and non-patients, comment on what measures might be appropriate to consider in the development of an overall risk management strategy that could reduce abuse and diversion without restricting access to drugs by patients in need of treatment.