The Food and Drug Administration is increasing its requirements for safe prescription and use of pain medicines that contain opiates beginning with a meeting in early March with manufacturers. Additional input is planned through discussions with other government agencies, the addiction and pain treatment communities, and patient advocates.
The intensive new program is designed to reduce risk of misuse or accidental overdoses of powerful pain medicines and will probably put new requirements on physicians who prescribe them, pharmacists who dispense them, and patients who need them.
Manufacturers will be required to develop Risk Evaluation and Mitigation Strategies (REMS) to ensure that benefits of using the drugs outweigh their risks. REMS will be required to help prescribers, dispensers, and patients avoid risks of:
- Use of certain opioid products in patients who have not already developed tolerates to opiates.
- Abuse of opiate drugs.
- Both accidental and intentional overdoses.
Brand name drugs include Duragesic patches (fentanyl), Palladone (hydromorphone), Dolophine (methadone), and extended release morphine capsules in Avinza, Kadian, and MS-Contin. Also requiring REMS are Oxy-Contin (extended release oxycodone) and Opana (extended release oxymorphone).
Generics include fentanyl, morphine, methadone, and oxycodone in various formulations from different manufacturers.
A list of both brand name and generic pain medicines that are being considered for REMS is being provided by the FDA.
In announcing the March 3rd meeting with manufacturers, the FDA said,
Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients. Opioid drugs have serious risks when used improperly. The FDA, drug manufacturers, and others have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.
MedPage Today has an audio report about the new FDA initiative.