Risk-Cutting Plan Covers Extended-Release Opioids; Advisory Panel Had Recommended Including Short-Acting Opioids
By Daniel J. DeNoon
WebMD Health News
Reviewed by Laura J. Martin, MD
The action calls for companies that make long-lasting or extended-release opioid pain drugs to develop a shared plan to educate patients and doctors about how to reduce the risk that the potentially addictive drugs will be abused.
The panel last July voted 24-10 to reject the plan and recommended stronger action that would include short-acting opioids.
"The agency concluded that there is a disproportionate safety problem associated with the extended-release and long-acting opioids which must be addressed, and will incorporate a step-wise approach to focus first on educating prescribers of extended-release and long-acting opioids," the FDA notes in a news release.
The FDA's "risk evaluation and mitigation strategy, or REMS, goes a bit beyond the usual package insert. REMS plans typically include a medication guide and a plan to communicate risk information to both patients and doctors.
In the case of long-acting opioids, the REMS plan is expected to help patients keep their prescription pain drugs out of the hands of potential abusers and to help doctors properly prescribe the drugs.
But for doctors, any education required by the plan will be voluntary.
Doctors will not be required to undergo special training to prescribe opioid pain drugs. However, the FDA is asking Congress to pass legislation that would link mandatory doctor training to getting a Drug Enforcement Administration number that doctors now need to prescribe controlled substances.
The advisory panel strongly supported such legislation.
Drugs covered by the new plan include many well-known brands:
- Kadian Capsules
- MS Contin
- Opana ER
The action covers these generic drugs:
- Fentanyl extended-release transdermal system
- Methadone (all versions, as methadone remains in the body for extended periods)
- Morphine extended-release tablets
- Oxycodone extended-release tablets
The FDA action is part of a collaborative effort between the departments of Justice, Health and Human Services, Veterans Affairs, and Defense. The effort seeks to cut prescription drug abuse and to keep prescription drugs from being diverted from patients to recreational users.
It's a big problem. For example, the 2008 National Survey on Drug Use and Health found that only 7% of OxyContin users got the drug from a doctor and 13% bought it from a drug dealer or other stranger. Nearly two-thirds got the drug from a friend or relative.
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SOURCES: News release, FDA.FDA web site: FDA briefing document for July 22-23 advisory committee meeting, "Proposed Risk Evaluation and Mitigation Strategy (REMS) for Long-Acting and Extended-Release Opioids." Medscape Medical News, July 23, 2010.
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