profession
FDA opioids education plan rejected
NEWS IN BRIEF — Posted Aug. 9, 2010
A Food and Drug Administration advisory panel rejected as too lenient an agency proposal to require manufacturers of extended-release opioids to boost their efforts to educate physicians and patients about the abuse dangers of the drugs through medication guides, patient education sheets and continuing medical education.
The joint panel of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 25-10 to reject the plan, known as a Risk Evaluation & Mitigation Strategy. The proposal would not have required physicians to take the CME courses to prescribe opioids. Many expert panel members said such a mandate is needed to ensure that doctors can spot misuse and properly select patients for whom opioids are appropriate.
Fatal poisonings from opioid overdoses tripled to nearly 14,000 deaths between 1999 and 2006, according to the Centers for Disease Control and Prevention. Emergency department visits involving the pain-relieving medications doubled to 305,885 from 2004 to 2008. However, a federal survey of individuals who used opioids recreationally found that just 7% said they got the drugs directly from a physician. FDA officials said they now may work with Congress to formulate legislative language aimed at stricter requirements for physicians prescribing opioids.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2010/08/09/prbf0809.htm.
