Industry begins offering CE for pain relievers in MarchMarch 10, 2013
Health care practitioners, including optometrists, will receive the first offers of free, industry-sponsored continuing education (CE) in March as part of the U.S. Food and Drug Administration’s (FDA) new Risk Evaluation and Mitigation Strategy (REMS) program to ensure the benefits of drugs or biological products outweigh any risks.
Under the REMS program, more than 20 manufactures of extended-release (ER) and long-acting (LA) opioids, such as Vicodin, Percodin, and Percoset, are expected to begin notifying health care practitioners of REMS CE opportunities.
Participation in the CE programs is optional for health care practitioners, the AOA Advocacy Group and AOA Clinical Resources Group noted.
While the FDA mandates drugmakers offer the CE courses, health care practitioners are not mandated to take them.
Participation in the CE courses is not required for practitioners who wish to prescribe the pharmaceuticals, the FDA confirmed. However, the CE could become mandatory in the future for health care practitioners who are registered with the U.S. Drug Enforcement Administration to prescribe controlled substances.
The new REMS program was authorized under the federal Food and Drug Administration Act of 2007 to combat increases in health problems or outright abuse associated with prescription pharmaceuticals.
An REMS Blueprint for prescriber education on ER and LA opioids was approved by the FDA in July 2012.
In most cases, REMS CE will be offered through established CE providers under grants from manufacturers. Drugmakers were to begin notifying prescribers of the new REM CE offerings March 1, 2013.
Consumer education campaigns will also directly help patients understand the risks of ER/LA opioids.
Since the REMS program was authorized, the FDA has developed risk mitigation initiatives for almost 70 drugs, most centering around medication guides and consumer education. The new initiative on ER/LA opioids is among the first to involve formal continuing education for prescribers.
For additional information on the FDA REMS program, visit http://tinyurl.com/FDAREMS. Information on the REMS ER/LA initiative can be found at http://tinyurl.com/REMSERLAopioids and http://tinyurl.com/REMSERLAblueprint.