Opioids Training Approved

Abstract

A risk-evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids has received Food and Drug Administration approval. The new safety measures, which pertain to approximately 30 currently available medications, will require the manufacturers to make FDA-approved education materials available to prescribers no later than March 1, 2013. The companies must provide grants to continuing education providers that will develop and deliver the training, FDA Commissioner Dr. Margaret A. Hamburg said in a media briefing. “It is important to note that we are focusing on extended-release and long-acting opioid medications … because these have very specific safety problems that have to be addressed very carefully,” according to Dr. John Jenkins, director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research. The prescriber-education component of the REMS will include information regarding the risks and benefits of opioid therapy for individual patients, choosing patients appropriately, patient management and monitoring, and patient counseling, Dr. Jenkins explained. It also will include guidance on the potential for misuse, abuse, and addition. The REMS will include information materials for consumers. An updated medication guide and patient-counseling document will describe how to safely use, store, and dispose of these analgesics, specific instructions for recognizing the signs of potential overdose and advice for preventing accidental exposure to family and household visitors. With respect to the assessment and auditing component of the program, the FDA has established goals, which the manufacturers are expected to achieve, for the percentage of prescribers who complete the training and for assessing prescribers' understanding of the risk information. Participation in the educational programs is not mandatory for prescribers, Dr. Hamburg stated. The assessments are required to evaluate whether the REMS adversely affects patient access to these drugs, she said. “Patients in pain must have continued access to medications they need,” she added. The new REMS program is one component of a multiagency, national strategy unveiled by the White House in 2011 to address prescription drug abuse, “which is this country's fastest-growing drug problem,” said Dr. Hamburg, In the absence of the legislative changes needed to fulfill the comprehensive White House plan, the REMS “is an important and timely step by the FDA to supplement prescriber training and consumer information,” R. Gil Kerlikowske, director of the White House Office of National Drug Control Policy, said during the telebriefing.