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WASHINGTON—The Food and Drug Administration has approved a risk management plan to help combat the misuse and abuse of long-acting opioid prescription pain medications.
The FDA's new Risk Evaluation and Mitigation Strategy, adopted Monday, will affect more than 20 companies that manufacture opioid analgesics. They will be required to make educational programs available to prescribers based on an FDA blueprint.
The companies also will be required to provide educational materials for patients and perform periodic assessments of the mitigation program's implementation and success.
Affected drugmakers include Janssen Pharmaceuticals Inc., Mallinckrodt Inc., Pfizer Inc., Purdue Pharma L.P. and Sandoz, now a unit of Novartis A.G.
The program is one component of a multiagency, national strategy to address opioid prescribing problems that include addiction, overdoses and thousands of U.S. deaths annually from the highly potent drugs.
Those problems have become evident in the treatment of workers compensation claimants because pain often is a component of workplace injuries, observers said.
About 22.9 million long-acting opioid prescriptions were dispensed in the United States during 2011, with more than 320,000 prescribers writing at least one prescription, according to the FDA.
“Misprescribing, misuse and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” FDA Commissioner Dr. Margaret A. Hamburg said in a statement. “The FDA's goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”