FDA approves REMS for ER, long-acting opioids

July 17, 2012

FDA has approved a new risk evaluation and mitigation strategy for extended-release and long-acting opioids that requires that healthcare professionals are educated on how to safely prescribe the drugs and that patients understand how to safely use the drugs.

FDA has approved a new risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids.

The FDA action is expected to affect more than 20 companies that manufacture opioid analgesics. FDA Commissioner Margaret A. Hamburg, MD, said, “Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge. The FDA’s goal with this REMS approval is to ensure that healthcare professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”

The REMS will require opioid manufacturers to make FDA-approved patient education materials on the safe use of these drugs available, and perform periodic assessments of the REMS implementation.

The opioid manufacturers must also produce educational programs for prescribers that will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, monitoring patients, and counseling patients on the safe use of the drugs. The prescriber educational programs will be based on an FDA Blueprint and developed with input from stakeholders.

Manufacturers must start offering continuing education to prescribers by March 1, 2013.