FDA Introduces New Safety Measures for Opioid Medications

On July 9, 2012, FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid medications. The REMS is part of a federal initiative to address the potential for misuse and abuse of prescription drugs, and will affect more than 20 companies that produce extended-release or long-acting opioid drugs. Companies will be required to make educational programs available to prescribers based on a blueprint provided by FDA. In addition, companies will be required to make FDA-approved patient education materials available, and to perform periodic assessments of the implementation of the REMS.

There are three key components to the initiative:

• Training for prescribers that includes information on the risks and benefits of opioid therapy, choosing patients appropriately, monitoring patients, and counseling patients on the safe use of these types of opioids

• An updated medication guide and patient counseling document

• Assessment and auditing, to determine whether companies have achieved FDA-established goals for the percentage of prescribers completing the training, and to assess whether the REMS is adversely affecting the ability of patients to access necessary pain medication.

Of note, the REMS applies only to extended-release and long-acting opioid medications, not to immediate release formulations, because FDA has concluded that there is a disproportionate safety problem (i.e., abuse, misuse, and overdose potential) associated with these products that must be addressed. At this time, prescriber training is voluntary, and not a precondition for prescribing extended-release or long-lasting opioids to patients. However, according to the FDA press release, the Obama Administration is pursuing legislation that would make opioid prescriber training mandatory and link training to registration with the Drug Enforcement Agency.