The Hospice Clinician Blog

In April 2011, the Obama administration released its “Epidemic: Responding to America’s Prescription Drug Abuse Crisis” plan, which is part of the White House's national action plan to fight prescription drug abuse (we wrote about this in the July 2011 issue of The Clinician Newsletter and on this blog). Yesterday, the FDA took first steps toward implementing this multi-faceted plan by approving a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain. The new REMS will affect more than 20 companies that manufacture ER and LA opioid analgesics via a three-pronged approach:

Training for Prescribers

Manufacturers of ER and LA opioids will be required to make education programs available to prescribers based on an FDA Blueprint . It is expected that companies will meet this obligation by providing educational grants to continuing education (CE) providers, who will develop and deliver the training. The education programs will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, the education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for ER/LA opioid analgesics. It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013.
These education programs will initially be voluntary. There is no mandatory requirement that prescribers take the training and no precondition to prescribing ER/LA opioids to patients. However, the Obama Administration is currently pursuing legislation that would make training a mandatory component of DEA registration.

Updated Medication Guide and Patient Counseling Document

The REMS also will require companies to make available FDA-approved patient education materials on the safe use of these drugs. These materials contain consumer-friendly information on the safe use, storage and disposal of ER/ LA opioid analgesics. Included are instructions to consult one’s physician or other prescribing health care professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.

Assessment/Auditing

Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of ER/ LA opioids who complete the training, as well as assess prescribers’ understanding of important risk information over time. According to the FDA, there are about 320,000 prescribers of long-acting opioid analgesics in the U.S., and the agency expects 25% of them to be trained at the end of the program's first year. The goal is to have 60% of prescribers trained by year three. The assessments also cover whether the REMS is adversely affecting patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments. The FDA will review these assessments and may require additional elements to achieve the goals of the program.

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