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Last updated: March 2014

Only relevant and helpful information posted here. To read more about the ongoing changes with REMS and the FDA, use the FDA's website.


Read AAPM's response to PROP here.

Read editorial by Dr. Jeffrey Fudin here.

On July 26, 2012, a group of physicians filed a petition with the FDA to futher limit the prescribing of opioids for chronic, non-cancer pain. This petition contains recommendations to limit opioid use to severe pain in the CNCP setting, restrict daily morphine equivalent dosage to 100mg or less, and restrict prescribing to no more than 90-days consecutive.

On July 9, 2012, the U.S. Food and Drug Administration (FDA) approved a risk management program, known as a Risk Evaluation and Mitigation Strategy (REMS), for a class of potent pain medicines called extended-release and long-acting (ER/LA) opioid analgesics. The REMS was developed by FDA and there are more than 20 companies and more than 30 products (NDAs and ANDAs) affected by the REMS. This new REMS will require ER/LA opioid analgesic companies to make available training for health care professionals who prescribe ER/LA opioid analgesics on proper prescribing practices and also to distribute educational materials to prescribers and patients on the safe use of these powerful pain medications.

Under the new REMS, companies will be required to make education programs available to prescribers based on an FDA Educational 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 REMS also will require companies to make available FDA-approved patient education materials on the safe use of these drugs. The companies will be required to perform periodic assessments of the implementation of the REMS and the success of the program in meeting its goals. The FDA will review these assessments and may require additional elements to achieve the goals of the program.

Key components of the ER/LA opioid analgesics REMS include:

Training for prescribers. Based on an FDA Blueprint, developed with input from stakeholders, educational programs for prescribers of ER/LA opioids 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.

Updated Medication Guide and patient counseling document. 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. 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.

It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013.

There is no mandatory requirement that prescribers take the training and no precondition to prescribing ER/LA opioids to patients. However, the Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 as part of its comprehensive plan to address the epidemic of prescription drug abuse. The program, which would be linked to DEA registration by providers, would require legislative changes that are being pursued by the Administration.

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require companies to develop and implement a REMS when necessary to ensure that the benefits of a drug or biological product outweigh its risks. The new ER/LA opioid analgesic REMS advances the Agency’s goal of improving the safe use of ER/LA opioid analgesics while ensuring continued access to these medications for patients who need them. The new ER/LA opioid analgesics REMS is also part of the national prescription drug abuse plan (PDF - 306KB) announced by the Obama Administration in 2011 to combat prescription drug misuse and abuse.

REMS FAQ (July 9, 2012 version)