December 07, 2011
ASA Comment Letter on Draft Blueprint for Prescriber Education Under Opioid REMS
On December 7, ASA submitted comments to the Food and Drug Administration (FDA) in response to a Federal Register notice seeking input on a draft Blueprint that provides core messages for continuing education (CE) providers as they develop educational materials to train prescribers on long-acting and extended-release opioids (LA/ER). This educational program is required by the class-wide Risk Evaluation and Mitigation Strategy (REMS) for LA/ER opioids, one step in the federal government’s action plan to combat prescription drug abuse. The prescriber education program will be voluntary and should be provided without cost to health care professionals. According to the draft Blueprint, the prescriber education program will include information on why prescriber education on LA/ER opioids is important, assessing patients for treatment, initiating therapy, modifying dosing, and discontinuing use, managing therapy, counseling patients about safe use, and general and specific drug information for LA/ER opioid products. In the comment letter, ASA offered recommendations for revising the Blueprint and reiterated concerns we identified in our June 30, 2009 comment letter to the FDA on REMS for certain opioid drugs.
According to the FDA, REMS is a “risk management plan that FDA can require a drug company to develop and implement to manage serious risks associated with a drug.” Under the Food and Drug Administration Amendments Act of 2007, the FDA may require a manufacturer to develop and implement REMS when the FDA finds it is necessary to ensure that the benefits of a drug outweigh its risks. All REMS include a timetable for submission of assessments of the strategy, and may also include a Medication Guide, communication plan, other elements to assure safe use of the drug, and an implementation system. The REMS for LA/ER opioids, in addition to the voluntary prescriber education program, will include a timetable for submission of assessments, a Medication Guide, and materials that prescribers can use to educate patients.
Read the comments ASA submitted to FDA on the draft Blueprint.
Read FDA’s Federal Register notice and draft Blueprint.