FDA Public Meeting on Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics

In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers. Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training. On May 9th and 10th, 2017, the Food and Drug Administration held a public meeting, discussing how to train health care providers on pain management and the safe use of opioid analgesics. This meeting follows a May 2016 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the risk evaluation and mitigation strategy (REMS) for ER and LA opioids would reach intended goals. In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016, seeking comments on the most promising approaches in prescriber education/training programs and effective ways to leverage HHS programs to implement/expand them. The FDA Education Bluepr...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs