On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also […]
Day Two of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) was lively and full of debate and conversation. The day started out with comments from the FDA, followed by presentations by Joanna G. Katzman, MD, MSPH, of the […]
For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act of 2007 which requires REMS (Risk Evaluation and Mitigation Strategy) from drug and biologics manufacturers for products to ensure that any serious risks are outweighed by its benefits. REMS requirements can impose special […]
The Food and Drug Administration (FDA) held a meeting on July 25th and 26th, 2013, to discuss Risk Evaluation and Mitigation Strategies (REMS). The FDA posted information about the meeting, including FDA slide presentation, agenda, and further reading. We have covered this topic on many occasions. As part of the reauthorization of the Prescription Drug […]
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This is the first time that the FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future […]
The Food and Drug Administration (FDA) released a “Blueprint for Prescriber Continuing Education Program” regarding the use of opioids. The draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended release opioids under the required risk evaluation and mitigation strategy (REMS) for these […]
During last month’s Joint Meeting of the Anesthetic and Life Drugs Advisory Committee (ALSDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM), the Accreditation Council for Pharmacy Education (ACPE) delivered comments regarding Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. The presentation, which was delivered by ACPE Executive Director Peter […]