The Food and Drug Administration intends to update its Risk Evaluation and Mitigation Strategy requirements for extended-release and long-acting opioid analgesics, and extend the same requirements to immediate-release opioid analgesic products, FDA Commissioner Scott Gottlieb, M.D., announced this week. The existing REMS requires companies that manufacture extended-release and long-acting opioid analgesics to make education programs available to prescribers and patients. According to Gottlieb, the new REMS will modify the prescriber education blueprint to include more information on pain management, safe use of opioid analgesics, addiction medicine and opioid use disorders. The REMS also will require manufacturers to make training available to more than physician prescribers, such as nurses and pharmacists involved in pain management. In addition, he said the agency is exploring whether provider education should be mandatory. According to FDA, about 90% of opioid prescriptions in the U.S. are for immediate-release formulations.

Related News Articles

Headline
The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response will provide $23 million for Merck to produce…
Headline
The Food and Drug Administration yesterday approved a new antibiotic to treat adults with community-acquired bacterial pneumonia.
Headline
The number of U.S. hospitals with an antibiotic stewardship program that meets all core elements recommended by the Centers for Disease Control and Prevention…
Headline
The Centers for Medicare…
Headline
Beginning with open enrollment for plan year 2020, the Centers for Medicare…
Headline
Currently available public hospital quality rating systems frequently offer conflicting results, which may mislead stakeholders relying on the ratings to…