View Entire Collection
By Clinical Topic
Diabetes – Summer 2012
Future of Nursing Initiative
Heart Failure - Fall 2011
Influenza - Winter 2011
Nursing Ethics - Fall 2011
Trauma - Fall 2010
Traumatic Brain Injury - Fall 2010
Fluids & Electrolytes
MONDAY, July 26 (HealthDay News) -- On July 23, two U.S. Food and Drug Administration advisory panels voted against the FDA's plan for reducing abuse of long-acting and extended-release opioid drugs.
In February, the FDA issued a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid drugs in an attempt to rein in the growing misuse and abuse of the drugs by educating physicians and patients about associated risks. Extended-release and long-acting opioids pose an increased risk of serious adverse events compared with shorter-acting formulations due to their formulations and chemical properties.
However, during the joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, committee members voted 25 to 10 against the FDA's proposal. John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said at a news conference that the members who voted no believe a REMS is needed but that the FDA's proposal did not go far enough. Specifically, he said those who voted no wanted the training for prescribing physicians to be mandatory, not voluntary. He noted that the magnitude of such a training program would be extremely large.
"There are concerns about the burden that would place on the health care system. Because of the size of the program, there were concerns that some prescribers might choose to opt out of the program, and that might impact on patients' access to care for relief of their pain," Jenkins added.
Sign up for our free enewsletters to stay up-to-date in your area of practice - or take a look at an archive of prior issues
Join our CESaver program to earn up to 100 contact hours for only $34.95
Explore a world of online resources
Back to Top