FDA Panel: Physician Opioid Training Should Be Mandatory
Written by Editor   
Friday, June 03, 2016 12:00 AM

Physician training on the risks of prescription opioids should be mandatory, a US Food and Drug Administration (FDA) advisory panel concludes. The FDA’s Drug Safety and Risk Management Advisory Committee and its Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted to modify the extended-release (ER) and long-acting (LA) formulations opioid analgesic Risk Evaluation and Mitigation Strategies (REMS).

In addition to most panel members recommending that the training be mandatory and include IR drugs, some suggested that it also focus on pain management rather than on opioids, be tied to the recently released Centers for Disease Control and Prevention (CDC) guidelines, and involve mental health and suicide screening.

At the meeting, the joint committee discussed results of assessments of ER/LA REMS. A central component of the ER/LA opioid analgesics REMS is an education program for prescribers, including physicians. It requires that opioid manufacturers make available education programs to prescribers.  Applicant holders provide education grants to accredited continuing education (CE) providers who offer training to prescribers at no or nominal cost. One of the requirements of this training is that it include all elements of the FDA Blueprint for Prescriber Education for ER/LA opioids.

This blueprint includes information on proper patient selection for opioid use, guidance on safely initiating therapy, modifying dosing, discontinuing use, monitoring patients, and counseling patients and caregivers about safe use of these drugs. Prescribers also get information on how to recognize misuse, abuse, and addiction.

From background information provided by the FDA, deaths from prescription opioid overdoses have been increasing since 2001. In 2014, the number was in excess of 18,000. The estimated number of IR opioid prescriptions in the United States was 130.9 million in 2005 and peaked at about 184.1 million in 2011–2011 before dropping to 166.4 million in 2014. For ER/LA opioids, the number was 17.0 million in 2005, rising to 22.3 million in 2010 and slipping slightly to 21.2 million in 2014.

Source:  http://www.medscape.com/viewarticle/862968