FDA’s Woodcock joins podcast to discuss opioid safety

Opioid Action Plan initiatives include approval of warning label language and Medication Guides, potential addition of IR opioids to REMS program

FDA Center for Drug and Evaluation and Research Director Janet Woodcock, MD, joined the agency’s December 20, 2016, podcast to discuss the agency’s steps to address the opioid epidemic. The efforts, which follow initiatives outlined in the FDA’s February 2016 Opioid Action Plan, include the approval of warning label language and Medication Guides for a range of controlled substances, as well as the potential addition of immediate-release (IR) opioids to the Risk Evaluation Mitigation Strategy (REMS) program.

Previous FDA efforts also targeted prescribers, including a REMS program that required manufacturers of extended-release/long-acting opioids to fund continuing medical education following an FDA-designed “blueprint” of mandatory topics. According to Woodcock, FDA has begun additional conversation about how to add IR opioids to the REMS program and determine related content.

“We are definitely going to expand our blueprint that I referred to earlier—this set of things that [a practitioner] should be trained on—to include pain management. Because for an immediate-release opioid, the question is: Should you write [a prescription for] an opioid or give [the patient] some other kind of treatment or pain management intervention that would perhaps have fewer liabilities?” Woodcock said on the podcast.

“And then we are going to be continuing to work with the stakeholders about the issue of mandatory training, and how can we make sure that all practitioners—be they physicians, nurse practitioners, dentists, etc.,—that all prescribers who prescribe opioids really are armed with the correct tools to understand the uses and liabilities of these drugs and the alternatives to them,” she said.

“This is not an easy intervention to make, and we have heard that many of the professional societies do not feel that a federal mandate is the best option. So we need to think through various ways this could be brought about, and we are working on that.”

The safety labeling changes (SLCs) address the dangers of combining opioids and benzodiazepines, a class of central nervous system (CND) depressant drugs. Combining opioids and benzodiazepines may cause harm to patients including respiratory depression, coma, and death.  Another SLC highlights the risk of neonatal opioid withdrawal syndrome (NOWS) in infants born to women who abuse opioids or who are undergoing medication-assisted treatment (MAT) with the use of methadone and buprenorphine products.

Notably, FDA required many SLCs across all prescription opioid products to include additional information regarding each product’s risks, including an updated indication for IR opioids to clarify that they should be used for pain severe enough for opioid treatment and for which alternative treatment options are inadequate or not tolerated.

As of August 2016, Medication Guides for prescribers were also to be updated to be more patient focused and to place greater emphasis on the potentially life-threatening consequences of taking benzodiazepines and prescription opioid analgesics at the same time. The updated guides will be required to highlight dangers of taking combinations of cough suppressants that contain opioids and benzodiazepines.

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