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FDA Redirects Opioid Efforts toward Patients in Need, Provider Education

July 9, 2018
While still working to protect the public from misuse and abuse of opioids, the agency is now also paying more attention to those in need of medication for chronic pain.

As pressure and questions mount regarding how to safely care for patients living with chronic pain, FDA Commissioner Scott Gottlieb, MD, released a statement on balancing access to opioids for those patients in need with the agency’s efforts to prevent misuse and abuse of opioids.

 “While we work to ensure appropriate and rational prescribing of opioids, we won’t lose sight of the needs of Americans living with serious chronic pain or coping with pain at the end of life,” he said in the statement , marking another shift in the agency’s opioid messaging, which has been slowly pivoting over the past year.

The statement came as the agency held another Patient-Focused Drug Development meeting as part of its efforts to gather perspectives from both adult and pediatric patients living with chronic pain (read about the program here ). “We want to better understand the challenges or barriers patients face accessing various treatments for pain,” said Dr. Gottlieb.

While reinforcing the 2016 CDC guidelines on prescribing opioids and the agency line that “opioids should only be used for the treatment of acute pain and prescribed for short durations of time,” Dr. Gottlieb added that the FDA is aware of certain circumstances where opioids may be administered over longer periods, specifically calling out metastatic cancer pain and, perhaps surprisingly, episodic migraine pain. “In select patients and for certain medical conditions, opioids may be the only drugs that provide relief from devastating pain,” he said, echoing the voices of chronic pain patients—and their practitioners—who have been stating this repeatedly since the issuance of the CDC guidelines. 

Noting that the agency has now heard the concerns of these patients, including their fear of being stigmatized, their difficulty in finding physicians willing to help treat their pain, and their loss of quality of life, Dr. Gottlieb deemed the situation “unacceptable.” Confirming that “patients in pain deserve thoughtful, careful and tailored approaches to the treatment of their medical conditions,” he recapped the steps being taken by the FDA to help ensure appropriate, evidence-based care for patients with pain. While the agency’s definition of “evidence-based”  may warrant further discussion among the clinical research and practice community, Dr. Gottlieb pointed to these ongoing efforts:

  • Implementation across the healthcare profession of the agency’s revised blueprint for the treatment and monitoring of patients with pain. This document, released in January 2018, addresses the core training that opioid drug manufacturers are required to make available to prescribers, including for acute as well as chronic pain, pharmacological and alternative therapies, addiction, and opioid use disorders. “For the first time, we’re requiring training to be offered on non-opioid alternatives for the treatment of pain, and extending this educational material to other health care professionals who participate in the treatment and monitoring of pain, such as pharmacists and nurses, in addition to prescribers,” explained Dr. Gottlieb.
  • Use of the blueprint in combination with the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy, which was revised in February 2018 to include immediate release products.
  • The encouragement of medical professional societies to collaborate on the development of evidence-based guidelines for appropriate prescribing of opioids for different medical indications.
  • The development of novel medical devices, including digital health and diagnostics, aimed at pain management. 

Overall, the agency’s evolving approach to opioid prescribing emphasizes a revamping of pain management education among healthcare practitioners, including widening the breadth of training to include all providers involved in treating pain. “Many say that we find ourselves in the situation we’re in today, facing an epidemic of addiction because as providers, we didn’t sufficiently inform ourselves as a profession in the study and treatment of pain,” said Dr. Gottlieb. At the same time, patient perspectives seem to be making more effective inroads to the agency’s decision-making.

Where these efforts end up in terms of changes to prescribing guidelines remains to be seen.


Last updated on: July 9, 2018
Continue Reading:
FDA, AAPM Open Talks on Evidence-Based Opioid Prescribing
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