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FDA, AAPM Open Talks on Evidence-Based Opioid Prescribing

April 13, 2018
Administrative tone regarding opioid use for chronic pain management takes a turn. Plus: A call to increase the number of naloxone carriers.
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In a follow-up statement to an announcement by FDA Commissioner Scott Gottlieb, MD, the American Academy of Pain Medicine (AAPM) has issued its support for the development of evidence-based opioid prescribing guidelines.

The federal agency’s announcement seemed to mark a shift in approach from the 2017 declared opioid public health emergency and the administration’s “avoid opioids at all costs” mentality, not to mention its alleged temporary retreat from “evidence-based” medicine.

In his statement, titled "In Search of More Rational  Prescribing," Commissioner Gottlieb indirectly acknowledged legacy patients who have successfully and safely managed chronic pain with opioids for years: “We’re now faced with the urgent need to craft policies that rationalize prescribing, and set a new and more appropriate medical standard for the use of opioids. At the same time, we will take heed that the drugs work, and there will be patients who need these medicines; for example, for the management of severe pain. In some medical circumstances opioids are the only drugs that work for some patients, such as those with metastatic cancer,” he said.

The 2016 CDC guidelines on opioid prescribing, which have been criticized for their lack of scientific research and which have spun the chronic pain management community and its patients into a tumultuous environment, were oddly not mentioned in the statement (CDC researchers admitted over-reporting prescribed opioid-related deaths in a recent editorial). Regardless, AAPM has jumped at the opportunity to have a role in drafting the agency’s future opioid guidelines, stating: "We stand at the ready to participate in the development of these guidelines for common procedures that could then be incorporated into drug labeling, including the need to safely control patients’ post-operative pain, with time-limited opioid medications when necessary, while at the same time limiting any over-prescribing of opioid medications.” The academy also reiterated its primary mission toward patient care through a multidisciplinary approach.

Dr. Gottlieb did provide some insight into FDA’s potential strategies for addressing opioid prescribing challenges, noting the agency will continue to reduce overall exposure to opioids while still preserving access for those patients who will benefit. Over-prescribing and patient diversion were noted as potential areas to tackle, as well as the assessment of analgesic use in both primary care and surgical settings. In fact, the commissioner came down hard particularly on post-operative prescribing, noting that in FDA’s modeling, most patients undergoing common procedures only required one day’s dose of opioids. The agency will, therefore, expand its risk-management plans, he said, to include, “for the first time, all opioid analgesics that are intended for use in the outpatient setting, including the immediate-release, or IR drugs.”

The commissioner further noted FDA’srevised Blueprint for Health Care Provider Education, which focuses on provider education regarding pain management and opioid prescribing. “We require that the manufacturers make this training available to prescribers,” he stated, suggesting that such training be tied to prescribers’ DEA registration and renewal. 

“This way,” he said, “all providers who train on the appropriate prescribing of opioids would also be trained on how to diagnose and treat opioid use disorder.” The commissioner also placed more attention on the treatment of opioid use disorder, which is often confused with physical dependence , and options for treatment. In fact, a few days after the commissioner’s statement, the US Surgeon General issued a separate advisory recommending that patients currently taking high doses of prescribed opioids as well as other members of the medical community and general public carry naloxone, the opioid overdose rescue medication, as a preventative measure. 

AAPM issued a secondary statement in support of the Surgeon General’s call to action  “AAPM strongly supports easy and widespread access to naloxone as an important tool for reversing potentially fatal opioid overdoses as part of the comprehensive response to the opioid epidemic,” says AAPM President Steven P. Stanos, DO. “The Academy looks forward to working with the Surgeon General’s Office to further raise awareness, education, and support related to the use of naloxone.” See a followup Q&A with Dr. Stanos on this subject.

Update: On April 20, 2018, Commissioner Gottlieb encouraged "more widespread innovation and development of medication for use in medication-assisted treatments" for OUD. He announced the issuance of a related draft guidance for industry: Opioid Dependence: Developing Buprenorphine Depot Products for Treatment, which outlines the agency's current thinking about drug development and trial design issues relevant to the study of sustained-release “depot” buprenorphine products (eg, modified-release products for injection or implantation). 

Last updated on: June 13, 2018
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