By Pat Anson, Editor

An anti-opioid activist group has sent an “Urgent Action Request” to it members, asking them to oppose plans by the Food and Drug Administration to give new guidance to health care providers about prescribing opioid pain medication.

The initial draft of the guideline for Prescriber Education for Extended-Release and Long-Acting Opioids Risk Evaluation and Mitigation Strategies – more simply known as REMS -- warns prescribers at length about the risk of overdose, addiction and the “epidemic of prescription opioid drug abuse.” But Physicians for Responsible Opioid Prescribing (PROP) doesn’t think the draft goes far enough.

“The current draft is seriously flawed,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in an email to supporters urging them to leave a comment in the Federal Register before the public comment period on the REMS guideline ends on Monday, July 10.

“Please post a comment about the draft on the FDA federal docket. FDA is required to review the comments and tally them. If FDA receives enough critical comments, there is a good chance they'll improve the document.” 

Kolodny’s email provides a “sample comment” for PROP members to use, urging the FDA to adopt an upper dose limit on opioids, mention the “lack of evidence supporting long-term opioid use” and provide a list of pain conditions for which opioids are “inappropriate” – such as fibromyalgia and chronic headache.

Until now, the REMS draft guideline – an update to a similar guideline released in 2012 – has drawn little public attention. Less than 300 comments have been made in the Federal Register, most of them focused on whether acupuncture and chiropractic care should be included as alternative treatments to opioids. 

The 10-page guideline warns doctors repeatedly about using caution when prescribing opioids, but it stops short of setting an artificial ceiling on doses, such as those recommended last year by the Centers for Disease Control and Prevention and an even tougher guideline recently adopted by the Departments of Veterans Affairs and Defense (VA/DOD).

“We believe the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline,” wrote Kolodny and other PROP board members in a letter to FDA commissioner Scott Gottlieb, MD. “The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.”

“I don't agree that the new blueprint is inconsistent with recommendations from other government agencies. For one thing, there is a specific statement in the blueprint that HCPs (health care providers) should know about the CDC guideline and other guidelines regarding safe opioid prescribing,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of pain management providers.

“Let me also point out that PROP's call for inclusion of ‘an upper dose limit consistent with recommendations from other federal agencies’ perpetuates the myth that the CDC guideline contains such an upper dose limit. CDC was very clear when it issued the guideline that it should be considered to contain recommendations, not limits.”

The REMS guideline not only does not endorse a specific limit on opioids, it recommends that “a comprehensive treatment plan should be developed and customized to the needs of the individual patient.”  The focus on individualized patient care is something else that PROP takes issue with.

“Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS,” wrote Kolodny his his letter. “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

But opioids are being prescribed more cautiously and have been since 2010, as we learned from a new CDC study. Yet the nation’s opioid crisis continues to worsen, fueled by heroin, illicit fentanyl, counterfeit painkillers, and failed strategies to control the crisis by denying many pain patients their only form of treatment.   

To see the FDA’s draft REMS guideline, click here. To leave your own comment on the Federal Register, click here.