By Dr. Geoffrey Modest
The FDA published a “proactive response to prescription opioid abuse” in New Engl J Med (see http://www.nejm.org/doi/full/10.1056/NEJMsr1601307?jwd=$db.getCUSTOMERID()&jspc=$db.getSPECIALTY(). This article reflects the direction they plan to follow:
Background:
- In the course of one year, 100 million people in the US suffer from pain; 9-12 million have chronic or persistent pain. All should benefit from pain relief
- But, there are increasing issues of addiction, diversion, and death (19,000 overdose deaths in 2014)
- Around 300 million opioid prescription are now written annually in the US
Approach:
- They asked the National Academy of Medicine (NAM, used to be the Institute of Medicine) to help develop a regulatory framework for opioid review, approval, and monitoring, one which balances the individual’s need for pain control with the broader public health/societal issues (this process will take a pretty long time)
- The FDA’s Science Board will meet in March to discuss the role of meds in pain management, development of alternative pain meds, and post-marketing surveillance (as a means to address the more immediate concerns)
- Special focus will be on extended-release or long-acting opioids, including extensive post-marketing research (11 mandated studies) around safety concerns. Also manufacturers of these long-acting preparations will be subject to a Risk Evaluation and Mitigation Strategy (REMS) requiring them to fund voluntary CME courses around these products. The FDA will also require mandatory provider education
- Support the development of abuse-deterrent formulations of opioids, as well as countermeasures (e.g. naloxone, intranasal or via auto-injector) and ways to improve their access
- Prioritize the development of non-opioid alternatives for pain relief
- For children, focus on making sure that evidence-based medicine is used to identify appropriate indications and dosing, with a focus on safe and effective opioid prescribing, and reduce use for inappropriate indications. The Pediatric Advisory Committee will address specifics
- They acknowledge the elephant in the room: “the field of chronic pain treatment is strikingly deficient in …scientific evidence … to assess the risk and benefits of intended use of medical products”, and that a key lesson learned by the FDA is the need for continued research. The risks are clear, and there are reasonable data on the benefits of non-opioids. But not a lot of data on the long-term benefit of opioids themselves
For older blogs on chronic pain management and opiates, see https://stg-blogs.bmj.com/bmjebmspotlight/category/pain/. This includes a rather striking blog on the use of appropriate provider-prescribed opiates in kids (e.g., post-surgery) and their subsequent opioid misuse (these were kids who had a low pretest probability of doing so).
The blog/critique of the CDC recommendations of Dec 2015 (which are being reviewed because of lots of negative public feedback — see: https://stg-blogs.bmj.com/bmjebmspotlight/2015/12/23/primary-care-corner-with-geoffrey-modest-md-new-cdc-recommendations-for-opiate-prescribing/ . Though I should add that the FDA noted in the current article that they are “supporting the CDC’s Guidelines for Prescribing Opioids for Chronic Pain”).