{"id":974,"date":"2016-02-17T14:33:26","date_gmt":"2016-02-17T14:33:26","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/?p=974"},"modified":"2017-08-21T11:10:03","modified_gmt":"2017-08-21T11:10:03","slug":"primary-care-corner-with-geoffrey-modest-md-fda-response-to-prescription-opioid-abuse","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2016\/02\/17\/primary-care-corner-with-geoffrey-modest-md-fda-response-to-prescription-opioid-abuse\/","title":{"rendered":"Primary Care Corner with Geoffrey Modest MD: FDA Response to Prescription Opioid Abuse"},"content":{"rendered":"<p><strong>By Dr. Geoffrey Modest<\/strong><\/p>\n<p>The FDA published a &#8220;proactive response to prescription opioid abuse&#8221; in New Engl J Med (see\u00a0<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMsr1601307?jwd=$db.getCUSTOMERID()&amp;jspc=$db.getSPECIALTY()\">http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMsr1601307?jwd=$db.getCUSTOMERID()&amp;jspc=$db.getSPECIALTY()<\/a>. This article reflects the direction they plan to follow:<\/p>\n<p>\u200bBackground:<\/p>\n<ul>\n<li>In the course of one year,\u00a0100 million people in the US suffer from pain; 9-12 million have chronic or persistent pain. All should benefit from pain relief<\/li>\n<li>But, there are\u00a0increasing issues of addiction, diversion, and death (19,000 overdose deaths in 2014)<\/li>\n<li>Around 300 million\u00a0opioid prescription are now written annually in the US<\/li>\n<\/ul>\n<p>Approach:<\/p>\n<ul>\n<li>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&#8217;s need for pain control with the broader public health\/societal issues (this process will take a pretty long time)<\/li>\n<li>The FDA&#8217;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)<\/li>\n<li>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\u00a0Strategy (REMS) requiring them to fund voluntary CME courses around these products. The FDA will also require mandatory provider education<\/li>\n<li>Support the development of abuse-deterrent formulations of opioids, as well as countermeasures (e.g. naloxone, intranasal\u00a0or via auto-injector) and ways to improve their access<\/li>\n<li>Prioritize the development of non-opioid alternatives for pain relief<\/li>\n<li>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\u00a0Pediatric Advisory Committee will address specifics<\/li>\n<li>They acknowledge the elephant in the room: &#8220;the field of chronic pain treatment is strikingly deficient in &#8230;scientific evidence &#8230; to assess the risk and benefits of intended use of medical products&#8221;, and that a key lesson learned by the FDA is the need for continued research. The risks are clear, and there\u00a0are reasonable data on the benefits of non-opioids. But not a lot of data on the long-term benefit of\u00a0opioids themselves<\/li>\n<\/ul>\n<p>For older blogs on chronic pain management and opiates, see\u00a0<a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/category\/pain\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/category\/pain\/<\/a>.\u00a0This 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).<\/p>\n<p>The blog\/critique of\u00a0the CDC recommendations of Dec 2015 (which are being reviewed\u00a0because of lots of negative public feedback &#8212; see:\u00a0<a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/12\/23\/primary-care-corner-with-geoffrey-modest-md-new-cdc-recommendations-for-opiate-prescribing\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/12\/23\/primary-care-corner-with-geoffrey-modest-md-new-cdc-recommendations-for-opiate-prescribing\/<\/a>\u00a0. Though I should add that the FDA noted in the current article that they are &#8220;supporting the CDC&#8217;s Guidelines for Prescribing Opioids for Chronic Pain&#8221;).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Primary Care Corner with Geoffrey Modest MD: FDA Response to Prescription Opioid Abuse [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2016\/02\/17\/primary-care-corner-with-geoffrey-modest-md-fda-response-to-prescription-opioid-abuse\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":148,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14283],"tags":[],"class_list":["post-974","post","type-post","status-publish","format-standard","hentry","category-archive"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/974","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/users\/148"}],"replies":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/comments?post=974"}],"version-history":[{"count":0,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/974\/revisions"}],"wp:attachment":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/media?parent=974"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/categories?post=974"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/tags?post=974"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}