With millions of Americans misusing and abusing opioids and more than 40 people dying every day from overdoses involving prescription opioids, it’s clear that we need to do everything we can, including working with stakeholders, to get ahead of this crisis.
Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids. And too many prescriptions are written for longer durations of use than are appropriate for the medical need being addressed.
Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills – maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed. In some cases, the excess pills that aren’t used by patients may end up being diverted to illicit markets or misused or abused by friends or family members.
In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse and addiction. This presents a difficult challenge both for the U.S. Food and Drug Administration and for health care providers.
FDA has awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner.
As part of this work, NASEM will also scan the landscape of existing opioid analgesic prescribing guidelines, examine how they were developed and any potential gaps in evidence for those guidelines, as well as outline the research needed to generate that evidence. Additionally, NASEM will hold a series of meetings and public workshops to engage a broad range of stakeholders who can contribute expert knowledge on existing guidelines and on emerging evidence or specific policy issues related to the development and availability of opioid analgesic prescribing guidelines based on their specialties.
The guidelines generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific, and would be based on prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain. Our work could potentially inform drug labelling. These two efforts are highly complementary and serve adjacent goals.
The FDA also continues important work to educate prescribers on appropriate prescribing practices through the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). The REMS requires opioid analgesic manufacturers to make training available to health care providers. In order to comply, this training will use the FDA “Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain”) that provides information on acute and chronic pain management, safe use of opioid analgesics or other non-opioid or non-drug treatments, as well as material on addiction medicine and opioid use disorders. Once finalized later this year, the REMS will, for the first time, apply to drug companies with approved immediate-release opioid analgesics intended for use in an outpatient setting, in addition to the extended release and long-acting formulations of these drugs that have been subject to a REMS since 2012.
