On August 22, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics.
Gottlieb noted that analysis done by the FDA show that the first prescription for many common, acute indications could often be for fewer pills, such as just a day or two of medication rather than a 30-day supply. In some cases, the excess pills that aren’t used by patients may wind up in illicit markets or may be 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.
Dr. Gottlieb went on to note that the FDA wants to reduce the likelihood of misuse and abuse of drugs while ensuring the needs of patients are continuing to be met. Gottlieb believes that one of the ways the FDA and medical professional societies can be good stewards of public health is by developing a framework that can assist them in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed.
In the statement, Gottlieb announces that the FDA 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 aim of work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid prescribing are sufficient.
NASEM will scan the landscape of existing opioid analgesic prescribing guidelines, examine how they were developed and look for any potential gaps in evidence for those guidelines, as well as outline the research needed to generate that evidence. Additionally, NASEM is expected to 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.
Gottlieb also stated that the FDA is continuing 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’s revised Blueprint 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.
The hope of the FDA is that these evidence-based guidelines can help decrease unnecessary and/or inappropriate exposure to opioids and the rate of new addiction, while ensuring that patients with a true clinical need are getting thoughtful, careful, and tailored approaches to treatment.