FDA Teams With NASEM on New Opioid Guidelines
The US Food and Drug Administration (FDA) on Wednesday announced it 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.FDA Commissioner Scott Gottlieb said NASEM will conduct a study and issue a report on its findings, beginning with an identification and prioritization of “procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices.”
Gottlieb said in a statement: “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.”
As part of its contract, NASEM also will scan existing opioid analgesic prescribing guidelines, examine how they were developed and identify any gaps in those guidelines, as well as outline the research needed to generate evidence.
Gottlieb noted that the guidelines would be distinct from corresponding work by the Centers for Disease Control and Prevention because it would be indication-specific and would be based on evidence drawn from evaluations of clinical practice and the treatment of pain.
In addition, NASEM will hold a series of meetings and public workshops to engage a range of stakeholders who can contribute on existing guidelines and on emerging evidence or specific policy issues related to the development and availability of opioid analgesic prescribing guidelines.
The announcement of the contract follows last week’s move by the Department of Justice and Drug Enforcement Administration to reduce the manufacturing of opioids for those frequently misused.