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FDA to Re-Examine Rational Opioid Prescribing, Starting with Acute Pain

August 24, 2018
Commissioner Gottlieb speaks to the agency’s latest efforts in developing evidence-based, indication-specific guidelines.

The US Food and Drug Administration continues to seek ways to curb the opioid epidemic—with the agency's latest efforts turned toward preventing diversion, misuse, or abuse at the acute level.

“Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication,” said FDA Commissioner Scott Gotlieb, MD, in an August 22, 2018 statement. “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,” he said.

According to Dr. Gottlieb, the agency’s analysis of prescriptions for acute indications demonstrates that prescribers are typically writing scripts for a 30-day supply—rather than the recommended 1- to 2-day supply—which can widen the door to unused pills being diverted, misused, or abused.

As the agency still wishes to ensure that the medical needs of chronic pain patients are being met,  Dr. Gottlieb said that FDA is, therefore, re-examining how opioid analgesics are being prescribed for acute pain. Part of this effort involves the development of comprehensive, evidence-based guidance that addresses appropriate prescribing for specific medical conditions and common surgical procedures for which acute medications are prescribed. “Ultimately, our public health goal is to support more rational prescribing practices,” he said.

Part of the plan includes a new contract with the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of such guidelines. The contract is independent of but complementary to the academy’s recent Action Collaborative on Countering the US Opioid Epidemic. NASEM will conduct a consensus study and issue a report on its findings, starting with the “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,” Dr. Gottlieb described.

The Commissioner made a point in his statement of acknowledging the CDC’s work on pain management and prescribing guidelines, noting that the agency’s newly announced efforts will build on that work by generating “evidence-based guidelines” where needed (an area that has been harshly judged by the practicing medical community), including for “indication-specific” conditions.

Dr. Gottlieb further pointed to recent FDA actions on opioid prescribing, including its the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) and revised Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain. Expected to be finalized by the end of 2018, 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,” said Dr. Gottlieb.

Overall, he noted, “Our hope is that these evidence-based guidelines can help decrease unnecessary and/or inappropriate exposure to opioids and the rate of new addiction, while importantly ensuring that patients with a true clinical need are getting thoughtful, careful, and tailored approaches to treatment.”

Last updated on: August 24, 2018
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