FDA Workshop To Discuss Uniform Prescriber Education Requirements for Opioids

Federal drug regulators are considering a mandatory education program for doctors dispensing opioids, to make all prescriptions for the powerful and addictive pain killers uniform across the country.

A public workshop will be held by the U.S. Food and Drug Administration (FDA) on October 13-14, to reconsider mandatory prescriber education for opioids, according to an agency brief issued September 8.

The workshop and proposed program come amid an ever-worsening opioid abuse epidemic in the United States, and is intended to outline a prescriber education program that would be establish a uniform set of guidelines for safe and appropriate use of the medications, as well as guidelines regarding misuse and abuse.

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A number of studies have indicated the opioid epidemic and increasing overdose deaths in recent decades has been largely driven by doctor overprescribing and offered kickbacks by drug companies.

The number of dispensed opioid prescriptions has decreased since 2012, from 84 per 100 residents then, to 43 per 100 residents by 2020. However, despite those decreases, opioid-involved deaths have continued to climb, largely driven by overdoses, especially among those combining opioids with other drugs like cocaine, methamphetamine and benzodiazepines.

An estimated 70% of all drug overdose deaths in the United States now involved opioids.

Opioid deaths have also significantly been driven by overdose deaths involving illicit heroin and fentanyl. However, users of these substances are generally first exposed to opioids through use of prescription painkillers, experts say.

As of 2020, prescription opioids were involved in 16,000 fatal overdoses per year. This is more than seen at the peak of opioid dispensing in 2012.

Some public and private entities independently implemented prescriber education programs and interventions for safe opioid prescribing as abuse and overdoses began to increase, but there is no consistent program for all prescribers.

“The opioid crisis continues to evolve and there are still relevant concerns with overprescribing, especially among vulnerable populations,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Although many public and private entities have independently implemented their own education programs and other interventions to encourage safe and effective prescribing practices for opioid analgesics, there is no consistent education that all prescribers are required to take about the safe use of opioid medicines. Therefore, these programs likely differ with regard to content, focus and duration.”

Topics for discussion at the workshop will include the need for mandatory opioid prescriber education and the value of a single source for education on the appropriate use of opioids, risks, and treatment for opioid use disorder and abuse.

Opioid REMS Program Under Consideration

The agency indicates the public workshop is the first of series of discussions focusing on mandatory opioid prescriber education. The FDA is considering the need for mandatory opioid prescriber education through the Opioid Analgesic (OA) Risk Evaluation and Mitigation strategy (REMS).

REMS is an FDA program typically reserved for monitoring medication with a high potential for serious adverse effects, or those such as opioids, carry a high risk of abuse or misuse. REMS programs usually require doctors go through an educational program before they are allowed to prescribe that particular drug.

The FDA usually decides to place a drug in the REMS program when it is first approved by the FDA or new adverse side effects are reported. However, in some cases, REMS programs are required after a drug is already on the market due to post-marketing surveillance showing it to carry an unexpected risk.

The two-day public workshop will be held October 13 and 14. A second public workshop is also being planned for the future. Details on how to attend or provide input to the workshop is available in the Federal Register notice.

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