FDA Program for Reducing Unsafe Opioid Prescribing and Adverse Events Fails to Produce Clear Results

It is unclear whether the government’s strategy for reducing unsafe opioid prescribing and adverse events associated with opioids is working, according to a report published today in JAMA Internal Medicine. The findings were based on an analysis of documents obtained from the Food and Drug Administration (FDA).

To reduce risks associated with extended-release/long-acting (ER/LA) opioids, the FDA in 2012 mandated a Risk Evaluation and Mitigation Strategy (REMS) for ER/LA products. The REMS required ER/LA manufacturers to offer continuing education to health care providers on safe prescribing of ER/LA opioids, develop medication guides to inform patients about risks of the medications, and monitor and annually report on prescribing behavior and adverse events, according to the report.

“[T]he ER/LA REMS was intended to be the FDA’s primary tool ‘to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse,’” wrote James Heyward, M.P.H., of Johns Hopkins Bloomberg School of Public Health and colleagues. The researchers analyzed assessments conducted by drug companies participating in the ER/LA REMS program and other relevant documents, obtained from the FDA through a Freedom of Information Act request.

Findings from the analysis include the following:

• The REMS goal was for 60% of ER/LA opioid prescribers to take a REMS-adherent continuing education course between 2012 and 2016. The data revealed 27.6% of prescribers had done so by 2016.
• A review conducted by the FDA following 36 months of the REMS program concluded that data on prescribing behavior—which were derived from national prescription claims databases and prescriber and patient surveys—were inadequate to assess whether the REMS was meeting its goals in reducing inappropriate prescribing. (The FDA discontinued the analysis after 36 months.)
• In reports following 36, 48, and 60 months of the REMS program, the FDA noted it was unable to assess if the REMS program was reducing ER/LA-related adverse events based on the data submitted by the companies because of a lack of studies directly examining the association between participation in REMS training and changes in clinical practice.

“Instead of bold, effective action, the FDA has implemented the Risk Evaluation and Mitigation Strategy programs that, as shown in the article by Heyward and colleagues … do not even meet the limited criteria set out by the FDA,” William K. Hubbard, M.A., a former FDA official, wrote in an editorial. Hubbard described actions the FDA could take to control opioid prescribing, manufacturing, and distribution.

“One intervention that has shown promise in reducing opioid abuse is restriction on prescribing,” he wrote. “Florida, once known for pill mills, has banned pain management clinics from dispensing drugs and established requirements for medical examinations and follow-ups before and after prescribing opioids for chronic pain, resulting in a two-thirds reduction in pain clinics. … As Florida did, the FDA could restrict distribution of prescription opioids.”

For related information, see the Psychiatric News article “Study Finds REMS Program for Fentanyl Formulation Inadequate.”

(Image: BCFC/Shutterstock)

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