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 areport published today inJAMA 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 assessment s 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 ...
Source: Psychiatr News - Category: Psychiatry Tags: distribution Food and Drug Administration JAMA Internal Medicine James Heyward opioids REMS Risk Evaluation and Mitigation Strategy William Hubbard Source Type: research