Intensity, duration of drug shortages are spiking, FDA says

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The FDA is not only seeing an increased incidence of drug shortages,  there's also been a jump in the intensity and duration of the shortages, according to Regulatory Focus.

Matthew Rosenberg, a senior operations research analyst at the FDA, discovered the trend after analyzing FDA archives and IQVIA national sales databases to better understand drug shortages in terms of occurrence, duration, intensity and potential health effect. He presented the results at an FDA and Duke Margolis Center for Health Policy event Nov. 27.

Mr. Rosenberg found that shortages have become more prevalent in the last year, there are more persistent shortages than ever before, and the intensity of drug shortages has spiked as more than two-thirds of historical volumes have been unavailable.

At the presentation, Mr. Rosenberg highlighted that some active drug shortages have lasted more than eight years, including liotrix tablets, multivitamin infusions and leucovorin calcium powder for injection.

"These examples really underscore the challenges of anticipating and coping with long-lasting drug shortages," Mr. Rosenberg said.

The FDA said it remains committed to helping reduce drug shortages but it can’t require a company to disclose why a shortage occurs, make a drug or produce higher volumes of the drug.

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