Drugs

Could Drug Shortage Data be Improved?

Two University of California, Irvine, researchers are asking whether it is possible to have better, more complete, data on drug shortages at little additional costs. Writing in Health Affairs, the two describe the significant differences they found between the FDA shortage database and the data from the University of Utah’s Drug Information System (UUDIS).

They note that the two organizations track shortages for different purposes and in different ways. Thus, FDA aims to capture market-wide disruptions, while UUDIS is intended to support practicing pharmacists and clinicians.

The article reports that of the 149 drugs on the UUDIS shortage list as of 5/5, only 52 of them (34%) were also on the FDA list. In terms of acute versus non-acute care drug categorization, 69% of those on both the UUDIS and FDA lists were acute care drugs, about 10 percentage points higher than the percent on either the full FDA list or full UUDIS list.

“In an age of electronic ordering systems, social media, big data, and predictive analytics, can we build on existing data sources to create a richer, more complete understanding of current drug shortages?” the authors ask. What if those with a Drug Enforcement Administration number, a National Provider Identifier, or some other prescription-related credential could text or upload to a Web site a report on the difficulty of obtaining a specific drug? While such reporting would be voluntary, it could, assuming enough providers participate, serve as an early warning system, alerting regulators and the public not only to what drugs may be in short supply, but where those bottlenecks may be occurring, that is, in what locations and settings. This is just one of many ways in which we can begin to get a better understanding of where to put our efforts. Without a clear picture of where and when shortages occur, we are severely constrained in determining the causes of shortages. And without understanding the root causes of shortages, a long-term solution to persistent drug shortages seems less likely.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome