Drug Shortages an 'Urgent Public Health Crisis'

Marcia Frellick

June 12, 2018

CHICAGO — Drug shortages, including those compounded by last year's hurricanes, are an "urgent public health crisis," according to a report prepared by the American Medical Association (AMA) Council on Science and Public Health.

On Monday, the AMA House of Delegates adopted the final report here at the AMA 2018 Annual Meeting.

The report urges the US Food and Drug Administration (FDA) to require drug makers to be more transparent in disclosing where drugs are produced and to better communicate causes of shortages and the expected duration.

It also urges the Department of Homeland Security and the Department of Health and Human Services to consider drug shortages a matter of national security and to treat drug-production sites as part of the critical infrastructure plan.

That plan includes systems and assets that are "so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety, or any combination of those matters."

The report asks that the AMA push the FDA or Congress to require drug makers to have a strategy to avert shortages and to have a contingency plan to provide an uninterrupted supply of life-sustaining medications and vaccines.

"This plan should include establishing the necessary resiliency and redundancy in manufacturing capability to minimize disruptions of supplies in foreseeable circumstances, including the possibility of a disaster affecting a plan," the report states.

The recommendations received wide support in a committee hearing on Sunday.

Jenni Bartlotti Telesz, MD, testified on behalf of the American Society of Anesthesiologists. She pointed out that a recent survey conducted by the society found that "98% of our members are currently experiencing drug shortages and 95% are currently having to modify patient care because of those shortages."

Society members described shortages affecting epidurals for labor and pre- and postoperative care and causing surgery cancellations. In addition, some clinicians reported having to switch to older drugs with significant adverse effects, which can be a threat to patient safety because of their lack of experience with these drugs, Telesz explained.

Nancy Crum-Cianflone, MD, an alternate delegate speaking on behalf of the Infectious Disease Society of America, pointed out, in the reference committee hearing, that fluid shortages are also a threat to care.

Fluid shortages have limited the use of several intravenous medications, including antibiotics, in the past year, and that has changed antibiotic choices, she told Medscape Medical News.

"Without adequate availability of IV saline fluids, we were limited in our ability, in many cases, to administer narrow-spectrum, preferred antibiotics," she said. "This has led to the downstream effects of undermining antibiotic stewardship efforts."

Last fall, supplies of saline fluids were devastated by Hurricane Maria's assault on Puerto Rico, the primary manufacturing location for small-volume parenteral solution products, such as saline bags.

Up-to-date lists of drug shortages can be found on the FDA website and the website of the American Society of Health-System Pharmacists.

Crum-Cianflone and Bartlotti Telesz have disclosed no relevant financial relationships.

American Medical Association (AMA) 2018 Annual Meeting. Presented June 10, 2018.

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