Sunday, October 24, 2021

Why health workers shouldn’t know about looming drug shortages

As a result of her agency’s recent recommendations, many federal employees could be at greater risk of their work getting affected by severe drug shortages.

A review of thousands of pages of documents shows that the Department of Health and Human Services’ National Institute of Occupational Safety and Health conducted a rigorous investigation into the adequacy of government drug supply and didn’t find sufficient options.

In a January memo, the NIEHS director Carol D. Albin, Ph.D., stated that the safety agency “is unsure how an announcement of impending shortages would affect employee work being done, if shortages were to occur.”

Yet, when a letter went out announcing that Pfizer had notified the Food and Drug Administration (FDA) that a single shortage existed for critical drugs used in heart attack and bypass surgeries and pediatric cancer treatment, Dr. Carolyn Clancy, M.D., the HHS’ director of the Centers for Disease Control and Prevention, overruled the safety agency’s experts and recommended FDA officials get Pfizer to let some employees know about the shortages of three drugs – anesthetics for surgery, an antibiotic for pneumonia and a blood pressure medication.

Related Image Expand / Contract Federal employees could be at greater risk of their work getting affected by severe drug shortages. (cnsnews.com)

The DHS experts wrote: “Should a total shortage of anesthetics emerge, the [insurance] safety officers who advise the [FDA] on the types of medications it requests to have available or provide off-label instructions for use to its employees would most likely need to change the language used in those communications if the [insurance safety officers] want to ensure that the physician who is prescribing anesthetics is adequately informed.”

Albin previously stated that the staff could be in a situation where they could be exposed to substandard drug batches in instances of extreme shortages.

Some agencies would just swap out or dilute generic, inexpensive drugs in favor of expensive ones as a way to resolve shortages, but even though the FDA doesn’t purchase generic drugs, its employees could be at greater risk since it oversees several drug manufacturers.

A DHS spokesperson said a review of DHS personnel and workload levels had been completed but it was “uncomfortable with the fact that any member of the DHS workforce could face shortages.” He added, “we had not identified which HHS employees would be directly impacted by the shortage but we want to maintain the integrity of the medical safety of our employees and so we advised the FDA that due to the proximity of the DHS employees to patients, the HHS would not promote or suggest that they change the type of communications they use.”

A Pfizer spokesperson sent the following statement on the DHS’ recommendation and its impact on employees:

“Pfizer was surprised by the views expressed by the DHHS in the [FDA] FIP [Fact Sheet] case. We have voluntarily committed to fulfilling the FDA’s request and working with [insurance safety officers] at HHS and FDA on these shortages for a full six months, instead of the two weeks they were initially notified of. We are working in tandem with the FDA to ensure that all members of the workforce receive product. We consider it a privilege to work with DHS and CDC.”

Daniel Drezner is a professor of international affairs at Tufts University.

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