COMMENTARY

Antimicrobial Shortages? There's an App for That

Paul G. Auwaerter, MD

Disclosures

May 26, 2015

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This is Paul Auwaerter, speaking for Medscape Infectious Diseases about drug shortages, an all-too-common topic nowadays. For those who need anti-infectives, this is not an unusual situation.

I recently encountered this problem with a patient who had Stenotrophomonas maltophilia pulmonary infection. We see this organism infrequently, but when we do, we rely on certain drugs, one of which is ticarcillin/clavulanic acid, an injectable antibiotic.

We discussed using this drug but found out that, even though it is in our formulary, the drug is not currently available. I assumed that the lack of availability was caused by a drug shortage, but I went to the US Food and Drug Administration (FDA) webpage and found that the drug has been discontinued by its manufacturer, GlaxoSmithKline, for unclear reasons. This drug seems to be no longer available in the US marketplace.

This problem is not uncommon, and the FDA has a sortable website as well as an app for that.[1] This is 21st-century infectious diseases. You can access the FDA Drug Shortages app through the iPhone store, or the Google Play store on Android devices. It is sortable and easy to use. Contents include current drug shortages, resolved drug shortages, and discontinuations. I perused this today and found seven anti-infective drug shortages and nine discontinuations. I also found links to helpful information—provider letters, especially for discontinuations; planned availabilities—and to links highlighting the lack of information [for a particular drug]. Compared with 20 or 30 years ago, drug shortages seem to be a very common problem today.

Two Studies Illustrate the Growing Problem

Two studies have looked into this recently. Quadri and colleagues[2] reviewed antibacterial shortages from 2001 to 2013 and found a real uptick, especially in the past 8 years or so, with an average of 10 antibacterial drug shortages per year; 22% of antibacterials had multiple drug shortage periods.

McLaughlin and colleagues[3] looked at shortages of all anti-infectives at a large Midwestern hospital during a 1-year period, from 2011 to 2012. They found 47 shortages, which they called "transient"; generic-only anti-infectives comprised 53% of shortages, and brand name–only drugs comprised 21%. The mean shortage lasted more than 40 days. The reasons included product discontinuation; deficiencies in manufacturing capabilities, including increased demand; and shortfalls in raw materials. Ten shortages in this hospital actually prompted changes in recommendations from the hospital's antibiotic stewardship team.

This small snapshot certainly tells me that it is harder than ever to try to keep up. The reasons for these shortages are quite complex, but with the rather dramatic rise in drug prices on many fronts, both for generics and brand-name drugs, I am surprised at the increasing frequency of shortages. However, it could be a complex problem—that is, related not only to supply-and-demand issues but also to supply-chain issues.

This FDA app may help you. It certainly has helped me. The kind of information you are looking for may not always be there; for example, many drugs do not have availability information, but that is not necessarily the fault of the FDA. They can only include the information they are given. The 2012 FDA Safety and Innovation Act requires manufacturers to report these shortages. Thus, this information probably will become more timely and quite helpful to pharmacists or other clinicians. The app includes all drugs, not only anti-infectives.

Thanks for listening.

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