Reasons Unclear for Widespread Antibiotic Shortage

OB/GYN News,  March 15, 2000  by Betsy Bates

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Explanations ranging from "just in time" shipping to Y2K hoarding to generic drug recalls are being floated as possible reasons for the antibiotic shortages being reported by infectious disease specialists nationwide.

In a survey nearly 90% of 481 respondents, all of them members of the Infectious Diseases Society of America (IDSA), reported shortages of at least one of the following drugs at their hospitals since September 1999: penicillin G, meropenem, ticarcillin/clavulanate, cefazolin, or gentamicin. Other survey respondents are having trouble obtaining amoxicillin, ampicillin, Bactrim, cefotetan, and nafcillin, the IDSA reported recently

More than 80% of those surveyed said inadequate supplies of the drugs had forced them to alter their treatment regimens, impacting an estimated 10,000 patients nationwide.

"I'm surprised at how widespread the problem appears to be," said Dr. Catherine Wilfert, president of IDSA. "It's not just a single drug, like [intravenous] penicillin G, which initially called attention to this issue. It's a much broader and more serious problem than we thought."

Shortages of penicillin G were reported by 76% of the hospital-based infectious disease specialists queried. Gentamicin also was in scant supply, with half of specialists saying that they had been unable to get the drug at some point in the last quarter.

Nearly 40% reported shortages of meropenem; 24% could not get ticarcillin or clavulanate.

"This seems very strange," said Dr. Larry Strausbaugh, who directs the IDSA's Emerging Infections Network. "The reason for [the antimicrobial shortage] is unknown, and we think there needs to be an investigation."

"If we were to have a pandemic of this or that, would we have the drugs available to treat large numbers of patients?" Dr. Strausbaugh asked.

He expressed concern that shortages of narrow-spectrum antibiotics will exacerbate the already alarming increase in antibiotic resistance.

Calls to major pharmaceutical manufacturers and distributors turned up various speculations but no simple explanation for the shortages.

A spokeswoman for Bergen Brunswig Corp., the nation's third largest pharmaceutical distributor, confirmed that a significant number of drugs, including many of those cited in the IDSA survey, were categorized as unavailable or in short supply throughout the fall and winter months.

Some drugs were listed as unavailable until April.

But neither Schering-Plough' Corp. nor Wyeth-Ayerst's subsidiary Elkins-Sinn, both listed in the Physicians' Desk Reference as manufacturers of gentamicin, reported any record of shortages or delays in production of the drug.

The Bergen Brunswig representative suggested that generic manufacturers, who supply the bulk of widely used antibiotics, may simply have been caught off-guard by a "relentless" flu season and unpredictable increases in other seasonal infectious diseases.

Other theories abound.

A holiday-related slump in production, Y2K "hoarding," and the impact of Food and Drug Administration recalls of common antibiotics produced by several large generic pharmaceutical houses have all been cited as possible reasons for shortages.

One factor, certainly is the shift of production of old standby antibiotics from major pharmaceutical houses to generic firms, since these drugs are mostly off patent and only marginally profitable.

"These are still good drugs, but companies don't want to spend a lot of time on something that has such a narrow profit margin," said B. Joseph Guglielmo, Pharm.D., professor and vice chairman of clinical pharmacy at the University of California, San Francisco.

Quality control issues have led to recalls of a number of widely used generic drugs, including penicillin G, FDA records show.

Other factors also may be at play.

Dr. Michael Osterholm, chairman of the IDSA's emerging infection committee, suspects that part of the problem may be the gradual adoption of a "just in time" delivery system by the pharmaceutical industry.

Originally used in the automotive and electronics industries, this system involves shipping products only as they are needed, eliminating storage rooms full of bulk supplies.

The system may not be appropriate for the delivery of medications, particularly for those that are needed to treat infectious diseases, he said.

"The episodic nature of infectious disease is such that having a razor-thin inventory of antimicrobial agents will not suffice," Dr. Osterholm said.

Representatives of several pharmaceutical manufacturers said that they could find no record of delays in shipping available drugs to hospitals requesting them.

Meanwhile, physicians and pharmacists are becoming increasingly frustrated with the bare spaces on pharmacy shelves.

"In my experience, these are real shortages," said Dr. Strausbaugh, hospital epidemiologist and staff physician at the Veterans Affairs Hospital, Portland, Ore.