Short-lived shortages sign of larger Rx problem

OB/GYN News,  Feb 15, 2002  by Joyce Frieden

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In late December, Dr. Clifford Moy, clinical director of the Austin (Tex.) State Hospital, did something he almost never has to do: In consultation with attending physicians, he switched 17 patients from one drug--the antipsychotic quetiapine fumarate (Seroquel)--to other medications.

Supply problems forced him to make the switch. At one point, the hospital system's drug distributor ran completely out of it. "We don't want to use it if we don't have a reliable supply," he said.

Across the country in Tewksbury, Mass., Tom Kelley, assistant director of the Office for Pharmacy Services for the state of Massachusetts, narrowly avoided a similar dilemma.

"There was a possibility [we were going to run out], and we were anxious about it," he said. But the problem was solved before the supply of Seroquel was completely depleted. "We had on hand enough to get us through, and then the company got another lot approved and shipped it out quickly. If we had gone another week, we would have run out."

Jim Minnick, spokesman for Seroquel maker AstraZeneca, Wilmington, Del., said that the company had experienced a temporary backorder" for the drug, due to "some issues at the manufacturing plant that were outside the product. The issues have been resolved completely, and the product has been shipped." The problem lasted for only a few weeks.

Shortages of drugs are becoming a more common problem, according to Joseph Deffenbaugh, professional practice associate at the American Society of Health-System Pharmacists in Bethesda, Md. "We started to experience problematic shortages about 4 years ago with a few products, and then over the last year and a half, the number of products has gone up significantly," he said. "There's also a domino effect within particular drug categories, so if one drug product within a category is not available, then other products within that category are quickly depleted as well."

There are a variety of reasons for the worsening drug shortages, Mr. Deffenbaugh said. The three most common reasons are raw material shortages, manufacturing difficulties, and product discontinuations-the last of which shows no sign of slowing down. "There have been a number of consolidations in the pharmaceutical industry, and when they take place, there is a reexamination of product lines. Invariably, there seems to be a reduction of products in the new merged company Most likely, these mergers are going to continue."

These uncertainties in drug supply "make it very difficult to manage patients over time, and for hospitals to manage their [drug] budgets because as drugs get in short supply, their alternatives are sometimes far more costly," he said.

To find out about which drugs are in short supply, physicians can go to either the ASHP Web site (http://www.ashp. org/shortage/) or to the Food and Drug Administration's shortages page (http://www.fda.gov/cder/drug/shortages).

But not all shortages will be listed on the FDA's page, since the FDA has very specific criteria about when shortages will be posted.

"Shortages that are self-limited in nature are not usually listed on he Web page, since these shortages are expected to be resolved quickly," said Valerie Jensen, drug shortage project manager at the FDA's Center for Drug Evaluation and Research, Rockville, Md. She also noted that "shortages, which are limited to a specific strength or package size usually are not listed" if other strengths of the same drug can be substituted.

COPYRIGHT 2002 International Medical News Group
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