COVER STORY

RUNNING ON EMPTY

What's behind the current rampant drug shortages? Pharmacists want to know

Fentanyl, phenobarb, flu vaccine—the mere mention of these drugs, and a host of others, sends chills down pharmacists' spines. Pharmacists everywhere have come to dread the sight of a delivery printout and the words product unavailable. One shortage after another in recent years has made a nightmare of the once innocuous task of ordering drugs.

Pharmacists, physicians, and patients across the country have been asking, "Why?" Why have there been so many shortages lately? Why can some pharmacies get products, while others can't? Why are some prices skyrocketing? The Food & Drug Administration, state pharmacy boards, and groups such as ASHP have been hard at work looking for answers.

According to the FDA and ASHP, shortages can be caused by several situations. The issue "is multifactorial ... and it doesn't look like it's going away," said Joe Deffenbaugh, M.P.H., professional practice associate for ASHP.

Manufacturers can spark shortages by abruptly discontinuing medications, either temporarily or permanently. Often, this is purely a financial decision. If a product isn't profitable, there isn't much incentive for a company to continue making it. When only two or three companies make a certain drug, discontinuation by one firm leaves the others holding the bag. Unlike other commodities, drug products can take months to manufacture. Even if the remaining companies scramble to step up production, it can be some time before they are able to fill the void.

This situation has been aggravated by company mergers. After combining forces, companies look at their product lines and eliminate poor performers. Also, if both firms have been manufacturing a particular drug, they may consolidate production of that drug. According to ASHP, this makes the product more vulnerable to shortage problems by reducing the number of manufacturers that make it.

Still another problem is aging facilities. Deffenbaugh pointed out that most of the drugs in short supply have been injectables. Manufacturing these drugs is complex and expensive. "What we've heard is that several manufacturers' sterile product facilities are getting old," he said.

As equipment ages, breakdowns are apt to occur more often. This stalls production as repairs are made. Some manufacturers are busy correcting the situation by building new plants. Others, when confronted with expensive major renovation requirements, have decided it's not worth manufacturing the product in question.

Unfortunately, no one has studied the phenomenon, so there is no way of knowing just how many plants need updating, said Deffenbaugh. Even worse, it's uncertain how many products may be affected in the future. Manufacturers are not exactly forthcoming with their plans. However, corporations do inform their stockholders of changes that may affect earnings, and Deffenbaugh said these reports have been a good source of information.

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