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HOW TO FILL AN UNFILLABLE PRESCRIPTION:
Treat it like gold and pork bellies // Scratch out the expiration date // Hire a buyer and start hoarding // Find a less-than-ideal substitute.

Drug Shortages: Museum Pieces

By Timothy Gower // Photographs by Chris Turner // Summer 2011
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Chris Turner

Sodium thiopental was once the most commonly used injectable anesthetic. In recent years, anesthesiologists came to rely on other medications, such as propofol, but sodium thiopental (also called thiopental injection, and sold under the trade name Pentothal) was still preferred for some types of surgery—including emergency cesarean sections, because it was less likely than propofol to sedate the infant.

But beginning in 2009, hospital pharmacists frequently found sodium thiopental to be in short supply. Hospira, its only manufacturer, cited unspecified problems at its factories. Then, in early 2011, sodium thiopental was gone for good. Hospira had tried to move production of the drug to a plant in Italy, which company officials say was better equipped to make it. But Italian authorities demanded assurances that sodium thiopental made at the facility would not be used for one specific nonmedical procedure: lethal injections. Although Hospira had never condoned that application, sodium thiopental had long been part of a three-drug cocktail used to execute condemned prisoners in the United States. Unable to make that guarantee, Hospira decided to stop producing the drug altogether.

Though the reasons for sodium thiopental’s disappearance may seem unique, its demise points to increasingly serious disruptions in the supply chain for prescription drugs in the United States. In 2010, for example, 211 different drugs—triple the number in 2005—were in short supply or completely unavailable for all or part of the year, according to the University of Utah Drug Information Service, which provides shortage data for the American Society of Health-System Pharmacists (ASHP). What’s more, shortages are lasting longer. “This is as bad as it has been in three decades,” says Michael Link, a pediatric oncologist at Stanford University School of Medicine and president-elect of the American Society of Clinical Oncology (ASCO).

For hospital pharmacists, the shortfalls have meant a constant battle to keep medications in stock. “For the past two years, we’ve had persistent shortages of ‘workhorse’ drugs,” says Meg Clapp, chief of pharmacy at Massachusetts General Hospital. “I don’t see any relief in sight.” And when medications are unavailable, patients feel the effects. In an anonymous survey last year by the Institute for Safe Medication Practices (ISMP), in which 1,800 health practitioners (about two-thirds of them hospital pharmacists) were asked about the impact of drug shortages at their institutions, respondents noted more than 1,000 cases in which people had been harmed or endangered or had had care delayed. At least two people died, in both cases because caregivers mistakenly thought they were giving the patient morphine; because that drug wasn’t available, it had been replaced by hydromorphone, which is 7 to 10 times more potent. (Morphine shortages have led to a run on hydromorphone, which now can also be difficult to keep on hand.) And there have been reports of patients who may have died because chemotherapy drugs weren’t available and treatment was postponed or not received at all.

Some hospitals have resorted to using expired drugs—a risky proposition, given uncertainty about the safety and effectiveness of medicine past its “use by” date. Pharmacists have begun comparing the situation to that of a medicine-starved developing nation—a stunning development in a country that spends more than $65 billion a year creating pharmaceutical products. While medicine shortfalls have been seen before, some on the front lines now think shortages are becoming more common because manufacturers are putting economic interests ahead of the needs of patients and insist that fundamental changes are needed in the way medicine is made and distributed in the United States. Otherwise, they fear, more doctors will soon hear that the drug a patient needs—a treatment that a doctor has prescribed for years, the one he or she knows will work—is no longer available.

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Why Drugs Run Out

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According to data compiled by the University of Utah Drug Information Service, these are the most common reasons for drug shortages.

Drug Distributors: On The Gray Market

Though pharmaceutical products are tightly regulated, distributors aren’t, and that has led to a netherworld of dealers ready to exploit—or create—drug shortages.

Still Running Short

Although drug shortages have lessened in recent years, some key classes of medications remain in short supply.

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1. “ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems,” [pdf] by Erin R. Fox et al., American Journal of Health-System Pharmacy, Aug. 1, 2009. A primer from a panel, convened by the American Society of Health-System Pharmacists, on why shortages occur, with advice on strategies for coping.

2. “The Reality of Drug Shortages—The Case of the Injectable Agent Propofol,” by Valerie Jensen and Bob A. Rappaport, The New England Journal of Medicine, Aug. 26, 2010. A shrinking number of pharmaceutical companies produce older injectable drugs because they’re not profitable enough, a key reason shortages are on the rise. The authors explore the case of the sedative propofol.

3. “Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety,” ISMP Medication Safety Alert! Sept. 23, 2010. Drug shortages have led to substandard care, as the Institute for Safe Medication Practices found in a poll of 1,800 health care practitioners.

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