New York Times Asks, ‘Are Hospitals Running on Borrowed Medicine?’
Doctors, pharmacists and federal regulators have become "increasingly concerned" about a "growing" number of drug shortages, especially at hospitals, with some facilities experiencing shortfalls of two dozen "critical" medicines last year, the New York Times reports. "This past year's shortages have been the worst I've seen in 26 years of hospital practice," Dr. Burnis Breland, director of pharmacy at Columbus Regional Medical Center in Columbus, Ga., said, adding, "We have not had any life-threatening cases, but it certainly could have happened." Some shortages, such as the nationwide delays in production of the flu vaccine, have had "public health consequences," while others have caused patients to use substitute medicines or just "do without."
Explaining the Shortage
According to the Times, the shortages result from a variety of factors, including the pharmaceutical industry's "rapid consolidation," leading to fewer companies making each drug;" federal regulators' moves to shut down production at problem drug factories; and big drug companies' decisions to reserve factory capacity for newer drugs, which net higher profits than older medicines. James Jorgenson, director of pharmacy at the University of Utah's hospitals and clinics, said, "You can't just order drugs any more and just assume they will be there." The pharmaceutical shortfalls, many involving older drugs now sold as lower-priced generics, cost U.S. hospitals and patients tens of millions of dollars annually because newer brand-name alternatives often prove several times more expensive. In addition, drugmakers, distributors and hospitals have exacerbated the shortages by minimizing medicine supplies to save on storage costs and "tie up" less funds in drugs "sitting on shelves." Joseph Deffenbaugh, an associate at the American Society of Health System Pharmacists, said that hospital pharmacists around the nation have "complained" that administrators require them to "cut back" on drug purchases and inventories. "We've seen the enemy, and he is us," Deffenbaugh said. The shortages also have raised "difficult" ethical questions for hospitals about rationing lifesaving drugs. "How can we say one person needs a drug more than another?" Dr. Linda Tyler, director of the University of Utah's drug information services, asked.
Coming Up with the Goods
To prepare for shortages, the FDA, CDC and doctors at the Infectious Diseases Society of America have attempted to pinpoint the "most vulnerable" drugs. J. Todd Weber, senior medical officer at the National Center for Infectious Diseases, said that many substitute drugs that hospitals must use might not prove as effective and have additional side effects. "The pharmaceutical companies -- generic and innovator alike -- are aware of manufacturing problems in advance of anyone else," Weber said, adding, "It behooves the companies to be forthcoming with information about which antimicrobials and other drugs are soon to be in short supply." The FDA recently launched a Web site that lists some of the shortages, and the ASHSP plans to establish an electronic system to inform hospitals about new shortfalls. In addition, the FDA has worked to "minimize" some shortages by tapping companies willing to manufacture a drug or supply the raw materials and then expediting the regulatory approval for those new producers and suppliers. The agency also has helped drug firms correct manufacturing problems more rapidly. Still, FDA officials say that they can only mitigate the shortages, not eliminate them. "We can't control who is making drugs. That is determined by the marketplace," Dr. Mark Goldberger, an FDA official who monitors drug shortages, said. With shortages on the rise, hospital pharmacists fear that the problem will only intensify. "Shortages are now a fact of life. We have to find ways to deal with them," Tyler said (Petersen, New York Times, 1/3).