Hospitals Say Drug Shortages Harm Patient Care
"Profound shifts in the economics of the pharmaceutical industry" have resulted in shortages of drugs that are commonly used in hospitals, putting patients across the country at risk, the Los Angeles Times reports. As drug makers cease production of "older, less profitable" medicines in favor of "newer, more lucrative medications tailored to the outpatient market," physicians and nurses have been "forc[ed]" to "ration their limited supplies" of certain drugs, the Times reports. Temporary manufacturing or distribution problems have contributed to disruptions in drug production and supply. In addition, "cost-cutting mandates" from managed care companies and the federal government have led hospitals to keep "increasingly smaller amounts" of expensive medicines in their inventories. Although shortages have not been linked to any patient deaths, physicians, pharmacists and ICU managers in several cities say that the dwindling stock of some drugs has "threatened patient care." Below are some examples of adverse events linked to drug shortages:
- Fetanyl: A recent shortage of fetanyl, a "specialized painkiller," is partially responsible for a "significant increase" in cases of respiratory distress among surgery patients, according to Dr. John Eichhorn of the University of Mississippi's medical school. The shortage occurred when fetanyl manufacturer ESI/Lederle suspended production of the drug, stating that "it wasn't worth incurring the cost of upgrading manufacturing practices" as ordered by the FDA. Although ESI/Lederle recently resumed production of the drug and the FDA recently ruled that it is "no longer in short supply," Eichhorn said that physicians in the South, as well as some in Utah, are continuing to experience problems accessing the drug.
- Wydase: Shortages of Wydase, which aids the distribution of fluids in tissues, is affecting the care of eye surgery patients and premature infants. The Times reports that Wydase manufacturer Wyeth-Ayerst halted production of the drug because it did not wish to "spend the money to bring its manufacturing plant up to FDA standards."
- Succinylcholine: A lack of succinylcholine, a medicine that helps patients swallow breathing tubes during anesthesia without damage to the esophagus, has caused hospitals to delay some surgeries "for months." Drug firms "have not stepped up production" of the medicine because they feel the market is "insufficiently profitable," the Times reports.
Most of the drugs in short supply are injectables, which are "used almost exclusively in hospital treatment or outpatient surgery." Injectable drugs are often less profitable for drug companies to manufacture, as they are used by fewer people and bring in less revenue than pills. Economists say that a "wave of mergers and acquisitions" has prompted "surviv[ing]" drug firms to focus on the development of new products. In addition, the hospital market is "less attractive" to drug firms than the outpatient market, which is "much larger and more susceptible to advertising and promotions." Production requirements also contribute to companies' failure to produce certain drugs. Unlike pills, injectable medicines must be produced in a sterile environment, which many small generic manufacturers do not possess. Carole Ben-Mamion, a physician and chair of the Generic Pharmaceutical Association, said, "You need special air-handling units, and the people going in and going out have to gown and glove. You're limited in what you can make in [a sterile] facility." Meanwhile, some drug makers have also experienced difficulty obtaining "key ingredients" from overseas suppliers," further aggravating production difficulties.
Federal law does not require drug firms to give advance notice when they plan to halt production of a drug unless the medicine is used to treat a life-threatening condition and is made by only one company. However, hospital pharmacists and doctors say the problem of drug shortages "has reached the point that government intervention is needed, if only to give hospitals more warning of impending shortages," the Times reports. Mark Goldberger, a physician at the FDA's Center for Drug Evaluation and Research, said that shortages are occurring even when more than one company is manufacturing a drug. The Pharmaceutical Research and Manufacturers of America recently convened a meeting between industry officials, physicians, pharmacists, hospital representatives and FDA staffers to address the issue, although the organization declined to comment on the topic. Jackie Cottrell, PhRMA spokesperson, said, "There could be a variety of different reasons for different drugs. We really have no information, and individual companies have to address it for their individual circumstances." The American Society of Health-System Pharmacists is urging the federal government to consider requiring companies to notify the FDA and health care providers if they "anticipate shortages of any drugs" (Rubin/Gosselin, Los Angeles Times, 5/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.