Drug shortages forcing some risky alternatives
Unprecedented shortages of injectable drugs have forced doctors to resort to medications that are less safe or postpone or cancel procedures, often at the last minute, according to the Food and Drug Administration and health care groups.
Anesthesiology and oncology have been hit particularly hard. Last month, the only U.S. maker of Pentothal, used for 70 years to induce anesthesia, said it had abandoned plans to resume production, which it had halted a year and a half earlier.
"I can say right now it's as bad as it's ever been," says pharmacist Bona Benjamin of the American Society of Health-System Pharmacists, which has tracked shortages since 2001. The number of drugs in short supply has tripled since 2005, Benjamin says. "It's drugs that are potentially lifesaving or critically important in care." The painkiller morphine; amikacin, an antibiotic for serious bacterial infections; and carmustine, a chemotherapy drug, are among about 150 drugs in short supply, her group says.
Hospital pharmacists and doctors report that patients have deteriorated or died because a drug wasn't available, says pharmacist Michael Cohen, president of the Institute for Safe Medication Practices. Others, he says, have been harmed by dosing errors stemming from drug substitutions.
Drugmakers aren't required to alert the FDA to shortages or explain them, but reasons commonly cited include greater demand, a shortage of raw materials and production delays.
Hospira hasn't said why it stopped making Pentothal in North Carolina. Hospira had planned to resume production in Italy, spokesman Dan Rosenberg says, but the supplier of its active ingredient bowed out. He says Italian authorities wanted Hospira to ensure Pentothal wasn't used for lethal injections, as in many states.
The newer drug propofol is used far more often than Pentothal, but they aren't interchangeable, says Jerry Cohen, president-elect of the American Society of Anesthesiologists. In emergency cesarean sections, for example, propofol can complicate matters by anesthetizing babies as well as moms.
Although the FDA had been working with Hospira to bring back Pentothal, the company did not notify the agency it had decided not to, says Valerie Jensen of the FDA's Drug Shortages Office. Because of tip-offs by makers, she says, the FDA was able to avert 38 drug shortages last year. The agency can help locate raw material suppliers and alternative production sites and arrange for foreign manufacturers to step in, she says.
Sen. Amy Klobuchar, D-Minn., is working on a bill to require companies to notify the FDA well in advance of shortages. "No patient should be put at risk simply because a drug happens to not be available on a certain day," she says.
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