Drug shortages make hospitals hunt for substitutes
LAURAN NEERGAARD | 6/1/2011, 1:16 a.m.
• Some leuprolide hormone injections used in fertility treatment.
No one is tracking patient harm. But last fall, the nonprofit Institute for Safe Medication Practices said it had two reports of people who died from the wrong dose of a substitute painkiller during a morphine shortage.
“Every pharmacist in every hospital across the country is working to make sure those things don’t happen, but shortages create the perfect storm for a medication error to happen,” says University of Utah pharmacist Erin Fox, who oversees the shortage-tracking program.
What can be done?
The FDA has taken an unusual step, asking some foreign companies to temporarily ship to the U.S. their own versions of some scarce drugs that aren’t normally sold here. That eased shortages of propofol, a key anesthesia drug, and the transplant drug thiotepa.
Affected companies say they’re working hard to eliminate backlogs. For instance, Hospira Inc., the largest maker of those injectable drugs, says it is increasing production capacity and working with FDA “to address shortage situations as quickly as possible and to help prevent recurrence.”
But the Generic Pharmaceutical Association says some shortages are beyond industry control, such as FDA inspections or stockpiling that can exacerbate a shortage.
“Drug shortages of any kind are a complex problem that require broad-based solutions from all stakeholders,” adds the Pharmaceutical Research and Manufacturers of America, a fellow trade group.
Lawmakers are getting involved. Sen. Herb Kohl, D-Wis., is urging the Federal Trade Commission to consider if any pending drug-company mergers would create or exacerbate shortages.
Also, pending legislation would require manufacturers to give FDA advance notice of problems such as manufacturing delays that might trigger a shortage. The FDA cannot force a company to make a drug, but was able to prevent 38 close calls from turning into shortages last year by speeding approval of manufacturing changes or urging competing companies to get ready to meet a shortfall.
“No patient’s life should have to be at risk when there is a drug somewhere” that could be used, says Sen. Amy Klobuchar, D-Minn., who introduced the bill.