May 31, 2011

Medication Shortages Becoming A Growing Concern

Shortages of medications for illnesses from cancer to cystic fibrosis to cardiac arrest have hospitals scrambling for substitutes to avoid patient harm, reports the Associated Press (AP).

"It's just a matter of time now before we call for a drug that we need to save a patient's life and we find out there isn't any," Dr. Eric Lavonas of the American College of Emergency Physicians said in a statement.

The number of medications in short supply has tripled over the past five years, to a record 211 medications last year.  According to the University of Utah's Drug Information Service, another 89 drug shortages have occurred in the first three months of 2011.

Injectable medications used by medical centers hold the majority of the shortages. 

Some of the causes for the shortages include recalls of contaminated vials, trouble importing raw ingredients, spikes in demand and a temporary shut down for quality upgrades.

Some experts said pricier brand-name drugs are in short supply.  The Food and Drug Administration agrees that the overarching problem is that fewer and fewer manufacturers produce these older drugs.  Valerie Jensen, who leads FDA's shortage office, said if one company has trouble, then there are few others able to ramp up their own production to fill the gap.

The nonprofit Institute for Safe Medication Practices said last fall that two 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," University of Utah pharmacist Erin Fox, who oversees the shortage-tracking program, said in a statement.

The FDA has asked some foreign companies to temporarily ship their own versions of some scarce drugs to the U.S.

Hospira Inc., the largest maker of injectable drugs, told AP that it is increasing production capacity and working with the FDA  "to address shortage situations as quickly as possible and to help prevent recurrence."

However, the Generic Pharmaceutical Association said 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.

There is a legislation pending that would require manufacturers to give FDA advance notice of problems like 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.

"No patient's life should have to be at risk when there is a drug somewhere" that could be used, Senator Amy Klobuchar, D-Minn., who introduced the bill, told AP.


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