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A growing number of hospitals and patients are feeling the effects of severe drug shortages. According to Forbes:
In 2011, there were a record-high 267 new prescription drug shortages. This is 56 more than in 2010 and more than four times greater than the number of medication shortages in 2004, when just 58 drug shortages were reported.The worsening drug shortage problem impacts patient care, especially in hospitals, as chemotherapy, surgery and care for patients with pain and infections are disrupted as a result of a lack of critical medicines. The shortages have also delayed clinical trials and have led to extraordinary price extortion, causing many hospitals to have to pay extremely large markups for limited drugs.
The director of Oconee Medical Center's pharmacy in South Carolina, Bill Stevenson, said, "It's a crisis. It's a national crisis. It's as bad as I've seen in my 35 years of practice here." As of January, there were 4,242 medications on national backorder from the wholesaler where his pharmacy purchases its medication.
"It just delays patient care by not having the drugs you need to do the job," he reiterated.
In the end, hospitals must pass some of these increased costs on to patients, or they will go out of business altogether. "We're paying anywhere between a 400 and 1,100 percent price increase over what we were..." Stevenson said.
But the question remains, why the shortage?
The FDA says that "the shortages are primarily a result of manufacturing deficiencies...companies that end production of drugs that have small profit margins, consolidation in the generic drug industry, and not enough supplies of some ingredients."
However, a 2010 report from the Manhattan Institute puts things in a different light. It notes, "The FDA's mission is not only to bring safe and effective drugs to market but...to help 'speed innovations that make medicines and foods more effective, safer, and more affordable.'" Unfortunately, according to the report:
...patient access to newer medicines [has become] limited by a complex, expensive, and ever-lengthening drug-development process. Well-known studies from the Tufts Center for the Study of Drug Development have found that the period from the inception of research into the formulation of a molecule until approval by the Food and Drug Administration for marketing is currently about twelve years, two-thirds of which is consumed by clinical trials (whose scope is dictated by the FDA) as well as the FDA's own approval process...
The Manhattan Institute's study concludes by recommending, among other things, that the FDA streamline its approval process to alleviate the burden on manufacturers and patients, thereby also allowing them to utilize their resources on increased production.
Interested in checking out the status of your medications? Check out the FDA's "Drug Shortage" website here.
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