REGULATORY BURDEN CONTRIBUTING TO DRUG SHORTAGES
March 17, 2005
The United States has a growing problem of drug shortages, forcing some medical centers to seek drugs from outside the country, reports Amy Dockser Marcus of the Wall Street Journal.
- The FDA has 10 drugs on its list of medically necessary products for which the supply is inadequate to meet current or projected demand.
- The American Society of Health-System Pharmacists included 66 products on its lists of shortages for the first half of last year, the latest period for which data are available; in all of 2002, there were 73 drugs on the list, and in 2002, 119.
Erin R. Fox, a drug-information specialist at the University of Utah Hospitals and Clinic, says there are a number of reasons for the shortages:
- Complex Food and Drug Administration (FDA) regulations that are costly to meet.
- Problems in manufacturing that prolong the production process, as well as difficulties arising from out-of-date equipment or a lack of materials.
- Recent economic pressures has forced many hospitals to reduce their inventories, thus restricting their ability to respond to shortages.
- There is a lack of communication between pharmacies and manufacturers; often, pharmacies get no warning of a problem since manufacturers don't want to share information about supply problems for competitive reasons.
For example, currently there is a shortage of the childhood cancer drug methotrexate, which is used to treat the 4,500 U.S. children with leukemia, osteosarcoma, and non-Hodgkin's lymphoma.
Many cancer centers now require doctors to notify them before starting chemotherapy so they can first see if there is enough methotrexate available to finish the treatment. Some hospitals are being forced to hunt for the drug in places as far away as New Zealand.
Source: Amy Dockser Marcus, "Critical Cancer Drug Faces Shortage," Wall Street Journal, March 15, 2005.
For WSJ text (subscription required) http://online.wsj.com/article/0,,SB111085415351479585,00.html
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