Drug shortages present worrisome problem
DEAR DOCTOR K:
It seems like every day in the paper I read about doctors and hospitals running out of medicines because the pharmaceutical companies can't manufacture enough of them. Why are we having these problems?
You aren't just imagining this; the problem really has gotten worse. There have been shortfalls of common drugs for ADHD, cancer, pain and heart disease. Like other doctors, I'm frustrated. Understandably, our patients are scared.
Although drug shortages are not new, they seem to be on the upswing. According to The Associated Press, tracking information from the University of Utah Drug Information Service shows 267 newly reported drug shortages in the United States in 2011, up from just 58 in 2004. Clearly, this is not in the public interest.
For example, the drug methotrexate is in short supply. The Dana Farber Cancer Institute, one of the affiliated centers at Harvard Medical School, played a major role in discovering that this drug could treat and even cure some kinds of cancer. Now the institute can't get enough of the drug for its patients.
Many people believe that "the market" is the best way to deliver critical human services and products. At least at this point, it doesn't seem to be working. Some of my expert colleagues here at Harvard, such as Dr. Jerry Avorn, favor more regulation by the Food and Drug Administration (FDA).
The FDA surely does have the authority to monitor the production of medicines. In fact, the closure of some drug manufacturing plants because of quality control problems is contributing to the unavailability of some drugs.
A larger problem, according to Avorn and others, is the desire of drug companies to maximize their profit. For example, there have been many drug company mergers. One important goal of some mergers is to shed "unnecessary expenses" -- which has meant shuttering some manufacturing facilities. Neither the FDA nor any other governmental agency has the authority to stop the closing of a drug manufacturing plant because the closure might lead to a shortage of a particular drug.
The FDA can sometimes help ease a drug shortage. It can approve a manufacturer distributing a drug that it has in stock when the drug has expired or is close to expiring. The FDA also can help ramp up production of hard-to-get drugs by speeding approval of new production lines. It also can look for overseas sources for specific drugs, after checking their safety. The FDA has just announced it will allow methotrexate manufactured outside the U.S. to be sold here.
The FDA has a Drug Shortage Action Plan. Drug manufacturers are encouraged to share information on shortages, but are not required to do so.
If your doctor recommends a drug that is in short supply, ask about other medications that might work for you. Also, your pharmacist may be able to track down a source. When a medication is in short supply, be especially wary of Internet or faxed advertisements for alternatives (often highly priced and sometimes counterfeit products). Finally, if you've had trouble getting one of your medicines, go to this website to report it: http://www.fda.gov/Drugs/DrugSafety/DrugShortages.
(Dr. Komaroff is a physician and professor at Harvard Medical School. Go to his website to send questions and get additional information: www.AskDoctorK.com.)
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