TMB Will Consider Drug Shortages

Drug shortages and drug storage are mitigating factors in Texas Medical Board (TMB) investigations of physicians who use expired drugs, the board says.

TMB spokesperson Leigh Hopper said the board recently heard from a physician about a case in which doctors had to use expired emergency drugs to resuscitate a patient, thus raising the question of whether the board would consider the use of expired drugs a violation of the standard of care.

"The short answer is, if TMB investigates a complaint involving expired drugs, it will consider the drug shortage as well as storage conditions in making a determination," Ms. Hopper said in an email.

She noted that Texas physicians in all specialties are dealing with widespread drug shortages caused by manufacturing delays, scarcity of raw materials, and high demand. According to the National Cancer Institute, she added, "the trend is expected to worsen."

Ms. Hopper says a U.S. Food and Drug Administration (FDA) study that the military requested produced most of the information about drug expiration dates. "With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is many of the drugs, both prescription and over-the-counter, were good to use years after the expiration date. But the key was proper storage," she wrote. 

She added that there are no plans to amend board rules and the issue would arise only if someone filed a complaint against a physician. TMB would then investigate to determine "if the expired drug was used as a result of a documented shortage, and if so, was it stored properly."

For more information about the drug shortages, log on to the FDA or American Society of Health-System Pharmacists websites.


Action, March 1, 2012


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