Jeannette Y. Wick, RPh, MBA, FASCP
A survey of US neurologists found that a significant minority is unaware of FDA drug safety updates and many who are aware of the updates fail to act on them.
Neurologists in the United States may not be as aware of FDA safety warnings as they need to be, according to the results of a study
presented on March 21, 2013, at the American Academy of Neurology’s annual conference in San Diego.
In an online survey, the study authors asked neurologists about 4 recent FDA announcements regarding antiepileptic drug (AED) safety risks and whether the announcements had prompted the respondents to make changes in patient care. Of the 505 respondents, all members of the American Academy of Neurology, approximately 20% were unaware of the drug safety risks covered:
a new requirement for haplotype screening in patients of Asian descent initiating carbamazepine,
increased birth defect risks and impaired cognitive development due to in utero divalproex exposure, and
suicidality risk associated with newer AEDs
The researchers noted that although most neurologists surveyed knew about the haplotype screening requirement, almost 4 in 5 (77.5%) failed to perform it. In addition, 18 neurologists reported that their patients had hypersensitivity reactions to carbamazepine. The researchers found that neurologists had many ways of learning about drug safety risks, but that only notifications from specialty organizations appeared to lead to accurate knowledge of safety risks.
In order to improve communication of drug safety risks, a majority of the survey participants reported that they favored implementation of “a formal warning process via specialty organizations.” The neurologists also reported that emails written for specialists with updated product insert warnings would be helpful.
Pharmacists, too, must keep up with FDA drug safety warnings. Pharmacists can aid neurologists (and protect patients) by tracking the FDA warnings and sending along relevant information to neurologists that they work with.
Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a freelance writer from Virginia.