Pharmacoepidemiologic implications of erroneous varicella
vaccinations in pregnancy through confusion with Varicella zoster immune
globulin.
Wise RP, Braun MM, Seward JF, Mootrey GT, Shields KE, Salive ME, Krause PR.
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA),
1401 Rockville Pike, Rockville, MD 20852-1448, USA. wise@cber.fda.gov
A series of case reports to the varicella vaccine Pregnancy Registry described
inadvertent administrations during pregnancy of this live virus product instead
of the intended Varicella zoster immune globulin. Cases continued to accrue
despite an early publication about the pattern. The persistent problem warrants
specific educational efforts to prevent further repetitions. It also has more
general implications for medical product safety surveillance. First, this
problem's original detection depended on the Pregnancy Registry's open-ended
collection of information about pregnancy exposures. It could have escaped
recognition through surveillance limited to pre specified potential risks. This
need for unrestricted reporting and human vigilance to sift through case stories
has particular relevance for efforts to re-think methods to monitor gestational
drug exposures. In addition, the problem's persistence despite initial publicity
suggests that diligent surveillance may require continued follow-up of
identified safety issues. Periodic reassessments of selected preventable
problems might strengthen efforts to minimize product risks.
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