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Pharmacoepidemiologic implications of erroneous varicella vaccinations in pregnancy through confusion with Varicella zoster immune globulin
Author(s) -
Wise Robert P.,
Braun M. Miles,
Seward Jane F.,
Mootrey Gina Terracciano,
Shields Kristine E.,
Salive Marcel E.,
Krause Philip R.
Publication year - 2002
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.749
Subject(s) - medicine , pregnancy , publicity , vaccination , pediatrics , immunology , business , genetics , marketing , biology
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. Copyright © 2002 John Wiley & Sons, Ltd.