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Risk minimization practices for pregnancy prevention: understanding risk, selecting tools
Author(s) -
Uhl Kathleen,
Trontell Anne,
Kennedy Dianne
Publication year - 2007
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.1312
Subject(s) - medicine , risk assessment , drug , risk analysis (engineering) , pregnancy , risk management , pharmacoepidemiology , intensive care medicine , pharmacology , computer science , computer security , management , biology , economics , genetics , medical prescription
According to the March of Dimes, approximately 4% (1/28) of babies are born in the US each year with a birth defect. For the majority of birth defects the etiology is unknown, although chemicals, including drug exposures, probably account for less than 1% of all birth defects. The identification of potential human teratogenicity during drug development is important because drug‐induced adverse fetal effects are potentially preventable with the application of risk assessment strategies and risk minimization tools and programs to minimize risk of pregnancy exposure while preserving access to drug benefits; risk assessment and risk minimization together comprise risk management. It is important that risk minimization programs intended to limit fetal exposure use a consistent approach and are tailored to the product‐specific risk concerns in order to optimize the benefit–risk balance for a particular drug. This paper highlights general considerations in developing specific risk minimization programs to prevent fetal drug exposure including the relative advantages and disadvantages of each strategy. Published in 2006 by John Wiley and Sons Ltd.