Surveillance of antiretroviral drug toxicity during pregnancy and breastfeeding
This document provides an overview of proposed approaches for assessing the safety of antiretroviral (ARV) drugs used during pregnancy and the breastfeeding period. It is intended for national HIV/AIDS programme managers and implementing partners, such as non-governmental organizations and academic institutions, that are responsible for implementing systems to monitor the safety of ARV drugs.
The proposed approaches include the development and maintenance of a prospective pregnancy-exposure registry; a birth-defect surveillance programme; and a prospective monitoring of cohorts of mother–infant pairs, during the breastfeeding period at sentinel sites.
This document describes briefly the methods employed, their strengths and limitations, tools available for implementing them, and practical issues that would need to be considered for a particular setting/country.