Safety monitoring of maternal and newborn health
The Committees were informed of recent work to
strengthen data quality and harmonize data collection for safety monitoring of medicines and vaccines in
pregnant and breastfeeding women and neonates,
including the results of a pilot study of the WHO minimum maternal and newborn health data sets (mMNHDS).
The Committees discussed support for harmonization
of definitions and methods used in monitoring maternal and newborn health and use and improvement of
existing data sources, particularly on means of collection, such as electronic clinical records and pregnancy
exposure registries.
The Committees recommended that the mMNHDS be
enhanced by developing an implementation strategy,
including it in registers, creating training materials for
health-care professionals and data managers, and advocating for its dissemination (core and catalogue data
sets).
Updates were provided on harmonization of data for monitoring maternal, fetal and newborn outcomes and on analysis of pregnancy exposure registries in low– middle-income countries. An overview was provided of work by WHO on assessment of causality for adverse events following maternal immunization (AEFMI).
The WHO PVG provided an overview of a project for harmonizing data for monitoring maternal, fetal and newborn outcomes in a set of standardized indicators and data elements. An interdepartmental team comprising 12 WHO departments developed a minimum maternal and newborn health dataset (WHO mMNHDS), which comprises 15 core indicators to be collected in all WHO regions and countries and 62 complementary “catalogue” indicators. The next stage is to assess collection of the WHO mMNDHS in settings with limited resources. A pilot study is under way in nominated hospitals in 8 countries eligible for funds from the Global Fund for HIV, Malaria and Tuberculosis.
The Committee was also provided with details of a project to improve causality assessments for AEFMIs involving WHO, the International Clinical Epidemiology Network in India, the AEFI Committee, the National Centre for Immunisation Research and Surveillance in Australia, the University of Buenos Aires in Argentina and the Paul-Ehrlich-Institut in Germany. The expected outcomes of the work are collection of data on the mother, fetus and the neonate at the time of AEFMI reporting and investigation. Software has been developed to guide systematic, standard causality assessments of AEFMIs for use by members of AEFI or AEFMI committees, physicians, immunization programme managers and others and as an education and research tool for various stakeholders. The new approach is intended to reduce errors and ensure better understanding of AEFMIs. This work is anticipated to be completed by the end of 2025.