报告-加强数据质量，支持对妊娠和哺乳期使用的药品进行安全监测

Opening TheDirector of Regulation and Prequalification opened the webinar discussing how globalpharmacovigilance has been impacted by the decision of regulatory agencies not to share full datawith the global WHO database maintained by the WHO Collaborative Center for International drugmonitoring - Uppsala Monitoring Centre, or when national regional or sub-regional clusters try toestablish standards which are not aligned with the international agreed standards. Lack of the fullpharmacovigilance information diminishes capacity of prompt response to protect human life. This webinar highlights the technical work that needs to be done to integrate systems of MemberStates for universal health coverage and for response in emergencies. One of the main critical issuesin the area is the limited data quality for health outcomes monitoring. This is due to lack ofharmonization of standardized data and methods to collect evidence. During COVID-19 and todayduring mpox empirical decisions were made because of lack of standardized tools and methods. WHOis working to create a global digital health framework, with new and adequate data standards. Need for harmonization of standardized data sets for monitoringmaternal, fetal and newborn outcomes The work on harmonization of data sets for monitoring maternal and newborn outcomes started in2017 when representatives from different WHO entities found that poor data quality in terms ofmaternal and newborn health was due to diversity in terminology, definitions and methods used,which prevented data comparability and meta-analysis between studies.To address these challenges,a harmonized set of standardized health indicators and data elements for collection across all whoregions and MemberStatesneeded to be defined. Therefore, the pharmacovigilance team initiated the WHO interdepartmental task force that gathersrepresentatives from 12 different entities of WHO headquarters with different areas of work,with the aim to define standardized WHO minimum maternal newborn health data set (MNHDS).Based on 60 documents published across these areas of work, 1001 indicators were identified.Following mapping and deduplication, 211 different indicators were classified across the continuumof care. The two-stage consensus activity, which is a modified Delphi method was used to develop acandidate minimum data set and to sought input from the members of the WHO Interdepartmentaltask force as well as external experts, colleagues from WHO regional and country offices. Stakeholdersgave their input based on whether these indicators were action focused, important, simple andvalued, operational and feasible (Figure 1). The resulting core data set included 15 indicators, for which consensus was obtained, to be universallycollected across WHO entities, regions and countries. This core data set is accompanied by a cataloguedata set not obtained by consensus, but it’s specific for each area of work and, for the moment,contains 62 indicators. That means that working in safety requires monitoring core data set andselected catalogue indicators pertaining to safety. Similarly, for colleagues working in nutrition theyneed to monitor the core data set and the specific indicators for nutrition of the catalogue data set.All WHO MNHDS have definitions, computations and other aspects of data element measurements.To facilitate monitoring, the 15 core indicators are classified in five different groups: mortality,maternal, newborn, vaccination exposure, maternal newborn, drug exposure and inverse events,maternal, fetal and newborn outcomes, maternal risk factors and screening (Figure 2). WHO minimumMNHDS (mMNHDS) were compared to data set from WHO programmes and global initiatives tostrengthen global harmonization and collaboration. When indicators were comprised to WHOprogrammes and global initiatives, we found an alignment with those. Next step included assessment of whether different health settings were able to collect WHOmMNHDS. For this reason, a pilot study was initiated in healthcare facilities with primary objective todetermine the capacity of nominated hospitals to prospectively collect the required elements.Moreover, secondary objectives included: identification of elements posing challenges in the settings,identificationof elements already captured in the routine health systems,support futureimplementation strategy of this data set and subsequent revisions. The data collection period was ofconsecutive 28 days, including holidays and vacation. Prospective data collection was chosen tofacilitate data collection. Countries from African, Southeastern Asia and Eastern Mediterraneanregions were interested in participating in the study. Referral hospitals were nominated from theministries of health of seven countries (Bangladesh, Ethiopia, Gambia, Nepal, Nigeria, Pakistan,Uganda) from these regions. The pilot study started with the preparatory phase consisting of meeting study teams and drafting thetools and t