Pharmacovigilance Indicators in Health Services: A Systematic Review. Are There Still Relevant Gaps?

The aim of this study was to identify potentially applicable pharmacovigilance (PV) indicators for health services available in the literature.

We searched MEDLINE, EMBASE, LILACS, IBECS, CUMED, SciELO, and Google Scholar bibliographic between January 1, 2004 and January 23, 2023, and 25 websites from different organizations for studies describing specific PV indicators in health services. The methodological quality of the included studies was assessed using the Appraisal of Indicators through the Research and Evaluation (AIRE) tool. The indicators were differentiated into structure, process and outcome, and also grouped according to the applicability of the PV activities carried out in health services, based on the domains proposed by the Centers for Disease Control and Prevention.

We identified 14 studies and 100 PV indicators classified as structural (51%), process (32%), and outcome (17%). The indicators classified according to the aspect of the PV activities they measure cover "Results of PV/ External impact" (45%); "How does the PV unit works/Management of their information" (32%); "The PV unit and team" (23%). According to AIRE, the methodological quality of the included studies varied considerably. In consensus, we selected 55 indicators that could potentially be useful to health services.

This systematic review made it possible to identify a considerable number of indicators. Many of them aim to evaluate different aspects of PV activities that can be valuable from a public health and health system perspective. Therefore, we propose a new classification and a set of indicators useful for health services.