ADVERSE DRUG REACTION REPORTING: BEYOND REPORTING / A STATE OF THE ART
Resumen
Adverse drug reaction reporting constitutes a central component of pharmacovigilance systems; however, its implementation in real-world settings does not follow a linear correspondence with the normative frameworks that underpin it. From both health sciences and social sciences perspectives, this field has been progressively problematized as a situated practice shaped by organizational dynamics, working conditions, institutional arrangements, and diverse professional rationalities.
This state-of-the-art review examines how reporting has been addressed in the literature, shifting its understanding from a purely technical act to a complex sociotechnical practice. The study was conducted as a nonsystematic, theoretically informed review, employing a data triangulation approach that integrated empirical, normative, and institutional sources. Analysis was carried out through thematic coding and interpretive synthesis, enabling the identification of patterns, tensions, and gaps within the field. Findings indicate that underreporting cannot be explained solely by individual deficits but emerges from structural misalignments between system requirements and the concrete conditions of clinical work. Recurrent tensions were identified between regulation and practice, institutional design and effective use, as well as procedural demands and care dynamics. In this sense, the review provides an analytical reconstruction of the field, enabling a deeper understanding of reporting beyond its procedural dimension, situating it at the intersection of institutional arrangements, professional practices, and organizational contexts, and offering an interpretive basis for further analysis.
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