Contribución de los Farmacéuticos Comunitarios en la detección y notificación de reacciones adversas en Andalucía

Miguel Romero Pérez; Manuel Sánchez Polo; José Alberto  Ayala Ortiz; Blanca Contreras Aguilar; María José Zarzuelo-Romero

doi:10.30827/ars.v66i1.31598

Authors

Miguel Romero Pérez Universidad de Granada https://orcid.org/0000-0003-0578-1099
Manuel Sánchez Polo Universidad de Granada, Facultad de Farmacia, Departamento de Química Inorgánica, Granada, España. https://orcid.org/0000-0002-7802-6505
José Alberto Ayala Ortiz Universidad de Granada, Facultad de Farmacia, Aula de Farmacovigilancia PVpharm
Blanca Contreras Aguilar Universidad de Granada, Facultad de Farmacia, Aula de Farmacovigilancia PVpharm
María José Zarzuelo-Romero Universidad de Granada, Facultad de Farmacia, Aula de Farmacovigilancia PVpharm. Facultad de Farmacia, Departamento de Farmacia y Tecnología https://orcid.org/0000-0001-8635-8094

DOI:

https://doi.org/10.30827/ars.v66i1.31598

Keywords:

Adverse drug reactions, Pharmacovigilance, Community pharmacy, Drug safety, FEDRA

Abstract

Introduction: Monitoring the safety profile of a drug is crucial after its commercialization, particularly regarding adverse drug reactions (ADRs) during the first years on the market. In Spain, the Spanish Pharmacovigilance System for Medicinal Products for Human Use collects, analyzes, and processes ADR reports from healthcare professionals, the pharmaceutical industry, and patients, contributing to public health. Community pharmacists, due to their direct contact with patients, play a key role in identifying and reporting ADRs, improving care quality. However, few studies address the effectiveness of pharmacovigilance in community pharmacies. This study analyzes ADR reports submitted by community pharmacists to the Andalusian Pharmacovigilance Center over the past 20 years, focusing on patient characteristics and the therapeutic subgroups involved.

Method: A longitudinal observational study was conducted on ADR reports detected and submitted by community pharmacists using the yellow card system between 2003 and 2023.

Results: The ADR reporting rate by community pharmacists was low (8.3 %) compared to other healthcare professionals. This appears to be related to factors such as complacency, lack of awareness, or underestimation of ADR severity. Adults (18–65 years) had the highest reporting rate, with most reactions classified as “non-serious.” The main therapeutic groups involved were antihypertensives, antibacterials, lipid-modifying agents, and analgesics.

Conclusions: Improving the integration of ADR reporting into pharmacy practice and expanding access to pharmacovigilance activities could enhance pharmacists’ contributions, ensuring greater safety post-marketing.

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