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Contribution of Latin America to Pharmacovigilance

Head of Pharmacovigilance, Merck Sharp & Dohme, Bogotá, Colombia

Victoria E Arango, BScPharm

Manager of Regulatory Affairs and Quality Assurance, Johnson & Johnson Medical Devices & Diagnostics Group, Bogotá

Thomas R Einarson, PhD

Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada

Reprints: Dr. Einarson, University of Toronto, 144 College St., Toronto, ON M5S 3M2, Canada, fax 416/978-8511, t.einarson{at}utoronto.ca

BACKGROUND: Pharmacovigilance activities have been ongoing for 4 decades. However, little is known (especially outside of the area) about the contribution of Latin America to this field.

OBJECTIVE: To review and quantify the published literature on pharmacovigilance in Latin American countries.

DATA SOURCES: We searched electronic databases including MEDLINE (1966-2004), EMBASE (1980-2004), International Pharmaceutical Abstracts (1970-2004), Toxline (1992-2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-2004), Sistema de Información Esencial en Terapéutica y Salud (1980-2004), and the Pan American Health Organization Web site (1970-2004) for articles on pharmacovigilance or adverse drug reactions in any of the 19 major Latin American countries. Papers were retrieved and categorized according to content and country of origin by 2 independent reviewers.

STUDY SELECTION AND DATA EXTRACTION: There were 195 usable articles from 13 countries.

DATA SYNTHESIS: Fifty-one of the papers retrieved dealt with pharmacovigilance centers (15 national centers, 10 hospitals, 26 other), 55 covered pharmacovigilance itself (21 theoretical papers, 9 with description of models, 25 educational papers), and 89 were pharmacoepidemiologic studies of adverse drug reactions (69 case reports, 13 observational cohorts, 2 cohort studies, 1 randomized clinical trial, 4 clinical papers on adverse reaction management). Studies have increased exponentially since 1980. Five countries (Argentina, Brazil, Chile, Costa Rica, Venezuela) published reports from national centers. No studies were found from 6 countries: Dominican Republic, El Salvador, Honduras, Nicaragua, Paraguay, or Uruguay. Most studied categories were antiinfectives and drugs affecting the central nervous system, cardiovascular system, and musculoskeletal system.

CONCLUSIONS: Contributions of Latin American countries to the field of pharmacovigilence have been remarkable, considering the constraints on these countries. A need exists for an increased number of formal pharmacovigilance studies and research using methodologically stronger pharmacoepidemiologic models.

Key Words: adverse drug reactions, drug monitoring, Latin America, pharmacovigilance

Published Online, July 25, 2006. www.theannals.com, DOI 10.1345/aph.1H052