Adverse drug reactions in Colombian patients, 2007-2013: Analysis of population databases.
BACKGROUND
Recognizing adverse drug reactions (ADRs) is becoming more important in clinical practice.


OBJECTIVE
To determine the frequency of adverse drug reactions and ADR suspicions among the population affiliated to the Colombian health system and to describe the drugs, reactions and associated variables.


METHODS
We revised ADRs and ADRs suspicion databases from drugs dispensed by Audifarma, S.A., both for inpatient and outpatient care from 2007 to 2013. Variables included ADR report date, city, drug, drug's Anatomical Therapeutic Classification (ATC), ADR severity, ADR type, ADR classification and ADR probability according to the World Health Organization's definitions.


RESULTS
We obtained 5,342 reports for 468 different drugs. The ATC groups with the most reports were anti-infectives for systemic use (25.5%), nervous system agents (17.1%) and cardiovascular system drugs (15.0%). The drugs with the highest number of reports were metamizole (4.2%), enalapril (3.8%), clarithromycin (2.8%), warfarin (2.5%) and ciprofloxacin (2.4%). The most common ADR, classified following the World Health Organization adverse reaction terminology, were: skin and appendages disorders (35.3%), general disorders (14.2%) and gastrointestinal system disorders (11.8%). Overall, 49.4% of the ADRs were classified as "moderate" and 45.1% as "mild".


CONCLUSIONS
An increasing number of ADR reports were found coinciding with a worldwide tendency. Differences between inpatient and outpatient ADR reports were found when compared to scientific publications. The information on ADR reports, mainly gathered by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos - Invima, should be made public for academic and institutional use.
Grupo de investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira; Audifarma, S. A., Pereira, Colombia. machado@utp.edu.co.
Jorge Enrique
JE
Machado-Alba
Manuel José
MJ
Londoño-Builes
Luis Felipe
LF
Echeverri-Cataño
Sergio Andrés
SA
Ochoa-Orozco
D016907:Adverse Drug Reaction Reporting Systems; D003105:Colombia / Q000453:epidemiology; D003430:Cross-Sectional Studies; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D060735:Pharmacovigilance; D012189:Retrospective Studies
Colombia; Drug-related side effects and adverse reactions; adverse drug reaction reporting systems; pharmacovigilance