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Abstract
Pharmacovigilance in the last 10 years: update of concepts and classifications. Achievements and challenges for thefuture in ColombiaIntroduction: the science and activities relating to the detection, assessment, understanding and prevention of adverseeffects or any other drug related problem. Since the creation of the Colombian Pharmacovigilance Program led by INVIMA(National Institute of Drug and Food Surveillance) in 1998, there have been significant progress and there are numerousresearch Colombian experiences regarding this topic. They have also been updated some important concepts and classificationsfor the practice of the discipline. Objectives: to present published studies on adverse drug reactions/adverse drug events(ADR/ADE) in Colombian patients. Also, to describe the history of Pharmacovigilance in Colombia in briefly, and update themost important definitions and classifications. Methods: the databases reviewed were Medline, SciELO, LILACS and EMBASE.Results: there were 13 published studies aimed at detecting ADR/ADE in Colombian patients, conducted between 1998 and2007. The frequency of ADR/ADE in hospitalized patients was between 1.2 and 45% while the same frequency as the reasonfor consultation or hospitalization was between 0.03% and 6.8%. These figures overlap with the international literatureand differences between frequencies are mainly explained by the detection system that was used. The new classificationsclinical and mechanistic (DoTS and EIDOS) of ADR seem to be very useful in practice, one of which was used successfullyin a Colombian study. Conclusions: the Pharmacovigilance in Colombia has made significant progress in the last decade.However, it is necessary to improve the articulation of responsibilities between all actors involved and make the detectionand reporting of ADR/ADE a routine practice by all health professionals, especially for those drugs that have recently beenmarketed.
Keywords: Pharmacoepidemiology. Colombia. Drug utilization. Medicamentous disease. Secondary effect. Emergency medicalservices. Hospitalization. Ambulatory care.
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