Impact of an Active Pharmacovigilance Program in a Third-Level Clinic in Barranquilla, Colombia

Abstract

Abstract:The objective of this study is to assess the impact of APV (active pharmacovigilance) and PPV (passive pharmacovigilance) by detection of ADEs (adverse drug events), through PIs (pharmaceutical interventions). Authors have used observational pre-post intervention study. Dader methodology was used in 123 patients with data obtained from medical records and pharmaceutical interview. Detection of ADE was made by direct observation and laboratory tests, with statistical significance 0.05. In PPV, 47 ADEs were detected: nausea, vomiting, skin rash and skin redness. In APV, 100 ADEs are presented, similar to those described in the PPV, in which Dipyrone produced 26.2%. The causes of DRPs (drug related problems) were: probability of adverse events 36%, personal characteristics 30%, and dose regimen and/or inadequate duration 22%. Out of 127 PIs performed, 91.34% were accepted and resolved. The patient satisfaction rate was 82.7% for APV and doctor satisfaction 90.4% with high impact, surpassing the 80%. The impact of APV was 93.6% and 53% in PPV for PIs and ADEs. PIs were performed to the ADEs with a high percentage of accepted and solved ones. Evaluation of satisfaction of patients and doctors in APV had a high impact. The assessment of APV generated a high impact on compliance and PPV a low one.