Signal detection of adverse drug reaction to first line anti tuberculosis drugs using the Indonesian pharmacovigilance database

Abstract

Introduction: Pharmacovigilance is a key component to identify risks associated with drug use. The safety of antituberculosis drugs (ATDs) is a concern. Aim: To detect first-line ATD signals in the Indonesian pharmacovigilance database. Methods: A retrospective cohort with a sample report of ADRs obtained from the National Agency of Drug and Food Control (NADFC) from 2012 to May 2018. The validity was seen from the completeness of the data. The signals found were verified against registered product labels, books, and reports from other countries' databases. Results: ATD ADRs reported was 5.3%. The ATD that met the requirements as a signal was rash maculopapular (PRR 4.53; ROR 6.19; IC 0.74 and p=035) for Rifampicin-Isoniazid-Pyrazinamide-Ethambutol (RHZE) and rash (PRR 2.94; ROR 4.23; IC 1.41 and p=0.046) for RH. Conclusion: Safety signals detected in the Indonesian pharmacovigilance database between 2012 and May 2018 were rash maculopapular.