SETYO UTAMI, 051614153011 (2018) DETEKSI SINYAL KEAMANAN OBAT ANTI TUBERKULOSIS LINI PERTAMA (Studi Pada Database Farmakovigilans Indonesia). Thesis thesis, Universitas Airlangga.

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Abstract

Pharmacovigilance (PV) is a key component of the drug regulatory system to identify risks associated with drug use. The safety of antituberculosis drug (ATDs) is a concerned because of the increase of Multi-Drug Resistance (MDR) cases and the number of reported ADRs. This study aimed to detect the First Line ATD signals in the Indonesian Pharmacovigilance database. The research method used was a retrospective cohort used the report of ADRs in the Indonesian Pharmacovigilance database in National Drug and Food Control (NADFC) from 2012 to May 2018. The data validity was indicated by data completeness. Data analysis determines ADRs profiles and the calculation of PRR, ROR, and IC. The signals found were verified against registered product labels, standard books, and reportage from other countries' databases. ADRs ATD reported was 5.3% of the total report on Indonesian PV database. The most ADRs were digestive disorders, skin disorders, and hepatic disorders. Nausea was the most widely reported. There were 2 ADRs from 2 firstline ATD combinations that confirm the requirements as a signal, RHZE combinations that were rash maculopapular (PRR 4.53; ROR 6.19; IC 0.74 and p = 0.035) and RH combinations that were rash (PRR 2, 94; ROR 4.23; IC 1.41 and p = 0.046). A confirmed signal of RHZE in Indonesian PV database was rash maculopapular. To conclude, Safety signal of 1st line ATD (RHZE combination) has detected in Indonesian PV database was rash maculopapular.

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