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Epidemiology and policy
SP3-52 A difference in ADRs (adverse drug reactions) mortality rate in Thai tuberculosis patients between year 2008 and 2009
  1. S Wechwithan,
  2. P Sriphiromya
  1. Health product Vigilance Center, Nonthaburi, Thailand

Abstract

Background Surveillance of adverse drug reactions in Thailand is conducted through the spontaneous voluntary reporting system by hospital pharmacists and healthcare professionals. Adverse drug reactions reports have been collected in national spontaneous reporting database called Thaivigibase since year 1985. Public health program using medicine in AIDS, Tuberculosis (TB) control program have collected the patients' records. Integrating public health program in TB patients and spontaneous reporting system can receive ADRs mortality rate compare difference in anti-tuberculosis drug group. This ADR mortality rate may reflect TB drug group safety surveillance system.

Objective This study is aimed to compare difference in ADRs mortality rate in Thai tuberculosis patients, between year 2008 and 2009.

Study Design Descriptive observational study design is used for this study.

Materials and Methods Adverse reaction reports of patients to anti tuberculosis drugs from Thaivigibase and TB patient disease surveillance database from Bureau of Epidemiology during year 2008–2009 were retrieved and calculated. The pattern of spontaneous fatal adverse reactions to anti-tuberculosis drugs were described by analysing the data from Thaivigibase between year 2008 and 2009.

Results/Conclusion ADRs mortality rates to anti-tuberculosis drugs were 1.97 per 1000 patients in year 2009 compared with 4.35 per 1000 patients in year 2008. Stevens–Johnson Syndrome and hepatitis resulting in fatal outcome were detected in patients taking rifampicin, ethambutol, isoniazid and pyrazinamide. Anaphylactic shock was observed in patients with injected streptomycin. Skin and appendages disorders was the most common adverse effects reported. The result can be predictor of TB surveillance system to develop plan for TB patients surveillance.

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