European Journal of Biomedical and Pharmaceutical Sciences

ANALYSIS OF PHARMACOVIGILANCE DATA AT THE ADVERSE DRUG MONITORING CENTRE PERTAINING TO ANTI TUBERCULAR DRUGS -A RETROSPECTIVE CROSS-SECTIONAL STUDY

Dr. M. Nandhini Priya M.D., DTCD., *Dr. S. Anusha M.D.* and Dr. N. Shanthi M.D.

ABSTRACT

Background: The pharmacovigilance programme of India aims to improve patient safety and welfare of Indian population by identifying and analysing new signals from the reported cases and generating evidence based information on safety of medicines. The purpose of this study is to collect the data of adverse drug reactions to the antitubercular drugs and analyse them. India accounts for one fourth of global tuberculosis burden. In 2017, elimination of tuberculosis in India by 2025 was announced as a national goal. Antitubercular drugs are more prone to cause adverse drug reactions. This in turn may lead to poor compliance paving way for the development of drug resistance tuberculosis. Early detection and proper management minimizes this risk. The vision is to communicate the safety information to the health care professionals and public hence reducing the drug related complications. Methodology: This is a retrospective cross sectional study of adverse drug reactions reported to the adverse drug reactions monitoring centre regarding the antitubercular drugs. The data collected were from the CDSCO’s adverse drug reactions reporting form, reported in the time period of June 2015 – July 2017. Results: The demographic pattern, causality, severity of the adverse drug reactions were analysed. 187 adverse drug reactions were reported during the study period which included 133 men and 54 women. The mean age of the reported adverse drug reactions was 46.4±17.59 years. Among the antitubercular drugs pyrazinamide was more prone to cause adverse drug reactions followed by streptomycin. In 62.6% of cases the antitubercular drugs were the probable cause and in 37.4% of adverse reactions ATT were the possible cause. 91.4% of them were non serious and 8.6% of them were serious adverse drug reactions. Most common adverse drug reaction reported was dermatological reactions followed by gastrointestinal and neurological side effects. The study showed that there was a significant association between the causality and seriousness of the adverse reactions encountered. Conclusion: This study serves to stress the importance of pharmacovigilance programme, create awareness and intensify the ADR reporting by the health care workers. This is also useful in educating the drug related complications to the patients and the public.

Keywords: Adverse drug reactions, pharmacovigilance, antituberculosis drugs, causality, severity.