A cross-sectional study of patterns of adverse drug reactions reported in the department of pharmacology of a tertiary care teaching hospital in North East India

Shanta Das Sutradhar, Debasis Ray, Tutor
International Journal of Comprehensive and Advanced Pharmacology   unpublished
Adverse Drug Reactions (ADRs) are a great cause of concern to the general public, medical profession, the patients and the pharmaceutical industry. For this reason Pharmacovigilance, which is an evolving science dedicated for reducing medicine related harm to patients, is a good tool for ensuring safe and effective use of medicine. The information may be useful in identifying and minimizing preventable ADRs, while generally enhancing the knowledge of the prescribers to deal with them more
more » ... ith them more efficiently. There are hardly any studies regarding ADR patterns in North East India. Hence a study was undertaken to record and analyze the pattern of adverse drug reaction in a Tertiary Care Hospital of North East India. Materials and Methods: All the ADRs that were collected in ADR monitoring centre of Department of Pharmacology of our Institute during the period of January 2015 to July 2016 were analysed according to demographic distribution, organ system wise distribution, most commonly involved drugs associated with ADRs and causality analysis was done by using WHO causality analysis scale. Results: Only 272 ADRs were reported during the 18 months study period. Females were affected more than males. Skin and subcutaneous tissue was the most commonly affected system followed by GIT and CNS. Among drug classes anticancer agents were responsible for highest number of ADRs followed by 3 rd generation Cephalosporin and NSAID Aceclofenac. Conclusion: The ADR reporting rate is very less in our study. So there is an urgent need streamlining of hospital based ADR reporting and monitoring system to create awareness and to promote the reporting of ADR among Healthcare Professionals.