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Prospective observational study to evaluate adverse drug reactions pattern in a tertiary level teaching hospital

Vaishali S Thakare, Kavitha VD, Deepak Langade.


Background: Adverse drug reactions (ADRs) are a major cause of morbidity and hospitalizations have consistently increased, leading to economic burden to developing countries like India. Identification of ADRs and their reporting pattern can provide useful information for their management.

Aims and Objectives: The objective of the study was to assess the pattern of ADRs in tertiary care teaching hospital with respective to various parameters.

Materials and Methods: The present study was an observational, prospective study. ADR reports of 40 patients were collected from various clinical departments of Dr. D. Y. Patil School of Medicine, Navi Mumbai. The ADRs were collected during January 2018–July 2018, with ADR reporting form of Central Drugs Standard Control Organization, New Delhi. Data were analyzed using descriptive statistics.

Results: A total of 40 ADRs were reported during this study; the mean age of the patients being 43.14 (±2.27) years. Gender distribution of the patients showed 26 (65%) female preponderance. The majority of ADRs were implicated to pulmonary department 13 (32.5%) and least in OBGY 2 (5%). Using Naranjo’s causality assessment scale, there were 24 (60%) probable, 12 (30%) possible, and 4 (10%) doubtful/unlikely causality of the ADR with the suspected offending drug.

Conclusion: We conclude that antitubercular, injectable iron, pentavalent vaccines, and psychotropic drugs are responsible for most of the ADRs and middle-aged population are most commonly affected with ADR. Completeness score was an average of 32.2 ± 2.6. The completeness score can be improved if the reporter spends sometime considering its their moral responsibility.

Key words: Pharmacovigilance; Causality; Adverse Drug Reaction; Evaluation of Adverse Drug Reaction Reporting Pattern

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