Background: Adverse drug reactions (ADRs) are unintended and harmful reactions to medications that occur at doses normally used for therapeutic purposes. The reporting of ADRs is essential for the identification and prevention of ADRs.
Aims and Objectives: The aim of the study was to estimate the frequency and distribution of spontaneously reported ADRs in the tertiary care teaching hospital.
Materials and Methods: A retrospective cross-sectional study was conducted from July 2020 to June 2023, from spontaneously reported ADRs by the ADR Monitoring Centre, MGM Medical College, Kishanganj, Bihar. Distribution of age, gender, department, medication groups, and systems involved were examined. Utilizing certain scales, causality, severity, and preventability were evaluated.
Results: Total 47 ADRs were reported during the study period. The most common ADRs were cutaneous ADRs (n = 19,40.43%) followed by the central nervous system (CNS) (n = 12, 25.53%), gastrointestinal system (GI) (n = 9, 19.15%), musculoskeletal (n = 4, 8.51%) and others. The most commonly implicated drugs were Antibiotics (21.28%) followed by analgesics (12.77%), DMARD (12.77%), antihypertensive (12.77%), and others shown in the study. The severity assessment of ADRs was done by Modified Hartwig et al. severity assessment scale and was found mild (87%), followed by moderate (8.5%) and severe (4.3%). Using the modified Schumock and Thronton preventability scale preventability assessment of ADRs was done and was found 51.06% of ADRs were definitely preventable, 38.30% were probably preventable and 12.77% of ADRs were not preventable.
Conclusion: The findings of this study emphasize the significance of pharmacovigilance and the requirement that medical personnel be knowledgeable about the indications and symptoms of ADRs.
Key words: Adverse Drug Reaction; Pharmacovigilance Programme of India; Cross-sectional Study; Health-care Professionals
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