M R M, Karant C, BVS C, K S. A Retrospective analysis of adverse drugs reactions at a tertiary care center – patterns, causality, predictability and preventability. Pharm Biomed Res 2025; 11 (3)
URL:
http://pbr.mazums.ac.ir/article-1-688-en.html
1- Karwar Institute of Medical Sciences
2- GSL Medical College and General Hospital
3- Yadgiri Institute of Medical Sciences
Abstract: (22 Views)
Background: Adverse drug reactions (ADRs) are associated with significant morbidity and mortality. They can cause negative impact on health care resources and financial burden to patients.
Objectives: To assess the causality, severity, predictability and preventability of reported ADRs as per the standard scales.
Methods: A retrospective observational study was conducted in KRIMS, Karwar from April 2018 – August 2019. All suspected ADRs reported from the outpatients and inpatients of various clinical departments were collected and analyzed.
Results: A total of 159 ADRs were reported from 136 patients. Majority of the patients were adults aged 18-65 years (88.2%). Female preponderance was noted. The skin and the CNS were the predominant organ systems affected (29.6% each). The most common ADRs reported were rashes (14.5%) followed by sedation (8.2%). Antibiotics were the most common drug class involved (38.5%). Among the individual drugs, beta lactam antibiotics were the most common drugs implicated (16%). Most of the drugs causing ADRs were administered by oral route (67.5%). The causality of the reported ADRs was probable in 64.2%. Most of the reported ADRs were non-serious (91.2%). 61% of the patients experiencing ADRs recovered completely. 83.6% of ADRs were mild. 51.6% of ADRs were predictable. 85.5% of ADRs were not preventable. Majority of the ADRs subsided after withdrawing the offending drug (66.7%).
Conclusion: Early detection of causal relationship between drugs and adverse reactions is important for its effective management and prevention.