Abstract

"A prospective-observational study to detect, document, assess and report the suspected Adverse Drug Reaction was conducted in a private corporate hospital. Suspected ADRs were analyzed for causality, severity and preventability using appropriate validated scales. ADR alert card was prepared and given to patients. A total of 44 ADRs were identified in 3237 general medicine ward admissions during the study period. Severity of the suspected ADRs assessed using Modified Hartwig and Siegel Scale, revealed that 2(4.5%) suspected ADRs were severe, 27 (61.4%) ADRs were moderate and 15(34.1%) ADRs were mild in severity. Causality assessment was done by Naranjo scale showed that 26(59.1%) ADRs were possibly drug-related, whereas 18(40.9%) were classified as probably or definitely related to the drug.9 patients (20.5%) were admitted due to an Adverse Drug Reaction compared to 35(79.4%) who were affected by ADR after hospital admission.The majority (36.5%) of patients who suffered from ADRs were above 30 years. System most commonly affected were Dermatological 16(36.3%), Gastrointestinal 9 (20.4%), CNS 4(9.1%) and Cardiovascular 2(4.5%). The drug class mostly associated with ADR was Antibiotics in 14(31.8%) and NSAID in 8(18%). In 29 (66%) cases the drug was withdrawn, dose altered in 8(18.2%) and no change was made in 7(16%) patients. The final outcome revealed 41(93.2%) got recovered, while in 3(68%) cases the ADRs decreased. No fatal case was reported in our study.Preventability of ADRs were assessed by using Modified Schumock and Thornton scale which revealed that 35(79.5%) ADRs were definitely preventable while 3(6.8%) ADRs were probably preventable. Our study documented an increased risk of suspected ADRs in elderly patients, and almost 85% of reactions were preventable.. Intervention was required in all ADRs as it indirectly contributed to affect the patient’s Quality of Life. The results were circulated to all the healthcare professionals. "

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