Detection, Monitoring and Assessment of Adverse Drug Reactions at a Private Corporate Hospital

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 In 29 (66 %) cases the drug was withdrawn, dose altered in 8 (18.2 %) and no change was made in 7 (16 %) patients.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 patients Quality of Life. The results were circulated to all the healthcare professionals.