Hospital based Intensive Medication Safety Monitoring; an Observational Prospective Study in a North Indian Private Tertiary Care Teaching Institute

Objective: To identify and characterize adverse drug reactions (ADRs) in patients admitted in intensive care units and wards of a private tertiary care hospital. Materials and Methods: This prospective, observational study was conducted on inpatients. During their hospital stay, whenever a new symptom unrelated to disease or change in laboratory values was observed; ADR was identified using World Health Organisation's definition and recorded in the patient's case sheet. ADRs were classified based on Naranjo's probability scale, Modified Hartwig's criteria of severity and Schumock-Thornton preventability scale. Further, ADRs were analyzed in terms of age, gender, organ system involved, number of medications, and length of stay. Results: Of the 1000 study patients, 35 patients developed 43 ADRs (reported incidence: 3.5%). Twenty-seven patients developed one ADR, while eight patients developed 2 ADRs each. Anti-infective drugs were suspected to have caused the majority (44%) of the ADRs. The most affected organ systems were the gastrointestinal system (44%) and hematological system (26%). On the causality scale, 81.39% ADRs were probably related to suspected medications. About 91% ADRs were probably preventable and 58% ADRs were moderately severe. Number of patients with ADRs was significantly more (P < 0.05) in patients (51.42%) prescribed >11 medications. Further, the number of patients with ADRs was significantly more (P < 0.05) among patients (80%) with a longer stay (>6 days); suggesting, polypharmacy and length of patient's stay as important contributors to developing ADRs. Conclusion: Medication use is majorly associated with the occurrence of ADRs in inpatients. Such surveys on a larger scale would be a useful effort in making medication use safer.