RESEARCH PAPER
Year : 2020  |  Volume : 11  |  Issue : 1  |  Page : 19-24

Hospital based intensive medication safety monitoring; an observational prospective study in a north Indian private tertiary care teaching institute


1 Department of Pharmacology, MMIMSR, Maharishi Markandeshwar Deemed to be University (MMDU), Ambala, Haryana, India
2 Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Mohali, Punjab, India

Correspondence Address:
Pramil Tiwari
Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Mohali - 160 062, Punjab
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpp.JPP_109_19

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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.


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