MONITORING AND REPORTING OF ADVERSE DRUG REACTIONS WITH ANTIMICROBIAL AGENTS IN A TERTIARY CARE HOSPITAL

S M. Biradar*, Nikita Katti, N V. Kalyane, Ch. Srinath Reddy.,
Vinod M. and V Aishwarya.

ABSTRACT

Background: Antimicrobials are the most frequently prescribed drugs among hospitalized patients. Antimicrobial resistance, adverse drug reactions (ADRs) and ADRs in biological systems substantially raises health care costs and increases patient’s morbidity and mortality rate. With respect to above perspective, the present research was carried out to study the type of ADRs, severity, preventability, probability and Consequences of ADRs involved with the prescription of antimicrobial agents. The commonest drugs involved in ADRs, features of ADRs and biological systems involved in ADRs also been studied. Methods: A prospective study was carried out for a period of 9 months from Jan. 2014 to Sept. 2014 with the sample size of 160 patients. ADRs were assessed from the in-patient’s case report from, yellow forms, medication chart and through patient interviews. ADRs were evaluated by using different scales, such as Naranjo’s Assessment scale for Probability, Modified Hartwig Scale for severity and Modified Shumock & Thoronto Scale for Preventability of ADRs. Results: A total number of 160 patients were included in to the study population, out of which 92(57.5%) were males and 68(42.5%) were females. The higher number of ADR’s were seen in male (28) compared to female patients (23). Majority of ADRs occurred in age the group of 36-45 yrs. Out of 51 ADRs, 21 were during hospital admission, 13 were due to ADR induced hospital stay, 12 were during chart review and 5 were through spontaneous reporting. Among 51 ADRs Type A were 39 and Type B were 12 in number. According to Naranjo’s probability assessment scale most of ADRs were possible 29 and probable were 22. Using the Modified Hartwigscale the ADRs were divided into mild 10 (19.60%), moderate 28 (54.90%), severe 13 (25.49%). According to Modified Shumock & Thoronto criteria Preventability assessment of ADRs were divided into Not preventable 01 (1.96%), probably preventable 41(80.39%) and definitely preventable were 11 (21.56%). The commonest system/organ involved in ADRs were skin accounting for 14 (56.20%), Heamatic 13(41.61%), GIT 9 (34.46%), Hepatobiliary 7 (36.01%), Opthalmic 4 (16.61%), musculoskeletal 2 (7.14%) and CNS 1 (4.34%). In 51 ADRs 10 (19.60%) were of the type anaemia, followed by blurred vision, hepatomegaly.Anti viral agents were found to be major class involved in ADRs around 37.25%. Conclusion: A wide range of ADRs may be produced with many numbers of prescribed drugs including antimicrobial agents; hence every health care professional must have to update the knowledge drug’s ADRs and be cautious while prescribing the drugs. The present study provides the greater possibilities of ADRs of antimicrobials agents, which could be helpful to the prescribers for the selection of antimicrobials agents with least ADRs for better patient compliance.

Keywords: Prospective study, Antimicrobial Agents, Adverse Drug Reactions.