A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

Abstract

Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. Identification of ADRs and their reporting pattern can provide useful information for their prevention. Hence this study was done to see the pattern of reported ADRs in Patna Medical College and Hospital, Patna in a 3 months of study.Methods: It was an observational and retrospective study carried out between July 2022 to September 2022. Both outpatients and inpatients were included in the study. The ADRs in the form of Individual Case Safety Reports (ICSRs) were sent to the nearby adverse drug reaction monitoring centre (AMC).Results: The occurrence of ADRs was more common in females (56.25%) as compared to males (43.75%). Patients of age-group 21-40 years (40.625%) were most commonly involved. Medicine department (34.375%) reported the maximum percentage of ADRs. Antimicrobials (37.50%) was the most common drug-group causing ADRs. Maximum reported ADRs (81.25%) were probable, 9.375% were possible, 6.25% were certain, while 3.125% were unlikely with the suspected drug as per Naranjo scale.Conclusions: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital setup elsewhere, along with a few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

Adverse drug reaction monitoring of commonly prescribed antimicrobial agents in patients at Rama medical college, hospital and research centre, Kanpur

“…The NPPV of India was launched in 2010 to monitor the safety of drugs in India, but the reporting of ADRs is still voluntary, and under-reporting is a major problem. 17 A study published in the Indian Journal of Medical Sciences in 2021 found that the reporting rate of ADRs to antimicrobials in India was only 0.07%, which is much lower than the estimated incidence of ADRs. 18 The current study was to identify the incidence and pattern of adverse drug effects (ADRs) of antimicrobial drugs.…”

“…A study published in the Indian Journal of Pharmacology in 2022 found that the incidence of ADRs to antimicrobials in India was 17.7%, with the most common ADRs being skin reactions, gastrointestinal reactions, and allergic reactions. 17 In terms of ADR reporting on antimicrobials, India is still in its early stages. The NPPV of India was launched in 2010 to monitor the safety of drugs in India, but the reporting of ADRs is still voluntary, and under-reporting is a major problem.…”