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A novel way to overcome the challenge of under-reporting of adverse drug reactions in a tertiary care hospital: A pharmacovigilance study

Shailander Singh, Lokesh Patil, Radhika B Patil.


Background: Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health-care costs all over the world. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects, or any other drug related problems. Thus, the information generated is useful in educating doctors about ADRS as well in the official regulation of drug use. However, the pharmacovigilance program faces the challenge of under reporting of ADRs and one needs to find the ways to overcome it.

Aim and Objectives: The aim of the study was to improve the reporting of ADRs from the hospital and overcome the problem of under-reporting of ADRs.

Materials and Methods: A prospective observational study was conducted as part of pharmacovigilance program over 6 months between June 2021 and December 2021. Undergraduate students were trained to collect cases of ADR from hospital during their clinical postings. The details of cases obtained by such active surveillance were filled into suspected ADR–CDSCO forms and submitted to pharmacovigilance unit. Causal relationship was assessed and categorized by Naranjo algorithm and WHO-UMC causality scale. All values were expressed in percentages.

Results: A total of 120 cases were reported over 6 months compared to just 20 cases during the past year. Among them, 66% were in males and 55% were in females. The majority of ADRs were due to antimicrobial agents (40.78%) followed by hematinics (12%) and anti-epileptics (10%). The maximum number of patients (30.25%) reported with dermatological manifestations. The highest number of ADRs was reported from the Department of Medicine (45%). As per Naranjos scale, 54% reports were assessed as probable and 46% as possible.

Conclusion: This new way of training and involving undergraduates significantly improved the number of ADR cases being reported to the pharmacovigilance center. This helped overcome the problem of under reporting of cases and has strengthened the pharmacovigilance activity in our institute.

Key words: Adverse Drug Reactions; Under Reporting; Adverse Drug Reaction Reporting Systems; Pharmacovigilance

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