Cross-Language Comparison of Pharmacovigilance Reporting Errors in India

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Er. Priyanshi

Indian Institute of Information Technology Guwahati (IIITG)s

Assam, India

priyanshi@iitg.ac.in

Abstract

Pharmacovigilance (PV) in India faces unique challenges due to the country’s vast linguistic diversity, which can lead to reporting errors, misinterpretations, and underreporting of adverse drug reactions (ADRs). This manuscript presents a comprehensive cross‑language comparison of PV reporting errors across five major Indian languages—Hindi, Bengali, Tamil, Telugu, and Marathi—benchmarked against English‑language reporting. Employing a convergent mixed‑methods design, we analyzed 1,200 ADR report forms submitted to the Pharmacovigilance Programme of India (PvPI) over a 12‑month period, categorizing errors into data‑entry inaccuracies, terminological inconsistencies, and semantic misinterpretations. Quantitative analysis demonstrated that non‑English reports exhibited a 23.5% higher overall error rate, with semantic misinterpretations most prevalent in Bengali (18.2%) and Tamil (16.7%) submissions. Qualitative interviews with 50 PV staff and 100 reporting healthcare professionals revealed systemic factors driving these discrepancies: the absence of standardized medical terminology in regional languages, inadequate training in PV concepts delivered in vernacular, low familiarity with technical scripts, and the constraints of high patient caseloads. We further explore how script mismatches—such as the use of Latin script for native terms—and reliance on colloquial descriptors compromise data integrity. Based on these insights, we propose three strategic interventions: (1) the development and dissemination of a centrally maintained, multilingual PV terminology glossary; (2) the implementation of targeted, language‑specific training modules and workshops for clinicians, pharmacists, and PV coordinators; and (3) the adoption of an electronic reporting platform featuring built‑in language‑support tools, real‑time script validation, and standardized term autocomplete functionality. Together, these measures aim to reduce error rates, enhance ADR signal detection sensitivity, and strengthen India’s overall drug‑safety monitoring infrastructure, thereby improving patient outcomes and fostering greater confidence in the healthcare system.

Keywords

Pharmacovigilance, adverse drug reactions, reporting errors, cross‑language comparison, India

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