A critical comparison of pharmacovigilance reporting forms in six countries with the WHO-UMC recommendations (form of the form)

Saurav Misra; Manmeet Kaur; Jayant Kumar Kairi

doi:10.1515/jbcpp-2025-0084

Artikel

A critical comparison of pharmacovigilance reporting forms in six countries with the WHO-UMC recommendations (form of the form)

Saurav Misra , Manmeet Kaur und Jayant Kumar Kairi

Veröffentlicht/Copyright: 17. Juli 2025

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Aus der Zeitschrift Journal of Basic and Clinical Physiology and Pharmacology Band 36 Heft 4

Abstract

Objectives

This study will identify strengths and weaknesses of ADR reporting forms of study countries.

Methods

This was an observational study conducted at the Department of Pharmacology at Kalpana Chawla Government Medical College, Karnal. We obtained the WHO-UMC adverse event reporting guidance document for designing the ADR form for member countries. We similarly collected and analysed ADR forms from Australia, Canada, India, South Africa, the UK, and the US. Data fields were grouped into different subgroups.

Results

An analysis of ADR reporting forms from six countries revealed a total of 70 data fields. The US-FDA’s FORM 3500 has the most fields at 50 (71 %), followed by India’s CDSCO with 42 fields (60 %). According to WHO-UMC recommendations, Canada and Australia have the highest number of suggested fields at 10 (83 %). All forms were one page long except for the US-FDA’s, which is five pages.

Conclusions

Improving patient feedback and organisational engagement is essential to raise awareness of the reporting system. A proposed generic ADR form provides detailed information for causality assessment and could serve as a basis for a standard global reporting form.

Keywords: pharmacovigilance; World Health Organization (WHO); Uppsala Monitoring Center (UMC); adverse drug reactions (ADRs)

Corresponding author: Dr. Saurav Misra, MBBS, MD, Assistant professor, Department of Pharmacology, Kalpana Chawla Government Medical College, Karnal, India, E-mail: saurav181087@gmail.com

Research ethics: The local Institutional Review Board deemed the study exempt from review.
Informed consent: Not applicable.
Author contributions: SM - Study conception and design, review and editing, supervision, Draft manuscript, review and editing. MK - Study conception, methodology, Data collection, Data analysis and interpretation of results, Draft manuscript, review and editing. JKK - Study conception and design, review and editing, supervision.
Use of Large Language Models, AI and Machine Learning Tools: None declared.
Conflict of interest: The authors state no conflict of interest.
Research funding: None declared.
Data availability: Yes.

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Received: 2025-05-03

Accepted: 2025-06-28

Published Online: 2025-07-17

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Artikel in diesem Heft

https://doi.org/10.1515/jbcpp-2025-0084

Schlagwörter für diesen Artikel

pharmacovigilance; World Health Organization (WHO); Uppsala Monitoring Center (UMC); adverse drug reactions (ADRs)