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A critical comparison of pharmacovigilance reporting forms in six countries with the WHO-UMC recommendations (form of
Saurav Misra1, Manmeet Kaur1, Jayant Kumar Kairi1
1Department of Pharmacology, Kalpana Chawla Government Medical College, Karnal, India.
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.
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