title: Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form.
abstract: Despite comprehensive and stringent phases of clinical trials and surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after the drug is marketed. ADR reporting is an important aspect of an efficient and effective pharmacovigilance program. Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and reports, a number of countries design and use their respective ADR forms. This review compares similarities and dissimilarities of 13 ADR forms of countries representing their geographical location. This study extracted 73 data elements mentioned in 13 different ADR forms. Only 13 elements were common. An ADR form of Malaysia and Canada covers the highest number of data 43, while Brazil falls to the opposite end with a number of 17 data elements in lieu with the Generic ADR Form. The result of this review highlights 58 data elements of the proposed generic ADR form which ensures that requisite reporting information essential for correct causality assessment of ADRs are included. The proposed "Generic ADR form" could be adopted worldwide mandatorily for reporting any/all ADRs associated with marketed drugs.
authors.affiliation: Care Institute of Medical Sciences, Ahmedabad, Gujarat, India.
authors.forename: Anshi
authors.initials: A
authors.lastname: Singh
authors.forename: Parloop
authors.initials: P
authors.lastname: Bhatt
keywords: Causality assessment; generic form; pharmacovigilance