title: Quality check of spontaneous adverse drug reaction reporting forms of different countries.
abstract: Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.
authors.affiliation: Department of Infectious Diseases and Department of Interdisciplinary Research and Technology, Maharashtra University of Health Sciences, Maharashtra, India.
authors.forename: M S
authors.initials: MS
authors.lastname: Bandekar
authors.forename: S R
authors.initials: SR
authors.lastname: Anwikar
authors.forename: N A
authors.initials: NA
authors.lastname: Kshirsagar
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006761:Hospitals / Q000706:statistics & numerical data; D006801:Humans; D020407:Internet; D011787:Quality of Health Care