Reporting Adverse Drug Reactions With Emphasis on the Designing National Minimum Data Set

One of the most common causes of death is the adverse drug reactions. The volume and dispersion of information is one of the problems of information systems for registering unwanted adverse drug reactions. This study aims to design a National Minimum Dataset (NMDS) for reporting the unwanted adverse drug reactions.

 This descriptive-comparative study was conducted in Mashhad University of Medical Sciences in 2020 in three steps. The first step was to review the literature by searching in PubMed, Web of Science, and Scopus databases with a publication year over 10 years conducted countries leading in the field of reporting unwanted adverse drug reactions. Then, the reporting process of the selected countries was studied. In the final phase, the proposed NMDS was validated using the Delphi technique based on the opinion of 15 experts.

Out of 109 data elements, 45 elements were polled, of which 33 obtained the necessary points in the first stage of Delphi process and 6 elements in the second stage. They were finally categorized into 7 groups; Patient information (8 elements), hospital (2 elements), complication (7 elements), medication (11 elements), the drug preparation method (3 elements), the reporter (4 elements), and others (4 elements).

Reporting adverse drug reactions is considered as an important part of drug monitoring and safety internationally. Therefore, based on the obtained results, this set of minimum data can be used for the Iranian reporting system to avoid the scattering of non-practical information and reports.