Tabulation and analysis of pharmacovigilance data using the medical dictionary for regulatory activities

Under ICH agreements MedDRA(TM)dagger will become the standard for electron ic transmission of safety data between companies and regulatory authorities . The practical implications of its use have not yet been widely discussed. This paper addresses some issues in the analysis of safety data using MedD RA with emphasis on construction of appropriate search strategies using its hierarchical and multiaxial structure. For illustration purposes, a test database was built from spontaneous: adve rse reaction data for a single constituent product held on the UK ADROIT da tabase. Flexible search software was employed in order to build varied sear ches and interrogate the database in an interactive manner for purposes of performing test analyses and to provide a training tool. The results of the analyses illustrated that, while MedDRA provides a compr ehensive framework for pharmacovigilance analysis, there must be detailed m edical understanding of the: issues before searches are performed. The mult iaxial nature of MedDRA allows flexibility in approach to data retrieval. H owever, the data retrieved in Primary and Secondary System Organ Class sear ches may differ according to the axis on which a search is based. In order to help standardize retrieval, further development of Special Search Catego ries mediated by the maintenance organization might be useful. Copyright (C ) 2000 John Wiley & Sons, Ltd.