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

Under ICH agreements MedDRA(TM) will become the standard for electronic 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 MedDRA with emphasis on construction of appropriate search strategies using its hierarchical and multiaxial structure.For illustration purposes, a test database was built from spontaneous adverse reaction data for a single constituent product held on the UK ADROIT database. Flexible search software was employed in order to build varied searches 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 comprehensive framework for pharmacovigilance analysis, there must be detailed medical understanding of the issues before searches are performed. The multiaxial nature of MedDRA allows flexibility in approach to data retrieval. However, the data retrieved in Primary and Secondary System Organ Class searches may differ according to the axis on which a search is based. In order to help standardize retrieval, further development of Special Search Categories mediated by the maintenance organization might be useful. Copyright (c) 2000 John Wiley & Sons, Ltd.