Abstract

BackgroundThe Systematic Nomenclature of Medicine Clinical Terms (SNOMED CT) is being advocated as the foundation for encoding clinical documentation. While the electronic medical record is likely to play a critical role in pharmacovigilance - the detection of adverse events due to medications - classification and reporting of Adverse Events is currently based on the Medical Dictionary of Regulatory Activities (MedDRA). Complete and high-quality MedDRA-to-SNOMED CT mappings can therefore facilitate pharmacovigilance.The existing mappings, as determined through the Unified Medical Language System (UMLS), are partial, and record only one-to-one correspondences even though SNOMED CT can be used compositionally. Efforts to map previously unmapped MedDRA concepts would be most productive if focused on concepts that occur frequently in actual adverse event data.We aimed to identify aspects of MedDRA that complicate mapping to SNOMED CT, determine pattern in unmapped high-frequency MedDRA concepts, and to identify types of integration errors in the mapping of MedDRA to UMLS.MethodsUsing one years' data from the US Federal Drug Administrations Adverse Event Reporting System, we identified MedDRA preferred terms that collectively accounted for 95% of both Adverse Events and Therapeutic Indications records. After eliminating those already mapping to SNOMED CT, we attempted to map the remaining 645 Adverse-Event and 141 Therapeutic-Indications preferred terms with software assistance.ResultsAll but 46 Adverse-Event and 7 Therapeutic-Indications preferred terms could be composed using SNOMED CT concepts: none of these required more than 3 SNOMED CT concepts to compose. We describe the common composition patterns in the paper. About 30% of both Adverse-Event and Therapeutic-Indications Preferred Terms corresponded to single SNOMED CT concepts: the correspondence was detectable by human inspection but had been missed during the integration process, which had created duplicated concepts in UMLS.ConclusionsIdentification of composite mapping patterns, and the types of errors that occur in the MedDRA content within UMLS, can focus larger-scale efforts on improving the quality of such mappings, which may assist in the creation of an adverse-events ontology.

Highlights

  • The Systematic Nomenclature of Medicine Clinical Terms (SNOMED CT) is being advocated as the foundation for encoding clinical documentation

  • We describe the issues that were encountered in an exercise aimed at creating a map between Medical Dictionary of Regulatory Activities (MedDRA) and SNOMED CT, focusing on highfrequency MedDRA terms for adverse reactions and therapeutic indications in one year’s worth of Adverse Events Reporting System (AERS) data, which was recorded between July 1, 2008 and April 30, 2009

  • We summarize the highlights of the mapping below: when we use a concept ID of the form Cnnnnn, we refer to the Unified Medical Language System (UMLS) CUI

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Summary

Introduction

The Systematic Nomenclature of Medicine Clinical Terms (SNOMED CT) is being advocated as the foundation for encoding clinical documentation. Within the US and internationally, the controlled vocabulary that forms the basis of adverse event reporting, both for post-marketing surveillance as well as for drug agency-regulated clinical trials, is the Medical Dictionary for Regulatory Activities (MedDRA) [11], developed by the International Conference on Harmonization (ICH). The “Adverse Events” include errors in prescribing, dispensing and formulation of therapeutic agents, interactions of drugs with other drugs or food, as well as errors that were intercepted before they reached the patient Both SNOMED CT and MedDRA are components of the Unified Medical Language System (UMLS) [12], a compendium (“meta-thesaurus”) of a large number of biomedical vocabularies that is distributed by the National Library of Medicine (NLM)

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