Thomas R. Fulda

Methodology for assessing drug-drug interaction evidence in the peer-reviewed medical literature

Abstract Objective The aim of this study was to create a methodology for evidence-based assessment of published drug-drug interaction information and presentation of that information in a standardized format. Background Inconsistencies in drug-drug interaction information among major medical compendia have been documented and are of major concern to physicians, pharmacists, drug utilization review (DUR) program operators, and patients. Most compendia fail to document their methodology for listing or rating the potential clinical severity of drug-drug interactions. Inconsistent information about drug-drug interactions can cause prescribing problems and variations, possibly increasing the incidence of morbidity and mortality. Methods The available literature (MEDLINE ® , EMBASE ® , International Pharmaceutical Abstracts) on systematic reviews, methodologic quality assessment of research articles, and causality assessment of adverse drug events was searched to identify the best practices for creation of an evidence-based drug-drug interaction information review process. A suggested format for standardized presentation of this information is described. Results The following 5-step process was created to assess published drug-drug interaction information: (1) search the medical literature for published drug-drug interaction information; (2) assess the relevance of the articles; (3) assess the quality of the articles; (4) assess drug-drug interaction causality; and (5) abstract the findings and present the evidence. Conclusions Evidence-based assessment of published drugdrug interaction information appears to be feasible and would help clinicians, DUR program operators, and patients. Assessment of this information on a large scale, however, will require significant resources and the resolution of a number of technical issues.