Incomplete Information as a Limiting Factor in Causality Assessment of Adverse Drug Reactions and its Practical Consequences

Abstract

The last ten years have seen the development of a number of different methods for standardized causality assessment. One of the major results of these efforts has been the understanding that available information on suspected cases is often inadequate. There has also developed a general concensus about what information is most important, and this has resulted in published guidelines for literature reports. The large number of existing methods are consistent with ongoing differences of opinion related less to reproducibility of any method than to its “correctness.” One approach to this dilemma is to develop information using experimental methods; however, a more ethical and practical approach is to rate data for importance in achieving a more refined concensus. The questions remain as to how far the methods can realistically be refined and whether expert opinion is still needed. Continued efforts to develop a standard method are important, particularly if the method is used to define areas of disagreement and to classify cases for subsequent analysis.