Early Recognition of Potential Drug Safety Problems

Abstract

Experts say that out of every 100 problems 20 are really important and that 80% of resources should be spent on them and that the remaining 20% of resources are usually enough to deal with the rest. If this is also true of ADRs then we need tools to identify those 20 important cases. Early recognition of potential drug safety problems is of particular importance to larger monitoring systems because of possible bottlenecks in processing them and thus the need to identify the important ones as soon as possible. The article describes two concepts developed to that end. In the first, a set of discerning parameters not requiring initial involvement of medical evaluators is proposed and the second is based on a simple six-question algorithm. Twenty thousand consecutive case reports were used to test this concept and the results seem to indicate that indeed no more than 30% of cases would require full assessment by expert evaluators who could spend more of their valuable time on more relevant problems.