A ranked presentation of the MHRA/CSM (Medicines & Health Care Regulatory Agency/Committee on Safety of Medicines) Drug Analysis Print (DAP) data on practolol.

摘要

PURPOSE: To display a ranked presentation of the data given in the Drug Analysis Prints (DAPs) provided by the MHRA/CSM so that the monitoring clinician may be readily alerted to the most important findings. The practolol DAP is taken as an example of the presentation. METHOD: The data for the ranked system organ classes, the ranked deaths and the ranked reaction reports within each system organ class are considered separately. RESULTS: It has been found that there are advantages in considering the system-organ classes, the deaths and the reports of the individual reactions separately and then, within these groupings, providing the mathematically ranked data. The results for practolol, withdrawn due to the associated oculomucocutaneous syndrome, are given as a single worked example. CONCLUSIONS: Presentations of the ranked data arising from spontaneous adverse drug reactions reporting may have useful advantages.