Pharmacovigilance (PV) is "the science and activities related to the detection, evaluation, understanding, and prevention of adverse drug effects or other drug-related problems."
Post-marketing surveillance (PMS) is a type of PV activity that takes into account the characteristics of pharmaceuticals and is carried out according to an implementation plan.
In PMS, doctors write medical information on questionnaires and accumulate it in a database dedicated to the survey. The information is coded, logically checked, re-examined, etc. in the data management (DM) process, and then compiled by the analysis department. The process from DM to analysis is multi-step, and when unexpected data is received, a lot of time is spent to identify the cause and respond. In addition, it was difficult to confirm the results unless it was made into a report using a SAS program. Therefore, we started using JMP. JMP's interactive visualization and analysis functions made it easy to monitor data (discover irregularities) and examine the causes with staff in non-analysis departments, contributing to the smooth operation of the work. Currently, we are also trying to automate preprocessing using Workflow Builder with the aim of improving the data quality of the adverse drug reaction information management database that accumulates all safety information, including PMS data. In this presentation, I would like to introduce some of these efforts and discuss the prospects for using JMP.
