What happens to the safety data once it is captured in the database in the Pharmacovigilance unit:

Safety data collected from the original reporting sources (i.e apart from partners’ exchange safety data and reports from regulatory authorities) is like raw material and it requires further processing and evaluation in order to determine the reporting criteria and further identify its safety signals.

To ensure complete and correct data is captured in the database, regulatory authorities require single cases and follow-up information to be processed. An important tool for a pharmacovigilance department is, therefore, an efficient follow up system, equipped with reminders and instant retrieval of contact/reporter details. It helps keep track of the development of patients’ health conditions as well as detecting potential safety signals.

The pharmacovigilance department needs to systematically and periodically review the cumulative safety data for signals, and generate periodic reports for regulatory reporting. Coding and assessment are key to identifying a reliable safety signal (for signal detection, incomplete reports containing less than the four minimum criteria also count). This process can be improved by designing a system that prioritizes specific safety issues based on medical significance and highlights new safety trends in the collected data.