Ten of the Best

Few areas in pharma can benefit more from a top ten list than that of pharmacovigilance (PV). Ongoing developments in areas like E2B formats, potential FDA tome requirements, data-mining, DSM Boards needs, Eudravigilance, and EDI gateways have made the world a complex and challenging place for PV professionals today. In that context, a top 10 list devoted to pharmacovigilance can be of great service, either as a planning tool – for those wondering how to respond to these challenges – or as an internal check-up – for those looking to make a mid-course correction. So here’s my top 10 tips relating to PV. It is my way of organising the PV world into an action list.

1. THINK PAPERLESS

Yes, ‘paperless’ can be a cliché, but within clinical development, it is more and more of a reality. EDC systems collect data at sites without paper case report forms. Field monitors produce trip reports ‘online’ within their company’s clinical trial management system. The same reports are reviewed and signed electronically by management. On the back-end of the clinical process, data managers and even medical monitors are reviewing the data with online tools that provide sorting, graphing and searching capabilities.

Yet in the PV world, case processing still consists of piles of folders, passed physically from one desk to another. Red folders for ‘hurry’; blue folders for ‘no hurry’; the whole scene could come from an office in the 1950s. Searching the files of vacationing colleagues for needed documents is a typical story that only magnifies the sense of deja vu.

It is ironic that today’s adverse events systems allow electronic routing of cases, scanning and storage of external documents and other capabilities that make the folders obsolete. Yes, you can still print a document or a listing as a working copy, but the official record remains within the validated, secure system. The technology supporting this is mature and ready to be used.