We were in Paris, guests of the French affiliate of a multinational pharmaceutical company, for a training session on SafetyDrugs. During the three days we spent together, we saw in detail with the client the whole cycle of cases process.
Some reflections emerged on three functions present in the database and strategic in the daily management of pharmacovigilance.
It is a novelty of SafetyDrugs that consents the massive acquisition of HL7 files. It also allows you, before importing, to view the most significant content, perform triage and select only those cases that hae to be included in the database. The implementation has been appreciated as it facilitates and streamlines the daily workload of pharmacovigilance operators.
Database internal query
They allow to identify cases based on the combination of over 80 filters. The results obtained can be exported to Excel for analysis purposes and reconciliation activities.
A particular question that raised concerns the management of the cases excluded as they are not applicable and which could be requested during the inspection phase. SafetyDrugs provides a text window in which the operator or pharmacovigilance manager inserts a comment to justify the exclusion.
The experience in Paris gave us an important opportunity to measure the compliance of SafetyDrugs with a specific need: France uses a medical evaluation method called Méthode française or Méthode Bégaud, made mandatory by the regional pharmacovigilance centres (CRPV). SafetyDrugs allows you to impute in semi-automatic modality the final evaluation by combining the three criteria provided by the method: chronologiques, sémiologiques and bibliographiques.