Italian monitoring registries: a tool for a safer use of innovative drugs? Data from the national pharmacovigilance system.

Objectives: Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying whether the registries could be useful tools for a safer use of innovative drugs.

Methods: All ADR reports included in the Italian Pharmacovigilance Network database from January 1 2013 to December 31 2015 (vaccines and literature cases excluded) were analysed. We compared the ADR reports of MR and non-MR drugs with the same ATC class at III level.

Results: The percentage of ADR reports with a completed 'Section 7' was significantly lower for MR compared to non-MR drugs (2.0 versus 6.2, p < 0.001). The difference concerned in particular the ADR reports related to abuse/misuse, medication errors and overdose. These reports, more strictly related to inappropriate use, were less frequent for MR drugs in all the considered ATC classes.

Conclusions: Our study suggests that monitoring registries could be a useful tool for the reduction of frequency of ADRs related to inappropriate use, besides the control of pharmaceutical budget.