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

作者：Magro Lara; Arzenton Elena; Moretti Ugo; Sottosanti Laura; Potenza Simona; Leone Roberto^*

来源：Expert Opinion on Drug Safety, 2016, 15(sup2): 69-75.

DOI：10.1080/14740338.2016.1248942

• Adverse drug reactions
• Italian monitoring registries
• abuse
• misuse
• overdose
• off-label use
• Italian 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 1st 2013 to December 31st 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.

• 出版日期2016-12