Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures

ABSTRACT

Aims: Additional risk minimization measures (aRMMs) may be needed to ensure that the benefits continue to outweigh the risks for medicines associated with serious risks. Prior research showed an increasing trend in medicines with aRMMs. We assessed whether the European pharmacovigilance legislation may have impacted the number and type of aRMMs.

Methods: We included new active substances approved between 1 January 2010 and 31 December 2015. Information extracted from the summary of the Risk Management Plan at the time of licensing included date and type of marketing authorization, presence and type of aRMMs. We tested for differences using Pearson’s Χ² test and segmented Poisson regression.

Results: We identified 231 medicines approved during the study period, of which 30% had aRMMs at the time of licensing. ARMMs were in place for 38% of medicines before July 2012 and for 28% after (p = 0.16). Segmented Poisson regression did not show changes in trend or level of medicines with aRMMs.

Discussion and conclusion: During the study period, no significant differences in the proportion or trend of products with aRMMs at the time of licensing before and after the pharmacovigilance legislation were identified.

KEYWORDS:

• Pharmacovigilance
• drug safety
• pharmaceutical risk management
• additional risk minimization measures

Author contributions

All authors have been involved in the conception and design of the study, analysis, and interpretation of the data, and the drafting of the paper. All authors have approved the version to be published and agreed to be accountable for all aspects of the work.

Declaration of interest

MCJMS declares they are a principle investigator in regulatory required post-authorization safety studies for Novartis, but has no direct conflicts with regard to this paper. All other authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper has not been funded.