Reynold D C Francisca1,2, Inge M Zomerdijk1,2, Miriam C J M Sturkenboom1,3, Sabine M J M Straus1,2. 1. a Department of Medical Informatics , Erasmus Medical Centre , Rotterdam , The Netherlands. 2. b Department of Pharmacovigilance , Medicines Evaluation Board , Utrecht , The Netherlands. 3. c Julius Global Health , University Medical Centre Utrecht , Utrecht , The Netherlands.
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.
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.
Authors: Josep Pane; Reynold D C Francisca; Katia M C Verhamme; Marcia Orozco; Hilde Viroux; Irene Rebollo; Miriam C J M Sturkenboom Journal: Pharmacoepidemiol Drug Saf Date: 2019-07-18 Impact factor: 2.890
Authors: Christina E Hoeve; Reynold D C Francisca; Inge Zomerdijk; Miriam C J M Sturkenboom; Sabine M J M Straus Journal: Drug Saf Date: 2020-01 Impact factor: 5.606