a Department of Medical Informatics , Erasmus Medical Centre , Rotterdam , The Netherlands.
b Department of Pharmacovigilance , Medicines Evaluation Board , Utrecht , The Netherlands.
Expert Opin Drug Saf. 2018 Oct;17(10):975-982. doi: 10.1080/14740338.2018.1512579. Epub 2018 Aug 22.
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.
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 Χ test and segmented Poisson regression.
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.
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.
可能需要采取额外的风险最小化措施（aRMMs），以确保与严重风险相关的药物的益处继续超过风险。先前的研究表明，具有 aRMMs 的药物呈上升趋势。我们评估了欧洲药物警戒立法是否可能影响 aRMMs 的数量和类型。
我们纳入了 2010 年 1 月 1 日至 2015 年 12 月 31 日期间批准的新活性物质。从许可时的风险管理计划摘要中提取的信息包括营销授权的日期和类型、aRMMs 的存在和类型。我们使用 Pearson's Χ 检验和分段泊松回归进行了检验。
我们确定了研究期间批准的 231 种药物，其中 30%在许可时具有 aRMMs。在 2012 年 7 月之前，38%的药物采用了 aRMMs，而在之后，这一比例为 28%（p=0.16）。分段泊松回归并未显示具有 aRMMs 的药物的趋势或水平发生变化。
在研究期间，在药物警戒立法前后，许可时具有 aRMMs 的产品的比例或趋势没有显著差异。
