Abstract
Background: Additional risk minimisation measures (aRMMs) may be required to strengthen the benefit–risk profile of medicines that are associated with serious risks. ARMMs may be required at the time of authorisation, but risks may also become evident during the life cycle. Moreover, the recommended actions in the aRMMs may become part of clinical practice and aRMMs may therefore no longer be required. There is limited information about post‐authorisation amendments (PAA) to aRMMs of medicines authorized in the European Union (EU).
Objectives: The aim of this study is to describe PAA to aRMMs for medicines authorized in the EU.
Methods: We performed a retrospective cohort study that included all new active substances authorized through the EU centralized procedure between January 1st 2006 and December 31st 2017. Medicines were followed up until July 1st 2018, when data extraction took place. We extracted the following data from European Public Assessment Reports (EPARs) available on the website of the European Medicines Agency (EMA) on www.ema.europa.eu: active substance, Anatomical Therapeutic Chemical (ATC) classification, date of Marketing Authorisation, presence (yes/no) of aRMMs at the time of MA, PAA to aRMMs (yes/no) and type of PAA to aRMMs (introduction/discontinuation), and date of PAA. Descriptive statistics were used to analyze frequency data.
Results: There were 476 medicines authorized during the study period with a total of 32.514 months of follow‐up. Median follow‐up time was 60 months (range 8–150). At the time of marketing authorisation, aRMMs were required for 27.3% of the medicines. During the study period, 19 (4%) medicines were identified with PAA to aRMM including introduction of aRMM for 15 products (79%) and discontinuation of existing aRMMs for four products (21%). The median time to PAA to aRMM was 46 months for introduction, 90 months for discontinuation. All products with PAA to aRMM were approved between 2006 and 2013. No PAA to aRMM occurred between 2006 and 2008; introduction of aRMMs in the post‐authorisation phase occurred since 2009, while the discontinuation of aRMMs occurred since 2015. The ATC groups with the highest proportion of PAA were “Blood and blood‐forming organs” (15.8%), “Musculoskeletal system” (15.4%) and “Various” (8.0%).
Conclusions: The proportion of medicines with PAA to aRMM was low (4%) and the majority of amendments to aRMM concerned introductions of new aRMMs. Notably, the proportion of discontinuation of aRMMs post‐authorisation is very low.
Objectives: The aim of this study is to describe PAA to aRMMs for medicines authorized in the EU.
Methods: We performed a retrospective cohort study that included all new active substances authorized through the EU centralized procedure between January 1st 2006 and December 31st 2017. Medicines were followed up until July 1st 2018, when data extraction took place. We extracted the following data from European Public Assessment Reports (EPARs) available on the website of the European Medicines Agency (EMA) on www.ema.europa.eu: active substance, Anatomical Therapeutic Chemical (ATC) classification, date of Marketing Authorisation, presence (yes/no) of aRMMs at the time of MA, PAA to aRMMs (yes/no) and type of PAA to aRMMs (introduction/discontinuation), and date of PAA. Descriptive statistics were used to analyze frequency data.
Results: There were 476 medicines authorized during the study period with a total of 32.514 months of follow‐up. Median follow‐up time was 60 months (range 8–150). At the time of marketing authorisation, aRMMs were required for 27.3% of the medicines. During the study period, 19 (4%) medicines were identified with PAA to aRMM including introduction of aRMM for 15 products (79%) and discontinuation of existing aRMMs for four products (21%). The median time to PAA to aRMM was 46 months for introduction, 90 months for discontinuation. All products with PAA to aRMM were approved between 2006 and 2013. No PAA to aRMM occurred between 2006 and 2008; introduction of aRMMs in the post‐authorisation phase occurred since 2009, while the discontinuation of aRMMs occurred since 2015. The ATC groups with the highest proportion of PAA were “Blood and blood‐forming organs” (15.8%), “Musculoskeletal system” (15.4%) and “Various” (8.0%).
Conclusions: The proportion of medicines with PAA to aRMM was low (4%) and the majority of amendments to aRMM concerned introductions of new aRMMs. Notably, the proportion of discontinuation of aRMMs post‐authorisation is very low.
| Original language | English |
|---|---|
| Pages (from-to) | 222-223 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 28 |
| Issue number | S2 |
| Publication status | Published - Aug 2019 |