Objective:

The objective of this study was to analyse the characteristics of medicines subject to additional monitoring. We assessed the following aspects: the criteria applied to approve a medicine as being subject to additional monitoring; the authorized dispensing conditions; the pharmacological groups to which they belong; and their post-authorisation safety.

Method:

We analysed the list published by the European Medicines Agency in January 2017 (EMA/245297/2013 Rev.41). Information for the analysis was obtained from the web sites of the European Medicines Agency and the Spanish Agency of Medicines and Medical Devices.

Results:

We assessed 316 medicines subject to additional monitoring. The most common criterion used to assign a medicine as being subject to additional monitoring was it being a new active substance (n = 197 (62.3%)). Other common criteria were requiring a post-authorisation safety study (n = 52 (16.5%)) and being a biologic medicine but not a new active substance (n = 49 (15.5%)). Regarding dispensing conditions, nearly 66% of these medicines were authorized under restricted conditions. Until January 2017, the Spanish Agency of Medicines and Medical Device published 14 safety reports related to medicines subject to additional monitoring.

Conclusions:

The group of medicines subject to additional monitoring mainly includes new active substances. The most common pharmacological group is antineoplastic and immunomodulating agents. The post-authorisation safety study has already produced information published by the Spanish Agency of Medicines and Medical Devices.