5PSQ-207 Analysis of the medicines under additional monitoring authorised in the European Union from 2017 to 2019

Background and importance The medicines under additional monitoring (MUAMs), identified with a black inverted triangle (d), are subject to strict control for 5 years after their authorisation or until the European Medicines Agency (EMA) considers that they are safe. Aim and objectives The main objective was to analyse the characteristics of the MUAMs authorised by the EMA from 2017 until 2019. We also evaluated whether additional measures should be implemented in the hospital pharmacy services to improve the follow-up of MUAMs. Material and methods A descriptive analysis of the EMA’s MUAMs list was conducted, which was updated on 25 March 2020, limiting the authorisations from 1 January 2017 to 31 December 2019. The following aspects were studied: criteria for inclusion in the list, year of inclusion and marketing status in Spain. Post-marketing safety was also analysed by reviewing the information notes published by the Spanish Agency for Medicines and Health Products in these 3 years. The main limitation was the dynamism of the MUAMs list, which is updated monthly. Results 181 MUAMs were studied; 33% were authorised in 2017, 44% in 2018 and 23% in 2019. The criteria for inclusion in the MUAMs list were: new active substances: 113 (62.4%); new biologicals: 55 (30.4%); post-authorisation security studies (PASS): 8 (4.4%); conditional authorisation and exceptional circumstances: 4 (2.2%); and security restrictions: 1 (0.5%). More than 60% of the MUAMs authorised between 2017 and 2019 were marketed in Spain, mostly antineoplastic and immunomodulatory drugs. During these 3 years, the AEMPS published 13 notes referring to MUAMs and they related to safety (30.7%), contraindications for use (30.7%), restrictions on use (23%) and informative notes (15.4%). Only two of these notes affected one of the authorised MUAMs from 2017 to 2019 (tofacitinib). Conclusion and relevance The most frequent designated criteria were new active substance, followed by new biologicals, PASS and conditional/exceptional authorisations. The high number of MUAMs authorised each year in Europe and their special characteristics justifies the need to implement a circuit in the hospital pharmacy services that includes: sessions to remind staff of their importance, patient information sheets to reinforce greater follow-up and explain the most common adverse effects as well as a wider dissemination of information about restrictions of use and contraindications. References and/or acknowledgements Conflict of interest No conflict of interest