Medicines under additional monitoring in the European Union
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 pharmacologic...
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| Format: | Article |
| Language: | English |
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Elsevier
2019-01-01
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| Series: | Farmacia Hospitalaria |
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| Online Access: | http://www.aulamedica.es/fh/pdf/11041.pdf |
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| _version_ | 1846144742209880064 |
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| author | Esther Salgueiro Gloria Manso Fernando Neira Sandra Ortega Luis H Martín Arias Maria Sainz |
| author_facet | Esther Salgueiro Gloria Manso Fernando Neira Sandra Ortega Luis H Martín Arias Maria Sainz |
| author_sort | Esther Salgueiro |
| collection | DOAJ |
| description | 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 postauthorisation safety study has already produced information published by the Spanish Agency of Medicines and Medical Devices. |
| format | Article |
| id | doaj-art-a9b2859d7c5d417dacc078471a2d515c |
| institution | Kabale University |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2019-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-a9b2859d7c5d417dacc078471a2d515c2024-12-02T06:56:17ZengElsevierFarmacia Hospitalaria1130-63432171-86952019-01-01431192310.7399/fh.11041Medicines under additional monitoring in the European UnionEsther Salgueiro 0Gloria Manso 1Fernando Neira 2Sandra Ortega 3Luis H Martín Arias 4Maria Sainz 5Departamento de Medicina, Área de Farmacología, Universidad de Oviedo, Oviedo. EspañaDepartamento de Medicina, Área de Farmacología, Universidad de Oviedo, Oviedo. EspañaDepartamento de Medicina, Área de Farmacología, Universidad de Oviedo, Oviedo. EspañaDepartamento de Medicina, Área de Farmacología, Universidad de Oviedo, Oviedo. EspañaCentro de Estudios sobre Seguridad de Medicamentos (CESME), Universidad de Valladolid, Valladolid. EspañaCentro de Estudios sobre Seguridad de Medicamentos (CESME), Universidad de Valladolid, Valladolid. EspañaObjective: 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 postauthorisation safety study has already produced information published by the Spanish Agency of Medicines and Medical Devices.http://www.aulamedica.es/fh/pdf/11041.pdfDrug monitoringEuropean UnionPharmacovigilanceBiosimilar pharmaceuticalsMandatory reporting |
| spellingShingle | Esther Salgueiro Gloria Manso Fernando Neira Sandra Ortega Luis H Martín Arias Maria Sainz Medicines under additional monitoring in the European Union Farmacia Hospitalaria Drug monitoring European Union Pharmacovigilance Biosimilar pharmaceuticals Mandatory reporting |
| title | Medicines under additional monitoring in the European Union |
| title_full | Medicines under additional monitoring in the European Union |
| title_fullStr | Medicines under additional monitoring in the European Union |
| title_full_unstemmed | Medicines under additional monitoring in the European Union |
| title_short | Medicines under additional monitoring in the European Union |
| title_sort | medicines under additional monitoring in the european union |
| topic | Drug monitoring European Union Pharmacovigilance Biosimilar pharmaceuticals Mandatory reporting |
| url | http://www.aulamedica.es/fh/pdf/11041.pdf |
| work_keys_str_mv | AT esthersalgueiro medicinesunderadditionalmonitoringintheeuropeanunion AT gloriamanso medicinesunderadditionalmonitoringintheeuropeanunion AT fernandoneira medicinesunderadditionalmonitoringintheeuropeanunion AT sandraortega medicinesunderadditionalmonitoringintheeuropeanunion AT luishmartinarias medicinesunderadditionalmonitoringintheeuropeanunion AT mariasainz medicinesunderadditionalmonitoringintheeuropeanunion |