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Impact of Regulatory Interventions on Ulipristal Acetate 5 mg (Esmya) Use in Spain: An Interrupted Time-Series Analysis.
Monreal-Di Bello, Marta; González-Bermejo, Diana; Castillo-Cano, Belén; Rodriguez-Pascual, Alfonso; Montero-Corominas, Dolores.
Afiliación
  • Monreal-Di Bello M; Pharmacoepidemiology and Pharmacovigilance Division, Medicines for Human Use Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
  • González-Bermejo D; Pharmacoepidemiology and Pharmacovigilance Division, Medicines for Human Use Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
  • Castillo-Cano B; Pharmacoepidemiology and Pharmacovigilance Division, Medicines for Human Use Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
  • Rodriguez-Pascual A; Pharmacoepidemiology and Pharmacovigilance Division, Medicines for Human Use Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
  • Montero-Corominas D; Pharmacoepidemiology and Pharmacovigilance Division, Medicines for Human Use Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
Pharmacoepidemiol Drug Saf ; 33(9): e70004, 2024 Sep.
Article en En | MEDLINE | ID: mdl-39290036
ABSTRACT

PURPOSE:

Since late 2017, the use of ulipristal acetate 5 mg (UPA; Proprietary name Esmya) has been under review in the European Union, due to an emerging hepatic risk. In February 2018 and in July 2018, the Spanish Agency of Medicines and Medical Devices and the marketing authorization holder put two risk minimization measures (RMM) in place, in order to inform about new safety information and to mitigate this risk. This study aims to assess RMM effectiveness in Spain, by performing an interrupted time-series (ITS) analyses, between 2014 and 2019.

METHOD:

Two quasi-experimental ITS analyses to examine the use of UPA before and after the RMM release were performed (a) an ecological study using aggregated data from a drug consumption database; and (b) a study using primary healthcare data gathered from electronic clinical records.

RESULTS:

Regulatory interventions were associated with an immediate and significant decrease level of DID (the number of DDD dispensed per 100 000 inhabitants and day) and incidence. The DID was 70% less than expected 12 months after the interventions. This value was 59% for the incidence. However, a change in the slope was not observed and the use started rising again in the last segment of the study period.

CONCLUSION:

Despite RMM had an immediate strong impact on UPA use, the last segment upward trend in the long-term might have been affected by the lack of comparable therapeutic alternatives. Further studies should be performed to confirm the increase trend observed and analyze subsequent measures and additional data.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Análisis de Series de Tiempo Interrumpido / Norpregnadienos Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Pharmacoepidemiol Drug Saf Asunto de la revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Análisis de Series de Tiempo Interrumpido / Norpregnadienos Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Pharmacoepidemiol Drug Saf Asunto de la revista: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido