Impact of Regulatory Interventions on Ulipristal Acetate 5 mg (Esmya) Use in Spain: An Interrupted Time-Series Analysis.
hepatic failure
incidence
interrupted time series analysis
pharmacoepidemiology
post‐marketing drug surveillance
ulipristal acetate
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
Sep 2024
Sep 2024
Historique:
revised:
28
06
2024
received:
25
01
2024
accepted:
16
08
2024
medline:
18
9
2024
pubmed:
18
9
2024
entrez:
18
9
2024
Statut:
ppublish
Résumé
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. 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. 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. 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.
Substances chimiques
ulipristal acetate
YF7V70N02B
Norpregnadienes
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e70004Subventions
Organisme : Spanish Agency on Medicines and Medical Devices (AEMPS)
Informations de copyright
© 2024 John Wiley & Sons Ltd.
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