Table2_Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis.xlsx

Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure the impact of the 2018 revision of the RMMs in Europe by assessing the utilisation patterns of isotretinoin, alitretinoin and acitretin, contraceptive measures, pregnancy testing, discontinuation, and pregnancy occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to compare level and trend changes after the risk minimisati... Mehr ...

Verfasser: Carlos E. Durán
Judit Riera-Arnau
Shahab Abtahi
Romin Pajouheshnia
Vjola Hoxhaj
Magdalena Gamba
Ema Alsina
Mar Martin-Perez
Patricia Garcia-Poza
Ana Llorente-Garcia
Diana Gonzalez-Bermejo
Luisa Ibánez
Mònica Sabaté
Xavier Vidal
Elena Ballarín
Gabriel Sanfélix-Gimeno
Clara Rodríguez-Bernal
Salvador Peiró
Aníbal García-Sempere
Francisco Sanchez-Saez
Valentina Ientile
Ylenia Ingrasciotta
Claudio Guarneri
Matilde Tanaglia
Michele Tari
Ron Herings
Eline Houben
Karin Swart-Polinder
Emily Holthuis
Consuelo Huerta
Rosa Gini
Giuseppe Roberto
Claudia Bartolini
Olga Paoletti
Giorgio Limoncella
Anna Girardi
Giulia Hyeraci
Morten Andersen
Sarah Brøgger Kristiansen
Christine Erikstrup Hallgreen
Olaf Klungel
Miriam Sturkenboom
Dokumenttyp: Dataset
Erscheinungsdatum: 2023
Schlagwörter: Pharmacology / Basic Pharmacology / Clinical Pharmacology and Therapeutics / Clinical Pharmacy and Pharmacy Practice / Pharmaceutical Sciences / Pharmacogenomics / Toxicology (incl. Clinical Toxicology) / Pharmacology and Pharmaceutical Sciences not elsewhere classified / oral retinoids / isotretinoin / contraceptive measures / dermatologic conditions / acne / risk minimisation measures / pregnancy prevention programme
Sprache: unknown
Permalink: https://search.fid-benelux.de/Record/base-29174838
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.3389/fphar.2023.1207976.s005

Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure the impact of the 2018 revision of the RMMs in Europe by assessing the utilisation patterns of isotretinoin, alitretinoin and acitretin, contraceptive measures, pregnancy testing, discontinuation, and pregnancy occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to compare level and trend changes after the risk minimisation measures implementation was conducted on a cohort of females of childbearing age (12–55 years of age) from January 2010 to December 2020, derived from six electronic health data sources in four countries: Denmark, Netherlands, Spain, and Italy. Monthly utilisation figures (incidence rates [IR], prevalence rates [PR] and proportions) of oral retinoids were calculated, as well as discontinuation rates, contraception coverage, pregnancy testing, and rates of exposed pregnancies to oral retinoids, before and after the 2018 RMMs. Results: From 10,714,182 females of child-bearing age, 88,992 used an oral retinoid at any point during the study period (mean age 18.9–22.2 years old). We found non-significant level and trend changes in incidence or prevalence of retinoid use in females of child-bearing age after the 2018 RMMs. The reason of discontinuation was unknown in >95% of cases. Contraception use showed a significant increase trend in Spain; for other databases this information was limited. Pregnancy testing was hardly recorded thus was not possible to model ITS analyses. After the 2018 RMM, rates of pregnancy occurrence during retinoid use, and start of a retinoid during a pregnancy varied from 0.0 to 0.4, and from 0.2 to 0.8, respectively. Conclusion: This study shows a limited impact of the 2018 RMMs on oral retinoids utilisation patterns among females of child-bearing age in four European countries. Pregnancies still ...