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
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 utilisa...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| Repositorio: | r-FISABIO. Repositorio Institucional de Producción Científica |
| OAI Identifier: | oai:fisabio.fundanetsuite.com:p15574 |
| Acceso en línea: | https://fisabio.portalinvestigacion.com/publicaciones/15574 |
| Access Level: | acceso abierto |
| Palabra clave: | oral retinoids isotretinoin contraceptive measures dermatologic conditions acne risk minimisation measures pregnancy prevention programme |
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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 analysisDurán CERiera-Arnau JAbtahi SPajouheshnia RHoxhaj VGamba MAlsina EMartin-Perez MGarcia-Poza PLlorente-Garcia AGonzalez-Bermejo DIbánez LSabaté MVidal XBallarín ESanfélix-Gimeno GRodríguez-Bernal CPeiró SGarcía-Sempere ASanchez-Saez FIentile VIngrasciotta YGuarneri CTanaglia MTari MHerings RHouben ESwart-Polinder KHolthuis EHuerta CGini RRoberto GBartolini CPaoletti OLimoncella GGirardi AHyeraci GAndersen MKristiansen SBHallgreen CEKlungel OSturkenboom Moral retinoidsisotretinoincontraceptive measuresdermatologic conditionsacnerisk minimisation measurespregnancy prevention programmeBackground: 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 occur during retinoid use, and oral retinoids are still prescribed to pregnant women. Contraception and pregnancy testing information was limited in most databases. Regulators, policymakers, prescribers, and researchers must rethink implementation strategies to avoid any pregnancy becoming temporarily related to retinoid use.FRONTIERS MEDIA SA2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/15574Frontiers in PharmacologyISSN: 16639812reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p155742026-06-11T12:45:17Z |
| dc.title.none.fl_str_mv |
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 |
| title |
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 |
| spellingShingle |
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 Durán CE oral retinoids isotretinoin contraceptive measures dermatologic conditions acne risk minimisation measures pregnancy prevention programme |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| dc.creator.none.fl_str_mv |
Durán CE Riera-Arnau J Abtahi S Pajouheshnia R Hoxhaj V Gamba M Alsina E Martin-Perez M Garcia-Poza P Llorente-Garcia A Gonzalez-Bermejo D Ibánez L Sabaté M Vidal X Ballarín E Sanfélix-Gimeno G Rodríguez-Bernal C Peiró S García-Sempere A Sanchez-Saez F Ientile V Ingrasciotta Y Guarneri C Tanaglia M Tari M Herings R Houben E Swart-Polinder K Holthuis E Huerta C Gini R Roberto G Bartolini C Paoletti O Limoncella G Girardi A Hyeraci G Andersen M Kristiansen SB Hallgreen CE Klungel O Sturkenboom M |
| author |
Durán CE |
| author_facet |
Durán CE Riera-Arnau J Abtahi S Pajouheshnia R Hoxhaj V Gamba M Alsina E Martin-Perez M Garcia-Poza P Llorente-Garcia A Gonzalez-Bermejo D Ibánez L Sabaté M Vidal X Ballarín E Sanfélix-Gimeno G Rodríguez-Bernal C Peiró S García-Sempere A Sanchez-Saez F Ientile V Ingrasciotta Y Guarneri C Tanaglia M Tari M Herings R Houben E Swart-Polinder K Holthuis E Huerta C Gini R Roberto G Bartolini C Paoletti O Limoncella G Girardi A Hyeraci G Andersen M Kristiansen SB Hallgreen CE Klungel O Sturkenboom M |
| author_role |
author |
| author2 |
Riera-Arnau J Abtahi S Pajouheshnia R Hoxhaj V Gamba M Alsina E Martin-Perez M Garcia-Poza P Llorente-Garcia A Gonzalez-Bermejo D Ibánez L Sabaté M Vidal X Ballarín E Sanfélix-Gimeno G Rodríguez-Bernal C Peiró S García-Sempere A Sanchez-Saez F Ientile V Ingrasciotta Y Guarneri C Tanaglia M Tari M Herings R Houben E Swart-Polinder K Holthuis E Huerta C Gini R Roberto G Bartolini C Paoletti O Limoncella G Girardi A Hyeraci G Andersen M Kristiansen SB Hallgreen CE Klungel O Sturkenboom M |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
oral retinoids isotretinoin contraceptive measures dermatologic conditions acne risk minimisation measures pregnancy prevention programme |
| topic |
oral retinoids isotretinoin contraceptive measures dermatologic conditions acne risk minimisation measures pregnancy prevention programme |
| description |
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 occur during retinoid use, and oral retinoids are still prescribed to pregnant women. Contraception and pregnancy testing information was limited in most databases. Regulators, policymakers, prescribers, and researchers must rethink implementation strategies to avoid any pregnancy becoming temporarily related to retinoid use. |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://fisabio.portalinvestigacion.com/publicaciones/15574 |
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https://fisabio.portalinvestigacion.com/publicaciones/15574 |
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Inglés |
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Inglés |
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info:eu-repo/semantics/openAccess |
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openAccess |
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FRONTIERS MEDIA SA |
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FRONTIERS MEDIA SA |
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Frontiers in Pharmacology ISSN: 16639812 reponame:r-FISABIO. Repositorio Institucional de Producción Científica instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
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r-FISABIO. Repositorio Institucional de Producción Científica |
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r-FISABIO. Repositorio Institucional de Producción Científica |
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