Evidence map›Paper›PMID 42848129›Full record

ArticleDrug safety2026

Switching Patterns of Oral Retinoids to Alternative Medications: An Interrupted Time-Series Analysis of Four European Countries.

Judit Riera-Arnau, Shahab Abtahi, Mònica Sabaté Gallego, Elena Ballarín, Magdalena Gamba, Romin Pajouheshnia, Vjola Hoxhaj, Ema Alsina, Mar Martin-Perez, Patricia Garcia-Poza and 24 more

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Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

34 authors.

Judit Riera-ArnauClinical Pharmacology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Shahab AbtahiDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Universiteit Utrecht, Utrecht, the Netherlands.
Mònica Sabaté GallegoClinical Pharmacology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain. monica.sabate@vallhebron.cat.ORCID http://orcid.org/0000-0001-6206-1085
Elena BallarínClinical Pharmacology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Magdalena GambaDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Universiteit Utrecht, Utrecht, the Netherlands.
Romin PajouheshniaDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Universiteit Utrecht, Utrecht, the Netherlands.
Vjola HoxhajDepartment of Data Science and Biostatistics, Julius Centre for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, the Netherlands.
Ema AlsinaDepartment of Data Science and Biostatistics, Julius Centre for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, the Netherlands.
Mar Martin-PerezAgencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Patricia Garcia-PozaAgencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Ana Llorente-GarciaAgencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Diana Gonzalez-BermejoAgencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Gabriel Sanfélix-GimenoHealth Services Research and pharmacoepidemiology Unit, The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO), Valencia, Spain.
Clara Rodríguez-BernalHealth Services Research and pharmacoepidemiology Unit, The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO), Valencia, Spain.
Salvador PeiróHealth Services Research and pharmacoepidemiology Unit, The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO), Valencia, Spain.
Aníbal García-SempereHealth Services Research and pharmacoepidemiology Unit, The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO), Valencia, Spain.
Francisco Sánchez-SáezDepartment of Applied Statistics and Operational Research, and Quality, Universitat Politècnica de València, Valencia, Spain.
Valentina IentileDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.
Ylenia IngrasciottaSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Claudio GuarneriDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.
Matilde TanagliaSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Michele TariCaserta Local Health Unit, Caserta, Italy.
Eline HoubenPHARMO Institute, Utrecht, the Netherlands.
Rosa GiniAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Giuseppe RobertoAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Claudia BartoliniAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Olga PaolettiAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Giorgio LimoncellaAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Anna GirardiAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Giulia HyeraciAgenzia Regionale di Sanità Della Toscana (ARS), Florence, Italy.
Sarah Brøgger KristiansenPharmacovigilance Research Center, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Olaf KlungelDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Universiteit Utrecht, Utrecht, the Netherlands.
Miriam SturkenboomDepartment of Data Science and Biostatistics, Julius Centre for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, the Netherlands.
Carlos E DuránDepartment of Data Science and Biostatistics, Julius Centre for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, the Netherlands.

Funding

European Medicines Agency Framework service contract nr. EMA/2017/09/PE/04European Medicines Agency Lot 4European Medicines Agency Specific Contract 02
6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe European Pregnancy Prevention Program for oral retinoids was updated in 2018, yet its impact on switching to retinoid alternative medications remains unclear. Thus, we aimed to measure its impact on the switching patterns from oral retinoids to retinoid alternative medications in women of childbearing potential in four European countries.

methodsA cross-sectional study was conducted in six databases across four European countries: the Netherlands (NL-PHARMO), Spain (ES-VID and ES-BIFAP), Italy (IT-ARS and IT-Caserta) and Denmark (DK-DNR), covering women of childbearing potential prescribed/dispensed oral retinoid between 2010 and 2020. The utilisation of retinoid alternative medications and switching from oral retinoids to retinoid alternative medications after discontinuation were measured. Changes in the rates of switching before and after implementation of the Pregnancy Prevention Program were analysed using an interrupted time series analysis.

resultsFrom 88,992 women of childbearing potential previously exposed to retinoids, 32.0% (28,446) switched to a retinoid alternative medication over the study period. Overall, ten out of 80 median discontinuers per month switched. Median switching monthly rates ranged from 1.8 to 6.5% and from 1.2 to 2.3% pre-implementation and post-implementation, respectively. For overall switching rates, the interrupted time series analysis revealed a small but statistically significant decrease in slope post-intervention in IT-Caserta (- 0.035%; p < 0.01), ES-VID (- 0.04%; p < 0.01) and ES-BIFAP (- 0.03%; p = 0.02). These changes disappeared when excluding the coronavirus disease 2019 lockdown period from the analysis.

conclusionsThe 2018 risk minimisation measures showed a limited impact on switching patterns, with possible differences between northern and southern countries. Further research is needed to investigate the reasons and choices behind switching, and the impact of the Pregnancy Prevention Program on the utilisation patterns of individual retinoid alternative medications, particularly those with teratogenic potential.

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.