TY - JOUR
T1 - 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
T2 - an interrupted time series analysis
AU - Durán, Carlos E
AU - Riera-Arnau, Judit
AU - Abtahi, Shahab
AU - Pajouheshnia, Romin
AU - Hoxhaj, Vjola
AU - Gamba, Magdalena
AU - Alsina, Ema
AU - Martin-Perez, Mar
AU - Garcia-Poza, Patricia
AU - Llorente-Garcia, Ana
AU - Gonzalez-Bermejo, Diana
AU - Ibánez, Luisa
AU - Sabaté, Mònica
AU - Vidal, Xavier
AU - Ballarín, Elena
AU - Sanfélix-Gimeno, Gabriel
AU - Rodríguez-Bernal, Clara
AU - Peiró, Salvador
AU - García-Sempere, Aníbal
AU - Sanchez-Saez, Francisco
AU - Ientile, Valentina
AU - Ingrasciotta, Ylenia
AU - Guarneri, Claudio
AU - Tanaglia, Matilde
AU - Tari, Michele
AU - Herings, Ron
AU - Houben, Eline
AU - Swart-Polinder, Karin
AU - Holthuis, Emily
AU - Huerta, Consuelo
AU - Gini, Rosa
AU - Roberto, Giuseppe
AU - Bartolini, Claudia
AU - Paoletti, Olga
AU - Limoncella, Giorgio
AU - Girardi, Anna
AU - Hyeraci, Giulia
AU - Andersen, Morten
AU - Kristiansen, Sarah Brøgger
AU - Hallgreen, Christine Erikstrup
AU - Klungel, Olaf
AU - Sturkenboom, Miriam
N1 - Publisher Copyright:
Copyright © 2023 Durán, Riera-Arnau, Abtahi, Pajouheshnia, Hoxhaj, Gamba, Alsina, Martin-Perez, Garcia-Poza, Llorente-Garcia, Gonzalez-Bermejo, Ibánez, Sabaté, Vidal, Ballarín, Sanfélix-Gimeno, Rodríguez-Bernal, Peiró, García-Sempere, Sanchez-Saez, Ientile, Ingrasciotta, Guarneri, Tanaglia, Tari, Herings, Houben, Swart-Polinder, Holthuis, Huerta, Gini, Roberto, Bartolini, Paoletti, Limoncella, Girardi, Hyeraci, Andersen, Kristiansen, Hallgreen, Klungel and Sturkenboom.
PY - 2023/8/17
Y1 - 2023/8/17
N2 -
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.
AB -
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.
KW - acne
KW - contraceptive measures
KW - dermatologic conditions
KW - isotretinoin
KW - oral retinoids
KW - pregnancy prevention programme
KW - risk minimisation measures
UR - http://www.scopus.com/inward/record.url?scp=85169601692&partnerID=8YFLogxK
U2 - 10.3389/fphar.2023.1207976
DO - 10.3389/fphar.2023.1207976
M3 - Article
C2 - 37663263
SN - 1663-9812
VL - 14
SP - 1
EP - 12
JO - Frontiers in Pharmacology
JF - Frontiers in Pharmacology
M1 - 1207976
ER -