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1. 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

Author

Durán, Carlos E., primary, Riera-Arnau, Judit, additional, Abtahi, Shahab, additional, Pajouheshnia, Romin, additional, Hoxhaj, Vjola, additional, Gamba, Magdalena, additional, Alsina, Ema, additional, Martin-Perez, Mar, additional, Garcia-Poza, Patricia, additional, Llorente-Garcia, Ana, additional, Gonzalez-Bermejo, Diana, additional, Ibánez, Luisa, additional, Sabaté, Mònica, additional, Vidal, Xavier, additional, Ballarín, Elena, additional, Sanfélix-Gimeno, Gabriel, additional, Rodríguez-Bernal, Clara, additional, Peiró, Salvador, additional, García-Sempere, Aníbal, additional, Sanchez-Saez, Francisco, additional, Ientile, Valentina, additional, Ingrasciotta, Ylenia, additional, Guarneri, Claudio, additional, Tanaglia, Matilde, additional, Tari, Michele, additional, Herings, Ron, additional, Houben, Eline, additional, Swart-Polinder, Karin, additional, Holthuis, Emily, additional, Huerta, Consuelo, additional, Gini, Rosa, additional, Roberto, Giuseppe, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Limoncella, Giorgio, additional, Girardi, Anna, additional, Hyeraci, Giulia, additional, Andersen, Morten, additional, Kristiansen, Sarah Brøgger, additional, Hallgreen, Christine Erikstrup, additional, Klungel, Olaf, additional, and Sturkenboom, Miriam, additional

Published
2023
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2. 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

Author

Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Abstract

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

Published
2023

3. 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

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Published
2023

4. 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

Author

Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Abstract

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

Published
2023

5. 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

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Published
2023

7. Extracting pregnancies from heterogeneous data sources in Europe: A novel algorithm in the conception project

Author

Limoncella, Giorgio, Bartolini, Claudia C., Duran, Carlos, Girardi, Anna, Hyeraci, Giulia, Arnau, Judit Riera, Llorente, Ana, Soriano, Lucia Cea, Martin-Perez, Mar, Garcia-Poza, Patricia, Sanchez-Saez, Francisco, Gabriel Sanfélix-Gimeno, Nordeng, Hedvig, Hurley, Eimir, Maglanoc, Luigi A., Holthuis, Emily, Swart, Karin, Ientile, Valentina, Tanaglia, Matilde, Brown, Jeremy, Wing, Kevin, Schink, Tania, Pajouheshnia, Romin, Cunnington, Marianne, Sturkenboom, Miriam, and Gini, Rosa

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