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Impact of regulatory restrictions on the use of valproic acid in women of childbearing age: An Italian study.

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Title: Impact of regulatory restrictions on the use of valproic acid in women of childbearing age: An Italian study.
Authors: Di Vito, Lidia (AUTHOR), Mazzoni, Stefania (AUTHOR), Belotti, Laura Maria Beatrice (AUTHOR), Poluzzi, Elisabetta (AUTHOR), Baldin, Elisa (AUTHOR), Zenesini, Corrado (AUTHOR), Bisulli, Francesca (AUTHOR), Tinuper, Paolo (AUTHOR), Mostacci, Barbara (AUTHOR)
Source: Epilepsia (Series 4). Apr2023, Vol. 64 Issue 4, p910-918. 9p.
Subjects: European Medicines Agency, Childbearing age, Valproic acid, Time series analysis, Mental illness
Geographic Terms: Northern Italy
Abstract: Objective: Due to significant risks to the offspring after intrauterine exposure, the European Medicines Agency issued recommendations in 2014 and 2018 restricting the use of valproate (VPA) in women of childbearing age (WOCA). We aimed to evaluate their impact in the Emilia‐Romagna region (ERR) of Northern Italy. Methods: Using administrative databases, we identified all the ERR residents who received antiseizure medication (ASM) prescriptions from 2010 to 2020. Time series of incidence rates by sex and age group were evaluated for all ASMs. Focusing on VPA, an interrupted time series analysis was applied to assess the impact of the restrictions in WOCA with epilepsy (WOCA‐E) and WOCA with psychiatric disorders (WOCA‐P). We then evaluated the chronological order of ASM prescriptions with regard to the position of VPA. Results: Incidence rates of VPA prescriptions overall decreased over time. A significant decrease was observed only for females. The effect was stronger for WOCA, after both the first (incidence rate ratio [IRR] =.85, 95% confidence interval [CI] =.75–.96) and the second restriction (IRR =.67, 95% CI =.55–.82). The decrease was significant after the second restriction both for WOCA‐E (IRR =.43, 95% CI =.27–.68) and for WOCA‐P (IRR =.49, 95% CI =.35–.70), as well as VPA as a first prescription in both populations. VPA prescriptions as further choice did not show the same trend. Significance: After the regulatory restrictions, an overall significant decline in the use of VPA in WOCA was observed in ERR. The second restriction has been effective in consolidating the prescription trend. However, VPA appears still to be a commonly used drug in WOCA when other ASMs have failed. [ABSTRACT FROM AUTHOR]
Copyright of Epilepsia (Series 4) is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Impact of regulatory restrictions on the use of valproic acid in women of childbearing age: An Italian study.
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  Data: <searchLink fieldCode="AR" term="%22Di Vito%2C+Lidia%22">Di Vito, Lidia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mazzoni%2C+Stefania%22">Mazzoni, Stefania</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Belotti%2C+Laura+Maria+Beatrice%22">Belotti, Laura Maria Beatrice</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Poluzzi%2C+Elisabetta%22">Poluzzi, Elisabetta</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Baldin%2C+Elisa%22">Baldin, Elisa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zenesini%2C+Corrado%22">Zenesini, Corrado</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bisulli%2C+Francesca%22">Bisulli, Francesca</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tinuper%2C+Paolo%22">Tinuper, Paolo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mostacci%2C+Barbara%22">Mostacci, Barbara</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Epilepsia+%28Series+4%29%22">Epilepsia (Series 4)</searchLink>. Apr2023, Vol. 64 Issue 4, p910-918. 9p.
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  Data: <searchLink fieldCode="DE" term="%22European+Medicines+Agency%22">European Medicines Agency</searchLink><br /><searchLink fieldCode="DE" term="%22Childbearing+age%22">Childbearing age</searchLink><br /><searchLink fieldCode="DE" term="%22Valproic+acid%22">Valproic acid</searchLink><br /><searchLink fieldCode="DE" term="%22Time+series+analysis%22">Time series analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Mental+illness%22">Mental illness</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22Northern+Italy%22">Northern Italy</searchLink>
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  Label: Abstract
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  Data: Objective: Due to significant risks to the offspring after intrauterine exposure, the European Medicines Agency issued recommendations in 2014 and 2018 restricting the use of valproate (VPA) in women of childbearing age (WOCA). We aimed to evaluate their impact in the Emilia‐Romagna region (ERR) of Northern Italy. Methods: Using administrative databases, we identified all the ERR residents who received antiseizure medication (ASM) prescriptions from 2010 to 2020. Time series of incidence rates by sex and age group were evaluated for all ASMs. Focusing on VPA, an interrupted time series analysis was applied to assess the impact of the restrictions in WOCA with epilepsy (WOCA‐E) and WOCA with psychiatric disorders (WOCA‐P). We then evaluated the chronological order of ASM prescriptions with regard to the position of VPA. Results: Incidence rates of VPA prescriptions overall decreased over time. A significant decrease was observed only for females. The effect was stronger for WOCA, after both the first (incidence rate ratio [IRR] =.85, 95% confidence interval [CI] =.75–.96) and the second restriction (IRR =.67, 95% CI =.55–.82). The decrease was significant after the second restriction both for WOCA‐E (IRR =.43, 95% CI =.27–.68) and for WOCA‐P (IRR =.49, 95% CI =.35–.70), as well as VPA as a first prescription in both populations. VPA prescriptions as further choice did not show the same trend. Significance: After the regulatory restrictions, an overall significant decline in the use of VPA in WOCA was observed in ERR. The second restriction has been effective in consolidating the prescription trend. However, VPA appears still to be a commonly used drug in WOCA when other ASMs have failed. [ABSTRACT FROM AUTHOR]
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  Group: Ab
  Data: <i>Copyright of Epilepsia (Series 4) is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1111/epi.17526
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        Text: English
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        PageCount: 9
        StartPage: 910
    Subjects:
      – SubjectFull: European Medicines Agency
        Type: general
      – SubjectFull: Childbearing age
        Type: general
      – SubjectFull: Valproic acid
        Type: general
      – SubjectFull: Time series analysis
        Type: general
      – SubjectFull: Mental illness
        Type: general
      – SubjectFull: Northern Italy
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              Text: Apr2023
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