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Authors
Sousa-Ferreira, Paula https://orcid.org/0000-0001-5712-1338
Ribeiro, Inês https://orcid.org/0000-0002-3442-8158
Alves, Teresa Leonardo https://orcid.org/0000-0003-4967-1916
Rocha, João https://orcid.org/0000-0002-0303-8085
Torre, Carla https://orcid.org/0000-0002-5542-9993
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Funding
Funding for this research was provided by:
European Medicines Agency (contract nr EMA/2018/18/PE)
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Article History
Received: 25 March 2025
Accepted: 20 October 2025
First Online: 21 November 2025
Declarations
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: Not applicable.
: Ethical approval was granted by the ethics committee of the Faculty of Medicine of the University of Porto (Ethics committee process CE 407-19). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
: Informed consent was obtained at the start of the survey. For the interview, informed consent was sought in advance via email.
: Not applicable. The questionnaire responses and the interviews conducted did not collect any data that could identify participants and were recorded anonymously and handled in accordance with the General Data Protection Regulation (GDPR) (EU) 2016/679 of 27 April 2016.
: All data generated or analysed during this study are available in an institutional repository and will be provided upon request during peer review.
: Not applicable.
: Survey development, implementation, and analysis were centrally managed within the international study “Impact of EU label changes and PPP for medicinal products containing valproate and related substances: risk awareness and adherence (ValproateRiskAware)”. Paula Sousa-Ferreira contributed to the review of the study design, survey design, and translation, as well as to Portuguese data collection, the review of data analysis, and the preparation of the first draft of the manuscript and subsequent versions. Inês Ribeiro was involved in the review of the study design, survey design, and translation, as well as in Portuguese data collection and the review of data analysis. Teresa Leonardo Alves contributed to the conceptualisation, design, survey design, analysis, data interpretation, draft review, and final approval. All authors (Paula Sousa-Ferreira, Inês Ribeiro, Teresa Leonardo Alves, João Rocha, Carla Torre) participated in data interpretation, reviewed all drafts of the manuscript, and provided feedback. All authors read and approved the final manuscript.
