{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T03:39:30Z","timestamp":1785469170168,"version":"3.56.0"},"reference-count":17,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,11,12]],"date-time":"2024-11-12T00:00:00Z","timestamp":1731369600000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100016372","name":"Desitin Arzneimittel","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100016372","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100014756","name":"Hexal AG","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014756","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013180","name":"G.L. Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013180","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015512","name":"Wockhardt","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100015512","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100024580","name":"Orion Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100024580","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100014751","name":"Neuraxpharm","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014751","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To assess the impact of the 2018 European additional risk minimisation measures (aRMMs) regarding the use of valproate in women of childbearing potential (WCBP) and during pregnancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A cross\u2010sectional, non\u2010interventional survey conducted in six European countries among 1982 healthcare professionals (HCPs) (July\u2013October 2020) and 779 WCBP treated with valproate for epilepsy, bipolar disorder or other indications (August 2020\u2013February 2021). HCPs were prescribing physicians (neurologists, psychiatrists, paediatricians and GPs), gynaecologists and pharmacists. Prespecified criteria were defined for success in the dimensions of awareness, knowledge and behaviour (correct answers to \u2265\u200980% of questions at individual level) and overall success (\u2265\u200990%\/80% successful HCPs\/patients respectively, in the behaviour dimension and one of the two other dimensions).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>HCPs and patients did not meet the success criteria either overall or in any dimension. Highest success rates were in the behaviour dimension for gynaecologists (71.7%), pharmacists (49.7%) and patients (51.2%), and in the awareness dimension for prescribing physicians (23.6%). HCPs reported being unfamiliar with some educational materials and lacked knowledge of detailed prescribing conditions for valproate and the need for contraception regardless of sexual activity. More than 50% of patients were aware of the relevant patient materials and knew about the teratogenic risks of valproate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Self\u2010reported levels of awareness, knowledge and behaviour varied considerably by HCP type and among patient respondents. Further investigation is needed into why certain measures of the pregnancy prevention programme are not well known and followed, to improve their effectiveness. This will be addressed in a qualitative study which will be based on interviews with HCPs and patients.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70046","type":"journal-article","created":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T11:27:22Z","timestamp":1731497242000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Effectiveness of the Additional Risk Minimisation Measures for Valproate Among Healthcare Professionals and Patients: A Cross\u2010Sectional Survey in Six European Countries"],"prefix":"10.1002","volume":"33","author":[{"given":"Sandrine","family":"Colas","sequence":"first","affiliation":[{"name":"Epidemiology and Benefit Risk, Global R&amp;D, Sanofi  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8754-1417","authenticated-orcid":false,"given":"Tiffany","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Real World Solutions, IQVIA  Courbevoie France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9837-040X","authenticated-orcid":false,"given":"Isabelle","family":"Dresco","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Sanofi  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3352-8480","authenticated-orcid":false,"given":"Sigal","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Epidemiology, Teva Pharmaceutical Industries Ltd  Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8715-2220","authenticated-orcid":false,"given":"Karine","family":"Marinier","sequence":"additional","affiliation":[{"name":"Real World Solutions, IQVIA  Courbevoie France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-2019-9144","authenticated-orcid":false,"given":"Aude","family":"Lachacinski","sequence":"additional","affiliation":[{"name":"Patient Safety &amp; Pharmacovigilance, Sanofi  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2606-776X","authenticated-orcid":false,"given":"Marie\u2010Laure","family":"K\u00fcrzinger","sequence":"additional","affiliation":[{"name":"Epidemiology and Benefit Risk, Global R&amp;D, Sanofi  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6780-0676","authenticated-orcid":false,"given":"Massoud","family":"Toussi","sequence":"additional","affiliation":[{"name":"Real World Solutions, IQVIA  Courbevoie France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,11,12]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"\u201cEuropean Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC) \u201d Assessment Report. 2014 Procedure Under Article 31 of Directive 2001\/83\/EC Resulting From Pharmacovigilance Data. Substances Related to Valproateaccessed May 15 2023 https:\/\/www.ema.europa.eu\/en\/documents\/referral\/valproate\u2010and\u2010related\u2010substances\u2010article\u201031\u2010referral\u2010prac\u2010assessment\u2010report_en.pdf."},{"key":"e_1_2_12_3_1","unstructured":"\u201cEuropean Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC) \u201d Assessment Report Referral Under Article 31 of Directive 2001\/83\/EC Medicinal Products Containing Substances Related to Valproateaccessed May 31 2023 https:\/\/www.ema.europa.eu\/documents\/referral\/valproate\u2010article\u201031\u2010referral\u2010prac\u2010assessment\u2010report_en.pdf."},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5119"},{"key":"e_1_2_12_5_1","unstructured":"\u201cEuropean Medicines Agency \u201d Summary of the EMA Public Hearing on Valproate in Pregnancy. accessed July 11 2024 https:\/\/www.ema.europa.eu\/system\/files\/documents\/other\/wc500236051_en.pdf."},{"key":"e_1_2_12_6_1","unstructured":"\u201cEuropean Medicines Agency \u201d New Measures to Avoid Valproate Exposure in Pregnancy Endorsed Press Releaseaccessed July 11 2024 https:\/\/www.ema.europa.eu\/en\/news\/new\u2010measures\u2010avoid\u2010valproate\u2010exposure\u2010pregnancy\u2010endorsed."},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-022-01234-8"},{"key":"e_1_2_12_8_1","unstructured":"\u201cIQVIA \u201d OneKey List Finder. Custom HCP and HCO Data Lists accessed August 26 2024 https:\/\/www.iqvia.com\/locations\/united\u2010states\/solutions\/life\u2010sciences\/information\u2010solutions\/onekey\u2010reference\u2010data\/onekey\u2010list\u2010finder#physicians."},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2021.1933429"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/ane.13231"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/ane.13581"},{"key":"e_1_2_12_12_1","unstructured":"\u201cValproate Risk Aware \u201d Impact of EU Label Changes and Pregnancy Prevention Programme for Medicinal Products Containing Valproate and Related Substances: Risk Awareness and Adherenceaccessed May 23 2023 https:\/\/www.encepp.eu\/encepp\/viewResource.htm?id=49662."},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/ane.13337"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.3399\/BJGPO.2020.0104"},{"key":"e_1_2_12_15_1","unstructured":"\u201cEpilepsy Ireland \u201d Valproate Survey December 2019\u2013February 2020accessed May 23 2023 https:\/\/www.epilepsy.ie\/content\/survey\u2010results\u2010awareness\u2010risk\u2010factors\u2010associated\u2010sodium\u2010valproate\u2010epilim."},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph20032215"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-023-01314-3"},{"key":"e_1_2_12_18_1","unstructured":"\u201cNewristics \u201d Attentional Bias accessed July 31 2024https:\/\/newristics.com\/heuristics\u2010biases\/attentional\u2010bias."}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70046","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,28]],"date-time":"2025-01-28T03:42:45Z","timestamp":1738035765000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.70046"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11]]},"references-count":17,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1002\/pds.70046"],"URL":"https:\/\/doi.org\/10.1002\/pds.70046","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11]]},"assertion":[{"value":"2024-02-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70046"}}