{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:22:18Z","timestamp":1777879338116,"version":"3.51.4"},"reference-count":40,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T00:00:00Z","timestamp":1753315200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T00:00:00Z","timestamp":1753315200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Western Balkans Mobility Scheme (WBMS) \u2013 POLICY ANSWERS R&I POLICY making, implementation ANd Support in the WEsteRn BalkanS","award":["Grant Agreement No 101058873 WBMS-017 PREVALT proj"],"award-info":[{"award-number":["Grant Agreement No 101058873 WBMS-017 PREVALT proj"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Valproate (valproic acid, sodium valproate) is authorised in Montenegro for epilepsy and bipolar disorder treatment. Due to known teratogenicity, risk minimisation measures were introduced in 2014 and further reinforced in 2018 by the implementation of the Pregnancy Prevention Programme (PPP). Despite these measures, consumption of valproate in Montenegro increased in the period 2016\u20132022.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To investigate the effects of risk minimisation measures on valproate prescription in Montenegro.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>A retrospective, observational, 7-year, nationwide study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The Primary Health Care Information System (PHCIS) was used as a data source. The health records of women of childbearing potential (12\u201355\u2009years) for the period 2016\u20132022 were analysed. Additionally, unstructured data were reviewed to determine the number and characteristics of valproate-exposed pregnancies. The software PASW, version 25.0 (SPSS Inc., Chicago, IL, USA) was used for the statistical analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      A total of 2247 women of childbearing potential using valproate were identified during the observed period. The number of patients using valproate for epilepsy treatment decreased by 24% while the use of valproate in psychiatry increased by 45% over the observed period. The age of the patient was the only predictive factor for successful PPP implementation (chi-square\u2009=\u200935.811, df\u2009=\u20094 and\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001). The odds ratio (OR) for the age category was 1.22 (95% CI: 1.10\u20131.35). Contraception prescription was recorded in only 1.5% of patients following the PPP implementation. A total of 11 cases of exposed pregnancies were identified, while epilepsy was the indication in 5 (45%) cases.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Regulatory risk minimisation measures had a limited impact on reducing the risk of valproate teratogenicity in Montenegro, with the most success in the group of youngest patients. Measures were more effective in the epilepsy indication. The rising use of valproate for psychiatric indications is concerning. Targeted education, better preconception care and improved coordination among healthcare professionals are necessary.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420986251360888","type":"journal-article","created":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T14:30:53Z","timestamp":1753367453000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["How effective is the implementation of the valproate pregnancy prevention programme in Montenegro? \u2013 A 7-year national retrospective study"],"prefix":"10.1177","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-3777-3289","authenticated-orcid":false,"given":"Veselinka","family":"Vuki\u0107evi\u0107","sequence":"first","affiliation":[{"name":"Institute for Medicines and Medical Devices (CInMED), Ivana Crnojevi\u0107a 64a, Podgorica 81000, Montenegro Faculty of Medicine, University of Montenegro, Podgorica, Montenegro"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sne\u017eana","family":"Mugo\u0161a","sequence":"additional","affiliation":[{"name":"Institute for Medicines and Medical Devices (CInMED), Podgorica, Montenegro"},{"name":"Faculty of Medicine, University of Montenegro, Podgorica, Montenegro"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gordana","family":"Stanojevi\u0107","sequence":"additional","affiliation":[{"name":"Institute for Medicines and Medical Devices (CInMED), Podgorica, Montenegro"},{"name":"Faculty of Medicine, University of Montenegro, Podgorica, Montenegro"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Vezmar Kova\u010devi\u0107","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,7,24]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"Institute for Medicines and Medical Devices. Register of medicines for human use https:\/\/cinmed.me\/en\/humane-medicines\/human-medicine\/?id=1014 (2024 accessed 13 Dec 2024)."},{"key":"e_1_3_4_3_2","unstructured":"U.S. Food and Drug Administration. Drug Databases. Drugs@FDA. FDA-Approved Drugs. Depakote ER. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/021168s049lbl.pdf (2025 accessed 08 June 2025)."},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2008.04.022"},{"issue":"11","key":"e_1_3_4_5_2","article-title":"Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child","volume":"11","author":"Weston J","year":"2016","unstructured":"Weston J, Bromley R, Jackson CF, et al. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev 2016; 11(11): CD010224.","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2009.04.026"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(12)70323-X"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2008.01.010"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000339399.64213.1a"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2013.08.001"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2011.06.014"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.2270"},{"key":"e_1_3_4_13_2","unstructured":"European Medicines Agency. Valproate and related substances Article-31 referral assessment report https:\/\/www.ema.europa.eu\/en\/documents\/referral\/valproate-and-related-substances-article-31-referral-prac-assessment-report_en.pdf (2014 accessed 13 Dec 2024)."},{"key":"e_1_3_4_14_2","unstructured":"Institute for Medicines and Medical Devices. Direct healthcare professional communication https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/DHPC-Valproati.pdf (2014 accessed 13 Dec 2024)."},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2021.1997286"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5166"},{"key":"e_1_3_4_17_2","unstructured":"European Medicines Agency. New measures to avoid valproate exposure in pregnancy endorsed https:\/\/www.ema.europa.eu\/en\/documents\/referral\/valproate-article-31-referral-new-measures-avoid-valproate-exposure-pregnancy-endorsed_en.pdf-0 (2018 accessed 13 Dec 2024)."},{"key":"e_1_3_4_18_2","unstructured":"Institute for Medicines and Medical Devices. Direct Healthcare Professional Communication https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Valproati-DHPC-za-ljekare.pdf (2018 accessed 13 Dec 2024)."},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-023-01314-3"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5670"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40801-023-00394-y"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5427"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0b013e3181577654"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2024.110065"},{"key":"e_1_3_4_25_2","unstructured":"Institute for Medicines and Medical Devices. Analysis of medicines consumption in Montenegro in the period 2018-2022. https:\/\/cinmed.me\/wp-content\/uploads\/2024\/02\/Analiza-potrosnje-ljekova-u-Crnoj-Gori-za-period-2018-2022_korekcije_2.pdf (2023 accessed 08 June 2025)."},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.3390\/socsci12050262"},{"key":"e_1_3_4_27_2","unstructured":"European Commission. National Policies Platform. Youth Wiki. Montenegro. Health | Well-Being. Mental Health. https:\/\/national-policies.eacea.ec.europa.eu\/youthwiki\/chapters\/montenegro\/75-mental-health (2019 accessed 08 June 2025)."},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2020.00739"},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2020.01.004"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-019-00694-4"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2019.09.007"},{"key":"e_1_3_4_32_2","doi-asserted-by":"publisher","DOI":"10.1177\/10398562231169369"},{"key":"e_1_3_4_33_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.12680"},{"key":"e_1_3_4_34_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjno-2023-000433"},{"key":"e_1_3_4_35_2","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp19X701897"},{"key":"e_1_3_4_36_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2016.01.019"},{"key":"e_1_3_4_37_2","unstructured":"European Parliamentary Forum for Sexual & Reproductive Rights. EPF. Contraception Policy Atlas Europe 2022. https:\/\/www.epfweb.Org\/node\/964 (2022 accessed 13 March 2025)."},{"key":"e_1_3_4_38_2","doi-asserted-by":"publisher","DOI":"10.1080\/13625187.2018.1493100"},{"key":"e_1_3_4_39_2","doi-asserted-by":"publisher","DOI":"10.3399\/BJGPO.2020.0104"},{"key":"e_1_3_4_40_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-058312"},{"key":"e_1_3_4_41_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2024-085167"}],"container-title":["Therapeutic Advances in Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986251360888","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20420986251360888","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986251360888","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:41:00Z","timestamp":1777592460000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20420986251360888"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,24]]},"references-count":40,"alternative-id":["10.1177\/20420986251360888"],"URL":"https:\/\/doi.org\/10.1177\/20420986251360888","relation":{},"ISSN":["2042-0986","2042-0994"],"issn-type":[{"value":"2042-0986","type":"print"},{"value":"2042-0994","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,24]]},"article-number":"20420986251360888"}}