{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T21:49:17Z","timestamp":1791841757315,"version":"4.3.4"},"reference-count":21,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,5,13]],"date-time":"2022-05-13T00:00:00Z","timestamp":1652400000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014588","name":"Sanofi Pasteur","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014588","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":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>We evaluated the effectiveness of additional risk minimisation measures (aRMMs; i.e., educational materials) distributed to prescribers to ensure that only individuals with evidence of prior dengue infection (PDI, i.e., dengue seropositive) would be vaccinated with the tetravalent dengue vaccine (CYD\u2010TDV; Dengvaxia\u00ae).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A survey was conducted in 2020 among 300 CYD\u2010TDV prescribers in Brazil and Thailand to ascertain three success criteria: prescribers' awareness of the materials (receiving and reading them); knowledge of the key messages; and whether their self\u2010reported behaviour regarding practice\u2010related scenarios was aligned with the updated guidance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The aRMMs were not generally effective as &lt;80% of prescribers in both countries met two of the three predefined success criteria. In Brazil, 98.7% were aware of the aRMMs whereas in Thailand this criterion was fulfilled by 74.0%. Almost all prescribers knew that CYD\u2010TDV was recommended only in individuals with PDI (98.7% and 96.7% in Brazil and Thailand, respectively). In Brazil, where vaccination was restricted to those with a documented history of PDI, 11.3% considered that confirmation should be done through a blood test. More than 75% in both countries considered additional signs of dengue, as early warning signs, and not only those regarded as such by the 2009 WHO guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These results do not support that the aRMMs were effective as the predefined success criteria were not met. The use of reliable rapid diagnosis tests together with the revised prescribing information and educational materials will facilitate the implementation and compliance with pre\u2010vaccination screening for CYD\u2010TDV eligibility.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5447","type":"journal-article","created":{"date-parts":[[2022,5,4]],"date-time":"2022-05-04T05:43:55Z","timestamp":1651643035000},"page":"758-768","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A cross\u2010sectional survey to evaluate prescribers' knowledge and understanding of safety messages following <scp>Dengvaxia<\/scp>\u00ae product information update"],"prefix":"10.1002","volume":"31","author":[{"given":"Mariana F.","family":"Almas","sequence":"first","affiliation":[{"name":"IQVIA Real World Solutions  Porto Salvo Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massoud","family":"Toussi","sequence":"additional","affiliation":[{"name":"IQVIA Real World &amp;Analytics Solutions  La D\u00e9fense France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Valero","sequence":"additional","affiliation":[{"name":"Global Pharmacovigilance, Sanofi Pasteur  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annick","family":"Moureau","sequence":"additional","affiliation":[{"name":"Global Biostatistical Sciences, Sanofi Pasteur  Marcy l'Etoile France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lydie","family":"Marcelon","sequence":"additional","affiliation":[{"name":"Epidemiology and Benefit Risk, Global Pharmacovigilance, Sanofi Pasteur  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,13]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(14)61060\u20106"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1411037"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(12)61428\u20107"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2018.01.018"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1800820"},{"issue":"36","key":"e_1_2_12_7_1","article-title":"Dengue vaccine: WHO position paper\u2014September 2018","volume":"93","author":"World Health Organization","year":"2018","journal-title":"Wkly Epidemiol Rec"},{"key":"e_1_2_12_8_1","volume-title":"Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control","author":"World Health Organization","year":"2009"},{"key":"e_1_2_12_9_1","unstructured":"Pediatric Infectious Diseases Association of Thailand and the Infectious Diseases Society of Thailand.Guidance for clinical practice of DengvaxiaTM dengue vaccine. Accessed 23 June 2021.https:\/\/www.pidst.or.th\/A655.mobile?action=download&file=766_%E0%B8%84%E0%B8%B3%E0%B9%81%E0%B8%99%E0%B8%B0%E0%B8%99%E0%B8%B3%20Dengvaxia%20%E0%B9%81%E0%B8%9E%E0%B8%97%E0%B8%A2%E0%B9%8C%201%20%E0%B8%AA.%E0%B8%84%2061.pdf."},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0007012"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0003241"},{"key":"e_1_2_12_12_1","unstructured":"Center for Drug Evaluation and Research (CDER)\/Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.Survey methodologies to assess REMS goals that relate to knowledge. Guidance for industry (draft guidance); 2019. Accessed 18 January 2022.https:\/\/www.fda.gov\/media\/119789\/download."},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4434"},{"key":"e_1_2_12_14_1","unstructured":"MadisonT AriasA DiSantostefanoR et al.Evaluating the effectiveness of additional risk minimisation measures via surveys in europe: challenges and recommendations;2016. Accessed 18 January 2022.https:\/\/pharmacoepi.org\/pub\/?id=f46953df-de69-31e7-8f74-725bd7fa685f."},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.13\u20100676"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/tmi.13155"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1179\/2046904712Z.00000000052"},{"key":"e_1_2_12_18_1","volume-title":"In Honor of the 80th Anniversary of the Queen","author":"Kalayanruj S","year":"2016"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejsp.2420150303"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1177\/0163278718807744"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12874\u2010015\u20100016\u2010z"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0749\u20103797(00)00258\u20100"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5447","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5447","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5447","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,18]],"date-time":"2023-08-18T06:27:51Z","timestamp":1692340071000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5447"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,13]]},"references-count":21,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1002\/pds.5447"],"URL":"https:\/\/doi.org\/10.1002\/pds.5447","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,13]]},"assertion":[{"value":"2021-07-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-04-21","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-13","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}