{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T12:29:14Z","timestamp":1791116954538,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,12,29]],"date-time":"2014-12-29T00:00:00Z","timestamp":1419811200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"LFB"},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Novonordisk"},{"name":"Octapharma"},{"DOI":"10.13039\/100004702","name":"Baxter","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004702","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>The choice of plasma\u2010derived products (PdP) vs. recombinant products (RP) for treating haemophilia is influenced by the infectious and perceived safety of the products. Batch recall of PdP due to the risk of variant Creutzfeldt\u2010Jakob disease (<jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content>) may have unfavourable psychological impacts on haemophilia patients and influence their product preferences. This study aimed to assess the psychological impact of batch recalls of PdP in six haemophilia patients and their therapeutic demands, and to discuss the ethical problems in physicians\u2019 management of this event. A survey was conducted using a new interview form and an existing anxiety and depression questionnaire. Batch recalls produce recurrent negative emotional outcomes in haemophiliacs and their families. The quality, understanding and efficiency of the batch recall announcements were unsatisfactory in some respects. Only one patient still had some of the vials in question, and only three patients understood the real reason for the batch recall. Four patients asked to change their PdP for RP; a fifth patient was considering doing so. Here, topics for discussion include the delivery of an unclear message to patients about a very uncertain risk of a frightening disease, the reasons to maintain PdP when RP are largely available, except in specific cases, and the related discomfort for caregivers. The ethical questions revealed by batch recalls and the high psychological impact of <jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content> risk on patients can no longer be ignored, and require surveys assessing the rationales and choices of the healthcare authorities, manufacturers, prescribers and users.<\/jats:p>","DOI":"10.1111\/hae.12515","type":"journal-article","created":{"date-parts":[[2014,12,29]],"date-time":"2014-12-29T12:14:12Z","timestamp":1419855252000},"page":"27-33","source":"Crossref","is-referenced-by-count":2,"title":["Batch recall of French plasma\u2010derived products due to variant Creutzfeldt\u2010Jakob disease risk: the psychological impact on haemophilic patients, changes in their therapeutic demands and behaviour and ethical considerations"],"prefix":"10.1111","volume":"21","author":[{"given":"A.","family":"Aouba","sequence":"first","affiliation":[{"name":"Center for Haemophilia Care and Department of Haematology H\u00f4pital Necker Enfants\u2010Malades Universit\u00e9 Paris\u2013Descartes Assistance Publique\u2013H\u00f4pitaux de Paris Paris France"},{"name":"Medical Ethics Department EA 4569 Universit\u00e9 Paris\u2013Descartes PRES Sorbonne\u2010Paris\u2010Cit\u00e9 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Harroche","sequence":"additional","affiliation":[{"name":"Center for Haemophilia Care and Department of Haematology H\u00f4pital Necker Enfants\u2010Malades Universit\u00e9 Paris\u2013Descartes Assistance Publique\u2013H\u00f4pitaux de Paris Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Frenzel","sequence":"additional","affiliation":[{"name":"Center for Haemophilia Care and Department of Haematology H\u00f4pital Necker Enfants\u2010Malades Universit\u00e9 Paris\u2013Descartes Assistance Publique\u2013H\u00f4pitaux de Paris Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. \u2010F.","family":"Torchet","sequence":"additional","affiliation":[{"name":"Center for Haemophilia Care and Department of Haematology H\u00f4pital Necker Enfants\u2010Malades Universit\u00e9 Paris\u2013Descartes Assistance Publique\u2013H\u00f4pitaux de Paris Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Rothschild","sequence":"additional","affiliation":[{"name":"Center for Haemophilia Care and Department of Haematology H\u00f4pital Necker Enfants\u2010Malades Universit\u00e9 Paris\u2013Descartes Assistance Publique\u2013H\u00f4pitaux de Paris Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Fran\u00e7ois","sequence":"additional","affiliation":[{"name":"Medical Ethics Department EA 4569 Universit\u00e9 Paris\u2013Descartes PRES Sorbonne\u2010Paris\u2010Cit\u00e9 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. \u2010F.","family":"Mamzer\u2010Bruneel","sequence":"additional","affiliation":[{"name":"Medical Ethics Department EA 4569 Universit\u00e9 Paris\u2013Descartes PRES Sorbonne\u2010Paris\u2010Cit\u00e9 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,12,29]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Federation of Hemophilia Montreal QC Canada 2005.Guidelines for the management of hemophilia. Available athttp:\/\/www.wfh.org."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2012-01-394411"},{"key":"e_1_2_8_4_1","unstructured":"Food and Drug Administration.Draft quantitative risk assessment of vCJD risk potentially associated with the use of human plasma\u2010derived Factor VIII manufactured under United States (US) license from plasma collected in the US 2006. Available athttp:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/SafetyAvailability\/BloodSafety\/UCM095104.pdf. Accessed November 27 2006."},{"key":"e_1_2_8_5_1","unstructured":"National Hemophilia Foundation board of Directors May 22 2011.MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders May 1 2011; MASAC document # 202. Available athttp:\/\/www.hemophilia.org. Accessed May 1 2011."},{"key":"e_1_2_8_6_1","volume-title":"Textbook of Hemophilia, Third Edition. Edited by Christine A. Lee, Erik E. Berntorp and W. Keith Hoots. \u00a9 2014 John Wiley & Sons, Ltd.","author":"Millar C"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(96)91412-9"},{"key":"e_1_2_8_8_1","unstructured":"AndrewsNJ.Incidence of variant Creutzfeldt\u2010Jakob disease diagnoses and deaths in the UK 2012. Available athttp:\/\/www.cjd.ed.ac.uk\/documents\/cjdq72.pdf."},{"key":"e_1_2_8_9_1","first-page":"1","article-title":"New case of transfusion\u2010associated variant CJD","volume":"16","author":"Health Protection Agency (HPA)","year":"2006","journal-title":"Comm Dis Rep Weekly"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)16811-6"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2011.02508.x"},{"key":"e_1_2_8_12_1","unstructured":"Advisory Committee on Dangerous Pathogens. Guidance from the ACDP TSE Risk Management Subgroup 2013. Available athttp:\/\/www.dh.gov.uk\/health\/2012\/11\/acdp-guidance\/. Accessed November 27 2012."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2516.2009.02181.x"},{"key":"e_1_2_8_14_1","unstructured":"Septi\u00e8me actualisation des travaux du groupe d'experts pluridisciplinaire. Analyse du risque de transmission de la variante de la maladie de Creutzfeldt\u2010Jakob (vMCJ) par les produits de sant\u00e9 d'origine humaine. Rapport de Juillet2009. Available athttp:\/\/www.afssaps.sante.fr. Accessed July 2009."},{"key":"e_1_2_8_15_1","unstructured":"Committee for Medicinal Products for Human Use (CHMP). EMA\/CHMP\/BWP\/303353\/2010 CHMP position statement on Creutzfeldt\u2010Jakob disease and plasma\u2010derived and urine\u2010derived medicinal products. London 23 June 2011. Available athttp:\/\/www.ema.europa.eu. 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