{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T01:18:26Z","timestamp":1787793506129,"version":"build-2784847793"},"reference-count":22,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T00:00:00Z","timestamp":1787702400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T00:00:00Z","timestamp":1787702400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a cross\u2010sectional survey among national competent authorities, marketing authorization holders, physicians, pharmacists and other stakeholders involved in implementation or use of RMCTs in Austria, Greece, Latvia, the Netherlands, Portugal, Slovenia, Spain and Sweden. The following eight products were included: Aspaveli\u00ae, Fintepla\u00ae, Revlimid\u00ae\/generics, Soliris\u00ae\/biosimilars, Spravato\u00ae, Strimvelis\u00ae, Uptravi\u00ae and Yescarta\u00ae. Experiences were assessed across two implementation phases: regulatory implementation and integration into healthcare. Outcomes were perceived ease of implementation, barriers and enablers. Descriptive analyses were performed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We received 202 valid entries, representing 286 stakeholder\u2010product combinations. Experiences with regulatory implementation were heterogeneous. Approximately 75% of respondents rated regulatory implementation as difficult or very difficult for Fintepla\u00ae and Spravato\u00ae, compared with about 25% for Uptravi\u00ae. The complexity of RMCTs was a key barrier, while prior experience and peer learning were enablers. Integration into healthcare was predominantly perceived as easy, with easy or very easy ratings ranging from over 90% for Fintepla\u00ae and Spravato\u00ae to about 75% for Revlimid\u00ae\/generics. Administrative effort was the main barrier, whereas clinical guidelines, training, peer learning and prior experience facilitated integration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>RMCT implementation was generally perceived as feasible, although regulatory implementation was more challenging than integration into healthcare. Successful implementation may benefit from flexible design, alignment with existing systems, feasibility assessment, stakeholder engagement and clear guidance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70783","type":"journal-article","created":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T00:27:16Z","timestamp":1787790436000},"source":"Crossref","is-referenced-by-count":0,"title":["Implementation and use of risk minimization control tools in the EU: A multistakeholder survey"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2079-4816","authenticated-orcid":false,"given":"Sharon C. M.","family":"Essink","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"},{"name":"Department of Pharmacovigilance, Medicines Evaluation Board  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris R.","family":"Joosse","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Salcher\u2010Konrad","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Walter","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Deligianni","sequence":"additional","affiliation":[{"name":"School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitra","family":"Tsioumela","sequence":"additional","affiliation":[{"name":"School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christos","family":"Kontogiorgis","sequence":"additional","affiliation":[{"name":"School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elita","family":"Poplavska","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacotherapy, Faculty of Pharmacy and Institute of Public Health Riga Stradi\u0146\u0161 University  Riga Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iluta","family":"\u017d\u012bgure","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacotherapy, Faculty of Pharmacy and Institute of Public Health Riga Stradi\u0146\u0161 University  Riga Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina E.","family":"Hoeve","sequence":"additional","affiliation":[{"name":"Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa Leonardo","family":"Alves","sequence":"additional","affiliation":[{"name":"Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6226-5491","authenticated-orcid":false,"given":"Ella D.","family":"van Vliet","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"},{"name":"Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renato","family":"Ferreira\u2010da\u2010Silva","sequence":"additional","affiliation":[{"name":"RISE\u2010Health, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine University of Porto  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Kodri\u010d","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy University of Ljubljana  Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitja","family":"Kos","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy University of Ljubljana  Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Erviti","sequence":"additional","affiliation":[{"name":"Innovation and Organization Unit, Navarre Health Service Spain\/Navarra Institute for Health Research (IdiSNA)  Pamplona 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