{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T02:18:48Z","timestamp":1771553928504,"version":"3.50.1"},"reference-count":11,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,10,31]],"date-time":"2018-10-31T00:00:00Z","timestamp":1540944000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005740","name":"Iowa Space Grant Consortium","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005740","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":[[2018,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>In 2012, the Committee for Medicinal Products for Human Use (CHMP) restricted prescription of trimetazidine (TMZ) to \u201cadd\u2010on therapy for patients with stable angina pectoris who are inadequately controlled by or intolerant to first\u2010line therapies.\u201d TMZ was no longer indicated for ophthalmology and otolaryngology. Risk minimization measure (RMM) was communicated to physicians. The survey presented here evaluated effectiveness of the RMM and assessed physicians knowledge and compliance with RMM. It also analyzed actual prescribing pattern of TMZ.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A cross sectional, web\u2010based survey was developed and conducted among prescribing physicians of TMZ across 12 European countries. Physicians' samples were weighted to account for the actual proportion of specialties within and across countries.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Using weighted samples, data from 1123 physicians and 8332 prescriptions were analyzed. Most (74.0%) of the physicians assumed stable angina pectoris to be an indication for TMZ. Three quarter of (75.7%) of these physicians were aware of the approved indication. Vertigo (62.1%), tinnitus (42.5%), declined visual acuity, and visual field disturbances (45.1%) were also presumed to be approved indications for TMZ, and physicians actually prescribed for these indications. Only 29.8% of the physicians remembered receiving RMM communications regarding TMZ. Most (90.5%) of the physicians expressed their interest to know and comply with the safety communications. Of all prescriptions, 33.9% were issued for add\u2010on therapy for patients with stable angina pectoris.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>RMM for TMZ prescription have been moderately effective. Improvement in physician's compliance with safety information of TMZ is necessary for patient's safety.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4675","type":"journal-article","created":{"date-parts":[[2018,10,31]],"date-time":"2018-10-31T13:30:09Z","timestamp":1540992609000},"page":"1385-1392","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Evaluation of the effectiveness of risk minimization measures for trimetazidine: A cross sectional joint PASS survey among physicians in selected European countries"],"prefix":"10.1002","volume":"27","author":[{"given":"Dorothea","family":"von Bredow","sequence":"first","affiliation":[{"name":"Department of Pharmacoepidemiology and Drug Safety IQVIA (formerly QuintilesIMS RWI)  Courbevoie La D\u00e9fense France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Massoud","family":"Toussi","sequence":"additional","affiliation":[{"name":"Department of Pharmacoepidemiology and Drug Safety IQVIA (formerly QuintilesIMS RWI)  Courbevoie La D\u00e9fense France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdus","family":"Samad","sequence":"additional","affiliation":[{"name":"Department of Drug Safety and Risk Management Lupin Limited, Kalpataru Inspire  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3352-8480","authenticated-orcid":false,"given":"Sigal","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Department of Patient Safety &amp; Pharmacovigilance Teva Pharmaceutical Industries LTD  Petach Tikva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M\u00f3nika","family":"Domahidy","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Gedeon Richter Plc  Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanka","family":"de Voogd","sequence":"additional","affiliation":[{"name":"Department of Clinical Vaccines &amp; Anti\u2010Infectives Mylan EPD  Amstelveen Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stella","family":"B\u00f6hmert","sequence":"additional","affiliation":[{"name":"Department of Post\u2010marketing Studies Sandoz International GmbH  Holzkirchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita Silveira","family":"Ramos","sequence":"additional","affiliation":[{"name":"Department of Scientific Affairs and Pharmacovigilance Generis Farmac\u00eautica, S.A.  Amadora Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deepa","family":"Arora","sequence":"additional","affiliation":[{"name":"Department of Drug Safety and Risk Management Lupin Limited, Kalpataru Inspire  Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,10,31]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03261989"},{"key":"e_1_2_10_3_1","unstructured":"EMA\u2010EU\u2010PV\u2010Module 15. Module XV\u2014Safety communication.Ema\/118465\/2012.2013;(January):1\u201369."},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3305"},{"issue":"4","key":"e_1_2_10_5_1","first-page":"233","article-title":"Off\u2010label prescriptions: how to identify them, frame them, announce them and monitor them in practice?","volume":"68","author":"Le JC","year":"2013","journal-title":"Th?rapie"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4203"},{"key":"e_1_2_10_7_1","unstructured":"European Medicines Agency (EMA). Assessment report for trimetazidine containing medicinal products.2012;44(September)."},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-017-0535-0"},{"key":"e_1_2_10_9_1","unstructured":"European Medicines Agency (EMA). Guidelines on good pharmacovigilance practices (GVP).2016;"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-016-0284-y"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/0163278707307899"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/jamia.2000.0070426"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.4675","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4675","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,15]],"date-time":"2023-09-15T17:27:23Z","timestamp":1694798843000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4675"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,10,31]]},"references-count":11,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["10.1002\/pds.4675"],"URL":"https:\/\/doi.org\/10.1002\/pds.4675","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,10,31]]},"assertion":[{"value":"2017-10-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-09-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}