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dc.contributor.authorAnđelković, Marija
dc.contributor.authorBjörnsson, Einar
dc.contributor.authorDe Bono, Virgilio
dc.contributor.authorDikić, Nenad
dc.contributor.authorDevue, Katleen
dc.contributor.authorFerlin, Daniel
dc.contributor.authorHanževački, Miroslav
dc.contributor.authorJónsdóttir, Freyja
dc.contributor.authorShakaryan, Mkrtich
dc.contributor.authorWalser, Sabine
dc.date.accessioned2017-08-15T15:59:07Z
dc.date.available2017-08-15T15:59:07Z
dc.date.issued2017-06-20
dc.identifier.citationThe development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines. 2017, 17 (1):419 BMC Health Serv Resen
dc.identifier.issn1472-6963
dc.identifier.pmid28633634
dc.identifier.doi10.1186/s12913-017-2235-y
dc.identifier.urihttp://hdl.handle.net/2336/620270
dc.descriptionTo access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked Filesen
dc.description.abstractFalsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool.
dc.description.abstractThe tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under "real-life conditions" in 371 patients in 5 ambulatory and in-patient care sites ("sub-studies"). The physicians participating in the study scored the patients and classified their risk of harm as "unlikely" or "probable" (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool's value.
dc.description.abstractIn 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm's. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm's): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm's) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm's. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors.
dc.description.abstractThis "decision aid" is a systematic tool which helps find in medical practice patients harmed by FFCm's. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm's, current patterns of use and case reports may sustain positive public health impacts.
dc.description.sponsorshipEDQMen
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttps://bmchealthservres.biomedcentral.com/track/pdf/10.1186/s12913-017-2235-y?site=bmchealthservres.biomedcentral.comen
dc.rightsArchived with thanks to BMC health services researchen
dc.subjectLyfjanotkunen
dc.subjectSpurningalistaren
dc.subjectFalsaniren
dc.subjectGAS12en
dc.subjectLYF12en
dc.subject.meshCounterfeit Drugsen
dc.subject.meshSurveys and Questionnairesen
dc.titleThe development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines.en
dc.typeArticleen
dc.contributor.department[ 1 ] Sports Med Assoc Serbia, Belgrade 11000, Serbia Show the Organization-Enhanced name(s) [ 2 ] Landspitali Univ Hosp, Eiriksgata 5, IS-101 Reykjavik, Iceland [ 3 ] Network Family Doctors Rome, Ordine Med Roma, Rome, Italy [ 4 ] VZW Stedelijk Ziekenhuis, B-9300 Aalst, Belgium [ 5 ] Istarski Domovi Zdravlja Casa Salute Istria, Pula 52100, Croatia [ 6 ] Obiteljska Med, Zagreb 10000, Croatia [ 7 ] Sci Ctr Drug & Med Technol Expertise, Yerevan 0051, Armenia [ 8 ] European Directorate Qual Med & HealthCare EDQM, OMCL Network & HealthCare DBO, Dept Biol Standardisat, Until March 2016,Council Europe,CS 67081, Strasbourg, Franceen
dc.identifier.journalBMC health services researchen
dc.rights.accessOpen Access - Opinn aðganguren
refterms.dateFOA2018-09-12T16:39:35Z
html.description.abstractFalsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool.
html.description.abstractThe tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under "real-life conditions" in 371 patients in 5 ambulatory and in-patient care sites ("sub-studies"). The physicians participating in the study scored the patients and classified their risk of harm as "unlikely" or "probable" (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool's value.
html.description.abstractIn 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm's. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm's): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm's) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm's. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors.
html.description.abstractThis "decision aid" is a systematic tool which helps find in medical practice patients harmed by FFCm's. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm's, current patterns of use and case reports may sustain positive public health impacts.


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