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10.1186/s12913-017-2235-y http://scihub22266oqcxt.onion/10.1186/s12913-017-2235-y C5477164!5477164 !28633634     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=28633634 &cmd=llinks): Failed to open stream: HTTP request failed! 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The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines |pdf=|usr=}}{{28633634 }} gab.com Text The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines JO: BMC Health Serv Res http://www.kidney.de/pget.php?&tw=1&pmid=28633634 #FOAvip BACKGROUND: Falsely 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. METHODS: The 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. RESULTS: In 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. CONCLUSIONS: This "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. Twit Text FOAVip The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines ????BMC Health Serv Res http://www.kidney.de/pget.php?&tw=1&pmid=28633634 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=28633634 #FOAvip English Wikipedia <ref>{{Cite pmid|28633634 }}</ref> The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines #MMPMID28633634 An?elkovi? M ; Björnsson E ; De Bono V ; Diki? N ; Devue K ; Ferlin D ; Han?eva?ki M ; Jónsdóttir F ; Shakaryan M ; Walser S BMC Health Serv Res 2017[Jun]; 17 (1 ): 419 PMID28633634 show ga BACKGROUND: Falsely 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. METHODS: The 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. RESULTS: In 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. CONCLUSIONS: This "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. |*Counterfeit Drugs/adverse effects [MESH] |*Drug Labeling [MESH] |Adolescent [MESH] |Adult [MESH] |Decision Support Techniques [MESH] |Europe [MESH] |Female [MESH] |Humans [MESH] |Male [MESH] |Middle Aged [MESH] |Pilot Projects [MESH] |Prevalence [MESH] |Public Health [MESH] |Retrospective Studies [MESH] |Self Report [MESH] |Surveys and Questionnaires [MESH]The development and appraisal of a tool designed to find patients harm(epmc).pdf DeepDyve Pubget Overpricing