Maria Cristina Gaudiano, Paola Bertocchi, Daniela De Orsi, Livia Manna, Eleonora Antoniella, Andrea Rodomonte, Angela Sorbo, Federica Aureli, Monica Bartolomei
{"title":"一个变相药物的案例:晕动病贴片作为含有活性药物物质的医疗设备出售。","authors":"Maria Cristina Gaudiano, Paola Bertocchi, Daniela De Orsi, Livia Manna, Eleonora Antoniella, Andrea Rodomonte, Angela Sorbo, Federica Aureli, Monica Bartolomei","doi":"10.4415/ANN_22_04_05","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>A case study is reported on anti-motion sickness transdermal patches sold in the Internet, claiming to contain only natural ingredients but, actually, containing undeclared medicinal active substances. The visual inspection of the samples evidenced many inconsistencies in secondary and primary packaging, missing of various legal information and a non-compliant \"CE\" mark.</p><p><strong>Methods: </strong>The qualitative analysis was performed by liquid chromatography - high resolution mass spectrometry and the quantitative by liquid chromatography with diode array detector.</p><p><strong>Results: </strong>The analyses evidenced the presence of the antihistaminic drug Diphenhydramine and of other active substances (Capsaicin, a transdermal absorption enhancer, and Diclofenac in traces, probably a contaminant from other productions of the same plant). Moreover, the presence of several trace elements, including those potentially toxic to humans, was assessed by ICP-MS analysis.</p><p><strong>Conclusions: </strong>The case discussed is a new case of \"medicines in disguise\" never reported in literature, and shows the presence of tangible risks for public health.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"254-263"},"PeriodicalIF":1.1000,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances.\",\"authors\":\"Maria Cristina Gaudiano, Paola Bertocchi, Daniela De Orsi, Livia Manna, Eleonora Antoniella, Andrea Rodomonte, Angela Sorbo, Federica Aureli, Monica Bartolomei\",\"doi\":\"10.4415/ANN_22_04_05\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>A case study is reported on anti-motion sickness transdermal patches sold in the Internet, claiming to contain only natural ingredients but, actually, containing undeclared medicinal active substances. The visual inspection of the samples evidenced many inconsistencies in secondary and primary packaging, missing of various legal information and a non-compliant \\\"CE\\\" mark.</p><p><strong>Methods: </strong>The qualitative analysis was performed by liquid chromatography - high resolution mass spectrometry and the quantitative by liquid chromatography with diode array detector.</p><p><strong>Results: </strong>The analyses evidenced the presence of the antihistaminic drug Diphenhydramine and of other active substances (Capsaicin, a transdermal absorption enhancer, and Diclofenac in traces, probably a contaminant from other productions of the same plant). Moreover, the presence of several trace elements, including those potentially toxic to humans, was assessed by ICP-MS analysis.</p><p><strong>Conclusions: </strong>The case discussed is a new case of \\\"medicines in disguise\\\" never reported in literature, and shows the presence of tangible risks for public health.</p>\",\"PeriodicalId\":8246,\"journal\":{\"name\":\"Annali dell'Istituto superiore di sanita\",\"volume\":\"58 4\",\"pages\":\"254-263\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2022-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annali dell'Istituto superiore di sanita\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4415/ANN_22_04_05\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annali dell'Istituto superiore di sanita","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4415/ANN_22_04_05","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances.
Introduction: A case study is reported on anti-motion sickness transdermal patches sold in the Internet, claiming to contain only natural ingredients but, actually, containing undeclared medicinal active substances. The visual inspection of the samples evidenced many inconsistencies in secondary and primary packaging, missing of various legal information and a non-compliant "CE" mark.
Methods: The qualitative analysis was performed by liquid chromatography - high resolution mass spectrometry and the quantitative by liquid chromatography with diode array detector.
Results: The analyses evidenced the presence of the antihistaminic drug Diphenhydramine and of other active substances (Capsaicin, a transdermal absorption enhancer, and Diclofenac in traces, probably a contaminant from other productions of the same plant). Moreover, the presence of several trace elements, including those potentially toxic to humans, was assessed by ICP-MS analysis.
Conclusions: The case discussed is a new case of "medicines in disguise" never reported in literature, and shows the presence of tangible risks for public health.
期刊介绍：
Annali dell’Istituto Superiore di Sanità is a peer reviewed quarterly science journal which publishes research articles in biomedicine, translational research and in many other disciplines of the health sciences. The journal includes the following material: original articles, reviews, commentaries, editorials, brief and technical notes, book reviews.
The publication of Monographic Sections has been discontinued. In case you wish to present a small number of coordinated contributions on specific themes concerning priorities in public health, please contact the Editorial office.
The journal is in English.
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