A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances.

IF 1.1 4区医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Annali dell'Istituto superiore di sanita Pub Date : 2022-10-01 DOI:10.4415/ANN_22_04_05

Maria Cristina Gaudiano, Paola Bertocchi, Daniela De Orsi, Livia Manna, Eleonora Antoniella, Andrea Rodomonte, Angela Sorbo, Federica Aureli, Monica Bartolomei

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引用次数: 0

Abstract

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.

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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。

导言:一个案例研究报道了在互联网上出售的抗晕动病透皮贴片，声称只含有天然成分，但实际上含有未申报的药用活性物质。对样品的目视检查表明，二级包装和初级包装有许多不一致之处，缺少各种法律信息，并且不符合“CE”标志。方法:采用液相色谱-高分辨质谱法进行定性分析，液相色谱-二极管阵列检测器进行定量分析。结果:分析证明了抗组胺药苯海拉明和其他活性物质的存在(辣椒素，一种透皮吸收促进剂，微量双氯芬酸，可能是同一植物其他产品的污染物)。此外，通过ICP-MS分析评估了几种微量元素的存在，包括那些对人类有潜在毒性的元素。结论:所讨论的病例是文献中从未报道过的“变相药物”的新病例，表明存在切实的公共卫生风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annali dell'Istituto superiore di sanita PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

3.80

自引率

4.80%

发文量

审稿时长

>12 weeks

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.