Public health concerns for anti-obesity medicines imported for personal use through the internet: a cross-sectional study.
Public health concerns for anti-obesity medicines imported for personal use through the internet: a cross-sectional study.
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DOI：
10.1136/bmjopen-2012-000854
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发表时间：
2012
期刊：
影响因子：
2.9
通讯作者：
Kimura K
中科院分区：
文献类型：
--
作者：
Khan MH;Tanimoto T;Nakanishi Y;Yoshida N;Tsuboi H;Kimura K
探索抗肥胖药物在互联网上的流通及其质量。横断面研究。可从日本访问的互联网药店和药品供应商。使用日本谷歌搜索引擎上的相关关键词购买抗肥胖药物。博客和纯广告网站被排除在外。与样品制造商和药品监管机构合作调查样品的真实性。使用高效液相色谱法通过药典分析评估样品的质量。 82 个样品是从 36 个网站购买的。大约一半的网站没有提及实际地址，45% 的样本没有包含说明书。对样品的运输进行了各种海关申报：个人保健品、补充剂、药品、日用百货、茶叶等。在82个样品中，对52个样品进行了药典质量检查。 20 家制造公司中只有 5 家提供了真实性答复。经药典分析和真伪调查，其中3个样品被鉴定为假药，不含任何有效成分。其中两个样品经正品制造商确认为假冒产品。即使经过多次沟通尝试，另一个样品的制造商也没有回应我们的真伪检查请求。世界卫生组织西太平洋区域快速警报系统已报告这些假冒案件。许多假冒和未经批准的抗肥胖药物在运输过程中可能很容易绕过监管检查，并通过互联网广泛传播。监管机构应采取措施阻止这些药物进入各国，以保护其公民。在线抗肥胖药物的质量。通过互联网流通未经批准的抗肥胖药物。发现假冒伪劣抗肥胖药物奥利司他。一些运输公司做出虚假和模糊的报关单，以绕过对未经批准的在线药品的监管检查。样本量小和真实性回复率低是本研究的局限性。然而，该研究为监管机构提供了有关未经批准的假药如何通过互联网流通的宝贵信息。正品制造商和药品监管机构必须共同努力打击假货并确保在线消费者获得优质药品。
To explore the circulation of anti-obesity medicines via the internet and their quality. Cross-sectional study. Internet pharmacies and pharmaceutical suppliers accessible from Japan. Anti-obesity medicines were purchased using relevant keywords on Japanese Google search engine. Blogs and advertisement-only sites were excluded. The authenticity of the samples was investigated in collaboration with the manufacturers of the samples and medicine regulatory authorities. Quality of the samples was assessed by pharmacopoeial analyses using high-performance liquid chromatography. 82 samples were purchased from 36 internet sites. Approximately half of the sites did not mention a physical address, and 45% of the samples did not contain a package insert. A variety of custom declarations were made for the shipments of the samples: personal health items, supplement, medicines, general merchandise, tea and others. Among 82 samples, 52 samples were analysed to check their pharmacopoeial quality. Authenticity responses were received from only five of 20 manufacturing companies. According to the pharmacopoeial analyses and authenticity investigation, three of the samples were identified as counterfeits and did not contain any active ingredients. Two of these samples were confirmed as counterfeits by the manufacturer of the authentic products. The manufacturer of the other sample did not respond to our request for an authenticity check even after several communication attempts. These counterfeit cases have been reported at the rapid alert system of Western Pacific Region of the WHO. Many counterfeit and unapproved anti-obesity medicines may be easily bypassing regulatory checks during shipping and are widely circulated through the internet. Regulatory authorities should take measures to prevent these medicines from entering countries to safeguard their citizens. Quality of online anti-obesity medicines. Circulation of unapproved anti-obesity medicines via the internet. Counterfeit and substandard anti-obesity medicines, orlistat are identified. False and vague custom declarations were made by some of the shipping companies to bypass regulatory checks of unapproved online medicines. Small sample size and low authenticity response rate are limitations of this study. However, the study provides valuable information for regulatory authorities on how unapproved and counterfeit medicines are being circulated through the internet. Concerted efforts of authentic manufacturers and medicine regulatory authorities are a must to combat counterfeits and ensure access of quality medicines to online consumers.
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影响因子：
3.3
作者：
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通讯作者：
White, NJ
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3.3
作者：
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