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首页> 外文期刊>Journal of medical Internet research >Packaging and Labeling of Pharmaceutical Products Obtained from the Internet
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Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

机译：从互联网获得的药品包装和标签

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Background: For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging.Objective: The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging.Methods: During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States.Results: Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms.Conclusions: Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.
机译：背景：对于患者而言，处方容器标签可能是有关如何服药的唯一说明来源。在美国，处方标签的法律要求由联邦法律和州法规设定。该容器应与制造商用于包装药品的容器具有可比性，并且应保留产品的标识，强度，质量和纯度并防止污染。应提供安全功能，例如可防止儿童进入的闭合装置。从国际在线药店购买的药品未经美国食品药品监督管理局（FDA）批准，可能不符合美国的标签和包装准则。目的：研究目的是确定从国际在线药店获得的常用药品是否具有可比性方法：在2006年3月至2007年1月期间，从国际互联网药房网站上获得41种药物口服剂型样品进行评估：18种通用辛伐他汀样品，18种通用氨氯地平样品和5个通用西地那非样品。观察并记录每个包装的内容，并将这些产品的处方标签和包装与美国的处方标签和包装要求进行比较。结果：在12个国家/地区的在线药房获得的41种药品中，只有1种产品（来自加拿大）将符合在美国分配的产品的标签和包装准则。在不符合要求的药品中，有7个装在了纸质信封里，上面贴有手写的或打字的标签，上面写着缺少的信息，例如配药者的姓名和地址，处方者的姓名，患者的姓名以及使用说明。另外3种产品没有贴有药品的标签，但信息打印在包装中随附的纸质文档上，而28种产品没有贴有药品的标签。总共41种药品的包装中，有39种不符合美国指南。除加拿大产品外，在符合美国规定的容器中仅分配了一种墨西哥产品。总共有35种产品未分配在塑料小瓶中，而是分配在单位剂量包装，带有松散剂型的纸质信封，与橡皮筋固定在一起的药品泡罩包装或这些包装形式的组合中。国际通用药品的包装和包装标准不等于美国的标签和包装标准。这表明与美国相比，分配过程不相同且不合标准，这反过来又对患者的理解和健康素养提出了挑战，并可能影响患者对药物治疗方案的依从性。这些发现对药品质量，患者预后，治疗效果和安全性具有重要意义。

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