@Article{信息:doi 10.2196 / / jmir。1441，作者=“Veronin, Michael”，标题=“从互联网获取的药品包装和标签”，期刊=“J Med Internet Res”，年=“2011”，月=“2”，日=“15”，卷=“13”，数=“1”，页=“e22”，关键词=“互联网药店;网上药店;进口药品;药品标签;背景:对于患者来说，处方容器标签可能是关于如何服药的唯一指示来源。在美国，处方标签的法律要求是由联邦法律和州法规规定的。容器应与制造商用于包装药品的容器相当，并应保持产品的特性、强度、质量和纯度并防止污染。应提供安全功能，如儿童防关闭。从国际网上药店购买的药品没有得到食品和药物管理局(FDA)的批准，可能不符合美国的标签和包装指南。 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. ", issn="1438-8871", doi="10.2196/jmir.1441", url="//www.mybigtv.com/2011/1/e22/", url="https://doi.org/10.2196/jmir.1441", url="http://www.ncbi.nlm.nih.gov/pubmed/21324833" }