A Veronin,Michael %+ Rangel药学院，药物科学系，Texas A&M Health Science Center, MSC 131, 1010 West Avenue B, Kingsville, 78363-8202, United States, 1 361 593 4324，veronin@tamhsc.edu %K互联网药房%K在线药房%K药品进口%K药品标签%K药品包装%D 2011 %7 15.02 2011 %9原文%J J医学互联网研究%G英文%X背景:对于患者来说，处方容器标签可能是如何服用药物的唯一指导来源。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，并应保持产品的标识、强度、质量和纯度，并防止污染。应提供防儿童封闭等安全功能。从国际网上药店购买的药品未经食品和药物管理局(FDA)批准，可能不符合美国标签和包装指南。目的:研究目的是确定从国际网上药店购买的常用药品是否与在美国销售的产品在标签和包装方面具有可比性。方法:2006年3月至2007年1月，从国际互联网药店网站获取41种药物口服剂型样品进行评价:辛伐他汀仿制药18种、氨氯地平仿制药18种、西地那非仿制药5种。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:在从12个不同国家的网上药店获得的41种药品中，只有1种产品(来自加拿大)符合在美国销售的产品的标签和包装指南。 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. %M 21324833 %R 10.2196/jmir.1441 %U //www.mybigtv.com/2011/1/e22/ %U https://doi.org/10.2196/jmir.1441 %U http://www.ncbi.nlm.nih.gov/pubmed/21324833