TY -的盟Veronin迈克尔PY - 2011 DA - 2011/02/15 TI -医药产品的包装和标签从互联网获得乔- J地中海互联网Res SP e22六世- 13 - 1 KW -互联网药房KW -网上药店KW -药物进口KW -药物标签KW -制药包装AB -背景:对于患者,处方容器标签可能的唯一来源说明如何把他们的药品。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。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配发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个药物口服剂型样品进行评价:18个辛伐他汀仿制样品，18个氨氯地平仿制样品，5个西地那非仿制样品。观察和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)符合在美国配发的产品的标签和包装指南。在不符合要求的药品中，有7种是装在信封里分发的，贴上的标签要么是手写的，要么是打字的，而且缺少配药人的姓名和地址、处方者的姓名、患者的姓名和使用说明等信息。 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. SN - 1438-8871 UR - //www.mybigtv.com/2011/1/e22/ UR - https://doi.org/10.2196/jmir.1441 UR - http://www.ncbi.nlm.nih.gov/pubmed/21324833 DO - 10.2196/jmir.1441 ID - info:doi/10.2196/jmir.1441 ER -