Ziance Ronald J
College of Pharmacy, University of Southern Nevada, Henderson, USA.
J Am Pharm Assoc (2003). 2008 Jul-Aug;48(4):e71-88; quiz e89-91. doi: 10.1331/JAPhA.2008.07069.
To describe (1) the international scope of counterfeit drugs, (2) international and U.S. anticounterfeiting initiatives, and (3) the enhanced roles and challenges facing pharmaceutical organizations and individual pharmacists to thwart counterfeit drugs.
PubMed and Ovid from 1970 to 2008 using the search terms counterfeit drugs, counterfeit pharmaceuticals, and counterfeit medicines, with English as the limiting term. Nonprimary literature sources included the U.S. Food and Drug Administration (FDA) Web site (www.fda.gov) from 1990 to 2008 using the search term counterfeit drugs, presentations from meetings or workshops attended or accessed via the Internet, and Web sites of professional organizations. Additional resources were identified from personal bibliographies collected by the author and bibliographies of gathered articles.
Counterfeit drugs--defined as those containing no active ingredient, an incorrect amount of active ingredients, incorrect ingredient, and/or unapproved labeling and packaging--represent an unquantified problem of international proportions. The existing situation has been facilitated by inconsistent national regulatory oversight, disparate unlinked databases, lack of unified anticounterfeiting actions, and inability to track the distribution of domestically produced or imported drug products between, among, and within nations. In the United States, several important anticounterfeiting initiatives announced by FDA in 2004 have been implemented but the benefits of others, such as electronic tracking of a drug's movement through the U.S. distribution chain to a dispensing pharmacy, will not be realized in the near future. The role of pharmacists as patient educators, prudent purchasers, and detectors of counterfeit drugs can typically be accomplished with minimal added expense or work; however, the impact of electronic tracking on pharmacies' expenses and workflow is unknown. Pharmacists need to be included in efforts to thwart receipt of counterfeit drugs by patients, but this must be accomplished with minimal negative impact on pharmacy practices.
Although consistent detection of counterfeit drugs is difficult, pharmacists can take several reasonable measures to lessen the chances they are dispensing counterfeit drugs. However, the increased role of pharmacists is accompanied by several important challenges involving increased expense and altered business practices.
描述（1）假药的国际范围，（2）国际和美国的防伪举措，以及（3）制药组织和个体药剂师在防范假药方面面临的强化作用和挑战。
1970年至2008年期间在PubMed和Ovid数据库中检索，检索词为“假药”“假冒药品”和“假冒药物”，限定语言为英语。非原始文献来源包括1990年至2008年期间美国食品药品监督管理局（FDA）网站（www.fda.gov），检索词为“假药”，以及通过互联网参加或获取的会议或研讨会的报告，还有专业组织的网站。其他资源来自作者收集的个人文献目录以及所收集文章的参考文献目录。
假药被定义为那些不含活性成分、活性成分含量不正确、成分错误和/或标签及包装未经批准的药品，这是一个规模无法量化的国际性问题。国家监管不一致、数据库分散且无关联、缺乏统一的防伪行动以及无法追踪国内生产或进口药品在国家之间、国家内部的流通情况，这些因素导致了当前的局面。在美国，FDA于2004年宣布的几项重要防伪举措已经实施，但其他一些举措，如通过美国分销链对药品流向配药药房进行电子追踪，在不久的将来无法实现其效益。药剂师作为患者教育者、谨慎采购者和假药检测者的角色，通常只需增加极少的费用或工作量即可完成；然而，电子追踪对药房费用和工作流程的影响尚不清楚。必须让药剂师参与到防范患者收到假药的工作中来，但这一过程必须对药房业务造成最小的负面影响。
尽管持续检测假药很困难，但药剂师可以采取一些合理措施来减少调配假药的可能性。然而，药剂师角色的强化伴随着一些重要挑战，包括费用增加和业务操作的改变。
