Office of Applied Research, Food and Drug Research Center, Deputy Ministry for Food and Drugs, Ministry of Health and Medical Education, Tehran, Iran.
Public Health. 2011 Mar;125(3):165-71. doi: 10.1016/j.puhe.2010.11.015.
To gain insight into the pharmaceutical grey market in Iran by reviewing inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, Ministry of Health and Medical Education, and to define the counterfeit pharmaceutical pattern in Iran.
Cross-sectional retrospective study.
In total, 382 inspection files of pharmaceutical counterfeit cases between 2007 and 2008 were reviewed. A database was constructed in Microsoft Access, and all cases of counterfeit medicines together with the details recorded in the files were entered. A primary list of all items in all files was produced (n = 7910), and this contained 716 different counterfeit medicines. This article reports the analysis of these 716 items and the outcome. Subsequently, the list of items was further filtered, and a final working list of 100 items was selected for further analysis. Drug samples of the working list were collected and checked against a modified version of the 'Checklist for the visual inspection of medicines to identify suspicious drug products' of the US Pharmacopeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting Taskforce). Details of items in the working list recorded in the checklist were then entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel.
Of the 716 items, 64.5% were supplements, 10.2% were analgesics, 7.8% were hormones and 3.2% were antihistamines. Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genito-urinary systems, and drugs used for cardiovascular disease and diabetes represented 1-2% of items, and other drug groups accounted for <1% of the 716 counterfeit medicines. Drugs used in professional settings accounted for 20% and drugs used in non-professional settings accounted for 15% of the 716 items. Selected items were checked against the World Health Organization's visual checking tool, and the following observations were made: 15.8% showed mismatch between the label and the container, 7.9% showed the incorrect manufacturer's name and address, 82.9% showed existence or a different view of the logo and hologram of the product, and 18.4% used poor-quality paper for the insert. In 73.7% of products checked, the ink of the packaging or inserts was not smudge-proof.
Results from this study have been utilized by the Deputy Ministry for Food and Drugs in Iran and the outcome was a faster registration and market authorization of supplements compared with other pharmaceutical products. Inter- and intra-section collaboration, active vigilance and conducting educational programs at different levels would reduce the risk of counterfeit medicines and protect public health.
通过审查卫生和医学教育部食品和药品部特别检查股的检查档案，深入了解伊朗的医药灰色市场，并确定伊朗假冒药品的模式。
横断面回顾性研究。
共审查了 2007 年至 2008 年期间 382 份假冒药品案件的检查档案。在 Microsoft Access 中建立了一个数据库，将所有假冒药品案例以及档案中记录的详细信息输入其中。制作了一个包含所有文件中所有项目的基本清单（n = 7910），其中包含 716 种不同的假冒药品。本文报告了对这些 716 种物品的分析结果。随后，对项目清单进行了进一步过滤，选择了 100 种工作清单进行进一步分析。对工作清单中的药物样本进行了收集，并根据美国药典公约（US Pharmacopeia Convention，Inc.）的“药品目视检查清单，用于识别可疑药品”和 IMPACT（国际药品反假冒任务组）的修订版进行了检查。然后将工作清单中记录在清单中的项目详细信息输入数据库。使用社会科学统计软件包 12.0 和 Microsoft Excel 对数据进行分析。
在 716 种物品中，补充剂占 64.5%，镇痛药占 10.2%，激素占 7.8%，抗组胺药占 3.2%。无名称的物品和/或来源不明的物品占总数的 2.4%。草药、中枢神经系统药物、胃肠道系统和生殖泌尿系统药物以及心血管疾病和糖尿病药物分别占 1-2%的物品，其他药物组占 716 种假冒药品的<1%。专业场所使用的药品占 20%，非专业场所使用的药品占 716 种药品的 15%。对选定的物品进行了世界卫生组织的目视检查工具检查，观察到：15.8%的标签与容器不匹配，7.9%的制造商名称和地址不正确，82.9%的产品存在或具有不同的产品徽标和全息图，18.4%的插入物使用了劣质纸张。在检查的 73.7%的产品中，包装或插入物的油墨不防污。
伊朗食品和药品部利用该研究结果，加快了补充剂的注册和市场授权，与其他药品相比更快。跨部门和部门间的合作、积极的警惕性以及在不同层面开展教育计划，将降低假冒药品的风险，保护公众健康。
