柬埔寨卫生部采取果断行动打击劣药和假药

Laura Krech, Christi Lane-Barlow, S. Lang, S. Phanouvong, W. Yuan, Heng Bunkiet, Eav Dararath, T. Sovannarith, Lukas Roth
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引用次数: 10

摘要

自1998年首次发现假冒甲氟喹和青蒿琥酯以来,柬埔寨卫生部和药品和食品部一直在积极努力减少在制药部门流通的劣质药品的数量。2005-2012年期间,对柬埔寨12个省的合法私营部门设施和非法销售点进行了常规药品质量监测,方法是采集样本和检测各种抗感染药物,其中大多数是抗疟疾药物和抗生素。药品质量监测项目的现场样本通过现场和高级实验室检测三层次方法进行分析。2005-2012年收集和检测了4381种药物;106件质量检测不合格,总不良率为2.4%。不合格样品中有28个(26.4%)为假冒产品。最常见的假药是氯喹、青蒿琥酯、甲氟喹、氨苄西林和青霉素。截至2011年11月底,柬埔寨通过打击假冒伪劣药品部际委员会(IMC)关闭了99%以上的非法药店。过去,缺乏资源以及各部委之间的协调被确定为打击劣质药品存在的主要障碍。在美国国际开发署、PMI和其他捐助方的资金支持下,在美国促进药品质量药典公约项目的技术支持下,IMC制定了一项行动计划,以大幅减少不合格药品和假药的数量。根据所显示的数据,该计划已成功地将柬埔寨收集的样本不合格率从2006年的7.4%降至2011年的0.7%。需要继续努力监测和积极确保柬埔寨的药品质量,以保持这些低比率;这些努力的可持续性至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Cambodian Ministry of Health Takes Decisive Actions in the Fight Against Substandard and Counterfeit Medicines
Cambodia's Ministry of Health and the Department of Drugs and Food have been actively working to reduce the amount of poor quality medicines circulating in the pharmaceutical sector since fake mefloquine and artesunate were first found in 1998. From 2005-2012, legal private sector facilities and illegal outlets in twelve Cambodian provinces were targeted for routine surveillance of medicine quality through sample collection and testing of various anti-infective medicines, the majority of which were anti-malarials and anti-biotics. The Medicine Quality Monitoring program samples from the field were analyzed through a three level approach including field and advanced laboratory testing. 4,381 medicines were collected and tested from 2005-2012; 106 have failed quality testing resulting in an overall failure rate of 2.4%. 28 of the failed samples (26.4%) were counterfeit. The most commonly found counterfeit medicines were chloroquine, artesunate, mefloquine, ampicillin and penicillin. Cambodia has closed over 99% of illegal pharmacy outlets through the Inter-Ministerial Committee to Fight against Counterfeit & Substandard Medicines (IMC) by the end of November 2011. In the past, a lack of resources as well as coordination among the various ministries was identified as a major barrier in combating the presence of poor quality medicines. With financial support from USAID, PMI, and other donors, paired with the technical support from the U.S. Pharmacopeial Convention Promoting the Quality of Medicines program, the IMC developed an action plan to significantly reduce the number of substandard and counterfeit medicines. Based on the data shown, the plan has been successful in reducing the failure rates of samples collected in Cambodia from a high of 7.4% in 2006 to a low of 0.7% in 2011. Continued efforts to monitor and actively ensure the quality of medicines in Cambodia will be required to maintain these low rates; sustainability of these efforts is critical.
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