Post Marketed Chemical Drugs Included in the National Essential Medicines List of China: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

WU Jiayi ¹ , LEI Lei ¹ ,  HU Ming ¹ , SONG Minxian ¹ , JIANG Yu ² , CHEN Xiaoyuan ¹

1. West China School of Pharmacy, Sichuan University, Chengdu 610041, China;2. Center for Drug Evaluation, SFDA, Beijing 100038, China;

Corresponding author：

HU Ming, Email: huming@scu.edu.com

Keywords：

National essential medicines list; Post marketed chemical drugs; Selection of essential medicines

DOI：

10.7507/1672-2531.20100603

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Abstract Full text Figures/Tables Video References Cited by

Objective 　To analyze chemical drugs included in the National Essential Medicines List (EML) of China, to provide reference on how to improve the selection criteria and strengthen management and supply of essential medicines.
Methods 　Dosage form, specification and manufacturers of 201 kinds of chemical drugs included in the EML were retrieved through SFDA website, data collection and analysis were conducted using Excel software.
Results 　Domestic chemical drugs in EML involved 24 kinds of dosage forms, 644 kinds of specifications, 37 854 kinds of drugs for sales, and 2 908 manufacturers. Imported chemical drugs in EML involved 12 kinds of dosage forms, 43 kinds of specifications, 113 kinds of drugs for sales, and 53 manufacturers. Included drugs were primarily normal dosage forms while chemical drugs had many different specifications. Medicines duplication in production was serious and the distribution in market was unbalanced. The sole and exclusive dosage form variety lacked of effective evidence. Selection mechanism and reevaluation needed to be developed.
Conclusion 　It is suggested to include drug specification in EML, and refer to spectrum of diseases for detailed selection mechanism of essential drugs, reevaluation of the listed drugs and formulate strict drug bidding rules so as to optimize EML.

Citation： WU Jiayi,LEI Lei,HU Ming,SONG Minxian,JIANG Yu,CHEN Xiaoyuan. Post Marketed Chemical Drugs Included in the National Essential Medicines List of China: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2010, 10(12): 1402-1410. doi: 10.7507/1672-2531.20100603 Copy

1.	卫生部, 国家发展和改革委员会, 工业和信息化部, 监察部, 财政部, 人力资源和社会保障部, 商务部, 国家食品药品监督管理局, 国家中医药管理局. 关于建立国家基本药物制度的实施意见. 2009-08-18. http://www.sda.gov.cn/WS01/CL0056/40753. html.
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8.	王莉, 袁强, 成岚. 我国基本药物目录遴选与评价方法的问题与反思. 中国药房, 2010, 21(16): 1453-1456.
9.	程才, 熊鹰. 《WHO儿童基本药物示范目录》和《WHO基本药物示范目录》比较研究. 中国卫生事业管理, 2008, 11(12): 820-821.
10.	李勇. 忽视苯妥英钠片剂规格变化引起的药物中毒. 中国社区医师, 2007, 23 (10): 18-20.
11.	徐国. 基本药物“硬着陆”. 中国药店, 2010, (03): 22-23.
12.	代谨. 基药普惠三道坎儿. 中国医院院长, 2010, (07): 81-83.
13.	孟锐, 杨奔, 丁丽曼. 浅析我国药品数量多和《基本药物目录》品种数量少的问题. 中国药房, 2010, 21(20): 1850-1851.
14.	WHO. The selection and use of essential medicines- WHO Technical Report Series.
15.	WHO 18th Expert Committee on the Selection and Use of Essential Medicines. Additional information for applicants[EB/OL]. http://www.who.int/selection_medicines/ committees/expert/18/Add_info.pdf.2010-06-20.

1. 卫生部, 国家发展和改革委员会, 工业和信息化部, 监察部, 财政部, 人力资源和社会保障部, 商务部, 国家食品药品监督管理局, 国家中医药管理局. 关于建立国家基本药物制度的实施意见. 2009-08-18. http://www.sda.gov.cn/WS01/CL0056/40753. html.
2. 卫生部. 《国家基本药物目录（基层医疗卫生机构配备使用部分）》. 2009-08-18. http://www.sda.gov.cn/WS01/CL0053/40800.html.
3. 国家食品药品监督管理局. 关于印发2004年《国家基本药物》制剂品种目录的通知. 2004-12-31. http://www.sda.gov.cn/WS01/CL0055/10336.html.
4. 国家发展和改革委员会. 国家基本药物零售价指导价格表. 2009-09-28. http://www.gov.cn/gzdt/2009-10/02/content_1431745.htm.
5. 吴佳怡, 胡明, 宋民宪, 等. 我国生产上市的基本药物目录中成药品种分布状况研究. 中国药房, 2010, 21(24): 2214-2218.
6. 国家食品药品监督管理局. WHO《基本药物示范目录》品种数目历年变化情况怎样？2008-02-26. http://www.sda.gov.cn/WS01/CL0446/28060.html.
7. 王莉, 张川, 袁强. 我国和WHO基本药物目录2009年版比较分析. 中国循证医学杂志, 2009, 9(11): 1173-1184.
8. 王莉, 袁强, 成岚. 我国基本药物目录遴选与评价方法的问题与反思. 中国药房, 2010, 21(16): 1453-1456.
9. 程才, 熊鹰. 《WHO儿童基本药物示范目录》和《WHO基本药物示范目录》比较研究. 中国卫生事业管理, 2008, 11(12): 820-821.
10. 李勇. 忽视苯妥英钠片剂规格变化引起的药物中毒. 中国社区医师, 2007, 23 (10): 18-20.
11. 徐国. 基本药物“硬着陆”. 中国药店, 2010, (03): 22-23.
12. 代谨. 基药普惠三道坎儿. 中国医院院长, 2010, (07): 81-83.
13. 孟锐, 杨奔, 丁丽曼. 浅析我国药品数量多和《基本药物目录》品种数量少的问题. 中国药房, 2010, 21(20): 1850-1851.
14. WHO. The selection and use of essential medicines- WHO Technical Report Series.
15. WHO 18th Expert Committee on the Selection and Use of Essential Medicines. Additional information for applicants[EB/OL]. http://www.who.int/selection_medicines/ committees/expert/18/Add_info.pdf.2010-06-20.

Chinese Journal of Evidence-Based Medicine

Post Marketed Chemical Drugs Included in the National Essential Medicines List of China: A Systematic Review

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