A Comparative Study between the Newest Essential Medicine Lists of China and the WHO in 2009_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Li ¹ , ZHANG Chuan ^2,3 , YUAN Qiang ^1,4 , ZHANG Lingli ³ ,  LI Youping ¹

1. The Chinese Cochrane Centre / Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;2. West China School of Pharmacy, Sichuan University, Chengdu 610041, China;3. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, China;4. West China School of Medicine, Sichuan University, Chengdu 610041, China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Essential medicine; Essential medicine list; Essential medicine policy

DOI：

10.7507/1672-2531.20090213

Video：

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Objective 　To compare the newest essential medicine lists (EMLs) of China and the World Health Organization (WHO) in 2009, so as to provide the evidence for the selection, adjustment and implementation of the newest national EML of China.
Methods 　Differences in the procedures of selection, implementation and the categories as well as the number of medicines in 2009 EMLs of the WHO and China were compared by descriptive analysis.
Result 　Principles and procedures of selecting and updating EML of China were based on those of the WHO EML. However, the transparency of procedures, methods of selection, and evidence of efficacy, safety, cost-effectiveness and suitability were not enough. Essential medicines of the WHO were categorized by the Anatomical-Therapeutic-Chemical (ATC) classification system, while those of China were classified by clinical pharmacology. Twenty-one identical categories of the first class were found in the two lists. There were 8 and 3 unique categories in the WHO EML and China EML, respectively. A total of 358 and 255 medicines (including medicines in its explanation) were included in the EMLs of the WHO and China, respectively, with 133 identical medicines as well as 206 and 108 unique medicines. There were 51 antiinfective medicines in China EML, accounting for half of the WHO EML. Forty medicines were the same in both lists, and 11 and 60 anti-infective medicines were unique in EMLs of China and the WHO, except for 40 identical medicines. Among them, 22 and 31 antibacterials were included in the lists of the WHO and China with 17 identical medicines. Antifungal, antituberculosis and antiviral medicines in China EML were fewer than those in the WHO EML. The numbers of the identical medicines acting on the respiratory, digestive, and nervous systems and hormones in the both lists were 1, 7, 9, and 17, respectively, while the unique ones in China EML were 6, 12, 7, and 14, respectively. However, most of them were selected without adequate evidence in efficacy and safety. The medicines acting on cardiovascular system were 19 and 29 in both lists with 14 identical medicines. Some antihypertensive and antiarrhythmic medicines were included in China EML with similar mechanism, whereas some of them were excluded by the EML.
Conclusion 　The total numbers of both EMLs are close to each other with half of the identical medicines. The selection of China EML mostly meets the needs of disease burden in China. However, the transparency of selection and evidence are not enough. We suggest that health authorities should cooperate with other stakeholders to promote the transparency of selection, to enhance the capacity of producing high-quality evidence, to develop related technical documents and guidelines, and to disseminate and monitor the implementation of EML.

Citation： WANG Li,ZHANG Chuan,YUAN Qiang,ZHANG Lingli,LI Youping. A Comparative Study between the Newest Essential Medicine Lists of China and the WHO in 2009. Chinese Journal of Evidence-Based Medicine, 2009, 09(11): 1173-1184. doi: 10.7507/1672-2531.20090213 Copy

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2. 《国家基本药物目录（基层医疗卫生机构配备使用部分）》（2009版）http://www.gov.cn/gzdt/2009-08/18/content_1395524. htm.
3. 王莉, 周帮旻, 宋佳佳, 等. 25国基本药物目录循证评价. 中国循证医学杂志, 2009, 9(7): 754-764.
4. World Health Organization. WHO Technical Report Series 946: the selection and use of essential medicines. 2007: Geneva, Switzerland.
5. 卫生部、国家发改委、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、国家食药监局、国家中医药管理局. 国家基本药物目录管理办法（暂行）: 卫药政发 [2009]79号. [2009-08-18]. http://www.chinacourt.org/flwk/show. php?file_id=137594.
6. 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. 关于印发《关于建立国家基本药物制度的实施意见》的通知. [2009-08-18]. http://www1.www. gov.cn/gzdt/2009-08/18/content_1395423.htm.
7. 艾滋病及常见机会性感染免、减费药物治疗管理办法（试行） http://www.jincao.com/fa/10/law10.62.htm.
8. 卫生部、财政部关于将依非韦伦列入艾滋病免费抗病毒治疗药品名录的通知http://chinaivf.com/cms/www/3/2008-11/723.htm.
9. 卫生部办公厅抗疟药使用原则和用药方案（修订稿）. http:// www.moh.gov.cn/publicfiles/business/htmlfiles/mohjbyfkzj/ s3594/200907/41610.htm.
10. 扩大国家免疫实施方案. [2009-06-08]. http://www.chinacdc.net. cn/n272442/n272530/n272742/22210.html.
11. 计划生育药具工作管理办法. [2009-06-09]. http://www.chinapop. gov.cn/wxzl/zywx/200805/t20080501_47925.htm.
12. Global burden of disease 2004 update. http://www.who.int/healthinfo/global_burden_disease/en/index.htm.
13. 2009中国卫生统计年鉴. http://www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/ptjnj/200908/42635.htm.
14. 白剑峰. 我国率先在全球消除丝虫病, 人民日报, 2008年11月13日10版.
15. 徐淑云, 中华临床药物学. 北京: 人民卫生出版社, 2003: 364.
16. 磷霉素在细菌性感染治疗中的优势. 中国社区医师, 2009, 25(12): 11-12.
17. 张石革. 抗真菌药的进展与临床评价. 中国医院用药评价与分析, 2008, 8(2): 85-88.
18. LauerM S. Aspirin for primary prevention of coronary events. N Engl J Med, 2002, 346: 1468-1474.
19. MillerMG, LucasBD, Papademetriou U, et al. Aspirin under fire: aspirin use in the primary prevention of coronary heart disease. Pharmacotherapy, 2005, 25(6): 847-861.
20. 汪尤利, 江景新, 胡茂华. 景德镇市1996-2005年鼠药中毒流行病学分析. 医学动物防制, 2008, 24(1): 25-27.
21. 周帮旻, 王莉, 李幼平, 等. 成都市三圈7个乡镇和社区卫生服务机构药品使用现况调查——三圈七院六站预调查报告之三. 中国循证医学杂志, 2008, 8(7): 529-537.
22. Manyeba J, Haines ST, Zwarenstein M, et al. Reserpine for hypertension (Protocol for a Cochrane Review). In: The Cochrane Library [online database and CD-ROM], Issue 3.Oxford, Update Software, 2003.
23. Packer M, O’Connor CM, Ghali JK, et al. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. N Engl J Med, 1996, 335(15): 1107-1114.
24. Flynn JT, Newburger JW, Daniels SR, et al. A randomized, placebocontrolled trial of amlodipine in children with hypertension. J Pediatr, 2004, 145(3): 353-359.
25. Sica DA, Gehr TW. Calcium-channel blockers and end-stage renal disease: pharmacokinetic and pharmacodynamic considerations. Curr Opin Nephrol Hypertens, 2003, 12(2): 123-131.
26. Vergouwen MD, Vermeulen M, Roos YB. Lancet. Effect of nimodipine on outcome in patients with traumatic subarachnoid haemorrhage: a systematic review. Neurology, 2006, 5(12): 1029-1032.
27. Chrysant SG, Bal IS, Johnson B, et al. A comparative study of captopril and enalapril in patients with severe hypertension. J Clin Pharmacol, 1985, 25(2): 149-151.
28. Rumboldt Z, Marinkovi? M, Drinovec J. Enalapril versus captopril: a double-blind multicentre comparison in essential hypertension. Int J Clin Pharmacol Res, 1988, 8(3): 181-188.
29. Wang X, Effect of enalapril in patients with essential hypertension. Chinese Journal of Cardiovascular Diseases, 1990, 18(2): 79-81, 126.
30. Kang S, Wu YF, An N. A systematic review and meta-analysis of the efficacy and safety of a fixed, low-dose perindopril-indapamide combination as first-line treatment of hypertension. Clinical Therapeutics, 2004, 26(2): 257-270.
31. Krittayaphong R, Bhuripanyo K, Punlee K, et al. Effect of atenolol on symptomatic ventricular arrhythmia without structural heart disease: a randomized placebo-controlled study. Am Heart J, 2002, 144: 10.
32. 侯晓平, 缪京莉, 尹巧香, 等. 阿替洛尔单药治疗老年快速心律失常的疗效观察. 中华保健医学杂志, 2008, 10(3): 211-212.
33. Steinbeck G, Greene HL. Management of patients with lifethreatening sustained ventricular tachyarrhythmaias-the role of guided antiarrhythmic drug therapy. Progress in Cardiovascular Disease, 1996, 38(6): 419-428.
34. Reviewer No. 2 check list for application for deletion of QUINIDINE. http://www.who.int/selection_medicines/committees/ expert/17/expert/Quinidine_Reviewer_2.pdf.
35. 周帮旻, 王莉, 喻佳洁, 等. 成都市三圈7个乡镇和社区卫生服务机构抗感染药物合理用药调查——三圈7院六站预调查报告之五. 中国循证医学杂志, 2009, 9(1): 19-25.
36. 基本药物零售指导价拟9月发布. 抗肿瘤药不在此目录. http:// www.ce.cn/cysc/newmain/s/zyy/200908/21/t20090821_19600128. shtml.
37. 中华人民共和国卫生部. 消毒管理办法（卫生部第27号令）. [2002-03-28]. http://www.china.com.cn/chinese/PI-c/138286.htm.
38. 血液制品管理条例. 1996年12月30日发布. http://www.gov.cn/ banshi/2005-08/01/content_19125.htm.
39. 张川, 王莉, 袁强, 等. 我国基本药物目录、基本医疗保险药物目录和WHO基本药物目录比较. 中国循证医学杂志, 2009, 9(7): 765-773.
40. 胡善联, 张崖冰, 叶露. 国家基本药物制度研究. 卫生经济研究, 2007, (10): 3-5.

Chinese Journal of Evidence-Based Medicine

A Comparative Study between the Newest Essential Medicine Lists of China and the WHO in 2009

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