Pediatric Drug Shortage in China: Current Status and Reflection_Chinese Journal of Evidence-Based Medicine

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儿童; 药物短缺; 现状分析

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10.7507/1672-2531.20120181

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Citation： 张伶俐,李幼平,胡蝶,曾力楠,梁毅,刘砚韬,代表INDUD. Pediatric Drug Shortage in China: Current Status and Reflection. Chinese Journal of Evidence-Based Medicine, 2012, 12(10): 1159-1164. doi: 10.7507/1672-2531.20120181 Copy

1.	World Health Organization. World Health Statistics 2010 Part Ⅱ. Global Health Indicators. 2010. Available from: http://www.swpho.nhs.uk/resource/item.aspx?RID=78141.
2.	World Health Organization. The global burden of disease 2004 update. 2004. Available from: http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/.
3.	Crowley E, Williams R, Cousins D. Medication errors in children: a descriptive summary of medication error reports submitted to the United States Pharmacopeia. Curr Ther Res, 2001, 62(9): 627-640.
4.	张伶俐, 李幼平, 梁毅. 全球住院儿童超说明书用药现状的系统评价. 中国循证医学杂志, 2012, 12(2): 176-178.
5.	张伶俐, 李幼平, 梁毅. 全球门诊儿童超说明书用药现状的系统评价. 中国循证医学杂志, 2012, 12(3): 305-313.
6.	Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr, 2005, 164(9): 552-558.
7.	曾力楠, 张伶俐. 儿童药物临床试验的发展历史及研究现状. 儿童药学杂志, 2010, 16(2): 4-7.
8.	WHO. 药物: 儿童药物. 2010年6月, 实况报道第341号 [2012-02-04]. Available from: http://www.who.int/mediacentre/factsheets/fs341/zh/.
9.	张伶俐, 李幼平, 黄亮. 四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查. 中国循证医学杂志, 2011, 11(10): 1120-1124.
10.	张兰华, 魏萍. 我国儿科专用药注册现状分析及其对策. 解放军药学学报, 2011, 27(2): 178-180.
11.	杨悦, 粟高超. WHO儿童基本药物示范目录与我国基本药物目录中儿童用药的比较研究. 中国药房, 2011, 22(32): 2994-2998.
12.	张伶俐, 张川, 梁毅, 等. 我国2009版基本药物目录（基层）与WHO 2010版儿童基本药物示范目录比较分析. 中国循证医学杂志, 2010, 10(9): 1027-1036.
13.	余明莲, 杨悦. 我国儿童用药可获得性的调查分析. 解放军药学学报, 2011, 27(4): 368-340.
14.	刘菁, 张艳菊. 北京儿童医院口服中成药用法用量分析. 北京中医药, 2011, 30(6): 465-466.
15.	谷存芬. 影响儿童用药的有关因素分析. 临床和实验医学杂志, 2007, 6(11): 158-159.
16.	王丽. 高度关注儿童用药的安全性. 儿童药学杂志, 2009, 15(5): 1-4.
17.	WHO/FIP Training Workshop. 儿童处方的制剂研发. Available from: http://apps.who.int/preq ual/006-Pharmacovigilance-Safet_CHN.pdf.
18.	WHO. Development of paediatric medicines: points to consider in pharmaceutical development. Available from: www.who.int/.../expertcommittees/pharmprep/Rev2-PaediatricMedicinesDevelopment_QAS08-257Rev1_8102010.pdf.
19.	Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Final Rule:21 CFR Parts 201,312,314,601.Docket No.97N-0165.
20.	Menson EN, Walker AS, Gibb DM. Clinical trials in children. Lancet, 2004, 364(18/25): 2176-2177.
21.	国家发展改革委. 国家发展改革委关于印发《药品差比价规则》的通知. 发改价格[2011]2452号.
22.	四川省非基层医疗机构药品采购、配送、监督平台. Available from: http://fjc.scbid.gov.cn/BidMedicine.aspx.
23.	俞观文. 对药品生产成本的思考. 中国制药信息, 2006, 22(9): 1-3.
24.	FDA. Food and Drug Administration Modernization Act of 1997.Available from: http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/UCM089145.pdf.
25.	Daniel K, Benjamin JrP, Brian SM, et al. Safety and Transparency of Pediatric Drug Trials. Arch Pediatr Adolesc Med, 2009, 163(12): 1080-1086.
26.	Boot I, Sukhai RN, Klein RH, et al. Stimulation programs for pediatric drug research – do children really benefit? Eur J Pediatr, 2007, 166(18): 849-855.
27.	No anthors listed. Regulations requiring manufactures to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Regist, 1998, 63(231): 66631-66672.
28.	FDA. Best Pharmaceuticals for Children Act. Available from: http://bpca.nichd.nih.gov/collaborativeefforts/initiatives/index.cfm.
29.	FDA. Pediatric Research Equity Act. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf.
30.	Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products in children. London: European Medicines Agency, 1997.
31.	Editorial. A European Clinical Trials Registry for Children. Paediatric and Perinatal Drug Therapy, 2003, 5(3): 98-100.
32.	Breitkreutz J. European Perspectives on Pediatric Formulations. Clinical Therapeutics, 2008, 30(11): 2146-2154.
33.	European Commission. Paediatric Investigation Plan . Available from: http://www.child-medicines-research-info.com/paediatric-research-consultancy/paediatric-investigation-plans.asp.
34.	European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/09/WC500112071.pdf.
35.	Choonara I. Regulation of drugs for children in Europe. BMJ, 2007, 335(7632): 1221-1222.
36.	NIH. ClinicalTrials.gov. Available from: http://www.clinicaltrials.gov/ct2/results/map?term=pediatric trials.
37.	FDA. Best Pharmaceuticals for Children Act. Available from: http://bpca.nichd.nih.gov/collaborativeefforts/initiatives/index.cfm.

1. World Health Organization. World Health Statistics 2010 Part Ⅱ. Global Health Indicators. 2010. Available from: http://www.swpho.nhs.uk/resource/item.aspx?RID=78141.
2. World Health Organization. The global burden of disease 2004 update. 2004. Available from: http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/.
3. Crowley E, Williams R, Cousins D. Medication errors in children: a descriptive summary of medication error reports submitted to the United States Pharmacopeia. Curr Ther Res, 2001, 62(9): 627-640.
4. 张伶俐, 李幼平, 梁毅. 全球住院儿童超说明书用药现状的系统评价. 中国循证医学杂志, 2012, 12(2): 176-178.
5. 张伶俐, 李幼平, 梁毅. 全球门诊儿童超说明书用药现状的系统评价. 中国循证医学杂志, 2012, 12(3): 305-313.
6. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr, 2005, 164(9): 552-558.
7. 曾力楠, 张伶俐. 儿童药物临床试验的发展历史及研究现状. 儿童药学杂志, 2010, 16(2): 4-7.
8. WHO. 药物: 儿童药物. 2010年6月, 实况报道第341号 [2012-02-04]. Available from: http://www.who.int/mediacentre/factsheets/fs341/zh/.
9. 张伶俐, 李幼平, 黄亮. 四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查. 中国循证医学杂志, 2011, 11(10): 1120-1124.
10. 张兰华, 魏萍. 我国儿科专用药注册现状分析及其对策. 解放军药学学报, 2011, 27(2): 178-180.
11. 杨悦, 粟高超. WHO儿童基本药物示范目录与我国基本药物目录中儿童用药的比较研究. 中国药房, 2011, 22(32): 2994-2998.
12. 张伶俐, 张川, 梁毅, 等. 我国2009版基本药物目录（基层）与WHO 2010版儿童基本药物示范目录比较分析. 中国循证医学杂志, 2010, 10(9): 1027-1036.
13. 余明莲, 杨悦. 我国儿童用药可获得性的调查分析. 解放军药学学报, 2011, 27(4): 368-340.
14. 刘菁, 张艳菊. 北京儿童医院口服中成药用法用量分析. 北京中医药, 2011, 30(6): 465-466.
15. 谷存芬. 影响儿童用药的有关因素分析. 临床和实验医学杂志, 2007, 6(11): 158-159.
16. 王丽. 高度关注儿童用药的安全性. 儿童药学杂志, 2009, 15(5): 1-4.
17. WHO/FIP Training Workshop. 儿童处方的制剂研发. Available from: http://apps.who.int/preq ual/006-Pharmacovigilance-Safet_CHN.pdf.
18. WHO. Development of paediatric medicines: points to consider in pharmaceutical development. Available from: www.who.int/.../expertcommittees/pharmprep/Rev2-PaediatricMedicinesDevelopment_QAS08-257Rev1_8102010.pdf.
19. Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Final Rule:21 CFR Parts 201,312,314,601.Docket No.97N-0165.
20. Menson EN, Walker AS, Gibb DM. Clinical trials in children. Lancet, 2004, 364(18/25): 2176-2177.
21. 国家发展改革委. 国家发展改革委关于印发《药品差比价规则》的通知. 发改价格[2011]2452号.
22. 四川省非基层医疗机构药品采购、配送、监督平台. Available from: http://fjc.scbid.gov.cn/BidMedicine.aspx.
23. 俞观文. 对药品生产成本的思考. 中国制药信息, 2006, 22(9): 1-3.
24. FDA. Food and Drug Administration Modernization Act of 1997.Available from: http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/UCM089145.pdf.
25. Daniel K, Benjamin JrP, Brian SM, et al. Safety and Transparency of Pediatric Drug Trials. Arch Pediatr Adolesc Med, 2009, 163(12): 1080-1086.
26. Boot I, Sukhai RN, Klein RH, et al. Stimulation programs for pediatric drug research – do children really benefit? Eur J Pediatr, 2007, 166(18): 849-855.
27. No anthors listed. Regulations requiring manufactures to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Regist, 1998, 63(231): 66631-66672.
28. FDA. Best Pharmaceuticals for Children Act. Available from: http://bpca.nichd.nih.gov/collaborativeefforts/initiatives/index.cfm.
29. FDA. Pediatric Research Equity Act. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf.
30. Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products in children. London: European Medicines Agency, 1997.
31. Editorial. A European Clinical Trials Registry for Children. Paediatric and Perinatal Drug Therapy, 2003, 5(3): 98-100.
32. Breitkreutz J. European Perspectives on Pediatric Formulations. Clinical Therapeutics, 2008, 30(11): 2146-2154.
33. European Commission. Paediatric Investigation Plan . Available from: http://www.child-medicines-research-info.com/paediatric-research-consultancy/paediatric-investigation-plans.asp.
34. European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/09/WC500112071.pdf.
35. Choonara I. Regulation of drugs for children in Europe. BMJ, 2007, 335(7632): 1221-1222.
36. NIH. ClinicalTrials.gov. Available from: http://www.clinicaltrials.gov/ct2/results/map?term=pediatric trials.
37. FDA. Best Pharmaceuticals for Children Act. Available from: http://bpca.nichd.nih.gov/collaborativeefforts/initiatives/index.cfm.

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