Citation： 張伶俐,李幼平,胡蝶,曾力楠,梁毅,劉硯韜,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
Copyright ? the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
| 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. | 張伶俐, 李幼平, 梁毅. 全球住院兒童超說明書用藥現狀的系統評價. 中國循證醫學雜志, 2012, 12(2): 176-178. |
| 5. | 張伶俐, 李幼平, 梁毅. 全球門診兒童超說明書用藥現狀的系統評價. 中國循證醫學雜志, 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, 張伶俐. 兒童藥物臨床試驗的發展歷史及研究現狀. 兒童藥學雜志, 2010, 16(2): 4-7. |
| 8. | WHO. 藥物: 兒童藥物. 2010年6月, 實況報道第341號 [2012-02-04]. Available from: http://www.who.int/mediacentre/factsheets/fs341/zh/. |
| 9. | 張伶俐, 李幼平, 黃亮. 四川大學華西第二醫院兒科門診處方超藥品說明書用藥情況調查. 中國循證醫學雜志, 2011, 11(10): 1120-1124. |
| 10. | 張蘭華, 魏萍. 我國兒科專用藥注冊現狀分析及其對策. 解放軍藥學學報, 2011, 27(2): 178-180. |
| 11. | 楊悅, 粟高超. WHO兒童基本藥物示范目錄與我國基本藥物目錄中兒童用藥的比較研究. 中國藥房, 2011, 22(32): 2994-2998. |
| 12. | 張伶俐, 張川, 梁毅, 等. 我國2009版基本藥物目錄（基層）與WHO 2010版兒童基本藥物示范目錄比較分析. 中國循證醫學雜志, 2010, 10(9): 1027-1036. |
| 13. | 余明蓮, 楊悅. 我國兒童用藥可獲得性的調查分析. 解放軍藥學學報, 2011, 27(4): 368-340. |
| 14. | 劉菁, 張艷菊. 北京兒童醫院口服中成藥用法用量分析. 北京中醫藥, 2011, 30(6): 465-466. |
| 15. | 谷存芬. 影響兒童用藥的有關因素分析. 臨床和實驗醫學雜志, 2007, 6(11): 158-159. |
| 16. | 王麗. 高度關注兒童用藥的安全性. 兒童藥學雜志, 2009, 15(5): 1-4. |
| 17. | WHO/FIP Training Workshop. 兒童處方的制劑研發. 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. | 國家發展改革委. 國家發展改革委關于印發《藥品差比價規則》的通知. 發改價格[2011]2452號. |
| 22. | 四川省非基層醫療機構藥品采購、配送、監督平臺. Available from: http://fjc.scbid.gov.cn/BidMedicine.aspx. |
| 23. | 俞觀文. 對藥品生產成本的思考. 中國制藥信息, 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. 張伶俐, 李幼平, 梁毅. 全球住院兒童超說明書用藥現狀的系統評價. 中國循證醫學雜志, 2012, 12(2): 176-178.
- 5. 張伶俐, 李幼平, 梁毅. 全球門診兒童超說明書用藥現狀的系統評價. 中國循證醫學雜志, 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, 張伶俐. 兒童藥物臨床試驗的發展歷史及研究現狀. 兒童藥學雜志, 2010, 16(2): 4-7.
- 8. WHO. 藥物: 兒童藥物. 2010年6月, 實況報道第341號 [2012-02-04]. Available from: http://www.who.int/mediacentre/factsheets/fs341/zh/.
- 9. 張伶俐, 李幼平, 黃亮. 四川大學華西第二醫院兒科門診處方超藥品說明書用藥情況調查. 中國循證醫學雜志, 2011, 11(10): 1120-1124.
- 10. 張蘭華, 魏萍. 我國兒科專用藥注冊現狀分析及其對策. 解放軍藥學學報, 2011, 27(2): 178-180.
- 11. 楊悅, 粟高超. WHO兒童基本藥物示范目錄與我國基本藥物目錄中兒童用藥的比較研究. 中國藥房, 2011, 22(32): 2994-2998.
- 12. 張伶俐, 張川, 梁毅, 等. 我國2009版基本藥物目錄（基層）與WHO 2010版兒童基本藥物示范目錄比較分析. 中國循證醫學雜志, 2010, 10(9): 1027-1036.
- 13. 余明蓮, 楊悅. 我國兒童用藥可獲得性的調查分析. 解放軍藥學學報, 2011, 27(4): 368-340.
- 14. 劉菁, 張艷菊. 北京兒童醫院口服中成藥用法用量分析. 北京中醫藥, 2011, 30(6): 465-466.
- 15. 谷存芬. 影響兒童用藥的有關因素分析. 臨床和實驗醫學雜志, 2007, 6(11): 158-159.
- 16. 王麗. 高度關注兒童用藥的安全性. 兒童藥學雜志, 2009, 15(5): 1-4.
- 17. WHO/FIP Training Workshop. 兒童處方的制劑研發. 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. 國家發展改革委. 國家發展改革委關于印發《藥品差比價規則》的通知. 發改價格[2011]2452號.
- 22. 四川省非基層醫療機構藥品采購、配送、監督平臺. Available from: http://fjc.scbid.gov.cn/BidMedicine.aspx.
- 23. 俞觀文. 對藥品生產成本的思考. 中國制藥信息, 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.