The Exploration and Thinking of Using Children Defined Daily Dose to Assess the Rationality of Dose in Pediatrics △_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Lingli ¹² ,  LI Youping ¹ , ZENG Linan ² , WANG Zheng ³

1. Chinese Evidence Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China; 2.Department of Pharmacy, West China Second University Hospital, Chengdu 610041, China; 3. Department of Pediatric, West China Second University Hospital, Chengdu 610041, China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Child utilization index (cDUI); Pediatric dose; Rationality; Evaluation

DOI：

10.7507/1672-2531.20120022

Video：

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Objective 　Inappropriate drug dosage is a serious problem in pediatrics, mainly due to the lack of clinical evidence in children, suitable preparation formulation, and standardized methods for dose adjustment. A method for evaluating and monitoring appropriate dosage in pediatrics is urgently needed. The drug utilization index (DUI) based on the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) has been widely used in the assessment of appropriate dosage in adults. We explored possible methods for assessing appropriate dosage in children.
Methods 　Based on our previous studies, we discuss cDUI in the assessment of appropriate dosage in children as follows: the meaning of cDDD, the establishment of a standardized system, and the classified evaluation of dosage in pediatrics.
Results 　Although the definition of cDDD draws on the concept of defined daily dose (DDD), the meaning of cDDD is different from that of the latter. Specifically, the purpose of cDDD is to evaluate appropriate pediatric dose, while DDD is a unit of measurement. cDDD could be used to assess dose rationality for common and serious pediatric diseases, and would be refined over time. A single cDDD should be assigned per drug and indication and given per drug and route of administration. The influence of age, weight, diagnosis, and administration route on the dosage should be considered. Classified evaluation should be used and weight should be given to the above mentioned factors in order to evaluate the appropriate dose objectively and comprehensively.
Conclusion 　Dosage regulation in pediatrics has an important role in improving medical quality and protecting the safety, effectiveness, and economy of medical therapy in children. The establishment of a cDUI system is a good try in pediatric dosage evaluation. Although there are still defects within this proposed system and methodology, the principle seems feasible.

Citation： ZHANG Lingli ,LI Youping,ZENG Linan,WANG Zheng. The Exploration and Thinking of Using Children Defined Daily Dose to Assess the Rationality of Dose in Pediatrics △. Chinese Journal of Evidence-Based Medicine, 2012, 12(2): 125-128. doi: 10.7507/1672-2531.20120022 Copy

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2.	WHO. Rational use of medicines. http://www.who.int/medicines/ areas/ rational_ use/en/index. Html.
3.	Kaushal R, Bates DW, Landrigan C, et al . Medication errors and adverse drug events in pediatric inpatients. JAMA , 2001, 285(16): 2114-2120.
4.	Kozer E, Scolnik D, Macpherson A, et al . Variables associated with medication errors in pediatric emergency medicine. Pediatrics , 2002, 110(4): 737-742.
5.	Neuberta A, Wonga ICK, Bonifazi A, et al . Defining off-label and unlicensed use of medicines for children:Results of a Delphi survey. Pharmacological Research , 2008, 58(43): 316-322.
6.	Hsien L, Breddemann A, Frobel AK. Off-label drug use among hospitalised children: identifying area with the highest need for research. Pharm World Sci , 2008, 30(32): 497–502.
7.	彭翠英, 何周康. 507份药品说明书内容现状调查分析. 儿科药学杂, 2009, 15(4): 45-47.
8.	Santos DB, Clavenna A, Bonati M, et al . Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. European Journal of Clinical Pharmacology , 2008, 64(11): 1111-1118.
9.	Schirm E, Tobi H, de Jong-van den Berg LT. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics , 2003, 111(2): 291-295.
10.	韩璐, 曾力楠, 张伶俐, 等. 329例汶川地震妇女儿童伤病员药物利用分析. 中国循证医学杂志, 2009, 9(3): 265-227.
11.	World Health Organization. Introduction to Drug Utilization Research. Oslo, Norway, 2003. http://www.whocc.no/filearchive/publications/drug_utilization _research.pdf.
12.	Wade O. Drug utilization studies-the first attempts. Drug utilization studies: implications for medical care. Acta MedicaScandinavica , 1984, Suppl 683: 7-9.
13.	Dukes MNG. Development from Crooks to the nineties. In: Auditing Drug Therapy Approaches towards rationality at reasonable costs. Pharmaceutical Press, 1992.
14.	Bergman U. The history of the DrugUtilizati on Research Group in Europe1Phar macoep idemiol. Drug Saf , 2006, 15(2): 95-98.
15.	Baksaas AI. Drug dose statistics, list of defined daily doses for drugs registered in Norway. Oslo, Norsk Medicinal Depot, 1975.
16.	Ghodse AH, Baigent B, Evans TC, et al . The use of a drug utilisation index to monitor psychotropic drug use in hospitals. Journal of Social Psychiatry , 1987, 33(1): 21-29.
17.	阎爱荣, 武改梅. 我院2005年住院患者麻醉性镇痛药应用分析与评价. 中国药房, 2007, 18(32): 2493-2494.
18.	覃开羽. 我院2006年口服降糖药利用分析. 中国药房, 2008, 19(11): 819-821.
19.	刘鹰, 杨传辉, 李荡, 等. 门诊患者抗菌药物应用调查. 中华医院感染学杂志, 2008, 18(5): 701-711.
20.	WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2010. Oslo, Norway, 2009.
21.	金卫. 我院儿科门诊处方抗菌药物的利用分析. 广东药学, 2005, l15(6): 48-50.
22.	张振财. 某院门诊儿科抗菌素合理使用情况分析. 安徽医药, 2005, 9(12): 934-936.

1. 2 Wong IC, Ghaleb MA, Franklin BD, et al . Incidence and nature of dosing errors in paediatric medications: a systematic review. Drug Saf , 2004, 27(9): 661-670.
2. WHO. Rational use of medicines. http://www.who.int/medicines/ areas/ rational_ use/en/index. Html.
3. Kaushal R, Bates DW, Landrigan C, et al . Medication errors and adverse drug events in pediatric inpatients. JAMA , 2001, 285(16): 2114-2120.
4. Kozer E, Scolnik D, Macpherson A, et al . Variables associated with medication errors in pediatric emergency medicine. Pediatrics , 2002, 110(4): 737-742.
5. Neuberta A, Wonga ICK, Bonifazi A, et al . Defining off-label and unlicensed use of medicines for children:Results of a Delphi survey. Pharmacological Research , 2008, 58(43): 316-322.
6. Hsien L, Breddemann A, Frobel AK. Off-label drug use among hospitalised children: identifying area with the highest need for research. Pharm World Sci , 2008, 30(32): 497–502.
7. 彭翠英, 何周康. 507份药品说明书内容现状调查分析. 儿科药学杂, 2009, 15(4): 45-47.
8. Santos DB, Clavenna A, Bonati M, et al . Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. European Journal of Clinical Pharmacology , 2008, 64(11): 1111-1118.
9. Schirm E, Tobi H, de Jong-van den Berg LT. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics , 2003, 111(2): 291-295.
10. 韩璐, 曾力楠, 张伶俐, 等. 329例汶川地震妇女儿童伤病员药物利用分析. 中国循证医学杂志, 2009, 9(3): 265-227.
11. World Health Organization. Introduction to Drug Utilization Research. Oslo, Norway, 2003. http://www.whocc.no/filearchive/publications/drug_utilization _research.pdf.
12. Wade O. Drug utilization studies-the first attempts. Drug utilization studies: implications for medical care. Acta MedicaScandinavica , 1984, Suppl 683: 7-9.
13. Dukes MNG. Development from Crooks to the nineties. In: Auditing Drug Therapy Approaches towards rationality at reasonable costs. Pharmaceutical Press, 1992.
14. Bergman U. The history of the DrugUtilizati on Research Group in Europe1Phar macoep idemiol. Drug Saf , 2006, 15(2): 95-98.
15. Baksaas AI. Drug dose statistics, list of defined daily doses for drugs registered in Norway. Oslo, Norsk Medicinal Depot, 1975.
16. Ghodse AH, Baigent B, Evans TC, et al . The use of a drug utilisation index to monitor psychotropic drug use in hospitals. Journal of Social Psychiatry , 1987, 33(1): 21-29.
17. 阎爱荣, 武改梅. 我院2005年住院患者麻醉性镇痛药应用分析与评价. 中国药房, 2007, 18(32): 2493-2494.
18. 覃开羽. 我院2006年口服降糖药利用分析. 中国药房, 2008, 19(11): 819-821.
19. 刘鹰, 杨传辉, 李荡, 等. 门诊患者抗菌药物应用调查. 中华医院感染学杂志, 2008, 18(5): 701-711.
20. WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2010. Oslo, Norway, 2009.
21. 金卫. 我院儿科门诊处方抗菌药物的利用分析. 广东药学, 2005, l15(6): 48-50.
22. 张振财. 某院门诊儿科抗菌素合理使用情况分析. 安徽医药, 2005, 9(12): 934-936.

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