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加拿大一所大学附属医院需要配制的药物处方:一项横断面研究。

Drug Prescriptions Requiring Compounding at a Canadian University Affiliated Pediatric Hospital: A Cross-Sectional Study.

作者信息

Landry Émilie Kate, Autmizguine Julie, Bérubé Sophie, Kraus Raphael, Métras Marie-Élaine, Lebel Denis, Litalien Catherine

机构信息

The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the CHU Sainte-Justine, Montreal, QC H3T 1C5, Canada.

Department of Pediatrics, CHU Sainte-Justine, Montreal, QC H3T 1C5, Canada.

出版信息

Children (Basel). 2023 Jan 11;10(1):147. doi: 10.3390/children10010147.

DOI:10.3390/children10010147
PMID:36670697
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9857558/
Abstract

Despite ongoing international efforts, many drugs administered to children must be compounded from dosage forms designed for adults because they remain unavailable in commercial formulations that suit their needs. Even though oral drug compounding is common in pediatrics, the extent of this practice has not been well described in recent years. This cross-sectional and retrospective study was conducted at a Canadian university-affiliated, 484-bed, tertiary care pediatric hospital and its rehabilitation centre on two randomly selected days. A total of 606 hospitalized children with 5465 prescriptions were included. Overall, compounded drugs for enteral administration (CDEA) represented 13% of all prescriptions (enteral and parenteral) and 23% of prescriptions for enteral administration. Of the 390 prescribed drugs, 122 required compounding. CDEA were mostly liquids (n = 478 [67%]) and mainly included drugs of the central nervous (35%), cardiovascular (21%), and gastro-intestinal (12%) systems. Nearly half (N = 298 [49%]) of children had at least one CDEA prescribed in their medical file. Many CDEA are available as commercial products in other jurisdictions. Collaboration is needed between all stakeholders to make these drugs available to Canadian children.

摘要

尽管国际社会一直在努力,但许多给儿童使用的药物必须从为成人设计的剂型中调配,因为适合儿童需求的商业制剂仍然没有。尽管口服药物调配在儿科很常见,但近年来这种做法的程度尚未得到充分描述。这项横断面回顾性研究在加拿大一所大学附属的、拥有484张床位的三级护理儿童医院及其康复中心进行,研究时间为随机选择的两天。总共纳入了606名住院儿童的5465份处方。总体而言,肠内给药的调配药物(CDEA)占所有处方(肠内和肠外)的13%,占肠内给药处方的23%。在390种处方药中,122种需要调配。CDEA大多为液体(n = 478 [67%]),主要包括中枢神经(35%)、心血管(21%)和胃肠(12%)系统的药物。近一半(N = 298 [49%])的儿童在其病历中有至少一种CDEA处方。许多CDEA在其他司法管辖区有商业产品可供使用。所有利益相关者之间需要开展合作,以便加拿大儿童能够获得这些药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/446f72df1466/children-10-00147-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/b7464f78c595/children-10-00147-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/dc2d8920379a/children-10-00147-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/446f72df1466/children-10-00147-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/b7464f78c595/children-10-00147-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/dc2d8920379a/children-10-00147-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de42/9857558/446f72df1466/children-10-00147-g003.jpg

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本文引用的文献

1
Time for a regulatory framework for pediatric medications in Canada.加拿大需要建立儿科药物监管框架的时候了。
CMAJ. 2022 May 16;194(19):E678-E680. doi: 10.1503/cmaj.220044.
2
Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors.药物配制:历史、监管概述及配制错误的系统评价。
J Med Toxicol. 2021 Apr;17(2):197-217. doi: 10.1007/s13181-020-00814-3. Epub 2020 Nov 2.
3
Providing Suitable Pediatric Formulations for Canadian Children: A Call for Action.为加拿大儿童提供合适的儿科制剂:行动呼吁。
Can J Hosp Pharm. 2020 Fall;73(4):247-256. Epub 2020 Oct 1.
4
Pediatric drug data in Canadian drug monographs: a descriptive analysis.加拿大药品说明书中的儿科用药数据:描述性分析
CMAJ Open. 2020 Aug 31;8(3):E522-E529. doi: 10.9778/cmajo.20200010. Print 2020 Jul-Sep.
5
Retrospective survey of compounded medications for children in Japan.日本儿童用配制药物的回顾性调查。
Eur J Pharm Biopharm. 2020 Oct;155:122-127. doi: 10.1016/j.ejpb.2020.08.016. Epub 2020 Aug 24.
6
Is the provision of paediatric oral liquid unlicensed medicines safe?提供未经许可的儿科口服液药品是否安全?
Arch Dis Child Educ Pract Ed. 2018 Dec;103(6):310-313. doi: 10.1136/archdischild-2016-312132. Epub 2018 Jan 31.
7
An Algorithm to Identify Compounded Non-Sterile Products that Can Be Formulated on a Commercial Scale or Imported to Promote Safer Medication Use in Children.一种识别可在商业规模上配制或进口以促进儿童更安全用药的复方非无菌产品的算法。
Pharmacy (Basel). 2015 Nov 11;3(4):284-294. doi: 10.3390/pharmacy3040284.
8
Prospective Assessment of Pill-Swallowing Ability in Pediatric Patients.儿科患者吞服药丸能力的前瞻性评估
Clin Pediatr (Phila). 2018 Mar;57(3):300-306. doi: 10.1177/0009922817724399. Epub 2017 Aug 3.
9
Utilization and Costs of Compounded Medications for Commercially Insured Patients, 2012-2013.2012-2013 年商业保险患者使用和费用情况分析:复方药物。
J Manag Care Spec Pharm. 2016 Feb;22(2):172-81. doi: 10.18553/jmcp.2016.22.2.172.
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Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.住院儿科患者使用未标明适应证和未获许可的药物:一项系统评价
Eur J Clin Pharmacol. 2015 Jan;71(1):1-13. doi: 10.1007/s00228-014-1768-9. Epub 2014 Oct 16.