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Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study.儿科药物使用，重点关注瑞典医院的标签外处方 - 一项全国性研究。
Acta Paediatr. 2012 Jul;101(7):772-8. doi: 10.1111/j.1651-2227.2012.02656.x. Epub 2012 Mar 24.
2
Drug utilization study in pediatric prescriptions of a university hospital in southern Brazil: off-label, unlicensed and high-alert medications.巴西南部一家大学医院儿科处方中的药物利用研究：超说明书用药、未获许可药物和高警示药物。
Farm Hosp. 2012 Jul-Aug;36(4):180-6. doi: 10.1016/j.farma.2010.12.008. Epub 2011 Oct 24.
3
Concomitant prescribing and dispensing errors at a Brazilian hospital: a descriptive study.巴西一家医院同时发生的处方和配药错误：一项描述性研究。
Clinics (Sao Paulo). 2011;66(10):1691-7. doi: 10.1590/s1807-59322011001000005.
4
Improving pediatric drug safety: need for more efficient clinical translation of pharmacovigilance knowledge.提高儿科用药安全性：需要更有效地将药物警戒知识转化为临床应用。
J Popul Ther Clin Pharmacol. 2011;18:e76-88. Epub 2011 Mar 21.
5
Licensing and labelling of drugs in a paediatric oncology ward.儿科肿瘤科病房的药品许可和标签。
Br J Clin Pharmacol. 2011 Sep;72(3):474-81. doi: 10.1111/j.1365-2125.2011.03977.x.
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Children and ADRs (Adverse Drug Reactions).儿童与药品不良反应（ADRs）
Ital J Pediatr. 2010 Jan 15;36:4. doi: 10.1186/1824-7288-36-4.
7
[Position of the hospital pharmacist regarding the use of medication in non-authorised conditions].[医院药剂师对在非授权情况下使用药物的立场]
Farm Hosp. 2009 Sep-Oct;33(5):237-9. doi: 10.1016/s1130-6343(09)72462-6.
8
Pharmacists' role in facilitating evidence-based prescribing for unlabeled use of medications.药剂师在促进药物未标注用途的循证处方开具方面的作用。
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Adverse drug reactions in childhood: a review of prospective studies and safety alerts.儿童期药物不良反应：前瞻性研究与安全警报综述
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Determinants of under-reporting of adverse drug reactions: a systematic review.药品不良反应报告不足的决定因素：一项系统综述
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巴西一家教学医院儿童使用非处方药物的情况：一项描述性研究。

Use of non-formulary drugs in children at a Brazilian teaching hospital: a descriptive study.

作者信息

Tramontina Mariana Y, Heineck Isabela, Dos Santos Luciana

机构信息

Universidade Federal do Rio Grande do Sul; and Clinical Pharmacy Service, Hospital de Clínicas de Porto Alegre - HCPA. Porto Alegre (Brazil).

出版信息

Pharm Pract (Granada). 2013 Jan;11(1):17-23. doi: 10.4321/s1886-36552013000100004. Epub 2013 Mar 28.

DOI:10.4321/s1886-36552013000100004
PMID:24155845
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3780509/
Abstract

OBJECTIVE

To characterise the prescription of non-formulary drugs to children and neonates at a Brazilian teaching hospital and identify adverse drug reactions (ADRs), drug interactions, and prescription of potentially hazardous medicines.

METHODS

A prospective exploratory study was carried out between January and May 2011 at the general paediatric wards and paediatric oncology, paediatric intensive care, and neonatal care units of the study hospital. Non-formulary drugs were categorised as approved, off-label, or not approved for use in children according to Brazilian compendia. Electronic health records were actively searched for ADRs and the possibility of moderate to severe interactions between non-formulary drugs and other medicines was determined with the Micromedex® database.

RESULTS

Overall, 109 children or neonates received non-formulary drugs. Of these drugs, 54% were approved for use in children, 12.2% were used off-label, and 33.8% were not approved for use in children. Non-formulary drugs accounted for 13.4% of total prescriptions; 5.3% of drugs had a potential for interactions and five were possibly associated with ADRs.

CONCLUSIONS

Prescription of non-formulary drugs not approved for use in children was common at the study hospital. Studies such as this provide information on the use of medicines for special indications and permit assessment of the relevance of hospital formularies for the paediatric population.

摘要

目的

描述巴西一家教学医院儿童及新生儿使用非处方药物的情况，并识别药物不良反应（ADR）、药物相互作用及潜在危险药物的处方情况。

方法

2011年1月至5月在研究医院的普通儿科病房、儿科肿瘤科、儿科重症监护室及新生儿监护室开展了一项前瞻性探索性研究。根据巴西药典，非处方药物被分类为已批准、未标注适应证或未被批准用于儿童。积极检索电子健康记录以查找ADR，并使用Micromedex®数据库确定非处方药物与其他药物之间发生中度至重度相互作用的可能性。

结果

总体而言，109名儿童或新生儿接受了非处方药物。在这些药物中，54%被批准用于儿童，12.2%为未标注适应证用药，33.8%未被批准用于儿童。非处方药物占总处方的13.4%；5.3%的药物有相互作用的可能性，5种可能与ADR相关。

结论

在研究医院，未被批准用于儿童的非处方药物处方很常见。此类研究提供了关于特殊适应证用药的信息，并有助于评估医院处方集对儿科人群的相关性。