巴西一家儿科医院中药物的超说明书及未获许可使用情况。

Off-label and unlicensed utilization of drugs in a Brazilian pediatric hospital.

作者信息

Pereira Gomes Vanessa, Melo da Silva Kédma, Oliveira Chagas Suely, dos Santos Magalhães Igor Rafael

机构信息

Faculdade de Ciências Farmacêuticas, Universidade Federal do Amazonas, Manaus, Amazonas..

Instituto de Saúde da Criança do Amazonas, Manaus, Amazonas. Brazil..

出版信息

Farm Hosp. 2015 May 1;39(3):176-80. doi: 10.7399/fh.2015.39.3.8472.

DOI:10.7399/fh.2015.39.3.8472

PMID:26005894

Abstract

AIM

To describe the off-label and unlicensed utilization patterns of drugs in a Brazilian pediatric hospital.

METHODS

The research consisted of a descriptive, prospective and cross-sectional study.

RESULTS

A total of 1,158 medicines were prescribed for 320 patients, accounting for 65 different drugs. Regarding the classification of drug utilization, the majority of the drugs were prescribed as in-label (57.2%), followed by off-label (36.4%) and by unlicensed (6.3%). The prevalences of unlicensed and off-label utilization of drugs in the studied population were 20.9 and 77.8%, respectively. Polypharmacy was highly associated to both off-label and unlicensed regimen (OR 12.9; 95% CI 3.07-54.2 and OR 3.68; 95% CI 2.02-6.69, respectively) whereas preschool children were less prone to unlicensed prescription (OR 0.39; 95% CI 0.19-0.79). Sex and length of hospitalization were not related to these outcomes.

CONCLUSIONS

Further studies are necessary to verify the impact of this pattern on the occurrence of adverse drug events.

摘要

目的

描述巴西一家儿科医院药物的超说明书和未获许可使用模式。

方法

该研究为描述性、前瞻性和横断面研究。

结果

共为320名患者开具了1158种药物，涉及65种不同药品。关于药物使用分类，大多数药物按说明书用药（57.2%），其次是超说明书用药（36.4%）和未获许可用药（6.3%）。研究人群中药物未获许可使用和超说明书使用的患病率分别为20.9%和77.8%。联合用药与超说明书和未获许可用药方案均高度相关（比值比分别为12.9；95%置信区间3.07 - 54.2和3.68；95%置信区间2.02 - 6.69），而学龄前儿童较少出现未获许可用药情况（比值比0.39；95%置信区间0.19 - 0.79）。性别和住院时间与这些结果无关。