Schirm Eric, Tobi Hilde, de Jong-van den Berg Lolkje T W
Groningen University Institute for Drug Exploration (GUIDE), University of Groningen, Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen, The Netherlands.
Pediatrics. 2003 Feb;111(2):291-5. doi: 10.1542/peds.111.2.291.
To establish risk factors of unlicensed and off-label drug use by children outside the hospital.
A cross-sectional study based on 66 222 pharmacy dispensing records for the year 2000 was performed in the northern part of the Netherlands. All prescriptions were divided into the following categories: unlicensed (no product license), off-label (licensed drugs used outside the terms of the product license), and on-label (licensed drugs used according to the product license). For identifying possible problem areas, the proportions of unlicensed and off-label drug use were determined per age group (0-1, 2-5, 6-11, or 12-16 years) and per drug group. For all systemic drugs, a logistic regression was done that models the odds of receiving an unlicensed or off-label prescription as a function of several possible risk factors.
Unlicensed drug use in Dutch children is the highest among 0 to 1-year-olds, and off-label drug use is the highest among 12- to 16-year-olds. Drug groups with highest percentages of unlicensed and off-label drug use were ophthalmologicals/otologicals (80.7% of all prescriptions in this group), blood and blood-forming organs (mainly vitamin K for breastfed newborns; 75.7%), cardiovascular drugs (74.7%), and dermatologicals (73.3%). Prescriptions by specialists (outpatient), prescriptions for new drugs, prescriptions for drugs with a low use in the pediatric population, and prescriptions for infants were risk factors for using a systemic drug unlicensed or off-label.
Efforts to improve pediatric labeling are important and need full support. The present results can be used to focus these efforts.
确定院外儿童使用未获许可药物及超说明书用药的风险因素。
基于荷兰北部2000年66222份药房配药记录进行了一项横断面研究。所有处方被分为以下几类：未获许可（无产品许可）、超说明书（在产品许可范围外使用的已获许可药物）和说明书内用药（按照产品许可使用的已获许可药物）。为确定可能存在问题的领域，按年龄组（0至1岁、2至5岁、6至11岁或12至16岁）和药物类别确定未获许可药物及超说明书用药的比例。对于所有全身性药物，进行了逻辑回归分析，将接受未获许可或超说明书处方的几率建模为若干可能风险因素的函数。
荷兰儿童中，0至1岁儿童未获许可药物的使用率最高，12至16岁儿童超说明书用药率最高。未获许可药物及超说明书用药百分比最高的药物类别为眼科/耳科用药（该类别所有处方的80.7%）、血液及造血器官用药（主要是用于母乳喂养新生儿的维生素K；75.7%）、心血管药物（74.7%）和皮肤科用药（73.3%）。专科医生（门诊）开具的处方、新药处方、儿科人群中使用量低的药物处方以及婴儿处方是全身性药物未获许可或超说明书使用的风险因素。
改进儿科用药标签的工作很重要，需要全力支持。目前的结果可用于指导这些工作。
