Gonçalves Marcele Giacomin, Heineck Isabela
Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brasil.
Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brasil.
Rev Paul Pediatr. 2016 Jan-Mar;34(1):11-7. doi: 10.1016/j.rpped.2015.06.008. Epub 2015 Oct 9.
: To determine the frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in medium-sized municipality of Rio Grande do Sul, Brazil.
: Cross-sectional study with retrospective data collection, which analyzed prescriptions issued to 326 patients from August to December/2012 in two basic health units in the city of Viamão, state of Rio Grande do Sul. It included all prescriptions of patients whose medical records or service records were available and complete in relation to the date of presence, weight and date of birth. Off-label prescriptions were those which, in relation to the drug leaflet, showed dose different the recommended range, frequency of prescription and/or different form of administration and younger age than the indicated range. Descriptive statistics with absolute frequencies, means and standard deviations were used.
: During the study period, a total of 731 drug prescriptions were issued and the frequency of off-label medications prescribed was 31.7%, especially antihistamines and antiasthmatics (32.3% and 31.5%, respectively). The main type of off-label prescription was dose (38.8%), followed by age range (31.5%) and frequency of administration (29.3%). Regarding the dose off-label prescription, overdose was more frequent (93.3%) than the underdose (6.7%). Prescriptions of unapproved drugs were not identified.
: The study showed that off label prescription is common in both assessed units. The observed percentage of off label prescription was higher than that reported by European studies carried out in primary care. On the other hand, the prescription of drugs not approved for children was not observed.
确定在巴西南里奥格兰德州一个中等规模城市的初级卫生保健机构中，使用未标明适应症药物和未获儿科使用批准药物的处方频率。
采用回顾性数据收集的横断面研究，分析了2012年8月至12月期间在南里奥格兰德州维亚曼市两个基本卫生单位开具的326名患者的处方。纳入了所有病历或服务记录中有关就诊日期、体重和出生日期信息完整的患者的处方。未标明适应症的处方是指与药品说明书相比，显示剂量不同于推荐范围、处方频率和/或给药方式不同且年龄低于指示范围的处方。使用了绝对频率、均值和标准差的描述性统计方法。
在研究期间，共开具了731张药物处方，未标明适应症药物的处方频率为31.7%，尤其是抗组胺药和抗哮喘药（分别为32.3%和31.5%）。未标明适应症处方的主要类型是剂量（38.8%），其次是年龄范围（31.5%）和给药频率（29.3%）。关于剂量未标明适应症处方，过量用药比用药不足更常见（93.3%对6.7%）。未发现未获批准药物的处方。
该研究表明，在所评估的两个单位中，未标明适应症处方很常见。观察到的未标明适应症处方百分比高于欧洲在初级保健中开展的研究所报告的百分比。另一方面，未观察到未获儿童使用批准药物的处方。
