在联邦首都地区二级医疗机构就诊的儿童的超说明书用药情况

Godspower Onavbavba
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引用次数: 0

摘要

一种新药在任何国家被批准上市之前,必须经过三个阶段的临床试验,以评估其根据批准的建议使用时的有效性和安全性。在药物经过监管机构的测试和批准后,该药物通常会获得一个“标签”或“许可证”,这是一份描述药物预期用途和剂量的报告。本研究旨在评估药品在标签上所述条款之外的使用情况。本研究采用数据收集表格从患者病例档案中获取信息。使用社会科学统计软件包分析数据。研究纳入了449例患者的病例记录。患者年龄从4天到16岁不等。女性占51.7%(232人),男性占48.3%(217人)。患者共使用药物1866种,其中超说明书处方469种(25.13%)。超说明书用药类别最高的是适应症(45%)。这项研究揭示了药品超说明书使用的相当普遍,然而,需要在卫生保健设施中提供适当的药学护理,以尽量减少超说明书用药,防止因药物使用不当而产生药物不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Off-Label Use of Medicines in Children Attending a Secondary Healthcare Facility in Federal Capital Territory
Before a new drug is approved for marketing in any country, it must have undergone three phases of clinical trials designed to assess its efficacy and safety when used according to an approved recommendation. After a drug has been tested and approved by the regulatory authorities, the drug is usually given a ‘label’ or ‘license’ which is a report describing the drug intended use and dosage. This study aimed at evaluating the use of medicines outside the terms stated in the label. The study was conducted using a data collection form to obtain information from patients’ case file. Data were analysed using Statistical Package for Social Sciences. The case notes of 449 patients were included in the study. The ages of the patients ranged from 4 days to 16 years. Females constituted 51.7% (232) and males 48.3% (217). A total of 1866 drugs were administered to patients, of which 469 (25.13%) were off-label prescriptions. The highest category of off-label drug was indication (45%). This study has revealed a considerable prevalence of off-label use of medicines, there is however need for proper pharmaceutical care to be emplaced in healthcare facilities so as to minimize off-label drug use and prevent adverse effect of drugs as a result of inappropriate use of medicines.
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