对南非私营部门 0-2 岁儿童无证和标示外用药的定量研究:程度、挑战和影响》。

IF 1.3 Q3 PEDIATRICS Current Pediatric Reviews Pub Date : 2024-09-03 DOI:10.2174/0115733963303583240820043749
Hlayiseka Mathevula, Moliehi Matlala, Natalie Schellack, Samuel Orubu
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引用次数: 0

摘要

背景:全球范围内缺乏适合儿童的制剂,导致标签外和无证用药,带来巨大的不良反应风险。在全国范围内了解这种用药情况有助于指导采取干预措施,以获得更好的配方。本研究旨在衡量南非私营企业中儿童使用标签外和无证药品的普遍程度:本研究采用点流行方法,对 2022 年 1 月至 6 月期间在南非一家选定的药品福利管理公司注册的 0-2 岁儿童的用药情况进行了调查。按照 90% 的置信区间、50% 的流行率和 5% 的误差率计算出 1055 份处方的样本量。系统随机抽样方法从 91,973 个条目中每隔 7 个条目抽取一个样本,最终样本量为 13,139 个。数据包括患者年龄、药品数量和特点、数量和适应症。描述性统计分析并报告了无证用药和标签外用药的发生率:在 13,139 种处方药中,40%(5,246 种)属于标签外或无证用药,60%(7,893 种)属于标签内用药。在标签外/无证药品中,16.85%(2214 种)为无证药品,23.08%(3032 种)为标签外药品。甲泼尼龙是标签外用药的首位,益生菌是无证用药的首位,ICD10代码Z76.9是诊断的首位:研究发现,在 2022 年 1 月至 6 月期间,南非私营医疗机构为 40% 的 0-2 岁儿童开具了无证或标签外药品处方。这表明在南非私立医疗机构的儿科治疗中,无标签或无证处方的情况非常普遍。
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A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications.

Background: The global lack of suitable formulations for children leads to off-label and unlicensed medicine use, posing significant risks of adverse effects. Understanding this usage on a national level can help guide interventions for better formulations. This study aimed to measure the prevalence of off-label and unlicensed medicines among children in South Africa's private sector.

Methods: The study used a point prevalence methodology to review medicine use in children aged 0-2 years enrolled in a selected pharmaceutical benefit management company in South Africa from January to June 2022. A sample size of 1055 prescriptions was calculated using a 90% confidence interval, 50% prevalence rate, and 5% error margin. A systematic random sampling approach selected every seventh entry from 91,973 total entries, resulting in a final sample size of 13,139. Data included patient age, number and characteristics of medicines, quantity, and indications. Descriptive statistics analysed and reported the prevalence of unlicensed and off-label medicine use.

Results: Among the 13,139 prescribed medicines, 40% (5,246) were off-label or unlicensed, and 60% (7,893) were on-label. Of the off-label/unlicensed medicines, 16.85% (2,214) were unlicensed, and 23.08% (3,032) were off-label. Methylprednisolone was the top off-label medicine, probiotics were the top unlicensed, and the ICD10 code Z76.9 was the top diagnosis.

Conclusion: The study found that 40% of children aged 0-2 years were prescribed unlicensed or off-label medicines in South Africa's private healthcare sector between January and June 2022. This suggests a widespread practice of off-label or unlicensed prescriptions in paediatric treatment in the South African private sector.

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来源期刊
CiteScore
4.30
自引率
0.00%
发文量
66
期刊介绍: Current Pediatric Reviews publishes frontier reviews on all the latest advances in pediatric medicine. The journal’s aim is to publish the highest quality review articles dedicated to clinical research in the field. The journal is essential reading for all researchers and clinicians in pediatric medicine.
期刊最新文献
The Role of Newborn Pulse Oximetry Screening for Detecting Critical Congenital Heart Defects: A Narrative Review. Cardiology Consult for the General Pediatrician after Cardiac Manifestations from a SARS-CoV-2 Infection. Necrotizing Enterocolitis: A Current Understanding and Challenges for the Future. Practical Way to Use Supraglottic Airway Device. A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications.
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