沙特阿拉伯东部省儿科医生、全科医生和药剂师对给儿科患者开标签外药物处方的认识、做法和看法。

IF 1.3 Q3 PEDIATRICS
Layan Sameer Almintakh, Mariam Fahad Al Dossary, Abrar Mohmmadjamal Altesha, Rayanah Fahad Alqahtani, Samiah Mohammad Alsomali, Nuzhat Banu, Mohammad Daud Ali, Ayaz Ahmed
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引用次数: 0

摘要

背景:标签外用药是指将已获批准的药物用于未获批准的适应症、人群、给药途径或剂量。儿童的生理状态与成人不同,因此成人制剂对儿童有潜在危险。由于儿科制剂的开发面临挑战,标签外处方在儿童中十分常见。本研究旨在了解沙特阿拉伯东部省的儿科医生、全科医生和药剂师对给儿科患者开标签外处方的认识、做法和看法:在沙特阿拉伯东部省的儿科医生、全科医生和药剂师(临床和社区)中开展了一项基于问卷的横断面研究。统计分析使用从谷歌表格(美国加利福尼亚州山景城)和 Microsoft Excel(2016 版)导出的数据,然后导入 26.0 版社会科学统计软件包(SPSS)(IBM 公司,美国纽约州阿蒙克)。智方被认为是合适的。显著性水平设定为 0.05:在研究参与者中,53 人(35.09%)是药剂师,其次是 24 人(15.89%)其他人员、22 人(14.565%)儿科医生、19 人(12.58%)其他专科医生、17 人(11.25%)全科医生和 16 人(10.59%)临床药师。约 73 人(48.34%)正确描述了标签外的定义。约 114 名(75.49%)受访者认为必须告知家长和监护人有关给儿童开具的标签外药物。约 52 人(34.43%)对药物的安全性表示担忧,98 人(64.90%)认为应在儿科进行临床试验。此外,97 人(64.23%)认为自己对标签外药物的了解不够。参与者遇到的障碍如下:89(58.945%)人认为缺乏信息资源,71(47.01%)人认为缺乏培训,56(37.08%)人认为缺乏有关儿科辅料安全性的信息,47(31.12%)人认为缺乏处方集,44(29.13%)人认为缺乏指南,58(5.29%)人认为缺乏有关儿科辅料浓度安全性的信息。同意成人药物中的辅料可能对儿科有害的医护人员比例为 103(68.21%)。最常作为标签外处方的药物是扑热息痛 54(21.68%),其次是苯巴比妥 35(14%)和阿莫西林 33(13.25%):结论:有相当多的医护人员不了解标签外用药的描述。结论:相当多的医护人员不了解标示外药物的描述,大多数人对标示外药物的安全性和疗效表示担忧,认为儿科常用的标示外药物必须在儿科进行临床试验。此外,辅料的安全性数据对于确保儿科标示外用药的安全性也相当重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Awareness, Practice, and Views of Pediatricians, General Physicians, and Pharmacists about Prescribing Off-label Medication in Pediatric Patients in Eastern Province, Saudi Arabia.

Background: An off-label medication involves the use of an approved drug for an unapproved indication, population, route of administration, or dosage.The physiological state of children differs from that of adults, making the adult formulation potentially dangerous to children. Off-label prescribing is quite common in children due to challenges in the development of pediatric formulations. The current study was conducted to determine the awareness, practice, and views of pediatricians, general physicians, and pharmacists about prescribing Off-label medication to pediatric patients in Eastern Province, Saudi Arabia.

Methods: A cross-sectional study based on a questionnaire was conducted among pediatricians, general physicians, and pharmacists (clinical and community) in Eastern Province, Saudi Arabia. Statistical analysis was conducted using the data exported from Google Forms (Mountain View, California, USA) and Microsoft Excel (Version 2016) and then exported into Statistical Package for Social Sciences (SPSS) version 26.0 (IBM, Inc., Armonk, NY, USA). Chi-square was deemed suitable. The level of significance was set at 0.05.

Results: Among the study participants, 53(35.09%) were pharmacists, followed by 24(15.89%) others, 22(14.565) pediatricians, 19(12.58%) other specialists, 17(11.25%) general physicians, and 16(10.59%) were clinical pharmacist. About 73(48.34%) described the definition of off-label correctly. About 114(75.49%) believed that parents and guardians must be informed about off-label medicine prescribed to their children. About 52(34.43%) had concerns about the safety of the medication, and 98(64.90%) believed they should be tested in pediatrics during clinical trials. Further, 97(64.23%) considered themselves not enough knowledgeable about off-label medications. The barriers reported by the participants were as follows: 89(58.945%) said lack of information resources, 71(47.01%) said lack of training, 56(37.08%) said lack of information on the safety of excipients used in pediatrics, 47(31.12%) said lack of formulary, 44(29.13%) said lack of guidelines, and 58(5.29%) said lack of information related to the safety of excipient concentration in pediatrics. The proportion of healthcare professionals who agreed that excipients in adult medication may be harmful to pediatrics was 103(68.21%). The drugs most often prescribed as off-label were paracetamol 54(21.68%), followed by Phenobarbital 35(14%), and Amoxicillin 33(13.25%).

Conclusion: There are a considerable number of healthcare professionals unaware of the description of off-label medication. The majority have concerns over the safety and efficacy of the off-label drugs and believe that most frequently used off-label drugs in pediatrics must be tested in pediatrics during clinical trials. In addition, excipient safety data are of considerable importance to ensure off-label drug safety in pediatrics, who believe their knowledge is inadequate and need proper guidelines and training on this issue.

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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.
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