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评估沙特阿拉伯卫生部医院药房工作人员的非标签药物使用实践与知识:一项横断面研究。

Assessing pharmacy staff practices and knowledge of off-label drug use in Ministry of Health Hospitals, Saudi Arabia: A cross-sectional study.

作者信息

Alomary Mohammed A, Alshehri Norah F, Alzahrani Abdullah M, Alkatheeri Ayed A, Harbi Maan H, Almalki Migahed H, Almutairi Najwa A, Aldajani Shikhah G, Emam Dunya M, Alzahrani Rayan M, Almalki Mohammed O, Alzahrani Yahya A

机构信息

Department of Pharmacy, King Fahad General Hospital, Ministry of Health, Jeddah, Saudi Arabia.

Department of Pharmacy, Clinical pharmacy unit, East Jeddah Hospital, Ministry of Health, Jeddah, Saudi Arabia.

出版信息

Medicine (Baltimore). 2025 Aug 29;104(35):e44015. doi: 10.1097/MD.0000000000044015.

DOI:10.1097/MD.0000000000044015
PMID:40898478
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12401448/
Abstract

Despite the growing prevalence of off-label prescribing, there is limited research exploring pharmacists' actual knowledge and practices, particularly in the Saudi context. Existing literature mainly focuses on physicians, leaving a gap in understanding pharmacists' readiness to handle such prescriptions. This study aimed to assess the knowledge and practices of pharmacy staff in Saudi Arabia regarding off-label drug use and examined the impact of education, age, gender, and experience on these outcomes. A cross-sectional survey was conducted over 6 months (February-July 2024) targeting registered pharmacy staff working in healthcare settings in Riyadh and Jeddah, Saudi Arabia. Participants completed a content validated, structured questionnaire designed to assess their knowledge and practices related to off-label drug use. The survey also captured demographic and professional data, including age, gender, education level, hospital type, and years of experience. Among 302 pharmacy staff, the mean knowledge score was 54.7 ± 22.3, indicating moderate knowledge while Practice scores were higher (mean 68.2 ± 17.8), with over 75% correctly managing off-label prescriptions. Logistic regression showed hospital level as a significant predictor, staff in tertiary hospitals were more knowledgeable (OR = 4.5) and practiced better (OR = 3.6). Demographics had no significant impact. No association was found between self-rated knowledge and actual knowledge, but poor self-rated familiarity strongly correlated with poor practice (P < .0001). These findings underscore the need for SFDA-aligned training and regulatory initiatives to improve off-label prescribing, especially in primary and secondary care. Periodic national assessments are essential to monitor and enhance pharmacy staff competence amid ongoing healthcare reforms.

摘要

尽管超说明书用药的情况日益普遍,但探索药剂师实际知识和做法的研究有限,尤其是在沙特阿拉伯的背景下。现有文献主要关注医生,在了解药剂师处理此类处方的准备情况方面存在空白。本研究旨在评估沙特阿拉伯药房工作人员关于超说明书用药的知识和做法,并考察教育程度、年龄、性别和经验对这些结果的影响。在2024年2月至7月的6个月内进行了一项横断面调查,目标是在沙特阿拉伯利雅得和吉达医疗机构工作的注册药房工作人员。参与者完成了一份经过内容验证的结构化问卷,旨在评估他们与超说明书用药相关的知识和做法。该调查还收集了人口统计学和专业数据,包括年龄、性别、教育水平、医院类型和工作年限。在302名药房工作人员中,知识平均得分是54.7±22.3,表明知识水平中等,而实践得分更高(平均68.2±17.8),超过75%的人正确处理超说明书处方。逻辑回归显示医院级别是一个显著的预测因素,三级医院的工作人员知识更丰富(OR = 4.5)且实践更好(OR = 3.6)。人口统计学因素没有显著影响。自评知识与实际知识之间未发现关联,但自评熟悉程度差与实践差密切相关(P <.0001)。这些发现强调了需要开展与沙特食品药品管理局(SFDA)一致的培训和监管举措,以改善超说明书用药情况,尤其是在初级和二级医疗保健中。定期进行全国评估对于在持续的医疗改革中监测和提高药房工作人员的能力至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce8/12401448/6b11b0e17332/medi-104-e44015-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce8/12401448/6b11b0e17332/medi-104-e44015-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dce8/12401448/6b11b0e17332/medi-104-e44015-g001.jpg

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本文引用的文献

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Awareness, Practice, and Views of Pediatricians, General Physicians, and Pharmacists about Prescribing Off-label Medication in Pediatric Patients in Eastern Province, Saudi Arabia.沙特阿拉伯东部省份儿科医生、普通内科医生和药剂师对儿科患者开具非标签用药的认知、实践及观点
Curr Pediatr Rev. 2024 Jun 26. doi: 10.2174/0115733963298903240614072717.
2
Systematic analysis of off-label and off-guideline cancer therapy usage in a real-world cohort of 165,912 US patients.对 165912 名美国患者的真实队列中的癌症治疗超适应证和超指南使用进行系统分析。
Cell Rep Med. 2024 Mar 19;5(3):101444. doi: 10.1016/j.xcrm.2024.101444. Epub 2024 Feb 29.
3
Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.
儿科人群的超说明书用药——2012年至2022年文献综述
Pharmaceutics. 2023 Nov 21;15(12):2652. doi: 10.3390/pharmaceutics15122652.
4
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.比较欧洲药品管理局和美国食品和药物管理局在授予新冠病毒药物加速营销授权及其使用规定方面的情况。
Ther Innov Regul Sci. 2024 Jan;58(1):79-113. doi: 10.1007/s43441-023-00574-6. Epub 2023 Oct 20.
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J Multidiscip Healthc. 2023 Apr 28;16:1179-1190. doi: 10.2147/JMDH.S410925. eCollection 2023.
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