评估将社区药房纳入沙特食品和药品管理局监管的可行性。

IF 3.4 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Ahmed H Alanazi, Hessa H Alhaidar, Mohammad A Altamimi
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引用次数: 0

摘要

在沙特阿拉伯,社区药房的管理目前由卫生部负责。有必要将社区药房的监管框架转移到沙特食品和药物管理局(SFDA)之下,以与全球标准保持一致。然而,关于药剂师对沙特阿拉伯王国(KSA)社区药房当前监管框架的看法的知识有限。目的:本研究旨在评估药师对当前社区药房监管框架的认识、看法和偏好,以及将监管过渡到SFDA的可行性。方法:采用横断面调查设计来评估沙特阿拉伯社区药房的监管。样本采用随机抽样的方法,从不同行业抽取139名药师。在线分发了一份结构化的调查问卷,重点关注监管、意识和看法。通过专家评审,确保问卷的效度和信度。采用SPSS软件中的描述性统计进行数据分析。结果:调查结果揭示了整个制药行业的不同代表性。医院药师是最大的群体(37.4%,n = 52),其次是卫生部监管现场工作人员(21.6%,n = 30)和国家食品药品监督管理局(20.1%,n = 28),制药行业专业人员(11.5%,n = 16)和社区药师(9.4%,n = 13)。大多数参与者(51.8%,n = 72)有1-5年的经验,31.7% (n = 44)有6-10年的经验,16.5% (n = 23)有10年以上的经验。关于目前的监管监督,大多数(82.7%,n = 115)报告受卫生部监管,12.2% (n = 17)受SFDA监管。该研究显示,尽管大多数参与者(62.6%,n = 87)对当前的监管框架表示不满,但对当前监管框架的认知度很高(77.0%,n = 107)。值得注意的是,77.0% (n = 107)的人认为SFDA是未来的监管机构,80.6% (n = 112)的人认为SFDA在监管行业方面会表现更好。大多数参与者对拟议的监管改革表现出强烈的同意,78.4% (n = 109)同意P1, 79.1% (n = 110)同意P4关于监管改革的陈述。结论:该研究表明,由于对卫生部目前的监管不满意,整个行业的制药专业人员都强烈倾向于将社区药房监管转变为SFDA。所有专业类别和经验水平的共识表明从业人员期望SFDA监管将提高沙特阿拉伯的药品服务质量和监管有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of the feasibility of including community pharmacies under the regulation of the saudi food and drug authority.

In Saudi Arabia, the regulation of community pharmacies currently falls under the Ministry of Health (MOH). There is a need to shift the regulatory framework of community pharmacies to be under the Saudi Food and Drug Authority (SFDA) to align with global standards. However, there is limited knowledge about the perceptions of pharmacists regarding the current regulatory framework in community pharmacies in the Kingdom of Saudi Arabia (KSA).

Objectives: This study aims to assess pharmacists' knowledge, perceptions, and preferences regarding the current regulatory framework of community pharmacies and feasibility of transitioning regulatory oversight to SFDA.

Methodology: A cross-sectional survey design was used to assess the regulation of community pharmacies in Saudi Arabia. The sample consisted of 139 pharmacists from various sectors, selected through random sampling. A structured questionnaire focusing on regulation, awareness, and perceptions was distributed online. The questionnaire's validity and reliability were ensured through expert review. Descriptive statistics in SPSS were used for data analysis.

Results: The survey findings revealed a diverse representation across the pharmaceutical sector. Hospital pharmacists formed the largest group (37.4%, n = 52), followed by regulatory field workers from the Ministry of Health (21.6%, n = 30) and SFDA (20.1%, n = 28), pharmaceutical industry professionals (11.5%, n = 16), and community pharmacists (9.4%, n = 13). Most participants (51.8%, n = 72) had 1-5 years of experience, while 31.7% (n = 44) had 6-10 years, and 16.5% (n = 23) had more than 10 years of experience. Regarding current regulatory oversight, the majority (82.7%, n = 115) reported being under MOH regulation, with 12.2% (n = 17) under SFDA oversight. The study revealed high awareness of current regulations (77.0%, n = 107), though most participants (62.6%, n = 87) expressed dissatisfaction with the current regulatory framework. Notably, 77.0% (n = 107) preferred SFDA as the future regulator, and 80.6% (n = 112) believed SFDA would perform better in regulating the sector. Most participants demonstrated strong agreement with proposed regulatory changes, with 78.4% (n = 109) agreeing to P1 and 79.1% (n = 110) to P4 statements regarding regulatory reform.

Conclusion: The study reveals strong sector-wide preference among pharmaceutical professionals for transitioning community pharmacy regulation to SFDA, driven by dissatisfaction with current MOH oversight. This consensus across all professional categories and experience levels indicates practitioners' expectations that SFDA regulation would enhance pharmaceutical service quality and regulatory effectiveness in Saudi Arabia.

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来源期刊
Saudi Pharmaceutical Journal
Saudi Pharmaceutical Journal PHARMACOLOGY & PHARMACY-
CiteScore
6.10
自引率
2.40%
发文量
194
审稿时长
67 days
期刊介绍: The Saudi Pharmaceutical Journal (SPJ) is the official journal of the Saudi Pharmaceutical Society (SPS) publishing high quality clinically oriented submissions which encompass the various disciplines of pharmaceutical sciences and related subjects. SPJ publishes 8 issues per year by the Saudi Pharmaceutical Society, with the cooperation of the College of Pharmacy, King Saud University.
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