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巴基斯坦医疗保健专业人员对氟喹诺酮类药物安全性概况、用法及黑框警告的理解评估。

Evaluation of healthcare professionals' understanding of fluoroquinolones' safety profile, usage, and boxed warnings in Pakistan.

作者信息

Abbas Muhammad, Kashmiri Kashif, Rehman Inayat Ur, Ali Zahid, Rahman Aziz Ur, Khalil Asad, Ming Long Chiau, Shafique Muhammad, Khan Tahir Mehmood

机构信息

Department of Pharmacy, Abdul Wali Khan University Mardan, Mardan, Pakistan.

Department of Pharmacy, University of Peshawar, Peshawar, Pakistan.

出版信息

J Pharm Policy Pract. 2023 Nov 27;16(1):154. doi: 10.1186/s40545-023-00674-6.

Abstract

INTRODUCTION

Fluoroquinolones (FQs) is a distinct class of antibiotics which are prescribed and used quite frequently worldwide, despite the box warnings (BW) issued by Food and Drug Administration (FDA). Literature has shown in spite of BWs related to FQs there is minimal impact on health care professionals (HCPs) prescribing habits, potentially attributing towards limited and insufficient awareness. In Pakistan, FQs are mostly prescribed antibiotics for microbial treatments, therefore the purpose of this study was to determine the level of knowledge about the safety profile, use, and BW of FQs among HCPs working in Pakistan.

METHODS

A cross-sectional study was undertaken among the HCPs of Khyber Pakhtunkhwa province of Pakistan from October 2022 to December 2022. A validated questionnaire was used to assess the knowledge of HCPs regarding FQs, its safety profile and BW. A random convenient sample technique was used while recruiting HCPs in this study. As the HCPs comprised physicians, dentists, pharmacist and nurses, all were approached in person and the study objective was fully elaborated and explained to them. The statistic test like: one-way ANOVA, independent-t test, multivariate logistic regression were used keeping the p-value < 0.05 as statistically significant.

RESULTS

A total of n = 250 HCPs were approached, of which n = 186 HCPs completed the questionnaire with a response rate of 74.4%. FQs prescribing pattern was only assessed among the prescribers, i.e., physicians and dentists (39/186). The mean knowledge score for indications was 5.29 ± 3.05, while for the adverse effects was 7.70 ± 2.61. The highest score for knowledge for indications and adverse effect score was achieved by physicians followed by dentist. The mean knowledge score for the BW was 3.46 ± 2.93 and among the HCPs for the BW of FQs, 20.4% of the HCPs had appropriate knowledge score (score ≥ 50%). The knowledge score was significantly higher in males (p = 0.039), dentists (p = 0.001), HCPs having master/specialization level of education (p = 0.003), HCPs working in government sector hospitals (p = 0.010) and secondary care hospitals (p = 0.001) while the multivariate logistic regression analysis showed that HCPs working in primary care hospital (OR: 6.2) and secondary care hospital (OR: 20.3) were associated with the tendency to achieve 50% or above knowledge score.

CONCLUSION

Findings of this study reveals the unsatisfactory knowledge of HCPs regarding the safety profile, use, and BW of FQs putting patients at heightened risks of FQs associated AEs. Therefore, it is crucial to implement a national antimicrobial stewardship program, seminars and lectures aimed at continuously updating the knowledge of HCPs, regardless of their specialties, and effectively restrict the misuse of antimicrobial and disseminate FDA BWs in clinical practice.

摘要

引言

氟喹诺酮类药物(FQs)是一类独特的抗生素,尽管美国食品药品监督管理局(FDA)发布了黑框警告(BW),但它们在全球范围内的处方和使用仍然相当频繁。文献表明,尽管存在与氟喹诺酮类药物相关的黑框警告,但对医疗保健专业人员(HCPs)的处方习惯影响极小,这可能归因于认识有限和不足。在巴基斯坦,氟喹诺酮类药物是微生物治疗中最常开具的抗生素,因此本研究的目的是确定在巴基斯坦工作的医疗保健专业人员对氟喹诺酮类药物的安全性概况、用途和黑框警告的了解程度。

方法

2022年10月至2022年12月,在巴基斯坦开伯尔-普赫图赫瓦省的医疗保健专业人员中进行了一项横断面研究。使用经过验证的问卷来评估医疗保健专业人员对氟喹诺酮类药物、其安全性概况和黑框警告的了解。本研究在招募医疗保健专业人员时采用了随机便利抽样技术。由于医疗保健专业人员包括医生、牙医、药剂师和护士,所有人员均亲自联系,并向他们详细阐述和解释了研究目的。使用了单向方差分析、独立t检验、多变量逻辑回归等统计检验,将p值<0.05视为具有统计学意义。

结果

总共接触了n = 250名医疗保健专业人员,其中n = 186名医疗保健专业人员完成了问卷,回复率为74.4%。仅在开处方者(即医生和牙医,39/186)中评估了氟喹诺酮类药物的处方模式。适应症的平均知识得分为5.29±3.05,而不良反应的平均知识得分为7.70±2.61。医生的适应症知识得分和不良反应得分最高,其次是牙医。黑框警告的平均知识得分为3.46±2.93,在了解氟喹诺酮类药物黑框警告的医疗保健专业人员中,20.4%的医疗保健专业人员具有适当的知识得分(得分≥50%)。男性(p = 0.039)、牙医(p = 0.001)、具有硕士/专业教育水平的医疗保健专业人员(p = 0.003)、在政府部门医院工作的医疗保健专业人员(p = 0.010)和二级保健医院工作的医疗保健专业人员(p = 0.001)的知识得分显著更高,而多变量逻辑回归分析表明,在初级保健医院工作的医疗保健专业人员(OR:6.2)和二级保健医院工作的医疗保健专业人员(OR:20.3)与获得50%或更高知识得分的倾向相关。

结论

本研究结果揭示了医疗保健专业人员对氟喹诺酮类药物的安全性概况、用途和黑框警告的了解不尽人意,使患者面临与氟喹诺酮类药物相关不良事件的更高风险。因此,实施全国性的抗菌药物管理计划、研讨会和讲座至关重要,旨在持续更新医疗保健专业人员的知识,无论其专业如何,并有效限制抗菌药物的滥用,在临床实践中传播FDA黑框警告。

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