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沙特阿拉伯药物流行病学与上市后监测的现状及未来前景:文献综述

Current status, and future prospects of pharmaco-epidemiology and post-marketing surveillance in Saudi Arabia: A review of literature.

作者信息

El-Metwally Ashraf

机构信息

Epidemiology & Biostatistics Department, College of Public Health & Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.

出版信息

Saudi Pharm J. 2018 Jul;26(5):629-633. doi: 10.1016/j.jsps.2018.02.030. Epub 2018 Mar 6.

Abstract

BACKGROUND

Pharmacoepidemiology is the concept used for evaluating the impact of drugs among a large number of people in the post-marketing phase The use of this concept makes it increasingly necessary to detect the recurrence of drug-related anomalies that mostly occur through health care professionals or patients themselves. Pharmacoepidemiology is important since it helps to provide the right balance of benefits versus risks of the drug products while remaining an excellent tool to prepare the risk/benefit balance profile.

AIM

The objective of this study is to review and explore the current status and future prospects of pharmacoepidemiology and post-marketing surveillance in Saudi Arabia.

METHODS

A literature review has been conducted using keywords such as pharmacoepidemiology'; 'post-marketing'; 'surveillance'; 'Saudi Arabia'; 'ADRs'; and 'pharmacovigilance'. The study refines its focus on 13 pharmacoepidemiology and post-marketing surveillance research studies conducted in Saudi Arabia using the databases; Embase, PubMed, EBSCOhost, MEDLINE, and AMED.

RESULTS

Pharmacoepidemiology and post-marketing surveillance creates a body of research in Saudi Arabia, but within a restricted scope. The studies that were reviewed assessed the challenge from various perspectives. Lack of knowledge, post-marketing surveillance, ADR reporting, and increased use of generic products were reported.

CONCLUSION

The current level of research may be widened and increased through improving the process of ADRs reporting system. More research needs to be conducted based on nation-wide observational studies. Collaboration among medical professionals, academics and industries should continue to establish a more efficient and consistent post-marketing surveillance system.

摘要

背景

药物流行病学是用于评估药物在上市后阶段对大量人群影响的概念。使用这一概念使得越来越有必要检测主要通过医疗保健专业人员或患者自身发生的与药物相关异常情况的复发。药物流行病学很重要,因为它有助于在保持为准备风险/效益平衡概况的出色工具的同时,提供药品效益与风险的正确平衡。

目的

本研究的目的是回顾和探讨沙特阿拉伯药物流行病学和上市后监测的现状及未来前景。

方法

使用“药物流行病学”“上市后”“监测”“沙特阿拉伯”“药品不良反应”和“药物警戒”等关键词进行了文献综述。该研究通过Embase、PubMed、EBSCOhost、MEDLINE和AMED等数据库,将重点细化到在沙特阿拉伯进行的13项药物流行病学和上市后监测研究。

结果

药物流行病学和上市后监测在沙特阿拉伯形成了一定的研究成果,但范围有限。所审查的研究从各种角度评估了挑战。报告了知识缺乏、上市后监测、药品不良反应报告以及仿制药使用增加等情况。

结论

通过改进药品不良反应报告系统的流程,当前的研究水平可能会得到拓宽和提高。需要基于全国性观察性研究开展更多研究。医学专业人员、学术界和行业之间的合作应继续进行,以建立一个更高效、一致的上市后监测系统。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/341d/6035327/908d6a5b251a/fx1.jpg

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