沙特阿拉伯药物警戒面临的主要挑战的定性探索。
A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.
作者信息
Aljadhey Hisham, Mahmoud Mansour A, Alshammari Thamir M, Al-Dhaeefi Mohammed, Le Louet Herve, Perez-Gutthann Susana, Pitts Peter J
机构信息
Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Kingdom of Saudi Arabia. E-mail.
出版信息
Saudi Med J. 2015 Sep;36(9):1097-102. doi: 10.15537/smj.2015.9.12125.
OBJECTIVES
To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia.
METHODS
This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.
RESULT
Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.
CONCLUSION
The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.
目的
探讨沙特阿拉伯药物警戒面临的挑战，并从沙特阿拉伯医疗保健专业人员的角度制定改进建议。
方法
这是一项定性研究，在沙特阿拉伯利雅得国王沙特大学药学院和公共利益医学中心的主持下，与药剂师、医生和院士进行了4次焦点小组讨论。共邀请了29名符合条件的医疗保健专业人员参加讨论。该研究预先确定的主题是监管机构、医院、社区和学术界药物警戒的当前做法和主要挑战，以及改进药物警戒做法的建议。
结果
在邀请的29名参与者中，27人参加了讨论。监管机构面临的挑战包括复杂的药品不良反应（ADR）报告表、提交给沙特食品药品管理局的ADR缺乏反馈、地方当局缺乏撤药决定以及缺乏药物警戒数据。医院药物警戒面临的挑战包括对ADR报告重要性缺乏认识、工作量、指责文化以及监管机构与医院之间缺乏合作。然而，制药行业面临的挑战包括沙特阿拉伯缺乏药品制造商以及对药物警戒缺乏兴趣。改进药物警戒的建议包括沟通的必要性、更强有力的监管要求、研究的必要性、统一ADR报告的必要性以及持续教育和培训。
结论
该研究确定了沙特阿拉伯药物警戒面临的挑战，并提出了一些克服这些挑战的建议。这些建议可能有助于监管机构加强自发报告并促进药物警戒。
Zotero 插件