Makhene Nokuthula L, Steyn Hanlie, Vorster Martine, Lubbe Martie S, Burger Johanita R
Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa.
Medicine Usage in South Africa, Faculty of Health Sciences, North-West University, Potchefstroom Campus, 11 Hoffman Street, Potchefstroom 2531, South Africa.
Ther Adv Drug Saf. 2023 Jan 24;14:20420986221143272. doi: 10.1177/20420986221143272. eCollection 2023.
National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV guidelines in Southern African Development Community (SADC) countries, this study aimed to create a checklist that may be used to assess the rigour of PV guidelines in this region and provide guidance for the National Medicines Regulatory Agency (NMRA) authors.
A document analysis was performed based on harmonised international guidelines ( = 22) that prescribed methods of PV regulation to identify themes and items to incorporate into a checklist. The contextualisation of the checklist to the African pharmaceutical environment was accomplished by referencing peer-reviewed journal articles ( = 7). The checklist was subjected to face and content validation by non-experts and PV experts.
The document review yielded 5 themes, 18 sub-themes, and 73 items structured into the checklist. Themes encompassed PV systems, definitions, individual case safety reporting, aggregate reporting, and risk management. Under PV systems, aspects of the quality management system were outlined, that is, the legal basis for PV, a description of the marketing authorisation holder's (MAH's) PV system, archiving of data, contracting of PV tasks, and the duties of the person responsible for the MAH's PV obligations. Definitions of the key terms and major stakeholders were identified. Reporting of individual case safety reports (ICSRs) was explicated by considering the criteria for reporting, categories of reportable information, expedited reporting requirements, reporting timelines, and ICSR reporting format. Aggregate report submission during the development and post-marketing phases was addressed. Risk management encompassed signal detection, re-evaluation of the benefit-risk ratio, the safety decision-making process, risk management planning, risk minimisation and safety communication.
The developed checklist can contribute towards assisting SADC NMRAs to formulate national PV guidelines that reflect current international practice, with local context incorporated.
In Southern African Development Community (SADC) countries, the guidelines for medicine safety [pharmacovigilance (PV)] that marketing authorisation holders (MAHs) and healthcare professionals need to adhere to, are not aligned. We saw the need to develop a checklist that can be used to evaluate these guidelines. We studied international documents issued by the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Council for International Organizations of Medical Sciences (CIOMS) and the European Medicines Agency (EMA). On the organisational websites, we obtained 22 documents and identified 73 checklist items. All the items were arranged under 5 themes and 18 sub-themes to create the checklist. We adapted the checklist to the local context by using seven journal articles addressing PV concerns in Africa. Experts checked the content and usability of the checklist. The themes were PV systems, definitions, individual case safety reporting (ICSR), combined reporting and risk management. PV systems had six sub-themes: legal structure, description of the MAH's PV system, contractual agreements, information storage, the qualified person responsible for PV (QPPV) and where the QPPV is located. We included the definitions of keywords and role-players. The ICSR theme had five sub-themes, i.e. criteria for reporting, categories of reportable information, expedited reporting, reporting timelines, and reporting format. Submission of summary reports comprised an overview of the safety profile of a medicine once it is approved by regulators, as well as during clinical trials. Risk management included signal detection, re-evaluation of the benefit-risk ratio, safety decision-making process, risk management planning, risk minimisation, and safety communication. The checklist is applied by allocating yes/no scoring per item. The checklist may be used by regulators within SADC to assess their PV guidelines for alignment with international standards and suitability to the local environment.
南部非洲的国家监管体系处于不同的成熟阶段，药物警戒（PV）实践也不一致。由于南部非洲发展共同体（SADC）国家在制定PV指南方面缺乏指导，本研究旨在创建一份清单，用于评估该地区PV指南的严谨性，并为国家药品监管机构（NMRA）的编写人员提供指导。
基于规定PV监管方法的统一国际指南（共22份）进行文献分析，以确定纳入清单的主题和项目。通过参考同行评审期刊文章（共7篇），使清单与非洲制药环境相适应。该清单由非专家和PV专家进行了表面效度和内容效度验证。
文献综述产生了5个主题、18个子主题和73个项目，并构建成清单。主题包括PV系统、定义、个例安全性报告、汇总报告和风险管理。在PV系统主题下，概述了质量管理体系的各个方面，即PV的法律依据、上市许可持有人（MAH）PV系统的描述、数据存档、PV任务的委托以及负责MAH的PV义务的人员职责。确定了关键术语和主要利益相关者的定义。通过考虑报告标准、可报告信息类别、快速报告要求、报告时限和个例安全性报告（ICSR）报告格式，对ICSR的报告进行了详细说明。讨论了药品研发和上市后阶段汇总报告的提交。风险管理包括信号检测、效益风险比的重新评估、安全决策过程、风险管理计划、风险最小化和安全沟通。
所制定的清单有助于协助SADC的NMRA制定反映当前国际实践并结合当地情况的国家PV指南。
在南部非洲发展共同体（SADC）国家，上市许可持有人（MAH）和医疗保健专业人员需要遵守的药品安全[药物警戒（PV）]指南并不一致。我们认为有必要制定一份可用于评估这些指南的清单。我们研究了世界卫生组织（WHO）、人用药品注册技术协调国际理事会（ICH）、国际医学科学组织理事会（CIOMS）和欧洲药品管理局（EMA）发布的国际文件。在各组织网站上，我们获取了22份文件并确定了73个清单项目。所有项目按照5个主题和18个子主题进行排列，以创建该清单。我们通过使用7篇讨论非洲PV问题的期刊文章，使清单适用于当地情况。专家们检查了清单的内容和实用性。主题包括PV系统、定义、个例安全性报告（ICSR）、汇总报告和风险管理。PV系统有6个子主题：法律结构、MAH的PV系统描述、合同协议、信息存储负责PV的合格人员（QPPV）以及QPPV所在位置。我们纳入了关键词和参与者的定义。ICSR主题有5个子主题，即报告标准、可报告信息类别、快速报告、报告时限和报告格式。汇总报告的提交包括药品经监管机构批准后以及临床试验期间的安全性概况概述。风险管理包括信号检测、效益风险比的重新评估、安全决策过程、风险管理计划、风险最小化和安全沟通。通过对每个项目进行是/否评分来应用该清单。SADC内的监管机构可使用该清单评估其PV指南是否符合国际标准以及是否适用于当地环境。
