Walker Kingsley E W, Bankay Reshma, Jankie Satish, Dhingra Sameer
Department of Paraclinical Sciences, The University of the West Indies, St. Augustine, Trinidad and Tobago.
School of Pharmacy, Faculty of Medical Sciences, The University of the West Indies, St. Augustine, Trinidad and Tobago.
Curr Pharmacol Rep. 2023 May 18:1-11. doi: 10.1007/s40495-023-00320-4.
The constant surge in accessing essential medicines creates a greater need for continuous monitoring of usage. The inability to source active pharmaceutical ingredients during the COVID-19 pandemic resulted in drug shortages that increased online requests for medications. E-commerce and social sites have opened the floodgate for the marketing of falsified, substandard, and unregistered pharmaceuticals, making them easily accessible to consumers with the click of a button. A high prevalence of such products with compromised quality highlights further the need for enhanced post-marketing vigilance of safety and quality within the pharmaceutical industry. This review aims to assess the extent to which pharmacovigilance (PV) systems in selected Caribbean countries conform to the minimum World Health Organization (WHO) requirements, highlight the importance of PV in ensuring the safer use of medicines across the Caribbean region, and identify opportunities and challenges in building comprehensive PV systems.
The review finds that while major advancements in PV and adverse drug reaction (ADR) monitoring have occurred in Europe and other parts of the Americas, little has been done in the Caribbean region. Only a few countries in the region are active members of the WHO's global PV network, and ADR reporting is minimal. The reason for low reporting includes a lack of awareness, commitment, and participation of healthcare professionals, manufacturers, authorized distributors, and the general consumers.
Nearly all established national PV systems do not fully conform to the minimum PV requirements by the WHO. Legislation, regulatory framework, political commitment, adequate funding, strategies, and incentives to encourage reporting of ADRs are needed to build sustainable PV systems in the Caribbean.
获取基本药物的需求持续激增，这使得对用药情况进行持续监测的需求更为迫切。在新冠疫情期间，活性药物成分的供应短缺导致药品短缺，进而增加了在线药品需求。电子商务和社交网站为假冒、不合格和未注册药品的销售打开了闸门，消费者只需点击一下按钮就能轻松获取这些药品。此类质量有问题产品的高流行率进一步凸显了制药行业加强上市后安全和质量监管的必要性。本综述旨在评估选定加勒比国家的药物警戒（PV）系统符合世界卫生组织（WHO）最低要求的程度，强调PV在确保整个加勒比地区更安全用药方面的重要性，并确定建立全面PV系统的机遇和挑战。
该综述发现，虽然PV和药品不良反应（ADR）监测在欧洲和美洲其他地区取得了重大进展，但加勒比地区在此方面进展甚微。该地区只有少数国家是WHO全球PV网络的活跃成员，ADR报告极少。报告率低的原因包括医疗保健专业人员、制造商、授权经销商和普通消费者缺乏认识、承诺和参与。
几乎所有已建立的国家PV系统都未完全符合WHO的最低PV要求。在加勒比地区建立可持续的PV系统需要立法、监管框架、政治承诺、充足资金、鼓励报告ADR的策略和激励措施。
