Pal Eishita, Merchant Lubna, Koffi Alain K, Mehta Reema, Rusatira Jean Christophe, Kubiak Lev, Michtalik Henry Joseph, Caubel Patrick, Ahmed Saifuddin
Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Worldwide Medical & Safety, Pfizer, New York, NY, USA.
J Pharm Policy Pract. 2025 Sep 12;18(1):2550369. doi: 10.1080/20523211.2025.2550369. eCollection 2025.
The proliferation of substandard and falsified medical products (SFM) poses a significant threat to public health globally. Despite rigorous surveillance and law enforcement efforts, risk of exposure to SFM is on the rise, notably through online pharmacies. The current interventions predominantly target the pharmaceutical supply chains through legal and regulatory frameworks, while there is a noticeable deficiency in focusing on interventions for healthcare providers and consumers. This scoping review aims to summarise the current literature on SFM, focusing on their health and economic consequences, and to assess the knowledge, attitudes, and practices of healthcare providers and the general public.
A comprehensive literature search was conducted across PubMed, Embase, and Scopus databases, focusing on studies from the past 15 years that provided estimates on mortality, morbidities and economic impacts of SFM and covered the following topic areas: knowledge, attitudes and practices of healthcare providers, patients and general public; and population level interventions regarding SFM. We exclude non-peer-reviewed literature.
A total of 78 studies met the inclusion criteria and were analyzed. These studies suggest that the data on adverse effects on health and economic impact of SF medicines are predominantly based on statistical models, and empirical data are grossly lacking. Knowledge of risks, identification of SFM, and reporting to regulatory authorities are substantially low among healthcare providers and general public.
This review highlights the need for innovative, targeted strategies - such as digital health interventions, enhanced training programs for healthcare providers, and context-specific public awareness campaigns - to bridge the gap between awareness and effective practice.
Our study underscores that a multifaceted approach must not only reinforce regulatory frameworks and surveillance systems for protecting the supply chains but also proactively empower both health providers and consumers to identify and combat SFM in today's rapidly evolving digital landscape.
不合格和伪造医疗产品(SFM)的泛滥对全球公众健康构成重大威胁。尽管进行了严格的监测和执法工作,但接触SFM的风险仍在上升,尤其是通过在线药店。目前的干预措施主要通过法律和监管框架针对药品供应链,而在关注医疗服务提供者和消费者的干预措施方面存在明显不足。本综述旨在总结关于SFM的现有文献,重点关注其对健康和经济的影响,并评估医疗服务提供者和公众的知识、态度和行为。
在PubMed、Embase和Scopus数据库中进行了全面的文献检索,重点关注过去15年中提供SFM死亡率、发病率和经济影响估计值的研究,并涵盖以下主题领域:医疗服务提供者、患者和公众的知识、态度和行为;以及关于SFM的人群层面干预措施。我们排除了非同行评审文献。
共有78项研究符合纳入标准并进行了分析。这些研究表明,关于SF药品对健康的不良影响和经济影响的数据主要基于统计模型,严重缺乏实证数据。医疗服务提供者和公众对风险的认知、SFM的识别以及向监管机构报告的情况都很低。
本综述强调需要创新的、有针对性的策略,如数字健康干预、加强对医疗服务提供者的培训计划以及针对具体情况的公众意识宣传活动,以弥合认知与有效实践之间的差距。
我们的研究强调,多方面的方法不仅要加强保护供应链的监管框架和监测系统,还要积极使医疗服务提供者和消费者有能力在当今快速发展的数字环境中识别和打击SFM。