Objective Good quality cardiovascular medicines and devices are crucial in the prevention and management of the ever-growing threats of cardiovascular diseases (CVDs) globally. Yet our current understanding of the extent and impact of substandard and falsified (SF) cardiovascular medical products is poor. Our objective was to review the available literature on SF cardiovascular medicines/devices, with a focus on prevalence studies to discuss their impacts on public health. Methods Searches were conducted in Embase, PubMed, Web of Science, Google Scholar, Google and websites with interest in medicines/devices quality up to 31 August 2020. Articles in English and French identified in these searches were screened for eligibility. The Medicine Quality Assessment Reporting Guidelines was used to assess the quality of prevalence surveys, and we report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Results A total of 279 articles were included, which were subcategorised into prevalence surveys (n=28), equivalence studies (n=118), stability studies (n=5), routine quality control analyses (n=15), bioavailability studies (n=2), recalls/seizures/case reports (n=77), general discussions (n=24) and reviews (n=10). A failure frequency (defined as the proportion of samples that failed at least one quality test described in the report) of 525 (15.4%) was observed for the 3414 samples tested for quality in the 27 prevalence surveys with sufficient information for inclusion in our quantitative analysis. Nineteen surveys (70.4%) used convenience outlet sampling. The majority (88.8%, 3032/3414) of samples included in prevalence surveys were collected from low-income and middle-income countries. The most common defects were out-of-specification active ingredient(s) content, impurity/contaminant content and impaired dissolution. We found 26 incidents describing SF cardiovascular devices with 181 related deaths but no prevalence surveys. Conclusion The data suggest that SF cardiovascular products are likely to be a serious public health problem that has received limited attention. We do not suggest that 15.4% of cardiovascular medicines are SF, and our findings highlight the need for more research with robust methodology to provide more accurate prevalence estimates in order to inform policy and implement measures to ensure the quality of cardiovascular medicines and devices within the supply chain. Ensuring that CVD medical products are of good quality would help ensure effectiveness and that the benefits of therapy are realised in the prevention and treatment of CVDs. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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心血管疾病医疗产品的质量：全球心脏护理的差距

目标 高质量的心血管药物和器械对于预防和管理全球日益增长的心血管疾病 (CVD) 威胁至关重要。然而，我们目前对不合格和伪造 (SF) 心血管医疗产品的程度和影响的理解很差。我们的目标是回顾有关 SF 心血管药物/设备的现有文献，重点是流行研究，以讨论它们对公共健康的影响。方法 2020 年 8 月 31 日前在 Embase、PubMed、Web of Science、Google Scholar、Google 和对药物/设备质量感兴趣的网站上进行了搜索。对这些搜索中识别出的英文和法文文章进行了资格筛选。《药品质量评估报告指南》用于评估患病率调查的质量，我们根据系统评价和元分析的首选报告项目声明进行报告。结果共纳入279篇文章，细分为流行性调查（n=28）、等效性研究（n=118）、稳定性研究（n=5）、常规质量控制分析（n=15）、生物利用度研究（ n=2)、召回/癫痫发作/病例报告 (n=77)、一般性讨论 (n=24) 和评论 (n=10)。在 27 项流行率调查中，3414 个质量测试样本的失败频率（定义为报告中描述的至少一项质量测试失败的样本比例）为 525 (15.4%)分析。19 项调查（70.4%）使用了便利店抽样。大多数（88.8%，3032/3414) 包括在流行率调查中的样本是从低收入和中等收入国家收集的。最常见的缺陷是活性成分含量超标、杂质/污染物含量和溶出度受损。我们发现 26 起事件描述了 SF 心血管设备，其中 181 起相关死亡，但没有进行流行率调查。结论 数据表明，SF 心血管产品可能是一个严重的公共卫生问题，但受到的关注有限。我们不建议 15.4% 的心血管药物是 SF，我们的研究结果强调需要更多的研究和稳健的方法来提供更准确的患病率估计，以便为政策提供信息并实施措施以确保心血管药物和设备的质量。供应链。确保 CVD 医疗产品的质量将有助于确保有效性，并在 CVD 的预防和治疗中实现治疗的益处。与研究相关的所有数据都包含在文章中或作为补充信息上传。