Unit of Tropical Laboratory Medicine, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium.
Trop Med Int Health. 2011 Nov;16(11):1439-49. doi: 10.1111/j.1365-3156.2011.02852.x. Epub 2011 Sep 29.
The phenomenon of poor-quality medicines in resource-limited settings is well documented, and field observations reveal similar problems with medical devices (MDs) and in vitro diagnostics (IVDs). In scientific literature, however, there are only scarce reports and documents providing evidence of quality problems of MDs or IVDs in resource-limited settings. This discrepancy may be ascribed to (i) the poor regulatory oversight of MDs/IVDs in resource-limited settings, (ii) a general lack of awareness of the problem of poor-quality MDs/IVDs amongst the scientific community and decision-makers, and (iii) poor quality assurance in diagnostic laboratories in resource-poor settings, precluding tracing quality problems of IVDs from the other potential causes of diagnostic inaccuracy. The problem of poor-quality MDs/IVDs in resource-limited settings is a complex one to address. Firstly, operational definitions for substandard and counterfeit MDs/IVDs are required, as well as ad hoc field surveys, to ensure proper appraisal of the real extent of the problem. Investments are needed to reinforce the national regulatory oversights on MDs/IVDs in resource-limited settings, and to encourage a proactive and transparent exchange of information between Northern and Southern regulatory authorities. Industrialized countries can play a role by expanding and strengthening their regulatory oversight and quality labels to those MDs/IVDs that are frequently used in resource-poor settings. Hopefully, the combination of these measures will result in better protection of patients in resource-poor countries from the effects of being exposed to poor-quality MDs and IVDs.
在资源有限的环境中，劣质药品的现象已经得到了充分的记录，实地观察也揭示了医疗器械（MDs）和体外诊断试剂（IVDs）存在类似的问题。然而，在科学文献中，只有很少的报道和文件提供了资源有限环境中 MDs 或 IVDs 质量问题的证据。这种差异可能归因于以下几点：（i）资源有限环境中 MDs/IVDs 的监管监督不力；（ii）科学界和决策者普遍缺乏对劣质 MDs/IVDs 问题的认识；（iii）资源匮乏环境中的诊断实验室质量保证不足，无法从其他可能导致诊断不准确的原因追溯 IVDs 的质量问题。解决资源有限环境中劣质 MDs/IVDs 的问题是一个复杂的问题。首先，需要对标准和假冒 MDs/IVDs 进行操作定义，并进行专门的现场调查，以确保正确评估问题的真实程度。需要投资加强资源有限环境中对 MDs/IVDs 的国家监管监督，并鼓励北方和南方监管机构之间进行积极和透明的信息交流。工业化国家可以通过扩大和加强对那些在资源匮乏环境中经常使用的 MDs/IVDs 的监管监督和质量标签来发挥作用。希望这些措施的结合将有助于保护资源匮乏国家的患者免受劣质 MDs 和 IVDs 暴露的影响。
