Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Malar J. 2012 Dec 6;11:406. doi: 10.1186/1475-2875-11-406.
As more point of care diagnostics become available, the need to transport and store perishable medical commodities to remote locations increases. As with other diagnostics, malaria rapid diagnostic tests (RDTs) must be highly reliable at point of use, but exposure to adverse environmental conditions during distribution has the potential to degrade tests and accuracy. In remote locations, poor quality diagnostics and drugs may have significant negative health impact that is not readily detectable by routine monitoring. This study assessed temperature and humidity throughout supply chains used to transport and store health commodities, such as RDTs.
Monitoring devices capable of recording temperature and humidity were deployed to Burkina Faso (8), Senegal (10), Ethiopia (13) and the Philippines (6) over a 13-month period. The devices travelled through government supply chains, usually alongside RDTs, to health facilities where RDTs are stored, distributed and used. The recording period spanned just over a year, in order to avoid any biases related to seasonal temperature variations.
In the four countries, storage and transport temperatures regularly exceeded 30.0°C; maximum humidity level recorded was above 94% for the four countries. In three of the four countries, temperatures recorded at central storage facilities exceeded pharmaceutical storage standards for over 20% of the time, in another case for a majority of the time; and sometimes exceeded storage temperatures at peripheral sites.
Malaria RDTs were regularly exposed to temperatures above recommended limits for many commercially-available RDTs and other medical commodities such as drugs, but rarely exceeded the recommended storage limits for particular products in use in these countries. The results underline the need to select RDTs, and other commodities, according to expected field conditions, actively manage the environmental conditions in supply chains in tropical and sub-tropical climates. This would benefit from a re-visit of current global standards on stability of medical commodities based in tropical and sub-tropical climatic zones.
随着越来越多的即时检测诊断技术投入使用,需要将易腐医疗商品运输和储存到偏远地区。与其他诊断技术一样,疟疾快速诊断检测试剂(RDTs)在使用点必须高度可靠,但在运输过程中暴露于不利的环境条件下,有可能会降低检测试剂的性能和准确性。在偏远地区,劣质的诊断试剂和药品可能会对健康产生重大负面影响,而这些影响在常规监测中不易察觉。本研究评估了用于运输和储存医疗商品(如 RDTs)的供应链中的温度和湿度。
在 13 个月的时间里,在布基纳法索(8 个地点)、塞内加尔(10 个地点)、埃塞俄比亚(13 个地点)和菲律宾(6 个地点)部署了能够记录温度和湿度的监测设备。这些设备通过政府供应链运输,通常与 RDTs 一起运输到储存、分发和使用 RDTs 的卫生设施。记录时间超过一年,以避免与季节性温度变化相关的任何偏差。
在这四个国家,储存和运输温度经常超过 30.0°C;四个国家记录的最高湿度均超过 94%。在这四个国家中的三个国家,中央储存设施的温度记录有超过 20%的时间超过了药品储存标准,在另一个国家则有大部分时间超过了标准;有时甚至超过了周边站点的储存温度。
疟疾 RDTs 经常暴露在超过许多市售 RDTs 和其他医疗商品(如药物)推荐温度限制的温度下,但很少超过这些国家使用的特定产品的推荐储存温度限制。结果强调了根据预期的现场条件选择 RDTs 和其他商品的必要性,以及在热带和亚热带气候条件下积极管理供应链中的环境条件的必要性。这将得益于重新审视目前基于热带和亚热带气候带的医疗商品稳定性全球标准。