老挝六种药品质量筛选设备的现场比较评估。
A comparative field evaluation of six medicine quality screening devices in Laos.
机构信息
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
出版信息
PLoS Negl Trop Dis. 2021 Sep 30;15(9):e0009674. doi: 10.1371/journal.pntd.0009674. eCollection 2021 Sep.
BACKGROUND
Medicine quality screening devices hold great promise for post-market surveillance (PMS). However, there is little independent evidence on their field utility and usability to inform policy decisions. This pilot study in the Lao PDR tested six devices' utility and usability in detecting substandard and falsified (SF) medicines.
METHODOLOGY/PRINCIPAL FINDINGS: Observational time and motion studies of the inspections by 16 Lao medicine inspectors of 1) the stock of an Evaluation Pharmacy (EP), constructed to resemble a Lao pharmacy, and 2) a sample set of medicines (SSM); were conducted without and with six devices: four handheld spectrometers (two near infrared: MicroPHAZIR RX, NIR-S-G1 & two Raman: Progeny, Truscan RM); one portable mid-infrared spectrometer (4500a), and single-use paper analytical devices (PAD). User experiences were documented by interviews and focus group discussions. Significantly more samples were wrongly categorised as pass/fail with the PAD compared to the other devices in EP inspections (p<0.05). The numbers of samples wrongly classified in EP inspections were significantly lower than in initial visual inspections without devices for 3/6 devices (NIR-S-G1, MicroPHAZIR RX, 4500a). The NIR-S-G1 had the fastest testing time per sample (median 93.5 sec, p<0.001). The time spent on EP visual inspection was significantly shorter when using a device than for inspections without devices, except with the 4500a, risking missing visual clues of samples being SF. The main user errors were the selection of wrong spectrometer reference libraries and wrong user interpretation of PAD results. Limitations included repeated inspections of the EP by the same inspectors with different devices and the small sample size of SF medicines.
CONCLUSIONS/SIGNIFICANCE: This pilot study suggests policy makers wishing to implement portable screening devices in PMS should be aware that overconfidence in devices may cause harm by reducing inspectors' investment in visual inspection. It also provides insight into the advantages/limitations of diverse screening devices in the hands of end-users.
背景
药品质量筛选设备在上市后监测（PMS）中具有巨大的应用前景。然而，针对其在实践中的实用性和易用性，独立证据较少，无法为政策决策提供参考。本研究在老挝进行了一项试点研究，以测试六种设备在检测劣药和假药方面的实用性和易用性。
方法/主要发现：对 16 名老挝药品检查员在以下两种情况下的检查进行了观察性时间和动作研究：1）评估药房（EP）的库存，该药房的构造类似于老挝的药房；2）一组抽样药品（SSM）。未使用和使用六种设备（四种手持式分光计：近红外 MicroPHAZIR RX、NIR-S-G1 和两种拉曼 Progeny、Truscan RM；一种便携式中红外分光计 4500a 和一次性纸分析设备 PAD）进行检查。通过访谈和焦点小组讨论记录了用户体验。在 EP 检查中，与其他设备相比，PAD 错误分类的样品数量明显更多（p<0.05）。在 EP 检查中，错误分类的样品数量明显低于初始无设备视觉检查的三种设备（NIR-S-G1、MicroPHAZIR RX、4500a）。NIR-S-G1 对每个样本的测试时间最快（中位数 93.5 秒，p<0.001）。与不使用设备相比，使用设备进行 EP 视觉检查的时间明显更短，但在使用 4500a 时，可能会错过样本是假药的视觉线索。主要用户错误是选择了错误的分光计参考库和用户对 PAD 结果的错误解释。限制因素包括相同的检查员使用不同的设备重复检查 EP 和假药样本的数量较少。
结论/意义：本试点研究表明，希望在 PMS 中实施便携式筛选设备的决策者应该意识到，设备的过度自信可能会通过减少检查员对视觉检查的投入而造成危害。它还为决策者提供了有关不同筛选设备在最终用户手中的优缺点的见解。
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