Evaluation of portable devices for medicine quality screening: Lessons learnt, recommendations for implementation, and future priorities

Abstract

Portable devices able to detect substandard and falsified medicines are vital innovations for enhancing the inspection of medicines in pharmaceutical supply chains and for timely action before they reach patients. Such devices exist, but there has been little to no independent scientific evidence of their accuracy and cost-effectiveness to guide regulatory authorities in choosing appropriate devices for their settings. We tested 12 portable devices, evaluated their diagnostic performances and the resources required to use each device in a laboratory. We then assessed the utility and usability of the devices in medicine inspectors' hands in a pharmacy mimicking a real-life Lao pharmacy. We then assessed the health and economic benefits of using portable devices compared to not using them in a low- to middle-income setting. Here, we discuss the conclusions and practical implications of the multiphase study discussed in this Collection. We discuss the results, highlight the evidence gaps, and provide recommendations on the key aspects to consider in the implementation of portable devices and their main advantages and limitations.