Abstract
Falsified and substandard drugs are a global health problem, particularly in low- and middle-income countries (LMIC) that have weak pharmacovigilance and drug regulatory systems. Poor quality medicines have important health consequences, including the potential for treatment failure, development of antimicrobial resistance, and serious adverse drug reactions, increasing healthcare costs and undermining the public's confidence in healthcare systems. This article presents a review of the methods employed for the analysis of pharmaceutical formulations. Technologies for detecting substandard and falsified drugs were identified primarily through literature reviews. Key-informant interviews with experts augmented our methods when warranted. In order to aid comparisons, technologies were assigned a suitability score for use in LMIC ranging from 0–8. Scores measured the need for electricity, need for sample preparation, need for reagents, portability, level of training required, and speed of analysis. Technologies with higher scores were deemed the most feasible in LMICs. We categorized technologies that cost $10,000 USD or less as low cost, $10,000–100,000 USD as medium cost and those greater than $100,000 USD as high cost technologies (all prices are 2013 USD). This search strategy yielded information on 42 unique technologies. Five technologies were deemed both low cost and had feasibility scores between 6–8, and an additional four technologies had medium cost and high feasibility. Twelve technologies were deemed portable and therefore could be used in the field. Many technologies can aid in the detection of substandard and falsified drugs that vary from the simplest of checklists for packaging to the most complex mass spectrometry analyses. Although there is no single technology that can serve all the requirements of detecting falsified and substandard drugs, there is an opportunity to bifurcate the technologies into specific niches to address specific sections within the workflow process of detecting products.
Highlights
The health and economic consequences of falsified and substandard drugs are most severe in low- and middle-income countries (LMIC) with weak pharmacovigilance and drug regulatory systems [1]
We have provided a broad overview of the technologies used to detect counterfeit and substandard drugs, and to highlight those technologies most suitable for use in LMIC
Factors related to the testing site include whether there is a consistent electrical supply, what level of training the staff have, and if the purpose of the testing is either screening or confirmation
Summary
The health and economic consequences of falsified and substandard drugs are most severe in low- and middle-income countries (LMIC) with weak pharmacovigilance and drug regulatory systems [1]. Poor quality medicines have important health consequences, including the potential for treatment failure, the development of antimicrobial resistance, and serious adverse drug reactions, including death, all of which may result in lost economic activity and increasing healthcare costs and may undermine efforts to improve healthcare [7]. A variety of technologies from analytical chemistry and other scientific fields have been used to detect falsified and substandard drugs. These technologies vary considerably in characteristics that impact their appropriateness for use in LMIC. Technologies differ in the amount of training required for technicians to use them; some are portable and require little training while others require sophisticated laboratory equipment and a high level of technical expertise, making them more or less appropriate in LMIC
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