Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries

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.

Essential medicines for universal health coverage

“…Some techniques can be done through blister packs and bottles. 264,265 Although relatively capital expensive, they are inexpensive to run. 266 A suitcase-sized micro fl uidics device for rapid chemical analysis of medicines has been developed.…”

“…268 Laboratory-based evaluations of single systems for a few medicines have been done, but diagnostic accuracy, ease of use, or cost-eff ectiveness, especially for co-formulated medicines, have not been assessed. 264,269 Hand-held tools are not always accurate in detecting substandard medicines, but can be used to detect falsifi ed medicines that contain no active ingredients.…”

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations

“…Moreover, only small sample volumes are needed, there is only a low consumption of solvents, and no expensive columns with special modifications of the stationary phase are required. In view of the urgent need of implementing modern analytical techniques in low‐ and middle‐income countries , these features make CE an attractive cost‐effective technology for quality analysis and thus, for the detection of falsified and substandard medicines in laboratories with limited resources and infrastructural restrictions. Of note, compact and robust instruments have been constructed recently which are suitable of being used in tropical environments .…”

Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study

“…The detection of counterfeit medicines by customs officials usually occurs as a result of intelligence or random checks, suspect medicines are then sent away for laboratory-based analysis. Advancing technology has made a variety of techniques available which include spectroscopy, chromatography, SMS, handheld or portable laboratories, radiofrequency identification and serialisation 14. Serialisation is the process of identifying a medicine with a unique code printed onto the medicines pack and verification is the process for identifying and checking that code.…”