February 25, 2016
Researchers at the Promoting the Quality of Medicines (PQM) program report today results of a study that evaluated the effectiveness of a novel counterfeit medicines detection tool that could help low- and middle-income countries (LMICs) control the proliferation of poor-quality medicines. PQM conducted the study in collaboration with the U.S. Pharmacopeial Convention’s Center for Pharmaceutical Advancement and Training (CePAT), U.S. Food and Drug Administration (FDA), U.S. Agency for International Development (USAID), and other partners.
The tool evaluated in the study, called CD3+, is a simple, battery-operated, hand-held device developed by the U.S. FDA. It requires little training for effective use, and offers substantial cost-savings compared to more expensive, existing laboratory-based and field-based options. Increased accessibility to easy-to-use and affordable screening technologies, such as CD3+, are invaluable for LMICs that desire targeted, risk-based, cost-beneficial strategies for surveying and monitoring the quality of available medicines.
This study evaluated the effectiveness of CD3+ in detecting counterfeit or substandard versions of two commonly used antimalarial therapies in Ghana, the results of which are published online in the Malaria Journal. The study also assessed the effectiveness of CD3+ compared to existing field detection tools, and how the three field-based tools compared to the laboratory-based gold standard procedure, high-performance liquid chromatography (HPLC).
Researchers conducted a side-by-side comparison of CD3+ with Thermo Scientific’s TruScan® hand-held Raman spectrometer and Global Pharma Health Fund’s (GPHF) Minilab™. Using a total of 84 antimalarial samples of artemether-lumefantrine and artusenate-amodiaquine tablets, the researchers evaluated the technologies’ sensitivity in detecting counterfeit and substandard medicines, and specificity in determining genuine products compared to HPLC.
The study revealed that CD3+ has notable advantages compared to other available technologies: it is the only technology that provides comprehensive examinations of print style, packaging, and dosage unit. It can also easily be used with other technologies to improve the detection of counterfeit and substandard products. Using a combination of CD3+ with either Minilab™ or TruScan® to screen for medicine quality, however, was shown to provide the most comprehensive information for determining whether medicines in the study were counterfeit and substandard.
The prevalence of poor-quality medicines in low- and middle-income countries, particularly antimalarials, is alarming, and has been linked to poor health outcomes, including drug resistance, treatment failure, and increased mortality and morbidity. Simple, non-sophisticated, and affordable tools to establish quality are necessary. Bringing these novel technologies to scale and encouraging their appropriate and effective use could help detect and reduce the prevalence of poor-quality medicines in LMICs.
Funding for the activity has been provided by the Skoll Global Threats Fund. Testing was conducted under an agreement between U.S. FDA and USAID. Other partners include the National Institutes of Health and the U.S. Centers for Disease Control and Prevention.