The ultimate aim of this project is to improve the quality of medicines in the Greater Mekong Sub-region. Poor quality medicines are a serious public health concern. Products that are substandard, deliberately falsified or that have degraded over time can lead to treatment failure and side effects, as well as contributing to drug resistance; they also waste financial resources that are particularly precious in low- and middle-income countries.
Detecting poor quality medicines is therefore extremely important, both to protect patients and to assess the scale of the problem. New technologies can play a significant part in detecting poor quality medicines; with increased sophistication in falsification, more refined techniques are required to allow the detection of anomalies in packaging or products that are not immediately apparent.
A variety of technologies and devices are used, or under development. However, there is no clear global vision of which tests are reliable for which medicines at which point in the supply chain. The project will assess the accuracy, ease of use and cost effectiveness of different portable and handheld devices across a variety of essential anti-infective medicines commonly used in the Greater Mekong Sub-region to treat malaria and bacterial infections.
The work is funded by the Asian Development Bank and will be undertaken through a collaboration between the Georgia Institute of Technology, the Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), and the Infectious Diseases Data Observatory (IDDO), based at the Centre for Tropical Medicine and Global Health at the University of Oxford.
Dr Susann Roth, Senior Social Development Specialist at the Asian Development Bank, said: “The results of this research will provide Medicine Regulatory Authorities and international organisations with valuable information that will help them to make informed decisions about the best devices to use for their particular requirements. This research is therefore critical to ensuring that these devices are used to their full potential to improve medicine quality and protect patients.”
It is thought that certain devices will be more suited to specific uses and types of medicine, evaluating medicine packaging or assessing tablet composition, for instance. Technologies and devices - including colorimetric card tests and portable, battery-powered devices, based on Raman and near infrared spectroscopic technologies - will be tested with genuine, substandard, and falsified products of known packaging and chemical composition. A review of current evidence and an analysis of the cost-effectiveness of the technologies will also be undertaken.
Dr Céline Caillet, Scientific Coordinator of the IDDO Medicine Quality Group, said: “Laboratory-based evaluations of single technologies have been performed for a few medicines, but this will be the first time that evaluations have been undertaken for a wide variety of medicines. There is an urgent need to undertake this research to find out which of the devices are best suited to screening which medicines and at which points in the medicine distribution system.”
Prof Facundo Fernandez, Vasser-Woolley Professor in Bioanalytical Chemistry at the Georgia Institute of Technology, added: “There have been significant advances in forensic chemical analysis over recent years. These technological advances have the potential to enhance drug quality monitoring and, combined with the development of simple tests, provide a real opportunity to make progress against the significant threat of poor quality medicines.”
The project will build upon previous projects funded by the Asian Development Bank’s Regional Malaria and Other Communicable Diseases Trust Fund, which addresses the root causes of malaria drug resistance and the spread of communicable diseases. The results will be disseminated through communications with Medicine Regulatory Authorities, a report summarising the implications of the research, scientific publications, and a workshop for key stakeholders.