The proliferation of substandard and falsified (SF) medicines has remained a global scourge, particularly in low-and-middle-income countries (LMICs) like those in Africa, where supply chain security is limited, undermining progress towards meeting the Sustainable Development Goals (SDGs). Inadequate resource allocation to routine quality control (QC) and poor supply chain management, among other factors, increase the difficulty in combating SF medicines in Africa as compared to developed countries.
According to the World Health Organisation (WHO), 1 in 10 medical products in developing countries is substandard or falsified, and a great percentage of these products are being used in Africa. Using SF medicines has both health and economic consequences for the continent.
SF medicines result in treatment failures, adverse reactions, unnecessary deaths and reduced confidence in the health system. Use of SF medicines is also closely linked to an increase in antimicrobial resistance, and economically, it results in the wastage of resources.
The march towards globalisation has created ever-increasing complexities in our ability to provide quality medicines as exemplified by the proliferation of SF medicines
The continuous rise of SF medicines demands the incorporation of fast and effective methods of identification of poor-quality medicines throughout the supply chain. Africa must therefore be innovative and develop a practical and sustainable approach to combating SF medicines on the continent. Leveraging global advancements in technology can provide a viable solution to these challenges.
Adoption of technology in combating substandard and falsified medicines
Technology has played a significant role, leading to the development of innovative applications that provide efficient and reliable processing of information and dissemination of alerts to detect SF products. Common applications are medicine authentication tools (MATs) involving verification of the product packaging. Health Tech companies like mPedigree, Sproxil, and PharmaSecure have developed mobile apps and SMS based MATs for detecting falsified medicines.
These MATs make use of visible or scratchable code, which has been printed on the product package by the manufacturer. The patient sends this code to the respective authentication databases using SMS. In reply, a message is received stating whether the stocks inquired are tagged genuine or fake; scannable bar codes are also provided.
A major drawback to these MATs is that sometimes poor network gives rise to delayed responses, discouraging the patient. Another major setback is that the patient is required to pay for the medical product before getting the right to scratch. Despite these two obstacles, these MATs have served well on some occasions.
Although these have been widely adopted across Africa, there is still a critical need for applications that can be used for quality evaluation in field-testing to provide on-site and in-time results. Such screening technologies (STs) are invaluable tools for post-marketing surveillance of medicine quality, as they rapidly detect SF medicines in the field, employ significantly less resources than those of traditional QC confirmatory technologies, and increase the number of samples that can be tested.
These field kits use machine learning to identify and quantify a medicine based on its chemical nature or a unique fingerprint derived from drug interaction analysis. They offer National Medicines Regulatory Authorities and other such agencies fast and reliable means of detecting SF medicines on the field and removing them from the medicine supply chain.
These are also essential tools for pharmacists, who play a critical role in the supply chain, connecting producers and distributors to consumers, to authenticate the quality of medicines purchased for sale. One of the most popular medicine quality screening technologies commonly used globally is TruScan™ Portable Raman spectrometer.
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RxAll is another screening technology that has emerged. Several other screening technologies are emerging and there is a need to make sure they are accurate and comparable with QC data obtainable in the lab, since wide reaching decisions can come out of such results.
There is a need to validate results from screening technology before deploying them for public health interventions.
Bloom Public Health is partnering with the University of Michigan in a validation study of two commonly used screening technologies. The aim is to provide National Medicines Regulatory Authorities and pharmacists with a fast, reliable and affordable tool for detecting SF medicines on the field and in pharmacies.
The study will demonstrate the causal impact of using these screening technologies in identifying and removing nefarious suppliers and reducing the incidence of adverse reactions and illnesses from low-quality medicines.
This study will also show the benefits of the reduction in the proportion of low-quality drugs present in the pharmacies, by assessing the saved disability-adjusted life years for each protected patient had they received the poor-quality drug and developed a prolonged illness, required repeated treatment, suffered adverse reactions or died.
Hence, this analysis will inform policy makers on how this technology could be beneficial compared to its costs. Certainly no resources should be spared in the effort to protect public health and more innovators are required to support the fight against SF medicines across the world.
Conclusion
The march towards globalisation has created ever-increasing complexities in our ability to provide quality medicines as exemplified by the proliferation of SF medicines. Leveraging technology to provide affordable, easy to use, and portable tools to address this global healthcare challenge is critical to achieving medicine security in Africa and progressing towards meeting Sustainable Development Goals.
