Deploying novel technology to detect fake drugs

•Bloom Public Health, Harvard, University of Michigan commission study to test the quality of drugs in Onitsha, Kano, Yola, Port Harcourt, Lagos, Abuja

A team of United States (U.S.) and Nigerian researchers plan to demonstrate the potential of novel technology in identifying and removing nefarious suppliers and reducing the incidence of negative reactions and illnesses from low-quality medicines.

Members of the team include Dr. Elisa Maria Maffioli of the University of Michigan School of Public Health, US; Prof. Chimezie Anyakora of Bloom Public Health, Nigeria; and Dr. Marie Chantel Montás, Harvard T.H. Chan School of Public Health, U.S.

The researchers said if shown to be cost-effective, inspectors and pharmacies in the country could keep the supply chain safe for citizens as they use the Rxscanner.

The novel technology, RxScanner6, was developed to decentralise drug checking along the supply chain. By combining proprietary Artificial Intelligence (AI) algorithmic models of drug spectral signatures with advanced spectroscopy, it enables instant drug material analysis, by identifying sample materials on the spot in a matter of seconds. The RxScanner is 10x cheaper and 5x more portable than existing detection solutions.

Before now, current methods of laboratory analysis of drug samples have been demonstrated to be time-consuming, labour-intensive, and expensive. New mobile testing devices, such as Mass Authentication (MAS) Scratch Codes and mini-labs, make it possible to detect suspect samples in low-resource settings. However, they are bulky, do not provide real-time data maps of drug flows, and do not provide a legally admissible irrevocable record with timestamps of identified bad drugs.

Leader of the team, Prof. Anyakora, told The Guardian that a path to scale will aim to impact more than 200 million Nigerian residents, one of the largest markets in Africa. He said removing bad drugs from the markets would also benefit the poorest, as high prices still limit access to authentic ones.

Until now, researchers have shown that more than 10 per cent of medicines in developing countries are of low quality (counterfeit, substandard, or degraded), causing an estimated one million deaths yearly. However, the prevalence of low-quality medicines varies widely by country, with Southeast Asian and Sub-Saharan-African regions having the highest.

In Nigeria, the pharmaceutical industry was estimated to be worth $2.5 billion in 2020 and is expected to grow to $4 billion over the next 10 years. The country’s pharmaceutical market is highly import-dependent, with more than 60 per cent coming from countries such as India and China, and the rest produced locally. Medicines are then traded at wholesale markets, and then reach hospitals, pharmacies, and retail stores as well as local markets, before getting to consumers.

Several studies have shown that, in Nigeria, a significant proportion of medicines are found to be counterfeit, sub-standard, or degraded, such as 17 per cent of essential generic medicines and 30 per cent of anti-malarial.

To address the situation, BPH and Innovations for Poverty Action (IPA) are collaborating on a project, which has two main goals: to validate a novel and cheaper technology (RxScanner), compared to the gold standard (TruScan RM Raman Analyser) in the market, through drug testing, supported by BPH; and to evaluate the impact and cost-effectiveness of the technology, through the implementation of a randomised controlled trial.

BPH is a think-thank whose mission is to help protect and improve the health of people in the African continent, while IPA is a non-profit organisation dedicated to designing and evaluating potential solutions to global policy problems and supports decision-makers to use this evidence in policy.

Supported by BPH, Anyakora said they plan to test the quality of about 1,000 drugs purchased in pharmacies in six geo-political regions, encompassing both urban and rural areas, around the following cities: Kano, Yola in Adamawa State, Federal Capital Territory (FCT) Abuja, Onitsha in Anambra State, Lagos, and Port Harcourt in Rivers State.

He said a team of local pharmacology-trained technicians would act as mystery shoppers and purchase 20 drugs among the following five categories: analgesics; antibiotics; multivitamins; antimalarial and anti-hypertensives.

Anyakora, who is a pharmaceutical chemist and Chief of Party for Bloom Public Health in Nigeria, further explained: “The mystery shoppers will start at a random point in the city and purchase medicines every other pharmacy they encounter. The mystery shoppers will follow a pre-defined random order to know which drugs to purchase in each location. The collected drug samples will then be tested with RxScanner and TruScan.

The passing criteria of the tests will then be compared. We expect that a similar proportion of drugs pass the authenticity test (at some level, for example, 95 per cent matching with the database) for the RxScanner to be considered valid. This exercise will add further evidence that the novel technology is able to detect low-quality drugs according to the standards.”

“Supported by IPA, an impact evaluation will be conducted in 78 pharmacies. Half of them will be randomly provided with the novel technology (RxScanner), while the remaining half (39) will be used as a control group and no intervention will be implemented. This design allows us to causally test whether the use of this novel technology could improve transparency and monitoring of the supply chain.

“More specifically, outcomes on both the supply and demand sides will be measured. On the supply side, the primary outcome of interest is the proportion of low-quality medicines in the pharmacies, and the quantity and price at which medicines are sold. Secondary outcomes focus on assessing the procurement behaviour of pharmacists, including their knowledge, experience and perceptions of low-quality drugs. On the demand side, the behaviour of patients in terms of pharmacy and medicine choices will also be assessed.

“The estimated effectiveness of the RxScanner from the RCT will be combined with the costs of implementation to conduct a Cost-Effectiveness Analysis (CEA). This will shed some light on whether investing in the technology is worth it.”