Testing substandard and falsified medicines to fight AMR

Let’s imagine ten people in low- and middle-income countries (LMICs) go to the pharmacy to buy medicine. According to the World Health Organization (WHO), one of those ten people is likely to receive a bad medication. It may have the wrong active ingredient or no active ingredient at all (falsified medicines). Alternatively, it may have the wrong quantity of active ingredient, or the overall quality may be poor (substandard medicine). Medicines regulatory authorities (MRAs) and other actors involved in medicine procurement are responsible for preventing, detecting, and responding to substandard and falsified (SF) medical products. However in the field, medicine inspectors can usually only rely on visual inspection as they screen for circulating SF medicines, and confirmatory laboratory analyses are expensive, time-consuming and scarce in many countries.

SF medicines have huge consequences for patients, healthcare systems, and drug efficacy. They prevent patients from receiving the right treatment, which can impact their health, and also undermine their confidence in healthcare systems. And if those patients are taking SF anti-malarials or antibiotics—the most common type of SF medicines—their infections may grow stronger and more difficult to treat. Across patients and over time, life-saving drugs may lose their efficacy against increasingly resilient infections. This problem, known as antimicrobial resistance (AMR), has been identified as one of the top ten global public health threats facing humanity.

A key strategy to combat AMR is to reduce the over-use and misuse of antibiotics, starting with accurate and affordable diagnosis, which is at the heart of the mission of FIND. But this goal raises the question: what happens if patients get the right test and diagnosis, but don’t get the right medicine? Or what happens if the right medicines are no longer effective? Accurate diagnosis is part of a chain of care which contributes to proper and effective treatment for all.

With this context in mind, FIND carried out a project in collaboration with partners to improve how SF medicines could be detected in and removed from healthcare systems in LMICs. A first study asked how SF medicines get through healthcare systems and into patients’ hands in the first place. Our survey of 15 countries (14 in sub-Saharan Africa and one in South-East Asia) showed that inspectors and regulatory authorities currently lack training, appropriate procedures, and access to effective tools to successfully root out SF medicines.

The second part of the project explored the potential of portable screening tools to help inspectors in the field identify SF medicines for subsequent referral to central laboratories. At the moment, little data is available on the potential of existing tools to detect substandard medications and quantify their active ingredients. To address this knowledge gap, we conducted an extensive laboratory and in-field evaluation study in Laos that enabled us to collect significant amounts of data on the performance, utility, and usability of different testing tools, including three portable spectrometers and one mobile-based app.

But as our survey revealed, tools alone are not enough—they need to be part of a larger strategy. WHO recommends a three-layer approach to improve the detection and removal of SF medicines in countries with limited human and financial resources: 1) visual inspection of the medicine itself and its packaging, at every stage of the supply chain; 2) screening by trained inspectors equipped with adequate testing tools; and 3) inspection at official medicines control laboratories.

Thanks to this exploratory study, we were able to recommend to policy-makers and donors a path forward to implement better monitoring and removal of SF medicines. This project is one among several by FIND that addresses AMR, so that with the right tests, reliable and sustainable healthcare becomes accessible to all.