New studies alert to the risk of poor-quality human antibiotics and veterinary antimicrobials
New studies suggest that substandard and falsified (SF) antimicrobials, in particular antibiotics, are widely spread with higher prevalence in low-and middle-income countries (LMIC). The quality of the evidence available in the scientific literature is poor but the issue has significant risks for One Health.
Two papers, Substandard and falsified antibiotics: neglected drivers of AMR? (focus on human use medicines) and The quality of veterinary medicines and their implications for One Health, published in the BMJ Global Health show that interventions to enhance medicines regulatory functions to prevent, detect and respond to SF issues are needed to improve the global antimicrobial supply for both human and animal.
From the limited epidemiology data available, the Medicine Quality Research Group scientists, of IDDO, OCGHR and MORU Tropical Health Network, found that of all human antibiotics and veterinary anti-infectives collected and analysed in past scientific studies, 17.4% and 52.0% were of poor quality, respectively. Researchers concluded that SF antibiotics and veterinary anti-infectives have serious implications on animal and human public health. However, the paucity of objective underlying data means that these numbers cannot be extrapolated to suggest that 17.4% and 52% of human antibiotics and veterinary anti-infective globally are poor quality.
The most frequent reason for both human antibiotics and veterinary anti-infectives to be poor quality was failure of active pharmaceutical ingredient (API) content tests, with most that failed having lower than stated API content than pharmacopeia standards. In addition, one in ten human antibiotics tested for dissolution (the crucial step that allows the medicine to reach the blood stream) failed to dissolve properly, suggesting impairing bioavailability of the active ingredient, thus its efficacy. These findings show that SF antibiotics may expose human patients and animals to subtherapeutic levels, risking treatment failure and the selection and spread of resistant bacteria.
Animals and humans coexist in the same eco-environment, and many humans in all parts of the world depend on animals for food, livelihood, and companionship. The coexistence has also naturally led to the exposure and transfer of many pathogens between them. Therefore, the prevention and control of animal diseases are equally crucial to the health and wellbeing of humans, and in the achievement of the Sustainable Development Goals.
SF antibiotics used in humans can lead to poor clinical outcomes, induce adverse drug reactions, economic loss, diminish public confidence in health systems and drive Antimicrobial Resistance (AMR). Similarly, SF veterinary anti-infectives may lead to animal suffering, loss of agriculture production and economy, impacting human health and further adding to the emergence of AMR. However, the quality of antimicrobials used by both humans and animals have been neglected as potential drivers of AMR.
There are major gaps in the evidence, with geographical disparities; the majority of the samples were collected in LMIC, in Africa and Asia. Epidemiology studies on antimicrobials quality are concentrated in these regions as they are known hotspots for downstream distribution of SF medicines but no region is immune to this global issue.
The researchers conclude that the results of these studies are concerning but human antibiotic and animal antimicrobial quality epidemiology remain poorly understood and neglected. To better understand the mechanisms and address the impact of these SF products on human and animal health, agriculture production and their economy, and AMR requires enhanced research and discussion and multidisciplinary input from national and international organisations.