Pharmacovigilance as a key tool in the One Health approach to AMR

The following article is the second in a series authored by Marmar Nekoro and James Mount from the Department of medicinal products in veterinary use at the Swedish Medical Products Agency, to address the different elements of the One Health approach. This article introduces the interconnection between One Health and antimicrobial resistance (AMR), emphasising the actions needed to promote responsible use, improve infection control, and increase global cooperation. It also highlights the role of pharmacovigilance in AMR monitoring. Read the first article here.

ANTIMICROBIAL RESISTANCE (AMR) occurs when microorganisms such as bacteria, viruses, fungi, and parasites no longer respond to antimicrobial substances, making infections harder to treat and increasing the risk of a disease transmission, severe illness, and death. AMR is a significant threat to global health, with serious consequences for societies and economies due to its far-reaching repercussions on public and animal health and food security. A study in 2019 attributed 4.95 million human deaths globally to AMR. 

The development of antimicrobial resistance is accelerated by the excessive or improper use of antibiotics in human healthcare, veterinary medicine, and agriculture. Additionally, antimicrobial residues entering water bodies, soil, and food chains promote resistant bacteria, which can infect both animals and humans, exacerbating the cycle through ecosystems. Environmental emissions during the manufacturing of antimicrobials have also been highlighted as a significant contributor to AMR and remain largely unregulated.

Coordinated action is necessary and underway to safeguard antimicrobials for future generations. For example, the World Health Assembly adopted a global action plan on AMR in 2015, with a strong emphasis on infection prevention and control (IPC). Antimicrobial stewardship programmes, which promote and measure appropriate use of antimicrobial agents, have introduced decision-making classification systems regarding antimicrobial use in human and veterinary medicine. In 2024, the World Health Organization (WHO) released the first ever guidance on how to reduce pollution from antimicrobial manufacturing, addressing the environmental spread of antimicrobials.

By integrating pharmacovigilance (PV) into the One Health approach, we can better monitor use of antimicrobials and detect emerging resistance patterns. PV can help address AMR through surveillance and monitoring, data collection and analysis, identifying inappropriate use of antimicrobials, and supporting antimicrobial stewardship. Monitoring of information within human and veterinary PV databases has been highlighted as an innovative approach to early warning surveillance of AMR, as use-related issues are reported in spontaneous adverse event reports. This can include systematic collection and analysis of prevalence and patterns of AMR in settings such as hospitals, clinics, and the community. For example, clusters of adverse event reports coded with terms such as “drug ineffective”, “pathogen resistance”, “drug resistance” or “lack of efficacy” could potentially indicate an emerging resistance issue. These types of observations can be shared with other authorities for further investigation and the results can be integrated in existing monitoring programmes. 

Apart from being a source of data on suspected resistance, pharmacovigilance databases can be used to survey the appropriate use of restricted-use antimicrobials by monitoring the reports recorded as “off label use” or “product use in unapproved indication”. Analysis of these types of reports can be shared with policymakers to influence or correct the decision-making practices of prescribers. 

Antimicrobial resistance presents a formidable global health challenge requiring coordinated action through the One Health approach. While international initiatives like WHO’s global action plan, enhanced infection control measures, and antimicrobial stewardship programmes form the foundation of our response, pharmacovigilance serves as a critical ally in this effort. By monitoring adverse event reports for signs of emerging resistance and tracking off-label use of restricted antimicrobials, pharmacovigilance systems provide valuable early warning data that inform policy decisions and prescribing practices – ultimately strengthening our collective ability to preserve these vital medicines for future generations.