Case example: Development of an antimicrobial consumption application

Antimicrobial resistance (antibiotic resistance), especially for gram-negative bacteria, is a serious health threat. Fimea also wants to react and be involved in managing this quiet pandemic.

In February 2023, restrictions on the use of antimicrobials in animals took effect throughout the EU with the entry into force of the new EU veterinary legislation in 2022. The World Health Organisation (WHO) has issued a global call for national action programmes (NAPs) to manage antimicrobial resistance, and the EU has called on the EU/EEA countries to adopt so-called One Health measures to manage the resistance problem. In the EU, antimicrobial resistance has been identified as a silent pandemic, and ways to manage it should be actively sought, with 35,000 deaths per year in EU/EEA countries due to resistant microbial populations. In particular, resistant strains of gram-negative bacteria such as Escherichia coli increase mortality worldwide. The problem has been identified for a long time and has been discussed, for example, in Fimea’s Sic! online magazine in 2020 (in Finnish). 

In particular, the WHO monitors the strains and prevalence of methicillin-resistant Staphylococcus aureus (MRSA) and cephalosporin-resistant E. coli. Globally, the prevalence of both is increasing, but the resistance situation in Finland has remained stable (situation in 2020). Global tourism poses a risk that the situation may also deteriorate in Finland.

According to studies, the use of the more common antimicrobials has decreased in Finland between 2008 and 2019 in all age groups (Parviainen et al., 2018; Pyörälä et al., 2022). The number of antimicrobial prescriptions for children (0–17 years) decreased by 43% in 2008–2016 and for adults by 26% in 2008–2019. For example, the use of broad-spectrum antimicrobials, quinolones, decreased by 49% and tetracyclines by 39%. Although both register studies show that Finland has managed to reduce the use of antimicrobials in an exemplary way, the number of gram-negative E. coli resistance cases in Finland increased during the monitoring period.

Fimea works to manage antimicrobial resistance

Finland’s national antimicrobial resistance expert group (MTKA) includes Fimea’s experts in human and veterinary medicines. The group has published a national action plan (NAP) on antimicrobial resistance for 2017–2021 and is currently updating the plan. The action plan defines, for example, the responsibilities of different agencies in combatting the problem. Fimea’s role is to monitor antimicrobial consumption data. 

In 2022, Fimea began developing the antimicrobial consumption application in cooperation with Kela. The goal is a public application based on the prescription and delivery data in the Kanta Prescription Centre and the data in Fimea’s wholesale register. The application enables the responsible use of antimicrobials to be monitored and evaluated nationally and regionally in wellbeing services counties. In addition, the application includes a breakdown of antimicrobial consumption data for hospitals and outpatient care. While the decrease in the use of antimicrobials does not seem to correct the resistance problem, at least for gram-negative bacteria, monitoring consumption data still provides important information on the use of antimicrobials at national level. 

The planning and development of the antimicrobial consumption application began in 2022. The goal is that the application is ready by the end of 2023 and its use in wellbeing services counties begins in 2024.

The planning and development of the antimicrobial consumption application began in 2022. The goal is that the application is ready by the end of 2023 and its use in wellbeing services counties begins in 2024.

A prescription drug application developed jointly by Kela and Fimea, published in 2021, provides information on the purchase volumes and costs of medicines by medicine group. Due to the special measures during the COVID-19 pandemic, the costs of antimicrobials decreased in 2020–2021, but in 2022, after the end of the special measures during COVID-19, they increased even above the level in 2019. The data in the medicines information application only applies to outpatient medicines reimbursed by Kela, so the new antimicrobial application brings a significant new tool for monitoring consumption data.

Fimea also monitors the compliance of medical devices essential in the management of antimicrobial resistance (e.g. laboratory tests for the diagnosis of bacterial infections requiring antibiotics, devices containing antimicrobial components and personal protective equipment used in health care).