ECDC/EC/EFSA country visit to Montenegro to advance One Health responses against antimicrobial resistance

From 10 to 14 June 2024, the European Centre for Disease Prevention and Control (ECDC), the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and the European Food Safety Authority (EFSA) conducted a country visit to Montenegro which was supported by a consortium composed of Epiconcept and Integrated Quality Laboratory Services (IQLS) and was based on the ‘Methodology for conducting One Health country visits on antimicrobial resistance in the Western Balkans’ [1]. The visit was part of ECDC Accession Support to the Western Balkans and Türkiye, to advance a One Health approach to antimicrobial resistance (AMR) in the Western Balkans, funded by the Directorate-General for Neighbourhood and Enlargement Negotiations (DG NEAR) of the European Commission.

The report concludes that continued efforts are required at national level, starting with the planning and implementation of education and communication campaigns on the prudent use of antibiotics to reduce excessive use; introduction of targeted interventions based on surveillance data; provision of access to good-quality, timely microbiology services, and the development of guidelines and protocols for microbiological diagnostics, antimicrobial treatment and infection prevention and control (IPC). In addition, it would be useful to strengthen the role of the National Interdisciplinary Commission for the Control of Antibiotic Resistance (NIKRA) as the national body in charge of supervising AMR activities in a One Health perspective. NIKRA’s current mandate and terms of reference require revision to include specific roles, responsibilities, dedicated time and budget. Furthermore, it would be useful to strengthen intersectoral and interdisciplinary collaboration and the visibility of NIKRA. Evaluation of the current National Action Plan (NAP) 2022−2024 could guide the development of the next NAP, the implementation of which will also require continuous monitoring.

Montenegro has a well-equipped national reference laboratory (NRL) for the human health sector but faces significant hallenges with clinical microbiology laboratories, including shortage of staff, equipment and supplies. Clinical microbiology laboratory services are under-utilised and timely reporting of results remains challenging. AMR data are only collected for invasive isolates from blood and cerebrospinal fluid (CSF). Montenegro participates in the Central Asian and European Surveillance of Antimicrobial Resistance network (CAESAR). However, there is a need for comprehensive national AMR surveillance beyond invasive isolates and at the local level. This would help to better inform the selection of antimicrobial treatments within healthcare facilities and across community settings, enabling data-driven decision-making and targeted interventions. Antimicrobial consumption (AMC) is monitored through antibiotic sales data. Incorporation of analysis using the Access, Watch, Reserve (AWaRe) classification could strengthen the understanding of antibiotic usage patterns in the country. Analysing reimbursement data by indication and disseminating findings to healthcare providers could improve awareness of antimicrobial consumption trends.

Montenegro has well-trained human resources for antimicrobial stewardship (AMS) in hospitals supported by legal mandates for AMS teams. However, further implementation work is required, such as the development of comprehensive AMS programmes with clear objectives, indicators, interventions, and evaluation mechanisms. There is also a need for robust guidelines on microbiological diagnostics, antimicrobial treatment and IPC, as well as regular monitoring of compliance with best practices. While IPC committees exist in hospitals, IPC practices are suboptimal, and there is a lack of regular monitoring of hand hygiene compliance. Enhanced training of healthcare workers in IPC practices, including hand hygiene, glove use, and urinary catheter maintenance, is essential.  Although the reporting of healthcare-associated infections (HAIs) is mandatory, data analysis and feedback to clinicians is insufficient, limiting effective interventions. 

In the animal health and food safety sectors, Montenegro has the laboratory capacity to support AMR monitoring with accredited procedures in bacteriology and competent staff at the Specialist Veterinary Laboratory (SVL). The Laboratory Information and Management System (LIMS) is adequately linked with the Veterinary Information System of the Administration for Food Safety, Veterinary and Phytosanitary Affairs (AFSVPA), facilitating data sharing. The country has just started its engagement in EU-harmonised monitoring of AMR in zoonotic and commensal bacteria in certain animals and foods. However, the SVL has not been designated as the national reference laboratory for AMR, and the high cost of proficiency testing has hindered participation in essential EU proficiency programmes. The absence of early planning for AMR monitoring activities at the national level had also hindered effective planning for the provision of reagents and consumables in the laboratory.

The transposition of EU legislation on sales and use of antimicrobials in animals into national legislation has already begun. However, full incorporation of the requirements of Regulation (EU) 2019/6 into the national legal framework still have to be
completed. There is also a need to further develop legal mandates, data collection frameworks, and database interoperability between the AFSVPA and the Institute for Medicines and Medical Devices of Montenegro (CInMED) for optimal analysis and use of the data collected. Positive practices have been noted among veterinarians and farmers, however there are still challenges, such as inadequate human resources, incomplete incorporation of EU legislation, and prevalent use in veterinary settings of broad-spectrum antimicrobials that are critically important for human health.

The environmental sector faces significant challenges, particularly with the disposal of expired and unused medicines, a gap recognised in the NAP. Although Montenegro is participating in the Global Sewage Project, the lack of representation of the environmental sector in NIKRA and the absence of a National Waste Management Plan are hindering comprehensive oversight.