Legal framework of antimicrobial stewardship in hospitals (LEASH): a European Society of Clinical Microbiology and Infectious Diseases (ESCMID) cross-sectional international survey
Introduction
Antimicrobial stewardship (AMS) is defined as a coherent set of actions designed to use antimicrobials responsibly [1], [2]. AMS interventions include multiple activities that involve a broad range of stakeholders ranging from individual prescribers to healthcare systems and supranational incentives and regulators. AMS has been historically driven by professionals who were aware of the problem and were willing to use their expertise to improve antimicrobial prescribing. However, to be effective, the wider healthcare community, the regulators, and the general public must recognise the need for and value of AMS [3]. For purposes of sustainable deployment and development of AMS activities, a strategic and regulatory framework needs to be provided by national healthcare authorities [3], [4]. Recent European guidelines for prudent use of antimicrobials in human health emphasise the responsibility of national authorities for developing, implementing and supporting the policies, actions and structures necessary to ensure the prudent use of antimicrobials. Their responsibilities include legislation, regulation and auditing [5]. Little information on the legislative regulations of AMS in hospitals is available. At the European Union (EU) level, reports on the implementation of EU council recommendations on the prudent use of antimicrobial agents in human medicine did not specifically describe legislation on AMS activities in hospitals [6]. Two reports, a study on successful implementation of AMS in hospitals in the UK, USA and France, and a global survey of AMS programmes in hospitals, pointed to the differences in legislation and underlined the need for legislative requirements and national standards for implementation of AMS [3], [7]. The differences in legislative requirements for AMS between countries may reflect differences in healthcare systems and legislation in general [4], but also differences in health authorities’ commitment to addressing the issue of antimicrobial resistance. In this survey, we aimed to provide more complete insight into the legislative and regulatory framework of AMS in hospitals in European countries, in Israel and in Turkey. Knowledge of these regulations may provide an opportunity to share good practices and may stimulate further research on the impact of specific legal frameworks on AMS, on the consequent quality of antimicrobial prescribing and, ultimately, on antimicrobial resistance rates.
Section snippets
Study design
Legal Framework for Antibiotic Stewardship in Hospitals [LEASH] was an ESGAP (European Society of Clinical Microbiology and Infectious Diseases – ESCMID – Study Group for Antimicrobial StewardshiP) international internet-based cross-sectional survey. It was conducted from the end of October 2016 until the beginning of May 2017.
Questionnaire
The 44-item questionnaire (13 questions, 31 sub-questions) in English (Appendix A) was developed by a multidisciplinary group of experts in infectious diseases, pharmacy
The regulations of AMS in hospitals
The experts from 26 out of 34 eligible countries responded to all questions in the questionnaire (response rate 76%). However, for Italy, responses were collected for two regions only, and not for the whole country; therefore, the results refer to 25 countries and 2 regions.
Nationwide regulations of AMS in hospitals in the 25 countries and 2 regions are presented in Table 1.
Mandatory AMS activities in hospitals
Surveillance of antimicrobial consumption in hospitals is mandatory in 15 countries (Austria, Bulgaria, Croatia, France,
Discussion
In this study we investigated legislative framework of AMS in hospitals in 24 European countries and in Turkey and Israel. We examined the regulations enforced on the national or regional level in countries, if the experts reported that AMS was only regulated regionally. Roughly three-quarters of participating countries/regions reported having a document such as a law, regulation, strategy, or action plan adopted by the highest healthcare authority.
In 2000 Krcmery and co-authors reported that
Conclusion
In conclusion, the legal frameworks of AMS in hospitals in Europe seem very heterogeneous and insufficient. More regulations are needed, especially in countries with high antimicrobial consumption and resistance. Special attention should be paid to the implementation of the regulations and the sustainability of AMS activities. Supranational action plans and policymaker commitment [15], [23], [24] are important drivers for the development of the AMS activities, but the approach should be adapted
Acknowledgements
The LEASH study group: Franz Allerberger, Austria; Ria Benko, Hungary; Dag Berild, Norway; Robert Cunney, Ireland; Martine Debacker, Luxembourg; Aleksander Deptula, Poland; Uga Dumpis, Latvia; Oliver J Dyar, Sweden; Onder Ergonul, Turkey; Balint Gergely Szabo, Hungary; Cairine Gormley, UK; Malin Grape, Sweden; Thorolfur Gudnason, Iceland; Philip Howard, UK; Benedikt Huttner, Switzerland; Petros Ioannou, Greece; Ramona Ionescu, Romania; Emma Keuleyan, Bulgaria; Viviane Knepper, Luxembourg;
Declarations
None.
Funding
No funding.
Competing Interests
None.
Ethical Approval
Not required.
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