Legal framework of antimicrobial stewardship in hospitals (LEASH): a European Society of Clinical Microbiology and Infectious Diseases (ESCMID) cross-sectional international survey

https://doi.org/10.1016/j.ijantimicag.2018.07.019Get rights and content

Highlights

  • Legal framework of AMS in hospitals in Europe is heterogeneous.

  • In some countries AMS activities are successful without legal framework.

  • More regulations are needed in countries with high antimicrobial use and resistance.

  • Special attention should be paid to the implementation of the regulations.

Abstract

Antimicrobial stewardship (AMS) is the cornerstone activity in the combat against antimicrobial resistance. In order to ensure sustainable deployment and development of AMS, a strategic and regulatory framework needs to be provided by national healthcare authorities. Experts from 32 European countries, Israel and Turkey were invited to participate in a cross-sectional internet-based survey from October 2016 to May 2017 on the legal framework and mandatory components (structures, activities) of AMS in hospitals, i.e. components required by legislation or regulations. We collected data from 25 countries and two regions (in countries with federal health administration). Laws regulating AMS existed in seven countries and one region. Other health ministry regulations were applicable in 13 countries and one region. National strategies and/or action plans approved by ministries of health were in place in 13 countries and one region. Conversely, five countries and one region had no regulation of AMS in hospitals. Funding for AMS in hospitals was provided in five countries and one region. Eight countries and one region reported mandatory AMS structures and activities complying with the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) structure, policy and practice indicators. In 10/27 cases, however, the mandatory AMS activities were not being fully carried out. The survey showed heterogeneous legal frameworks for AMS in hospitals, and in many countries it was even lacking. The situation may be critical in countries with poor control of antimicrobial use and resistance. Recent international initiatives calling on policy-makers to address the threat of antimicrobial resistance could yield improvement.

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.

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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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