ECDC country visit to Spain to discuss antimicrobial resistance issues

Rationale and purpose of the country visit

A Council Recommendation dated 15 November 2001 on the prudent use of antimicrobial agents in human medicine (2002/77/EC) outlines the threat that AMR poses to human health and advocates a range of actions to be taken for its prevention and control. Council Conclusions on antimicrobial resistance (AMR) dated 10 June 2008 reiterate this call for action.

To assist Member States in implementing the Council Recommendation, ECDC has developed a process for country visits, which are carried out at the invitation of national authorities. These visits are designed to specifically discuss and assess the situation in the country regarding prevention and control of AMR through prudent use of antibiotics and infection control. The visits also help document how Member States have approached implementation of the Council Recommendation and deployed national resources in order to support the European Commission in evaluating implementation.

The main output of the visit is a report from ECDC provided to the national authority. To help ECDC ensure the consistency of the visits and follow up on progress, an assessment tool has been developed. The assessment tool includes ten topics which are regarded as the core areas for successful prevention and control of AMR, based on Council Recommendation 2002/77/EC and the Council Conclusions dated 10 June 2008. The assessment tool is used as a guide for discussions during the visit.

Following an invitation by the Spanish Ministry of Health, Social Services and Equality, an ECDC team conducted visits and meetings to discuss AMR issues in Spain with the overall objective of providing an evidence-based assessment of the situation in Spain with regard to prevention and control of AMR through prudent use of antibiotics and infection control.

Conclusions

• According to the data available from the Spanish surveillance systems, the AMR situation in Spain poses a major public health threat to the country. The current levels of meticillin-resistant Staphylococcus aureus (MRSA), extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae and Acinetobacter baumannii are high and are above the EU/EEA average. In addition, the rapid increase in carbapenemaseproducing Enterobacteriaceae (CPE) over the past five years represents a new threat to the safety of patients in Spanish hospitals and other healthcare facilities. This is also a health security issue since CPE are resistant to almost all antibiotic classes, leaving only a few options for the treatment of infected patients.
• Antimicrobial consumption in primary care and hospitals is among the highest in the EU/EEA and during the visit the ECDC team saw evidence that infection prevention and control (hand hygiene, contact precautions, isolation, environmental cleaning) and environmental cleaning measures vary significantly among hospitals and units. This results in suboptimal control of multidrug-resistant organisms (MDROs) which are spread from patient to patient, either directly via the hands of healthcare workers or indirectly via the environment. This situation contributes to the development of outbreaks in hospitals, with a number of unidentified patients carrying MDROs such as CPE that may spread between hospitals and/or between wards within the same hospital.
• Although CPE and AMR in general are perceived as important issues by the health professionals we met, we noted that the high levels of CPE and AMR observed were sometimes accepted, as if they were unavoidable and health professionals felt that they had done everything they could – or everything within their remit and the limit of their resources - to control the spread of CPE. The emergency nature of responding to the threat represented by AMR in general, and CPE in particular, needs to be communicated and understood at all levels in the country, and especially by those working in hospitals and other healthcare facilities.
• Nevertheless, there is commitment and a willingness to discuss AMR issues both at the national level, in the Autonomous Regions that we visited, and among professionals. The fact that there is a broad, comprehensive, structured National Strategic Action Plan, with involvement of all the major actors including six ministries, is also an indication of the commitment to addressing AMR and prudent use of antibiotics in the country.
• There are numerous examples of good practice at regional and local level, and within professional societies. Moreover, the Ministry of Health, Social Services and Equality has been promoting and coordinating prevention and control programmes since 2008. There are also many surveillance and alert systems at national, regional and local level that provide a good picture of antibiotic prescription and generate excellent data to support a response to CPE and other AMR threats. However, it appears that in most cases data produced by these surveillance systems are not used to generate and evaluate targeted action. We also had the impression that there was a lack of clarity as to who was responsible and what needed to be done.
• The Spanish Agency of Medicines and Medical Devices (AEMPS) is in charge of coordinating the implementation of the National Strategic Action Plan and has set up a Technical Committee that involves six ministries. This includes all the Directorates-General of the Ministry of Health, such as the DirectorateGeneral of Public Health and the Directorate-General of Professional Arrangement, as well as many scientific societies and professional organisations working with human and animal health. Moreover, tasks have been distributed to various working groups. However, this may have resulted in a dilution of responsibilities due to the fact that there are so many working groups.
• Spain is divided into 17 Autonomous Regions that are in charge of planning, managing and delivering health services. This is an obvious challenge when attempting to implement the National Strategic Action Plan. Consequently, a Committee of Autonomous Regions, composed of representatives from the different Autonomous Regions, was created to take this into account. This Committee of Autonomous Regions and the Technical Committee represent an opportunity to translate the success of the many initiatives taken at regional and local level, and by professional societies, into successful national initiatives that will ultimately help the National Strategic Action Plan to be realised. The regional implementation of the National Strategic Action Plan offers an opportunity to reduce the heterogeneity in the activities to control AMR developed by the different Autonomous Regions.

Recommendations

Based on these observations, ECDC’s team recommended the following actions:

• For each action in the National Strategic Action Plan, clearly indicate who is coordinating (person/position), which organisation is contributing, which Autonomous Regions are participating (the list of the latter will increase over time), set out clear deliverables and deadlines, and make this information publicly available on a website with regular, periodical updates on progress.
• The implementation of many actions in the National Strategic Action Plan relies on actions being taken by each Autonomous Region (and ultimately at the local level in each hospital, long-term and primary care facility in the country). Pledges of commitment by the political leadership of the Autonomous Regions are needed, with clear objectives, targets, deadlines and resources for implementation.
• The National Strategic Action Plan should include achievable targets for a selected number of outcome indicators that, when achieved, would clearly indicate how implementation of the Plan has an impact on AMR in the whole country.
• The commitment of the Autonomous Regions should extend to sharing tools, software and expertise (including infrastructural support) from successful initiatives with other regions and encouraging a culture of reciprocity of services and expertise between regions. A mechanism and platform (central, public repository) should be created to share examples of good practice, documents and tools that are produced by the Autonomous Regions that would be helpful to other regions. The mechanism/platform should also include initiatives from professional societies.
• A national hand hygiene programme, promoted by the Ministry of Health Social Services and Equality, in coordination with all the Autonomous Regions, started in Spain in 2008. However, its implementation and the level of compliance with hand hygiene practices in healthcare may vary among the Autonomous Regions. It is vital that Spain urgently evaluates the level and quality of the hand hygiene programmes implemented in hospitals and in the Autonomous Regions. This is an important step towards understanding the failures of previous programmes and assuring the sustainability of any future improvement. This will ensure that Spain fully implements the 2008–2009 WHO Guidelines for Hand Hygiene in Healthcare in all settings where healthcare is delivered. These Guidelines include a programme of education on the five moments and proper technique; availability of hand hygiene products at the point of care; a train-thetrainers approach to hand hygiene education and audit; regular compliance audits within all healthcare facilities; reporting and trend analysis of hand hygiene compliance, integral to and embedded within the patient safety culture of all settings where healthcare is delivered and coupled with the support of ongoing, high-profile national and regional information campaigns aimed at healthcare professionals and service users. Hand hygiene campaigns could also target the general public to promote awareness among all citizens (e.g. with messages highlighting the role of hand hygiene in the prevention of respiratory and gastrointestinal tract infections to reduce the need for antibiotics).
• Classify CPE and its control in Spanish healthcare as a public health emergency. For this, there should be an alert system that includes CPE as a communicable disease for which reporting is mandatory (with necessary epidemiological information and molecular typing information from the national reference laboratory). Mandatory reporting should be approved by all Autonomous Regions through the Interregional Council to ensure notification from local to regional level, and then from regional to national level. Health authorities at the national and regional levels and healthcare facility directors should be made accountable for achieving results (i.e. healthcare facility preparedness, implementation of information systems to identify cases – when transferred and on re-admission, reduction in the incidence of new cases, etc.)
• The creation of a national emergency response team of experts could support the Autonomous Regions in tackling emergency AMR situations, making use of field epidemiologists, expertise from the national reference laboratory and infection prevention specialists with competence in MDRO control to implement AMR control plans effectively.
• Incomplete data on human antimicrobial consumption in Spain is a threat to the representativeness of surveillance data and may impact evaluation of the National Strategic Action Plan’s implementation. Spain should acquire sales data on antibiotic consumption to include private prescriptions as well as the percentage of antibiotic sales without a prescription. Similarly, Spain should obtain data on antimicrobial consumption in the hospital sector and report them at EU-level to ESAC-Net. Sales data collected by the AEMPS could be used for this purpose, at national and regional level. In addition:
• The mapping exercise of the National Strategic Action Plan should also define which resources are currently available or would be needed to implement the plan. At national level, there is a need for specific funding at least to start implementing the coordination of the actions. At local level, any savings that could be made from good practice (e.g. from prudent use of antibiotics), could be channelled into the reinforcement of prevention and control activities. • Consider prevention and control of AMR and the prudent use of antibiotics as objectives in the contracts between the Autonomous Regions and hospitals and other healthcare facilities. It could also be considered as a point for accreditation of hospitals.
• Consider the funding necessary to make rapid point-of-care diagnostic tests more available to primary care doctors in order to aid in the prudent prescription of antibiotics at this level.
• Develop national guidelines for the prudent use of antimicrobial agents, including best practices for the diagnosis and identification of clinical situations where antimicrobial agents are not needed.
• Implement training on AMR and prudent use of antibiotics, at both pre-graduate and post-graduate levels, of all healthcare professionals involved in the prescription (doctors), dispensing (pharmacists) and administration (nurses) of antibiotics, as well as the laboratory diagnosis of infections that require antibiotic treatment (microbiologists).
• Given the extent and the scale of the threat posed by AMR in general and CPE in particular, it may be advisable to revisit the scope of practice of preventive medicine specialists in hospitals and scale up the number of these specialists specifically dedicated to infection prevention and control in Spanish healthcare.
• ‘Infectious Diseases’ are not recognised as a medical specialty, meaning that it is not possible to train specialists and this inevitably has an impact on the recruitment of infectious disease physicians in hospitals.
• Finally, to promote transparency towards stakeholders and the general public, the National Strategic Action Plan website (in preparation at the time of the visit) could include information on objectives and results achieved at national and regional level.