The Implementation of Strategies against Antimicrobial Resistance

(1)

The Implementation of Strategies against Antimicrobial Resistance

A Case Study of the Primary Care Sector within three Norwegian Municipalities

Eivind Sten Andreassen

Thesis submitted as a part of the Master of Philosophy Degree in Health Economics, Policy and Management

Faculty of Medicine

Department of Health Management and Health Economics

Supervisor: Frode Veggeland

UNIVERSITY OF OSLO

May 2019

(2)

2019

The Implementation of Strategies against Antimicrobial Resistance: A Case Study of the Primary Care Sector within three Norwegian Municipalities

Eivind Sten Andreassen

http://www.duo.uio.no

Trykk: Reprosentralen, Universitetet i Oslo

(3)

Abstract

The Implementation of Strategies against Antimicrobial Resistance A Case Study of the Primary Care Sector within three Norwegian Municipalities

Antimicrobial resistance is a growing problem globally. In Norway, this issue is being dealt with by the “National strategy against antibiotics resistance 2015-2020” and the follow-up

“Action plan against antibiotics resistance in the health care service”, which aim to reduce the overall use of antibiotics. These contain specific measures that are to be implemented.

Particularly important were the measures directed at the primary care sector. I conducted a case study of the implementation of these strategies within the primary care sector of three municipalities. There were three research questions I wanted to answer: How is the strategies being implemented in the primary care sector? Is there consistency between the National Strategy and municipal implementation? What factors explain the effectiveness of the implementation?

Two qualitative methods were used; document analysis, to provide context and to corroborate evidence, and semi-structured interviews, to understand the implementation process and how it is carried out. A total of nine interviews were conducted, with respondents from three governmental agencies and the selected three municipalities.

The results from the case study show that most of the measures aimed at the primary care sector are being implemented, but to a varying degree. Lack of experience with the strategies and measures was the main obstacle. One project outside of the measures, RASK, proved to be of particular interest and acting as a collaborative force in the implementation process. The strategies have a somewhat limited influence in the daily work of the municipal employees.

Within the municipalities, the implementation process is a form of experimental

implementation. The active roles and duties of the employees and their available resources have a great impact on the effectiveness of the implementation process. The implementation mainly relies on voluntary participation as opposed to mandatory enforcement. Horizontal peer pressure between clinicians is an important factor for making general practitioners participate.

(4)

Acknowledgements

When I started the master course in Health Economics, Policy and Management, I had very little idea what I was throwing myself into. Having just completed a bachelor degree in political science, I wanted to study something that was both practical and important in “real life”. This master course provided me with just what I looked for. With great curiosity, lots of reading and some frustrations along the way, I managed to make my way through and deliver this thesis. The process of completing this master thesis has been a long and arduous one, but it has also been very rewarding. I hope it may provide some interesting findings!

First of all, I would like to thank all the informants who kindly took the time out of their busy schedule to participate in my study. This thesis is all thanks to your contributions.

I must also thank my supervisor Frode Veggeland for providing me with the topic for the master thesis and helping we throughout the writing process. Thank you for all the important inputs and feedback along the way.

I would also like to a give a special thanks to my friend Tor Anders Bye who provided me with the necessary trick on how to handle the stress of writing a master thesis.

Finally, I must give my greatest gratitude to my family, whose never ending support carried me all the way through the master course and especially when writing the master thesis. My deepest gratitude to my parents and little sister, uncle and grandmother, whose love and encouragement kept me going.

(5)

Abbreviations

Antibiotic Centre for Primary Medicine ASP

Antimicrobial resistance AMR

Antimicrobial stewardship AMS

Defined daily dose DDD

Directorate of Health DOH

Institute of Public Health FHI

General practitioner GP

General Practitioner Committee GPC

Knowledge-based update visits KUPP

More correct antibiotic use in the municipalities RAK More correct antibiotic use for nursing homes in RASK the municipalities

Regional Health Authority RHA

(6)

Globally, there is a growing fear for the spread of antimicrobial resistance (AMR). It is the fear for a decreasing effect, or potential nullification, of antibiotics as a tool against diseases now long deemed safely treatable, such as tuberculosis, gonorrhoea and typhoid (Turner, 2014). The World Health Organisation recognises AMR as an “increasingly serious threat to global public health that requires action across all government sectors and society” and that “all countries need national action plans on AMR.” (WHO, 2018).

In order to meet the danger presented by AMR, several ministries on behalf of the Norwegian government, introduced in 2015 the “National strategy against antibiotics resistance 2015- 2020”. The primary goal is to “reduce the overall use of antibiotics and maintain responsible antibiotic utilization in all sectors, increase the knowledge base and be an international driving force to counteract antibiotic resistance” (Departementene, 2015, p. 7). There are also set sector-specific measures to be fulfilled during this period. These sectors include health, farm animals and pets, fishery, and the environment.

The following year, the Ministry of Health and Care Services introduced the “Action plan against antibiotics resistance in the health care service”. Its focus is on the health sector and the plan presents specific measures seen as necessary for fulfilling the goals set by the National Strategy. These measures target the general practitioners (GPs) and emergency doctors, specialist health services, municipal health institutions, dental services, and the general population. There are also measures set for the structure of implementation, strengthening the existing structure of the national and regional level of healthcare. The main goal of the Action plan is to reduce the use of antibiotics in the population by 30 percent by the end of 2020 (Helse- og omsorgsdepartementet, 2016, p. 2-4).

When it comes to the work to prevent increased levels of resistance, Norway is quite ahead of other European countries. A relatively low usage of antimicrobial agents combined with a range of successful antimicrobial policies makes AMR prevalence small, but the danger is nonetheless still present. Of the total sales of antibacterial agents for human use in 2017, around 82% were used in the primary care sector (NORM & NORM-VET, 2017, p. 10). This means that the main arena for reducing the effects of AMR within the human population in Norway is the primary care sector, that is, on the municipal level.

(10)

The objective of this thesis is to study how the National strategy against antibiotics resistance 2015-2020, hereby referred to as the National Strategy, and the Action plan against antibiotics resistance in the health care service, referred to as the Action Plan, are being implemented in the primary care sector. More specifically, I will look into how the implementation takes place, if the interventions are the same as those stated in the National Strategy and the Action Plan, and the effectiveness of this implementation process. Effectiveness here refers to the degree to which the measures are implemented according to plan. My goal is to confirm whether the implementation of these strategies is completed in an efficient and justifiable manner. In practice, this means to study the implementation of the measures contained within the National Strategy and the Action Plan. This will be done by conducting a case study of three Norwegian municipalities, using two qualitative methods to collect data and a theoretical framework for analysis. There are three separate yet connected research questions that I aim to answer:

(1) How is the National Strategy against antimicrobial resistance being implemented in the primary care sector in the municipalities?

(2) To what extent is there consistency between the National Strategy and municipal implementation?

(3) What factors may explain the effectiveness, or lack thereof, of municipal implementation?

Note that in the research questions “National Strategy” collectively refers to both the National Strategy (Departementene, 2015) and the Action Plan (Helse- og omsorgsdepartementet, 2016).

This is done because both strategies are part of the same work against AMR, and to avoid long winded repetitions when referring explicitly to these questions.

(11)

2. BACKGROUND

2.1 Health care in Norway

The Norwegian health care system follows a three level model consisting of different types of services provided at the government, county and municipal level. Specialist care was formerly provided by the counties, but following a major health care reform in 2002 this responsibility was moved over to the newly created Regional Health Authorities (RHAs). The government, through the Ministry of Health and Care Services, controls the four RHAs – Health North, Health Mid-Norway, Health West and Health South-East (Braut, 2018a). The counties still have the responsibility for providing dental service. The municipalities are responsible for delivering primary care services (Braut, 2019). In Norway, primary care (In Norwegian:

primærhelsetjenesten) is a general term for health services that are provided outside of traditional institutions. Primary care is often synonymously used for describing municipal health services (In Norwegian: kommunalhelsetjenesten). This includes preventative and health-promoting work, general practitioners (GPs), physiotherapy, school nursing, home nursing, midwife services, and 24 hour nursing and care services at home (Braut, 2018b). The municipality may provide these services directly or through private actors that have a contract with the municipality (Befring, 2007, p.113).

From a patient’s perspective, the GP will often be their first contact with the health care system and generally the most important. They have the responsibility for delivering necessary general medical services, often cooperating with the other social and care services within the municipality they work in (Helse- og omsorgsdepartementet, 2014). GPs also have the responsibility for prescribing antibiotics, which gives them a key role in regulating the amount and use of antibiotics in the general population. There are several regulations set for reducing the amount of antibiotics used. Among other things, the prescriptions made for antibiotics are only valid for ten days. This is to reduce overuse and misuse, caused by continued use beyond the recommended period of days (Helsedirektoratet, 2016; Helsedirektoratet, 2018a). There is also the option for patients to return their unused antibiotics to their local pharmacy (Legemiddelverket et al., 2017).

(12)

2.2 Measures to combat antimicrobial resistance

The United Nations has urged its member states to accelerate national response plans against AMR (Dall, 2019). They should increase collaboration with nongovernmental groups and organisations and encourage the development of new antibiotics. Emphasis should be on a One Health approach that includes the different sectors of society (ibid.). This international effort has resulted in a set of specific measures aimed at different levels. These are summarised up by Uchil et al. (2014):

• International level: Increased collaboration between sectors, surveillance, control for counterfeit antibiotics, research and development, creating and reinforcing programs to contain AMR.

• National level: Establish national committee to monitor AMR and provide intersectoral co-ordination and guidance, create national policies and strategies against AMR.

• Community level: Rational use of antibiotics, regulate over-the-counter antibiotics, guidelines, standards for hygiene.

• Hospital level/health care setting: infection prevention and control, hygiene practices, effective diagnosis and treatment, surveillance of resistance and use, improve quality and the supply chain, good microbiology practices.

• Personal/patient level: identifying and notifying about cases of resistance, educating personnel about AMR, addressing concerns regarding use of antibiotics, complying with antimicrobial policies and guidelines.

• Other measures outside of the health care sector: pharmaceutical promotion, reduce antibiotic use in animals, understand the mechanisms of AMR, innovate in new drugs and technology.

In the case of Norway, the work against AMR resulted in the National Strategy (Departementene, 2015) and the Action Plan (Helse- og omsorgsdepartementet, 2016). These are both crucial as many of the measures they present are either similar or identical to those listed above. The National Strategy presents a set of specific goals aimed at different sectors;

health care, farm animals and pets, fishery, and climate and environment. For health care, one of the main goals is to reduce antibiotic use by 30 percent measured in DDD/1000 inhabitants/day as compared to 2012 (Departementene, 2015, p. 8). It is from this goal the Action Plan has its basis and from which it presents the measures that are to be implemented.

Therefore, it is the central source of measures aimed at the health care sector, but the National

(13)

Strategy is still very relevant as it also lists several conceivable measures, many of which were included in the Action Plan.

In the National Strategy there are a total of 37 suggested policies and measures (Departementene, 2015, pp. 9-18). These are separated into several categories of tasks;

strengthen the knowledge base, increase the level of knowledge and competence in the use of antibiotics in the population and in prescribers, optimize prescription practices in all sectors, better infection control, strengthen normative, international cooperation, contribute internationally to the development of vaccines, new antibiotics and diagnostic aids, and follow- up and organization of the work on the strategy. Of the 37 listed measures, five stand out as specifically relevant regarding the primary care sector:

• Ensure that the population is informed about sensible antibiotic use

• Conduct county-wide infectious disease conferences for municipal physicians and other health personnel in the municipal health and care service, with particular emphasis on the implementation of professional guidelines for prescribing antibiotics

• Supervise the employer’s responsibility for informing about professional guidelines for prescribing antibiotics

• Introduce a requirement for diagnosis code on all antibiotic prescriptions for humans

• Investigate the establishment of a system for feedback to general practitioners and animal health personnel on the use of antibiotics in their own practice, including the offer for peer review of antibiotic prescription

(ibid., p. 11-14).

There are some important factors which explain why specifically these measures are of interest.

Firstly, the people who are able to prescribe antibiotics also have the responsibility of deciding if and when usage may not be necessary, as well as always informing when they are being used.

County-wide conferences for this personnel with focus on professional guidelines, together with having a system for feedback on their own use of antibiotics in practice and the amount prescribed, could lessen the danger of overprescribing and help decrease use over time.

Secondly, there is a constant danger of antibiotic resistance spreading to specialist and GP services, the consequences of which would be massive. There should therefore be a particular focus on infection control within municipalities, which would require supervision follow-up of professional guidelines, especially from the municipal chief physicians and infection control

(14)

doctors. Thirdly, the introduction of diagnosis codes will help facilitate better feedback for prescribers and increase their understanding and knowledge. GPs especially would be able to use this knowledge as a basis for internal control and quality improvements. Finally, there is also the question of whether measures such as these are considered to be mandatory or voluntary, and if so, to what degree. Here, the central actors conducting the implementation in practice will be of especial importance.

Following up, the Action Plan presents a total of 20 concrete measures, separated into six measurement areas: the national organisation of the work to be done, the general population, general practitioners and emergency doctors, specialist health service, municipal health institutions, and dental health services (Helse- og omsorgsdepartementet, 2016, p. 4). Only the measures aimed at GPs and emergency doctors and municipal health institutions are of interest, since these are focused on the primary care sector. However, we should mention the National steering committee. As one of the measures listed, this committee consists of the Directorate of Health, the National Institute of Public Health, the Norwegian Medicines Agency and the Directorate for e-health. Their main goal is to ensure that the measures set by the Action Plan are implemented, hence they are the managers and supervisors – the actors in charge of the implementation process from the top-down (ibid., p. 5).

There are four measures aimed at GPs and emergency doctors:

• Continue, and up-scale, knowledge-based update visits (In Norwegian:

Kunnskapsbaserte oppdateringsvisitter, KUPP) as a project when the current piloting period is over.

• Conduct review of GPs own antibiotic prescription at group level, where o (a) as many GPs as possible must be given the opportunity to participate o (b) most of the prescribers must wish to make use of the offer, and

o (c) there must be developed a way to deliver summaries of each individual physician’s prescriptions of antibiotics.

• Introduce electronic decision support, such as Electronic Patient Records (EPRs).

• Ensure a rapid introduction of diagnostic codes for all antibiotic prescriptions.

(ibid., pp. 11-12).

The first measure, KUPP, is considered to be established as a permanent, nation service for all GPs, based on their feedback and wishes and following (Dyrkorn & Langaas, 2015, p. 41).

(15)

Colleague-based discussion groups are based of colleague-based therapy guidance (In Norwegian: Kollegabasert terapiveiledning, KTV), a method developed by the University of Oslo. It is a program with great potential effect on GPs and emergency doctors (Helse- og omsorgsdepartementet, 2016, pp. 11-12). By having the people responsible for prescribing antibiotics discuss their own habits, there is the opportunity for having a significant effect in decreasing the overall number of prescriptions. This will in turn help decrease the total use of antibiotics in the human population. The third and fourth measures, although somewhat different, will have to be completed in the same manner. By developing and implementing EPRs, many of the potential problems with securing diagnosis codes for antibiotic prescriptions can be avoided. It could potentially even have a greater effect on the total use of antibiotics (ibid.). Regardless, both measures will cover the digital aspect of reducing use and help lessen the spread of AMR.

There are also four measures aimed at municipal health institutions:

• Better monitoring of antibiotic use in nursing homes.

• Assistance on the use of antibiotics from the regional competence centres for infection control to the regional nursing homes.

• Knowledge-based update visits for doctors in municipal health institutions (KUPP in nursing homes).

• Follow-up educational groups for doctors in municipal health institutions (ibid., pp. 17-18).

Most of these measures are quite self-explanatory, with the first and fourth measures being almost identical to those listed by Uchil et al. KUPP is the same as explained earlier, only here focusing on GPs in nursing homes. In the second measure, the RHAs are set to help the municipal institutions in their respective region with general infection control work, such as consultation, surveillance, skill development for personnel and clearing outbreaks of diseases.

This work is to be done through the regional competence centres (ibid., p. 17).

Overall, the measures I have selected here from the National Strategy and the Action Plan stand out as the most significant in regards to implementation within the primary care sector. Together with these measures there are also projects that are aimed at the primary care sector and which focus on the use of antibiotics. There are two currently on-going interventions that are of great

(16)

interest; “More correct antibiotic use in the municipalities” (RAK) and “More correct antibiotic use for nursing homes in the municipalities” (RASK).

RAK is a free clinical course aimed towards general practitioners and emergency doctors, where they will receive updated clinical knowledge, better overview of their own antibiotic prescriptions and increase the quality in their own practice. This intervention is led by the Antibiotic Centre for Primary Medicine (ASP) and works in conjunction with the Action Plan of 2016, where ASP has a key role in achieving the goal of reducing the percentage of antibiotic prescriptions (Antibiotikasenteret for primærmedisin, 2019a). The intervention works on a county basis where, as of 2019, all but five counties have participated or are currently participating (ibid.).

RASK started as a pilot project in Østfold county in December 2016. 40 out of the 42 total municipal institutions are currently participating or have participated, laying the groundwork for deployment of the intervention in other counties. This intervention is under the cooperative leadership of ASP and the Institute of Public Health (FHI) together with several other clinical institutions (Antibiotikasenteret for primærmedisin, 2019b). RASK consist of gathering as many municipal institutions as possible in each county into a start-up conference. The aim is to review current antibiotic guidelines for nursing homes and municipal emergency units in order to discuss correct diagnostics and the prevention of infections. Before this meeting, each nursing home receive the statistics of their own antibiotics consumptions, which they will then have to reflect on and discuss during the meeting. Subsequently, they will be asked to conduct suitable teaching programs, prepared by ASP, on their own employees (ibid.). It is both helpful and necessary to include RAK and RASK in this thesis, as they are both manifestations of, and part of, the implementation of the Action Plan and, subsequently, the National Strategy.

The reasons for choosing out these specific measures and projects is to have a clear basis and view of what is to be implemented in the primary care sector. The degree to which these are realised in practice could indicate how well the implementation process is proceeding. Having a select few measure also allows for me to more easily conduct my study and to analyse the findings. Focusing on only a few measures from both the National Strategy and the Action Plan could limit the results I acquire. However, since this thesis is a small case study, this limitation should not be a problem. The results from the study will still be valid.

(17)

3. THEORY

The three research questions I seek to answer focus on different parts of the implementation process; question (1) focuses on the tools, methods and structure, question (2) looks for differences between the measures set by the National Strategy and the Action Plan and the actual measures being implemented, while question (3) seeks after any potential factors which may help determine how effective the implementation is. Because of these differences, I find it both useful and necessary to apply several schools of theory when answering the questions.

As such, I will use a theoretical framework built on different, individual theories from the schools of implementation science, policy implementation theory and management theory.

The first two schools share the same goal; to implement a specific object or strategy, often called an intervention. The object they are implementing however is not necessarily the same.

In implementation science, the intervention(s) are specific clinical practices, while in policy implementation theory it is specific policies (Nilsen et al., 2013, p. 5). For this case study however this distinction is not as important. The measures (policies) set by the National Strategy and the Action Plan will directly involve changing current clinical practices. Thus, the policies, to some degree, are the clinical practices. It is therefore possible and desirable to use both schools of theory. Management theory is included for its explanatory power regarding the interactive relationship between the different levels of government involved in the implementation process, such as ASP–county or municipality–GP. This is especially crucial for this thesis, as an important aspect of implementation in practice is the level of awareness regarding AMR as a relevant danger among GPs and other primary care staff (see Vazquez- Lago et al. (2012) and Björkman et al. (2013) for examples). If municipal health care workers do not consider AMR to be a significant threat, it is very unlikely that they will focus on implementing the measures set by the National Strategy and especially the Action Plan. Before presenting the theoretical framework however, I will first give a clear definition of what is meant by “implementation” in the context of health care.

3.1 Implementation – the concept

In general terms, implementation can be described as “the process of putting to use or integrating new practices within a setting” (Nilsen, 2015, p. 2), the setting in this case being the primary care sector. To describe it in more practical terms, there are three overarching aims or tasks that must be fulfilled during and after the implementation process: guiding the

(18)

process of translating research into action, explaining what factors are influencing the

outcome of the implementation, and evaluating the implementation as a whole (ibid.). Further on, if we combine the definition above with these aims and place it in a health care context, we can define implementation science as “the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services and care.”

(ibid.; Eccles & Mittman, 2006, p. 1). Such a definition is necessary because the process of implementing the National Strategy and the Action Plan in the primary care sector is more than simply pushing through a policy. It is a long-drawn process that affects not only parts of but the sector as a whole.

An important aspect of implementation is the tools that are being used. Howlett, Ramesh &

Perl (2009) describe four categories of instruments or tools; Nodality, authority, treasure and organisation (NATO) (p. 116). Nodality are information-based instruments, such as

information campaigns and performance indicators. Authority-instruments are regulatory instruments. Treasure are economic-based instruments, such as grants, taxes and loans.

Organisation-based instruments includes enterprises, partnerships, markets and so on. (ibid., pp. 117-135). These tools fall on a spectrum from voluntary–mixed–compulsory, reflecting how the implementation process takes place (ibid., p. 170). These four tool-types also depend on the organisational capacity – knowledge, enforcement, money and administration – and the target beliefs – credibility, legitimacy, cupidity and trust. These will affect the NATO tools and their available resources (Howlett, 2011, pp. 54-55). This presents a dichotomous

relationship between “soft” and “hard” implementation. What type of tool is used and to what degree will have a great effect on the implementation.

3.2 An implementation framework

In order to answer the research questions, I use a number of different theories which will help to analyse the diverse aspects of the implementation process. First and foremost, when planning to implement the specific measures set by the National Strategy and Action Plan, there will be made use of several programs and interventions in order to influence the use of antibiotics.

These are called antimicrobial stewardship (AMS) programs. MacDougall & Pork (2005) detail the specific strategies that exist in AMS, including the procedure, what personnel are involved, and the potential advantages and disadvantages. These strategies are education/guidelines,

(19)

formulary/restriction, review and feedback, computer assistance, and antimicrobial cycling (, MacDougall & Pork, 2005, p. 640). The implementation of the National Strategy and the Action Plan can be described as an AMS program, meaning that these strategies are applicable for this specific case study, but to different degrees.

First, educating health care personnel and creating guidelines are an essential task for reducing the use of antibiotics, which is also included as a measure in the Action Plan. Second, formulary and restriction strategies aims at restricting the dispensing of specific antimicrobials intended for specific purposes or groups (ibid.). This strategy is not very suitable based on the measures set by either the National Strategy or Action Plan and can therefore be ignored. Third, review and feedback strategies, in comparison, is highly relevant. One of the specific measures listed, colleague-based discussion groups, is based entirely on this strategy. These discussion groups are a form of self-directed feedback, compared to for example a nursing home receiving feedback from the municipal health administration. Fourth, computer-based assistance allows for a system of “order-entry”, where the GP can receive recommendation for the patient in question. Information technology can also help to implement previous strategies (ibid., p. 640, 649-650). Several of the measures listed in the Action Plan can only be implemented in conjunction with other e-health programs, such as EPRs and diagnosis codes for antibiotic prescriptions. This strategy is therefore of some relevance. Fifth, antimicrobial cycling, or the scheduled rotations of types of antimicrobials being used, is the strategy least relevant for the National Strategy and the Action Plan. It can also be ignored. The three AMS strategies that have been deemed applicable are used as categories, to illustrate what “types” of measures are being implemented. This helps me give a clearer overview when presenting the results.

Regarding the actual implementation, we should have a focus on the context, process and outcome of the implementation. Fevzi Okumus identified a total of eleven key implementation factors. These were then classified into four categories: strategic content, strategic context, operational process and outcome (2003, pp. 874-875). Strategic content describes the development of a strategy and the how and why it is being initiated. Since I am not focusing on the creation of these strategies but their implementation, this category is irrelevant. The remaining categories however are very relevant. The strategic context, which can be split into external and internal context, includes factors such as environmental uncertainty, organisational structure, organisational culture and leadership (ibid., pp. 876-877). The operational process includes factors such as operational planning, resource allocation, people, communication and

(20)

control (ibid.). Finally there is the outcome, which are the intended and unintended results from the implementation process. This is especially important, as it considers whether the strategy was implemented according to plan, if the objective was achieved and if the outcome is satisfactory (ibid.). These three implementation factors are very useful when describing the implementation process and will be helpful for answering the research questions.

Another aspect of the implementation process to consider is what direction the implementation takes place; from the top-down or the bottom-up. These two types present very different perspectives which may have an effect on the implementation. The former sees implementation as a purely administrative process while the latter understands implementation, not as much as the introduction of policy, but as interaction between agents in a specific sector (Nilsen et al., 2013, pp. 2-3). Those subscribed to the bottom-up mindset see top-down as rigid and analytical, not taking context into the picture. Meanwhile, top-down supporters see bottom-up as loose and overemphasised on the autonomous staff rather than the process itself (ibid.). A major shortcoming of both perspectives is the assumption that the decision-makers, in this case the Norwegian government, give clear goals and directions to the agents, such as the Directorate of Health (DOH) and the municipalities. The reality is that between the initiation and the implementation of the interventions, the goals and direction may become distorted, vague or possibly even contradictory (Howlett, Ramesh & Perl, 2009, pp. 164-165 Both the top-down and bottom-up perspectives on implementation are of relevance, as the measures aimed at the primary care sector tackle both the clinical and the managerial roles regarding the use of antibiotics.

The last theoretical concept included in my framework comes from Kieran Walshe (2016). He presents three types of evidence which are meant to be used in decision-making, but are still very relevant and are highly applicable for this study. The first type, theoretical evidence, consists of “ideas, concepts and models used to describe the intervention, and to explain how and why it works and to connect it to a wider knowledge base and framework” (Walshe, 2016, p. 23). This would include how the National Strategy and the Action Plan fit into the overall work to combat AMR. An absence of this type of evidence could lead to a lacking understanding of how or why an intervention worked or not. The second type, empirical evidence, includes any information about the “actual use of the intervention and about its effectiveness and outcomes in use” (ibid.). This is the most important type of evidence. In order to know if the intervention works or not we must understand how it plays out in practice, to see

(21)

if it has any effect. The final type, experiential evidence, is information about how people experience “the service or intervention, and the interaction between the two” (ibid.). In practice, this means how the primary care personnel on the one hand and their patients on the other react to the measures being implemented. This is also highly important because, if for example GPs react very strongly to a specific measure or policy, their clinical practice can be affected as well.

Table 1: An implementation framework

Stages Concept Theory

Measures Education/guidelines, review and feedback, computer assistance

Measures

RAK

RASK

(MacDougall & Pork, 2005)

(Departementene, 2015;

Helse- og

omsorgsdepartementet, 2016)

(Antibiotikasenteret for primærmedisin, 2019a) (Antibiotikasenteret for primærmedisin, 2019b) Implementation Strategic context,

operational process, outcome

Top-down, bottom-up

(Okumus, 2003)

(Nilsen et al., 2013; Howlett, Ramesh & Perl, 2009) Evidence Theoretical, empirical,

experiential

(Walshe, 2016)

In my theoretical framework, I have created three stages. Each of these represent a specific part of the implementation process. The first stage is the measures, which includes the specific measures selected from the National Strategy and the Action Plan, plus RAK and RASK. These measures fall within the three AMS strategies, which are used to describe what type of intervention is implemented. The second stage is implementation, which focuses on the actual

(22)

process itself. This means the context, operation and outcome, in addition to the perspectives of the implementation process. The last stage, evidence, is meant to corroborate the findings from the previous two stages. Using the explanatory power of the three different types of evidence, I can analyse the implementation process as a whole; how and why the intervention works (or doesn’t), if the intervention works, and how it affects the humans involved in the process.

These stages will be used for different purposes during the study. The first stage will be used to present how the measures in the National Strategy and the Action Plan, together with RAK and RASK, were discussed during the interviews. They will be presented using quotations from the interviewees. This is to allow for further discussion about their implementation in an orderly and clear manner. The second stage is used for similar purposes. Here, the actual implementation process, specifically how the interviewees interpret it, is of importance.

Quotations will be used to describe the process. The third stage uses the three types of evidence to present important findings by separating them by the three types of evidence. These will be used to analyse the implementation process as a whole.

(23)

4. METHODOLOGY

I used the qualitative method to study the implementation of the National Strategy and the Action Plan. This method was chosen due to its open nature and the fact that it is well suited for describing phenomena in context and can provide interpretations that lead to greater understanding (Justensen & May-Meyer, 2012, p. 16). In this case, the phenomena was the process of implementing the National Strategy within the primary care sector. As explained in chapter 2.1, primary care in Norway is provided by the municipalities. Hence, we must study the municipalities to gain the necessary knowledge about the implementation process on the local level. I therefore chose to make this thesis a case study about the implementation of the National Strategy within a small set of municipalities in Norway.

4.1 Case study

For this case study I chose four, technically three, municipalities in Østfold county; Moss, Rygge, Sarpsborg and Halden. I state that these are technically three municipalities in total because Moss and Rygge municipality are currently in the process of merging into one municipality. This process is to be completed by 1.1.2020 (Forskrift om sammenslåing av Moss kommune og Rygge kommune til Moss kommune, 2017, § 1). These municipalities have a long common history and are geographical neighbours. I have therefore chosen to count them as one.

I considered anonymising the municipalities, but found that it would not be necessary. The people interviewed within these municipalities were already sufficiently anonymised.

These municipalities were chosen for their similarities; they are all part of Østfold county and are geographically close to each other and have high numbers of prescriptions for, and high use of, antibiotics. Østfold is the county with the highest number of sales of antibiotics, measured by DDD/1000 inhabitants/day, and this trend has been stable over time (NORM & NORMVET, 2017, pp. 32-33). The national average for delivery of antibiotic prescriptions is 379 per 1000 inhabitants. For Østfold county it is 434 per 1000 inhabitants, the highest in the country, and for each of the chosen municipalities – Moss, Rygge, Sarpsborg and Halden – it is 405, 395, 437 and 420 per 1000 inhabitants, respectively (Folkehelseinstituttet, 2017a;

Folkehelseinstituttet, 2017b; Folkehelseinstituttet, 2017c; Folkehelseinstituttet, 2017d).

Selecting municipalities that have a high number of prescription is the most fitting as the potential for reduction in the sale and use of antibiotics is not only great, but it may also give good indicators for the overall national use.

(24)

In order to maintain a clear and all-encompassing viewpoint of the implementation of the National Strategy and the Action Plan, the case study includes individuals that have different but important roles. This means individuals from governmental agencies at the central state level and individuals on the local, municipal level. More specifically; from the municipalities, I have included employees in the municipal health institutions, such as chief physicians, and primary care workers, including general practitioners. From the state level, I included employees in governmental agencies that are involved in the implementation process. More specifically, the Directorate of Health and the Institute of Public Health, whom are both part of the National steering committee, as well as the Antibiotic Centre for Primary Medicine.

Case studies are defined by three conditions: the research question, or questions, aim to answer

“how?” and “why?” in an explanatory fashion, the behaviour of events or individuals cannot be controlled, and it focuses on contemporary events (Yin, 2009, pp. 8-9). An additional factor is that there exists no clear border between the phenomena and its context, requiring an investigation that goes in-depth into the context of the subject matter and relies on multiple sources of evidence (ibid., p. 18). This last point is especially crucial as multiple sources may require multiple methods for gathering the evidence. It is for this reason that I decided to use two methods for data gathering; document analysis and semi-structured interviews.

4.2 Document analysis

When conducting my analysis, I used several different types of documents, which I have separated into three categories. The first category includes governmental publications such as the National Strategy and the Action Plan, which are vital for this topic. Both are publicly available and can be found on the official webpage for the Norwegian government, Regjeringen.no.

The second category includes laws and regulations for the health care system, especially the primary care sector. These were found using Lovdata.no, a public benefit foundation which offers a free information system and an overview over Norwegian laws. Searching with keywords such as “helse” (health), “kommune” (municipality), “smittevern” (infection control) and “fastlege” (GP), I found many relevant laws and regulations; Forskrift om fastlegeordning i kommune (Regulations on general practice in municipalities), Helse- og omsorgstjenesteloven

(25)

(Health and Care Services Act), Helseforetaksloven (Health Trust Act), Smittevernloven (Infection Control Act), and so on. Anne Befring’s book Jus i helse- og sosialtjenesten (2007) also provides a great deal of information and explanation on the different health care laws and regulations. These documents provide detailed descriptions of the Norwegian health care system, the different levels and institutions and their designated responsibilities and work duties.

The third category consists of statistics, data, guidelines and other documents relating to antibiotics, implementation and clinical practice. This category is the widest and the documents were gathered from several different sources. The Norwegian monitoring system for antibiotic resistance in microbes (NORM), the Norwegian Veterinary Institute and FHI jointly publishes a yearly, public report on the use of antimicrobial agents and occurrence of AMR in Norway.

The latest report, NORM & NORM-VET (2017) is an important source of statistics that was used to gain both contextual information and detailed data about the difference in use of antibiotics across Norway. On FHI’s webpage, FHI.no, I found their report “Antibiotic resistance in Norway” (2014), which is highly informative and relevant. FHI also publishes a yearly “public health profile” with statistics for all municipalities. In 2017 the theme for the profile was “Antibiotic resistant bacteria – a challenge for public health”. These profiles gave me access to statistics for the selected municipalities (Folkehelseinstituttet, 2017a;

Folkehelseinstituttet, 2017b; Folkehelseinstituttet, 2017c; Folkehelseinstituttet, 2017d). Google Scholar is a simple yet effective search engine which provided many relevant documents.

PubMed.gov and Web of Science were also used for the same purpose. Searching with keywords such as “AMR”, “national strategy”, “policy”, “implementation” and “primary care”, I gained access to many documents, several of which were included in my theoretical framework. On the webpage antibiotikaiallmennpraksis.no, I found the guidelines for use of antibiotics in the primary care sector (Antibiotikasenteret for primærmedisin, 2019c). It lists the different types of infections and their affiliated diseases, notes their characteristics, and states which antibiotics should be the first choice and the amount. It helps to give me insight to the clinical practice of GPs.

During my search of the relevant literature I found several articles describing the process of implementing an intervention. Carlfjord et al. (2010) and Carlfjord et al. (2012) both focus on implementation in the primary care sector in Sweden. The former is a qualitative case study based on implementation theory while the latter applies the Reach Effectiveness Adoption

(26)

Implementation Maintenance (RE-AIM) framework to evaluate two implementation strategies.

Egholm et al. (2018) discusses the implementation of guidelines in hospitals and municipalities in Denmark. The article was a great inspiration on the structure this thesis. Huttner, Harbarth

& Nathwani (2014) present several success stories of antimicrobial stewardship programs in different countries, including Sweden. These four articles are all of interest because the Nordic countries (Norway, Sweden, Denmark and Finland) are all very similar. They are proactive in the work against AMR and are generally very good regarding their use of antibiotics. Another article that was of significance was Fixsen et al. (2005), which provides a synthesis of the literature on implementation research, describing the components of implementation among other things. Outside of these articles it was hard to find documents and articles that provided facts and explanations pertaining to the process of implementing interventions, especially within the primary care sector.

The main purpose of analysing and using these documents is to gain a firm understanding of the strategies and the context of their implementation. The text data gained from these document allows for the tracking of changes and development over time, and can be used to verify or corroborate the gathered evidence (Bowen, 2009, pp. 29-30). These documents were also useful for helping to bring up potential topics and questions that could be asked about during the interviews.

4.3 Semi-structured interviews

I chose to use semi-structured interviews as my main source of data and evidence gathering.

This is because this method allows for the interviewer to ask a premade set of questions about a specific topic while also allowing for some deviations and backtracking, as well as allowing the interviewee to bring up unexpected but relevant topics and information. The interviewer is in charge, but the interviewee isn’t bound to simply answer yes-or-no questions (Justesen &

Mik-Meyer, 2012, pp. 53-54). The interview guide I used (see Appendix 2) has three parts;

introductory questions, reflection questions and ending questions (Tjora, 2012, pp. 145-147).

The introductory questions helped to get the interview started. The main point was to get the interviewee talking. This usually meant asking the interviewee about their work duties. This then led to the reflection questions, which focused on specific topics such as the measures.

These question were somewhat altered depending on the person in question. The GPs and the

(27)

nurse were asked about their clinical practice with antibiotics, followed up by the question of how the National Strategy/Action Plan affected this. For the employees working in the governmental agencies, including the chief physicians, the questions involved their work with the National Strategy/Action Plan and how they worked to implement the measures. I also asked whether there were any potential obstacles or problems they faced when conducting this work.

Their position and work practice (municipality versus agency) greatly affected the answers received. By having different questions for the two groups and allowing the conversation to slightly fluctuate, important details or context which would usually have remained hidden was brought up and discussed. This was the greatest strength of using the semi-structured interview method. When all the relevant questions had been asked and the conversation was beginning to slow down, I asked the interviewee for any additional thoughts or ideas that had not already been brought up. If there were none, the interview ended there. In the cases they did have more to say, the interview continued for a few more minutes. A lot of additional information was found here, bringing up new topics, substantiating previous ones, and overall bringing a clearer picture of the entire interview. These interviews were then finally concluded.

Figure 1: Interview process

The interviewing period spanned from the end of February to the middle of April 2019. All the interviews were audio recorded, with the interviewees consent, and then transcribed afterwards.

During the transcribing, all persons were anonymised so as to not be identifiable later. All interviews were also translated from Norwegian into English. The maximum time set for every interview was 45 minutes, in order to not affect the respondent’s work schedule too severely.

All interviews took place during normal work hours. For some interviewees this did have an effect, leading to a time constraint on their part. For most of them however there was no problem. The interviews all took place at the interviewee’s workplace, meaning the interviews

(28)

took place in Sarpsborg, Halden and Moss/Rygge municipality plus Oslo municipality. This was to allow for a calm and familiar environment and to make sure there would be no disturbances during the interview (Tjora, 2012, pp. 121-122). The time length of the interviews varied from 8 minutes 15 seconds at the shortest to 31 minutes 6 seconds at the longest, with the average time being 18 minutes 34 seconds.

During the study, I interviewed a total of nine people. I managed to interview one employee from each of the governmental agencies, that is, the DOH, FHI and ASP. From the three municipalities I managed to interview a total of six people. This includes two GPs, two municipal chief physicians, one infection control physician and one nurse. I will not specify from which municipality these interviewees come from, in order to maintaining their anonymity. Sufficed to say, the evidence that was gathered from these six people are highly applicable for all three municipalities. As such, maintaining their anonymity does not directly affect the results.

Table 2: Interviewees

Municipalities Governmental agencies

2 GP

2 municipal chief physicians 1 infection control physician 1 nurse

DOH FHI ASP

Total: 6 Total: 3

4.4 Limitations

The main method of data collection during the study was semi-structured interviews, which proved to be fruitful in many ways. The main drawback was not being able to acquire enough people to give a clearer representation of the situation. I planned to interview at least 1-2 GPs and 1-2 chief physicians in all three municipalities. This would have provided further information and helped to better answer the three research question. This did not happen due to time constraints. I had originally also planned to include Fredrikstad municipality in the case study, but was refused permission to conduct my study there. Fredrikstad is a much larger city than the other three, meaning the results from a study which included the municipality could have been representative for a much larger population.

(29)

Several of the interviewees in the municipalities had little experience with the measures and the implementation process, meaning that the gathered results were limited in their

explanatory power. For further studies on the topic, I would recommend conducting a larger study with many more informants. Interviews as a method was useful but was perhaps not used to its full capability. More interviewees from more sections of the health care system could have greatly benefit this study. Document analysis was used to give background data and context for the particular strategies and measurements. However, the method can be used to a greater degree and I recommend doing so. If document analysis and interviews are used in conjunction and to a similar degree, the findings can be triangulated, giving greater validity to the final results of the study.

(30)

5. RESULTS

Of the ten total measures I deemed relevant, excluding duplicates, six of them were brought up during the interviews. These were:

• Ensure that the population is informed about sensible antibiotic use

• Supervise employer’s responsibility for informing about guidelines for prescribing antibiotics

• Better monitoring of antibiotic use in nursing homes

• Colleague-based discussion group of own antibiotic prescriptions

• Diagnostic codes for all antibiotic prescriptions.

• Knowledge-based update visits for doctors in municipal health institutions (KUPP in nursing homes)

In conjunction with these measures, the RAK and RASK programs were found to be very relevant as well. Interviewees in both the municipalities and the governmental agencies pointed to these programs, RASK especially, as important measures for reducing the use of antibiotics and halting the development of AMR. The findings from the interviews are presented by the three stages in the theoretical framework: measures, implementation and evidence.

Table 3: Topics discussed during interviews

Municipalities Governmental agencies

General physicians:

- AMR in daily work

- Cooperation with municipality and chief physician

- RASK - Strategies

- Guidelines

- Electronic assistance - Support from FHI - GPC

- Attitudes towards use of antibiotics

ASP:

- Daily work/tasks

- Information work (population) - Educating health personnel - Research AMR

- Guidelines - National Strategy

- RAK - RASK

- Colleague-based discussion groups - Cooperation with municipalities

- Problems/obstacles

- Project participation - Statistics

(31)

Nurse:

- Use of antibiotics - RASK

- Insidens (new project)

FHI:

- Daily work/tasks - Surveillance - Counselling

- National/international cooperation - Antibiotic committee

- Action Plan

- AMR – 3 solutions

- Correct antibiotic use - Infection control

- Develop new antibiotics Chief physicians:

- Daily work/tasks - RASK

- Guidelines - Cooperation

- FHI - ASP

- Problems/obstacles

DOH:

- Action Plan

- National steering group - Cooperation with ASP - AMR internationally - RASK

- Implementation process

Infection control physician:

- Daily work/tasks

- Everyday infection control - Contagion tracking

- Routines - Guidelines

- Cooperation between Moss and Rygge municipality

- Strategies

- Vaccination - GPC

- Quota immigrants (Danger of spreading diseases in public places)

(32)

5.1 Measures

The national guidelines for use of antibiotics in primary care is provided by ASP (Antibiotikasenteret for primærmedisin, 2019c). The purpose is to provide GPs and other health care personnel with clinical assistance when needed and to help reduce the unnecessary use of antibiotics. In conjunction with this, there is the Regulations on general practice in municipalities, which states that the municipality is responsible for providing its citizens with the necessary general health services and provide access to GPs by means of a Regular General Practitioner (RGP) scheme (Forskrift om fastlegeordning i kommunene, 2013). If the GPs in question are not directly employed by the municipality but work as an independent contractor, it can cause some headache for the municipality:

Chief physician: Our responsibility is for the municipality to have a RGP scheme, and responsibility is also that ... one should have quality work in the GP's offices.

And it is a little strange provision in the Regulation on general practice, where the municipality is responsible for quality work at the GPs office, even though the GPs are not employed by us. They are self-employed. But we now have responsibility for their, for quality in the RGP. […] it is mostly the GP’s responsibility to keep up-to- date on all guidelines, and it is again not up to the municipality to make sure that they stay within the guidelines and that they are professionally responsible, that is up to the county governor. That’s why it is perhaps a little confusing that we are responsible for their quality work, and what it really means is not really good to say, but antibiotics resistance, it falls under quality work as I see it.

In most cases however, there is little trouble with GPs not having access to information. Even if the municipality cannot force GPs to apply the guidelines, they are more than likely to make use of it themselves. Information is abundant and easily available, particularly online:

GP: […] We’ve got lots of information about whether we should give antibiotics, on the right indication and the right antibiotics, right? So we have guidelines to follow on to things, right? We would like to use plain penicillin if we have to give something, and so on. […] but I use for example, NEL, the Norwegian Electronic Medical Handbook. And if I’m, if in doubt about which antibiotic to use in a particular situation, I follow their recommendations.

(33)

The guidelines are also useful for the municipal health administration, for example with handling infection control:

Infection control physician: […] there are also some so-called guides that come from the Institute of Public Health which are based on the legislation and regulations that are set. In practice, I will as one of several hundred infection control physicians, we sit and look at these guides from the Institute of Public Health and there we somehow have a recipe for how to go about if something turns up, and then a recipe for what we should do to recognise things that may appear.

And then you make procedures and plans to make sure you stay within what the state requires the municipality to have tabs on. To stay within what is determined.

Sometimes the guidelines themselves may prove to not be enough. The GPs and municipalities are therefore also able to receive counselling from FHI if needed:

FHI: We have a lot of counselling and stuff with the municipal health services, such that we sit daily with inquiries from municipal doctors and from doctors in nursing homes and so on, who ask for advice and about handling patients with resistant microbes […] and there it is often a lot of counselling and assistance with certain cases which they are supposed to handle. And there are we, who sit on the professional, national recommendations such as the MRSA guide, the guide for VRE … and so on. And all outbreaks must be notified [to us] … so when you have an outbreak with resistant microbes in the municipal health service that is something we also are usually involved in, with advice on handling [it].

The greater issue that GPs (and emergency doctors) have to handle however, is patient attitudes towards the use of antibiotics. Some patients are very adamant about receiving antibiotics when they request it, even if the GP disagrees. There are particular groups or types of patients that have the tendency to perpetrate this issue, such as immigrants:

GP: […] I’m think especially of those, some immigrants are used to getting penicillin for everything. And we don’t. No, you just have a cold. It’s a virus. You can come back later and if you get a fever that increases again and doesn’t go down with penicillin, then with, with paracetamol right? Then we can look at you once

(34)

more. (gasps and imitates a worried patient) “Do I have to come again? Am I not getting anything now?” Right? You meet that attitude, they want penicillin now, and then it should solve every (snaps fingers) problem.

This opinion was shared by the other GP I interviewed, mentioning other patient groups that also caused dilemmas:

GP: […] one has to say that there is a small problem, for example with immigrants

… because they tend to have antibiotics for (every) little infection. … And then, in a way, you have to explain more, you have to, well, work a lot more to get them to agree that light infections, virus infections should not be treated with antibiotics first, and you have to explain that it is so dangerous to use antibiotics because of the development of resistance … against antibiotics. And one more group, and that is those struggling with anxiety or psychic disorder. They also think that antibiotics help against inflammations, infections, and they ask for antibiotics … every time they get some infection. And I also consult the last group in which you use a lot of antibiotics, which are COPD patients. That’s in a way, there is a way of treatment where large amounts of antibiotics are provided to patients and they themselves must start using antibiotics when they get some infections. And then, in a way, you develop resistance very quickly.

It should be noted that this attitude of demanding antibiotics is not exclusive to immigrants or anxiety patient. The general opinion towards antibiotics has long been to use them in most cases of disease, even if it deemed unnecessary, just to “be safe”. For health care employees in primary care, especially GPs, there is a sort of balancing act between pressure from below and pressure from above; patients demand more antibiotics while the government agencies demand less use of antibiotics. However, in recent years this on-demand attitude has decreased rapidly:

ASP: […] discussing antibiotic use with patients is much easier [now] than it was 10 and 20 years ago, when the expectations very often were that they should get an antibiotic cure, even though the gain would probably be very small or nothing at all. But now when we discuss this with people, typically parents of young children, it is much easier to discuss it. If there comes a mother with a child with a pain in

(35)

the ear but who is in good shape, and then I say as a regular doctor that “Yes, your child has an ear infection but I think we can safely wait to see and probably he does not need antibiotics.” Then they would protest 20 years ago. But now they say “Yes, so nice, then he can drop that cure.”

GPs have also become more resilient towards pressure from patient, in many cases because of the national guidelines:

Chief physician: […] I have a clear impression that there is an increasing awareness about the use of antibiotics among the GPs and, for that matter, also in the population, that it’s not … the pressure to get antibiotics may not be as high as it was a few years ago.

[…] there is always someone who pushes for and wants it for things that are not relevant either, but it is, it is easier to resist when you have national guidelines that say that we should not.

Follow-up educational groups for doctors in municipal health institutions is one of three large tasks that ASP are responsible for, together with conducting information work aimed at the general population and to conduct research into antibiotics resistance. This education takes the form of clinical courses for health care personnel, especially GPs. The RAK project is based on follow-up educational groups, focusing especially on the use of antibiotics. In practice, these educational groups are quite similar to colleague-based discussion groups in form and content. Thus, when talking about one, we also include the other.

Of the six measures listed, colleague-based discussion groups is by far the widest and arguably the most important. This measure, like the educational groups, takes place in many different settings. Two of the biggest arenas for using this method is RAK and RASK, which are run by ASP and where the goal is for the GPs to reflect on their own prescribing habits:

ASP: What we have then built our strategy on is experience from a large study that we did 10 years ago called College-based Therapy, which again is based on a good deal of international studies. That which can get the GPs to change practice, is that

The Implementation of Strategies against Antimicrobial Resistance