Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders

National health systems may have several goals, but the ultimate is improving population health and well-being [1]. According to the World Health Organization (WHO), an effective health service system should meet these goals by providing equal access to affordable and high-quality services, including care and healing services, health promotion, prevention, and rehabilitation for the entire population [1, 2]. Access to medicines is essential to a well-functioning health system and is necessary to achieve public health goals [1, 3]. When successful, pharmacotherapy can save lives, maintain, or improve functional capacity, and mitigate or even prevent diseases or their symptoms, thus improving quality of life. The demand for and spending on pharmaceuticals are expected to grow due to aging populations, rising income levels, increasing costs of developing new technologies, and increased patient expectations [4]. Consequently, pharmaceuticals constitute a substantial portion of healthcare spending in Europe and globally. In Finland, pharmaceuticals accounted for 14–15% of the total social and health services costs in 2021 [5].

Many countries have experienced challenges in meeting all health service demands. Health inequalities, limited availability and access to services, safety, and productivity are the main shared concerns [6‐8]. In the last decade, a major social and health services reform has been prepared in Finland, aiming to improve the coordination, integration, and equality of access to services while balancing continuously growing health and social services costs [9, 10]. In many countries, including Finland, the government or another third party pays a significant part of pharmaceutical costs. Therefore, effective means are required to monitor and guide the safe and appropriate use of medicines and their cost-effectiveness. Pharmacotherapy can be considered inappropriate if it does not meet the conditions and core components of rationality defined by the WHO [11, 12]. According to the WHO, rational use of medicines occurs when patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period, and at the lowest cost to them and their community [11]. Due to the complex interrelationships of pharmaceutical and health system governance, countries have been recommended to find ways to harmonize better and align their pharmaceutical policy activities with national health policies and systems [1, 13].

As part of a national policymaking, the need for rational pharmacotherapy programs has been recognized in several countries [4, 14, 15]. Few detailed descriptions of national medicines policies (NMP), development processes, and implementation strategies are available. However, such descriptions would benefit other countries in compiling their own policies [14, 16] and developing international policy recommendations [3, 4]. According to WHO, a NMP serves as both a commitment to a defined objective and a strategic roadmap for actionable steps [13]. This national comprehensive framework articulates and prioritizes the government's medium- to long-term goals for the pharmaceutical sector and use of medicines, outlining key strategies to achieve these objectives. For example, NMP has guided development activities in Australia since 2000 [16]. The overarching goal of the Australian’s NMP has been to optimize health outcomes through a collaborative partnership with key stakeholders. A similar target has been set for the NMP implementation in New Zealand [17]. In 2022, the updated Australian’s NMP has emerged as a coordinating framework that sets out a vision, common aim and intended outcomes, for all partners to work towards quality use of medicines and medicines safety by focusing on the current and future health needs of people in Australia [18].

In Finland, the development of the pharmaceutical system has been guided by the NMP since 2003 [19]. The NMP was originally drafted to evaluate the development needs of the pharmaceutical system in a situation where medicine legislation had not been comprehensively assessed for an extended period. Moreover, Finland had joined the European Union (EU) in 1995, resulting in the harmonization of national legislation with EU regulations. The purpose of the NMP was to bring predictability in the operating environment to several stakeholders in the medicines sector. In the 2011 NMP update, Finland implemented the WHO's recommendation to commit various key stakeholders to NMP goals by involving them in an open, systematic consultation process when preparing the NMP [13, 20]. By doing so, Finland’s goal has been to develop the pharmaceutical sector and service system aligned with the health policy goals to meet the needs of the social and health services [21]. However, rapidly rising pharmaceutical costs, an aging population, and medication safety risks, especially among older adults, a fragmented operating system and culture, as well as pressures to promote the digitalization of healthcare formed complex challenges to be solved as part of the social and health services reform [22‐24]. Therefore, the Ministry of Social Affairs and Health (MSAH) initiated in 2016 the preparation of the targeted Action Plan promoting rational pharmacotherapy based on the government mandate [25].

The aims of this study were to 1) describe the collaborative and bottom-up development process of the national long-term Rational Pharmacotherapy Action Plan during 2016–2017 and the key process outcomes, and 2) to analyze the content of the Action Plan in the conceptual framework of integrated care.

Good scientific practices were followed throughout the research process [67]. Only reports available from open sources were used. The meeting memos were made available through a formal information request to the MSAH.

Drafting the RPAP was an intensive, time-consuming, but fruitful national process in Finland. It enabled a comprehensive review of the current pharmacotherapy practices and, based on that, the creation of the long-term vision of rational pharmacotherapy as part of the planned social and health services reform. Although final legal decisions on the future of the social and health services system and the structures of the pharmaceutical system integrated into it were missing during the planning phase of the RPAP, it was possible to define guiding visions and principles for the promotion of rational pharmacotherapy in the micro, meso and macro levels of the service system (Fig. 4).

A variety of authorities and stakeholders participated in the development of the RPAP. This bottom-up and co-creation process was chosen because of the good experience gained from preparing the NMP 2020 [20]. This approach has been recommended by the WHO [13], and later used to support EU pharmaceutical decision-making [62]. The chosen development process of the Action Plan has proved to be important for the stakeholder commitment and enabled consensus of the visions and principles that still carry the development. This reinforces the earlier finding that the policy process is just as important as the policy document since the process must create a mechanism to bring different views together and achieve a sense of shared ownership of the outcome [14]. For example, the rational pharmacotherapy website continues to be actively managed by MSAH. Plenty of practical tools developed to promote rational pharmacotherapy in everyday clinical practice have been identified and shared through coordination with Fimea [69] and national medication safety development network [70]. In addition, Fimea has integrated the RPAP communication campaign into Pharmacotherapy Day’s annual campaign week, which is now organized in collaboration with different stakeholders [71].

During the development of the Action Plan, there was a thorough discussion about the definition of rational pharmacotherapy which led to the extension of the concept towards equity. That reflected the national principal value base of equal rights, which had become threatened by rapidly increasing healthcare and pharmacotherapy costs. Consequently, in the 2000s, Finnish pharmaceutical policy and decision-making on pharmaceuticals revolved around how to curb the ever-increasing costs. To control costs, changes have been made, e.g., to the public medicines reimbursement system and pricing, which have led to relatively high deductibles for long-term medicine users [9] and may have led to a decline in the adherence to chronic diseases [72]. However, the entire medication use process which extends across the borders of several different organizations, had not been evaluated to ensure effective, appropriate, and cost-effective pharmacotherapy. The RPAP provided an opportunity for this comprehensive review and the identification of various development measures (Table s2 in Additional File 5).

Most of the medicines are used in outpatient care, so the measures of the Action Plan are largely focused there and are especially aimed at optimizing pharmacotherapy for chronic diseases and self-managing at home. However, the Action Plan’s goals were unrelated to the operational environment. The evolution of pharmaceutical services within inpatient care has been intensive after the launch of the RPAP. Traditionally, hospital pharmacy services have focused primarily on logistical functions, with only limited integration into clinical practices. The development of the information flow, task definitions, and responsibilities in the medication use process, as well as to defining consistent operating models for medication optimization and management have progressed quickly in inpatient care [73, 74]. The number of ward and clinical pharmacy staff has remarkably increased between 2017 and 2022 in Finland, and services have extended widely, focusing on system-based medication safety work and the development of comprehensive medication management [74]. However, there is a lot of regional variation in development and the goals of the Action Plan are still relevant. Especially in outpatient care, pharmaceutical services except for dispensing, counseling, and automated dose dispensing, are not well integrated into daily clinical practice [75]. The community pharmacies are willing to develop their services improving medication safety and supporting rational pharmacotherapy [76], but non-formed legislation and incentives have hampered the progression. The challenges of the legislation and delays in achieving the goals set in the Action Plan are partially explained by the national social and health services reform, the implementation of which has finally created the conditions for the beginning of legislation development of the pharmaceutical system.

Based on the results of this study, the ultimate goal of developing the pharmaceutical system should be to improve its integration into the social and health services system. In the Action Plan prioritized development activities can be promoted by renewing management, funding, and information sharing in the pharmaceutical, social and health services. During the implementation period of RPAP, the further planning for developing pharmacotherapy data and information management has progressed systematically at national level. MSAH has recently published the enterprise architecture of pharmacotherapy [48] and plans for the development of a centralized national information management services for pharmacotherapy [77] and medicinal data repository [78]. Community pharmacy system’s reform needs (e.g., tasks and operations) have been investigated in detail, also from the general public approach [79]. In the current legislative framework, where community pharmacies are regulated as a separate part of the social and health service system, it is not possible to develop the exchange of patient information, and the tasks of different professionals and organizations in the medication use process agilely as in inpatient care. In addition, the vision has matured that the national level decision-making processes to guide the use of medicines must be developed [80, 81], and the data and information about pharmaceuticals and pharmacotherapy which accumulates in different registers must be utilized better than at present [81, 82].

The Action Plan also highlighted the need for change in governance and funding, which require a new way of thinking to create incentives for various actors in the medication use process to promote rational pharmacotherapy. For example, community pharmacies currently make a profit primarily from the sale of medicines and the definition of profit margins rather than from services that optimize the use of medicines and monitor their effectiveness. The Action Plan set several goals for the regional well-being service counties for managing the medication use process, the governance of the services, and creating conditions for interprofessional and people-centered collaboration. The success of the several goals set for the well-being service counties may require the expansion of their operational mandate to the entire medication use process. Based on the restructuring of the social and health services, the well-being services counties should guide production more strongly than municipalities did before and pay special attention to those who use many services and may also use expensive medicines or several different medicines for their ailments [58]. However, the well-being services counties currently do not have a mandate, e.g., to guide or oblige community pharmacies to develop their services in the medication use process. To make pharmacotherapy more rational, the state and well-being services counties must succeed in integrating the region's community pharmacies into the service chains and by this enable better utilization of available knowledge and resources to medication use optimization and management. The well-being services counties play a central role in many prioritized actions in the Action Plan to promote rational pharmacotherapy. Therefore, they will be a significant player in medicines policy in the future.

The parallel development of the European-level pharmaceutical system increases the challenge of national development. The European Commission has recently published the proposal for the major EU pharmaceutical legislation reform [83]. The proposal complements the key previous changes and initiatives [63, 64]. The goal is to make medicines more equally available, accessible, and affordable in the EU region, boost competitiveness, fight against antimicrobial resistance, and give rules to digital transformation. These phenomena and challenges have partly been identified at the national level during the development of the preceding NMP 2020 [20] and RPAP [50]. Recent global, EU and national level policymaking are more strongly interlinked than before, where e.g., environmental consciousness as a sixth dimension of rational pharmacotherapy is emphasized as a new theme [62, 66, 84, 85].

The strength and uniqueness of the RPAP is the utilization of research in identifying the development needs. Research has not previously been utilized in preparing of medicines policy on the same scale in Finland, although the researchers were also involved in the preparation of the preceding NMP [20]. The importance of evidence-informed decision-making in implementing RPAP is reflected in the long-term research strategy and establishment of a research network to support the implementation of the RPAP [86, 87]. The utilization of academic research could also have influenced the fact that the coverage of the RPAP was comparable to other international NMPs published in other countries [17, 18, 88]. That reflects similar pharmacotherapy challenges in the health systems globally.

The RPAP was the crystallization of NMP thinking as part of the broader social and health policy during one term of government [25]. Currently, there is no updated comprehensive NMP in Finland and the progress of the implementation of the RPAP has also yet to be evaluated. However, to ensure the long-term implementation of the RPAP, a commitment across political party lines has been sought. The officials of the MSAH have developed frameworks for the pharmaceutical system development, which the previous (2019–2022) and current (2023–2027) governments have included in their programs [85, 89]. This commitment aims to ensure continuity and mutual support for long-term and predictable development, transcending different government periods. However, the key question is whether the subsequent governments will commit to a balanced policy that considers the different dimensions of rational pharmacotherapy supporting public health and national health policy goals. It would be appropriate to reform the structures of the pharmaceutical system in a controlled manner and create systemic conditions for implementing rational pharmacotherapy in Finland.

The study results are based on several publicly available documents published by the authorities (Table s1 in Additional File 1) and are consistent with the theoretical framework of integrated care [54]. Only one researcher was responsible for the analyses which is a limitation of this study. However, the interpretations have been validated by authors who have been strongly involved in the RPAP development work and have long experience in national development and working at the interface of politics from different approaches. Each author's point of view in the RPAP development process has been different, enabling the adoption of different perspectives and views during different phases of the analysis, thus strengthening the consensus. However, as a typical limitation to document analysis [57], the documents selected for the analysis and the documents used to verify interpretations have affected the results, i.e., the accuracy and comprehensiveness of the observations made. For example, the development needs to be related to pharmaceutical innovation activities remained few in the results. On the other hand, the pharmaceutical innovation theme was paid less attention due to the more urgent needs to evaluate the effects of the ongoing social and health services reform. The research materials consisted of the central available materials describing the process and the final results of the RPAP. The expertise of authors with the subject of the study compensates for the limitations of document analysis. With the help of the author group, consisting of civil servants and academics, and theories that guided the analysis, it has been possible to strengthen the reliability of the results. The results represent a national case study and are, therefore, not transferable as such to other countries. As presented in this study, the national descriptions of medicines policy and system development holds potential to be useful in several other countries. The results provide an opportunity for cross-country benchmarking and learning.

The major ongoing changes in the domestic and international operational environment affecting the whole pharmaceutical system in Finland require further research. National research in the key areas of rational pharmacotherapy covering structures, processes, and outcomes should be continued, as well as monitoring the impact of the policy measures taken [86]. In addition, the impact of the RPAP on stakeholders’ and patients’ experiences should be investigated. Further research is needed to investigate the prerequisites for integrating community pharmacy services into regional service chains and creating incentives. Internationally, further research is needed on the effectiveness of NMP guidance, and the indicators defined for implementing the NMP.

Through intensive stakeholder participation, the bottom-up approach created a national vision and principles of rational pharmacotherapy and a strong commitment to implementing the goals and measures. The concern lies in ensuring the continuity of the Action Plan implementation and achieving a balanced long-term development aligned with the integrated national social and health system. The development of the pharmaceutical system has several national and EU-level dependencies requiring long-term political commitment. While the Action Plan differs from the national medicines policy it forms a good basis for long-term development covering important parts of medicine policy at the micro, meso and macro levels of the service system.