Fimea has a strong role in pharmaceutical reform

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The Ministry of Social Affairs and Health is conducting a reform of pharmaceutical matters. The aim of the reform is to make pharmaceutical services more cost-effective, safeguard medication safety and guidance, and secure the availability, accessibility and smooth running of services. The reform is guided by the roadmap included in the Ministry of Social Affairs and Health’s report (2019:5), and the included measures extend across several government terms. 

Implementation of the roadmap for pharmaceutical matters consists of three areas:

  • Development of the guidance and funding of pharmacotherapy (sub-committee for the guidance and funding of pharmacotherapy)
  • Development of the pharmaceutical economy and the distribution of medicines (sub-committee for pharmacy services)
  • Developing information management and digital tools (sub-committee for information management in pharmacotherapy).

The progress, preparation and implementation of the reform is monitored and supported by a coordination group whose members come from various ministries and government agencies. Fimea has three representatives in the coordination group, plus their personal substitutes.  

Sub-committee for pharmacy services

The objective of the sub-committee for pharmacy services is to reduce the pharmacy system’s share of the pharmacotherapy costs in a way that ensures that the accessibility of services and the realisation of rational pharmacotherapy are not compromised. The sub-committee has defined the objective and duties of the retail distributors of medicines and, based on this, defines the development needs. 

Fimea has actively participated in the work of the sub-committee for pharmacy services and its subgroups. Fimea has had four representatives in the sub-committee. Fimea has prepared issues for discussion in the sub-committee for pharmacy services both internally and with the designated members of the sub-committee. The work of the sub-committee for pharmacy services was nearly completed in 2022, and the Ministry of Social Affairs and Health will publish the sub-committee’s report in 2023. 

In 2022, as part of the work of the sub-committee for pharmacy services, Fimea produced reports on the content of statutory drug advice provided by outpatient pharmacies, and the retail distribution of medicines and pharmacy systems in Europe. The Ministry of Social Affairs and Health commissioned these reports in January 2022 as part of the implementation of the reform of pharmaceutical matters. 

The report on the content of statutory drug advisory service provided by outpatient pharmacies aimed to map the status of the pharmaceutical advice provided by outpatient pharmacies and produce a preposition for content areas included in the statutory drug advisory service. According to the report, the users of medicinal products are generally satisfied with the pharmaceutical advice provided by pharmacies, and pharmacies are one of the most important sources of drug information for the population. However, increasing the customer-orientation and consistent quality of the advice were identified as development needs. There is a clear need for more detailed definition of the statutory drug advisory service to promote the uniform quality of the service.

The report on the retail distribution of medicines and pharmacy systems in Europe looked at ten European systems and compared them with Finland. With regard to pharmacy systems, the report studied pharmacy ownership, personnel structure, opening hours, product portfolio, drug advice, pharmacy services and the related legislation. In addition, the report compares the sales channels and locations for medicines, and the previous literature review on the effects of deregulation of the pharmacy system in Europe has been updated. The included countries are Iceland, Norway, Sweden, Denmark, the Netherlands, the United Kingdom, Portugal, France, Germany and Estonia. Based on the report, the level of regulation of pharmacy services varies by country. The most significant differences were related to the ownership of pharmacies and the drug sales channels. 

In 2022, Fimea also published a report on the current state and development needs of multidose drug dispensing. This report has also been utilised in the work of the sub-committee for pharmacy services. The aim of this report was to describe the current state of multidose drug dispensing in Finland and the present development needs as well as examine the need to update the publication “Lääkkeiden potilaskohtaisen annosjakelun hyvät toimintatavat” (Guide on good practices in patient-specific dispensing of medication). Based on Fimea’s report, the dose-dispensing services offered by pharmacies are considered to be useful and improve medication safety. However, legislation on multidose drug dispensing should be strengthened to clarify the roles and responsibilities of different actors. Tendering procedures should take into account not only price but also qualitative factors. It would also be important to define national quality criteria and the content of the service in order to ensure that the service contributes towards rational medicinal treatment. Further, it was considered important to update the “Lääkkeiden potilaskohtaisen annosjakelun hyvät toimintatavat” (Guide on good practices in patient-specific dispensing of medication) in cooperation with key authorities and stakeholders.

Sub-committee for information management

The work of the sub-committee for information management in pharmacotherapy consists of three areas: the Kanta medication list, the medicines data repository and use of pharmacotherapy and pharmaceutical services information. With regard to the two latter, the Ministry of Social Affairs and Health has commissioned Fimea to investigate the matter. All reports have been produced together with the Ministry, other agencies and institutions and other stakeholder groups.

The aim of the medicines data repository is to group information on medicinal products and pharmaceutical markets related to the tasks and services of different authorities. For example, the data repository would contain basic information about medicinal products and other relevant information, such as the price, availability, quality and safety information and summaries of product characteristics. At the moment, this information is scattered across different sources, making its use more difficult. Implementation of a national data repository would allow the use of data from several authorities and other actors, and would require building a drug information portal and a user interface. It would be a demanding, long-term project. Fimea’s reports give the big picture to help decide whether the development and operation of the medicines data repository should be financed. In 2022, we published a solution description and a user study on the medicines data repository. The solution description includes a detailed definition of the most important services to be developed first if the decision is made to implement the medicines data repository. As first-phase services, the solution description proposes a drug information portal, a pharmaceutical database in the Kanta Services and a user interface for authorities for accessing pharmaceutical market information. The customer needs related to this user interface were mapped through a user survey implemented by Kela’s information service designers together with Fimea’s and Kela’s content experts. The study interviewed representatives of university hospitals in different wellbeing services counties. In the last phase of the research, we produced a change impact assessment and analysed the cost-benefits of a medicinal data repository. 

The report on using pharmacotherapy and pharmaceutical services information has been compiled during 2022, and it will be submitted to the Ministry of Social Affairs and Health at the beginning of 2023. The report proposes operational models and a roadmap to develop and standardise the knowledge management methods of rational pharmacotherapy and pharmaceutical services. Knowledge management means promoting the organisation’s ability to produce value through information and competence. As a concept, it covers data-based management and information management.  The key message of the report is that knowledge management in the health and social services has been developed as part of the social and health care reform. This general development has not paid enough attention to needs related to guidance and supervision of pharmacotherapy and pharmaceutical services. The operating models proposed in the report are intended to be integrated into the general social and health care guidance and management.