Examination of the medicines data repository continued
Fimea's tasks, services and activities largely comprise information on medicinal products and the work of experts who produce and use information. Numerous other authorities and pharmaceutical industry actors also produce, store, use and disseminate information on medicinal products.
The aim of the overall examination of the medicines data repository is to improve the availability and accessibility of high-quality information that meets the needs of users. Another objective is to support cooperation through information management that promotes the implementation of rational pharmacotherapy and more goal-oriented development, management, supervision and guidance of activities related to pharmaceutical services and the pharmaceutical market.
Study a part of the pharmaceutical affairs reform
Investigating the operating prerequisites of the medicines data repository and clarifying the development needs for medicinal products information management are included in the Ministry of Social Affairs and Health's reform of pharmaceutical matters project.
In 2021, Fimea produced a follow-up report on the medicine data repository commissioned by the Ministry of Social Affairs and Health. The aim of the work was to specify the premises for the medicines data repository, supplementing the previous report (Ministry of Social Affairs and Health reports and memos 2021:3).
Common data repository for the information on a medicinal product
If implemented, the medicines data repository would bring together data on medicinal products, herbal medicinal products, reimbursable basic ointments and clinical nutritional products related to different authorities' tasks and services. In the current situation, the information on medicinal products needed by operators is often scattered in the data resources of different operators, which makes it difficult to utilise the information for different purposes.
The medicines data repository would be a data repository designed and maintained for use by several actors, whose data could be utilised especially for various uses of pharmacotherapy and related logistics as well as for the needs of guidance, supervision, preparedness and management with knowledge. The proposal for the main data groups contained in the medicines data repository is shown in the figure.
Pharmaceutical users and animal owners, those who prescribe medicines, pharmacy personnel and other professionals involved in the implementation of pharmacotherapy all need information on pharmacotherapy and logistics. In addition, pharmacotherapy and logistics data are utilised by pharmacy information system and client and patient information system suppliers, other health technology companies, pharmaceutical database intermediaries, dose distribution units, pharmacies, authorities, social welfare and health care units, wellbeing services counties and national information system services, such as the Kanta services.
With regard to information provided through guidance, the same knowledge base and situational awareness should serve both the needs of guidance at the national level and the needs of information management related to the organisation and provision of services in the wellbeing services counties.
Aiming for a common operating model
The follow-up report on the medicinal data repository contains a proposal for the data repository’s operating model as well as on a staggered and authorised development path. The operating model will be used to describe the operational structures of the target state of the medicinal data repository, including the key actors and operating processes related to the production and management of information on a medicinal product, the services of the medicinal data repository, the purposes of these services and the customer base.
A common data repository and a jointly agreed upon operating model would create preconditions for up-to-date, intact data sets and services that meet users' needs. In addition, the common operating model and enterprise architecture will give the measures needed to ensure consistent and high-quality management of the authorities' data a more definite form and ensure secure processing for the implementation of the publicity principle.
Study to continue in 2022
Work will continue on a solution description of the medicines data repository and an assessment on the impact of changes and their cost-benefit. The broad-based objective is to lay a comprehensive foundation for national decision-making on the implementation of the medicines data repository and the development of medicinal product information management over the next few years and in the long term.
Further reading
Follow-up report on the medicinal data repository:
Conditions for the medicinal data repository to operate as a national service (Publication Archive Valto)