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Browsing by Subject "rekisteritutkimus"

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  • Eri sidosryhmien kokemukset ja näkemykset toisiolaista ja sen toimintaympäristöstä rekisteriaineistojen tietojen hyödyntämisen ja tutkimuksen kannalta 
    Sihvola, Otto (2024)
    Finland has long traditions on the use and development of digital healthcare systems. This infrastructure, covering the entire population, has enabled the utilization of electronic healthcare records (EHR) collected in various registers for secondary purposes, such as research, development, and innovation (RDI) activities. Following the emergence of this activity, an operational environment supporting the reuse of data developed between these registers and data users, enabling diverse research activities. The Secondary Use Act, prepared on the basis of the General Data Protection Regulation (GDPR) and which came into force in May 2019, triggered many reforms for this operating environment. According to experts from various stakeholder groups, the reforms were seen as both beneficial and challenging, as observed in a small number of related studies already conducted. The purpose of this study was to investigate the current state of the impacts brought by the Secondary Use Act by mapping the views and opinions of representatives from different expert groups on key changes in the operating environment from their perspective and identifying potential areas for development. The study was conducted in early 2024 as a semi-structured interview study. The interviewees consisted of experts (n=8) from various stakeholder groups familiar with the operating environment for the secondary use of real-world data. The interviewees had extensive and significant experience with either the Secondary Use Act or its operating environment. Six distinct themes emerged from the material: data management in national registers, data utilization in research, the national process and guidance, the preparation process and culture of the Secondary Use Act, internationality, and actors and their equality. To identify new and significant observations, a comparison with previous research findings was conducted, ultimately identifying key factors that still challenge stakeholders. These factors related to inequalities among stakeholders, restrictions due to data protection requirements, lack of guidelines, and data harmonization. The results confirm the previous studies’ observations and highlight the particularly challenging areas for stakeholder groups in the current time. Overall, opinions about the data permit authority were mostly positive, while there was relatively more distrust towards register holders and legislators. Based on the study, there are clear grounds for developing the Secondary Use Act, but its timing is influenced by the progress of international projects, such as the EHDS model. Future research should increasingly focus on joint European projects to integrate Finland into the international operating environment.
  • Lääkkeiden saatavuus Suomessa : rekisteritutkimus Lääkealan turvallisuus- ja kehittämiskeskuksen aineistosta 2017-2020 
    Korhonen, Mira (2021)
    Good availability of medicines means that authorised medicines are placed on the market and not in a short supply. Drug shortages have increasingly become a common problem that has compromised the continuous availability of medicines. Drug shortages are caused by many complex factors, such as capacity constraints, manufacturing difficulties, business decisions, availability of raw materials, and sudden increase in demand. Drug shortages can cause adverse effects, medication errors, allergies, and delays in necessary treatments. There have been studies that have explained the reasons behind medicines shortages. However, more information is needed especially from the perspective of markets in Finland. The aim of this study was to reinforce and deepen the knowledge concerning the availability of medicines in Finland. The aim was to identify the group of medicines that are more exposed in short supply than others and define the root causes of medicine shortages. In addition, the aim was to form an overview of the availability of medicines in Finland. The study was based on a Finnish medicine agency's registry. Data were collected retrospectively from materials that contained shortage notifications from marketing authorisation holders and mandatory reserve supplies permissions for exemption to maintain lower stock levels. The study was dated between the years 2017 and 2020. More detailed data from the medicine shortage was only available from the year 2020 because of changes in procedures. The study also contained data from the register for all marketed and non-marketed medicinal products with marketing authorisation. The data classified with ATC-codes, because it is used internationally and thus makes the study to comparative to other studies. Data were analysed with cross-tabulation and frequency distributions. The study addressed that drug shortages were reported of medicines that are commonly used in Finland, such as nervous and cardiovascular system drugs. These medicines covered almost half of the annual shortage notifications. The number of drug shortage notifications has increased annually by approximately 40 percent. Correspondingly mandatory reserve supplies permission for an exemption to maintain lower stock levels were reported most on nervous system drugs and anti-infectives for systemic use. The number of annual permissions remained quite constant. The amount of the permissions increased 14 percent between the years 2017 and 2018 and a further 6 percent to the year 2019. However, the amount of permissions increased 26 percent in the year 2020. There is clearly recognized the effect of the COVID-19 pandemic when considered the rate of shortage notifications and mandatory reserve supplies permissions. The main reasons for the shortages were capacity constraints (32%) and increased demand (21%). Most of the drugs in short supply were drugs with national (33%) or decentralised (30%) marketing authorisation procedures. Broadly were able to state that the availability of medicines was at an acceptable level. 62 percent of all medicinal products with marketing authorisation were placed on the market. In addition, only 29 percent of older drugs with marketing authorisation accept during the years 1996 to 2003 were withdrawn from the market. In future, more large-scale studies are needed based on this study to improve the system that maintains the continuous and high-quality medicine distribution. Most important is to create a better tracking system and co-operation between national and international officials.

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