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Browsing by Subject "lääkkeiden saatavuushäiriöt"

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  • Drug shortages in Europe from perspective of one pharmaceutical company 
    Hussein, Zahra (2018)
    Drug shortages have become a global issue and reasons for drug shortages are several and multifactorial. Definition of drug shortages is not unambiguous. However, in literature are numerous different suggestions to determine the phenomenon of drug shortages. This study provides more focused information on drug shortages and the reasons behind them. The study was performed in cooperation with Orion Corporation. The aim of this study was to explore the in-depth reasons behind medicine shortages from the perspective of one European pharmaceutical company with special focus on Finland, Germany, the United Kingdom and Sweden. Interviews of the company employees were used to achieve this aim and build a few case studies. Further the aim was to investigate in-depth reasons for drug shortages using data from case studies. Case studies were provided by Orion since this enabled use of unpublished information compare the case studies with relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages. Reviewing available data from literature and from EUDRA GMDP database for drug shortages and investigate if the data is detailed enough to understand in-depth reasons for drug shortages. Based on the interview results the most common reasons behind drug shortages in Europe are mainly pharmaceutical market structure 38%. It contains many different factors, such as small stock size, local and foreign manufacturing issues, logistics and distribution issues, changes in demand and regulatory issues. However, the manufacturing (33%) or regulatory (29%) reasons are almost as numerous as pharmaceutical market structure issues. Pharmaceutical market structure issues include most common reasons which are categorized in supply-related and demand-related reasons. According to this study supply-related reasons are more common (73%) than demand-related reasons (27%). Some reasons behind drug shortages overlap and often cause a domino effect, whilst other are unique or stand alone, like reasons resulting from natural disasters. The results of this study seem generalizable because the EUDRA GDMP database shows same results and case studies illustrative same reasons behind drug shortages. This study provides more focused information on drug shortages and the reasons behind them from the perspective of pharmaceutical company and authorities.
  • Obligatory storing of medicines in Finland : a retrospective register study on the use and effectiveness of obligatory storages during medicine shortages 
    Aaltonen, Timi (2023)
    The obligatory storing of medicines is a vital part of the secure supply of medicines in Finland. Over the past few years, its importance has further increased due to the growing number of medicine shortages. Evaluating the effectiveness of the obligatory storing system is important in order to improve it, but so far research on the matter has been limited. The aim of this study was to investigate how the obligatory storages of pharmaceutical manufacturers and importers are used during medicine shortages in Finland, and to assess the effectiveness of their use in these situations. The material for this study consisted of medicine shortage notifications which had been received by the Finnish, Swedish and Norwegian medicine authorities with a forecasted starting date between January and June 2022. In addition, Finnish exemption permits for lower storage levels from the same time period were investigated. Medicine shortage notifications were grouped based on the obligatory storing status of the medicine. The share of obligatorily stored medicines out of all shortage notifications was the smallest in Finland (10%) when compared to Sweden and Norway. There were no statistically significant differences in any of the countries in the duration of a shortage between obligatorily stored medicines and medicines which are not obligatorily stored. In total, 151 exemption permits had been granted within the time period of the study, 129 (85%) of which did not have a coinciding medicine shortage. This suggests that a patient-affecting shortage had successfully been avoided. The remaining 22 exemption permits were linked to a shortage which started either prior to, or during the validity of the exemption permit. In the Finnish data, 91 notifications concerned obligatorily stored medicines but in 69 (76%) of these cases no exemption permit had been applied for or been granted in relation to the shortage. The results of this study indicate that the obligatory storing of medicines was used to respond to several medicine shortages during the first half of 2022, and in most cases, it seems to have been an effective way to avoid a patient-affecting shortage. However, in some cases the use of an exemption permit was not well-timed, a shortage was experienced despite the releasing of products from the storage, or obligatory storages were not used at all. Based on the results, further research on the practices of obligatory storing and the factors which affect the use of exemption permits is needed to develop the system further and to improve its effectiveness in responding to medicine shortages.

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