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Browsing by Subject "Lääkealan turvallisuus- ja kehittämiskeskus"

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  • Luhtanen, Päivi (2020)
    The pharmacy operations are strictly regulated in Finland and the operation of a pharmacy business requires a licence. Number of community pharmacies has stayed quite steady for the past 10 years. At the end of the year 2019 there were 817 pharmacies or their subsidiaries in Finland. The number of pharmacies is expected to increase, since 29 new pharmacies has been established since 2016. The inspection of pharmacies is a part of the legal duties of the Finnish Medicines Agency. In Finland, pharmacies are inspected based on a risk assessment, as often as it is necessary to ensure appropriate operations of a pharmacy. During a pharmacy inspection, the focus is on operations that are critical to drug safety and medication safety. The aim of an inspection is to make sure that pharmacy operations comply with the regulations. There are only few studies made on remote inspection of the pharmacies. The Finnish Medicines Agency hasn’t made remote pharmacy inspections before. The aim of this study was to develop, validate and test a questionnaire, which could be used to inspect community pharmacies remotely and to develop and test a process for remote inspections. The study was done in two parts. In the first part, a draft of the questionnaire was developed by studying the regulations and laws regulating the operations of a pharmacy and by using a content analysis. The material for the content analysis was a pre-inspection questionnaire form, answers to the pre-inspection questionnaires and defect lists of the inspection reports of those pharmacies (n=37), which had answered to the pre-inspection questionnaire before pharmacy inspection in 2019. Content of the pre-inspection questionnaire and the answers of pre-inspection questionnaire were compared to the content of the defect lists of inspection reports. The aim of the comparison was to find out how the existing pre-inspection questionnaire could be utilized when developing the questionnaire for the remote pharmacy inspections. In addition, the listed defects of the inspection reports were categorized to explore what were the most common defects observed during pharmacy inspections. In the second part of the study, the content of the developed questionnaire was validated by using a three round modified Delphi survey. Seven experts with good knowledge of the pharmacy inspections were chosen to the Delphi panel. The aim of the Delphi rounds was to achieve full consensus among the experts about the content of the questionnaire. Alongside the Delphi rounds, a process to remote inspect a pharmacy was developed. The remote inspection questionnaire and the process were tested internally in the Finnish Medicines Agency at the end of the second stage of study. The draft of the questionnaire included 15 sections and 164 questions. Based on the comments received during the Delphi rounds, the content of the questionnaire was modified. On the third Delphi round a full consensus of the content of the questionnaire was achieved among the experts. The final questionnaire for the pharmacy remote inspection included 14 sections and 184 questions. The process of the remote pharmacy inspection follows the procedure of an on-site pharmacy inspection. In the internal test, the process of the remote inspection was found to be a good way to inspect pharmacies remotely. The remote inspection process is a new way to inspect pharmacies. With the remote inspection, it is possible to find out the most common defects on the pharmacy operations by using the questionnaire and contact calls. The remote inspection questionnaire and the process need to be further tested to ensure that the process is optimal from the perspective of the authority and the pharmacies.
  • 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.