Browsing by Subject "apteekkivalvonta"

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.

The Finnish Medicines Agency, Fimea, is the authority responsible for supervision pharmacies in Finland. Recently, there has been more interest in Fimea to improve its supervision of community pharmacies. For this purpose, a questionnaire was made. Prior to the making of the questionnaire, community pharmacy supervision practices were studied in Nordic countries and in the UK. Additionally, faults found in Finnish community pharmacy inspections in 2016–2018 were classified by analysing anonymized fault lists (n=94) separated from inspection reports. When the most common faults were identified, it was possible to include questions concerning these faults into the questionnaire. A modified version of the Delphi method was used when developing the questionnaire. Comments on the applicability of the questions were given by a panel of experts consisting of inspectors of Fimea. The questionnaire was subsequently edited in accordance with the given comments. Separate versions of the questionnaire form were developed for community pharmacies and for their subsidiary pharmacies. At the end of this study, the questionnaire was sent to seven pharmacies and to three subsidiary pharmacies. After the results of the questionnaire were collected, Fimea gave feedback on the questionnaire. 25 categories were created by classifying faults found from pharmacy inspections. The most common inspection observations were faults in storage condition monitoring (97 % of pharmacies), narcotics (86 %), implementation of code of conduct (86 %), product errors (86 %) and preparation of medicines ready for use (81 %). The questionnaire begins by asking basic information about the pharmacy. Following questions concern the personnel and their further adequacy training. The questionnaire also includes several questions on the code of conduct within the pharmacy. Additionally, there are questions about storage condition monitoring, dispensary and accounting of narcotics. At the end of the questionnaire, there are also a few questions about the European Medicines Verification System (EMVS) which will be implemented by February 2019. Support from the inspectors of Fimea and studying regulations of pharmacies helped identify appropriate questions for the questionnaire. However, the perspective of the questionnaire may be limited due to the questionnaire being developed based up on faults found from inspections. The faults observed from inspections across pharmacies in Finland have been very similar with some of them being also alarmingly common. Because many of the observed faults are relatively easy to fix, simple corrective measures could be implemented to improve the situation across several pharmacies. Thus, usage of questionnaires, such as one made in this study, could be considered a feasible way of improving supervision of pharmacies.