Browsing by master's degree program "Proviisorin koulutusohjelma"

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.

The use of different methods of extended reality (xR) as a support in teaching has been under research for a long time. Although the use of various xR-technologies in other fields of healthcare, such as medical and nursing education, is already common, their use in pharmacy education is not yet well established. There is evidence that xR-technology has a positive impact for example on students’ motivation and learning outcomes. On the other hand, there are limiting factors that inhibit the technology becoming widespread, such as costs as well as a lack of knowledge about the technology usability. The aim of the study was to investigate usability and advantages of the augmented reality (AR) in a laboratory course as an educational supportive tool by using AR-glasses. The aim was also to investigate the learning outcomes of the students who participated in the study in three different phases: before carrying out the laboratory work (pre), immediately after the laboratory work (post) and in the course exam (delayed). Furthermore, the motivation of the students to use new technology in their studies was studied. The research was done in a collaboration with the Centre for University Teaching and Learning (HYPE) and with Sciar Company Oy. The researchers of HYPE were responsible for the pedagogical point of view, whilst the experts from the Faculty of Pharmacy were responsible for the study measurements of laboratory work related content knowledge. The research was implemented in two laboratory courses in Bachelor of Science level pharmacy studies: Medicinal product II and Pharmaceutical biology and asepsis in the fall of 2020. The students (n=18) prepared eye drops by using AR-glasses in the Medicinal product II -course and reference group (n=14) without AR-glasses. In the course of Pharmaceutical biology and asepsis, students (n=7) used AR-glasses to study the microbiological purity of the eye drops by utilizing membrane filtration method in cleanroom and reference group (n=9) without AR-glasses. ln addition, a serial dilution method was performed on a 96-well plate using an AR mobile application. The effect on learning outcomes was evaluated by using six open-ended questions measuring the understanding of content knowledge underlying the laboratory work, that were answered by the students at three different stages of the study (pre, post, delayed). To measure the usability of the AR equipment, a five-point Likert scale questionnaire studied the experimental groups students’ opinions on whether the AR mobile application could provide sufficient guidance and feedback while performing the laboratory work. In an open question, the students had the possibility to comment on the overall user experience of the AR mobile application. There were no statistically significant differences in learning outcomes between the AR-group and the reference group in both laboratory courses. The results showed indicative differences in short-term and long-term learning, with the AR-group achieving better learning outcomes in the short-term and the reference group in the long-term. In the course of Pharmaceutical biology and asepsis, the learning outcomes were the opposite. Students’ were found to be receptivity to the new technology that together with motivation supports positively the learning process. The use of AR-hardware increased certainty and reduced nervousness about the use of AR technology. As a conclusion, the study could not demonstrate the benefit of AR-technology in student learning outcomes. The study was limited by the small sample size. However, further studies are encouraged due to students’ positive attitudes and motivation towards AR technology. Regarding further studies, it is important to take into consideration the different backgrounds and learning methods of students. Thereby, the effects of xR-technologies on learning outcomes can be assessed as objectively as possible.

The price competition of biological medicines induced by biosimilars has started slower than expected in Europe. One of the main reasons has been the differences in physicians’ attitudes toward biosimilars. Switching biological medicines to clinically comparable alternatives is an important way to enhance the cost-effectiveness of using biological medicines. The focus of the conversation has shifted from the general similarity of biosimilars and the originators to whether frequent switching involves additional risks. The purpose of this master’s thesis was to investigate factors influencing physicians’ prescribing of biological medicines. In addition, their perceptions of the automatic substitution of biological medicines in Finland were explored. The study was based on structured personal interviews of rheumatologists and gastroenterologists including specialising physicians who work at HUS Helsinki University Hospital in the Hospital District of Helsinki and Uusimaa (n=48). They had a chance to comment on their responses at any time freely. The interview consisted of four sections: demographics, general attitudes toward biosimilars, factors affecting prescribing biological medicines, and perceptions of the automatic substitution of biological medicines. Study participants had a chance to comment on their structured responses during the interview. The interviews were recorded for further analysis of the comments. The results are based on a descriptive quantitative analysis and an inductive analysis of the comments. The interviewed physicians’ (n=27, response rate 56,3%) attitudes toward biosimilars were highly positive. Most of the physicians (21/27, 78%) also strive to motivate patients to switch biological medicines to clinically comparable but lower-cost options despite the challenges associated with switching, for example the differences in the administration devices. Of the previously determined factors, the ones affecting prescribing biological medicines the most were the willingness to support the price competition between the biological medicines, reimbursement status, and the hospital’s drug formulary when initiating the biological treatment in the hospital. The attitudes toward the automatic substitution of the biological medicines were positive among 13/27 (48 %) physicians. Our study results are in line with the results of earlier studies, but the open responses especially to the automatic substitution of biological medicines might indicate more positive perceptions on the subject among physicians in Finland.

Medication reviews can be used to assess the appropriateness of a patient’s medication and to identify and resolve clinically significant drug-related problems. Medication reviews have been highlighted in several health and medicines policy documents as ways to improve medication safety in older adults. Collaborative practices and their development are key strategies in promoting the coordinated care of patients. Medication reviews have been previously defined from a multi-professional perspective but no definition based on multi-professional consensus has been established. The aim of this study was to harmonize the definition of medication review from a multi-professional perspective to suit various healthcare contexts in Finland. The goal was to create a shared understanding for physicians, nurses, pharmacists, information management professionals for their collaboration in reviewing medications. Furthermore, the aim was to define the tasks and responsibilities of different professional groups in collaborative medication reviews in order to support its implementation. The study was conducted as a 3-round survey using the Delphi method. The Delphi method is a qualitative consensus method based on the views of experts aiming at reaching consensus on the studied subject. The Delphi rounds were conducted as electronic surveys in September-December 2020. Expert panelists assessed the proposed definition of a collaborative medication review and the tasks and responsibilities of health care professionals involved in conducting it. The expert panel consisted of 41 participants: 12 physicians, 13 pharmacists, 10 nurses, and 6 information management professionals. The results of the study were analyzed both quantitatively and qualitatively. Consensus was reached on the definition of medication review from a multi-professional perspective, while no consensus was reached on most of the responsibilities and tasks of different healthcare professionals involved. Most challenging was to define patient groups benefiting from medication reviews and the situations in which medication reviews should be performed. Therefore, further research is needed to define the division of responsibilities between care team members, for example by defining separately the responsibilities and tasks in different healthcare contexts. This is the most comprehensive attempt taken in Finland to define medication review as a concept from a multi-professional perspective. The results of the study imply to the development and harmonizing of medication review practices and standardizing patient data documentation. The expected outcomes relate to enhanced patient and medication safety, improved coordination in medication management with integrated medication reviews.

Family caregiving refers to the organization of home care for an older adult, disabled or sick person with the assistance of a relative or other close person. The number of elderly carers (> 65 years) of all family garegivers is significant. There are challenges concerning family caregiving for the older adults, due to increased age is in connection with decreased physical performance and increased number of medications and polypharmacy. Despite these factors, there has been little research on the medication safety in the family caregiving among older adults. The aim of this Master's thesis was to identify factors influencing the ability of a caregiver to cope with the medication management of the older adults. These factors were divided into subgategories: factors associated a family caregiver, associated a care recipient and system-oriented factors. The research was conducted as a method triangulation, in which the data were collected through two interviews with home visits (n = 21) and related questionnaires. The questionnaire data were quantitatively analyzed by calculating the frequencies and relative frequencies. The transcribed interviews were analyzed by abductive content analysis, combining both deductive and inductive approach. James Reason's theory of human error was used as the theoretical framework. Caregiving families participating in this research were very different compared with each other. Some family caregivers and care recipients were in good physical condition while others were severely disabled. However, the situation of the families was not individually considered when considering appropriate support services for the families. The workload of family caregivers due to the pain and the absence of days off contributed to the difficulty of medication management. The foremost system-oriented challenges in the management of the medications were: 1) difficult for the families to reach the physician and 2) for those families where assisted home care helped the caregiver, the families were not satisfied with its functioning. Due to the poor availability of physicians and the lack of a family physician, there was no one in control of the medication as a whole and there was inadequate monitoring of the medication. In the assisted home care, challenges were caused by the fact that home care visits were conducted over a wide period of time, which created challenges for giving the medications. Carers do not receive sufficient support from the society for the management of the medications. The medication safety of the older adults in the family caregiving is particularly affected by the difficulty of reaching a physician, the inadequacy of support from the assisted home care, the failure to recognize the individuality of caregiving families, and the caregivers’ burden due to pain and lack of days off. Support for caregivers must be at the forefront of society in the future, so that caregivers can cope with heavy nursing care and complicated medications, even without excessive self-activity.

Medication related risks have been identified as one of the main threats to patient safety, both internationally and nationally. In Finland, implementation of pharmacotherapy in health services system is guided by the Safe pharmacotherapy -guideline. The guideline instructs work units to implement a pharmacotherapy plan, which is a statu-tory quality management document to describe the unit’s pharmacotherapy process and related responsibilities and obligations. However, there is currently limited research data available on pharmacotherapy plans and their impact on medication safety. The aim of this study was to explore the use of pharmacotherapy plans as a tool for promoting medication safety in the Finnish health services system with an emphasis on systems-based risk management. The research was con-ducted as an electronic survey in November-December 2021. The target group of the survey was health care professionals licensed as nurses and pharmacists who are working in wards or clinics or otherwise participate in drawing up or updating of pharmacotherapy plans. The study analyzed 901 responses. Most respondents (90 %) worked as licensed nurses and 10 % as pharmacists. The majority of the respondents’ units (91,5 %, n=824) had a pharmacotherapy plan. Medication safety practices were comprehensively described in pharmacotherapy plans and no significant differences observed between work environments. The multi-professional development processes of pharmacotherapy plans were not complete, only 11,6 % of the units the writing was done in multi-professional collaboration. Medication safety practices were best implemented in university hospitals (m. 3,87, sd. 0,57), with the difference being statistically significant for primary healthcare wards (m. 3,51, sd. 0,63, p<0,001) and social care housing services units (m. 3,63, sd, 0,68, p=0,018). The comprehensiveness of the content in pharmacotherapy plans and the implementation of medication safety practices were correlated (r=0,60, p<0,001). Pharmacotherapy plan is an important tool for systems-based medication safety promotion in the Finnish health services system. There is need for improvement in the multi-professional collaboration when developing the plans and in training the healthcare staff of practices described in the unit’s pharmacotherapy plans. In the future, special emphasis should be placed on the medication safety and development of primary healthcare wards and social care units.

Safety of pharmacotherapies is an essential part of patient safety that promotes and supports rational use of medicines. Safety of pharmacotherapies can be divided into two areas; Drug safety and medication safety. Drug safety refers to the safety of a medicine as a product, such as the pharmacological properties and the quality of the manufacturing process. Medication safety ensures the safety of a drug therapy process preventing patients from harm during the course of using medicines. Significant inconsistencies have been identified in the terminology related to drug and medication safety. Challenges to terminology are posed by varying synonyms, ambiguity or overlap of concepts, and misclassification of events in the scientific literature. The primary objective of this study was to scope recent peer-reviewed literature related to the drug safety and medication safety terminology from the period pf 2010-2022. A secondary objective was to examine the relationship between the concepts as presented in the literature, including overlaps and differences between the terms. The study was conducted as a scoping review by using Scopus and Ovid Medline databases. The literature search covered studies from January 2010 to January 2022. The search was conducted by using the following phrases; "("medication safety" OR "drug safety" OR pharmacovigilance) W/5 (definition* OR terminology*)" in Scopus and "("medication safety" OR "drug safety" OR pharmacovigilance) ADJ/6 (definition* OR terminology*)" in Ovid Medline. The references of the included articles were reviewed for any additional material. The relevant material was selected by two researchers. A total of 71 articles were identified from the databases, of which two articles met the predefined inclusion criteria. In addition, one article was included in the study from outside the actual search. Two of the included articles were based on drug safety terminology whereas one article was based on medication safety terminology. The results revealed that there is still a considerable heterogeneity of the terms in the literature. The literature shows several terms and definitions for the same phenomenon and no noticeable consistency in the terms. It would be important to define what a uniform and systematically used terminology would require and to establish a commonly accepted guidelines for its use.

The objective of this research has been to investigate the management of alerts of Medicines Verification Systems in Europe. Verification of medicines according to Falsified Medicines Directive (FMD) came into force 9.2.2019. There is no standardized tool or system for the management of alerts, every Medicines Verification Organisation and manufacturer have had to find their own ways to manage the alerts. The research has been performed as a theme survey via questionnaire that has been sent to Medicines Verification Organisations in 30 European countries. Information to the questions of the questionnaire has also been gathered from the Internet pages that are mainly maintained by the Medicines Verification Organisations. This kind of method triangulation has been used in order to improve the reliability of the research. Answering rate of the survey was 17 %. By including the information gathered by method triangulation the overall yield percent of information in this study was 45 %. The information received via the questionnaire did not contradict with the public information. As conclusion, marketing authorization holders have been registered as users of the National Medicines Verification Systems or they have signed a contract with Medicines Verification Organisations. Marketing authorization holders are paying the costs of the Medicines Verification Systems. Penalties of FMD non-compliance are in use in part of the European countries. In the beginning of the implementation of the Medicines Verification System there has been stabilization periods in use which have already ended in half of the European countries. National competent authority is informed about system alerts typically in case of suspected falsification. In half of the European countries there is a separate computerized alert management system in use. Marketing authorization holder usually has access to the system. In some of the countries it is possible to integrate the system to the own serialization system of the marketing authorization holder. In six European countries there has been set a specific time for the alert investigation of the marketing authorization holder. Based on the results of this research the alert management system that covers the whole Europe that European Medicines Verification Organization is planning would really be needed. One common computerized system and common rules would ease up the alert management of all the stakeholders of the medicines verification.

Rational, or prudent, use of medicines is one of the cornerstones of Finnish politics guiding the public procurement of medicines as a part of the medicines supply. The definition of rational use of medicines, however, takes into account the sustainability aspects of neither the drugs used nor the manufacturers behind them even though, according to One Health way of thinking, there is a connection between the sustainability of medicines and people's health. Motivated by this contradiction, the aim of the research was to map the different dimensions and usability of the corporate social responsibility (CSR) reports of pharmaceutical companies in promoting the sustainable public procurement of medicines. The values guiding the companies' sustainability actions and the impact of the COVID-19 pandemic on the companies were also researched. The materials consisted of CSR reports from years 2019-2020 of seven pharmaceutical companies that participated in public drug procurement in 2019. Two classification systems for sustainability and key performance indicators presented in previous research literature were used as a theoretical basis. Public procurement of medicines was used as a framework through which the research was carried out by using the means of qualitative content analysis. The CSR reports typically discussed the company, the environment, people, stakeholders, ethics and CSR reporting itself. CSR activities completed in the financial year in question consisted mostly of social sustainability. As for the environmental issues, emissions and climate issues played a great role. Governance-related CSR actions were the least reported and usually discussed risk management, research, and ethics. Success and pioneering, robustness and sustainability, and community spirit were recognized as themes uniting the values that guide CSR. As for in promoting sustainable public procurement, information about CSR activities, adoption of principles set by external stakeholders, CSR-related metadata, sustainability rankings, and management of sustainability in the supply chain, among other things, were found potential. The CSR reports of pharmaceutical companies contain comprehensive information about the companies’ operations, response to global trends and the values guiding the CSR activities. The use of CSR reports in public procurement of medicines necessitates further uniformity of CSR reporting practices in the pharmaceutical industry.

Väestön ikääntyessä sairastavuus lisääntyy ja käytettyjen lääkkeiden määrä kasvaa altistaen lääkkeiden haitta- ja yhteisvaikutuksille. Iäkkäiden suuri sairastavuus, monilääkitys ja lääkkeiden aiheuttamat haitat voivat kasaantuessaan huonontaa elämänlaatua ja toimintakykyä. Lääkehoidon arviointien avulla voidaan tunnistaa ja ratkaista monilääkittyjen iäkkäiden lääkitysongelmia. Jos potilaan lääkehoidon kokonaisuutta ei arvioida säännöllisesti, lääkkeitä voidaan määrätä lisää perusteettomasti, mikä voi johtaa lääkkeiden kasautumiseen ja estettävissä olevien haittojen lisääntymiseen. Tämän tutkimuksen aineisto perustuu Lohjan kaupungin kotihoidossa vuosina 2015-2017 toteutettuun interventiotutkimukseen. Tämän tutkimuksen tavoitteena oli analysoida pseudonymisoiduissa lääkehoidon arviointiraporteissa (n=43) tunnistettuja lääkitysongelmia (drug-related problems, DRPs) 65 vuotta täyttäneillä PCNE-luokittelujärjestelmän avulla. Lisäksi tavoitteena oli tarkistaa erilaisten lääkehoidon tietokantojen ja työkalujen avulla olivatko farmasistien muutosehdotukset ja huomiot valideja ja hoitosuositusten mukaisia. Lisäksi tutkittiin, mihin ATC- pääryhmiin ja edelleen lääkeaineisiin muutosehdotukset kohdistuivat sekä miten ne toteutuivat. Muutosehdotuksille ja huomioille (n=167) yleisimmin koodattu PCNE-luokituksen mukainen ongelma (P) oli P2.1 “Lääkkeen haittatapahtuma (mahdollinen)” (65,3 % n=109). Yleisin koodattu syy (C) oli C1.1 “Epätarkoituksenmukainen lääke suhteessa suosituksiin” (34,1 %). Ehdotuksista toteutui seurannassa 37,7 % (n=63), joissa yleisimmät interventiot olivat I3.5 ”Lääkkeen lopetus tai tauotus” (n=27) ja I3.2 ”Annosmuutos” (n=23). Yleisimmin muutosehdotukset ja huomiot kohdistuivat hermostoon vaikuttaviin lääkkeisiin (43,7 %), ruuansulatuselinten sairauksien ja aineenvaihduntasairauksien lääkkeisiin (26,3 %) ja sydän- ja verisuonisairauksien lääkkeisiin (15,0 %). Muutosehdotuksista ja huomioista 37,1 % (n=62) liittyi Fimean Lääke 75+ -tietokannan mukaan iäkkäille varauksin soveltuviin (ns. C-luokka) ja 23,9 % (n=41) iäkkäillä vältettäviin lääkeaineisiin (ns. D-luokka). C-luokan lääkeaineisiin liittyneistä ehdotuksista toteutui 27,4 % ja D-luokan lääkeaineisiin liittyneistä ehdotuksista toteutui 37,5 %. Farmasistin muutosehdotuksista ja huomioista valideja oli 98,2 % (n=164/167). Farmasistien osaamista tulisikin hyödyntää enemmän lääkitysongelmien ratkomisessa, mikä tukisi lääkärien sekä muiden sosiaali- ja terveydenhuollon ammattilaisten työtä.