Browsing by master's degree program "Master's Programme in Pharmacy"
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(2021)Yhteiskunnan digitalisaatio on lisännyt verkkopalveluiden käyttöä monilla aloilla, ja suurin osa suomalaisista käyttää internetiä esimerkiksi palveluiden tai tuotteiden hankintaan. Erilaisten digitaalisten terveyspalveluiden käyttö on kasvanut viime vuosina, ja koronapandemia on nopeuttanut muutosta. Suomessa useat apteekit ovat perustaneet viime vuosina verkkopalveluita, mutta niiden käyttö on ollut edelleen vähäistä. Tämän tutkimuksen tavoitteena oli tutkia koronapandemian vaikutuksia Yliopiston Apteekin (YA) verkkopalvelun käyttöön. Tutkimuksessa tutkittiin rekisteriaineistojen perusteella kokonais- ja reseptiasiakasmäärän sekä reseptimäärän ja asiakasprofiilin muutosta ennen koronapandemiaa ja sen aikana vuosina 2018-2020. Lisäksi tutkittiin YA:n Lääkeneuvonta- ja asiakaspalveluyksikön (Tiepa) vastaanottamien puhelin- ja chat-yhteydenottojen määrää ja sisältöä sekä kyselyaineiston perusteella apteekin verkkopalvelun käyttäjien näkemyksiä koronapandemian vaikutuksista heidän apteekin verkkopalvelun käyttöön. Monimenetelmätutkimuksessa tutkittiin apteekin verkkopalvelussa tapahtunutta muutosta apteekin asiakas- ja myyntitietojen sekä asiakaskyselyn avulla. Tutkimuksessa hyödynnettiin YA:n myynti-, asiakas-, Tiepa- ja pikanoutorekisteriaineistoja sekä YA:n toteuttaman ’’Verkkoapteekki 2020’’ -kyselytutkimuksen aineistoa. Aineistot analysoitiin kvantitatiivisesti Microsoft Excel (16.0) ja IBM SPSS (26) ja R (4.0.3) tilasto-ohjelmistoilla. Myyntiä tai asiakasmääriä mittaavia aineistoja analysoitiin indeksin pisteluvuilla. Kokonais- ja reseptiasiakasmäärälle sekä reseptiasiakkaille keskimäärin toimitettujen reseptien lukumäärälle laskettiin myös tilastollinen merkitsevyys lineaarisella regressioanalyysillä 95 % luottamusvälein. Kyselytutkimuksen lopputulosmuuttujista tehtiin kuvaileva tilastoanalyysi frekvenssijakaumien ja prosenttiosuuksien avulla. YA:n verkkopalvelun käyttö lisääntyi merkittävästi tarkastelujaksolla 2018 – 2020. Kokonais- ja reseptiasiakasmäärän muutokset koronapandemian aikana olivat tilastollisesti merkitseviä. Pandemian vaikutus verkkopalvelussa vastasi pandemiaa edeltävän lineaarisen kehityksen perusteella kokonaisasiakasmäärässä 6 kuukauden ja reseptiasiakasmäärässä yli 3 vuoden kehitystä. Apteekin verkkopalvelun käyttö ja tiettyjen koronasairauden hoitoon median mukaan soveltuvien valmisteiden myynnit lisääntyivät merkittävästi kevään 2020 aikana. Tiepan chat-palvelua käytettiin paljon terveyteen ja hyvinvointiin liittyvien kysymysten selvittämiseen. Koronapandemia lisäsi erityisesti iäkkäämpien asiakkaiden (yli 55- ja erityisesti yli 65-vuotiaiden) apteekin verkkopalvelun käyttöä. Infektioriskin vähentäminen oli tärkeä syy apteekin verkkopalvelun käyttöön. Vuoden 2020 aikana apteekin verkkopalvelussa tapahtui digiloikka. Koronapandemia lisäsi merkittävästi ja tilastollisesti merkitsevästi apteekin verkkopalvelun käyttöä ja toi sen uusiksi käyttäjiksi myös iäkkäämpiä asiakkaita. Erityisesti reseptilääkkeiden hankinta apteekin verkkopalvelusta lisääntyi. Tiepa oli tärkeä tietolähde ennen koronapandemiaa ja sen aikana. Pandemia-aikana luotettavan lääkeinformaation tarve korostuu. Jatkotutkimuksissa on tärkeä tutkia apteekin verkkopalvelun käytön ja asiakasryhmien muutoksia sekä asiakkaiden kokemuksia verkkopalvelusta osana YA:n monikanavaista apteekkipalvelua.
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(2021)Obesity is a growing health challenge in Finland. Despite the fact, that obesity is recognized as a chronic disease, it remains underdiagnosed and undertreated. In the past few years, two new anti-obesity drugs have entered the market to support the lifestyle changes Anti-obesity medication would be a natural option to support lifestyle changes, but physicians have not widely adopted the medication in their treatment patterns. The aim of this study was to understand, what are the abilities of primary care physician (PCP) to treat obesity, considering their knowledge, resources and, local care pathways. In addition, the study sought to determine the most important factors, that are involved in the initiation of anti-obesity medication. The study was conducted as a semi-structured thematic interview. A total of nine PCPs from all over Finland were interviewed for the study. Of these, three worked on the private sector and six on the public sector. The interviews were conducted during October-November 2020. The framework of the interviews was built based on the previous studies and information within a pharmaceutical company specializing in the treatment of obesity. The content was analysed with inductive content analysis. PCPs interested in the treatment of obesity raised the topic of weight quite easily in various situations and some of them mentioned that they even find it easy to bring up the subject. However, the subject is mainly brought up when the patient already has some weight-related comorbidities. Preventively, weight is less often talked about, especially because of a lack of human and time resources. Currently the most comprehensive care pathways and interdisciplinary teams are in occupational healthcare. In occupational healthcare, resources are perceived as adequate and the interdisciplinary teams works well. In most healthcare centers, a separate care pathway for the treatment of obesity had not been built. In general, knowledge of the obesity treatment was considered adequate, but education on the biological basis of obesity is needed. Most of the PCPs knew about the new anti-obesity drugs and had positive attitude towards them, but they did not prescribe the drugs themselves. The most significant barrier to prescribe the anti-obesity drugs, was the price of the products and the lack of reimbursement. In addition, experience with anti-obesity drugs is limited and the need for education is high. Currently, occupational health physicians have better abilities to treat obesity in terms of care pathways, interdisciplinary teams and, resources than PCPs in public healthcare. The conditions are also better for the implementation of pharmacotherapy as resources and care pathways enables proper lifestyle guidance alongside pharmacotherapy. Prior to reimbursement, pharmacotherapy may not be a realistic option in the public sector, and the conditions for proper lifestyle guidance alongside pharmacotherapy are not sufficient in all locations.
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(2021)Pharmacotherapy plays a key role in the treatment of many conditions. Long-term medication therapy is an essential part of treatment in many common chronic conditions in Finland, such as diabetes, asthma, and cardiovascular diseases. However, medication therapy can be burdensome to patients and thus, influence their functional capacity and well-being. Therefore, patients’ lived experience of medication and its effect on their lives has a growing interest as a research area. The primary aim of this study was to test among Finnish patients with chronic conditions the consistency of a theoretical model ‘Patient’s Lived Experience with Medicine’ (PLEM) developed by a qualitative meta-synthesis by Mohammed et al. (2016). The secondary aim was to investigate the medication-related burden experienced by Finnish patients living with different chronic conditions. Based on the results of the content analysis of the focus group discussions, this study aimed to create a new, concise measure of medication-related burden to be utilized in a population-based online survey on medication use in Finland called Medicine Barometer (Lääkebarometri) by the Finnish Medicines Agency Fimea. The study was conducted as a qualitative focus group interview in summer 2020. Participated patients with chronic conditions (n=14) were recruited through four patient organizations. Focus group discussions (n=5) were held in groups of 2-3 people over Zoom. Deductive content analysis guided by PLEM model was used for data analysis. The measure of medication-related burden was formed on the grounds of the original PLEM model, content analysis of the interviews, research literature and expertise of the research group. The results of the focus group discussions (n=5) supported the functionality of the PLEM model. Study participants (n=14) described similar experiences of medication-related burden and beliefs and practices guiding the medication taking to those presented in the PLEM model. Burden caused by medication routines and healthcare system were most emphasized of the factors contributing to medication-related burden. As a new factor contributing to the burden, medication-related eco-anxiety emerged. The new measure for assessing medication-related burden consists of 13 items to be piloted by the Finnish Medicines Agency Fimea in the summer 2021. The experiences of the Finnish patients with chronic conditions are consistent with the PLEM model. Majority of the participants did not experience such burden from their medication that would significantly interfere with their daily lives. However, experiencing higher level of medication-related burden appeared to be related to independently modifying medication regimen or even neglecting the use of medicines. PLEM model and related patient interviews served as a solid foundation for developing items for the new measure to be piloted for assessing medication-related burden. The population-based survey will provide useful data for the further development of the measure and for researching the factors contributing to the burden.
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(2021)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.
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(2021)Medication reviews have been highlighted as one of the most important strategies for improving medication safety and medication management especially in older adults. Current electronic health records document and communicate e-prescriptions but their medication use related patient information content should be extended to cover e.g. medication review documentation. The documentation should be in structured format to be useful in clinical practice and evidence-informed decision-making. The aim of this study was to identify medication review related patient information and other patient data that should be in a structured form in electronic health record systems (EHRs) at a national and organizational level. The aim was also to determine which medication review related patient information should be documented in electronic health record systems. The study was conducted as 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 of the experts on the studied subject. The Delphi rounds were conducted as electronic surveys in September-December 2020. Expert panelists assessed which medication-related patient data and other data generated by healthcare providers should be documented in a structured form in EHRs and in which national digital data system services (Kanta and My Kanta Pages) the medication review related patient information should be accessible and by whom. 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 a total of 108 medication review related patient information topics that should be documented in a structured form in EHRs and that should be available for medication reviews through EHRs. Of the topics, 39 related to medication reviews in general, 25 to adverse drug reaction symptoms, 11 to the burden of adverse drug effects, 12 to laboratory tests and other test results, 12 to medication adherence and 9 to the use of intoxicants. Structuring the data was considered as important or important to some extent in most of the presented medication review related information topics. Especially, the documentation of renal function was rated by the expert panelists as a crucial piece of information to be structured. Medication adherence information and information related to the use of intoxicants were rated as less important to be documented in a structured form than other topics. Consensus was also reached on the accessibility of medication review documentation in the Kanta and My Kanta services. The expert panel of this study had a common and strong view that data related to medication reviews should be structured in EHRs. The expert panel reached a strong consensus that almost all of the data presented in the study should be structured. Based on this Delphi study, the expert panel identified the benefits of structuring and standardized recording. Because not all data can be structured at once, further prioritization of the data identified in this study is still needed. The practical implementation of the structured information could be accomplished in the form of a checklist. The study addresses a very current problem related to the shortcomings of medication information management and overall medication management.
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(2020)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.
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(2020)Iäkkäiden määrän lisääntyminen aiheuttaa tarpeen kehittää ja tutkia uusia lääkkeitä sekä lääkemuotoja entistä enemmän. Iän tuomat fysiologiset muutokset sekä useat sairaudet voivat aiheuttaa ongelmia perinteisten lääkkeiden annostelussa. Annosteluongelmien ratkaiseminen lääkemuodon muokkaamisella voi kuitenkin aiheuttaa riskin lääkitysturvallisuudelle. Tämän pro gradu -tutkielman tarkoituksena oli tutkia iäkkäitä potilaita hoitavien lääkäreiden kohtaamia lääkemuotoihin liittyviä ongelmia. Tutkimuksen avulla pyrittiin selvittämään, kohtaavatko lääkärit hoitotyössä lääkemuotojen aiheuttamia ongelmia, ja minkälaisia ongelmia lääkärit kohtaavat. Lisäksi lääkäreiden haastatteluissa esiinnousseita teemoja verrattiin hoitajien kolmen päivän seurantajakson aikana verkkokyselylomakkeelle kirjaamiin lääkemuotoihin liittyviin käytännön ongelmiin, joita käytännön hoitotyössä palveluasumisen yksiköissä ilmeni aiemmin toteutetussa tutkimuksessa. Tutkimuksessa haastateltiin viittä lääkäriä, joilla oli kokemusta iäkkäiden lääkehoidosta. Lääkärit etsittiin tutkimukseen mukaan sosiaalisen median kautta hakuilmoituksella. Puolistrukturoidut haastattelut nauhoitettiin ja litteroinnin jälkeen niiden analysoinnissa käytettiin aineistolähtöistä sisällönanalyysiä. Tabletteihin liittyviksi ongelmiksi lääkärit mainitsivat niiden ison koon ja pintaominaisuudet, joiden vuoksi niiden nieleminen vaikeutuu. Muita ongelmia olivat tablettien tunnistettavuus, jakouurteen puute sekä sopivien vahvuuksien puute, vaikkakin yleisesti lääkäreiden mielestä eri vahvuuksia on tarpeeksi markkinoilla. Kapseleiden ongelmiksi lääkärit mainitsivat myös ison koon sekä epäselvyyden siitä, saako kapselia avata vai ei. Oraaliliuosten ongelmiksi koettiin paha maku, liian laimeat vahvuudet, lasku- ja mittaamisvirheen riski sekä sekaantumisen vaara. Lääkelaastarit jakoivat mielipiteitä, mutta niiden ongelmiksi lueteltiin muun muassa iho-oireet ja laastarin irtoaminen. Yleisesti lääkärit eivät olleet tablettien murskaamisen kannalla, mutta jokainen haastatelluista lääkäreistä totesi murskaamisen olevan joissakin tilanteissa ainoa vaihtoehto. Lisäksi lääkärit luettelivat useita lääkemuotoihin liittymättömiä ongelmia, jotka liittyivät sekä potilaaseen mutta myös terveydenhuoltojärjestelmään. Jotta lääkemuotoihin liittyviä ongelmia voitaisiin vähentää, tulisi iäkkäiden kohdalla aina arvioida lääkehoito säännöllisesti. Arvioinnin perusteella iäkkäälle voitaisiin valita hänelle parhaiten sopivat lääkemuodot ja huolehtia siitä, ettei tarpeettomia valmisteita ole käytössä. Lääketeollisuuden ja lääkeviranomaisten vastuulla on edistää lääkkeiden kehitystä ja uusien innovaatioiden tuomista markkinoille. Käytännössä lääketeollisuus voi helpottaa terveydenhuollon ammattilaisten työtä tuottamalla selkeitä lääkeinformaatiotekstejä, joilla voisi esimerkiksi helpottaa murskaamispäätöksen tekemistä.
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(2024)Medicines are essential to human and animal well-being. They do, however, cause harmful effects to the environment, humans, and animals – especially to aquatic organisms. The most significant route for pharmaceutical residues to end up in the environment is the conventional use of medicines in people. Due to ageing of the population and medicalization, the amount of medicines used to treat humans will only increase in the future. Pharmaceutical residues may also end up in the environment from production sites of pharmaceutical manufacturers, which causes harmful environmental effects locally. Also, the transport of raw materials and finished pharmaceutical preparations produces climate emissions. There is still work to be done to improve sustainability of the pharmaceutical sector. Incorporating environmental criteria in public procurement of medicines is seen as a method of advancing responsibility within the sector. In the spring of 2023, the HUS Pharmacy tender invitations included, for the first time, environmental criteria. Yet at this point, the criteria did not have a decisive role in decision-making. The aims of this study included discovering how the representatives of those pharmaceutical companies participating in the HUS tender invitations experienced the HUS environmental criteria, how they viewed the environmental criteria in public procurement of medicines in general, and which actions or incentives they considered the most effective tools in guiding pharmaceutical production towards a more sustainable direction. The study was conducted as an internet survey and video interviews. The environmental criteria of HUS were perceived as quite clear but there had been difficulties in seeking for the information needed. This was due to the limited time available and the internationality of the organizations, among other things. The respondents hoped for the adoption of uniform criteria, which would easen responding to different tender invitations and reduce the time needed for fact-finding. This kind of criteria was hoped to be prepared for in collaboration with different stakeholders, also considering internationality. Keeping environmental criteria involved in tender invitations was seen as one possible means of advancing sustainability of pharmaceutical manufacturing. Clear and agreeing views were not achieved for all questions presented, but instead the responses divided quite a lot for some questions. This is probably partly connected to the complexicity of the subject and the fact that some of the questions presented were seen as somewhat ambiguous. Altogether, it may be stated that the general atmosphere was more positive than negative towards the environmental effects being taken into account. Utilizing environmental criteria in promoting environmental responsibility of the pharmaceutical sector will be of use. But when formulating the criteria, it should be remembered that too strict criteria may result in a decline in the amount of offers to tender invitations.
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(2021)Lääkkeen elinkaaren aikana on useita toimijoita, ja matka lääkkeen valmistuksesta käyttöön Suomessa on kirjallisuuden perusteella pitkä ja monimutkainen. Lisäksi lääkevalmisteita on lukuisia erilaisia. Vaikka lääkepakkausten materiaalit ja materiaalivaatimukset tunnetaan suhteellisen hyvin esimerkiksi lääkkeiden myyntilupien tuomien vaatimusten takia, on kvantitatiivista tietoa eri materiaalivirroista lääkepakkausten elinkaaren aikana vain vähän tietoa. Tämän tutkimuksen tavoitteena oli tutkia kuinka paljon ja millaista pakkausmateriaalia lääkevalmisteen elinkaaren aikana syntyy, ja miten ympäristöasiat on huomioitu lääkepakkausten elinkaaren aikaisissa materiaalivirroissa. Lisäksi pyrittiin löytämään ehdotuksia materiaalivirtojen kehittämiseksi sekä selvittämään, miten kuluttajaa tulisi ohjeistaa lääkepakkausten kierrätyksestä. Tutkimusmenetelmäksi valittiin teemahaastattelu. Toukokuun ja joulukuun välisenä aikana vuonna 2020 aineistoksi muodostui viisi puolistrukturoitua teemahaastattelua ja kaksi kirjallista vastausta. Aineisto analysoitiin aineistolähtöisellä sisällönanalyysillä. Tutkimustulosten perusteella lääkevalmisteiden elinkaaren aikana syntyviä materiaalivirtoja ei tunneta vielä kunnolla. Tutkimuksessa korostui apteekin rooli lääkkeitä jakavana toimijana sekä lääkejätteen kerääjänä. Tukkuliiketoiminnan havaittiin keskittyneen kahdelle suurelle toimijalle Suomessa. Esteinä materiaalivirtojen kehittämiselle nähtiin kankeat myyntilupakäytännöt, jotka tekevät varsinkin pitkään markkinoilla olleiden lääkevalmisteiden pakkausmateriaalimuutokset hankaliksi. Myyntilupaprosessi koettiin kalliiksi, mikä estää esimerkiksi vain sairaala-apteekkeihin tarkoitettujen pakkausten tarjoamisen markkinoille. Muita haasteita olivat esimerkiksi ympäristönäkökulman ja potilasturvallisuuden väliset ristiriidat. Lääkkeiden myyntilupa ei vaadi ohjeistamaan kuluttajaa pakkausmateriaalien kierrätyksessä. Tutkimuksen mukaan lääketeollisuudessa on mietitty, voisiko pakkauksen kierrätyksen mainita pakkausselosteessa ilman myyntilupaprosessin läpikäyntiä. Tulisi kuitenkin tutkia, olisiko merkinnällä vaikutusta lääkepakkausten kierrätykseen. Toinen huomio lääkepakkausten kierrättämisessä on se, ovatko esimerkiksi primääripakkaukset turvallisia kierrätyksen kannalta. Jatkotutkimusta tarvitaan lisää. Tämä Pro gradu on tehty SUDDEN-hankkeen viitekehyksessä, yhteistyössä Suomen ympäristökeskuksen kanssa. SUDDEN-hanke pyrkii löytämään ratkaisuja lääkkeiden elinkaaren aikana syntyvien ympäristöhaittojen vähentämiseksi ja edistämään kestävää lääketeollisuutta.
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(2021)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.
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Lääkityslista ja Omakanta lääkehoidon hallintaa tukevina työkaluina pitkäaikaissairaiden omahoidossa (2020)Current national medicines policy in Finland highlights the importance of rational use of medicines leading to effective, good quality, equal and safe medication therapy, in which the key is on well-implemented medication self-management. The aim of this study was to find out how well people with chronic diseases are in control with their own medication therapy. The special focus was on assessing whether people with chronic conditions: 1) are familiar with the therapeutic aim of their medication; 2) have medication lists of their medicines and are those lists up-to-date; and 3) utilize Omakanta-database. The aim was also: 4) to identify which factors are associated with the utilization of medication lists. A nationwide cross-sectional Internet survey was conducted among medicine users in Autumn 2017. The link for the survey was available via the Finnish Medicine Agency’s and Pharmaceutical Information Centre’s website. In addition, members of the national medicines information network forwarded the link through their own channels. Survey respondents with chronic diseases were included in this study (n=844). The majority of the people with chronic diseases (92 %) were aware about the therapeutic aims of their medication. Of the respondents, 39 % had a medication list. Availability of medication list was associated with the age of ≥ 65-years (OR 0.223; CI 0.103-0.485) and the use of multiple medicines (OR 0.218; IC 0.127-0.376). Of the medication lists used by people with chronic disease, 44 % were in the electronic form and the majority (92 %) of all the medication lists used by people with chronic disease were reported to be up-to-date. Omakanta-database was used by 93 % of the respondents. People with chronic disease are well aware of the therapeutic aims of their medication. However, the rarely have up-dated medication lists. Omakanta-database seems to be well known and utilized among people with chronic diseases. Older people using multiple medicines should be encouraged to use and supported with the up-date of their medication lists.
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(2024)Maailman terveysjärjestö on linjannut yhdeksi lääkitysturvallisuutta vaarantavaksi tekijäksi lääkitystiedon ajantasaisuuden puutteen. Myös Suomessa on havaittu puutteita lääkitystiedon ajantasaistamiskäytännöissä. Vuonna 2023 hyvinvointialueiden muodostumisen myötä syntyi Satakunnan hyvinvointialueella tarve yhtenäistää lääkitystiedon ajantasaistamisen, lääkityksen tarkistuksen ja lääkehoidon arvioinnin käytäntöjä. Tutkimuksen tavoitteena oli kartoittaa, mitä Satakunnan hyvinvointialueen asiantuntijoiden mielestä tulisi sisältyä lääkitystiedon ajantasaistamiseen, lääkityksen tarkistukseen ja lääkehoidon arviointiin. Tutkimuksen tavoitteena oli parantaa lääkitysturvallisuutta yhtenäisen toimintamallin muodostamisella Satakunnan hyvinvointialueella lääkitystiedon ajantasaistamiseen, lääkityksen tarkistamiseen ja lääkehoidon arviointiin. Tutkimuksen tavoitteena oli myös muodostaa yhtenäinen toimintamalli lääkitystiedon ajantasaistamisen, lääkityksen tarkistuksen ja lääkehoidon arvioinnin kirjaamisesta potilastietojärjestelmään. Tutkimus suoritettiin kaksikierroksisella Delfoi-menetelmällä. Delfoi-menetelmä on laadullinen tutkimusmenetelmä, jossa tavoitteena on löytää konsensus tutkittavasta aiheesta. Asiantuntijapanelistit (n=20) rekrytoitiin Satakunnan hyvinvointialueelta ja lopulliseen paneeliin sisältyi 5 lääkäriä, 5 sairaanhoitajaa sekä 10 farmaseuttia. Delfoi-kierrokset suoritettiin maalis-huhtikuussa 2024. Tutkimuksen asiantuntijapaneelilla oli vahva konsensus siitä, miten lääkitystiedon ajantasaistaminen, lääkityksen tarkistus sekä lääkehoidon arviointi tulisi toteuttaa. Tutkimuksessa saadut tulokset olivat samankaltaisia kuin aiemmat kansainväliset tutkimukset liittyen lääkitystiedon ajantasaistamiseen, lääkityksen tarkistukseen ja lääkehoidon arviointiin. Jatkotutkimusta tarvitaan selvittämään sitä, miten lääkitystiedon ajantasaistaminen, lääkityksen tarkistus ja lääkehoidon arviointi toteutuu tutkimuksen pohjalta koostetun yhteisen toimintamallin mukaisesti. Lisäksi tutkimusta tarvitaan siitä, parantavatko tutkimuksen perusteella muodostetut yhteiset toimintamallit lääkitysturvallisuutta Satakunnan hyvinvointialueella.
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(2021)The Finnish medicine reimbursement system is complex and several different conditions required by the Health Insurance Act (1224/2004) and the Social Insurance Institution of Finland (Kela) must be met in order to receive medicine reimbursement. The understanding of medicine reimbursement criteria from the perspective of medicine users has not been studied in Finland before, and little research has been done on the subject internationally. Medicine user-oriented research on the medicine reimbursement system, both in Finland and internationally, has largely focused on the financial opportunities of medicine users to purchase medicines and their opinions on the fairness of medicine reimbursements. The aim of this study was to obtain information on the understanding of medicine reimbursement criteria and the background factors affecting it, the implementation of price, generic substitution and medicine reimbursement counselling in pharmacies, seeking advice on medicine reimbursement, and the financial difficulties of buying prescription medicines. The material used in this study was from the population survey (n=1650), which examined the activation of price competition for pharmaceutical products and customers' expectations of pharmacy operations. The understanding of medicine reimbursement criteria, the price counselling provided in a pharmacy, the effect of financial challenges on the non-buying of medicines and the use of sources of advice related to the medicine reimbursement were described as frequency distributions. The effect of background factors on the understanding of medicine reimbursement criteria was compared using the chi-square test and logistic regression analysis. About a third (31%) of respondents told that they do not understand the basis on which medicine reimbursement is usually received for prescription medicines, and 13% had unclear why they had not been reimbursed for their prescription medicine in the past year. Especially younger age, low income, low medication use, depression and other mental health problems, lack of long-term illness, and insufficient medicine reimbursement counselling in a pharmacy were found to be associated with poorer understanding of medicine reimbursement. 72% of the participants in the study felt that they usually receive sufficient information about the prices of medicines and 61% about the reimbursement of medicines when buying prescription medicines from a pharmacy. Less than half (47%) of respondents felt that they have usually received sufficient information about how the amount of reimbursement for medicines is determined. Slightly over 70% of respondents said that they are usually told about the cheapest medicine available when buying a prescription medicine and/or are suggested to switch to a cheaper one. About 60% were usually told about the difference between the two interchangeable medicines. 88% of respondents would seek information about medicine reimbursement primarily from a pharmacy or pharmacy´s online services. About 3% of all respondents in the study had not bought a medicine prescribed by a doctor for financial reasons in the last six months. Based on the study, about a third of medicine users have remained unclear regarding medicine reimbursements, and not everyone feels that they have received sufficient counselling and information about medicine prices and medicine reimbursements when buying prescription medicines from a pharmacy. Counselling from a pharmacy was found to be related to understanding of medicine reimbursement criteria. Advise on the pricing, medicine reimbursement and generic substitution should continue to be actively provided to medicine users, so that the counselling meets the requirements of the law and the knowledge of the reimbursement system of medicine users can be improved. Based on the results of this study, counselling should be targeted in particular at younger, low-income and from mental health problems suffering medicine users, as well as those who are less familiar with reimbursement issues, for example due to low morbidity or medicine use.
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(2021)Background. Parallel importing of pharmaceuticals has potential to generate significant savings but results of previous theoretical and empirical studies on the consequences of parallel importing and its ability to generate competition have been contradictory. Little research on the effects of parallel importing has been conducted in Finland. In April 2017, the reference price system in Finland was extended to also cover substitution groups determined on the basis of parallel imports. The aim of the reform was to increase competition between direct and parallel imports and thus to generate savings in reimbursement costs. However, the impact of the reform has not yet been significantly studied. Aim. The aim of this study was to examine the effects of parallel importing and the expansion of the reference price system on the price development of direct and parallel imported medicines and reference prices. The purpose was to investigate in general the price development of products and reference prices in the period following the expansion of reference price system, to examine the importance of how long a reference group was involved in the system on price development, to examine the impact of the extension of the reference price system and the market entry of a competing parallel import in particular on prices of direct imported products and to examine the importance of the number of parallel imports competing with the direct imported product on price development. Methods. Reference price decisions and lists of prices of reimbursable medicinal products were used as research material. The data was found on the website of the Pharmaceuticals Pricing Board. Quarterly price data on the prices of products belonging to the reference price groups determined on the basis of parallel imports was extracted from the data. Price data was examined from January 2016 to October 2019. Price development was monitored as percentage changes on a quarterly and annual basis. The effect of extension of the reference price system and the entry of a competing parallel import was examined using a sort of before-after set-up by comparing the price development of products before the change to the price development of products after the change. Regression analysis was used to assess the statistical significance of the variables explaining price development of products. Results and conclusions. During the period, the prices of direct and parallel imports and the reference prices decreased in most of the reference price groups. Price increases amongst the groups were very rare. Based on price development and regression analyzes, both the expansion of the reference price system and the market entry of a competing parallel import significantly reduced the prices of direct imports. However, the time that the reference group was involved in the reference price system or the number of parallel imports competing with the direct import did not have a significant impact on the price development of direct and parallel imports. It can be stated that parallel imports are likely to generate significant savings in Finland and the expansion of the reference price system has contributed to the ability of parallel imports to generate savings. However, further research on the real savings generated by parallel imports is still needed.
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(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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(2020)Liposomes are nano-sized vesicles, that are composed of a phospholipid bilayer structure. They can be utilized as drug carriers, in which case the drug is incorporated either to their hydrophilic internal cavity, or into their hydrophobic bilayer structure. For anticancer drugs, liposomal formulations have exhibited their capability in reducing adverse effects of anticancer drugs. This is achieved mainly by the enhanced permeability and retention (EPR) effect, in which liposomes accumulate into tumour tissue. However, the conventional liposomes release their drug content passively, and a proportion of drug is distributed to off-target tissues. Therefore, there is a demand to develop liposomes from which the content can be released in a controlled manner, by an external stimulus. The objectives of this master’s thesis project were to determine the potential of light-activated paclitaxel (PTX) liposomes for the treatment of lung cancer, and to optimize a dynamic cell culture system, QuasiVivo® (QV), to study the off-target effects of light-activated PTX liposomes. The hypothesis was that the induction of the light-activated PTX liposomes would increase the efficiency of paclitaxel treatment. For QV experiments, it was expected that the presence of flow would improve the viability of the cells. The encapsulation efficiency of PTX into the liposomes and the effect of the PTX incorporation into the phase transition temperature of the liposomes were determined. The stability of liposomes was determined by monitoring the liposomal size and light sensitizer absorbance during a storage period. The cells of lung cancer cell line A549 were cultured inside QV system, and their viability was monitored with two commercial cell viability assays. Incorporation of PTX decreased the phase transition temperature, but the liposomes remained stable in the studied conditions. The PTX liposome treatments with and without light activation resulted in the similar efficacy as free PTX treatment did. A549 cells failed to display superior viability inside the QV compared to static conditions. Cells cultured under lower flow rate portrayed modestly higher viability. The light-activated PTX liposomes did not improve the efficacy of PTX treatment. Neither of the flow rates were optimal for A549 cells, as the variation between experiments was high. The EPR effect is the main reason for the improved effects of liposomal anticancer drugs, therefore, it is likely that in vivo experiments would elicit the differences between the efficacy of the liposomal and free PTX. The non-existent effects of light activation on the viability are likely caused by the low total concentration of the light sensitizer in the treatment solution.
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(2023)DNA-origamit ovat pitkästä DNA-juosteesta laskostettuja nanorakenteita, jotka voidaan suunnitella monen muotoisiksi ja kokoisiksi. DNA-origamit ovat muodostuneet luontaisesti biohajoavasta materiaalista, joten ne sopivat hyvin biolääketieteellisiin tarkoituksiin, kuten lääkekantajiksi. Aiemmissa tutkimuksissa on kuitenkin huomattu, että ihmiskehon entsyymit voivat hajottaa DNA-origamin rakenteen. DNA-origamien lipidipäällystäminen on yksi keino suojata rakennetta tällaiselta entsymaattiselta hajoamiselta. Tässä tutkimuksessa DNA-origameja päällystettiin kationisilla DOTAP (1,2-dioleyyli-3-trimetyyliammonium-propaani) lipideillä. Tutkimuksen tavoitteena oli tutkia ja optimoida päällystämisprosessia. Tutkimuksessa testattiin erilaisten inkubaatioaikojen ja -lämpötilojen sekä ionisten olosuhteiden vaikutusta muodostuvaan lipidipäällystykseen. Lipidipäällystettyjä DNA-origameja altisteettiin sonikaatiolle ja ekstruusiolle, jotta havaittaisiin, voisivatko nämä menetelmät häiritä muodostunutta lipidipäällystettä. Neutraalia DOPC (1,2-dioleoyyli-sn-glysero-3-fosfokoliini) lipidiä käytettiin tutkimaan, kuinka erilaiset lipidikombinaatiot vaikututtavat päällystyksen muodostumiseen. Työssä käytettyjä tutkimusmenetelmiä olivat dynaaminen valonsirontamenetelmä, agaroosigeelielektroforeesi ja transmissio-elektronimikroskopia. Kokeissa lipidipäällystäminen onnistui ionittomissa olosuhteissa ja 30 minuutin inkubaatioaika huoneenlämmössä oli riittävä päällystyksen muodostumiselle. DNA-origami-partikkelit olivat täysin päällystettyjä, kun käytettiin stoikiometristä suhdetta nDOTAP/nORIGAMI ≈ 20 000. Tällöin lipidipäällystetyt DNA-origamit muodostivat mikrometrien kokoisia rykelmiä. Kun käytettiin stoikiometristä suhdetta nDOTAP/nORIGAMI ≈ 10 000, TEM kuvissa oli havaittavissa päällystämättömiä ja satojen nanometrien kokoisia päällystettyjä DNA-origameja. Kylpysonikaation havaittiin häiritsevän aggregoituneita lipidi-DNA-partikkeleita muodostaen pienempiä partikkelirykelmiä. Kun käytettiin DOPC lipidejä, huomattiin, että ne eivät muodostaneet yhtenevää lipidipäällystettä DNA-origamien ympärille. Kokeissa ionisten olosuhteiden havaittiin epästabiloivat DNA-origamien päällystysprosessia, joka johti partikkelien kokojakaantuman lisääntymiseen. Tässä työssä DOTAP lipidejä käytettiin päällystämään DNA-origameja ja lipidimäärää kasvattamalla saatiin muodostettua monesta lipidikerroksesta muodostuneita lipidi-DNA-komplekseja. Sonikaation havaittiin olevan potentiaalinen menetelmä partikkelikoon pienentämiseen. Muita menetelmiä, kuten NTA-analyysia (engl. Nanoparticle Tracking Analysis), tarvitaan kuitenkin vahvistamaan muodostuneiden lipidi-DNA-partikkeleiden koosta saatuja tuloksia.
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(2020)Left ventricular hypertrophy (LVH) takes place when cardiomyocytes respond to excessive stress by growing in size. Cardiomyocytes have a very marginal capability to proliferate, which is why hypertrophic growth is almost their only option to meet the requirements of increased workload. In the long run, however, LVH leads to further problems, such as cardiac failure and an increased risk of myocardial infarction. Hypertension is the most prevalent cause of LVH, and its current treatment relies on antihypertensive drugs. They decrease the workload of the heart and therefore alleviate symptoms but have very little effect on the built damage and remodeling. Understanding the details of cellular level signaling pathways and genetic expression in LVH is crucial for future drug development. Regulation of gene expression is a very complex process, which involves more than just DNA being translated into a protein. In this project, two types of factors participating in this regulation were in focus: long non-coding RNAs (lncRNA) and transcription factors GATA4 and FOG2. LncRNAs are RNA sequences of more than 200 nucleotides that do not code for any protein final products themselves but are involved in chromatin remodeling as well as transcriptional and post-transcriptional gene regulation. They are highly organ-selective, which makes them potential targets for drug development. Our group has previously found a selection of cardiomyocyte-selective lncRNAs, which share a similar expression pattern in neonatal mouse hearts. In this project, three of them were silenced in a primary cardiomyocyte culture while simultaneously hormonally inducing hypertrophy. The goal was to see whether these lncRNAs have an effect on the hypertrophic response and apoptosis in the cardiomyocytes. Transcription factors are proteins with partially similar activities to lncRNAs; they regulate, which genes are expressed under certain circumstances. GATA4 is an important transcription factor in the heart as it targets various developmental and functional genes in cardiomyocytes. FOG2 is a cofactor of GATA4; interaction between them regulates the activity of GATA4. Our group has recently developed a selection of compounds that affect protein-protein interaction between GATA4 and NKX2-5, another important transcription factor. The second part of the project was to set up and optimize a compound screening assay for GATA4-FOG2 interaction. The results showed no change in hypertrophic response when the lncRNAs were silenced. Other experimental designs could still reveal if they have effects that could not be seen with these protocols. The silencing had no effect on apoptosis. As for the GATA4-FOG2 interaction experiments, transfecting COS-1 with GATA4 and FOG2 plasmids in a ratio of 10:1 resulted in a signal suitable for compound screening. Initial compound screening results indicated the compounds may have an effect on GATA4-FOG2 interaction, but further studies are needed before drawing conclusions.
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(2024)MDMA is an illegal stimulant known for its empathy-enhancing effects. Its positive effects are mainly based on increasing the concentrations of monoamines such as serotonin (5-HT), dopamine (DA) and norepinephrine (NE). In addition to its positive effects, MDMA can cause adverse effects such as hyperthermia and neurotoxicity. Especially with long-term use, MDMA can cause serotonergic and dopaminergic neurotoxicity. In addition, there are also indications of MDMA-induced neurotoxicity in systems where gamma-aminobutyric acid (GABA) functions as the main neurotransmitter. Glutamate decarboxylase (GAD) 67 is an enzyme that synthesizes GABA from glutamate and is a specific marker for GABAergic cells. The amygdala is a nucleus in the brain that regulates anxiety and fear response. In addition to GABAergic interneurons, there are also glutamatergic cells in the basolateral nucleus (BLA) of the amygdala, however in the central nucleus (CeA) there are only GABAergic cells. Disturbances in the GABAergic system can predispose to psychiatric diseases such as anxiety. The aim of thisstudy was to investigate the effects of MDMA (20 mg/kg) on the number of GAD67-positive cells in two nuclei of the mouse amygdala, BLA and CeA. In addition, this study aimed to examine the importance of the dose (4 or 16 injections) for neurotoxicity and the duration of the effects (2, 7 or 30 days). Adolescent wild type mice were divided into 12 groups according to the treatment (MDMA or saline), dose and timepoint. After euthanasia, the brain sections at the level of the amygdala were collected and stained with an immunohistochemical method and imaged using a confocal microscope. This study showed that MDMA reduced the number of GAD67-positive cells in the BLA when mice were given a total of 4 injections. This effect lasted up to 30 days. In contrast, MDMA did not reduce the number of GAD67-positive cells in the BLA in mice that were given 16 injections. Also, MDMA did not decrease the number of GAD67-positive cells in the CeA, regardless of dose. Statistical significance could have been improved, for example, by using more mice or analysing more sections from each individual animal. It is important to continue studying the effects of MDMA to better treat and prevent its adverse effects. In addition, increased understanding would urge users to exercise caution when using MDMA.
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(2024)Medication safety is critical in health and social care, and community pharmacies significantly participate in managing medication safety risks. The information systems in community pharmacies are pivotal, yet understudied tools supporting this task. This study investigates community pharmacy information system-related medication safety incidents reported by Finnish community pharmacies, focusing on how information systems act as defences or contributing factors to such incidents. The study is based on 1222 information system-related medication safety incident reports from the HaiPro system between October 2022 and September 2023. The structured fields of the incident reports were analysed with descriptive quantitative analysis using Microsoft Excel. An abductive content analysis was performed on narrative texts of the incident reports to identify information system-related risks or defences in the incidents. Reason's human error theory acted as a theoretical framework in this study. Results indicated that in 96% (n=1168) of the incidents, information systems were contributing factors, primarily during the selection of medicinal products for dispensing (n=945). The most common issue was the community pharmacy information system not offering generic substitutes for market-exited medicinal products (n=282). Another notable issue was compatibility problems between community pharmacy information systems and Electronic Patient Record (EPR) systems or between different community pharmacy information systems (n=154). Conversely, barcode recognition emerged as the most reported defence, preventing errors in 96% (n=52) of defensive cases (n=54). The study underscores the dual role of community pharmacy information systems in medication safety both as defences and contributing factors. It highlights the need for continuous system development and possible regulatory changes to enhance their effectiveness as defences. Future research should explore these systems' roles using alternative methodologies to address underreporting and better quantify their impact on medication safety.
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