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Faculty of Pharmacy

 

Recent Submissions

  • Eronen, Sini-Tuulia (2022)
    Introduction: When people age, the composition of sleep changes and sleep becomes more sensitive to external disturbances, making insomnia also more common. Medication is not the first-line treatment option for insomnia. Benzodiazepines or benzodiazepine receptor agonists for the treatment of insomnia have been in the focus of past studies. The content of the dosing instructions for the supplied medicines has not been studied. The dosing instructions should provide clear instructions on how to dose the medicine prescribed to the patient. The aim of this study was to investigate the content and quality of dosing instructions prescribed for the treatment of insomnia for Finns aged ≥75 years in 2020 based on the prospective reimbursement register data by the Social Insurance Institution of Finland (Kela). Materials and methods: The reimbursed purchases of all medicines by persons aged ≥75 years from 1.1.2020 to 31.12.2020 were selected by ATC code from the medicines data according to the Insomnia: Current Care guidelines. The data was gathered from Kela’s dispensations reimbursed under the National Health Insurance scheme. The dataset consisted of 1,080,843 delivery lines, which were screened, and 328,285 lines were included in the analyses. Dosage instructions were reviewed according to the following predetermined five categories: frequency of use, dose, timing, warnings or remarks, and inappropriate instructions. In addition, 1000 dosing instructions were randomly derived to study the phrasing and appropriateness of the dosing instructions in more detail. Results: In 2020, an average of 3.8 reimbursed hypnotic drug deliveries were made per elderly person. Of the deliveries, 68% were for women. 52% of drug deliveries were partially made later and not by original prescription. In the hypnotic dataset, the three most administered drugs were zopiclone (41%), mirtazapine (34%) and zolpidem (12%). The dosage was prescribed in 98–99% of the dosage instructions. Dosing schedule was reported in 83% of dosing instructions and regularity of use was reported in 57% of them. Only 3-6% of the dosing instructions had comments or warnings. 1–2% of the dosing instructions were vague. The duration or regularity of use was clearly indicated in 5% of the dosing instructions. Only 0.1% of dosage instructions contained instructions for discontinuation or reduction. Discussion: The dose and timing of administration were well reported, but the frequency of use was reported in only about half of the dosing instructions. Only few dosing instructions contained remarks or warnings even though hypnotics are at risk for the elderly. Among the three most administered drugs for the treatment of insomnia were two benzodiazepine receptor agonists, zopiclone and zolpidem. However, they may not be suitable for the elderly according to Beers criteria and their use should be avoided. During 2020, an average of four drug deliveries were made per elderly person for the treatment of insomnia, which may indicate prolonged hypnotics use. In addition, more than half of the deliveries were partially made later and not by original prescription. Thus, several drug packages are prescribed for prescriptions, although the drug-based treatment of insomnia should only be short-lived. Conclusions: There are significant deficiencies in the contents and quality in the dosing instructions for drugs delivered to the elderly for insomnia. Minimum information on dose, timing and duration of use was not found in all dosing instructions in this study. Understandable dosing instructions and the reduction in the amount of medication in the prescription could have a further effect on reducing the long-term use of hypnotics, also increasing the safety of medicine use in the elderly.
  • Lindstedt, Hanna (2022)
    Drug-induced liver injury (DILI) is a relatively rare hepatic condition that can be classified as predictable and unpredictable. However, DILI is a primary reason for drug withdrawals, post-marketing warnings, and restrictions of use. DILI is a problem for the drug users but also for the pharmaceutical industry and regulatory bodies. From the perspective of patients' and clinicians', DILI is the major cause of acute liver injury. At present, a major problem predicting DILI in drug discovery is a poor understanding of its mechanisms as well as the complexity of DILI pathogenicity. The main mechanism behind DILI are alterations in bile acid homeostasis, oxidative stress, and mitochondrial dysfunction. More than 50 % of drugs causing DILI are causing mitochondrial impairment. If the normal function of mitochondria is disturbed, the energy production of the cell decreases, and cell function decline leading eventually to the cell death. In this study prediction of mitochondrial toxicity was studied using cryopreserved primary hepatocytes of humans and rats. The aim of the study was to clarify if there are interspecies differences in the prediction of toxicity but also investigate possible differences in the mechanisms behind hepatotoxicity by using three well-known compounds toxic to mitochondria. To determine these differences, total cellular ATP was measured after 2- and 24- hour exposure time to gain information on overall viability and possible adaptive responses. Mitochondrial energy pathways were studied as a real-time monitoring acute exposure of test compounds. Morphology, location, and possible adaptive response of mitochondria were studied using a fluorescent probe and antibody staining combined with high content imaging (HCI). Overall, primary rat hepatocytes were more sensitive to the test compounds than human hepatocytes. Also, there were differences between human hepatocyte batches that may reflect the metabolic differences between hepatocyte donors. Immunolabeling did not bring any additional values compared to the fluorescent probe staining in the study of morphology of mitochondria. Additionally, it was noticed that treatment with paraformaldehyde significantly changed the hepatocyte mitochondria morphology. Overall, more effort is needed to develop image analysis of mitochondria morphology. Finally, studying mitochondrial morphology has proven to be difficult, and this study did not unfortunately reveal any information about the adaptive responses of mitochondria for drug-induced liver injury.
  • Lahti, Aapeli (2022)
    Lääkeaineiden niukkaliukoisuus on yhä enemmän esiintyvä ongelma lääketeollisuudessa. Erityisesti BCS ryhmän II lääkeaineet ovat potentiaalisia liukoisuusominaisuuksia parantaville menetelmille. Tässä työssä näistä menetelmistä keskitytään nanokiteen, ko-kiteen ja ko-amorfisen systeemin muodostukseen ja lääkeaineena käytetään inodmetasiinia (BCS ryhmä II). Kyseisillä menetelmillä on onnistuttu parantamaan indometasiinin liukoisuusominaisuuksia, mutta vertailevia tutkimuksia ei ole aiemmin tehty. Nanokide valmistettiin märkäjauhamalla käyttäen poloksameeri 188 -stabilisaattoria. Ko-kiteen valmistuksessa käytettiin liuottimen haihdutus -menetelmää ja ko-muodostajana sakariinia. Ko-amorfisten systeemien ko-muodostajina käytettiin l-tryptofaania ja sitruunahappoa ja valmistus toteutettiin kuulamyllyllä jauhamalla. Karakterisointimenetelmillä (DLS, DSC ja XRPD) oli mahdollista todentaa nanokiteillä ja ko-kiteillä halutut ominaisuudet (partikkelikoko ja kiderakenne). Ko-amorfinen systeemi ei työssä käytetyllä menetelmällä saavuttanut amorfista rakennetta kummallakaan ko-muodostajalla. Vaikka jauhe osittain muuttui kellertäväksi (viitaten amorfiseen indometasiiniin) olivat XRPD:n ja DSC:n tulokset kiteiselle aineelle tyypillisiä. Nanokiteellä ja ko-kiteellä saavutettiin puhdasta indometasiinia parempi ominaisliukenemisnopeus sekä liukenemisnopeus jauheesta lapamenetelmällä. Systeemien välisessä vertailussa huomattiin, että nanokiteellä oli parempi liukenemisnopeus molemmissa kokeissa. Ero on selkeämmin nähtävissä lapamenetelmässä: pieni partikkelikoko mahdollistaa suuren suhteellisen pinta-alan liukenemista varten. Systeemien fysikaalista stabiilisuutta tutkittiin yhdeksän kuukauden ajan suljetussa muoviastiassa laboratorio-olosuhteissa (huoneenlämpö ja normaali ilmankosteus). Kummassakaan systeemissä ei ollut nähtävissä kiderakenteen muutoksia. Nanokiteillä oli havaittavissa lievää partikkelikoon kasvua, mikä on selitettävissä ennen koetta tehdyn sekoituksen tehottomuudella
  • Kuosmanen, Hanna (2022)
    More and more drugs for the treatment of lung cancer are entering the market with limited research evidence and high cost. However, health care resources are limited. To provide rationale and sustainable treatment for all patients, the need for health technology assessments has increased. International value frameworks with varying uses, structures, and components have also been developed to help assess the value of drug therapies. The purpose of the study is to illustrate how physicians, authorities, and pharmaceutical industry experts define the value and the effectiveness of drug therapy. The study also aims to chart the attitudes of health care professionals towards international value assessment frameworks and to describe the current challenges in health technology assessments focusing on lung cancer therapy. In addition, the purpose of the study is to evaluate the importance of therapeutic and economic evaluation of lung cancer therapies. The research material includes interviews with physicians (n=2), authorities (n=3), and pharmaceutical industry experts (n=5). The interviews were conducted as an individual (n=8) and pair interviews (n=1). The interview method used was a semi-structured thematic interview. The interviews were analyzed by using inductive and abductive content analysis and theming. The theoretical framework in the study was related to the challenges of assessing the therapeutic and economic value of pharmacotherapies. According to the study, the value and effectiveness of drug therapy are determined in a varied and perspective-dependent manner. The value of drug therapy can be divided into three dimensions, which were therapeutic, social, and economic impact. Treatment’s effectiveness was primarily determined by the health benefits gained and by the effects the therapy has on patients, society and care pathways. Based on the data, the current challenges of the therapeutic and economic evaluation of pharmacotherapies are related to the implementation methods and criteria of evaluation and decision-making, resources, cooperation needs, scientific evidence, ethics, the structure of the health care system and legislation. Based on the results, physicians, authorities, and pharmaceutical industry experts have different opinions of the need for cooperation. The interviewees also evaluated differently the status of the current development activities and the importance of international evaluations. There were also differences in the opinions on how important the therapeutic and economic evaluation of lung cancer therapies was considered. If the importance was considered low, the importance of the evaluations was expected to increase only after the refinement of treatment recommendations and guidelines. According to the data, the international value frameworks are not actively used in Finland and their significance will be considered insignificant in the future as well. The usefulness of the value frameworks was primarily limited due to structural factors, the assessment of reliability and the current evaluation system in Finland. The benefits of the value frameworks were primarily related to the coherence of the evaluation process, easing the evaluation process and improving patient equality.
  • Korventausta, Susanna (2022)
    Etätyö yleistyi maaliskuussa 2020 äkillisesti COVID-19 pandemian seurauksena maailman terveysjärjestö WHO:n suosituksesta. Etätyö on ollut ennen koronapandemiaa harvinaista lääketeollisuudessa, joten etätyötä lääketeollisuudessa on tutkittu hyvin vähän. Etätyön on arvioitu jäävän pysyväksi ratkaisuksi, joten on ajankohtaista tutkia etätyön soveltuvuutta ja tehokkuutta lääketeollisuudessa. Etätyöntekijöiden tuottavuus kasvaa yleensä huomattavasti. Työpaikalla koetaan jatkuvasti keskeytyksiä, melua ja muita häiriötekijöitä, joiden lisäksi työmatkat kuormittavat työntekijöitä. Etätyöntekijät säästyvät suurimmalta osalta näistä ongelmista, jolloin suurempi osa heidän työpäivästään kuluu varsinaiseen työntekoon. Valtaosa etätyöntekijöistä tekee etätyötä osan työajastaan. Tutkimuksen tavoitteena oli selvittää kokemuksia etätyöstä, etätyön soveltuvuutta ja etätyön tehokkuuteen vaikuttavia tekijöitä lääketeollisuudessa. Tutkimus on toteutettu Orion Oyj:n Suomen toimipisteissä. Tutkimuksen toteuttamistapa oli kvantitatiivisen ja kvalitatiivisen kyselytutkimuksen yhdistelmä. Yhdistämällä kvantitatiivisia ja kvalitatiivisia kysymyksiä pyrittiin saamaan tarkempia tietoja kuin pelkällä kvantitatiivisella tutkimuksella voitaisiin saada. Kysely oli avoinna 15.11.–26.11.2021. Vastausprosentiksi saatiin 34,9 %. Etätyön merkittävimmiksi hyödyiksi havaittiin työ- ja vapaa-ajan joustavampi yhteensovittaminen ja se, että etätyössä keskittyminen on parempaa. Kommunikaation koetaan onnistuvan hyvin etätyössä, mutta kasvokkain tapahtuvaa kommunikaatiota pidetään myös tärkeänä. Esimerkiksi kehitys- ja ideointipalaverit olisi hyvä järjestää mahdollisuuksien mukaan kasvokkain. Lisäksi hiljaisen tiedon siirtyminen on vähäisempää etätyössä. Etätyö soveltuu hyvin tutkimus- ja tuotekehitystyöhön, eikä sen koeta heikentävän merkittävästi kykyä innovoida. Tulosten perusteella etätyötä haluttaisiin tehdä enemmän kuin 40 % työajasta ja etätyötä pidetään tehokkaana työskentelytapana. Kyselyssä ei selvitetty, minkälaisia etätyömääriä vastaajat ovat tehneet vahvan etätyösuosituksen aikana. Osa vastaajista on saattanut olla muita enemmän lähitöissä, mikä voi vaikuttaa tuloksiin. Saadut tulokset olivat kuitenkin samansuuntaisia kuin aikaisemmissa tutkimuksissa. Suurin osa tähän kyselyyn osallistuneista oli erittäin kokeneita ja työnsä hyvin osaavia työntekijöitä, mikä voi lisätä etätyömyönteisyyttä tuloksissa.