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  • Rantanen, Heta (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.
  • Horelli, Mari (2015)
    The purpose of this qualitative material thesis was to describe and summarize the pharmaceutical industry of pharmaceutical company Orion Oyj years between 1899 and 1998 in form of historical study. Previous publications concerning Orion's history have not had precisely industrial point of view. The study is mostly arranged by pharmaceutical forms and additionally some Orion's pharmaceutical products are displayed exemplary and their characters are analyzed. Also development of excipients and package materials are examined briefly. The notices of development of Orion's industrial pharmacy are constantly put into perspective by comparing it to the international industrial pharmacy. Analysis begins in 1899 due to the first finnish pharmaceutical company establishment which also had influences on the starting points of Orion. The study ends in 1998 because of Finland's associaton of European Union in 1995 which also had influences on the Orion's business. The material of the study consist of Orion's public documents including among others Orion's personnel journals, product indexes, sheets, history books and the other produced material of Orion. The material was gathered in the archive of Orion in Espoo during some weeks between October 2013 and Juny 2014. The material of Orion was compared to scientific literature in order to emphasize their worldwide influence. The most of the scientific reference material includes articles but some industrial pharmacy handbooks have been also used because of difficulties of having historical articles. According to the hypothesis the significance of Orion's pharmaceutical industry was minor on the scale of international pharmaceutical industry. The contacts to the foreign industrial countries and compliance with the guidelines of FDA and European Pharmacopoeia were on focus in Orion's aim to accompany international development of industrial pharmacy. One of the important themes in Orion's business was the transform from multi industry to the special industry which was supported by rationalization of production introduced in 1950's. In the context of quality control there have been many projects put in practise especially in 1960's and 1970's, for example the GMP-guidelines introduction, the trading licence system of the pharmaceuticals and the renovations of all the production rooms.Though the pioner of the industrial pharmacy, The United States, was in the quality control even several decades in advance of Finland and consequently Orion. Orion's major products were in the company's program with a licence system. Maybe the most considerable efforts have been made to advance conventional tablet production for example by enhancing equipment and process conditions. Contrary to conventional tablets pharmaceutical formulations like patches and soft capsules have been in Orion's program mainly to complete the company's selection.Some pharmaceutical forms were possible to produce in Orion quite early, for example vaccinations since 1940's and sterile eye drop producing since 1950's. In the last decades of this study, 1980's and 1990's, Orion was focused on the projects like Easyhaler and some own brand name drugs.
  • Monni, Reetta (2022)
    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.
  • Holopainen, Emmi (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.
  • Kiljunen, Sanna (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.
  • Yliniemelä-Sipari, Sanna (2022)
    Tämän tutkimuksen päätavoitteena oli selvittää Bayer Oy:n Turun tuotantolaitoksella käytettävän CAPA-prosessin kehittämiskohteita. Tutkimuksessa pyrittiin erityisesti selvittämään, kuinka korjaavien ja ehkäisevien toimenpiteiden eli CAPA-toimenpiteiden toteuttamista voidaan tehostaa ja mitkä tekijät vaikeuttavat aikataulussa pysymistä. Lisäksi tavoitteena oli etsiä syitä myös sille, miksi juurisyyanalyysi ja todellisten juurisyiden löytäminen koetaan haastavaksi. Tutkimusmenetelmänä käytettiin puolistrukturoitua teemahaastattelua, johon valittiin tavoitteellisella otannalla 10 tuotantolaitoksella työskentelevää asiantuntijaa. Haastattelut toteutettiin videohaastatteluina etäyhteyden kautta. Aineiston laadullinen analyysi tehtiin deduktiivisesti ATLAS.ti -ohjelmaa apuna käyttäen. Tutkimuksen tulosten perusteella CAPA-prosessin kehittämiskohteet voidaan jakaa neljään pääkategoriaan: suunnittelu ja resurssit, järjestelmä, koulutus sekä yhteistyö ja merkitys. Keskeiseksi kehittämiskohteeksi nostettiin selvitys- ja toteuttamisvaiheiden suunnittelu, niiden toteutumisen seuranta sekä riittävien resurssien (aika, henkilöstö) varmistaminen. Lisäksi sähköistä Dev@com-dokumentointijärjestelmää tulisi kehittää niin, että se tukee CAPA-prosessin eri vaiheita ja on helppokäyttöinen sekä yhteinen kaikille CAPA-tapauksille. Juurisyyanalyysissä hyödynnettävien menetelmien ja työkalujen käyttöön toivottaisiin lisäkoulutusta, jonka lisäksi CAPA-prosessin tavoitteita tulisi selventää. Myös yhteistyön lisääminen yli osastorajojen ja vastuun jakaminen useammalle henkilölle koettiin tärkeiksi keinoiksi kehittää CAPA-prosessia ja lisätä sen merkitystä eri työtasoilla ja koko tuotantolaitoksella. Tutkimuksen tulokset ovat linjassa kirjallisuudessa esitettyjen havaintojen ja mielipiteiden kanssa ja siten mahdollisesti yleistettävissä muihin lääkeyrityksiin tai lääkinnällisiä laitteita valmistaviin yrityksiin. Yleistettävyyttä voitaisiin parantaa vielä laajentamalla tutkimusta muihin lääkeyrityksiin. Tämä tutkimus on yksi ensimmäisistä julkaistuista laadullisista tutkimuksista, jossa saatiin hyödyllistä tietoa siitä, mikä auttaa lääkeyrityksiä tehostamaan CAPA-prosessia ja tukemaan toiminnan jatkuvaa parantamista.
  • Laine, Kauri (2023)
    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.
  • Tikkanen, Johanna (2020)
    Between 5% and 57% of patients experience an adverse drug event during their hospitalization. Reducing medication errors can help prevent adverse drug events. A particular risk for medication errors arises when a patient moves between home and care centers if accurate medication information is not transferred with the patient. Medication reconciliation is a process to ensure accurate and comprehensive medication information across transitions of care. The aim of the study was to find out how many and what kind of discrepancies can be detected by performing medication reconciliation in a primary care unit. In addition, pharmacists and nurses experiences of the medication reconciliation process and the medication reconciliation form were examined. Both quantitative and qualitative data were used in the study. Quantitative study data consisted of all Medication reconciliation forms (PASQ) completed in January-June 2014. Data were analyzed using quantitative descriptive methods. The qualitative research material consisted of six individual interviews conducted in June 2014. The material was subjected to inductive thematic content analysis. Patients (n = 117) had a mean age of 81 years and almost all (n = 105) had at least six regularly used medications after medications were reconciled. Almost every patient (n = 115, 98.3%) had at least one discrepancy in their medication compared to the patient information system. On average, patients had seven discrepancies in their medication lists. The most discrepancies were associated with psycholeptics (9.5% of all discrepncies). The most common types of discrepancies were new drug (45.4% of all discrepancies) and discontinued drug (19.6%). Nurses and pharmacists saw the medication reconciliation process as an important part of successful patient care. Challenges associated with reconciling medications were caused by lack of time, the fragmentation of information systems and the health status of patients (information given by patients could not be trusted). Only one-third of the patients were interviewed, although international publications on medication reconciliation strongly emphasize patient involvement. The results of this study are in line with previous research and confirm the view that medication reconciliation should always be done across all transitions in care. The role of the patient as part of the medication reconciliation process should be further emphasized in the future, as only interviewing the patient can provide a true picture of the patient's medication.
  • Blåfield, Karla (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.
  • Kallio, Rosanna (2017)
    A large part of patient safety incidents in health care is related to medicines and medication treatment. Medication safety is an important part of patient safety. In particular, transitions of care endangers continuity of care and patient safety. A poor flow of information between health care units increases a risk of medication errors. An accurate and up-to-date medication list can improve transfer of correct medical information with the patient. In addition to the medication list other organization-level defences are important to patient and medication safety. This study is part of a larger regional development project concerning reformation of service delivery in health and social care. One of the purposes of the project is to integrate health and social services of municipalities in central Uusimaa (Hyvinkää, Mäntsälä, Pornainen, Järvenpää, Nurmijärvi and Tuusula). The aim of this study was to investigate what kinds of medication lists are available in these municipalities and to design a medication list maintained by the patient which is regionally shared. The second aim of the study was to identify defences used by the municipal healthcare systems and to develop a medication management process model for the municipalities. The material consisted of medication lists from the municipalities participating in the study. Twelve (12) lists were selected for analysis. The medication list of Lääkekortti.fi was also included in the analysis (N=13). Data of the defences was collected by a questionnaire. In Hyvinkää the material was collected from primary health care and Hyvinkää hospital. Both the medication list and the defence data were systematically reviewed and collected in a Microsoft Excel table. The regional medication list for patients was developed based on the medication list data and the existing literature. The process model for medical treatment was developed based on the defence data. Almost every medication list contained space for personal data (n=11) and basic medication information, such as the name of the drug (n=12), strength (n=12) and dosage (n=13). Regular medication was usually separated from as-needed medication (n=8). Only two of the lists had a column for periodic medication. There were only two lists with columns for over-the-counter medicines and herbal products. Less than half of the lists (n=5) had space for indication. According to the survey, most of the defences listed in the questionnaire were used in all or almost all municipalities. According to the responses, medication lists, for example, are regularly reviewed. Some gaps in defences also emerged. Only in two municipalities high-alert medications were identified. Also only in two municipalities attention was paid to the storage of look-alike medicines. Written instructions for managing medication errors was available only in two municipalities. There are many different medication lists available in health care. A regionally shared medication list maintained by the patient can improve the transfer of the up-to-date medical information with the patient. The list must be comprehensive and easy to use. Both the patient and the healthcare professionals should be responsible for maintaining the accurate medication list. Most of the defences asked in the questionnaire have been taken into account in pharmacotherapy plans. In practice, however, the implementation of defences is unclear. For example patients' medication lists often contain errors even though lists should be reviewed regularly. There should be exact instructions as well as clearly defined roles and responsibilities for medication reconciliation. More attention should also be paid to the use of high-alert and look-alike medicines. Since errors occur despite the defenses, every health care unit should have written instructions in case of medication errors.
  • Rantanen, Ilona (2023)
    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.
  • Sjöblom, Annika (2015)
    Background: Medication errors are the most important individual factor that jeopardizes patient safety in human care. The patient's medication process is a chain of successive operations which involves different health care providers and the medicine user. All the stages of the medication process are susceptible to the medication errors. Medication errors are approached from the system's point of view by James Reason`s (1990) theory of Human Error. Instead of blaming individuals the theory concentrates on developing operations models which enable identification of medication errors in the organizations. The development of medication safety culture in the human medication has led to systems which tolerate human mistakes and prevent errors. The increasing number of animals and pets and their changing status in the society have raised discussion about the medication safety in veterinary care. Little research has been conducted in this field. Objective: The objective of the study was to identify the most typical veterinary medication errors and their root causes. The medication management processes of veterinary care can be developed safer by becoming aware of the root causes of medication errors. Study design and data: All the cases investigated by the Assessment Board for Damages in Veterinary Practice in 2002-2013 considering medication errors (n=79) were analysed with the help of the structured data collection sheet by using descriptive statistics. The most typical cases were studied more in detail by using simplified Root Cause Analysis (RCA). Results: The medication errors found were related to the care of dogs (n=34), horses (n=26), bovines (n=10), cats (n=7) and pigs (n=2). The most general therapeutic groups that had caused medication errors were antibacterials for systemic use (17% of all the medicines related to the medication errors), NSAIDs and antirheumatic drugs (12%), neuroleptics and tranquillizers (12%), and analgesics (12%). Of the drugs, 39% were high alert medicines. Of the errors, 36% were related to the off label use (usage deviating from the summary of product characteristics, SPC). The error types which appeared most commonly in the cases were wrong route of administration (18% of all the medication errors), wrong dose (16%) and untreated diagnosed conditions left without the medicine by the veterinarian (15%). Because of the character of the data the majority of the medication errors occurred in the beginning of the medication process. It was estimated that 81% of the medication errors would have been preventable. Some of the root causes found were the lack of the commitment to the established care practice, environmental factors, communication problems, availability of tools, hurry and factors related to management, information and staff. Conclusion: The material of Assessment Board for Damages in Veterinary Practice gives valuable information about the veterinary medication errors. It is possible to influence the root causes of veterinary medication errors by paying attention to the management related factors and communication in veterinary care and improving access to therapeutic guidelines and electronic databases, and by expanding the electronic prescribing to veterinary care. The highest priority is to get Pharmaca Fennica Veterinaria to an electronic form.
  • Koskinen, Kati (2013)
    Ensuring patient and medication safety is a widely acknowledged challenge in health care. Key concepts in medication safety are: a patient safety incident, a safety barrier, and a medication error. A patient safety incident is an incident which has led or could have led to harm for the patient. A safety barrier is a structure built into the medication use process, and it is designed to improve medication safety. A medication error is a deviation from the medication process. The medication safety of cancer patients is especially important. Chemotherapeutic agents usually have a narrow therapeutic index and they have toxic side effects even in therapeutic doses. Accordingly, chemotherapeutic agents are classified as high alert medications. This means that they have an increased risk for patient harm if used improperly. Cancer patients are often elderly people and they have comorbid diseases. As a result, they are more susceptible to adverse drug effects. Moreover, the use of anticancer drugs varies between patients and the different indications of a drug, and supportive therapies are often needed. Thus, cancer pharmacotherapy is complicated. In this registry study, safety in the medication process of cancer treatment was studied using voluntary patient safety incident reports in one university hospital district in Finland. The aim of this study was to describe medication errors in cancer treatment, and safety barriers in the medication use process. The reported medication safety incidents were analysed by combining quantitative and qualitative methods. Altogether 176 incident reports were analysed relating to the use of anticancer drugs and supportive therapies. The most common medication errors were administration (27 %), prescribing (11 %), and ordering errors (10 %). These medication errors were typically omission errors. There were safety barriers in the medication process, such as double-checking of medicines, but they were not always fully effective. Some barriers were missing, for example, computer programs lacked important safety features. Safety barriers are needed, and should be further developed especially in the prescribing, ordering and administration phases of the process. More effective barriers would increase patient and medication safety in cancer treatment. The classification of medication errors in patient safety incidents was not always correct. Therefore, reporting and analysing of reports should be improved. The results of this study can be utilised for improving medication safety in all organisations giving cancer pharmacotherapy.
  • Englund, Nia (2023)
    Tausta: Lääkehoitoon liittyvät haittatapahtumat aiheuttavat merkittävää inhimillistä kärsimystä ja taloudellista taakkaa yhteiskunnalle. Lääkitykseen liittyviä haittatapahtumia voidaan ehkäistä tunnistamalla ja puuttumalla lääkitysriskejä aiheuttaviin tekijöihin. Tavoitteet: Tutkimuksen tavoitteena oli tutkia lääkitysriskien hallintakeinoja lääkkeen toimittamisen yhteydessä suomalaisissa avohuollon apteekeissa. Tavoitteena oli selvittää, miten apteekeissa tunnistetaan ja puututaan asiakkaan lääkehoitoon liittyviin ongelmiin ja millaista lääkitysriskien hallintaan liittyvää osaamista ja lisäkoulutustarvetta apteekeissa työskentelevillä farmaseuteilla ja proviisoreilla on. Aineisto ja menetelmät: Tutkimus oli valtakunnallinen poikkileikkaustutkimus, jonka aineisto kerättiin syksyllä 2022 sähköisellä kyselyllä. Alkuperäinen kyselylomake luotiin vuonna 2015 kirjallisuuden ja järjestelmälähtöisen riskien hallinnan teorian pohjalta ja päivitettiin tätä tutkimusta varten. Tulokset: Kyselyyn vastasi 192 apteekkia (n=610). Apteekeissa tunnistettiin ja puututtiin lääkehoito-ongelmiin, mutta toimintatavat olivat harvoin systemaattisia. Yleisin puuttumistapa oli keskustelu asiakkaan kanssa ja kehotus ottaa yhteyttä lääkäriin, näin toimi 78 % apteekeista tilanteessa, joissa asiakkaan lääkitys ei toiminut toivotulla tavalla. Suurimmalla osalla apteekeista ei ollut muun terveydenhuollon kanssa yhteisesti sovittuja toimintatapoja lääkehoito-ongelmien ratkaisemiseksi. Myös apteekin sisäiset toimintaohjeet olivat puutteellisia Johtopäätökset: Apteekkien ja muun terveydenhuollon välinen nopea viestintäkanava ja yhteisesti sovitut toimintatavat voisivat parantaa apteekkien mahdollisuuksia puuttua lääkehoito-ongelmiin. Apteekkien rooli lääkitysriskien hallinnassa tulee määritellä tarkemmin. Apteekkien ja muun terveydenhuollon välisessä yhteistyössä on paljon hyödyntämätöntä potentiaalia.
  • Toivonen, Salla (2023)
    The lack of up-to-date medication information in healthcare electronic information systems, the transfer of medication information with the patient, and the overall management of medication are key challenges in health care. The number of cancer patients in Finland will increase in the future due to the aging of the population, early detection of cancer, improvement in cancer prognosis and the development of cancer treatments. The development creates a need for operating models that improve medication safety. Medication safety of cancer patients can be improved with clinical pharmacy services, such as medication reconciliation and medication review. The aim of this study was to investigate the accuracy of the medication charts and identify the drug related problems and risks related to home medications among patients with newly diagnosed cancer in the Oncologic Outpatient Clinic of Turku University Central Hospital. This was a retrospective register-based study carried out as an operational development project to obtain information about the current operational model of pharmacist-led medication reconciliation and to further develop it. The theoretical starting point for the study was the theory of human error, according to which factors endangering patient safety can be prevented by using system-based safety defences. In the study, almost every (93 %, 69/74) patient's medication information differed from the hospital's information. A total of 392 discrepancies related to medication information and an average of 5,3 discrepancies per patient were observed in the data (range 0-15 discrepancies). High alert medications accounted for 14 % (n=53/392) of all discrepancies. It took an average of 19 minutes per patient to confirm a medication reconciliation (range 5-48 minutes). During medication reconciliation the pharmacist recorded observations for the doctor in 15 (20 %, n=15/74) patients. In the retrospectively performed medication review, a total of 183 possible drug related problems or risks related to patients’ home medications were observed in 31 (84 %, n=31/37) patients. Pharmacist-led medication reconciliation proved to be a fast and effective way to find out the patient's overall medication. In the future, the operating model should be developed to detect drug related problems, and risks related to patients’ home medications. In situations of limited resources, the clinical pharmacy services should be targeted to patients with the highest risk to drug related problems.
  • Kähkönen, Asta (2017)
    According to international studies, medication records are often incomplete in hospitals' patient information system. Medication reconciliation is an effective method to prevent medication errors and improve medication safety. A medication review is a useful tool in the assessment of drug-related problems (DRPs). DRPs can cause severe patient harm and even cause death. Approximately one third of Finnish people are diagnosed with cancer during their lifetime. About 16 000 patients receive cancer treatments in the Helsinki University Central Hospital Cancer Centre (HUCHCC). There are no clinical pharmacy services in the division of the solid tumors of HUCHCC. Internationally clinical pharmacy services in oncology are patient oriented and often include medication reconciliations and reviews. The clinical pharmacy services have increased patient safety also in the oncological specialty. The aim of this study was to find out the accuracy of the medication charts and identify the DRPs among 70-80-year-old patients with 6 or more medicines in uro-oncological outpatient clinic of HUCHCC. Accuracy of the medication charts was assessed by pharmacist-led medication reconciliation with patient interview. Information concerning patient's medication was also searched from the national electronical prescription centre and from the records of previous hospital visits. DRPs, such as drug-drug interactions, adverse drug reactions and overlapping medications, were identified with the pharmacist-led medication review. Special attention was paid to renal insuffiency, high-alert medications and potentially inappropriate medication for patients over 75 years old. Pharmacist discussed the DRPs with the oncology specialist. The theoretical framework of this study was the theory of human error, where patient safety hazards can be prevented by using safety defences such as medication reconciliation and medication review. Altogether 30 patients with urological cancer were included in this study. On average, they were 74.3 years old and used 12.4 medications. On average, there were 6.8 discrepancies per patient in the hospital medication chart. Only one patient had the accurate medication chart. The discrepancies were most commonly related to paracetamol (n = 10), vitamin-D (n = 9) and the combination of calcium and vitamin-D (n = 8). The most common discrepancies of high-alert medications were related to enoxaparin (n=6) and oxycodone (n=6). Of the potentially inappropriate medications for over 75 years old, the most common discrepancies were related magnesium (n=8) and metoclopramide (n=5). In the medication review process, 4 acute and 44 non-acute DRPs were identified with 22 patients (2,2 per patient). 60 % of these were regarded clinically relevant and lead to actions by the oncology specialist. Reconsidering the need or efficacy of the medication was recommended 19 times and inappropriate dose or medication with renal insufficiency were identified six times in medication reviews. DRPs were usually related to non-oncological medications such as pantoprazol (n=8), the combination of calcium and vitamin-D (n=4) ja bisoprolol (n=3). The medication reconciliation process should be developed in the urology-oncology outpatient clinic. Multiprofessional medication review can be used to detect and resolve DRPs of patients with urological cancer. The results of this study can be exploited when clinical pharmacy services will be created and developed in HUCHCC.
  • Kuitunen, Sini (2014)
    The role of community pharmacy is to ensure and promote medication safety in treatment of outpatients. In Finland a national four-year medication safety program Apila was launched in 2012. The Apila program aims to improve medication safety with pharmaceutical counselling and followup, support development and implementation of new tools and practices promoting medication safety, increase awareness of medication safety as part of patient safety and increase co-operation between community pharmacies and other social- and healthcare services. The objective of this study was to investigate medication safety situation of Finnish pharmacies in the beginning of Apila program. Research data was collected electronically at the end of 2012 by using a two structured survey instruments. Target of the study was the whole pharmaceutical staff of Finnish community pharmacies. There were two separated study samples. Survey instruments were alike for both samples with the exception of one section. One survey was sent to all independent pharmacy owners (n=593) and managers of university pharmacies (n=18). The other survey was sent to one member of pharmaceutical staff in every community pharmacy (n=618) and university pharmacies (n=17). The response-rate of pharmacy owners (O) was 39 % (n=241) and response-rate of pharmaceutical staff (S) was 29 % (n=182). Representativeness of data was good compared to standard population. According to study the barriers built into the dispensing process worked well. Verifying dose (O: 100 %, S: 98 %), interactions (O: 97 %, S: 94 %) and duplicated medications (O: 79 %, S: 70 %) was a common part of dispensing process. Over half of pharmacies had a written standard operating procedure to medication counselling given when dispensing prescribed (O: 74 %, S: 60 %) and over the counter medicines (O: 60 %, S: 60 %). About 90 % of the pharmacies had a standard operating procedure to reporting and managing dispensing errors (O: 92 %, S: 84 %). According to almost all respondents (O: 96 %, S: 91 %) medication errors were reported in their workplace. Though discussing dispensing errors with whole staff (O: 73 %, S: 53 %) and changing course of action after managing dispensing errors (O: 85 %, S: 63 %) was not as common. The respondents were of the opinion that pharmacy had closer co-operation with home care and social services than with health care services. Some pharmacies had agreed with local healthcare how to manage interactions (O: 39 %, S: 23 %), contraindications (O: 36 %, S: 19 %) and prescribing errors (O: 28 %, S: 15 %) discovered in pharmacy. The study indicates that Finnish community pharmacies have good abilities to identify medication related problems. Co-operation between community pharmacies and other social- and health care services should be promoted, because it seems to be superficial. The biggest challenges in risk management are complete invocation of data collected through error reporting and including medication safety audits into quality management. Pharmacy owners' answers to the questionnaire were more positive than staff members', which indicates that actions to promote medication safety should be made more visible. Coordination of medication safety should be emphasized both national and individual pharmacy level. Low response-rates weaken the reliability of the study, but the results are suggestive.
  • Harju, Helena (2010)
    Immunoglobulin G is very unstable and that is why it is very challenging to formulate and process it. Because of the unstability, IgG is vulnerable to changes in pH, heat and mechanical stress. Exposure to these stresses makes IgG aggregate more easily and lose its biological activity. To restore stability, IgG is formulated to a solid product from which it can be regenerated. With TFF (Tangential Flow Filtration) IgG can be purified from other components. The filtration is based on a half-permeable membrane which permeates the other components except for the IgG. The filtration pressure is the force which keeps the liquid flowing. It is important to control this pressure, too high or too low pressure will damage the IgG. IgG can also be protected with polysorbate which is a surfactant going to the protein/liquid interface and therefore stabilizing IgG. IgG does not stay stable in liquid very long so it has to be lyophilized to improve its process- and storage stability. Lyophilization is a long and energy consuming process. Optimisation of the process is therefore essential to save time and resources. First IgG is freezed to produce ice. Primary drying is the second step, sublimation will change ice to water vapor. Secondary drying is based on water desorption, that way residual water is removed from the lyophilizate. The drying process is carried out altering shelf temperature on which the samples are placed. Chamber pressure is also an important factor in IgG stabilisation. These factors have their impact on IgG stability. Also adding disaccharide, trehalose, in the formulation increases the stability of IgG. The purpose of this work was to optimise both the filtration and lyophilisation process so that IgG would remain as stable as possible. During preliminary testing the results showed that magnetic stirring prior to filtration will damage the IgG, showing aggregation and less biological activity. Aggregation was measured with DLS and biological activity with ELISA. Changes in the secondary structure after lyophilisation were measured with CD. The actual filtration tests were carried out using three different filtration pressures and two different polysorbate 20 concentrations, and water. The results showed that IgG is most stable in 1,25 bar filtration pressure and 0,01 % polysorbate concentration. There was less aggregation and more biological activity. The filtration tests proved to be challenging because there were several parameters that were difficult to control. The same challenge was faced when analysing the results. Lyophilisation tests were carried out using three different pressures during primary drying and three different heating rates during secondary drying. The analysis methods were the same as during filtration tests. In addition, the IgG secondary structure changes were under investigation. The lyophilisation tests showed that trehalose clearly protects the IgG. Visually lyophilised samples which contained trehalose were mechanically more stable than those which did not contain trehalose. The analysis showed that the pressure of 60 mTorr and low heating rate (5 °C/h) resulted in better stability of IgG, aggregation was lower and biological activity higher. During lyophilisation no changes in the secondary structure was seen in CD. This was possibly due to lack of sensitivity of the analysis method.
  • Kraft, Hanna (2018)
    Liposomes are nanosized drug delivery vesicles composed of phospholipid membranes. They present an attractive drug delivery system due to their bioavailability and flexibility. Liposomes can be prepared by different techniques. They can carry both hydrophobic and hydrophilic molecules and their surface can be modified with targeting molecules. Coating the liposome surface with the PEG derivative makes their pharmacokinetics easier to predict. There are several liposome-based medicinal products already on the market. Triggering of drug delivery systems by different external or internal stimuli allows precise control of drug release. Light-triggered drug release is an attractive alternative due to the easy control and regulation of the stimulus. The problem with light-triggered therapy has previously been the need to use high-energy ultraviolet light that penetrates badly to the tissues and is not safe. In TTA-UC process the low-energy red or green light is converted to high-energy blue light. In this process photosensitive molecules are excited by visible light and after that the energy is transferred from sensitizer to annihilator molecules. Collision of two annihilators leads to the excitation of the other molecule while the other returns back to its general energy state. The excitation breaks up with fluorescence. In this process the highly permeable and safe red light is converted to blue light which has enough energy to induce drug release. The aim of this work was to optimize liposomal preparation method and prepare a pegylated and stabile liposome formulation for TTA-UC process. Hydrophobic light sensitive molecules were loaded into the phospholipid membrane as much as possible. One of the problems in this work was to find proper methods to measure the concentrations of these molecules. The lipid composition for formulation was chosen after thermostability studies. As a quality control, the size, capability to load calcein and phase transition temperature of liposomes were measured. The quality control of light sensitive molecules was operated too. In this work, the formulation for TTA-UC was prepared. In further studies TTA-UC process happened with sufficient efficacy. The formulation was pegylated and stable in physiological conditions and the concentrations of the molecules were high enough. This was the very first time to get TTA-UC to happen in this kind of liposome formulation that may be useful as a drug carrier. Long-term stability studies and further optimization of TTA-UC method are needed in the future. Some drug release studies are important to arrange in the future, too.
  • Nuolimo, Sirpa (2016)
    Tavoitteet. Työn tavoitteena oli pyrkiä selvittämään, kuinka lääkevalmisteiden ja CE-merkittyjen terveydenhuollon laitteiden ja tarvikkeiden välinen rekisteröintiprosessi ja rekisteröinnin käytännön työ eroavat toisistaan. Hakemusprosessien ja dokumentaation erojen tutkiminen viranomaisvaatimusten ja työn käytännön suorittamisen näkökulmista katsottiin tärkeäksi, jotta on mahdollista vertailla lääkevalmisteiden ja laitteiden välisiä rekisteröintiprosesseja kokonaisuutena sekä tarkastella valmisteen rekisteröintistatuksen vaikutusta rekisteröinnistä vastaavien henkilöiden työmäärään, ajankäyttöön ja työtehtävien sisältöön. Menetelmät. Tutkimus suoritettiin sähköisen kyselytutkimuksen avulla, joka lähetettiin Suomessa toimiville lääkkeiden myyntiluvan haltijoille ja CE-merkittyjen terveydenhuollon laitteiden ja tarvikkeiden rekisteröinnistä vastaaville valmistajille. Kyselytutkimus toteutettiin Helsingin yliopiston verkkolomaketyökalulla, jota hyväksikäyttäen rakennettiin kyselytutkimuksen runko, kerättiin vastausaineisto sekä käsiteltiin tutkimusaineistoa raportointivalmiiksi. Kysymysten sisältö määriteltiin rekisteröinnin jäsenjärjestön julkaisemiin urakuvauksiin sekä yritysten työpaikkailmoitusten työnkuvauksiin perustuen. Kyselytutkimuksen tekninen ja sisällöllinen toimivuus testattiin pilotoinnin avulla. Vastausaineiston sisältöanalyysi suoritettiin kvantitatiivisten tutkimusmenetelmien keinoin. Tulokset ja johtopäätökset. Lääkevalmisteiden ja CE-merkittyjen terveydenhuollon laitteiden ja tarvikkeiden rekisteröintiprosessit eroavat toisistaan merkittävimmin hakemusprosessien rakenteen ja viranomaistoiminaan osalta, vaikkakin molemmilla sektoreilla perimmäinen tavoite on sama; osoittaa valmisteen teho ja turvallisuus sille aiotussa käyttötarkoituksessa. Hakemusrakenteiden ja viranomaistoiminnan erojen voidaan nähdä olevan perustekijät, joista johtuvat muut rekisteröintityötä ja dokumentaatiovaatimuksia erottavat tekijät, myös käytännön tasolla. Kyselytutkimuksen vastausaineiston perusteella merkittävimmin käytännön työssä vaikuttavat erot liittyivät rekisteröintityön osuuteen kokonaistyöajasta, hallinnollisten tehtävien osuuteen sekä työn sisällön aiheuttamiin vaatimuksiin. Lääkerekisteröintityötä tekevien rekisteröintityön osuus kokonaistyöajasta ja hallinnollisen työn osuus rekisteröintityöstä oli laiterekisteröintityötä tekeviä merkittävästi suurempi. Työn sisällön asettamat vaatimuserot näkyivät muun muassa lääkerekisteröintityössä vastaajien enemmistön farmaseuttisena koulutustaustana ja laiterekisteröintityössä teknisenä koulutustaustana. Kaiken kaikkiaan työssä havaitut erot vaikuttaisivat rekisteröintistrategisesti suosivan valintaa CE-merkityksi lääkinnälliseksi laitteeksi sellaisissa rajatapaustilanteissa, joissa valmiste on mahdollista rekisteröidä joko lääkkeeksi tai lääkinnälliseksi laitteeksi.