Browsing by Subject "laadunvarmistus"

Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. The compounded preparations have many special features, such as the rapid/immediate need for the drug, the preparation of several pharmaceutical dosage forms, and the variation of batch sizes and manufacturing processes. Medicinal products prepared in hospital pharmacies may pose additional risks to patients compared to industrial products. These risks with limited evidence of quality, efficacy and microbiological purity can jeopardize patient safety. The aim of this study was to perform a product specific risk assessment of aseptically processed and terminally sterilized products belonging to the manufacturing range of the hospital pharmacy of Turku University Central Hospital. The study material contained 118 different products. The risk assessment was performed with the help of a risk matrix in which various quality and safety risks have been identified and assessed. The risk points obtained from the different areas of risks were multiplied together to obtain total risk points for each product. The products were qualitatively classified according to the total risk points into low-risk, medium-risk and high-risk products. All total parenteral nutrition (TPN) solutions of the study were classified as high-risk products. TPN solution prepared into a syringe without lipids and TPN solution prepared into an EVA bag without lipids had the highest risk points of the study (6561 points). Most of the eye drops (88 %) and patient controlled analgesia (PCA) pumps (68%) belonged to high-risk category. PCA pump containing morphine, clonidine, bupivacaine, ketamine and saline solution (1944 points) and autologous serum eye drops (1296 points) had the highest risk points of these product types. 60 percent of intraocular injections and half of pain products prepared into syringes were scored as high-risk products. Intravitreal bevacizumab had the highest risk points of intraocular injections (972 points). Medium-risk products were mainly different infusions. Infusions containing defibrotide, oxytocin and onasemnogene abeparvovec had the highest risk points in the medium-risk category. Liquid solutions and patient controlled analgesia (PCA) pumps were the second largest group in this category. All products used in allergy testing, all ointments and all inhalation solutions were in the low-risk category. The risk matrix used in the study can be used to identify high-risk compounded preparations in hospital pharmacies. Risk assessment enables targeting quality assurance more effectively to high-risk products. Risk assessment can be used to manage various risks in pharmaceutical compounding and reduce harm to patients. The results obtained in the study cannot be directly generalized to other hospital pharmacies because the products, manufacturing processes and the amounts of different products prepared vary among hospital pharmacies.

The importance of universities providing quality-assurance schemes has increased during the last two decades due to, among other things, an increased tendency in public administration to use evaluations as a tool to enhance efficiency and the changed nature of the state-university relationship. Moreover, we can witness an increased integration of European higher education. Also Finnish higher education has been exposed to these trends and external evaluation and quality assurance systems has become a recurring phenomenon. The objective of this research was to analyse organizational responses at universities to the demand of showing a QA-scheme, and to increase understanding on the role of audits in relation to national and supranational developments, from a perspective of organizational intuitionalism. In so doing, attention is put on what kinds of effects and practices a national form of evaluation has, if compared at the organizational level of two universities. The methodological approach builds on insights from qualitative methods, new-institutional theory and organizational institutionalism. The empirical materials used consisted of documents and half-structured interviews. The interviews were transcribed and analysed through the creation of reference codes in the program ATLAS TI. The reference codes were created according to logics of analytic coding. In the research, four core themes were witnessed. First, in implementing processes or reforms that might be perceived critically in universities, the role of commitment and semantics become of high importance, as does a degree of hierarchy. Second, responding to the demand of showing a quality assurance-scheme and succeeding in audits are not seen to be of high importance by university leadership in that only scarce resources were allocated to the exercise. Third, developing the QA-system was clearly accepted to be a response to European developments but this is hardly an instrument for governance that the Ministry of Education would value in comparison to other instruments. Finally, the recommendations made by the audit teams are not as neutral as they seem, in that they do define what the Universities should accomplish. However, the loosely coupled structure has in many ways lessened many of the impacts and recommendation gained from the audits.

Utaretulehdus eli mastiitti on yksi yleisimmistä tuotantoeläimiä hoitavan eläinlääkärin kohtaamista sairauksista. Eläinlääkärin tulisi hoitaa utaretulehdus maitonäytteen viljelytuloksen perusteella. Monet eläinlääkärit viljelevät näytteet ja suorittavat bakteeridiagnostiikan itse omalla vastaanotollaan, jolloin tulokset saadaan mahdollisimman nopeasti. Maitonäyteviljelyitä tehdään praktiikassa erityisesti viikonloppuisin, jolloin näytettä ei voi viljellä muualla. Eläinlääkäreiden valmiudet maitonäytteiden diagnostiikkaan vaihtelevat huomattavasti johtuen esimerkiksi vastaanoton varustelusta, henkilökohtaisesta kiinnostuksesta asiaan sekä praktiikan vilkkaudesta. Diagnostiikan laadussa on tämän vuoksi huomattavia poikkeamia. Diagnostiikan laatua ei kontrolloida tällä hetkellä mitenkään, eikä ole olemassa minimivaatimuksia bakteriologisen diagnostiikan tasolle. Laadunvarmistukseen ei praktiikkaolosuhteissa ei ole kiinnitetty juurikaan huomiota. Tässä tutkimuksessa pyrittiin selvittämään, miten laadukasta praktikkojen tekemä mastiittiviljely on heidän arkityössään käyttämillä menetelmillä. Tämänkaltaista tutkimusta ei ole tehty aiemmin Suomessa. Viitteitä ei löytynyt myöskään ulkomaisista julkaisuista. Tutkimuksen kulku oli samankaltainen kuin laboratorioille tehdyissä interkalibrointitutkimuksissa. Tutkimukseen osallistuville eläinlääkäreille lähetettiin neljä maitonäytettä, joihin oli istutettu yleisimpiä utaretulehdusbakteereja. Eläinlääkärit palauttivat viljelytulosten mukana kyselykaavakkeen omista viljelykäytännöistään sekä laadunvarmistukseen liittyvistä asioista. Yhteensä 30 eläinlääkäriä ilmoitti halukkuutensa osallistua ja heistä 28 lähetti vastauksensa. Vastaukset olivat hyvin eri tasoisia, osan päästessä lajitasolle ja osan pyrkiessä erottamaan esimerkiksi stafylokokit kolibakteereista. Myös käytetyissä menetelmissä oli runsaasti vaihtelua ja menetelmien valinta osin satunnaista. Laadunvarmistukseen ei kiinnitetty paljonkaan huomiota. Stafylokokit tunnistettiin parhaiten ja niiden osalta tulokset olivat hyvät. Kokonaisuudessaan tulokset olivat kohtalaisia. Praktiikassa tapahtuva bakteriologinen diagnostiikka kaipaa yhdenmukaistamista sekä ohjeistusta praktiikkaolosuhteisiin soveltuvasta laadunvarmistuksesta. Näin parannettaisiin tulosten luotettavuutta ja tuotettaisiin karjanomistajille tasavertaisia palveluita. Eläinlääkärin tulee kertoa karjanomistajalle, että praktiikassa tapahtuva viljely poikkeaa laadultaan laboratoriossa tehdystä, jotta karjanomistaja voi halutessaan toimittaa rinnakkaisnäytteen laboratorioon. Näytteen analysointi on aina subjektiivista, joten laboratorioidenkin tekemässä diagnostiikassa on tietty virhemarginaali. Äkillisissä, vakavissa utaretulehdustapauksissa praktikon itse suorittama maitonäytteen viljely voi olla eläimen hoidossa ratkaisevan tärkeä.