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The amount of informal caregiving has increased in Finland, with a growing emphasis on the older adults. Although the medication management process in informal caregiving has been studied and is known to have significant risks, research data focusing on the older adults is still limited. The aim of this study was to describe the medication management process of informal carers and care recipients of at least 65 years old. The aim was to identify medication errors and medication risks in the medication management process and to find out how the caregivers manage them. In addition, the study examined the informal carers and care recipients own development proposals to improve medication management process. A total of 21 volunteer informal carers and care recipients living in the Helsinki metropolitan area were recruited to this study. The study was conducted as a qualitative interview survey in the homes of the participants. The interviews were a combination of semi-structured interviews and narrative approach. The material to this study was collected during spring and summer 2018. The study was analysed with abductive content analysis combining both deductive and inductive approach. The aim was to find repetitive elements by encoding and grouping expressions. The results of this study were compared with previous theory and the results were supplemented with a picture of the medication management process and a fishbone diagram was drawn from the risk factors and contributing factors of the medication management process. The families had medication errors in all stages of the medication management process. The most frequent medication errors were found in counselling, medication administration and in medication treatment monitoring. As a contributing factor, the healthcare professionals’ haste and the responsibility of the caregiver recurred in the background of the medication errors. Family caregivers and care recipients wish to have more counselling, more monitoring of medication and better interaction with health care. Carers often felt left alone to take care of another person's medications and felt they lack support from healthcare. By facilitating access to a physician, improving the availability of a physician, increasing the amount of counseling and support provided by healthcare, including pharmacies, could the safety of medication management at home be improved.

About 10 % of the patients experience an adverse event during their treatment. About 1 % of the adverse events are serious. Extrapolated from international evidence adverse events cause death of 700 - 1700 patients annually in Finland. Medication errors are the most common single preventable cause of adverse events. According to several studies about half of the adverse events and medication errors are preventable. Therefore medication safety is a central part of the Finnish Patient Safety Strategy. One of the medication safety tools in Finland is unit-based pharmacotherapy plan for which the Ministry of Social Affairs and Health gives instructions in the Safe Pharmacotherapy guide. All social and healthcare units should develop a pharmacotherapy plan which describes the medication processes in the unit. The purpose is to harmonise the principles for the provision of pharmacotherapy, to clarify the division of responsibilities related to its provision, and to define the minimum requirements that must be complied. The aim of the study was to explore how the pharmacotherapy plans were made and to evaluate their implementation and benefits in hospitals, health centres and social care units for the elderly. Pharmacotherapy plans are studied as part of the Finnish Patient Safety Strategy, focusing on medication safety. Head nurses were chosen as target group. The data was collected by phone interviews. Forty (8 %) interviews were received from a random sample that was taken from a register of head nurses held by Tehy ry. The interview was semi-structured theme interview and the data was analysed using content analysis. Most of the studied units (n= 24, 60 %) had started to formulate the pharmacotherapy plan in 2007, soon after the Safe Pharmacotherapy guide was published. Pharmacotherapy plans were drawn up on organisation and/or unit level. There was a lot of variety in the working groups' sizes and professionals taking part in them. More instructions would have been needed. The most common way (n=20, 50 %) to induct the pharmacotherapy plan to the staff was to introduce it at the unit meeting. Most commonly mentioned changes to the operations in the units were related to error reporting (n=15, 38 %), certification procedures for distribution and administration of medicines (n=9, 23 %) and task allocation (n=8, 20 %). There were several benefits of the pharmacotherapy plan of which most common were starting or developing error reporting (n=19, 48 %), clarification and better availability of instructions (n=18, 45 %), better induction of new staff members and substitutes (n=16, 40 %) and standardization of procedures (n=10, 25 %). Allocation of tasks and responsibilities was considered a challenge in developing and using the pharmacotherapy plan. Limited resources caused difficulties in implementing and using the pharmacotherapy plan. The staffs' medication education was kept more up-to date after introduction of the pharmacotherapy plan but the education was also challenging for the units. Pharmacotherapy plans made the units develop their procedures and increased understanding of medication safety. All in all the plans have worked well as part of the Patient Safety Strategy. However the systematic development of the pharmacotherapy and the use of pharmacotherapy plans in social and healthcare units requires more effort.

Herbal preparations are widely used nowadays and the information given has developed a lot during the last decades. Herbal preparations haven`t been acknowledged as medicines and therefore their efficacy and adverse effects are still often underrated. In 2005 along the changes in legislation differently legislated group of herbal preparations was retired. Nowadays herbal preparations are divided to drugs and food products. The aim of the study was to make oneself familiar with the legislation of these products and the evolution of the pharmaceutical information given. The aim also was to compare warnings, prohibitions, contraindications and their evolution to prevalent legislation. The material of the study consisted of product information summaries, patient information leaflets and labeling of herbal medicines, traditional herbal medicines and their predecessors. In addition to this there was also other legislative material. Only herbal medicines and traditional herbal medicines according to directive 2004/24/EY of the European parliament and the council`s definition were taken in to account. According to 2004/24/EY herbal medicinal products is any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. There were all together 194 products included in the study. Documentation of 184 products was found on paper in Fimea`s archives. Of the remaining five out of ten products it was found some basic information in electronic rohdos-register and of one product on an on paper final act. Data of these six products was only used partly because of its deficiencies. The data of four products wasn`t found. Under a more detailed study there was all together 184 products between 1964 and 2011. The material was divided to time periods 1964 - 1983, 1984 - 1987, 1988 - 1995, 1996 - 2005 and 2006 - 2011 by the changes in legislation. The information given of herbal preparations was the most affected by the changes in legislation in 1994 and 2005. The amount of new licenses was increasing until the time period 1988 - 1995. Licenses were granted the most during 1988 - 1955. After 1996 the amount of warnings, prohibitions and contraindications rose and many of the products that got the license in previous time period 1966 - 1955 left the market or transferred under the food legislation. As well many products with less consumption left the market because new studies demanded were expensive and cumbersome. In 2005 along the changes in legislation a clear change in attitudes came true, when a vague group of herbal preparations was removed and herbal preparations were divided into pharmaceuticals and food products. Along this change it has become easier for health care professionals to assess the risks and benefits of herbal preparations and advise the clients while making the decisions.

There are many challenges in use of dosage forms in medication of elderly people. Especially swallowing of solid dosage forms can be difficult. Dosage forms are often altered to enhance drug intake. Medication adherence is a major contributor to the success of therapy. Adherence is a multidimensional phenomenon which is also affected by properties of medicinal product. Theoretical framework of this thesis is World Health Organization's multidimensional adherence model. Only few studies exist on how properties of dosage forms affect to the success of medical treatment of elderly. The aim of this study was to find out what kind of difficulties related to dosage forms occur in medical treatment of elderly people living in nursing homes. Future goal is to develop dosage forms better suited to elderly and hence improve their medication adherence. This study consisted of interviews and e-survey. This study was carried out in six nursing homes where 322 elderly residents fulfilled the inclusion criteria of the study. Nurses (n = 48) were interviewed to explore their views on difficulties related to dosage forms. Other difficulties in use of dosage forms were also surveyed as well as frequency of tablet crushing. Difficulties in use of dosage forms on the medical treatment of the elderly were gathered in the e-survey. Also, the need to crush tablets and open capsules was surveyed as well as need to split tablets to obtain the dose needed. Difficulties in use of dosage forms are common in medical treatment of elderly people. Majority of the interviewed nurses has encountered these difficulties at least few times a week. The most common problematic dosage form was the tablet. About half of the nurses named the big size of tablets and capsules as the most important difficulty in the use of current oral or peroral dosage forms. Over half of the nurses have crushed or given crushed drug daily. The most common reason for dosage form altering was the big size of the medicinal product. Majority of the nurses has often encountered also other than dosage form related difficulties of which the most common challenges are related to suspiciousness. In e-survey, nurses submitted entries regarding 111 elder people. Most cases were related to splitting of a tablet to obtain the desired drug dose. Tablet crushing was reported for little less than one-fifth of the elderly people. Both the splitting and crushing entries were distributed over multiple different medicinal products. Some other difficulties related to dosage forms were reported for less than one-tenth of the elderly people. Based on this study more appropriate dosage forms should be developed for the medical treatment of elderly people. Oral solutions, orodispersible tablets as well as transdermal patches all have advantages. Pharmaceutical research and development can facilitate medical treatment of elderly people and hence improve their medication adherence by introducing more appropriate dosage forms.

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.

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.

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.

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.

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.

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.