Browsing by Subject "Social Pharmacy"

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  • Metiäinen, Tiia (Helsingfors universitet, 2015)
    Health related issues are largely regulated at EU Member State level, whereas areas such as internal market and competition fall mainly under the remit of European Union competence. This creates tension not only between legislation governing health and that concerning internal market but also between national and EU legislation. Here the Court of Justice of the European Union (CJEU) plays a key role in developing case-law through its judgments, defining further interpretation both on European and national level. An example of a sector operating at the interphase between public health and internal market interests is community pharmacy, which was chosen as the focus area of the study. The aim of this master's thesis was, through the case-study example of the regulation of pharmacy establishment, ownership and distribution in EU Member States, to perform a documentary analysis on related CJEU judgments, focusing on statements present in them referring to public health and internal market, discussing potential impacts on the community pharmacy sector as well as relating the outcomes to the broader context of European health policy with reference to existing literature. The study material consisted of publicly available documentation related to four judgments (Case C-531/06, Joined Cases C-171/07 and C-172/07, Joined Cases C-570/07 and C-571/07 and Case C-367/12) that were made between the years 2009 and 2014, the first proceedings initiating in 2006. The prevalence and variety of statements related to public health were found to be much higher in the documents analysed compared to those relating to internal market. The most common argumentation present in the judgments was related to the statement that regulation of ownership of community pharmacies can be justified by public health reasons, deriving from the professionalism inherent to pharmacists as well as ensuring balance between public health and economic interests. This transmits a clear message of the importance of public health and indeed the Court has been perceived as a balancing force to the union's liberalisation agenda. Following this it seems unlikely that the interpretation for national regulation would change in the near future, meaning that Member States should be able to maintain community pharmacy regulation, to the extent that it is implemented in a consistent manner. However, there has been indication of other routes being used to push for the liberalisation agenda and therefore it continues being a part of the debate both at European and national level. The findings of this study support literature suggesting that spillover is taking place in relation to the Court of Justice and health. Furthermore, it has been clearly demonstrated that even though officially the EU has very limited competence (authority) in health, its influence on European health policy is in fact highly significant, taking place to a large extent via routes other than those officially assigned to it in relation to health in particular. Whether this is intentional or unintentional, it does not change the fact that health policy is being influenced. When it happens without explicit intention, the processes lose transparency and are driven by other, potentially competing agendas. Therefore it would be important to assess whether the decision making processes and other processes currently shaping the European healthcare policy are in line with what was originally intended and re-evaluate whether this dynamic is the preferred way to proceed in the future.
  • Kumpula, Eeva-Katri (Helsingfors universitet, 2009)
    Anticholinergic medicines are commonly used to treat e.g. incontinence. These medicines have side effects, which may cause and also exacerbate e.g. dryness of the mouth, increased heart rate, and even cognitive impairment. Older people may be more at risk for these side effects as they may be experiencing similar symptoms as a natural effect of aging, and because they may be using several medicines causing these effects. Older people often have a high medicine burden and also a high disease burden. Measuring anticholinergic effects to change medicine regimens and to reduce the symptoms is difficult as there is no golden standard method. This thesis investigated the published methods available for estimating anticholinergic burden in the literature review part, and used one anticholinergic scoring system, the Anticholinergic Risk Scale, in a cross-sectional study to test the effects of anticholinergics on mortality in 1004 older institutionalised patients from Helsinki area public hospitals. Cross-tabulations and Kruskal-Wallis or Chi square methods were used to detect differences between variables such as nutritional status or certain diagnoses when the patients were stratified according to their anticholinergic use. Cox Proportional Hazard regression, the logrank test and Kaplan-Meier curve were used to investigate the effects of anticholinergics on 5-year all-cause mortality. An in vitro serum assay and seven anticholinergic scoring systems were identified in the literature search. Also, 17 anticholinergic lists were identified, which covered 278 medicines, of which 21 appeared on at least eight of the lists. In the empirical study, the women's (n = 745) mean (± SD) age was 83.35 (± 9.99) years, and they were older than the men (n = 241, mean age ± SD 75.11 ± 11.48, p < 0.001). The 1004 patients (response rate 70 %) were using a mean (± SD) number of 7.1 ± 3.4 regular medicines (range 0-20). 455 patients used no anticholinergics, 363 had some anticholinergic burden (score 1 or 2), and 186 had a high burden, with anticholinergic scores of 3 or more. The mean ARS score (± SD) was 1.2 ± 1.5 (range 0-10). When three anticholinergic lists were compared, all three lists identified only 280/791 of patients who were anticholinergic users according to at least one list. No association was found between anticholinergic medicine use and mortality. There are several methods available for measuring anticholinergic burden, but there is a need for a consensus method. This was highlighted by the lack of agreement on medicines on different lists and when three anticholinergic lists tested identified different patients when compared to each other. Anticholinergic use was common in this frail, older patient sample, but no effect on mortality was shown in this study setting. The cross-sectional nature of the data limits the reliability of the study, and any conclusions beyond older patients in Helsinki area must be done very cautiously. Future research should define anticholinergics better and investigate their possible effect on mortality in a prospective, randomised, and controlled setting.
  • Saksi, Outi (Helsingfors universitet, 2016)
    The development and maintenance of the pharmaceutical workforce's know-how ensure the availability of medicinal consulting and service. Healthcare personnel in Finland are bound by law to uphold and improve their workmanship. Furthermore, a pharmacy owner is legally obliged to keep track of the development of healthcare professional's skills and to ensure the staff's sufficient participation for continuing education (CE). Pharmacists' development and maintenance of professional skills is not linked to preservation of professional competence in Finland. The goal of this study was to get a general view of the development and maintenance of professional skills of pharmacists working in community pharmacies as well as applicaple methods. Additionally, the aim was to determine whether community pharmacists' development of professional skills is systematical. As background material in this thesis, a sub-material of an online study regarding development and maintenance of professional skills was used, which was carried out by the Finnish Pharmacists' Association in September 2013 and it consists of 430 pharmacists' responses who work in community pharmacies. The results show that the methods community pharmacists use to develop and maintain their professional skills are diverse. The recommendation by the authorities is at least three days of CE for one person per year but the majority (83 %) of the participants of this study didn't follow it. Some of the pharmacists develop and maintain their professional skills by attending diligently CE's while the number of pharmacists who do not attend any CE has risen. The number of pharmacists who did not participate in any CE was 26 % in the year prior to this study. The results might point to changes in learning methods or the decline of CE activity. The results of this thesis show that development of professional skills was not systematical in the majority of the pharmacies. An annual personal develompent plan was drawn up in 24 % of the respondents' workplaces and development discussions were had in few. Independent planning, monitoring and evaluation of their own professional skill development were done by 10 % of the pharmacists. The planning of professional skill development was not found to impact CE participation. Development discussions and training schedules that are drawn up in workplaces were found to increase pharmacists' independent planning of their professional skills.
  • Bahadori, Tadjmohammad (Helsingfors universitet, 2010)
    This master's thesis explored the activities of interpreters used by immigrants in Finnish health care. The main aim was to find out the actual roles of interpreters in working life and how these roles compare and contrast with the roles defined in interpreters` professional code of practice. Additionally, this study explored: what are the most important roles and competencies in the interpreters work from their own perspective and how they perceive their impartiality and proficiency. The interpreters` professional code of practice, Forsander`s (1996) study on interpreters roles and Jalbert`s (1998) classification of interpreter roles were used as a theoretical background of this study. Structured interviews were conducted among interpreters (n=32) working in metropolitan Helsinki. The interpreters were recruited from one interpretation center employing altogether 60 interpreters. The interview guide was based on a previous literature and included questions on interpreters work: their professional code of practice, roles, skills and competencies needed in working life. Interpreters perceived that the role of oral translator, cultural brokers and social role of the various expert institutions were the most important roles in their work. The least important roles were: the role of witnesses, counselor, and an additional source of information. The interpreters reported that they need special support and training in their work. This training should be organized conjointly both with native Finns and other cultures representatives. A shared understanding between different cultures can also be in focus in interpreter services. Similarly with previous studies, language and communication difficulties were found as a major challenge in Finnish health care. Interpreters highlighted that they customers are commonly dissatisfied with the health care due to a continuous rush and lack of time, and attitudes of health care personnel. Immigrants were satisfied with maternity clinic services and high level of technology applied in Finnish healthcare. Interpreters also mentioned that healthcare professionals` cultural skills and experiences are varying: the more they have experience of immigrants, the easier is communication. Interpreters perceived that the majority of healthcare professionals were positive to immigrants and were interested in developing their own cultural competencies. The roles reported by interpreters were in line with the roles defined in interpreters` professional code of practice. Additionally, the characteristics of a competent interpreter as mentioned in the code of practice were also perceived as important among interpreters. This research highlighted the need for cultural education among health care professionals.
  • Nieminen, Jenni (Helsingfors universitet, 2016)
    The aged are the biggest age group of using psychotropics. The most used ones of these drugs are hypnotic and sedatives that consists mainly of benzodiazepines and related drugs. However, the aged are extremely sensitive for these drugs that are also noted as potentially inappropriate drugs for the aged in the national, but also in the various international recommendations and care guidelines. Despite the care guidelines, benzodiazepine compounds are usually used for years and often concomitantly. Research material of this longitudinal, observational study with two cohorts was collected from structured interviews at two similar acute wards in Pori City Hospital during one month in 2015. The research protocol of an early similar study which was conducted in 2004 was followed. Results of the two studies (2004 and 2015) were compared. Interviews were conducted among patients aged ≥ 65 years. Users of benzodiazepines or related drugs (2004: n=38, 2015: n=32) were further interviewed. The aim of this study was to compare the characteristics of the usage of benzodiazepine compounds in the aged between the years 2004 and 2015. In particular the medicines information sources and amount of information on these drugs i.e. knowledge on adverse drug reactions was studied and compared. Additionally a systematic review was conducted to explore the current evidence on interventions to rationalize the use of benzodiazepines and related drugs in the aged. In 2004, 54% of the interviewed patients (n=64) were using benzodiazepine compounds. However, in 2015 there were 34% (n=36) using. In 2015 regular usage of these drugs was decreased and irregular usage (given on an as-needed basis) was increased compared to the year 2004. None of the patients used long-acting benzodiazepines in 2015. Medicines information is provided notably more by doctors and pharmacies to 2004, but still the information focused more on benefits of drug other than adverse drug reactions. However, the patients' knowledge about the adverse drug reactions of benzodiazepine compounds has increased. The patients got presented adverse drug reactions known on mean of five in the year 2015, while the same value in 2004 was three. In the both years, the most of the patients were aware of the dependence these drugs may cause. The usage of benzodiazepine and related drugs in the aged has become better, but there is still need to improve multi-professional cooperation and applicate new interventions for rationalize the usage of benzodiazepinecompounds.
  • Saarenpää, Maija (Helsingfors universitet, 2014)
    The body changes its response to medicine by age. Thus, medicines information for the elderly needs to differ from information targeted to younger adults. Package leaflets (PLs) are among the key sources of medicines information among general public. Although not generally recommended, benzodiazepines are commonly used by the elderly. The aim of this study was to evaluate the usability of benzodiazepine PLs and their information content from the elderly perspective. Additionally, the study aimed to explore how medicines information targeted to elderly in PLs aligns with the information targeted to health care professionals (HCPs). The study focused on PLs of benzodiazepines and their derivatives (diazepam, alprazolam, oxazepam, zopiclone and temazepam) that are commonly used but not recommended for the elderly. The usability of PLs was evaluated by using the Medication Information Design Assessment Scale (MIDAS). The informational content of PLs was studied by identifying all references for the elderly and comparing them to information targeted to HCPs in Database of medication for the elderly, Beer's criteria, Kapseli 35 publication, Martindale, Current Care Guideline for insomnia and the Summaries of Product Characteristics. The usability of the PLs in this study required several improvements. The mean of MIDAS-credits was 6,22 (n = 27; range 5,00-7,00), the scale maximum being 13. Sufficient line spacing and highlighting of important information were among the poorly represented elements. The occurrence of different font-sizes also varied. The most proficiently represented features included headings, contrast and the usage of upper and lower case in text. The PLs included in the content-analysis contained references to the elderly in all cases except one (n = 35). The references were categorized to general warnings, side effects and dose recommendations. They were in line with the information targeted to HCPs, but relatively short and often inadequate. Most PLs did not give an adequate overall picture of the medicine use among the elderly. The PLs for benzodiazepines need to be improved from the elderly perspective both in terms of information content and usability. Attention both from the medicine authorities and the pharmaceutical industry is required. Alternatively, separate drug-specific information leaflets for the elderly may be developed.
  • Teittinen, Panu (Helsingfors universitet, 2017)
    Psoriasis (Ps) and Psoriatic Arthritis (PsA) are chronic inflammatory diseases that are associated with profoundly impaired quality of life. Psoriasis is incurable and therefore the treatment aims to relieve patient's symptoms and improve the quality of life. Biologics are an efficacious treatment option for moderate-to-severe Ps and PsA but their relatively high costs limit their use. Health care resources are scarce and therefore economic evaluations provide crucial information for decision-makers. The objectives of this study was to determine 1) What is the incremental cost-effectiveness of biologics for moderate-to-severe Ps and PsA, and 2) What is the quality of cost-utility analyzes examining the subject. The theory section of this Master's thesis considers the current treatment alternatives for Ps and PsA and costs relating their use. The main principles and methodologies conducting economic evaluation and systematic review are also discussed in the theory section. The empirical section concerns the previous systematic reviews regarding the cost-effectiveness of biologics for the treatment of moderate-to-severe Ps and PsA, while also addressing the results of this systematic review and the quality of included cost-utility analyzes. 1425 references were found with the systematic literature search and 17 of them were included in this study. Eight articles concerned the cost-effectiveness of biologics for the treatment of Ps and nine articles for the treatment of PsA. All of the included studies used cost-utility modelling approach. Based on the results of this systematic review, biologics are cost-effective compared standard care for the treatment of severe Ps. Biologics are also cost-effective compared to the standard care for the treatment of moderate-to-severe PsA. However, future studies, independent of influence of pharmaceutical industry, are needed to confirm these results. The quality of cost-utility analyzes included in this study varied substantially. The main shortcomings related to reporting of the data included, modelling methodologies and the arguments for choosing the treatments compared. The strengths of this study are a comprehensive and systematic literature search, careful evaluation of included data and the transparency of methodologies. The main weaknesses relate to generalizability of the results and the possibility of biases. This study updates the current knowledge of cost-effectiveness of biologics for Ps and PsA, while providing a good foundation for the future studies to be conducted.
  • Joensuu, Jaana (Helsingfors universitet, 2013)
    Rheumatoid arthritis (RA) is a chronic autoimmune disease with prevalence of 0.8% among Finnish adult population. Consequent medical treatment, joint replacement surgery and productivity losses lead to significant expenses for society. While biological treatments for RA are costly, they can improve patients' quality of life and work participation. Economic evaluations provide information on the benefits and costs of these expensive treatments to aid optimal utilization of limited healthcare resources. This master`s thesis comprises the description of the Finnish Current Care Guidelines for RA, the cost of biological treatments and the principles of economic evaluations and health technology assessment. A systematic literature review was performed to identify existing studies examining the cost-effectiveness of biological treatments for RA. Of the 4890 references found with the literature search, 38 original studies and 9 previous systematic reviews were included in the current systematic literature review. Details of the methods as well as information on treatments, costs, benefits and incremental cost-effectiveness were extracted. Quality of the original studies was evaluated using quality assessment tools. Ninety percent (34/38) of the original studies used cost-utility modeling approach. Quality of life estimates were derived from RA specific health assessment questionnaire in a majority of the studies. Based on the current systematic literature review, the evidence on the cost-effectiveness of biological treatments is inconsistent. The incremental cost-effectiveness of the tumor necrosis factor (TNF) blockers was 13 500-772 000 €/ quality adjusted life year (QALY) in comparison to conventional disease modifying anti rheumatic drugs (DMARD) among patients without previous treatment with DMARDs. Several studies reported incremental cost-effectiveness ratios over 100 000 €/QALY in this population. Among patients with insufficient response to DMARDs, TNF blockers provided incremental cost-effectiveness ratios between 6 700 and 317 000 €/QALY. In most studies Rituximab was found to be a cost-effective alternative in contrast to other treatments among patients with insufficient response to TNF blockers. Biological treatments are not cost-effective among patients naïve to conventional DMARDs. Meanwhile, in patients with previous DMARD failure TNF-blockers might be cost-effective. The evidence on the cost effectiveness of biological treatments supports Finnish Current Care Guidelines. The quality assessment of the included studies revealed several sources of bias, consequently reducing the validity of the studies. Only a few of the conference abstracts in current subject has been published later as an article indicating existence of reporting bias. This study has several strengths. First, a comprehensive literature search was performed. Second, the quality of included studies was carefully evaluated. Finally, the methods and reporting are transparent. Weakness of the current study is one person extracting data and assessing the quality of the studies, which may reduce the reliability of this study. This systematic literature review is a basis for future studies examining cost-effectiveness of biological treatments in Finnish healthcare system.
  • Tyyskä, Miia (Helsingfors universitet, 2009)
    Diabeetikoiden määrä lisääntyy jatkuvasti. Samalla hoitokulut ovat kasvaneet merkittävästi. Paras tapa hillitä kustannusten kasvua on hoitaa diabetesta mahdollisimman hyvin. Näin voidaan ehkäistä myös diabetekseen liittyvien oheissairauksien syntyä. Diabeteksen hoidossa on tärkeää kiinnittää huomiota hoidon jatkuvuuteen ja potilaan hoitoon sitoutumiseen. Apteekin henkilökunnan asema on noussut yhä keskeisemmäksi diabeetikon hoitoon sitoutumisen edistäjänä. Tämän pro gradu -tutkielman tavoitteena oli selvittää, mikä on apteekin farmaseuttisen henkilökunnan rooli diabetespotilaan hoitoon sitouttamisessa, elämäntapamuutosten toteuttamisessa ja niiden pysyvyyden varmistamisessa. Asiaa tarkasteltiin voimaantumisen teorian näkökulmasta. Tarkoituksena oli selvittää, miten voimaantuminen yksilössä tapahtuu, miten sitä voidaan apteekkineuvonnalla edistää ja mikä on apteekin rooli ulkopuolisena voimaannuttajana. Tämän tutkimuksen aineisto on kerätty Mäntyharjun Havu apteekissa ja se on osa laajempaa tutkimusta, jonka päätavoitteena on kehittää ja testata apteekkeihin soveltuva yksilökeskeinen toimintamalli tyypin 2 diabeteksen hoidon tukemiseen. Toimintamalli perustuu säännöllisiin neuvontatapaamisiin apteekissa. Pro gradu -tutkielmaan analysoitavaksi valittiin tutkimusjoukosta (n=19) ne, joilla tapahtui apteekkiohjelman aikana eniten positiivisia muutoksia yksilötasolla sekä elämäntapamittareilla mitatuissa arvoissa että kliinisissä parametreissa (n=4). Kvaliatiivisessa analyysissä käytettiin sekä deduktiivista että induktiivista lähestymistapaa. Vaikka diabeetikoilla oli tietoa sairaudesta ja elämäntapojen merkityksestä, niin käytännön tasolla jokainen henkilö kaipasi hoitoon ja erityisesti muutosten toteuttamiseen tukea ulkopuoliselta taholta. Apteekin rooli ulkopuolisena voimaannuttajana koettiin erityisen keskeiseksi. Tapaamiset loivat oikeanlaisen ympäristön ja ilmapiirin elämäntapamuutosten toteuttamiseen ja voimaantumisprosessin etenemiseen. Voimaantuminen ruokavaliomuutoksiin oli koko intervention aikana melko nousujohteinen prosessi. Sen sijaan voimaantuminen liikunnalliseen elämäntapaan oli aaltoilevaa. Apteekkitapaamiset sosiaalisena tapahtumana paransivat asiakkaan hoitoon sitoutumista. Asiakas koki, että häntä kohdellaan yksilönä kokonaisvaltaisesti. Voimaantuakseen yksilö tarvitsi aikaa. Vuoden mittaisen intervention aikana voitiin saavuttaa pysyviä muutoksia elämäntapoihin, mikäli yksilöllä itsellään oli halu ja motivaatio sitoutua tukiohjelmaan. Tämä tutkimus osoitti, että tämänkaltaista apteekkiohjelmaa tarvitaan. Nykyisessä kiireyhteiskunnassa ihmiset arvostavat, jos jollakin on aikaa paneutua yksilöön itseensä ja hänen sairautensa hoitoon kokonaisvaltaisesti.
  • Tenhola, Heli (Helsingfors universitet, 2013)
    Prostate cancer is the most common cancer among men in Finland. Today, new prostate cancers are diagnosed in an early phase of the disease when the cancer is still local and effectiveness of the treatments good. There are many effective treatment options for localised prostate cancer but all of them cause multiple side effects. No comprehensive information about prostate cancer patients' experiences, treatment consequences and outcomes has been available. National Institute for Health and Welfare (THL) carried out a nationwide survey to prostate cancer patients diagnosed in 2004. The questionnaire was sent by mail in 2009. Patients were asked to report their experiences during the diagnosis and treatment selection (prostatectomy, hormone therapy, external beam radiation, brachytherapy, surveillance). They were asked about amount and harmfulness of side effects and satisfaction with outcome of the treatment. An association between the side effects and satisfaction with the treatment outcome was also studied. A total of 1239 responses were accepted for the study (response rate 73%). All treatments caused several side effects, and up to half of the patients had some adverse effect still present at the time of the survey. Most of the side effects concerned urinary or sexual dysfunction, in external beam radiation also bowel dysfunction. All treatments caused sexual dysfunction, but radiation therapy less than the other treatments. Side effects caused by hormone therapy were specific for this treatment, like hot flashes and mood disturbances. Patients treated with prostatectomy were least satisfied with the outcome of the treatment and dissatisfaction was mostly associated with sexual and urinary dysfunction. Patients treated with radiation therapy were most satisfied with the outcome. Urinary and bowel dysfunction impaired the satisfaction in patients treated with external beam radiation. All prostate cancer treatments cause plenty of potentially harmful side effects that may be challenging for psychological and psychosocial well-being of the patients. Thus, both treatment modalities and means to support well-being of the patients should be developed further. Actions that enhance well-being and prevent and relieve side effects should be an essential part of standard clinical procedures for every prostate cancer patient.
  • Ylinen, Varpu (Helsingfors universitet, 2016)
    Chronic myeloid leukemia (CML) is a malignant hematologic disorder, which is fatal without a treatment. Oral tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of CML and transformed the disease to a chronic condition that can be treated at patient's home. The common problem in the treatment of CML is patient's poor adherence to TKIs. The regular, consistent use of TKIs is crucial to keep disease under control. For this reason and to obtain an optimal treatment outcome, adherence to TKIs is extremely important. The aim of the study was to assess reasons for poor adherence to TKI-medications in Finnish CMLpatients, including patient characteristics, treatment related factors, comorbidities and concomitant medications. In addition, patients' experiences, beliefs, knowledge and perception about CML and its treatment were explored and how these could contribute to nonadherent behaviour. This study is part of the larger study, assessing adherence to TKI treatment among Finnish CML population. The data was obtained by using patient questionnaires and semi-structured theme-interview during patient meetings in 2012. Study population consisted of Finnish adult CML patients who had been on TKI -medication (imatinib, nilotinib or dasatinib) for more than six months prior to the study baseline. Patients' adherence was measured using Morisky Medication Adherence 8-Item Scale (MMAS-8) and based on their score, patients were divided into three groups: high, medium and low adherence. Both quantitative and qualitative methods were used in data analysis. Study findings show that 21% (n=18) of the patients were low adherent and 23% (n=20) were high adherent to their treatment. Patient sociodemographic characteristics or experienced adverse drug reactions (ADRs) did not predict adherence, while more concomitant medications and comorbidities were associated with high adherence. However, ADRs had negative effect on the quality of life of several nonadherent patients. All nonadherent patients reported unintentional nonadherence and the most common reason was forgetting. Two-thirds of the patients (n=12) reported intentional nonadherence, which often was a result of experienced ADRs. The knowledge of CML and its treatment was poor among all patients while over half of the nonadherent patients (n=11) thought that they received enough information received. Overall, patients were very satisfied with care provided by the hospitals, physicians and other healthcare professionals. Managing TKI-treatment regimen is challenging for many patients and ADRs can have a negative impact on the quality of life. Healthcare professionals should regularly assess patient adherence and provide information and support for the patients to help them to succeed in medication management. Reasons for poor adherence are complex and have to be identified from each individual patient so that adherence can be improved.
  • Viljemaa, Kati (Helsingfors universitet, 2017)
    The economic burden of adverse events (AEs) is substantial and in direct relation to current increasing drug utilisation. According to previous research, the annual cost of AEs in the U.S. may be as high as 22.9 billion euros. In Europe AEs are considered to contribute to 3.6 percent of hospital admissions, have an impact on 10 percent of inpatients during their hospital admission and are responsible for less than 0.5 percent of inpatient deaths. AEs thus clearly constitute a major clinical issue. Fluoroquinolones have been in clinical use since the 1980s and are globally among the most consumed antimicrobials. Fluoroquinolones are generally well tolerated antimicrobials. The most common AEs are mild and reversible, such as diarrhea, nausea and headaches. Nevertheless, fluoroquinolones are also associated with more serious AEs, including Clostridium difficile associated diarrhea (CDAD), rate-corrected electrocardiographic prolonged QT interval, tendinitis and tendon rupture, dysglycemia, hepatic toxicity, phototoxicity, acute renal failure and serious AEs involving the central nervous system, such as seizures. Health service use and costs specifically associated with fluoroquinolone-related AEs have not been evaluated previously. The theory section of this Marter's thesis considers adverse events and fluoroquinolones. The main principles of conducting a systematic review are also discussed. The empirical section is a systematic review. The aim of this study is to identify health care use and costs associated with ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin -related AEs. A literature search covering Medline, SCOPUS, Cinahl, Web of Science and Cochrane Library was performed in April 2017. Two independent reviewers systematically extracted the data and assessed the quality of the included studies. All costs were converted to 2016 euro in order to improve comparability. Of the 5,687 references found in the literature search, 19 observational studies, of which 5 were case-controlled, fulfilled the inclusion criteria. Hospitalization was an AE-related health care use outcome in 17 studies. Length of stay associated with AEs varied between <5 - 45 days. The estimated cost of an AE episode ranged between 140 and 18,252 €. CDAD was associated with the longest stays in hospital. However, a mere 10 studies reported AE-related length of stays and only 5 evaluated costs associated with AEs. Although rare, in particular serious fluoroquinolone-related AEs can have substantial economic implications, in addition to imposing potentially devastating health complications for patients. Further measures are required to prevent and reduce health service use and costs associated with fluoroquinolone-related AEs. Equally, better-quality reporting and additional published data on health service use and costs associated with AEs are essential. The strengths of this study are a comprehensive and systematic literature search and transparency of methodologies and reporting. The main weakness is the generalizability of the results.
  • Seikola, Anniina (Helsingfors universitet, 2011)
    The Ministry of Social Affairs and Health published a report on development needs of elder care and geriatric pharmacotherapy in 2006. The major concern in this report was related to several challenges in pharmacotherapy of the aged, such as deficiencies in medical knowledge of nurses working with elderly people. One way to improve the medication expertise of those various parties involved in caring elderly people is continuing education (CE). The aim of this study was to explore pharmacotherapy-related training needs of health care professionals involved in the home care services for the elderly in the Social and Health Care Cooperation Region of Lohja, Siuntio, Inkoo and Karjalohja (the LOST Region). This study was started by conducting a survey among nurses working in home care services for the elderly in the LOST Region in 2009 (response rate 47%). To deepen understanding of the key findings of the survey, focus group discussions (FGDs) and face-to-face interviews were conducted among nurses, nursing aids, their managers and physicians (1 FGD among nurses, n=6; 1 FGD among their managers, n=6; and face-to-face interviews with 4 physicians). The survey data were analyzed separately for nurses (n=9), practical nurses (n=53) and home aids (n=9), but results were the same in every group. Of the theoretical training needs, topics related to pharmacokinetics and special characteristics of using medicines in the elderly, effects, adverse effects and interactions of medicines, were most important. In addition, the theoretical training needs covered professional ethics issues, such as accuracy and carefulness of nursing practice. The main training needs related to collaborative practice in pharmacotherapy concerned monitoring medicine user's condition and medication, and dosing medicines (right medicine, dose, strength, dosage) in the right time, and administration routes of medicines. Focus group discussions and face-to-face interviews of the physicians provided a deeper understanding of the results of the survey. One of the main findings of this qualitative part of the study was challenges in cooperation in home care services in the LOST Region. Implementation and monitoring geriatric pharmacotherapy can be improved by improving multiprofessional cooperation and training for nurses and physicians working in home care services. The most important diseases and disorders for which the nurses would like to have shared operational guidelines were diabetes, cardiovascular diseases, pain, memory and psychiatric disorders. Training needs also covered special characteristics of pharmacotherapy for the elderly, and formulations and administration routes of medicines. Finally, a synthesis was made of the results of the survey, focus group discussions and face-to-face interviews. On the basis of the synthesis, a proposal for a multiprofessional training was developed for the LOST Region. The training plan includes topics related to geriatric pharmacotherapy and improving collaborative practices and communication as identified by those involved in different stages of the study.
  • Rydman, Saara (Helsingfors universitet, 2013)
    With advancing age the kidneys undergo anatomical and physiological changes. The most significant physiological changes are decreased renal blood flow and glomerular filtration rate (GFR). GFR is declined approximately in two thirds of the aged. Dosages of drugs eliminated mainly by the kidney should be adjusted carefully in patients with renal insufficiency. Nevertheless, according to earlier studies renal insufficiency among elderly patients is underdiagnosed and renal function is often overlooked when prescribing. Serum creatinine level is used as a screening test for renal dysfunction. However, it is a poor measure among elderly patients. Instead, calculated GFR should be the preferred method in estimating kidney function among this patient group. The aim of this study was to assess if comprehensive medication review can improve the quality of drug therapy among aged nursing home residents with impaired renal function. The data consisted of 153 comprehensive medication reviews (CMRs) conducted by Farenta Oy. CMR case reports were used to assess intervention recommendations made by pharmacists because of renal insufficiency, other kidney-related findings and resulting medication-related interventions. In addition, the prevalence of renal insufficiency, degree of renal insufficiency diagnoses and relationship between serum creatinine and estimated GFR were assessed. Clinical significance of the interventions was not assessed. The mean age of patients was 82,4 years. The estimated GFR was available for 145 patients (94,8%). 86,9% (n=126) had declined renal function (GFR<80 ml/min). Of these, serum creatinine levels were within normal range or under in 73,8% of all patients with renal insufficiency. Physicians had documented 4,8% of renal insufficiency cases in clinical patient files. Pharmacists identified inappropriate drugs due to renal function in 34,9% (n=44) of the patients with renal insufficiency. In total, pharmacists made 71 intervention recommendations. Physicians approved 60,6% of the pharmacists' recommendations as made. At least one intervention recommendation was approved as made in nearly one fourth (23,0%) of the patients with renal insufficiency. The most common drug-related intervention was changing the drug (25,4 %). Cardiovascular drugs accounted for 33,8% of the intervention recommendations, nervous system drugs 19,7 %. According to this study renal insufficiency among aged nursing home residents is common but underdiagnosed. Approximately one third of patients with renal insufficiency are using inappropriate medicines or dosages. These drug-related problems can be indentified and resolved during the comprehensive medication review procedure.
  • Valkohaapa, Anna-Mari (Helsingfors universitet, 2014)
    In Finland the elderly residents of long-term care facilities are often prescribed a lot of medications, especially psychotropic drugs. It also happens that a patient or a resident has to be physically or chemically restrained. Chemical restraining can be defined in many ways, for example as using a drug - usually an antipsychotic - to restrict the freedom or movement of a patient and to control his or her behavior. In nursing homes the staff is in a key position when it comes to deciding on the use of chemical restraining or PRN medication. A legislation to guarantee the self-determination of a patient and to define how physical restraining can be used is now being prepared in Finland. Only a few studies on chemical restraining from a nurses' point of view have been made so far. Thus, the aim of this study is to provide more information on the level of knowledge, the attitudes and perceptions of nurses regarding chemical restraining and the effect of those on deciding whether to use chemical restraints or not. Three focus groups with nurses were conducted in Hyvinkää nursing homes (n=13). The groups were recruited both by e-mail and directly from the wards. The focus group discussions were digitally audiotaped and transcribed verbatim. The content of the transcripts was then analyzed using a constant comparative method. According to the study most of the antipsychotics used in long-term care were used daily. However, it is not uncommon for the nurses to be unsure about their knowledge on the use of medicines. It is thus important to help the nursing staff to increase their knowledge and skills in pharmacology. The nurses also wished to get extra training for treating people with dementia. The concept of chemical restraining is quite ambiguous, and the use of chemical restraints is a complex ethical issue because the reasons for and effects of administering it vary depending on the situation. The study shows that the chemical restraining is most often considered justified when it is used to ensure the safety of a patient, relieve anxiety or to keep the working conditions of the staff tolerable. Also a shortage of manpower and a request by the family can influence the decision on using chemical restraints. The lack of proper common guidelines causes confusion and wide variation in the use of chemical restraints. Many interviewees were hoping for more open discussion and cooperation on using chemical restraining. The nurses also mentioned many alternatives to rely on instead of using chemical restraints, such as soothing, comforting and creating a safe feeling for the patients, daily routines and stimulus. One of the key factors for taking to these instead of chemical restraints are the manpower resources in the facilities. Educating the staff can also help them to find more options for chemical restraining and make staff members recognize new or remember forgotten routines for caring for the patients without using psychotropic drugs.
  • Salminen, Sanna (Helsingfors universitet, 2011)
    The background of this study is increase in the ageing population and in medication use. Aged-related changes in pharmacodynamics and pharmacokinetics may change medication response in elderly patients and lead to adverse reactions. For elderly people the risk of being hospitalized due to adverse drug reactions is four times higher than for younger people. Many of these problems could be prevented by avoiding the use of certain drugs in the elderly. Several criteria have been developed to assess medication appropriateness in the elderly. The aim of this study was to develop a new Finnish Medication Risk Assessment (MRA) tool to be used by trained nurses to assess the presence of risks related to use of medicines in outpatients aged 65 years and older. A preliminary tool was developed through a comprehensive literature review of tools to indicate appropriateness and risks of elderly medications, and through expert opinions. The tool was then validated by using three-round Delphi-method. Delphi-method is a qualitative consensus method which is based on group judgement of a subject matter. The first and the second Delphi-rounds measured the tool's suitability and the third Delphi-round measured the importance of the items of the tool in estimating risks related to the use of medications of elderly patients. In this study, 33 expert geriatric panelists were approached of whom 11 physicians, three pharmacists MSc (Pharm.) and four nurses agreed to participate. The results from the Delphi-rounds were evaluated both quantitatively and qualitatively. Through the three-round Delphi-method was developed a MRA -tool that contains 19 items. According to the panelists the items of the tool are either important or moderately important. This indicates that the tool is valid to estimating medication risks in use of medications in this population. Further studies are needed to test the tool among nurses and patients. The MRA -tool was primary developed for estimating risks in medication use, but it could also be used for educational purposes. In the future, it is possible to implement safer and more appropriate pharmaceutical treatment for elderly patients by using this Medication Risk Assessment -tool.
  • Niskanen, Anna (Helsingfors universitet, 2013)
    Polypharmacy and age-related changes in pharmacodynamics and pharmacocinetics may lead to drug-related problems in elderly patients. Accurate medication reconciliation and medication review on admission may help to control drug-related problems and optimize drug therapy in elderly patients. Several models have been developed to reconciliate and review medications at this point of care. A Finnish model can be developed on the basis of the se models. The aim of this study was to develop a tool for medication reconciliation and medication review on admission for ward pharmacists’ use in the Lahti city hospital. The tool was developed with an action research method in cooperation with the multiprofessional study group. A preliminary tool was developed through doctors’ (n = 2), nurses’ (n = 3) and ward pharmacists’ (n = 2) interviews, a literature review and the expertise of the multiprofessional study group. The preliminary tool was piloted twice in the Lahti city hospital. After the first pilot a view changes were made to the too l by the experiences of the ward pharmacists. Doctors (n = 3) who worked at the study ward during the first pilot were interviewed to find out their views on the medication reconciliation and medication review process so that their views could be taken into consideration in the development of the final version of the tool. After second pilot ward Pharmacists (n = 2), researchers (n = 2) and an expert of geriatrics from the study group took part in a group conversation. Through the group conversation and doctors’ interviews was developed the final version of the tool. The developed tool contains sections for patient’s background information, patient interview, medication reconciliation, drug-related problems, proposed medication changes and doctor’s decisions on the proposed changes. Also instructions of the medication reconciliation and medication review process were developed for ward pharmacists. The developed tool will be used in an intervention study in the Lahti city hospital. In the future a new version of the tool could also be developed to be used in other hospitals in Finland to reconciliate and review medications at the time of hospital admission.
  • Aaltonen, Kalle (Helsingfors universitet, 2010)
    Rheumatoid arthritis is an inflammatory autoimmune disease with prevalence of 0,8 per cent of Finnish people. Rheumatoid arthritis may lead to immobility and premature death. Treatment of Rheumatoid Arthritis includes disease modifying anti-rheumatic drugs and surgery. TNF-blockers are efficacious new drugs, which halt the progression of joint destruction caused by inflammation. The first TNF-blocker to receive permission of the national agency for medicines was Infliximab in 1999. Since then Infliximab has been followed by Etanercept, Adalimumab, Golimumab and Certolizumab. TNF-blockers have been found to be more efficacious than placebo in both clinical trials and register studies. In addition they are considered to be safe enough for clinical use despite the increased risk for tuberculosis and certain cancers. The number of patients annually treated with TNF-blockers in Finland increased threefold between 2004 and 2008. In 2008 the medication costs per patient were 11 669€ for Etanercept and 13 074€ for adalimumab. Systematic literature review is a study, which searches, identifies and combines individual studies. Usually Systematic reviews include a meta-analysis, which uses statistical methods to combine the results of the studies. Meta-analysis aims for increasing power and generalisibility of the studies and reducing the potential bias in individual studies. In order not to introduce bias by itself the systematic review must be done following the methods approved by the scientific community. In addition the process must be documented in detail. Following a predefined search strategy the systematic literature search found 5308 references. After a process involving the evaluation of the patients, intervention, control, outcomes, study design and the risk of bias 27 studies were selected to be included in the systematic review and meta-analysis. Of the included studies, nine had adalimumab, six had etanercept, five had infliximab, four had golimumab and three certolizumab as intervention. TNF-blocker was used either alone or in combination with methotrexate whereas control was either placebo or methotrexate. Altogether, there were 11 533 patients in the intervention group and 9027 in the control group. The results of the meta-analysis indicate reveal that the patients treated with TNF-blockers are twice as likely to reach a 20 % increase on ACR criteria compared to control patients. The likelihood to reach improvements of 50 and 70 % was 3 and 3.5 times higher, respectively. There were no statistically significant differences in efficacy between individual TNFblockers. Increasing the dosage of a TNF-blocker did not increase efficacy. However, combination of TNF-blocker and methotrexate was superior to monotreatment of TNF-blocker without increasing the likelihood of discontinuation of treatment. There were no statistically significant differences between the efficacy of TNF-blocker monotherapy and methotrexate. Adalimumab, infliximab and certolizumab lead more often to treatment discontinuation compared to etanercept and golimumab, which do not differ from control. This systematic review probably found all studies that investigated the efficacy of TNF-blockers in a randomized controlled trial. Study selection and evaluation were based on widely accepted methods. This study has two weaknesses. Firstly, literature search and study selection and evaluation were done only by a single researcher. Secondly, unpublished studies and study results were not actively obtained outside electronic databases.
  • Pakarinen, Tiina (Helsingfors universitet, 2014)
    Clinical pharmacy is defined as a service which a pharmacist provides for example to a ward or a medical center. In Finland clinical pharmacy (or ward pharmacy) was started in the 1980s but it hasn't expanded widely until at the end of the 2010s. Need for cost-effectiveness research has been under discussion because of increasing health care costs. This kind of research helps to choose the most effective services. Naturally also clinical pharmacy is under effectiveness consideration. A systematic review was conducted considering the cost-effectiveness research of clinical pharmacy. The aim of this review was to find clinical pharmacy interventions which have been proven costeffective. Literature research found 7 articles. Three of these studied pharmacokinetic patient surveillance and in the rest four articles pharmacist worked as a part of multidisciplinary team. In six studies the cost savings were greater than the costs. The other part of this study was about clinical pharmacy in the hospital district of Helsinki and Uusimaa (HUS). Data was collected from Helsinki University Central Hospital (HUCH) wards which had had clinical pharmacy services during the years 2009-2012. Collected data included clinical pharmacy costs and amount of work gained with those costs, drug consumption, drug waste amounts, amounts of drugs returned to HUS-pharmacy and amounts of HaiPro-reports. Collected data was presented as a time series. The costs of clinical pharmacy had followed the trend of other health care costs during 2009-2012. Wards with clinical pharmacy had somewhat larger amount of drug waste than the other wards. Amounts of drugs returned to the pharmacy were greater in the wards with clinical pharmacy. The amount of HaiPro-reports grew by a factor of 15 from 2009 to 2012. Especially amounts of drug administration errors and errors in writing down prescriptions were greater in clinical pharmacy wards. The data in this thesis describes only a small part of clinical pharmacists' work in the HUCH area. Making final conclusions about the cost-effectiveness of clinical pharmacy isn't possible with this data. The systematic review can give ideas to improve clinical pharmacy in HUS in a more cost-effective direction.
  • Korkeamäki, Laura (Helsingfors universitet, 2013)
    The status of herbal products has changed over time and due to changes in medicines legislation in Finland. The study period starts from 1964, when marketing authorisation procedure became obligatory for medicinal products. In 1994 medicines regulation introduced the term "herbal remedy" and in 2005 the terms "herbal medicinal product" and "traditional herbal medicinal product". In recent years there has been an increasing interest in medicines information regarding children. For example in 2007 a new paediatric medicines regulation was given by the EU. In Finland a new medicines information strategy was published in 2012 by the Finnish Medicines Agency. The aim of this study was to find out how the medicines information of herbal products regarding children has changed over time and changes in legislation. The material of this study were the documents of herbal products under medicines regulation in Finland 1964 - 2012. The information was gathered from summary of product characteristics, package leaflets, labellings and their predecessors. In total there were 195 products of which 189 had relevant documents for this study. The method of this study was content analysis. The information was collected from the documents to data sheets. The analysis was based on the legislative periods. Medicines information has become more accurate during the study period 1964 - 2012. Information was less accurate between years 1988 and 1995. The amount of medicines information has increased after the term "herbal remedy" and terms "herbal medicinal product" and "traditional herbal medicinal product" were introduced. Some of the changes in medicines information could be tracked to specific regulatory changes. The study gives historical perspective on the changes in medicines information of herbal products in Finland. It is clear that the legislative changes have limited effect on medicines information, if the amount of paediatric scientific studies is not increased. In the future there is a need to study the prevalence of the use of herbal medicinal products and traditional herbal medicinal products in children and in other population groups. There is also a need to study how the medicine information differs in herbal medicinal products and traditional herbal medicinal products and what are the differences compared to the information on dietary supplements.