Browsing by discipline "Social Pharmacy"

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.