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Browsing by discipline "Social pharmacy"

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  • Falck, Jenni (2019)
    Biological medicines are gaining ground in drug therapy. However, biological medicines are considerably expensive. Top ten drugs that caused the most drug reimbursement expenses included six biological drugs in Finland in 2017. A biosimilar is a biological medicine which is highly similar to another biological medicine (the reference medicine) that has already approved. Biosimilar prices are cheaper than the original medicines because their clinical development program does not have to be as extensive. A wide use of biosimilars save costs for both the patient and society without changing the effectiveness of drug therapy. The aim of this study is to investigate the automatic substitution of biological drugs containing the same active ingredient, especially from the point of view of medication safety. The study was conducted as a systematic literature review. Literature search was carried out by using Pubmed and Scopus databases. The literature was also searched manually from references of the articles and from the industry experts. The literature search produced a total of 454 articles after the deletion of duplicates. A title, abstract and full text screening was conducted by two independent researchers. All in all, 65 articles met the inclusion criteria of the study. As no studies were found on the automatic substitution of biological medicines from the point of view of medication safety, it was decided to include in the study original studies investigating the substitution of biological drugs from the point of view of doctors (n=8), pharmacists (n=3), patients (n=1) and various stakeholders (n=2). The original studies were all surveys except one study. In addition, the review included statements of various medical associations and organizations (n=23), descriptive reviews (n=27), and expert views (n=2) on the automatic substitution of biological drugs. According to the results of the original studies (n=13), it can be stated that automatic substitution is not considered generally acceptable. Doctors consider it is very important that the pharmacist informs them if substitution occurs. They also think it’s critical that doctors should be able to prevent substitution. Patients are also sceptical about the substitution of biological drugs. The quality of the original studies was assessed by the generalizability of the research results. The generalizability of the results of the original studies is weak due to the methodological shortcomings of the studies. Although the automatic substitution of biological drugs is legal in some countries, such as in France and in Australia, it has not been studied from the point of view of medication safety. In order to be safe to implement automatic substitution of biological medicines, more should be investigated on the subject. From the point of view of medication safety, healthcare professionals and patients will need further target group education on biosimilars. In addition, it should be clarified what kind of education the healthcare professionals and patients would need if the automatic substitution of biological medicines was to be realized.
  • Mäkinen, Arttu (2018)
    This is a systematic review aiming to investigate the efficacy, effectiveness, and safety of biosimilars in the treatment of inflammatory bowel diseases. Biosimilar drugs used to treat inflammatory bowel diseases include biosimilar infliximab and biosimilar adalimumab. Biosimilar infliximab has been authorized by the European Medicines Agency (EMA) in 2013 and by the US Food and Drug Administration (FDA) in 2016. Biosimilar adalimumab has been authorized by EMA and FDA in 2017 and, at the time the literary search for this systematic review was conducted no studies were found regarding the treatment of adalimumab biosimilar for inflammatory bowel diseases. To acquire marketing authorization for biosimilars, it must be proven that the biosimilar is biologically similar to the original medicinal product. Bioequivalence is demonstrated through physicochemical trials and clinical trials. However, clinical trials do not have to be performed with all of the indications for which the original medical product is registered. After proving bioequivalence with one or more indication it is possible to extrapolate the biosimilar to be used in all of the original medical products indications. This has raised the question of whether biosimilars are really comparable to the originator in indications for which no clinical trials have been conducted. This systematic review was implemented using the Cochrane Handbook for Systematic Reviews and Interventions. Systematic literature searches were made in Cochrane, Medline (Ovid®), PubMed and Scopus databases on 12.05.2017. 14 observational studies, one systematic review and a randomized clinical trial that met the inclusion criteria were included in the systematic review. The quality of the publications was evaluated using the STROBE-, NOS- and CONSORT-checklists and information regarding the efficacy, effectiveness and safety of biosimilars was extracted. CD-patients receiving tumor necrosis factor alpha inhibitors for the first time, the clinical response was achieved in 50.0 % to 97.2 % of patients depending on patient population and the duration of treatment. Similarly, for UC-patients, the clinical response was achieved in 62.2 % to 100.0 %. The clinical remission was achieved among 28.9 % to 84.4 % of CD-patients and among 28.9 % to 84.4 % of UC-patients, depending on patient population and treatment follow-up. After the switch from original infliximab to biosimilar, the proportion of patients in clinical remission during follow-up ranged from 62.3 % to 100.0 % in CD-patients and from 45.5 % to 100.0 % in UC-patients. Clinical remission was sustained throughout the whole follow-up in 70 % to 100 % of CD-patients and 66.7 % to 92.0 % of UC-patients. The incidence of adverse events leading to the discontinuation of drug treatment was between 0.0 % and 25.0 %, and the incidence of all adverse events ranged from 0.0 % to 93.6 % in CD- and UC-patients. Biosimilar infliximab seems to be comparable to the original product regarding the efficacy, effectiveness and safety. This result is supported by the systematic literature review published earlier. Conducting a meta-analysis of the information contained in this systematic literature review could have led to a more final decision considering efficacy, effectiveness and safety of biosimilar-infliximab in the treatment of inflammatory bowel diseases.
  • Vainio, Sanna (2019)
    Despite the long history of skin grafting, there is no standardized treatment for split-thickness skin graft donor sites. These sites cause a notable amount of pain and discomfort to the patients and open wounds also introduce a risk for infection. There is an extensive need for treatment options promoting the fastest and least painful healing possible while also being infection-free. The treatment of split-thickness skin graft donor sites is constantly studied and there is plenty of scientific literature available about this topic. In the theory section of this Master’s thesis, the structure of skin, the process of wound healing, skin grafting surgery and wound care products for split-thickness skin graft donor sites are briefly introduced. Additionally, the method of systematic review is described. In the empirical section, a systematic review is performed to compare animal- and non-animal-based wound care products in the treatment of split skin graft donor sites. The methodological quality of the included studies is reviewed. In the literature search, 3552 references were found. In this systematic review a total of 23 articles were included comprising of 21 comparative clinical studies and two previous literature reviews. Of the original studies, 20 reviewed healing, 14 infection and 17 pain of the split-thickness skin graft donor sites. Based on the results of the systematic review, animal-based wound care products might promote healing and reduce pain experienced by patients in the treatment of split-thickness skin graft donor sites when compared with non-animal-based wound care products. The results concerning infection were inconsistent. Generally, the reporting of the clinical original studies was not comprehensive enough for proper evaluation of methodological quality. Some defects, mostly in the blinding of the patients, study personnel and the assessors of outcomes, were also found. Moreover, the studies were heterogeneous in their definitions and measuring of the reported outcomes. Therefore, there is substantial uncertainty in the results of this systematic review. The systematic and transparent way of conducting the literature search, the review of the methodological quality and the reporting of the outcomes can be considered as a strength of this thesis. The main weakness is, that only one person performed the critical steps of this study, which might increase the risk of bias and reduce the repeatability of the study.
  • Peltoniemi, Jonne (2020)
    Erenumab (Aimovig®) is a first-in-class calcitonin gene-related peptide (CGRP) inhibitor approved for the preventive treatment of migraine by the FDA in May 2018 and by European Commission (EC) in July 2018. It is a human monoclonal antibody (mAb) binding to the CGRP receptor, antagonizing the effect of CGRP. The marketing authorization of Aimovig® was based on two phase II and two phase III clinical trials. In all trials, erenumab with doses 70 mg/mL and 140 mg/mL was found to have a significantly superior effect compared to placebo, with a similar safety profile between all groups. These conclusions are mainly in line with studies conducted post marketing authorization. However, questions about the optimal dose, and the frequency and types of adverse events in larger patient populations remain to be studied. A European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) are required by the European Commission for each human medicine with a marketing authorization within the European Union. The SmPC is produced by the applicant and it should contain all relevant information of the medicinal product as distilled during the assessment process. The SmPC can thus be viewed as a kind of summarized version of the EPAR. The aim of this study was to investigate the post-marketing efficacy and safety information of erenumab from three perspectives: 1) the EPAR was compared with recent systematic reviews and meta-analyses assessing the efficacy and safety of erenumab, 2) all existing literature on the efficacy and safety of erenumab on different subgroups of migraine patients was assessed and summarized, and 3) the efficacy and safety information of the EPAR was compared to those of the SmPC, to resolve whether important information is missing. This review found several points regarding the efficacy and safety of erenumab. First, the status of erenumab was further established as a safe and effective treatment for the prevention of migraine. Second, meta-analyses (n=3) with more extensive cohorts compared to those of the EPAR and SmPC, present a further case for the superiority of the 140 mg dose compared to the 70 mg dose. The difference in dose effect is addressed in the EPAR but its assessment may be based on limited information. Third, different subgroups seem to respond differently to erenumab treatment. This aspect should be further investigated by head-to-head studies. Lastly, the safety information of the SmPC seems insufficient due to lack of mention of upper respiratory infections. This adverse event was among the most common in all of the four clinical trials and has since been observed in a real-world study. Based on these findings, neither the EPAR nor the SmPC of erenumab seem to be fully up to date and information related to the dose and upper respiratory infections as a risk should be reconsidered.
  • Korhonen, Juha (2020)
    Traditionally pharmacists’ activities have focused on the manufacturing and compounding of medicinal products. The production of medicines has shifted from pharmacies to industrial mass production since the 1960s, and correspondingly, the production of medicinal products by pharmacists in community pharmacies has declined and is now almost completely absent. It has been concluded that pharmacists are over-educated, and their skills are not fully utilized. Authorities and pharmacy organizations have expressed interest in pharmacists’ extended role, which includes patient care and cognitive services. Professional identity refers to the conscious understanding and awareness of oneself as a professional, which is based on an individual's life history: it is the relationship between the individual, work and profession, and its future. Professional identity has been seen to influence the performance of health workers, in terms of both competence and responsiveness. The purpose of this study is to describe pharmacists’ perceptions of their professional identity and its possible change from the beginning of 1990 to 2019. A systematized review was conducted in October 2019. Altogether 12 publications were selected in the systematized review. All the studies were qualitative. In eight studies, interviews were used as the research method. Two selected studies used a focus group discussion as the research method, and two studies used both interviews and focus group discussions. One study used interviews and focus group discussions as well as survey as research methods. From the basis of this study, no conclusion can be drawn that the professional identity of pharmacists has evolved from a product orientation towards a more patient-centered care provider. Because of the complex and dispersed nature of community pharmacy practices, and the many factors that are involved in them in different contexts, it is difficult to interpret and understand what the core function of a pharmacist is in a community pharmacy. Pharmacists could not describe their activities and their roles explicitly. The researchers concluded that pharmacists had not attained as clear and strong professional identity in their current occupation, as it had been in the past when drugs were still manufactured in the community pharmacy. Community pharmacists balanced between two conflicting roles as pharmacists and business managers. Pharmacists, patients, and politicians alike perceived community pharmacy as a business. This view is further supported by the context, the physical premises of the community pharmacy, which are generally more suitable for retail than patient care. This may represent a challenge for the implementation of pharmacists’ extended role.
  • Wikman, Essi (2019)
    Streptococcus pneumoniae is a bacterium that causes invasive pneumococcal disease (IPD) such as bacteraemia and meningitis, and pneumonia. The prevalence of pneumococcal diseases is high in infants and in ≥65-year-olds. Also, the incidence of pneumococcal disease is higher in medical risk groups compared to the base population. Pneumococcal diseases can be prevented by vaccinations and since 2010 pneumococcal vaccine PCV10 has been in the national vaccination programme for infants in Finland. The aim for this study is to evaluate the cost-effectiveness of pneumococcal vaccinations in national vaccination programme for the 65-year-olds in medical risk groups (diabetes, chronic coronary artery disease, asthma and COPD). Secondary aim is to examine uncertainty factors that are related to economic evaluations of pneumococcal vaccinations in the elderly. Cost-utility analysis was used as the economic evaluation method. It is a method where health gains are measured by quality-adjusted life years (QALYs). Static multicohort model was chosen for the modelling. Some of the used parameters were acquired from the literature and most of the epidemiology and cost parameters were acquired from research reports and articles published by National Institute for Health and Welfare. Analyses were made for both pneumococcal vaccines that are registered for adults (PCV13 and PPV23) and in 2 different scenarios: Finland’s present situation where PCV10 is in the vaccination programme for infants (scenario A), and hypothetical situation where PCV13 would be in the vaccination programme for infants (scenario B). Based on the analysis, when PCV10 was in the vaccination programme for infants (scenario A), vaccinating 65-year-olds in medical risk groups was cost saving intervention in the health care perspective for both vaccines in chronic coronary artery disease and asthma and COPD risk groups. In diabetes risk group the costs per QALY’s gained were 2 100 € in scenario A. When PCV13 was in the vaccination programme for infants (scenario B), costs per QALY’s gained for PCV13 vaccinations were: diabetes 52 400 €, chronic coronary artery disease 35 900 € and asthma and COPD 22 000 €. The uncertainty of results was tested with deterministic and probabilistic sensitive analysis. In scenario B the results were sensitive for the waning of the PCV13 produced immune protection, the price of the vaccine, the proportion of pneumonia caused by S. pneumoniae, the changes in the pneumococcal disease incidences and the effect that pneumonia has for the health related quality of life. The cost-effectiveness of vaccinating 65-year-olds with pneumococcal vaccines was different depending on the risk group and on which pneumococcal vaccine is in the vaccination programme for infants. In addition, there are several uncertainty factors that have an impact on the results of economic evaluation of pneumococcal vaccinations.
  • Niittynen, Ilona (2018)
    Medication-related events are a significant cause of in-hospital adverse events. Intravenous medication errors occur more frequently and are more likely to result in serious harm than other medication therapies. Closed loop medication management which seamlessly integrates automated and intelligent systems barriers, is used for reducing medication errors. The aim of this systematic review was to identify what kind of scientific studies exist regarding closed loop medication in intravenous medication therapy and barriers related to it. This study is part of a larger systematic review. The literature search indentified 2292 scientific papers. Of these, only 57 were included in the larger review since most of the references were excluded based on titles, abstracts or full-texts. Of these, 21 studies regarding closed loop medication management in intravenous medication therapy were included in this thesis. The studies conserned intelligent infusion devices, computerized physician order entries, clinical decision support systems, automated workflow management systems reducing compounding errors and bar-code confirmation of drugs and patients. According to this review, closed loop medication management potentially reduces medication errors related to intravenous medication therapy. It seems to be more effective to seamlessly integrate the closed loop medication management barriers to each other and to the medication management process than to implement the barriers separately. It’s important to plan the implementation carefully by a multidisciplinary team. In addition, the latest care guidelines need to be taken in to account. Significant resources must be allocated to training and engaging employees and to systematically maintaining and developing the process to manage the successful implementation of the process. This review provides valuable information for Finnish hospitals implementing the closed loop medication management since the concept is not yet well-known in Finland.
  • Nurmi, Tuomas (2020)
    Automated dispensing cabinets can improve patient safety by reducing medication errors, and consequently, the incidence of adverse drug events, as well as reduce the number of outdated drugs and the size of ward inventory. They can reduce the amount of time nurses and other staff spend on distribution and ordering of medicines, and time spent on taking inventory. In conjunction with an electronic narcotics registry, they may significantly reduce the time needed for filling, checking and correcting narcotics registry forms. This study evaluated the impact of automated dispensing cabinets on the amount of time nurses spend on selecting and picking doses for patients, as well as its effect on the size of ward inventory and wastage of drugs. The amount of time nurses, pharmacists, and technical staff spent on narcotics registry related activities in the hospital ward and hospital pharmacy was also measured. No evidence was found to support the conclusion that automated dispensing cabinets speed up selection and picking of doses, and they may in fact slow it down. With current number of narcotics distributed in the hospital annually, the overall time taken by narcotics registry activities can be 10.9 full time equivalents. Most of this time, roughly 8.7 FTE, consists of nurses filling narcotics registry forms while administering drugs, though only a tiny proportion of each nurses’ time is spent on this activity. On average, it the cost of labor needed to fill one form is 9.3 €. An electronic narcotics registry in combination with and ADC could reduce this down to 0.36 € - 1.16 € per narcotics package by removing the need to fill redundant information in different registries.
  • Karasti, Eveliina (2019)
    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.
  • Tikkanen, Johanna (2020)
    Between 5% and 57% of patients experience an adverse drug event during their hospitalization. Reducing medication errors can help prevent adverse drug events. A particular risk for medication errors arises when a patient moves between home and care centers if accurate medication information is not transferred with the patient. Medication reconciliation is a process to ensure accurate and comprehensive medication information across transitions of care. The aim of the study was to find out how many and what kind of discrepancies can be detected by performing medication reconciliation in a primary care unit. In addition, pharmacists and nurses experiences of the medication reconciliation process and the medication reconciliation form were examined. Both quantitative and qualitative data were used in the study. Quantitative study data consisted of all Medication reconciliation forms (PASQ) completed in January-June 2014. Data were analyzed using quantitative descriptive methods. The qualitative research material consisted of six individual interviews conducted in June 2014. The material was subjected to inductive thematic content analysis. Patients (n = 117) had a mean age of 81 years and almost all (n = 105) had at least six regularly used medications after medications were reconciled. Almost every patient (n = 115, 98.3%) had at least one discrepancy in their medication compared to the patient information system. On average, patients had seven discrepancies in their medication lists. The most discrepancies were associated with psycholeptics (9.5% of all discrepncies). The most common types of discrepancies were new drug (45.4% of all discrepancies) and discontinued drug (19.6%). Nurses and pharmacists saw the medication reconciliation process as an important part of successful patient care. Challenges associated with reconciling medications were caused by lack of time, the fragmentation of information systems and the health status of patients (information given by patients could not be trusted). Only one-third of the patients were interviewed, although international publications on medication reconciliation strongly emphasize patient involvement. The results of this study are in line with previous research and confirm the view that medication reconciliation should always be done across all transitions in care. The role of the patient as part of the medication reconciliation process should be further emphasized in the future, as only interviewing the patient can provide a true picture of the patient's medication.
  • Luoma, Maaria (2018)
    Inappropriate polypharmacy refers to a situation where more than appropriate amount of medicines are used by a patient. Aged people with multiple morbidities and medications use a lot of health care services and are thus especially vulnerable to iatrogenesis, the health hazards resulting from the acts of a health care system. As a part of normal ageing, geriatric syndromes (e.g. falls, delirium and urinary incontinence) are clinical conditions and symptoms crossing several organ systems and they cannot be connected to a certain individual disease. Geriatric syndromes complicate recognition of adverse drug reactions on aged. This increases the risk of prescribing cascade, where medicines are prescribed to treat adverse drug reactions caused by another medicine. In this master´s thesis the root causes for inappropriate polypharmacy and drug-related problems (DRP) with home-dwelling aged were researched retrospectively from the viewpoint of risk management. Research method was based on root cause analysis (RCA) that was simplified suitable for this research. Research material was based on an intervention research conducted in 2015– 2017 on home-dwelling aged receiving regular home care from the City of Lohja, Finland. In the intervention research, a coordinated community-based medication management model for home-dwelling aged in primary care was developed to identify homedwelling aged with clinically significant drug-related problems. As research material, there were five (n=5) patient cases used who received comprehensive medication review (CMR) in the intervention research to solve their drug-related problems. The research material composed of individual patient interviews conducted at patients’ homes as a part of their CMR visits. Also, the nurses (n=3) of home care and physicians (n=2) from local health centres having participated in the treatment of the home-dwelling aged in question, were interviewed individually. Markings made in the patient records were utilized as well as research material. The interviews of the nurses and physicians were recorded, transcribed and analysed with inductive content analysis considering principles of root cause analysis. According to the nurses and physicians, central clinically significant medication-related problems with home-dwelling aged are various prescribing care parties, multiple medications, the increased use of over-the-counter (OTC) medicines and natural products, the uncertainty of health care professionals of the medication of a home-dwelling aged as well as the occurrence and medication of pain and sleeping disorders with aged. Other essential problems related to the health care system are various attending physicians, obscurely recorded medication data in patient record system, the use of benzodiazepines and other psychopharmaceuticals and ignored renal function in medicine dose adjustment. Problems related to home-dwelling aged are attachment for medicines, resistance to change and desire to take care of their own medication. In addition, memory disorders and vertigo were mentioned as problems related to the medication of aged. Seven root causes for inappropriate polypharmacy and drug-related problems were observed: lack of health care resources, segmented treatment between various health care parties, varying skills and knowledge of health care professionals, ambiguous division of responsibilities between health care professionals, challenges in communication between different care parties, the heterogeneity of patient record systems and problems related to their use as well as the knowledge, opinions and personal situation of a home-dwelling aged. Based on the research, the medication of home-dwelling aged should be improved by striving for centralizing care in one physician either on private or public health care. Among home care nursing personnel there is a need for additional training on medications and pharmacists should participate in regular medication reviews for home-dwelling aged. Patient record systems and data transmission between them should be improved and medication data should be recorded more precisely. Cooperation and communication between home care and health centre should be developed and the division of responsibilities should be clarified. Participation of the home-dwelling aged and their relatives in the care should be promoted. Furthermore, geriatric expertise should be utilized better in the care of the home-dwelling aged.
  • Skullbacka, Simone (2019)
    Many drugs are associated with the risk of QT prolongation and torsades de pointes (TdP). The risk increases with other risks factors for QT prolongation. Recognizing risk factors and QT prolonging drugs is critical in the management of this drug-related problem. The aim of this master’s thesis was to study the prevalence of use of QT prolonging drugs in older adults receiving home care. Additionally, the aim was to study concomitant use of QT prolonging drugs as well as clinically significant QT prolonging drug-drug interactions in the participants. The secondary objective was to study the most commonly used QT prolonging in the participants. The material used in this master’s thesis originated from a randomized controlled trial in City of Lohja, Finland, which enhanced a coordination in medication risk management for older home care clients. The analysis of the baseline data collected in fall 2015 was only deepened regarding QT prolonging drugs. The participants (n=188) were older adults (≥65 years) receiving regular home care from City of Lohja, randomized into an intervention group (n=101) and a control group (n=87). The majority of the participants were women (69%). The mean age of the participants was 83 years. Data on the participants’ drugs were collected from their medication lists. Clinically significant drug-drug interactions were identified using the SFINX database. The QTDrugs Lists of CredibleMeds were used for identifying drugs associated with QT prolongation and TdP. On average, the participants (n=188) used 2.3 drugs (SD 1.3, median 2.0) associated with QT prolongation and TdP. Of the participants, 36% (n=67) used drugs with known risk of TdP (QTDrugs List 1). The most commonly used drugs with known risk of TdP were donepezil and citalopram. The prevalence of QTDrugs List 2 drugs (possible risk of TdP) was 36% (n=67). Most of the participants (n=156, 83%) used drugs which under certain circumstances are associated with TdP (QTDrugs List 3). One fifth (21%) of the participants used concomitantly 2-3 drugs associated with QT prolongation and TdP. QT prolonging drugdrug interactions (SFINX-D interactions) were found in 3% of the participants. The drugs involved in the drug-drug interactions were donepezil, (es)citalopram and haloperidol. The prevalence of use of clinically relevant QT prolonging drugs (QTDrugs Lists 1-2) was higher in this study compared with the prevalence in outpatients in previous studies. Concomitant use of QT prolonging drugs is common in outpatients. Health care professionals need to be educated on the risks of QT prolongation, TdP and the risks of using QT prolonging drugs concomitantly. Risk assessment tools considering patient-specific risk factors could be more widely used, as they may reduce modifiable risk factors, and actual events of QT prolongation and TdP may be avoided. There is a need for systematic procedures for assessing and managing the risks of QT prolongation and TdP in the Finnish health care system.
  • Kanerva, Meeri (2019)
    Breast cancer is the most common cancer among women world wide and it´s incidence is constantly growing. The prognosis of local breast cancer is good and patients with metastatic breast cancer are living longer with their disease. The growing survivorship and population of chronically ill breast cancer patients has made quality of life one of the most important aspects in the treatment of breast cancer. Cytotoxic chemotherapy is a widely used treatment for breast cancer. Chemotherapy can cause difficult adverse events, which can affect the patients’ quality of life. Chemotherapy can also relieve the symptoms caused by cancer when used to treat metastatic breast cancer. The aim of this systematic review was to collect the currently available literature about breast cancer patients´ health related quality of life as comprehensively as possible, review the quality of the literature and the effects of chemotherapy on breast cancer patients ‘quality of life. The literature search produced 1666 references. According to the inclusion and exclusion criteria, 107 full text articles were accepted to the final systematic review, 53 of which reported the health related quality of life during adjuvant treatment of breast cancer, and 51 of which reported it during the treatment of advanced or metastatic breast cancer. In addition 3 previous systematic reviews were found. The basic information about the articles was extracted into a table. Articles were heterogeneous regarding their study settings, used quality of life instruments and reporting. Most studies used a disease specific quality of life instrument. The collected literature gave a strong indication of quality of life worsening during adjuvant chemotherapy of breast cancer. This observation was further supported by the previous systematic reviews. Most of the studies reporting the quality of life during chemotherapy for metastatic breast cancer, reported less than clinically important changes during the treatment. A few studies reported clinically important worsening or improvement in quality of life. 11 studies, which were made during or after 21: st century, which reported numerical data from quality of life, which reported predominantly quality of life and which had sample size of at least 100 patients in baseline, were accepted to further assessment of quality of the studies and closer observation. The quality of the studies was assessed with STROBE and CONSORT checklists. The quality of studies was heterogeneous as the studies fulfilled 44.8 % to 86.1 % of the scoring items. Only one randomized controlled trial reported quality of life as their primary end point. The data from these studies supported the previous observation of quality of life worsening during adjuvant chemotherapy of breast cancer. The effect of chemotherapy during metastatic breast cancer on quality of life was not unambiguous. Both clinically meaningful worsening and improvement of quality of life was reported. Breast cancer patients´ health related quality of life has been assessed in multiple publications, but the existing literature is heterogeneous and it´s use in decision making and economic evaluation is not easily feasible. Breast cancer patients´ health related quality of life worsened during adjuvant chemotherapy. Significant improvement in breast cancer patients´ health related quality of life was not observed during chemotherapy for metastatic breast cancer.
  • Asikainen, Arsi (2018)
    Breast cancer is the most common cancer in women worldwide and the number of new events is on the increase. Like many other serious diseases, breast cancer reduces patient’s health related quality of life (HRQoL) and breast cancer treatment burdens our society. Examination of breast cancer patient’s HRQoL makes it possible to calculate how effective breast cancer treatments are. Nevertheless, only cost-effectiveness analysis would further help us allocate the resources of our society in the best way possible. The aim of this study was to produce research about breast cancer treatment’s effects on patient’s HRQoL and to compare generic 15D- and EQ-5D-5L-instruments. The results can be used in the future research and the study might be useful, when it’s time to develop international protocol for measuring HRQoL. The study population included 152 breast cancer patients who were treated in HUCH and whose HRQoL were measured by 15D-, EQ-5D-5L- and VAS-instruments. All measurements were done twice, first before the treatments and then six months after the beginning of the treatments. 89 (58.6 %) patients answered both 15D-questionnaires and 81 (53.3 %) patients answered to both EQ-5D-questionnaires. 57 (37.5 %) patients didn’t respond to any questionnaire. Only some background information was available of this population. The average HRQoL for breast cancer patients’ was 0.92 before the treatments and 0.88 six months after the beginning of the treatments when measured by 15D. The same average HRQoL was 0.86 before the treatments and 0.80 six months after the beginning of the treatments when measured by EQ-5D-5L. During six months’ period, patients HRQoL reduced (-0.04) when it was measured by 15D and (-0.06) when it was measured by EQ-5D. The changes of HRQoL were clinically important (The minimum important change, MIC > ± 0,015) when measured by 15D. HRQoL reduced more with patients who received a mastectomy than with patients, who received a breast conserving surgery according to both instruments. According to the results, the chosen instrument has an effect of breast cancer patients’ HRQoL. It means that the chosen instrument also has an effect of treatment’s effectiveness. 15D offers higher HRQoL values, but EQ-5D offers a greater change in patient’s HRQoL. HRQoL was measured by two different generic instruments in two different times, which was assumed to be the strength of this study. The new 5L-version of EQ-5D-instrument was also used. This is possibly the first time, when 5L is used in this type of study.
  • Äijö, Nelli (2019)
    As the population becomes older and the amount of multimorbid patients increases, also health care spending increases. New care models are needed where patients’ needs are taken into consideration by providing preventive and patient-centred care. In Finland and internationally, new ways to treat elderly, chronically ill patients have been developed. One of the new models is the health and care plan model. This longitudinal, randomised, controlled trial studied the health and care plan model’s impact on healthcare costs, patients’ physical functioning and patients’ quality of life. The aim of the study was to study the cost-effectiveness of the health and care plan model compared to standard care practice. The goal of this study was to study if rational pharmacotherapy and self-management support can prevent the decline in physical functioning, the decline in quality of life and the increase in health service use and costs among elderly population. This study was conducted between 2014-2018 as a multi-disciplinary cooperation between Tornio health station, University of Helsinki Faculty of Pharmacy and Alatornio pharmacy. The patients in this study were over 75-year old, multimorbid, community dwelling, polypharmacy patients. The patients in the intervention group received an interview based clinical medication review and were formed a medication plan. Furthermore, the patients in the intervention group were planned a health and care plan that was combined with the medication plan into a comprehensive self-management plan in a multi-disciplinary meeting. A case manager was appointed for the patients in the intervention group and the case manager could be contacted by the patients in the intervention group at any point of the study if there arose a non-acute concern with the patient’s health. The patients in the control group were conducted a prescription review based on the information available in the electronic health records system and continued receiving the standard care practice. Cost and effectiveness data were gathered from the patients over the period of two years. The effectiveness data were gathered at Tornio health station where the intervention and control group’s quality of life was measured with the SF-36 generic quality of life measure and physical functioning was measured with Short Physical Performance Battery (SPPB). The quality of life data gathered with SF-36 were transformed into one preference based single index score SF-6D to calculate the quality of life and quality adjusted life years (QALY). Data about the use of health services were extracted from the electronic health records system and transformed into costs by using the national reference costs. At the beginning of the study, the intervention and control group were statistically significantly similar. During the two-year follow-up, no statistically or clinically significant differences were observed between the intervention and control group in their quality of life, in their physical functioning or in the costs of used health services. However, in the intervention group, the cost of used health services was on average 2 406 euros smaller than those of the control group’s during the two-year follow-up. The health and care plan model was cost-effective compared to standard care practice. The incremental cost-effectiveness ratio was -64 504 € per one QALY. Based on this study, it is recommended to support the self-management and physical functioning of the elderly with an intervention like health and care plan model to decrease the health care spending. The results of this study can be applied to Finnish healthcare system to decrease the health care spending of multimorbid, community dwelling and polypharmacy elderly patients. The use of real-world evidence increases the reliability of this study.