Introduction of new medicines in Sweden

Payers and providers face challenges in enabling appropriate and sustainable access to new medicines. To help enable rational use of new medicines various policy options exist. In Sweden, horizon scanning, forecasting, value-based pricing and reimbursement, treatment recommendations, and assessment of drug utilization patterns and patient outcomes in routine clinical practice have been used to facilitate rational introduction of new medicines. Such activities, however, should be informed by research and be subject to continuous evaluation. This thesis aims to examine selected elements of the process for managed introduction of new medicines. Study I provides an evaluation of the Swedish Horizon Scanning System. Study II assesses the impact of treatment recommendations on the use of new medicines in the specialized care setting. Finally, studies III and IV explore the utility of healthcare databases in the assessment of real-world use and outcomes of two specialist medicines prioritized for managed introduction. Different types of data were used in these studies, including public assessment reports published by the European Medicines Agency, early assessment reports prepared by the Swedish Horizon Scanning System, national sales data on all inpatient and outpatient medicines, regional administrative healthcare services data, and national registers of Statistics Sweden and the National Board of Health and Welfare. The evaluation of the Swedish Horizon Scanning System demonstrates that all innovative medicines that had substantial economic impact were identified and assessed prior to their introduction. The assessment of the impact of treatment recommendations shows that both local and regional treatment recommendations were associated with changes in the use of new medicines. Both regional and national healthcare databases provide the opportunity to study the use and outcomes of new medicines in routine clinical practice. The findings indicate that healthcare decision makers can rely on the outputs of the Swedish Horizon Scanning System to keep informed of new medicines. Moreover, treatment recommendations appear to influence the uptake and utilization of new specialist medicines. Finally, even though the existing Swedish data sources provide unique research opportunities, the assessment of appropriate use and relevant outcomes of the growing number of new specialist medicines may still be impeded by a lack of fit-for-purpose data

Holistic health care: Patients\u27 experiences of health care provided by an Advanced Practice Nurse

Introduction: Advanced Practice Nurse (APN) is a fairly new role in the Swedish health care system. Aim: To describe patients\u27 experiences of health care provided by an APN in primary health care. Methods: An inductive, descriptive qualitative approach with qualitative open‐ended interviews was chosen to obtain descriptions from 10 participants regarding their experiences of health care provided by an APN. The data were collected during the spring 2012, and a qualitative approach was used for analyze. Results: The APNs had knowledge and skills to provide safe and secure individual and holistic health care with high quality, and a respectful and flexible approach. The APNs conveyed trust and safety and provided health care that satisfied the patients\u27 needs of accessibility and appropriateness in level of care. Conclusion: The APNs way of providing health care and promoting health seems beneficial in many ways for the patients. The individual and holistic approach that characterizes the health care provided by the APNs is a key aspect in the prevailing change of health care practice. The transfer of care and the increasing number of older adults, often with a variety of complex health problems, call for development of the new role in this context

Lifestyle\u27s influence on community-dwelling older adults\u27 health: A mixed-methods study design

Background: Aging often involves health problems and difficulties, such as physical and psychological impairments, isolation, and loneliness, causing social and existential consequences. Studies have explored aging from different perspectives. However, few studies have examined healthy older adults’ genetic backgrounds, lifestyles, and meaning in life separately or in combination. This study aims to describe how healthy older adults experience aging, health, lifestyles, and meaning in life and explore potential genetic correlations. Methods and Design:The project will comprise three main parts: a quantitative section featuring the development and testing of a lifestyle questionnaire, a quantitative genetic analysis, and a qualitative interview study. Participants will be community-dwelling, healthy, older adults between 70 and 95 years of age. A sample size of 800 older adults will be invited to participate in seminars in collaboration with the national Swedish association Active Seniors. Data will be collected through lifestyle questionnaire, DNA extracted from saliva samples, and interviews. Based on questionnaire responses, profile groups will be created and compared statistically with variations in genetic backgrounds, providing the basis for recruiting participants to the qualitative interviews. Discussion: This study’s expected outcome will be to gain knowledge about variations in genetic backgrounds correlated with individual experiences regarding aging, health, and meaning in life. This knowledge can improve the understanding of motivations for healthy lifestyle changes. The results can reveal potential implications for individual prerequisites to healthy aging and how health-promoting aging and lifestyle counseling can be adjusted to meet individual needs

Life without professional work-perceptions about one’s self, interpersonal relations and social life after retirement

The aim of this study is to understand how healthy, older adults in Sweden perceive their life situation after retirement. The study is based on a lifeworld approach, and a phenomenographic method was used. Eighteen participants were interviewed, and data were analysed according to the phenomenographic principle of qualitatively different categories. Two categories were developed. The first category, “perceptions that draw attention inward, towards one’s self”, was further described in three subcategories: Sense of decreased status in society, the desire to keep aging at a distance, and contemplation of one’s own existence. The second category, “perceptions that draw attention outward, away from one’s self” was further described in the following four subcategories: caretaking of family members, involvement in social relationships, finding of deep meaning in animals and nature and engagement with society. In the discussion, the findings are further illuminated through comparisons with concepts such as maturity, wisdom and gerotranscendence, and reflections on the findings’ relevance to a caring context follow. The conclusion suggests this study can provide knowledge that will allow healthcare providers to bridge the gap between generations in order to provide high-quality care. However, for a more profound caring dialogue, for example, about the end of life, a deeper analysis is required

Everyday Life and Wellbeing among the Oldest Elderly in Norway—A Qualitative Study

Background: Demographic changes in the European countries are resulting in an increase in the proportion of elderly. The life conditions and mental health of older people are fields with insufficient knowledge. Demographical changes, socioeconomic factors, as well as urban-rural dimensions affect their situation and demand multifactorial developmental approaches. This is also in line with the emerging gerontological theory of gerotranscendence. There has been a tendency to see the elderly as a homogeneous group, an idea that is challenged by recent research on the “third” and “fourth” age. The everyday life and health of older people―particularly in relation to their mental health ―are thus affected by many different circumstances and developments in society, which also interact with each other in complex patterns. Objectives: To develop a deeper understanding of how older people experience, regard and describe their life situation and mental health in urban and rural areas. Method: A descriptive and exploratory qualitative study, where elderly older than 80 in rural and urban areas in Norway were interviewed. In total, 23 interviews were completed (7 men, 16 women, 83 to 94 years old). The data were analyzed by means of a qualitative content analysis. Results: The analysis shows some differences between the two geographical areas, and gerotranscendence can be recognized. The main findings are analyzed as six themes: Satisfaction and enjoying life as a basic mood, An organized everyday life, built on activities. To manage on your own is of utmost importance. Strategies to handle hardships and challenges, an indispensable social network, and trust in the welfare state, however sometimes are conditioned. Conclusions: People in the “fourth age”, interviewed in this study have developed strategies to handle their everyday life and experience wellbeing. The empirical findings seem to be well in line with the theory of gerotranscendence. Urban-rural differences are found to be limited and related to the individual’s life storiespublishedVersio

Unreported births and deaths, a severe obstacle for improved neonatal survival in low-income countries; a population based study

<p>Abstract</p> <p>Background</p> <p>In order to improve child survival there is a need to target neonatal mortality. In this pursuit, valid local and national statistics on child health are essential. We analyze to what extent births and neonatal deaths are unreported in a low-income country and discuss the consequences at local and international levels for efforts to save newborn lives.</p> <p>Methods</p> <p>Information on all births and neonatal deaths in Quang Ninh province in Northern Vietnam in 2005 was ascertained by systematic inventory through group interviews with key informants, questionnaires and examination of health facility records. Health care staff at 187 Community Health Centers (CHC) and 18 hospitals, in addition to 1372 Village Health Workers (VHW), were included in the study. Results were compared with the official reports of the Provincial Health Bureau.</p> <p>Results</p> <p>The neonatal mortality rate (NMR) was 16/1000 (284 neonatal deaths/17 519 births), as compared to the official rate of 4.2/1000. The NMR varied between 44/1000 and 10/1000 in the different districts of the province. The under-reporting was mainly attributable to a dysfunctional reporting system and the fact that families, not the health system, were made responsible to register births and deaths. This under-reporting has severe consequences at local, national and international levels. At a local level, it results in a lack of awareness of the magnitude and differentials in NMR, leading to an indifference towards the problem. At a national and international level the perceived low mortality rate is manifested in a lack of investments in perinatal health programs.</p> <p>Conclusion</p> <p>This example of a faulty health information system is reportedly not unique in low and middle income countries where needs for neonatal health reforms are greatest. Improving reporting systems on births and neonatal deaths is a matter of human rights and a prerequisite for reducing neonatal mortality in order to reach the fourth millennium goal.</p

Data management and data analysis techniques in pharmacoepidemiological studies using a pre-planned multi-database approach : a systematic literature review

PurposeTo identify pharmacoepidemiological multi-database studies and to describe data management and data analysis techniques used for combining data. MethodsSystematic literature searches were conducted in PubMed and Embase complemented by a manual literature search. We included pharmacoepidemiological multi-database studies published from 2007 onwards that combined data for a pre-planned common analysis or quantitative synthesis. Information was retrieved about study characteristics, methods used for individual-level analyses and meta-analyses, data management and motivations for performing the study. ResultsWe found 3083 articles by the systematic searches and an additional 176 by the manual search. After full-text screening of 75 articles, 22 were selected for final inclusion. The number of databases used per study ranged from 2 to 17 (median=4.0). Most studies used a cohort design (82%) instead of a case-control design (18%). Logistic regression was most often used for individual-level analyses (41%), followed by Cox regression (23%) and Poisson regression (14%). As meta-analysis method, a majority of the studies combined individual patient data (73%). Six studies performed an aggregate meta-analysis (27%), while a semi-aggregate approach was applied in three studies (14%). Information on central programming or heterogeneity assessment was missing in approximately half of the publications. Most studies were motivated by improving power (86%). ConclusionsPharmacoepidemiological multi-database studies are a well-powered strategy to address safety issues and have increased in popularity. To be able to correctly interpret the results of these studies, it is important to systematically report on database management and analysis techniques, including central programming and heterogeneity testing. (c) 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.Peer reviewe

Resonant Enhancement of Inelastic Light Scattering in the Fractional Quantum Hall Regime at ν=1/3\nu=1/3

Strong resonant enhancements of inelastic light scattering from the long wavelength inter-Landau level magnetoplasmon and the intra-Landau level spin wave excitations are seen for the fractional quantum Hall state at $\nu = 1/3$. The energies of the sharp peaks (FWHM $\lesssim 0.2meV$) in the profiles of resonant enhancement of inelastic light scattering intensities coincide with the energies of photoluminescence bands assigned to negatively charged exciton recombination. To interpret the observed enhancement profiles, we propose three-step light scattering mechanisms in which the intermediate resonant transitions are to states with charged excitonic excitations.Comment: 5 pages, 5 figure

Did we see it coming? An evaluation of the Swedish early awareness and alert system

Early awareness and alert (EAA) systems have been established in many countries but evidence on their ability to accurately prioritize new medicines (for early assessment) is limited. The purpose of this study is to assess whether the Swedish EAA System identified and prioritized (i.e. produced early assessment reports for) new medicines that would go on to have a substantial economic impact. Methods We adapted a study design commonly used in the assessment of diagnostic test accuracy. The prioritization made by the Swedish EAA System prior to marketing authorization comprised the index test and national drug sales data in the second year post-authorization served as the reference standard. All initial marketing authorization applications for medicinal products processed by the European Medicines Agency (EMA) between 2010 and 2015 (study population) were classified using the index test and the reference standard. Results Two hundred and fifty-three new medicinal products processed by EMA comprised the study population. Of these, 71 were prioritized by the Swedish EAA System and 21 were classified as having a substantial economic impact. The sensitivity and positive predictive value were 76.2% and 22.5%, respectively. Subgroup analyses showed that the accuracy of prioritization, in terms of sensitivity, was 100% for antineoplastic/immunomodulating agents. Conclusions The Swedish EAA System identified all new medicines that would go on to have a substantial economic impact and prioritized most of these medicines. Our findings provide reassurance to decision makers who rely on the outputs of the Swedish EAA System to keep informed about new medicines. Moreover, this study also provides valuable insights to stakeholders willing to establish and/or evaluate their own EAA activities and systems

Early awareness and alert system in Sweden : history and current status

Abstract Summary: We describe the evolution and the current state of the Swedish Early Awareness and Alert System for new drugs, a national level EAA system successfully implemented in a country with decentralized health care managed by 21 regions. Our work is of interest to countries already having EAA systems in place as well as for those seeking to establish EAA activities. Introduction: Over the past decades, early awareness and alert (EAA) activities and systems have gained importance and become a key early health technology assessment (HTA) tool. While a pioneer in HTA, Sweden had no national level EAA activities until recently. We describe the evolution and current status of the Swedish EAA System. Methods: This was a historical analysis based on the knowledge and experience of the authors supplemented by a targeted review of published and grey literature as well as documents produced by or relating to the Swedish EAA System. Key milestones and a description of the current state of the Swedish EAA System is presented. Results: Initiatives to establish a system for the identification and assessment of emerging health technologies in Sweden date back to the 1980s. Since the 90s, the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) supported the development of EuroScan and was one of its founder members. In the mid-00s, an independent regional initiative, driven by the Stockholm Drug and Therapeutics Committee, resulted in the establishment of a regional horizon scanning unit. By 2009, this work had expanded to a collaboration between the four biggest regions in Sweden. The following year it was further expanded to the national level. Today, the Swedish EAA System carries out identification, filtration and prioritization of new drugs, early assessment of the prioritized drugs, and dissemination of the information. Its outputs are used to select new drugs for inclusion in the Swedish national process for managed introduction and follow-up. Conclusions: The Swedish EAA System started as a regional initiative and rapidly grew to become a national level activity. An important feature of the System today is its complete integration into the national process for managed introduction and follow-up of new drugs. The System will continue to evolve as a response both to the changing landscape of health innovations and to new policy initiatives at the regional, national and international levels