Mikael Hoffmann

Multifaceted national and regional drug reforms and initiatives in ambulatory care in Sweden: global relevance

It is a continual challenge trying to improve the quality of prescribing while concurrently trying to address increasing pharmaceutical development, utilization and expenditure. National and regional reforms and initiatives in Sweden have moderated growth in ambulatory drug expenditure to 2.7% per annum in recent years despite increasing volumes. National reforms include mandatory generic substitution and value-based pricing alongside devolution of drug budgets to the regions. Regional initiatives include strengthening the role of the regional Drug and Therapeutic Committees, further budget devolution as well as strategies incorporating prescribing guidance and monitoring coupled with financial incentives. The extent and nature of the regional initiatives vary depending on their characteristics. In this article, we compare initiatives undertaken in two major counties, Stockholm and Östergötland, and their outcomes. Outcomes include annual drug budget savings while achieving agreed quality as well as increased adherence to prescribing targets and guidance; the latter associated with savings. Appraising these multifaceted reforms can provide guidance to other countries and regions in view of their diversity. Future steps must incorporate measures to improve the utilization of new expensive drugs, which should include horizon scanning and forecasting activities as well as post-launch activities involving monitoring of prescribing and registries. This may well require cooperation with other European countries.

The Nordic prescription databases as a resource for pharmacoepidemiological research—a literature review

All five Nordic countries have nationwide prescription databases covering all dispensed drugs, with potential for linkage to outcomes. The aim of this review is to present an overview of therapeutic areas studied and methods applied in pharmacoepidemiologic studies using data from these databases.

Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

The prevalence of symptoms possibly related to the climacteric in pre- and postmenopausal women in Linköping, Sweden

BACKGROUND Some extragenital symptoms have been suggested to be associated with the menopause and thus to be affected by estrogen status. In such case extragenital symptoms may be more frequent in postmenopausal women without hormone replacement therapy (HRT) than in premenopausal women or women using HRT. OBJECTIVE To assess if the prevalence of a number of extragenital symptoms is higher in postmenopausal women without than with HRT, or in premenopausal women of the same age. MATERIAL AND METHODS All women aged 53 and 54 years in the community of Linköping (n=1760) were sent a validated questionnaire about use of HRT, time since last menstruation and about different extragenital symptoms. RESULTS 1298 (73.8%) women answered the questionnaire and answers from 1180 (67%) women were possible to analyze. Postmenopausal women woke up significantly more often during night than premenopausal, and those without HRT often due to hot flushes and sweating. Women with HRT reported more muscular pain than the others. We found no other significant difference in prevalence of extragenital symptoms between the three groups of women. CONCLUSIONS Sleeping disorders, arthralgia, xerophthalmia, xerostomia and dry skin are not more prevalent in 53 and 54 years old postmenopausal women without HRT than in women with HRT or in premenopausal women of the same age. It may still be that some of these symptoms are related to estrogen deficiency, but do not develop until some years after menopause. It may also be that women with the most severe symptoms decided to use HRT and thereby decreased symptoms to the same level as in non-users.

Utilization and costs of glucose lowering therapies following health technology assessment for the new reimbursement scheme in Sweden

INTRODUCTION A new reimbursement scheme (RS) for lipid modifying therapies (LMT) was implemented in Sweden in June 2009. Products on the market were continued, restricted or excluded in the new RS. The aim of this study was to compare utilization, costs and switching behavior in patients treated with LMT before and after the new RS. MATERIALS AND METHODS This is a quasi-experimental study using data on dispensed LMT and costs from a database on dispensed individual prescriptions in Sweden. Segmented regression analyses were used to assess utilization and costs of LMT. RESULTS Number of patients treated with products with restricted reimbursement increased in level (P=0.0336) following the changes in the scheme, while decreased in level (P<0.0001) for products excluded from the RS. Patients initially treated with products excluded from the RS discontinued to a greater extent, and switched to higher doses of the same substance or to generic simvastatin. The total annual costs decreased moderately. CONCLUSIONS The decreasing trend in utilization of low-dose atorvastatin and rosuvastatin was accelerated and so was the increasing trend in utilization of generic simvastatin following the new RS. Switching to higher doses and discontinuation increased and expected savings were overestimated.

The First Decade with the Swedish Prescribed Drug Register – A Systematic Review of the Output in the Scientific Literature

The aim of this study was to quantify and characterize the scientific output from the Swedish Prescribed Drug Register (SPDR) the first decade after its establishment. A systematic literature search was performed in Medline, EMBASE and PubMed (2005–2014). Additional publications were identified by personal knowledge, reference lists, contact with active authors and a citation search in Web of Sciences. Publications using SPDR data were included in the analysis and characterized regarding study type, presence of patient‐level record linkage, target population and topic. A total of 719 publications were identified in the literature search and an additional 148 by other strategies. Three hundred and thirty‐eight studies fulfilled the inclusion criteria. The majority were analytic (n = 166; 49.1%) or descriptive (n = 100; 29.5%). The remaining studies focused on validation (n = 20; 5.9%), health economics (n = 16; 4.7%) or miscellaneous (n = 36; 10.7%). The analytic studies investigating effects of drug exposure focused mainly on safety (n = 46) and/or effectiveness (n = 24). The first publications appeared in 2007 (n = 6), and in 2014, 90 articles using SPDR were published. Over the years, linkage with other registers using the personal identity number increased (0–88.9% of the publications). The population was often selected by age (49.7%), condition (45.0%) and/or drug (22.8%) and concerned predominantly psychiatric (29.0%) and cardiovascular (20.4%) diseases. In conclusion, this study illustrates that the establishment of a nationwide individual‐based register on dispensed prescription drugs facilitates an encouraging development of pharmacoepidemiological research, both regarding the number of publications and the scientific level of the analyses.

Surveillance of antibiotic resistance in ICUs in southeastern Sweden

Background: A study was designed to assess a computer‐based program for continuous registration of antibiotic resistance, statistics concerning severity of illness, and consumption of antibacterial drugs.

Phases in development of an interactive mobile phone-based system to support self-management of hypertension

Hypertension is a significant risk factor for heart disease and stroke worldwide. Effective treatment regimens exist; however, treatment adherence rates are poor (30%–50%). Improving self-management may be a way to increase adherence to treatment. The purpose of this paper is to describe the phases in the development and preliminary evaluation of an interactive mobile phone-based system aimed at supporting patients in self-managing their hypertension. A person-centered and participatory framework emphasizing patient involvement was used. An interdisciplinary group of researchers, patients with hypertension, and health care professionals who were specialized in hypertension care designed and developed a set of questions and motivational messages for use in an interactive mobile phone-based system. Guided by the US Food and Drug Administration framework for the development of patient-reported outcome measures, the development and evaluation process comprised three major development phases (1, defining; 2, adjusting; 3, confirming the conceptual framework and delivery system) and two evaluation and refinement phases (4, collecting, analyzing, interpreting data; 5, evaluating the self-management system in clinical practice). Evaluation of new mobile health systems in a structured manner is important to understand how various factors affect the development process from both a technical and human perspective. Forthcoming analyses will evaluate the effectiveness and utility of the mobile phone-based system in supporting the self-management of hypertension.

Knowledge of reproductive physiology and hormone therapy in 53- to 54-year-old Swedish women: a population-based study.

Objective: To investigate knowledge of hormone therapy (HT), reproductive physiology, and menopause in a population of 53- to 54-year-old women. Further aims were to determine whether the knowledge differed between users and nonusers of HT and between groups with different levels of education. Design: In 2003, all 53- and 54-year-old women (N = 1,733) in Linköping, Sweden, were sent a questionnaire containing questions about reproductive physiology related to menopause and HT. Answers from 73% of the women were analyzed. Results: Swedish women had limited knowledge of HT, reproductive physiology, and menopause irrespective of HT use or educational level. Most of the women knew that hot flashes are common around menopause and decreasing estrogen production causes the menopause. They knew little about the effects of progestagens and the effects of HT on fertility. Women with low educational level were more likely to answer the questions by stating that they were unsure than did women with high educational level. Ever-users of HT knew more than never-users about risks and benefits of HT in relation to breast cancer and osteoporosis, and ever-users thought that the risks of thrombosis and myocardial infarction were lower than did never-users. Conclusions: Women need improved knowledge of the risks and benefits of HT as well as education about the reproductive system around menopause. This would probably better support and empower women to manage an important period of their lives.

Risk communication in consultations about hormone therapy in the menopause: concordance in risk assessment and framing due to the context

Background It is important for the physician and the patient to have a mutual understanding of the possible consequences of different treatment alternatives in order to achieve a partnership in decision-making. Objective The aim of this study was to explore to which degree first-time consultations for discussion of climacteric discomfort achieved shared understanding of the risks and benefits associated with hormone therapy in the menopausal transition. Methods Analysis of structure and content of transcribed consultations (n = 20), and follow-up interviews of the women (n = 19 pairs of consultations and interviews), from first-time visits for discussion of climacteric discomfort and/or HT with five physicians at three different outpatient clinics of gynecology in Sweden. Results Four distinctively different interpretations of risk, depending on whether or not benefits were discussed in the same context, emerged from the analysis. On average, five advantages (range 0–11) and two (0–3) disadvantages were mentioned during the consultations. In the interviews, the women expressed on average four advantages (0–7) and one disadvantage (0–3). There were major variations between advantages and disadvantages expressed in the consultation and the following interview. Conclusion Even though the consultations scored high in patient involvement, the information in most consultations was not structured in a way that made it possible to achieve a shared or an informed decision-taking.