New users of anxiolytics and sedatives in Sweden-Drug type, doses, prescribers' characteristics, and psychiatric comorbidity in more than 750,000 patients.

OBJECTIVES: Anxiety and sleep disorders are common in the population and anxiolytics and sedatives are widely used. Our aim was to describe the drug utilization of new users of anxiolytics and sedatives in adults including type of drug, doses, prescribers' characteristics, and psychiatric comorbidity. METHODS: A register-based cohort study of new users (18-64 years) of anxiolytics and sedatives in 2015-2019, free of any such drug 5 years prior to inclusion. The individuals were linked to national registers on dispensed drugs and recorded diagnoses. RESULTS: In total, 764,432 new users of anxiolytics and sedatives were identified, which corresponds to an incidence of 26/1000 inhabitants and year. The proportion of new users of benzodiazepines (including both anxiolytics and sedatives) decreased, whereas the proportion of sedative antihistamines and melatonin increased. The most common drug dispensed was hydroxizin (33%) followed by benzodiazepine related drugs (zopiclone and zolpidem; 20%), propiomazine (14%) and benzodiazepines (13%). The majority (68%) of the prescriptions were from primary care. Most new users were prescribed 1-30DDDs and 52% among women and 49% among men were dispensed their drug only once during the first year. Half of the new users had a previous comorbid psychiatric disorder. CONCLUSIONS: The findings are well reflecting the recommendations in national guidelines.

Pediatric use of prescribed melatonin in Sweden 2006-2017: a register based study.

Sleep disturbances are common in the pediatric population and should primarily be treated non-pharmacologically. Most medicines for sleep disturbances are not approved for pediatric use and data on long-term safety is scarce. In Sweden, melatonin is classified as a prescription medicine. The aim of the present study was to characterize the prevalence and incidence of dispensed melatonin prescriptions, long-term treatment, concomitant dispensation of psychotropic medication, and psychiatric comorbidity, in children and adolescents aged 0-17 years living in Sweden during 2006-2017. Data was retrieved by linking the national population-based registers, the Swedish Prescribed Drug register and the National Patient register. In 2017, nearly 2% of the pediatric population 0-17 years was dispensed at least one prescription of melatonin, which was more than a 15-fold increase for girls and a 20-fold increase for boys, when compared to 2006. Among the children in the age group 5-9 who initiated a melatonin treatment in 2009, 15% of girls and 17% of boys were found to be continuously prescribed melatonin 8 years later. Nearly 80% of all children with dispensed melatonin had concomitant dispensations of psychotropic medications. The most common combination was melatonin together with centrally acting sympathomimetic medicines (23% of girls and 43% of boys). About half of the children (47% of girls and 50% of boys) had at least one registered diagnosis of mental or behavioral disorders. The most common diagnosis was attention deficit hyperactive disorder, across all age groups and genders. The continuous increase of use of melatonin in children, often concomitant with other psychotropic medications, together with a high proportion of younger children with prescriptions of melatonin on a long-term basis, suggests the need for further structured follow up studies, in particular of long-term use.

Increased availability of paracetamol in Sweden and incidence of paracetamol poisoning: using laboratory data to increase validity of a population-based registry study.

PURPOSE: To estimate the incidence trend and outcome of paracetamol poisoning, in relation to increased availability of paracetamol from non-pharmacy outlets in 2009. METHOD: Patients' serum paracetamol results over 14 years (2000-2013) from 20 (out of 21) regions in Sweden were linked to national registers of hospital care, cause of death, and prescriptions. Paracetamol poisonings were defined by serum paracetamol levels, hospital diagnoses, or cause of death. The change in incidence of poisonings following increased availability of paracetamol was analysed by using segmental regression of time series. RESULTS: Of the 12 068 paracetamol poisonings, 85% were classified as intentional self-harm. Following increased availability from non-pharmacy outlets, there was a 40.5% increase in the incidence of paracetamol poisoning, from 11.5/100 000 in 2009 to 16.2/100 000 in 2013. Regression analyses indicated a change in the trend (p < 0.0001) but not an immediate jump in the incidence (p = 0.5991) following the increased availability. Adjusting for trends in hospital episodes for self-harm, suicides, and the sales volume of paracetamol did not influence the result. All-cause mortality at 30 days (3.2%) did not change over time. CONCLUSIONS: The incidence of paracetamol poisoning in Sweden has increased since 2009, contrasting the decreased incidence in the period of 2007-2009. The change in trend was temporally associated with the introduction of availability of paracetamol from non-pharmacy outlets but did not appear to be related to sales volume of paracetamol or general trends in self-harm or suicides. © 2017 Commonwealth of Australia. Pharmacoepidemiology and Drug Safety © 2017 John Wiley & Sons, Ltd.

Health care professionals' perspectives on automated multi-dose drug dispensing.

BACKGROUND: During the 1980s, manual repackaging of multi-dose medications from pharmacies in Sweden was successively substituted with automated multi-dose drug dispensing (MDD). There are few studies evaluating the consequences of automated MDD with regard to patient safety, and those that investigate this issue are not very extensive. OBJECTIVES: To investigate Swedish health care professionals' perceived experience of automated MDD and its effects on patient adherence and patient safety. METHODS: Three questionnaire forms, one for physicians, nurses, and assistant nurses/nursing assistants, were developed based on reviews of the literature and pilot testing of the questions in the intended target groups. The target groups were health professionals prescribing or administrating MDD to patients. A sample (every sixth municipality) was drawn from the sampling frame of Swedish municipalities, resulting in 40 municipalities, about 14% of all municipalities in Sweden. Email addresses of general practitioners were obtained from county councils, while the municipalities assisted in getting contact details for nurses, assistant nurses and nursing assistants. A total of 915 questionnaires were distributed electronically to physicians, 515 to nurses, and 4,118 to assistant nurses/nursing assistants. The data were collected in September and October 2012. RESULTS: The response rate among physicians, nurses and assistant nurses/nursing assistants was 31%, 43% and 23%, respectively. The professionals reported that automated MDD reduces duplication of medication, contributes to correct dosages, helps patients take their medication at the right time, and reduces confusion among patients. Fifteen per cent of the physicians and about one-third of the nurses and assistant nurses/nursing assistants reported that generic substitution makes it more difficult for the patient to identify the various medicines available in the sachets. The physicians did, however, note that prescribing medicine to patients with automated MDD is complicated and can be a risk for patient safety. Both physicians and nurses requested more information on and training in automated MDD. They also asked for more medication reviews. CONCLUSIONS: The professionals generally had a positive attitude to automated MDD with regard to improved medication adherence, but said they believed that the electronic prescribing system posed a safety risk for patients.

Non-prescription medicines for pain and fever--a comparison of recommendations and counseling from staff in pharmacy and general sales stores.

OBJECTIVES: The purpose of this study is to map and analyze the content and quality of the encounter when customers buy non-prescription medicines for pain and fever. METHODS: 297 pharmacies and 801 general sales stores (GSS) in Sweden were selected. A "Mystery shopper" exercise was conducted. Three scenarios were used and a total of 366 units were selected for each scenario. There were in total 625 observers: 208 in the child with fever scenario, 225 in the Reliv scenario, and 192 in the painkiller during pregnancy scenario. DATA COLLECTION: 21st September to 20th November 2011. RESULTS: In two out of three visits to GSS, the staff proposed a medicine for a heavily pregnant woman. The staff suggested in 9% of the visits a medicine that is inappropriate in late pregnancy. The corresponding percentage in pharmacies was 1%. Both pharmacies and GSS proposed, in 6% a medicine that is inappropriate for babies to a feverish child. Only 16% of the pharmacists and 14% of the staff in GSS asked for the age of the child. General sales staff recommended in 10% ibuprofen and in 4% an acetylsalicylic acid product when an acetaminophen preparation was requested. The corresponding percentage in the pharmacy were 4% ibuprofen, 2% diclofenac, and 1% an acetylsalicylic acid product. CONCLUSIONS: The staff in GSS and pharmacies do not pay sufficient attention to the heterogeneity of painkillers, which lead to inappropriate recommendations.

Initiating therapy with antidepressants after discontinuation of hormone therapy.

OBJECTIVE: This work aims to determine whether discontinuation of hormone therapy (HT) in perimenopausal and postmenopausal women is associated with an increased risk of initiating antidepressant therapy. METHODS: A population-based cohort study was conducted using data from the Swedish Prescribed Drug Register and the Total Population Register for the period July 2005 to June 2009. We included women aged 45 to 70 years who had used HT continuously for more than 6 months before July 2008. Women with previous use of antidepressants since July 2005 were excluded. We compared the incidence rates of initiating antidepressant therapy during HT and after withdrawal of HT. The women were followed from July 2008 until the first dispensing of antidepressants, restart of HT, migration, death, or end of the study period, whichever occurred first. Poisson regression analysis was used to estimate the incidence rate ratios adjusting for potential confounders (age, calendar time, duration of HT use, and number of HT prescriptions). RESULTS: Of the 101,911 women enrolled in the cohort, 39.8% discontinued HT during follow-up. Discontinuation of HT was associated with an increased risk of antidepressant use (incidence rate ratio, 1.24; 95% CI, 1.11-1.38). Women 65 years or older and women who had used HT for 3 years or more had the highest risk estimates, but effect modification by age and duration was not significant. CONCLUSIONS: We found a slightly increased risk in the use of antidepressant therapy after discontinuation of HT.

Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden.

OBJECTIVE: To examine the risk of neurological and autoimmune disorders of special interest in people vaccinated against pandemic influenza A (H1N1) with Pandemrix (GlaxoSmithKline, Middlesex, UK) compared with unvaccinated people over 8-10 months. DESIGN: Retrospective cohort study linking individualised data on pandemic vaccinations to an inpatient and specialist database on healthcare utilisation in Stockholm county for follow-up during and after the pandemic period. SETTING: Stockholm county, Sweden. Population All people registered in Stockholm county on 1 October 2009 and who had lived in this region since 1 January 1998; 1,024,019 were vaccinated against H1N1 and 921,005 remained unvaccinated. MAIN OUTCOME MEASURES: Neurological and autoimmune diagnoses according to the European Medicines Agency strategy for monitoring of adverse events of special interest defined using ICD-10 codes for Guillain-Barré syndrome, Bell's palsy, multiple sclerosis, polyneuropathy, anaesthesia or hypoaesthesia, paraesthesia, narcolepsy (added), and autoimmune conditions such as rheumatoid arthritis, inflammatory bowel disease, and type 1 diabetes; and short term mortality according to vaccination status. RESULTS: Excess risks among vaccinated compared with unvaccinated people were of low magnitude for Bell's palsy (hazard ratio 1.25, 95% confidence interval 1.06 to 1.48) and paraesthesia (1.11, 1.00 to 1.23) after adjustment for age, sex, socioeconomic status, and healthcare utilisation. Risks for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, and rheumatoid arthritis remained unchanged. The risks of paraesthesia and inflammatory bowel disease among those vaccinated in the early phase (within 45 days from 1 October 2009) of the vaccination campaign were significantly increased; the risk being increased within the first six weeks after vaccination. Those vaccinated in the early phase were at a slightly reduced risk of death than those who were unvaccinated (0.94, 0.91 to 0.98), whereas those vaccinated in the late phase had an overall reduced mortality (0.68, 0.64 to 0.71). These associations could be real or explained, partly or entirely, by residual confounding. CONCLUSIONS: Results for the safety of Pandemrix over 8-10 months of follow-up were reassuring -notably, no change in the risk for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, or rheumatoid arthritis. Relative risks were significantly increased for Bell's palsy, paraesthesia, and inflammatory bowel disease after vaccination, predominantly in the early phase of the vaccination campaign. Small numbers of children and adolescents with narcolepsy precluded any meaningful conclusions.

Reductions in use of hormone replacement therapy: effects on Swedish breast cancer incidence trends only seen after several years.

Studies from Western countries have found evidence of a recent decline in breast cancer incidence rates in postmenopausal women, findings which have been hypothesized to reflect a reduced use of hormonal replacement therapy (HRT). We examined breast cancer incidence trends in Sweden between 1997 and 2007, a period characterized by a drop in the use of HRT. Incidence trends were assessed using data from three population-based Regional Clinical Registries on breast cancer covering 2/3 of the Swedish population. Information on HRT sales was obtained from national pharmacy data. The prevalence of HRT use in age group 50-59 years decreased from a peak of 36% in 1999 to 27% in 2002 and further to 9% in 2007. Incidence rates of breast cancer in women 50 years and older increased between 1997 and 2003. A significant decrease in incidence between 2003 and 2007 was confined to women 50-59 years of age, the group in which the prevalence of HRT use has been highest and the decrease in use most pronounced. As opposed to the immediate effects reported from the United States and other regions, there was a time lag between the drop in HRT use and clear reductions in breast cancer incidence. This may reflect between country differences with regard to types of HRT used, and the rate, magnitude and pattern of change in use. The present findings give further support to the notion that HRT use is a driver of breast cancer incidence trends on the population level.

Adherence to drug treatment in association with how the patient perceives care and information on drugs.

AIM: This study was to explore concordance with drugs prescribed and the patient's self-reported drug consumption, in relation to the older patient's perceived care and information given. BACKGROUND: Lack of adherence to prescriptions may lead to therapeutic failure with risks for relapse, unnecessary suffering and increased costs. DESIGN: A cross-sectional study with structured interviews of 200 patients who had recently been treated in a medical ward. METHODS: Patients' medical records were studied to obtain information on their current use of drugs. The data were analyzed by logistic regression, adherence being the dependent response variable. RESULTS: The mean age of the study group was 79 years. The number of drugs reported in the medical chart ranged from one to 17 with a mean of 6.9. The patients reported a drug consumption ranging from 0 to 24 with a mean of 7.3. When comparing the interview results with the information in the medical charts, 30% of the patients showed adherence. An association was found between adherence and self-reported health status. Patients in the non-adherent group reported a higher consumption of drugs. Patients felt that the opportunity to ask questions of either the responsible physicians or of the nurses was influential in decreasing risk. CONCLUSION: In this study, the patient's total drug consumption was considered. The study showed a large discrepancy between the drugs stated in the medical chart and patient's self-reported drug consumption. The study failed to show that perceived information or educational level had an impact on the results but implicate that the quality of information influences adherence. RELEVANCE TO CLINICAL PRACTICE: It is of importance to recognize patients at risk for non-adherence. Decreased health status and many drugs are the main risk factors for patients being non-adherent, and should be recognized as such.

A prospective study of health, life-style and psychosocial predictors of self-rated health.

The aim of this study was to investigate what psychosocial predictors, life-style factors and health behaviors in early adulthood are of importance for self-ratings of health after the age of 45. Like-sexed adult twins born 1926-1950 (n = 16,080) from the Swedish Twin Registry that participated in a questionnaire in 1973 and in a telephone interview conducted between 1998 and 2002 were included. Exposure data was collected in 1973 and information on self-rated health and covariates was collected at the second contact 25 years later. Logistic regression using Generalized Estimating Equations was used to evaluate the associations. Conditional logistic regression was used to control for familial and genetic effects in the sample. Pain, lack of exercise, smoking, obesity, unemployment, perceived stress and personality are associated with future poor self-rated health, after controlling for age, sex, illness, education and socio-economic status. Familial and genetic effects influence the associations between recurrent headache, exercise, obesity, and poor self-rated health. Overall, these findings provide support for long-term effects of health behavior and psychosocial risk factors on poor self-ratings of health, beyond the influence of obvious health consequences such as disorders or illnesses. Genetic and familial factors are of importance only for some of these associations.

Drug use and perceived health in recently hospitalized older people.

Older patients often have multiple diseases, resulting in treatment with many drugs. This may increase the risk for drug-related problems. This study aimed to analyse the congruence between the patient's self-reported drug use and the medical record, and the relationship to perceived health among older patients recently discharged from hospital. A total of 200 patients over 65 years of age who were admitted to a medical ward and were treated with at least one drug participated in an interview study one week after discharge from the hospital. The patients provided information on their current drug therapy. This information was compared to the prescriptions documented in the medical record. Thirty per cent of the study population reported a drug use which was in congruence with the medical record, 28% used less drugs than prescribed, and 42% more. Statistical analysis showed a high probability of non-congruence with prescriptions among patients who reported poor health.

Predictors of mortality: an international comparison of socio-demographic and health characteristics from six longitudinal studies on aging: the CLESA project.

PURPOSE: Multiple factors contribute to mortality in the elderly, but the extent to which traditional factors contribute independently to mortality in different countries is not known. Our objective is to determine the differential impact of socio-demographic variables, selected diseases, health habits and disability on all-cause mortality, among older people living in five European countries and Israel. METHODS: From six longitudinal studies on aging (TamELSA-Tampere (Finland), CALAS-Israel, ILSA-Italy, LASA-Netherlands, AL-Leganés (Spain), SATSA-Sweden), a harmonized common database was created in the context of the CLESA Project (Cross-national determinants of quality of life and health services for the elderly). A common five-year follow-up was used. RESULTS: The highest mortality rate was found in Tampere among females (98.7%) and in Israel among males (108.3%), whereas the lowest was observed in Leganés for males (72.3%) and in The Netherlands for females (44.6%). In multivariate models, some predictors were homogeneously, significantly distributed across the six countries, including older age (HR = 1.57) and male sex (HR = 1.60) among the socio-demographic variables; smoking status (HR = 1.15) and alcohol consumption (HR = 0.81) among the health habits variables; presence of heart disease (HR = 1.34), diabetes (HR = 1.46), cancer (HR = 1.93), respiratory disease (HR = 1.19), and disability (HR = 2.92) among the health status variables. Marital status, education, and drug use did not have homogeneous effects in the six countries. DISCUSSION: This large international study shows that multiple factors contribute to increased risk of all cause mortality among older people and that most risk factors are similar across countries. Disability, age greater than 80 years, cancer and male sex were identified as the strongest common risk factors of mortality.

Self-rated health among older adults: a cross-national comparison.

Self-rated health (SRH) may have different implications in various social and cultural settings. However, few studies are available concerning SRH among older persons across countries. The aim of this study was to analyse whether there are cross-national differences in the association between status characteristics, several diseases common among older persons, activities of daily living (ADL), and SRH. The study base was the Comparison of Longitudinal European Studies on Aging (CLESA), which includes data from six population-based studies on aging conducted in Finland, Israel, Italy, The Netherlands, Spain and Sweden. The study population comprised 5,629 persons, with participants from all countries except Italy. Logistic regression analyses were used to assess the relationship between status characteristics, health conditions, ADL and SRH. To examine whether the association among status characteristics, health conditions, ADL and outcome differed across the CLESA countries, interaction terms defined as "variable*country" were considered separately for each variable. Regression analyses revealed that sex, education, lifetime occupation, heart disease and respiratory disease were differently distributed across countries. Among homogeneous factors, marital status (OR=1.21), hypertension (OR=1.41), stroke (OR=1.67), diabetes (OR=2.15), cancer (OR=1.47), musculoskeletal diseases (OR=2.44), and ADL (OR=2.72) turned out to be significantly associated with fair or poor SRH. The results indicate that there are differences in self-ratings of health across countries. These differences cannot be explained entirely by status characteristics, self-reported diseases or functional ability. However, an important finding was that in all countries most of the indicators of medical and functional health were homogeneously associated with SRH.

A Swedish population-based study on the relationship between the SF-36 and health utilities to measure health in hypertension.

The aim of this study was to determine the relationship between a psychometric health-related quality-of-life instrument (the SF-36)-and two health utility measures [the time trade-off (TTO) and rating scale (RS) methods) among hypertensives in a general population. In the analyses were adjusted for comorbidity. The study was based on a postal questionnaire that was sent to a random sample of 8000 inhabitants aged 20-84 years (response rate 68%) in Uppsala County, Sweden, in 1995. The results showed only a moderate correlation between the TTO and the RS methods. The different dimensions of SF-36 were overall lower correlated with the TTO method than with the RS method. Co-morbidity was not associated with the RS or the TTO method among hypertensives. The regression equations explained 58% of the variance in RS among hypertensives. The corresponding value for the TTO method was about 20%. In conclusion, our study found that among hypertensives the SF-36 is low to moderate correlated to the TTO and RS methods. Health utilities and psychometric measures represent different attributes of health. It is therefore important to be aware of the differences between psychometric and utility measures when interpreting results from studies using different methods. More work is needed to explicate if health utilities can be obtained from the SF-36.

Cross-national determinants of quality of life from six longitudinal studies on aging: the CLESA project.

BACKGROUND AND AIMS: The Comparison of Longitudinal European Studies on Aging (CLESA) Project, here presented for the first time, is a collaborative study involving five European and one Israeli longitudinal study on aging. The aim of this paper is to describe the methodology developed for the harmonization of data and the creation of a Common Data Base (CDB), and to investigate the distribution of some selected common variables among the six countries. The design of each study is briefly introduced and the methodology leading to the harmonization of the common variables is described. METHODS: The study base includes data from five European countries (Finland, Italy, the Netherlands, Spain, Sweden) and Israel, for older people aged 65-89 living both in the community and in institutions (total, 11557 subjects). For two age classes (65-74 and 75-84), the prevalence ratios or the mean values of the following selected variables are provided: a) sociodemographic variables; b) health habits; c) health status; d) physical functioning; e) social networks and support; and f) health and social services utilization. RESULTS: Statistically significant differences were found between most of the investigated characteristics across the CLESA countries, with very few exceptions. While some of the differences found may be due to cultural variations, others require further investigation and should be encompassed in the main framework of the Project, which is to identify predictors of hospitalization, mortality, institutionalization and functional decline. CONCLUSIONS: A common data base is available for the study of the aging process in five European and one Israeli population. These data provide a unique opportunity to identify common risk factors for mortality and functional decline and increase our understanding of country-specific exposures and vulnerability.

Are IADLs comparable across countries? Sociodemographic associates of harmonized IADL measures.

BACKGROUND AND AIMS: Independence in Instrumental Activities of Daily Living (IADLs) is determined not only by physical ability but also by the environmental and cultural surroundings of the individual. The present study describes the harmonization of data on IADL functioning of the Comparison of Longitudinal European Studies on Aging (CLESA) Project. The focus of this report is to examine the comparability of IADLs across countries and to study the association of IADLs with age, gender and socioeconomic status, and the scalability of the measure. METHODS: The study base includes data from five European countries (Finland, Italy, The Netherlands, Spain, Sweden) and Israel, for older people aged 65-89 living both in the community and in institutions, for a total of 11,557 subjects. In this report, only community-dwelling respondents were included (N=8420). The common IADL items in all six countries were: preparing meals, shopping, and doing housework. The analyses include how these items are distributed by age group and gender, and the associations between independence in these items and socioeconomic status (SES) with logistic regression modeling. The scale properties of these three items are also examined. RESULTS: Independence in IADLs decreases steadily with age in all countries. Associations with gender and SES follow largely similar patterns across countries. The reliability of the 3-item scale is satisfactory in most countries, and Cronbach's alpha-coefficient for the complete CLESA sample was 0.75. CONCLUSIONS: The associations between sociodemographic variables and independence in preparing meals, shopping, and doing housework are similar across countries. Results suggest that the predictors of IADLs in different countries are comparable.