Prevalence of torture and trauma history among immigrants in primary care in Denmark: do general practitioners ask?

BACKGROUND: Torture survivors typically present with varied and complex symptoms, which may challenge assessment by general practitioners (GPs). This study explored the prevalence of torture and trauma history among immigrants born in non-Western countries presenting to GPs in Denmark and the extent to which GPs ask this population about torture or trauma history. METHODS: Based on a self-reported questionnaire among non-western immigrant patients, we used bivariate analyses to determine the prevalence of torture and trauma history and the proportion of patients being asked by their GP about this. Data were analysed using multivariate logistic regression. RESULTS: From 46 GP clinics, 300 questionnaires were finalized by immigrant patients. Twenty-eight percent of the patients had a history of torture. Of these, significantly more were men (70%) than women (29%). About half of the torture survivors (55%) had been asked by their GP about torture history. The odds ratio (OR, 95% confidence interval) for being asked about torture history by the GP was 1.28 (0.46-3.53) among women compared with men. Compared with Southeast Europe, OR for being a torture survivor among male immigrants from Middle East-North African region and South and East Asia was 1.83 (0.81-4.15) and 0.25 (0.08-0.82), respectively. CONCLUSIONS: Our results suggest that torture and trauma are widespread among immigrants presenting to GPs. In our study, the GPs had managed to detect half of the torture survivors. A more systematic approach to detection in General Practice is advisable, and more knowledge on how and when to ask is needed.

Sociodemographic and diagnostic characteristics of prescribing a second-line lipid-lowering medication: ezetimibe used as initial medication, switch from statins, or add-on medication.

OBJECTIVE: Ezetimibe is used as a second-line lipid-lowering medication (LLM) if statin therapy is not tolerated or cholesterol targets are not reached by statins alone. We aimed to investigate the impact of sociodemographic factors on ezetimibe initiation as (a) incident LLM therapy, (b) add-on therapy, and (c) switch from statins. METHODS: All individuals aged 30+ who had filled at least one prescription for either statins (N = 581.074) or ezetimibe (N = 7.932) in 2011 were followed in the nationwide Danish registries to explore LLM prescribing patterns from 1 January 2011 to end 2012. Using logistic regression analyses, the odds ratio (OR) with 95% confidence intervals (CIs) was calculated for (a) incident ezetimibe use among LLM initiators (N = 77,472), (b) ezetimibe switching by discontinuing statin users (N = 37,509), and (c) ezetimibe as add-on by non-discontinuing statin users (N = 442,672). RESULTS: Women had higher odds for initiating ezetimibe than men (switch OR = 1.55; 95% CI = 1.32-1.82). While prior use of newer high-potency statins was the strongest predictor (add-on (5.56; 4.95-6.24), income was the strongest socioeconomic predictor for incident LLM use (1.33; 1.14-1.56) and switching (1.64; 1.27-2.13). Both income and education were predictors for add-on therapy, with the educational effect mediated by prior use of high-potency statins. Odds for ezetimibe prescribing were highest in myocardial infarction patients. CONCLUSION: While higher income is a predictor for switching to ezetimibe, both higher education and income are weak predictors for using ezetimibe as add-on therapy. Women and individuals with myocardial infarction are more likely to be prescribed ezetimibe than others, despite lack of evidence of ezetimibe lowering the risk of cardiovascular events.

Antidepressant utilization after hospitalization with depression: a comparison between non-Western immigrants and Danish-born residents.

BACKGROUND: Antidepressant (AD) therapy is recommended for patients 4-12 months after remission from depression. The aim was to examine whether immigrants (refugees or family reunited immigrants) from non-Western countries are at greater risk than Danish-born residents of 1) not initiating AD therapy after discharge and 2) early AD discontinuation. METHODS: A cohort of immigrants from non-Western countries (n = 132) and matched Danish-born residents (n = 396) discharged after first admission with moderate to severe depression between 1 January 1996 and 31 May 2008 was followed in the Danish registries.Logistic regression models were applied to explore AD initiation within 30 days after discharge, estimating odds ratio (OR) for immigrants versus Danish-born residents.Early discontinuation was explored by logistic regression, estimating OR for no AD dispensing within 180 days after the first dispensing, and by Cox regression, estimating hazard ratio (HR) for discontinuation (maximum drug supply gap) within 180 days. RESULTS: Immigrants had higher odds for not initiating AD treatment after discharge than Danish-born residents (OR = 1.55; 95% CI: 1.01-2.38). When income was included in the model, the strength of the association was attenuated. Odds for early discontinuation was non-significantly higher among immigrants than Danish-born residents (OR = 1.80; 0.87-3.73). Immigrants also had a non-significantly higher hazard of early discontinuation (HR = 1.46; 95% CI: 0.87-2.45). Including income had only minor impact on these associations. CONCLUSION: Immigrants seem less likely to receive the recommended AD treatment after hospitalization with depression. This may indicate a need for a better understanding of the circumstances of this vulnerable group.

Adherence to preventive statin therapy according to socioeconomic position.

AIM: To explore whether long-term adherence to preventive statin therapy depends on socioeconomic position (SEP). METHODS: A cohort of individuals without established cardiovascular disease (CVD) or diabetes initiating preventive statin therapy during 2002-2005 was followed in the individual-level Danish registries for 4 years or until censoring events (death, emigration, CVD or diabetes). Only individuals aged 40-84 years for whom information was available on the SEP indicators, education and income were included (N = 76,038). Two different aspects of poor adherence were applied as outcome measures: (1) Proportion of days covered (PDC) with medication below 80 %, assuming a daily dose of one tablet (continuity); (2) Discontinuation defined as a gap between two consecutive prescriptions exceeding 365 days (persistence). Stratum-specific logistic regression analyses were applied to estimate the odds ratio (OR) for PDC <80 % across SEP, adjusting for age and hypertension. Hazard ratio (HR) for discontinuation was estimated by Cox regression analyses. RESULTS: Adjusting mutually for income and education, the OR for PDC <80 % decreased with increasing income. Comparing the highest income quintile with the lowest, the OR were 0.64 (95 % Confidence Interval 0.64-0.65) and 0.73 (0.73-0.74) in men aged 40-64 and 65-84 years, respectively; in women, the figures were 0.79 (0.79-0.79) and 0.95 (0.94-0.95), respectively. While observed increases in adherence with longer education in unadjusted analyses were attenuated after adjustment for income among men, the potential inverse relationship between length of education and adherence was enhanced among women. Applying discontinuation as outcome, analogous differences were demonstrated. CONCLUSION: Adherence to preventive statin therapy in Denmark decreases with decreasing income-especially in men aged 40-64 years.

Impact of a Treatment Guide on Intravenous Fluids in Minimising the Risk of Hospital-Acquired Hyponatraemia in Denmark.

Hypotonic intravenous (IV) fluids are associated with an increased risk of hospital-acquired hyponatraemia, eventually leading to brain injury and death. We evaluated the effectiveness of a treatment guide to improve prescribing practices of IV fluids. We conducted a before-and-after cross-sectional survey among physicians working at Danish emergency departments. The primary outcome was prescribing practices of IV fluids. Participants were asked which IV fluid they would select in four clinical scenarios. We applied multivariate logistic regression models to estimate the odds ratio of selecting hypotonic fluids. Secondary outcomes included knowledge about IV fluids and hyponatraemia, and the receipt, reading, and usefulness of the treatment guide. After the intervention, about a third (47/154) reported that they would use hypotonic fluids in patients with increased intracranial pressure, and a quarter (39/154) would use hypotonic maintenance fluids in children, both of which are against guideline recommendations. A total of 46% selected the correct fluid, a 3% hypertonic saline solution for a patient with hyponatraemia and severe neurological symptoms. None of the knowledge questions met the predefined criteria of success of 80% correct answers. Of the respondents, 22% had received the treatment guide. Since the implementation failed, we recommend improving distribution by applying methods from implementation science.

Infection with SARS-CoV-2 following Second Dose Pfizer-BioNTech mRNA COVID-19 Vaccine BNT162b2 in Danish Adolescents Aged 12-18 Years: A Real-World Nationwide Danish Cohort Study.

In this real-world cohort study based on Danish nationwide registers, the cumulated proportion, relative risk (RR) of SARS-CoV-2 breakthrough infections, and vaccine effectiveness (VE) were investigated in adolescents aged 12-18 years following vaccination with the BNT162b2 vaccine compared to unvaccinated controls. Adolescents with and without vaccination with the first dose of BNT162b2 between 1 May and 30 September 2021 were included. Effect estimates include proportions with a positive SARS-CoV-2 RT-PCR test among vaccinated and unvaccinated, RR, and VE at three different time points. During Delta-dominance, VE was first 97.6% (95% CI 96.3-98.4), then 96.2% (95% CI 95.4-96.9) in the age group 12-15 and 95.1% (95% CI 94.1-96.0) followed by 95.5% (95% CI 94.8-96.1) in the age group 16-18 years, respectively. During Omicron dominance, VE was 5.8% (95% CI 4.6-7.0) in ages 12-15 years and 9.2% (95% CI 7.7-10.6) in ages 16-18 years. Thus, BNT162b2-vaccine protection was limited during the Omicron era.

Symptom-Specific Hospital Contacts in 12-18-Year-Olds Vaccinated against COVID-19: A Danish Register-Based Cohort Study.

In this register-based real-life cohort study, changes in symptom-specific hospital contacts among 12-18-year-olds following two doses of the BNT162b2 COVID-19 vaccine compared to unvaccinated peers were investigated. Using national register data, vaccinated and unvaccinated adolescents were sex and age-matched each week during the inclusion period from May to September 2021. Symptom-specific hospital contacts covering ICD-10 R diagnoses were assessed before first the vaccine dose and after the second vaccine dose. Taking previous rates of symptom-specific hospital contacts into account, differences between vaccinated and unvaccinated adolescents were found. For some hospital contacts, higher rates were seen among the vaccinated, and for others, higher rates were seen among the unvaccinated. Unspecific cognition symptoms may be important to monitor in vaccinated girls, and likewise for throat and chest pain in vaccinated boys within the first months post-vaccination. In perspective, symptom-specific hospital contacts after vaccination against COVID-19 must be assessed by taking the risk of infection and symptoms following COVID-19 infection into account.

The Impact of Vaccination against SARS-CoV-2 on Health Outcomes and Hospital Visits after Omicron Infection in Children and Adolescents Aged 5-18 Years: A Danish Nation-Wide Cohort Study.

This study investigates the impact of vaccination against SARS-CoV-2 on health outcomes and hospital contacts in children and adolescents aged 5-18 years infected with the SARS-CoV-2 Omicron variant, comparing previously vaccinated with unvaccinated. Using national register data, vaccinated and unvaccinated Danish children and adolescents with a positive SARS-CoV-2 test between 1 January and 31 March 2022 (Omicron dominance period) were included. The Prior Event Rate Ratio (PERR) was used to explore differences in hospital contacts (hospitalizations and emergency room (ER) visits), while Inverse Treatment Probability Weighted (IPW) risk ratios were used to explore the risk of severe health outcomes within six weeks following SARS-CoV-2 infection. Vaccinated 5-11-year-old girls had fewer visits to the ER compared to unvaccinated ones, PERR 0.92 (95% CI 0.84-1.00). Vaccinated 5-11-year-old boys had fewer hospitalizations (PERR 0.79 (0.64-0.99)) and more ER visits (PERR 1.13 (1.04-1.22)) compared to unvaccinated ones. An unadjusted and significant lower risk of febrile seizure among vaccinated 5-11-year-olds compared to unvaccinated ones was found (risk ratio 0.12 (0.04-0.39), p ≤ 0.01. No significant differences were found for severe conditions or for croup or pneumonia in either age group. The results indicate a modest protective effect of the vaccine in terms of hospital contacts, but no protective effect on health outcomes after SARS-CoV-2 Omicron infection in this population of Danish children and adolescents.

Drug utilization according to reason for prescribing: a pharmacoepidemiologic method based on an indication hierarchy.

PURPOSE: To develop a pharmacoepidemiologic method for drug utilization analysis according to indication, gender, and age by means of register-based information. Statin utilization in 2005 was applied as an example. METHODS: Following the recommendations for statin therapy, we constructed an indication hierarchy with eight mutually exclusive levels of register markers of cardiovascular disease and diabetes. Danish residents, as of January 1, 1996, were followed at the individual level in nationwide registers with respect to dispensed prescriptions of cardiovascular drugs and antidiabetics (1996-2005) along with discharge diagnoses and surgical procedures (1977-2005). The highest current possible indication level was assigned to all cohort members. Stratified by indication, gender, and age, statin treatment prevalence and incidence were calculated. RESULTS: Statin treatment prevalence was highest among individuals with myocardial infarction and tended to be higher among men with indications in the upper part of the hierarchy, but it was higher among women (especially the elderly) in the lower part of the hierarchy. Treatment incidence rates followed roughly the same pattern. Women with no register marker or primary hypertension accounted for almost 50% of all incident female users; among men, the figure was 35%. The proportion of incident users with ischemic heart disease or myocardial infarction increased with age. CONCLUSION: The proposed indication hierarchy provided new insight into prescription patterns of statins. The method can be implemented for other drug categories and could be useful for studying trends in drug utilization, differential drug adherence, and cross-national comparisons.

Is the high-risk strategy to prevent cardiovascular disease equitable? A pharmacoepidemiological cohort study.

BACKGROUND: Statins are increasingly prescribed to prevent cardiovascular disease (CVD) in asymptomatic individuals. Yet, it is unknown whether those at higher CVD risk - i.e. individuals in lower socio-economic position (SEP) - are adequately reached by this high-risk strategy. We aimed to examine whether the Danish implementation of the strategy to prevent cardiovascular disease (CVD) by initiating statin (HMG-CoA reductase inhibitor) therapy in high-risk individuals is equitable across socioeconomic groups. DESIGN: Cohort study. SETTING AND PARTICIPANTS: Applying individual-level nationwide register information on socio-demographics, dispensed prescription drugs and hospital discharges, all Danish citizens aged 20+ without previous register-markers of CVD, diabetes or statin therapy were followed during 2002-2006 for first occurrence of myocardial infarction (MI) and a dispensed statin prescription (N = 3.3 mill). MAIN OUTCOME MEASURES: Stratified by gender, 5-year age-groups and socioeconomic position (SEP), incidence of MI was applied as a proxy for statin need. Need-standardized statin incidence rates were calculated, applying MI incidence rate ratios (IRR) as need-weights to adjust for unequal needs across SEP.Horizontal equity in initiating statin therapy was tested by means of Poisson regression analysis. Applying the need-standardized statin parameters and the lowest SEP-group as reference, a need-standardized statin IRR > 1 translates into horizontal inequity favouring the higher SEP-groups. RESULTS: MI incidence decreased with increasing SEP without a parallel trend in incidence of statin therapy. According to the regression analyses, the need-standardized statin incidence increased in men aged 40-64 by 17%, IRR 1.17 (95% CI: 1.14-1.19) with each increase in income quintile. In women the proportion was 23%, IRR 1.23 (1.16-1.29). An analogous pattern was seen applying education as SEP indicator and among subjects aged 65-84. CONCLUSION: The high-risk strategy to prevent CVD by initiating statin therapy seems to be inequitable, reaching primarily high-risk subjects in lower risk SEP-groups.

Short- and Long-Term Self-Reported Symptoms in Adolescents Aged 12-19 Years after Vaccination against SARS-CoV-2 Compared to Adolescents Not Vaccinated-A Danish Retrospective Cohort Study.

This study investigated self-reported short- and long-term symptoms among adolescents receiving the BNT162b2 (Pfizer/BioNTech) vaccine against SARS-CoV-2 and those who did not. A retrospective cohort study based on Danish national survey (collected between 20 July and 15 September 2021) and register data was conducted. Differences in short-term (<14 days) and long-term (>two months) symptoms were explored using logistic regression adjusted for confounders. A total of 747 vaccinated (first dose n = 326; second dose n = 421) and 6300 unvaccinated adolescents were included in analyses of short-term symptoms and 32 vaccinated and 704 unvaccinated adolescents in long-term symptom analyses. In the first 14 days after the first and second vaccine dose the most reported symptoms included headache and muscle or joint symptoms. In both vaccinated and unvaccinated adolescents, the 15−19-year-olds reported significantly higher proportions of all symptoms compared to the 12−14-year-olds. After the second vaccine dose vaccinated 12−14-year-olds reported significantly more headache in adjusted analyses (OR 2.20 (95% CI 1.24; 3.90)). Among the 15−19-year-olds, significantly more vaccinated adolescents reported gastrointestinal symptoms (1.38 (1.06; 1.81)), headache (1.66 (1.24; 2.22)), and tiredness (1.44 (1.08; 1.93)). No differences were found in long-term symptoms. Vaccinated adolescents reported significantly more short-term symptoms including headache, tiredness, and gastrointestinal symptoms after the second vaccine dose than unvaccinated adolescents. Long-term symptom results should be interpreted with caution due to limited sample size.

From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding.

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.

A cross-sectional survey of knowledge pertaining to IV fluid therapy and hyponatraemia among nurses working at emergency departments in Denmark.

INTRODUCTION: Inappropriate fluid therapy may induce or worsen existing hyponatraemia with potentially life-threatening consequences. Nurses have an important role in assisting physicians in IV fluid prescribing. However, research is lacking in Denmark about nurses' knowledge pertaining to IV fluid therapy and hyponatraemia. METHODS: An explorative cross-sectional survey was performed among Danish emergency department nurses in Spring 2019. Knowledge about IV fluid therapy was assessed for three common clinical scenarios, and multiple-choice questions were used to measure knowledge about hyponatraemia. RESULTS: 112 nurses responded to all scenario questions corresponding to 6.2% (112/1815) of the total population of nurses working at emergency departments in Denmark. In two of the three scenarios, a minority of nurses (8-10%) inappropriately selected hypotonic fluids. Nearly one third (31%) selected a hypotonic fluid for a patient with meningitis, which is against guideline recommendations. The study revealed limited knowledge about severe symptoms of hyponatraemia, patients at high risk, and hyperglycaemia-induced hyponatraemia. CONCLUSION: In accordance with guideline recommendation, the majority of nurses did not select hypotonic fluids in three clinical scenarios commonly encountered in the emergency department. However, when setting up an educational program, further awareness is needed regarding symptoms of hyponatraemia, high-risk patients, and hyperglycaemia-induced hyponatraemia.

Are Further Interventions Needed to Prevent and Manage Hospital-Acquired Hyponatraemia? A Nationwide Cross-Sectional Survey of IV Fluid Prescribing Practices.

BACKGROUND: Hyponatraemia is associated with increased morbidity, increased mortality and is frequently hospital-acquired due to inappropriate administration of hypotonic fluids. Despite several attempts to minimise the risk, knowledge is lacking as to whether inappropriate prescribing practice continues to be a concern. METHODS: A cross-sectional survey was performed in Danish emergency department physicians in spring 2019. Prescribing practices were assessed by means of four clinical scenarios commonly encountered in the emergency department. Thirteen multiple-choice questions were used to measure knowledge. RESULTS: 201 physicians responded corresponding to 55.4% of the total population of physicians working at emergency departments in Denmark. About a quarter reported that they would use hypotonic fluids in patients with increased intracranial pressure and 29.4% would use hypotonic maintenance fluids in children, both of which are against guideline recommendations. Also, 29.4% selected the correct fluid, a 3% hypertonic saline solution, for a patient with hyponatraemia and severe neurological symptoms, which is a medical emergency. Most physicians were unaware of the impact of hypotonic fluids on plasma sodium in acutely ill patients. CONCLUSION: Inappropriate prescribing practices and limited knowledge of a large number of physicians calls for further interventions to minimise the risk of hospital-acquired hyponatraemia.

Swedish patients' trust in the bioequivalence of interchangeable generics. What factors are important for low trust?

BACKGROUND: Generic substitution (GS), is a cost-containment strategy meant to contain pharmaceutical expenditure without compromising health objectives. In order to shape GS into a policy that is both efficient and safe it is crucial to understand which factors are most important for patients' trust in GS. OBJECTIVE: To assess Swedish patients' level of trust in the bioequivalence of cheap and expensive generic medicines, and the association between trust and various factors. METHODS: A cross-sectional study was conducted. Questionnaires were handed out at 12 community pharmacies in Sweden, selected through stratified sampling, between March and April 2015. The questionnaire included seven socio-demographic questions in addition to 18 items divided into three sections: the 'views on generic medicine'-scale, information on and prior experiences of GS, financial aspects and change of color/name. Odds Ratios (ORs) were estimated applying adjusted logistic regression analyses with trust in the bioequivalence of generic medicines used as outcome variable and various factors as predictors. RESULTS: A total of 719 patients participated (response rate 85.7%). The results show that 70.7% of the respondents' trust that cheap and expensive interchangeable generic medicines are equal. Of the respondents 36.0% considered the change in appearance and 40.8% the change in names to complicate adherence. Lower trust in the bioequivalence of generic medicines were associated with being female (aOR=1.82, 95%CI 1.20:2.75, p<0.01), patients perceiving that changes in product name and appearance make adherence more complicated (aOR=2.18, 95%CI 1.48:3.19, p<0.001), disagreeing in that GS saves money for me (the customer) (aOR=2.68, 95%CI 1.58:4.55, p<0.001) or that GS saves money for society (aOR=3.21, 95%CI 1.46:7.08, p<0.01). CONCLUSIONS: Seven out of ten respondents had trust in the bioequivalence of generic medicines, and one in three considered GS to complicate adherence. Four factors were associated with lower trust in GS, i.e. female gender, agreeing that changes in product name and appearance complicates adherence, disagreeing in that GS saves money for me or disagreeing in that GS saves money for the society. Low trust in GS needs to be addressed, not least in the communication between health professionals and patients.

Pattern of statin use changes following media coverage of its side effects.

BACKGROUND: The media plays a role in shaping opinions about medical decisions, for example, whether to initiate or stop treatment. An association between negative media attention and statin discontinuation has been demonstrated, but it may differ depending on the reason for prescription and whether the user is new (incident) or long term (prevalent). AIM: The aim of this study is to explore whether a Danish newspaper article featuring the side effects of statins affects statin discontinuation in incident versus prevalent users, with the reason for prescription also taken into account. METHODS: The study relies on a quasi-experimental design and uses registry data on statin purchases to explore discontinuation and treatment duration. As a proxy for reason for prescription, data on filled prescriptions and hospital diagnoses from a Danish registry were used. We compared statin discontinuation in all statin users in Denmark in 2007 before the media event (n=343,438) and after it in 2008 (n=404,052). RESULTS: Compared to 2007, statin discontinuation among prevalent users in 2008 increased by 2.97 percentage points (pp). The change in discontinuation varied with the indication for statin use. Those with myocardial infarction had the smallest increase (1.98 pp) and those with hypercholesterolemia or primary hypertension had the largest increase (3.54 pp). Incident statin users had a higher level of discontinuation and a larger difference in discontinuation between 2007 and 2008. Compared to 2007, more people (5.52 pp) discontinued statin treatment in 2008. Again, those with myocardial infarction had the smallest decrease in statin discontinuation (1.49 pp), while those with a potential atherosclerotic condition (7.05 pp) and hypercholesterolemia or primary hypertension (6.10 pp) had the largest increase. CONCLUSION: Statin discontinuation increased in 2008 following a media event, but especially among individuals prescribed statins for primary prevention and among new statin users.

The influence of generic substitution on the content of patient-pharmacist communication in Swedish community pharmacies.

OBJECTIVES: The objective was to study the relationship between the length and content of patient-pharmacist communication in community pharmacies, and generic substitution. METHODS: The study was conducted in six community pharmacies in Sweden. Non-participant observations with audio recordings and short structured interviews were conducted. Out of 32 pharmacists 29 agreed to participate (90.6%), as did 282 out of 407 patients (69.3%). Logistic regression analysis was applied to calculate odds ratio for occurrence of generic substitution. Linear regression (ß-coefficients) was applied to test for differences in time spent on different categories. KEY FINDINGS: In encounters where generic substitution occurred more time (19.2 s) was spent on non-medical (for instance administrative or economical) issues (P = 0.01, 95% confidence interval 4.8-33.6). However, the total time of the encounter was not significantly longer. The amount of time spent on non-medical issues increased with age of patient (age 60+: ß, 33 s, P < 0.001). The results indicate that more time was spent on medical issues with patients who have a higher education (high school: ß, 10.8 s, P = 0.07, university: ß, 10.2 s, P = 0.11) relative to those with only elementary school education. CONCLUSIONS: Occurrence of generic substitution was correlated with more time spent on communicating on non-medical, but not on medical, issues. No extra time was spent on medical information for the groups normally overrepresented among those with low health literacy. This study suggests that pharmacists need to further embrace their role in promoting rational use of medicines, not least when generic substitution occurs.

Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database.

Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported in the European Summary of Product Characteristics (SPCs). The ADE report database at Danish Medicines Agency was searched for all quetiapine ADRs involving individuals (<18 years) in the period 1997-2015. Fifteen ADE case reports were retrieved, scrutinized, and categorized. The average age was 14.8 years (range 10-17 years) and six patients were boys. The main reported ADEs were (i) endocrine, for example, hyperprolactinemia and hyperthyroidism, (ii) cardiac, for example, tachycardia and QT prolongation, (iii) neurological, for example, seizures and cerebral hemorrhage, and (iv) psychiatric, for example, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns.

Statin prescribing according to gender, age and indication: what about the benefit-risk balance?

RATIONALES, AIMS AND OBJECTIVES: The increasing dispensing of statins has raised concern about the appropriateness of prescribing to various population groups. We aimed to (1) investigate incident and prevalent statin prescribing according to indication, gender and age and (2) relate prescribing patterns to evidence on beneficial and adverse effects. METHODS: A cohort of Danish inhabitants (n = 4 424 818) was followed in nationwide registries for dispensed statin prescriptions and hospital discharge information. We calculated incidence rates (2005-2009), prevalence trends (2000-2010) and absolute numbers of statin users according to register proxies for indication, gender and age. RESULTS: In 2010, the prevalence became highest for ages 75-84 and was higher in men than women (37% and 33%, respectively). Indication-specific incidences and prevalences peaked at ages around 65-70, but in myocardial infarction, the prevalence was about 80% at ages 45-80. Particularly, incidences tended to be lower in women until ages of about 60 where after gender differences were negligible. In asymptomatic individuals (hypercholesterolaemia, presumably only indication) aged 50+, dispensing was highest in women. The fraction of statin dispensing for primary prevention decreased with age: higher for incident than prevalent prescribing. Independent of age, this fraction was highest among women, e.g. 60% versus 45% at ages 55-64. The fraction for potential atherosclerotic condition (PAC, e.g. heart failure) increased with age. CONCLUSION: Prevalence of statin utilization was highest for ages 75-84, although indication-specific measures were relatively low. Despite inconclusive evidence for a favourable risk-benefit balance, statin prescribing was high among people aged 80+, asymptomatic women and PAC patients.

Social Pharmacy Research in Copenhagen-Maintaining a Broad Approach.

Social Pharmacy (SP) is a multidisciplinary field to promote the adequate use of medicine. The field of SP is increasingly important due to a numbers of new trends all posing challenges to society. The SP group at the University of Copenhagen has for several years used a broad approach to SP teaching and research, often illustrated by the four levels: individual, group, organizational, and societal. In this paper the relevance of maintaining a broad approach to SP research is argued for and examples of the importance of such type of research is presented.