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The aim of this study is to revisit the inter-rater reliability of drug treatment assessments according to the Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) criteria.Potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) were independently identified by two physicians in two cohorts of older people (I: 200 hip fracture patients, median age 85 years, STOPP/START version 1; II: 302 primary care patients, median age 74 years, STOPP/START version 2). Kappa statistics were used to evaluate inter-rater agreement.In cohort I, a total of 782 PIMs/PPOs, related to 68 (78%) out of 87 criteria, were identified by at least one assessor, 500 (64%) of which were discordantly identified by the assessors, that is, by one assessor but not the other. For four STOPP criteria, all PIMs (n = 9) were concordantly identified. In cohort II, 955 PIMs/PPOs, related to 80 (70%) out of 114 criteria, were identified, 614 (64%) of which were discordantly identified. For three STOPP criteria, all PIMs (n = 3) were concordantly identified. For no START criterion, with ≥1 PPO identified, were all assessments concordant. The kappa value for PIM/PPO identification was 0.52 in both cohorts. In cohort II, the kappa was 0.37 when criteria regarding influenza and pneumococcal vaccines were excluded. Further analysis of discordantly identified PIMs/PPOs revealed methodological aspects of importance, including the data source used and criteria wording.When the STOPP/START criteria are applied in PIM/PPO research, reliability seems to be an issue not encountered in previous reliability studies.

Purpose To investigate the prevalence and initiation of statins as well as treatment intensity in the oldest old, with younger olds as a reference. Methods A population-based cohort was used, including record-linked data from the Total Population Register, the Swedish Prescribed Drug Register, and the Swedish Patient Register. In each year over the study period (2009–2015), statin use was described in individuals 85 years or older and 65–84 years of age, and initiation rates were calculated among individuals with no statin treatment during a preceding 3-year period. Results A total of 1,764,836 individuals ≥ 65 years in 2009, increasing to 2,022,764 in 2015, were included in the analyses. In individuals 85 years or older, the prevalence of statin therapy increased from 11% in 2009 to 16% in 2015, the corresponding initiation rates being 1.3% and 1.7%, respectively. Corresponding prevalence and incidence figures in 65–84-year-olds were 23 to 25% and 3.0 to 3.3%, respectively. Overall, the proportion of individuals initiating statin with high-intensity treatment (atorvastatin ≥ 40 mg or rosuvastatin ≥ 20 mg) in the oldest old increased from 1 to 36% during the study period, and a similar increase was seen in the younger age group. Over the study years, the presence of an established indication for statin treatment varied between 70 and 76% in the oldest old and between 30 and 39% in the younger olds. Conclusion Prevalence and initiation of statin therapy are increasing among the oldest old, despite the fact that randomized controlled trials focusing on this age group are lacking and safety signals are difficult to detect.

The efficacy and safety of clopidogrel compared with ticagrelor as part of dual antiplatelet therapy in patients, and in older patients, with acute coronary syndrome is reviewed. PubMed, Embase, the Cochrane Library, MEDLINE, and HTA databases were searched (September 2, 2020) for randomized controlled trials (RCTs). Pooled risk differences (clopidogrel minus ticagrelor) were estimated using random-effects meta-analyses, and certainty of evidence was assessed according to Grading of Recommendations Assessment, Development, and Evaluation. In all, 29 RCTs were identified. The risk difference for all-cause mortality was 0.6% (-0.03% to 1.3%), cardiovascular (CV) mortality: 0.6% (95% confidence interval: 0.01% to 1.1%), myocardial infarction (MI): 0.9% (0.4% to 1.3%), stent thrombosis: 0.7% (0.4 to 1.1%), clinically significant bleeding: -1.9% (-3.7% to -0.2%), major bleeding: -0.9% (-1.6% to -0.1%), and dyspnea: -5.8% (-7.7% to -3.8%). In older patients, there were no differences between the comparison groups regarding all-cause mortality, CV mortality, and MI, whereas the risk of clinically significant bleeding and major bleeding was lower in the clopidogrel group, -5.9% (-11 to -0.9%, 1 RCT) and -2.4% (-4.4% to -0.3%), respectively. Compared with ticagrelor, clopidogrel may result in little or no difference regarding all-cause mortality. Although not evident in older patients, it cannot be excluded that clopidogrel may be slightly less efficient in reducing the risk of CV mortality and MI, whereas ticagrelor is probably more efficacious in reducing the risk of stent thrombosis. Clopidogrel results in a reduced risk of dyspnea and clinically significant bleeding and in older people probably in a reduced risk of major bleeding.

Background According to previous studies, older patients frequently have serum concentrations of antidepressant medication above the recommended reference range. Objective The aim of this study was to investigate whether prescribed doses of antidepressants and the proportion of individuals with serum concentrations above the recommended reference range in older individuals (≥ 65 years) have changed over a 10-year period in Norway. Methods Serum concentration measurements and prescribed daily doses of antidepressants in 2007 and 2017 were extracted from a therapeutic drug monitoring (TDM) database at the Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway. The database contains routine follow-up serum concentration measurements of psychotropic drugs for patients from all parts of the country. For citalopram, escitalopram, sertraline, mirtazapine and venlafaxine, the differences between 2007 and 2017 in mean prescribed doses and the proportion of patients with at least one serum concentration above the reference range, according to the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) guidelines, were compared. For the proportion of patients with serum concentrations above the recommended reference range, differences between individuals aged 65–79 and ≥ 80 years were also examined. Results The analyses of prescribed doses included 806 patients from 2007 and 1932 patients from 2017, with 972 and 2441 TDM samples, respectively. Between 2007 and 2017, modest reductions in prescribed daily doses were observed for citalopram (20 vs. 17 mg/day) and escitalopram (11 vs. 10 mg/day), but the proportion of patients with serum concentrations above the recommended reference range was unchanged for both drugs, i.e. 11.5% vs. 12.4% for citalopram and 3.6% vs. 2.9% for escitalopram. For mirtazapine and venlafaxine, prescribed doses were reduced from 28 to 25 mg/day and 150 to 125 mg/day, respectively. A significant reduction in the proportion of individuals with serum concentrations above the recommended reference range was observed for mirtazapine (27.1% vs. 11.5%) and for individuals aged ≥ 80 years using venlafaxine (60.0% vs. 30.0%). For sertraline, no differences in prescribed doses or serum concentrations above the recommended reference range were observed. Conclusions Over a 10-year period, prescribed doses of antidepressants have been slightly reduced in older Norwegian patients, but a considerable proportion is still exposed to high serum concentrations of antidepressants. Electronic supplementary material The online version of this article (10.1007/s40266-020-00784-9) contains supplementary material, which is available to authorized users.

Adequate knowledge in pharmacology is crucial in many professions but a non-negligible proportion of students fail the exams and knowledge of underlying factors is largely lacking. This study was performed to evaluate to what extent various factors are related to student performance in pharmacology-related courses in higher education, linking administrative data to attendance at non-mandatory teaching sessions and questionnaire replies. A total of 596 students (median age: 22 years; 70% female) were included from eight courses which are part of either the medical, pharmacy, dentistry, nursing, or biomedical analyst degree programs at the Sahlgrenska Academy, Gothenburg, Sweden. In all, 380 (64%) students passed the regular program- and course-specific exam. Multivariate logistic regression analysis revealed that a high participation rate in non-mandatory teaching sessions, as well as a perceived great interest in pharmacology, was associated with students’ passing of the exam; adjusted odds ratio (95% confidence interval): 1.30 (1.19 to 1.42; per 10 percentage unit increase in attendance) and 3.38 (1.86 to 6.12), respectively. Working for wages during the course weeks and pre-university grades used in the program application were significant factors in subgroups of students, negatively and positively associated with the exam results, respectively. Age, having Swedish as a second language, and time spent studying were only associated with the exam result in the univariate analyses. To conclude, both students and teachers can contribute significantly to successful education within pharmacology, students by participating in the teaching sessions and teachers by encouraging students to find the subject interesting. Electronic supplementary material The online version of this article (10.1007/s40670-020-01026-8) contains supplementary material, which is available to authorized users.

Purpose To investigate the clinical relevance of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), and to evaluate the association between PIMs/PPOs and inadequate drug treatment. Methods PIMs/PPOs, concordantly identified by two physicians applying the STOPP/START criteria, the EU(7)-PIM list, and a Swedish set in 302 consecutive older primary care patients, were assessed regarding clinical relevance for the specific patient. The physicians determined, in consensus, whether an action related to the medication was medically justified prior to the next regular consultation. If so, the drug treatment was categorised as inadequate, and if not, the treatment was considered adequate. Results In all, 259 (86%) patients had 1010 PIMs/PPOs, 150 (15%) of which, in 81 (27%) patients, were assessed as clinically relevant (kappa: 0.26). A total of 75 (50%) clinically relevant PIMs and PPOs were prioritised for medical action before the next regular consultation. Action-requiring clinically relevant PIMs most often concerned acetylsalicylic acid (ASA) for primary prevention (four out of 68 patients on ASA). The corresponding PPOs concerned beta-blockers in ischaemic heart disease (four out of 61 patients with this condition). When an overall medical perspective was applied, 164 (63%) out of 259 patients with PIMs/PPOs were assessed as having adequate treatment. In adjusted logistic regression, number of PIMs and/or PPOs and number of drugs were associated with inadequate drug treatment. Conclusion One in seven PIMs/PPOs may be clinically relevant, half of these not of priority for medical action. Cautious interpretation is warranted when PIMs/PPOs are used as outcome measures.

To investigate the prevalence and initiation of statins as well as treatment intensity in the oldest old, with younger olds as a reference.A population-based cohort was used, including record-linked data from the Total Population Register, the Swedish Prescribed Drug Register, and the Swedish Patient Register. In each year over the study period (2009-2015), statin use was described in individuals 85 years or older and 65-84 years of age, and initiation rates were calculated among individuals with no statin treatment during a preceding 3-year period.A total of 1,764,836 individuals ≥ 65 years in 2009, increasing to 2,022,764 in 2015, were included in the analyses. In individuals 85 years or older, the prevalence of statin therapy increased from 11% in 2009 to 16% in 2015, the corresponding initiation rates being 1.3% and 1.7%, respectively. Corresponding prevalence and incidence figures in 65-84-year-olds were 23 to 25% and 3.0 to 3.3%, respectively. Overall, the proportion of individuals initiating statin with high-intensity treatment (atorvastatin ≥ 40 mg or rosuvastatin ≥ 20 mg) in the oldest old increased from 1 to 36% during the study period, and a similar increase was seen in the younger age group. Over the study years, the presence of an established indication for statin treatment varied between 70 and 76% in the oldest old and between 30 and 39% in the younger olds.Prevalence and initiation of statin therapy are increasing among the oldest old, despite the fact that randomized controlled trials focusing on this age group are lacking and safety signals are difficult to detect.

Purpose To describe presented interaction alerts in older patients, and the extent to which these require further medical action for the specific patient or are already being addressed. Methods Interaction alerts presented at a physician consultation, for 274 consecutive primary care patients treated with two or more drugs (median age: 75 years; 59% female), were extracted. These alerts are based on Janusmed, a decision support integrated in the medical records that provides recommendations for managing the interactions. One general practitioner (GP) and one GP/clinical pharmacologist determined in retrospect, first independently and then in consensus, whether the alerts justified further medical action, considering each patient’s health condition. Results In all, 405 drug interaction alerts in 151 (55%) patients were triggered. Medical action in response was deemed medically justified for 35 (9%) alerts in 26 (17%) patients. These actions most often involved a switch to a less interacting drug from the same drug class (n = 10), a separate intake (n = 9), or the ordering of a laboratory test (n = 8). Out of 531 actions suggested by the alert system, only 38 (7%) were applicable to the specific patient, as, for instance, laboratory parameters were already being satisfactorily monitored or a separate intake implemented. Conclusions More than every other older patient receives drug treatment that triggers drug interaction alerts. Nine in ten alerts were already being addressed or were not relevant in the clinical setting, whereas, for the remaining tenth, some medical action, that for unknown reasons had not been taken, was reasonable. These findings show that interaction alerts are questionable as indicators of problematic prescribing.

Purpose To describe methodological and reporting issues in non-randomised comparative drug safety studies pooled in meta-analyses, with focus on confounding by indication. Methods All studies included in statistically significant meta-analyses in a recent publication investigating fall risk properties of cardiovascular drugs were reviewed. Study characteristics were extracted and assessed. Results Nine studies, including between 498 and 321,995 individuals, contributed data to the significant meta-analyses in which loop diuretics and beta-blockers were associated with falls, five published in 2015. Five individual studies reported a statistically significant association. In the five cohort studies, characteristics of exposed vs unexposed individuals were either not reported (n = 3) or differed substantially regarding morbidity (n = 2). Drug treatment was determined at baseline, and data on falls were collected for up to 2 years thereafter. Out of the four case-control studies, the cases and controls in only one study were matched for morbidity. Morbidity characteristics of fallers compared with non-fallers were either not reported (n = 2) or they differed (n = 1) or were reported according to the matched-for diseases (n = 1). Confounding by indication was explicitly discussed in two studies. None of the abstract conclusions considered causality issues or the possibility of confounding by indication. Conclusions Confounding by indication is a major issue in non-randomised comparative drug safety studies, a problem which may be concealed in meta-analyses. To enhance such research, compared groups need to be balanced regarding relevant factors including morbidities and characteristics adequately reported. Confounding by indication needs to be explicitly discussed and highlighted in the abstract conclusion.

Aim To investigate methodological aspects potentially related to the diverging scientific literature on the prevalence of drug-related hospitalisations, focusing on causality assessments. Methods Original studies contributing data to a recent meta-analysis were reviewed. Methodological aspects, in particular those related to causality assessments, were extracted and compiled. Results Thirteen studies provided data on the prevalence of drug-related admissions. Seven studies focused on adverse drug reactions (prevalences 1.3-10%), and six studies used the broader concept of drug-related problems (prevalences 4.5-41%). In 10 out of 13 studies, causality between the drug and the specified problem was assessed. One study required a probable causal relationship; the remaining studies merely required a possible causal relationship. Five studies assessed the association between the problem assumed to be related to drug therapy and the admission, at one end requiring the former to be demonstrated as the underlying cause and, at the other, merely requiring a temporal relationship between drug intake and admission. Three out of eight studies involving multiple assessors for all/some cases reported the inter-rater agreement, ranging from none to almost perfect. Physicians were involved in the assessments in five studies, reporting prevalences of 3.2% to 4.5%, while studies without such medical input reported prevalences of 8.8% to 41%. Conclusions This review illustrates that methodological issues contribute to the diverse literature on drug-related admissions. We provide suggestions for harmonisation of research, including explicitly assessing the drug-problem-admission relationships from a medical perspective, focusing on problems where the drug treatment is the probable culprit. Funding Agencies|Swedish Network for Pharmacoepidemiology; Swedish government [ALFGBG-716941]; county councils (the ALF-agreement) [ALFGBG-716941]; Swedish Research CouncilSwedish Research CouncilEuropean Commission [2013-02639]

AIMS To investigate inter-rater agreement on the quality of drug treatment, and the relationship between the drug treatment and hospital admission. METHODS Three specialist physicians and two resident physicians determined, independently and in consensus, the quality of drug treatment from an overall medical perspective, and its association with admission, in 30 randomly selected patients (50% female, median age 72 years) admitted to Sahlgrenska University Hospital, Sweden, in April 2018. The inter-rater agreement was evaluated with Gwet's agreement coefficient (AC1 ). RESULTS In all, 200 (95%) out of 210 drugs at admission and 238 (97%) out of 245 drugs at discharge were assessed as reasonable drug treatment by all assessors. Conversely, none of the drugs at admission, and two at discharge, were assessed as unreasonable drug treatment by all assessors (AC1 : 0.88 and 0.94 [all], 0.86 and 0.95 [specialists], 0.92 and 0.92 [residents], respectively). The assessments regarding the association between the drug treatment and the hospital admission (not related or main/contributory reason) were consistent between the assessors for 16 out of 30 patients (AC1 : 0.67 [all], 0.74 [specialists], 0.54 [residents]). In none of the three cases where the hospital admission was considered possibly attributable to a prescribing error did the assessors make consistent assessments. CONCLUSIONS As the inter-rater agreement ranged between weak and almost perfect, the reliability of assessments of drug treatment quality, as well as adverse consequences, appears to be a methodological concern. To yield acceptably reliable results regarding both drug treatment aspects at issue, specialist physicians should be involved.

People with Parkinson’s disease (PwP) have been suggested to be more vulnerable to negative psychological and psycho-social effects of the COVID-19 pandemic. Our aim was to assess the potential impact of the COVID-19 pandemic in PwP. A Danish/Swedish cohort of 67 PwP was analysed. Health-related quality of life (HRQL), depression, anxiety, apathy, sleep and motor symptom-scores were included in the analysis. Additionally, the Danish participants provided free-text descriptions of life during the pandemic. Overall, the participants reported significantly better HRQL during the COVID-19 period compared with before. Reduced social pressure may be part of the explanation. Despite worsened anxiety, night sleep improved.

Objective: Since several recent meta-analyses report a dose-response relationship for the antidepressant effect of the selective serotonin reuptake inhibitors (SSRIs), we investigated how these drugs are dosed in clinical practice. Methods: Through linkage of nation- or region-wide registers, we describe SSRI doses in 50,365 individuals residing in Region Västra Götaland, Sweden, with an incident diagnosis of depression and initiating SSRI treatment between 2007 and 2016. The primary question was to elucidate to what extent these individuals had been prescribed a daily dose that according to recent meta-analyses is required to elicit the maximum antidepressant effect, that is >20 mg citalopram, >10 mg escitalopram, >10 mg fluoxetine, >10 mg paroxetine or >50 mg sertraline. Results: In all, 21,049 (54%) out of 38,868 individuals

Many people are treated with ≥1 drug, implying that risks of drug interactions need to be considered. The aim of this study was to describe drug interaction queries from healthcare professionals to a drug information centre in Sweden over 10 years focusing on drugs frequently asked about and the advice provided. Advice was recorded in mutually exclusive groups: Avoid, Adjust dose, Separate intake, Vigilance or No problem. For queries with Avoid, Adjust dose or Separate intake advice, alerts were extracted from an interaction database (Janusmed). Of 4335 queries to the centre in 2008‐2017, 589 (14%) concerned interactions. Most were posed by physicians (91%) and concerned a specific patient (83%) before treatment initiation (76%). Sertraline, warfarin and methotrexate were the most frequently asked about, whereas queries about cyclophosphamide and rifampicine occurred most often in relation to the number of exposed patients. Advice provided in 557 (95%) replies comprised Avoid: n = 85 (15%), Adjust dose: n = 57 (10%), Separate intake: n = 17 (3%), Vigilance: n = 235 (42%) or No problem: n = 163 (29%). In all, 113 (71%) of 159 queries with Avoid/Adjust dose/Separate intake advice elicited an action alert on Janusmed, whereas 31 (20%) did not result in any alert at all. Summarized, seven in ten replies from the drug information centre recommended an explicit drug treatment action, regarding either specific prescribing aspects, for instance dose adjustments, or active follow‐up including monitoring potential adverse reactions and/or laboratory results. Readily accessible decision support regarding drug interactions often provides relevant action alerts, but cannot be solely relied on.

Background As prescribing skills are a prerequisite for rational use of medicines, and education and training are important in acquiring these skills, we aimed to explore what aspects junior physicians find important when being taught the art of prescribing. Methods Written feedback from 34 interns after participating in an educational session as part of a randomized controlled study at a university hospital formed the qualitative data in this study. Manifest content analysis was performed, guided by the research question “Educating junior physicians in the art of prescribing: what aspects do they find important?” Meaning units were extracted and categorized, and emergent themes were identified. Results Five themes emerged. The first, clinical relevance, was exemplified by the categories valuable for health care; perceived relevance for one’s own work; and translating theory into practice while the second, applicable content, included categories such as clinical advice; practical tips on using the electronic medical record system; and tools that facilitate. The third and fourth themes, reality-based teaching and creative discussions, were exemplified by the categories patient cases and feedback; and discussion-based teaching; wide-ranging discussions and a permissive and open atmosphere, respectively. In the last theme, effective structure, we identified the categories clear structure; small group teaching; allocated time for discussion; well-organized administration; and home assignment for practice. Conclusion Creative discussions, effectively structured in small group sessions, with clinically relevant, reality-based content built on case studies and feedback, are aspects which junior physicians find important when educated in the art of prescribing.

Background The prescribing of psychotropic drugs, i.e. antidepressants, sedatives (anxiolytics, hypnotics), and antipsychotics is considerable and a large proportion is prescribed by general practitioners (GPs). There are concerns about dependency and medicalisation, and treatment decisions in psychiatry may appear arbitrary. Increased knowledge of GPs’ opinions on the prescribing of psychotropics may lead to more rational use of these drugs. We aimed to quantify GPs’ attitudes, beliefs and behaviour towards various aspects of psychotropic drug prescribing. Methods A questionnaire was distributed to physicians in all 199 GP practices in Region Västra Götaland, Sweden. The questions concerned determinants of psychotropic drug prescribing that had been identified in a previous, qualitative study. Results Questionnaires from 516 physicians (64% of whom were specialists in family medicine, 21% interns in family medicine, 15% others) at 152 GP practices (59% of which were state owned, 72% in an urban area, with a median of 7808 registered patients) were returned (estimated response rate: 48%). A majority – 62% – of GPs found it easier to start prescribing psychotropic drugs than to stop (95% confidence interval, 57%, 66%) vs. 8% (6%, 10%). Most GPs considered psychotherapy more suitable than psychotropic drugs in cases of mild psychiatric disease: 81% (77%, 84%) vs. 4% (3%, 6%). The problems treated with psychotropic drugs were considered to be mostly socioeconomic, or mostly medical, by similar proportions of physicians: 38% (34%, 42%) vs. 40% (36%, 45%). GPs were on average satisfied with their levels of antidepressant and sedative prescribing in relation to medical needs. More GPs regarded their prescribing of antipsychotics as being too low rather than too high: 33% (28%, 39%) vs. 7% (4%, 10%). Conclusions This study illustrates the complexities of psychiatric drug treatment in primary care and identifies potential drivers of increased prescribing of psychotropics. The manifold factors, medical and non-medical, that affect prescribing decisions may explain a sense of arbitrariness surrounding psychotropic drug treatment. This notwithstanding, GPs seem mostly content with their prescribing. Electronic supplementary material The online version of this article (10.1186/s12875-018-0885-4) contains supplementary material, which is available to authorized users.

To investigate statin use in the elderly by age (≥ 80 vs. 65–79 years) in relation to established indications. A population-based cohort, including data from four registers, encompassing inhabitants in Region Vastra Gotaland, Sweden, was used. Statin users were defined as those filling statin prescriptions ≥ 75% of the year 2010. Primary care and hospital diagnoses in 2005–2010 regarding ischemic heart disease, stroke, transient ischemic attacks, and diabetes were considered established indications. A total of 278,205 individuals were analyzed. In individuals aged ≥ 80 and 65–79 years (n = 81,885 and n = 196,320, respectively), 17% (95% confidence interval 17%; 18%) and 23% (23%; 23%) respectively, were statin users. Among the statin users, 74% (73%; 74%) of those aged ≥ 80 and 60% (59%; 60%) of those aged 65–79 years had ≥ 1 established indication. Conversely, of those with ≥ 1 established indication, 30% (30%; 31%) and 53% (52%; 53%) were on statins in the respective age groups. Logistic regression revealed that age, nursing home residence, and multi-dose drug dispensing were the most prominent negative predictors for statin use; adjusted odds ratios (95% confidence interval): 0.45 (0.44; 0.46), 0.39 (0.36; 0.42), and 0.47 (0.44; 0.49), respectively. In the oldest old (≥ 80 years), statin users were fewer and had more often an established indication, suggesting that physicians extrapolate scientific evidence for beneficial effects in younger age groups to the oldest, but require a more solid ground for treatment. As the oldest old, nursing home residents, and those with multi-dose drug-dispensing were statin users to a lesser extent, physicians may often refrain from treatment in those with lower life expectancy, either due to age or to severely reduced health status. In both age groups, our results however also indicate some over- as well as undertreatment.

To evaluate whether an educational intervention based on collegial discussions on patient cases could increase interns’ professional confidence in prescribing. In a randomized controlled study at Sahlgrenska University Hospital, Gothenburg, Sweden, 69 interns (median age: 29 years, 54% female) were allocated to an intervention or control group. The intervention consisted of two 3-h seminars based on collegial discussions of patient cases focused on performing medication reviews. This included reconciling the drug treatment and ascertaining that it is reasonable given the patient’s current health status, as well as tips on practical handling of the medical records system and integrated decision support. Self-assessed confidence in performing medication reviews was evaluated with questionnaires distributed at baseline and at 6-month follow-up. Fifty-seven (83%) interns completed the questionnaires. Although the opposite was found at baseline, intervention interns, in comparison with controls, at follow-up, were more confident in performing medication reviews (4.3 ± 0.9 vs. 3.6 ± 1.3, P = 0.034; 1 = completely disagree to 5 = completely agree). At follow-up, the intervention participants had increased their confidence in prescribing to a greater extent compared with the control participants, including performing medication reviews as well as taking responsibility for the medication list at discharge: + 1.5/+ 1 vs ± 0 on the 5-point agreement scale (all P ≤ 0.01). Among other positive outcomes, the intervention increased the interns’ awareness of adverse effects as a potential cause of symptoms and their confidence in withdrawing a medication. Structured collegial discussions on pharmacotherapy, even of a relatively short duration, can increase junior physicians’ professional confidence in prescribing medicines.

Purpose To evaluate the concurrent validity of three European sets of drug‐specific indicators of prescribing quality Methods In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was assessed according to a gold standard as well as to three drug‐specific indicator sets (Swedish National Board of Health and Welfare, French consensus panel list, and German PRISCUS list). As gold standard, two specialist physicians independently assessed and then agreed on the quality for each patient, after initial screening with STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions) and START (Screening Tool to Alert to Right Treatment). Results According to the Swedish, French, and German indicator sets, 82 (41%), 54 (27%), and 43 (22%) patients had potentially inappropriate drug treatment. A total of 141 (71%) patients had suboptimal drug treatment according to the gold standard. The sensitivity for the indicator sets was 0.51 (95% confidence interval: 0.43; 0.59), 0.33 (0.26; 0.41), and 0.29 (0.22; 0.37), respectively. The specificity was 0.83 (0.72; 0.91), 0.88 (0.77; 0.94), and 0.97 (0.88; 0.99). Suboptimal drug treatment was 2.0 (0.8; 5.3), 1.9 (0.7; 5.1), and 6.1 (1.3; 28.6) times as common in patients with potentially inappropriate drug treatment according to the indicator sets, after adjustments for age, sex, cognition, residence, multi‐dose drug dispensing, and number of drugs. Conclusions In this setting, the indicator sets had high specificity and low sensitivity. This needs to be considered upon use and interpretation. Copyright © 2015 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons, Ltd.

Purpose Indicators based on the number of drugs in the medication list are sometimes used to reflect quality of drug treatment. This study aimed to evaluate the concurrent validity of such polypharmacy indicators, i.e., their ability to differentiate between appropriate and suboptimal drug treatment. Methods In 200 hip fracture patients (≥65 years of age), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was assessed according to a gold standard as well as to indicators based on the number of drugs in the medication list. As gold standard, two specialist physicians independently assessed and then agreed on the quality for each patient, after initial screening with Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START). Suboptimal drug treatment was defined as ≥1 STOPP/START outcomes assessed as clinically relevant at the individual level. Results A total of 141 (71 %) patients had suboptimal drug treatment according to the gold standard. The corresponding figures according to the indicators ≥5 and ≥10 drugs were 149 (75) and 49 (25 %), respectively. The sensitivity for the indicators ≥5 and ≥10 drugs to detect suboptimal drug treatment was 0.86 (95 % confidence interval: 0.80; 0.92) and 0.32 (0.25; 0.40), respectively. The specificity was 0.53 (0.41; 0.65) and 0.93 (0.82; 0.97). Conclusions The findings suggest that no polypharmacy indicator could serve as a general indicator of prescribing quality; cut-offs for such indicators need to be chosen according to purpose.

Background: In Sweden, medical students can work as employed doctor trainees under supervision during medical school breaks. The aim of the present study was to evaluate the educational value of such employments, as well as to compare university and non-university positions. Method: A questionnaire was administered to all employed doctor trainees at Sahlgrenska University Hospital, Gothenburg, in 2003-2004 (n = 67) plus all students in last term medical school 2005 who had had such a position inside or outside this university hospital (n = 43). The questionnaire included questions on trainee position/s, as well as statements regarding the educational value. Result: 75 unique individuals returned a filled-in questionnaire (response rate: 78%). The respondents experienced the positions as valuable concerning gain in professional confidence (mean ± standard deviation: 3.9 ± 1.1; 1 = total disagreement to 5 = total agreement) and independence (3.9 ± 1.1), subsequent learning in medical school (4.3 ± 0.9), and future professional work (4.2 ± 1.0). The gain in professional confidence and independence was greater for those who had worked in a non-university hospital (n = 17) than in a university hospital (n = 29): 4.4 ± 0.6 vs. 3.6 ± 3.6, P = 0.011; 4.3 ± 0.7 vs. 3.6 ± 1.1, P = 0.038. Conclusion: Employment as a doctor trainee seems to facilitate subsequent learning in medical school and enhance professional progress; the latter is particularly prominent in non-university hospitals.

To describe the discipline clinical pharmacology of today in the Swedish healthcare system from the performers’ point of view. A questionnaire was administered in December 2012 to physicians working within the specialty clinical pharmacology in the Swedish healthcare system (7 sites; 1–26 physicians per site). The questionnaire included questions pertaining to the characteristics of the responder and statements to which the responder indicated his/her level of agreement using a score ranging from 1 (total disagreement) to 5 (total agreement). A total of 61 completed questionnaires were returned (response rate: 97 %; 55 % male; 74 % specialists and/or consultants). In the preceding month, 79 % of the responders had performed educational activities, 74 % had functioned as an “expert”, and 75 % had performed research. The academic merits of the responders were high, with 72 % having at least a PhD degree and 23 % being professors. Among those performing research, the focus of 83 % was related to the field of clinical pharmacology, with the main sub-areas being pharmacoepidemiology (59 %) and/or pharmacogenetics (41 %). Regarding the apprehension questions, the responders strongly agreed that the specialty clinical pharmacology meets a need in the healthcare system (4.5 ± 0.7), that they wanted to continue to work within the specialty (4.5 ± 0.7), that their personal professional prospects were good (3.9 ± 1.0), and that they would recommend a colleague to specialize within the field (3.9 ± 1.1). The responders from the largest and first established site (Karolinska University Hospital) agreed with these points to a significantly greater extent than responders from other sites. The majority of the performers of clinical pharmacology in Swedish healthcare consider this specialty to be important to the medical community. By carrying out educational activities, providing expertise, and performing research, the performers seem to be content with their work and future prospects. Performers within the largest and oldest site in Sweden, generally held the most positive view of the specialty.

To compare drug treatment changes in older hip fracture patients with and without multi-dose drug dispensing (MDD) after discharge from hospital.Hip fracture patients (aged 65 years or older) for whom the same prescribing procedure was used at discharge and at the 6-month follow-up were extracted from two patient cohorts consecutively recruited in 2008 (n = 100) and 2009 (n = 99), respectively. Of these hip fracture patients, 107 patients used MDD and 47 used ordinary prescriptions (OP) throughout the study period. Drug treatment was registered at discharge and at the 6-month follow-up. Each drug was classified as changed (withdrawn, dosage adjusted or added) or unchanged. The association between MDD and changes in drug treatment was analysed with generalised estimating equations (GEE). Age, sex, cognition, year of study and type of drug (fall-risk-increasing, fracture-preventing or other) were included in the model.A total of 1,980 drugs were prescribed at discharge and at the 6-month follow-up to the 154 patients. Of the 1,413 drugs prescribed via MDD, 597 (43%) drugs were unchanged. The corresponding figure for drugs prescribed via OP was 166 out of 567 (29%) prescribed drugs. Analysis with GEE revealed an odds ratio (95% confidence interval) of 1.66 (1.20-2.31) to 1.77 (1.38-2.27) for a drug to be classified as unchanged when prescribed via the MDD system.MDD is associated with fewer changes in drug treatment compared with OP. Further studies of risks and benefits from this prescribing procedure are urged.

Purpose Psychiatric Adverse Drug Reactions (ADRs) are frequent in the pediatric population. The aim of the present study was to analyze spontaneously reported psychiatric ADRs in children during a 10-year period. Methods All spontaneously reported Individual Case Safety Reports (ICSRs) concerning children (

OBJECTIVE To evaluate the effects of a clinical pharmacist service on health-related quality of life (HRQL) and prescribing of drugs. METHODS A randomised controlled study was performed in two internal medicine wards. The intervention consisted of medication reviews with feedback to the physicians, drug treatment discussion with patients at discharge and medication reports. HRQL was evaluated at inclusion and after six months by self-rated global health (1: very poor; 5: very good) and by the EuroQol 5-dimension questionnaire (EQ-5D). Prescribing of drugs was analysed regarding three established drug-specific quality indicators (intervention and control patients) and potential drug-related problems (DRPs) during in-hospital care (intervention patients). RESULTS 345 patients (61% female; median age: 82) were analysed, 204 of whom (59%) completed the six-month HRQL follow-up. A total of 87 patients (53% of the intervention patients) received all parts of the intervention. Intention-to-treat analysis revealed no significant findings for any of the HRQL measures. Per-protocol analysis revealed significantly better HRQL in the intervention group at six-month follow-up as measured by global health (mean: 3.14 (SD: 0.87) vs 2.77 (0.94), p=0.020), but not as measured by summarised EQ-5D index (0.48 (0.36) vs 0.43 (0.37), p=0.57). The number of potentially inappropriate prescribings per patient according to the quality indicators (admission vs discharge) was 0.35 (0.73) versus 0.38 (0.72), p=0.47 (control patients), and 0.39 (0.83) versus 0.26 (0.56), p=0.039 (intervention patients who received the intervention). In the intervention group, 133 relevant potential DRPs were identified in 81 patients, 55 of which (41%) were acted upon by the attending physician. CONCLUSION A clinical pharmacist service during inpatient care may improve quality of prescribing and patients' HRQL. Trial registration clinicaltrials.gov Identifier: NCT01016301.

Hip fracture is a common diagnosis in the older population, with often serious consequences. Drug treatment may be of significance for both falls and fractures.To investigate drug treatment in older hip fracture patients, focusing on use of fall-risk-increasing and fracture-preventing drugs before and after the fracture.This was an observational study conducted in Sahlgrenska University Hospital, Gothenburg, Sweden. The participants were 100 consecutive hip fracture patients agedor =65 years with a median age of 86 (range 66-97) years. Seventy-three patients were female, and 87 patients had at least one strong risk factor for a fracture. Four patients died during the hospital stay, and a further 18 died within 6 months after discharge. Treatment with fall-risk-increasing and fracture-preventing drugs at admission to hospital, at discharge and 6 months after the hip fracture was measured.The numbers of patients treated with fall-risk-increasing drugs were 93 (93%), 96 (100%) and 73 (94%) at admission, discharge and 6-month follow-up, respectively. The median (range) number of such drugs was 3 (0-9), 4 (1-10) and 3 (0-10), respectively. A total of 17 (17%), 32 (33%) and 29 (37%) patients were treated with fracture-preventing drugs, predominantly calcium plus vitamin D, at admission, discharge and 6-month follow-up, respectively. Five patients (5%) used bisphosphonates or selective estrogen receptor modulators at admission. No additional patients had these drugs prescribed during the hospital stay. At 6-month follow-up, four more patients were treated with bisphosphonates.Treatment with fall-risk-increasing drugs was extensive among older hip fracture patients both before and after the fracture. The proportion of patients with fracture-preventing drugs was low at admission and increased slightly during the follow-up period. Hence, drug treatment in older hip fracture patients can be improved regarding both fall-risk-increasing drugs and fracture-preventing drugs.

Purpose A signal has been raised concerning montelukast and adverse drug reactions (ADRs) in children. The purpose of the present study was to evaluate psychiatric ADRs during treatment with montelukast in children. Methods We analyzed all reports of psychiatric disorders during treatment with montelukast in children (

To study the use of complementary and alternative medicine (CAM) drugs and methods in patients with inflammatory rheumatic diseases, at rheumatology clinics in western Sweden, and to investigate possible associations between CAM-using habits and other characteristics of the patients.Randomly selected rheumatology outpatients were asked to complete questionnaires about CAM usage, diagnoses, medication, quality of life (using the 36-item Short Form Health Survey, SF-36), fatigue (using the 20-item Multiple Fatigue Inventory, MFI-20), the Health Assessment Questionnaire (HAQ), and visual analogue scales (VAS) for global health, pain, and fatigue.A total of 200 patients were included, 137 women and 63 men, mean age 55+/-16 and 54+/-15 years, respectively. Ongoing CAM use was reported by 58 patients (29%): 45 (22.5%) were taking CAM drugs, 20 (10%) were using CAM methods. Altogether 130 patients (65%) had used CAM at some time of their lives; 103 patients (51%) had used CAM drugs ever and 90 patients (45%) had used CAM methods ever. Women used more CAM drugs compared with men. Younger patients used more CAM. CAM use was associated with parameters indicating poorer health, mental component score (MCS) and physical component score (PCS) of SF-36, and VAS for global health and fatigue. Ongoing CAM method was associated with less use of immunomodulatory drugs.CAM use is widespread among rheumatology patients in Sweden. A total of 65% of the patients had experience of CAM treatment. Female sex, younger age, and poor health were associated with CAM utilization.

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.

Purpose, The present article was built on the assumption that the form of an examination may influence learning, and may also reflect different kinds of knowledge. The aim of the study was to evaluate whether the results of an examination differ when short answer questions (SAQ) or modified essay questions (MEQ) are used. Method, Forty-nine students in the internal medicine course in Gothenburg, Sweden, performed a written examination in 2003, which included both SAQ and MEQ. Result, The correlation between the results of SAQ and MEQ was 0.59 (P < 0.001). The percentage correctly answered questions in the two types did not differ significantly. Some students had poor results in either SAQ or MEQ. Conclusion, The general outcome of the study indicates that results of SAQ and MEQ demonstrate a significant correlation. However, they may also reflect differences in mastery of the knowledge domain, which should be considered in relation to aspects of validity

Background: Although therapeutic drug monitoring (TDM) is considered an underused tool in psychiatric care, the prevalence of TDM is largely unknown. The aim of this study was to analyze the prevalence of TDM for antidepressants and antipsychotics during 2006–2013. Methods: The study population consisted of individuals ≥5 years of age residing in Stockholm County. The prevalence of TDM for each study year was calculated with the number of individuals in whom TDM had been performed as nominator (extracted from the TDM database at Karolinska University Laboratory) and the number of treated individuals as denominator (extracted from the Swedish Prescribed Drug Register). All data were obtained at the third and the fifth level of the anatomical therapeutic chemical classification system (pharmacological subgroup and chemical substance, respectively). The prevalence of TDM was compared between substances according to the level of TDM recommendation by guidelines. Results: For antidepressants, the prevalence of TDM decreased from 0.48% (95% confidence interval, 0.45%–0.52%) in 2006 to 0.36% (0.33%–0.39%) in 2013 (among 133,275 and 162,998 treated individuals, respectively). For antipsychotics, the prevalence of TDM increased from 2.3% (2.2%–2.5%) to 4.1% (3.9%–4.3%) (31,463 and 32,534 treated individuals). For both drug groups, TDM was more common in men than in women. The most frequently analyzed drugs were clozapine, perphenazine, zuclopenthixol, nortriptyline, and flupentixol. Although not reaching statistical significance, the TDM prevalence was greater for substances strongly recommended for TDM than for substances with a lower level of recommendation, median (interquartile range): 5.6% (2.8%–22%) versus 1.1% (0.2%–2.2%), P = 0.063. Conclusions: The prevalence of TDM is generally low, more frequent, and increasing for antipsychotics, and more frequent for men and substances where TDM is strongly recommended.

Aims Medication reviews by a third party have been introduced as a method to improve drug treatment in older people. We assessed whether this intervention reduces mortality and hospitalization for nursing home residents. Methods Systematic literature searches were performed (from January 1990 to June 2012) in Medline, EMBASE, Cochrane Library, ProQuest Nursing & Allied Health Sources and Health Technology Assessment databases. We included randomized and nonrandomized controlled trials (RCTs and non-RCTs) of medication reviews compared with standard care or other types of medication reviews in nursing home residents. The outcome variables were mortality and hospitalization. Study quality was assessed systematically. We performed meta-analyses using random-effects models. Results Seven RCTs and five non-RCTs fulfilled the inclusion criteria. The mean age of included patients varied between 78 and 86 years. They were treated with a mean of 4–12 drugs. The study quality was assessed as high (n = 1), moderate (n = 4) or low (n = 7). Eight studies compared medication reviews with standard care. In six of them, pharmacists were involved in the intervention. Meta-analyses of RCTs revealed a risk ratio (RR) for mortality of 1.03 [medication reviews vs. standard care; five trials; 95% confidence interval (CI) 0.85–1.23]. The corresponding RR for hospitalization was 1.07 (two trials; 95% CI 0.61–1.87). Conclusions Our findings indicate that medication reviews for nursing home residents do not reduce mortality or hospitalization. More research in the setting of controlled trials remains to be done in order to clarify how drug treatment can be optimized for these patients.

OBJECTIVES: To investigate whether medication reviews increase treatment with fracture-preventing drugs and decrease treatment with fall-risk-increasing drugs. DESIGN: Randomized controlled trial (1:1). SETTING: Departments of orthopedics, geriatrics, and medicine at Sahlgrenska University Hospital, Gothenburg, Sweden. PARTICIPANTS: One hundred ninety-nine consecutive individuals with hip fracture aged 65 and older. INTERVENTION: Medication reviews, based on assessments of risks of falls and fractures, regarding fracture-preventing and fall-risk-increasing drugs, performed by a physician, conveyed orally and in written form to hospital physicians during the hospital stay, and to general practitioners after discharge. MEASUREMENTS: Primary outcomes were changes in treatment with fracture-preventing and fall-risk-increasing drugs 12 months after discharge. Secondary outcomes were falls, fractures, deaths, and physicians' attitudes toward the intervention. RESULTS: At admission, 26% of intervention and 29% of control participants were taking fracture-preventing drugs, and 12% and 11%, respectively, were taking bone-active drugs, predominantly bisphosphonates. After 12 months, 77% of intervention and 58% of control participants were taking fracture-preventing drugs (P = .01), and 29% and 15%, respectively, were taking bone-active drugs (P = .04). Mean number of fall-risk-increasing drugs per participants was 3.1 (intervention) and 3.1 (control) at admission and 2.9 (intervention) and 3.1 (control) at 12 months (P = .62). No significant differences in hard endpoints were found. The responding physicians (n = 65) appreciated the intervention; on a scale from 1 (very bad) to 6 (very good), the median rating was 5 (interquartile range (IQR) 4-6) for the oral part and 5 (IQR 4-5.5) for the text part. CONCLUSION: Medication reviews performed and conveyed by a physician increased treatment with fracture-preventing drugs but did not significantly decrease treatment with fall-risk-increasing drugs in older adults with hip fracture. Prescribing physicians appreciated this intervention. Language: en

Background Psychotropic drug prescribing is problematic and knowledge of factors affecting the initiation and maintenance of such prescribing is incomplete. Such knowledge could provide a basis for the design of interventions to change prescribing patterns for psychotropics. The aim of this study was to explore the views of general practitioners (GPs), GP interns, and heads of primary care units on factors affecting the prescribing of psychotropic drugs in primary care. Methods We performed four focus group discussions in Gothenburg, Sweden, with a total of 21 participants (GPs, GP interns, and heads of primary care units). The focus group discussions were transcribed verbatim and analyzed using manifest content analysis. Results Three different themes emerged from the focus group discussions. The first theme Seeking care for symptoms, reflects the participants’ understanding of why patients approach primary care and comprised categories such as knowledge, attitudes, and society and the media. The second theme, Lacking a framework, resources, and treatment alternatives, which reflects the conditions for the physician-patient interaction, comprised categories such as economy and resources, technology, and organizational aspects. The third theme, Restricting or maintaining prescriptions, with the subthemes Individual factors and External influences, reflects the physicians’ internal decision making and comprised categories such as emotions, knowledge, and pharmaceutical industry. Conclusion The results of the present study indicate that a variety of factors may affect the prescribing of psychotropic medications in primary care. Many factors were related to characteristics of the patient, the physician or their interaction, rather than the patients’ medical needs per se. The results may be useful for interventions to improve psychotropic prescribing in primary care.

In medical schools small specialties like clinical pharmacology may be integrated in courses covering larger specialties and examined concomitantly. The results of a pilot study suggested that this approach would have negative consequences on the knowledge gained in clinical pharmacology with integration of this speciality in the course of internal medicine and concomitant examination. The aim of the present study was to assess in more detail whether students' presumed tendency to study selectively influences approval (the pass mark), a surrogate marker of the knowledge gained.A written examination for the integrated course in clinical pharmacology and internal medicine in Gothenburg, Sweden, was specifically designed in 2008 to evaluate the research question. The examination consisted of 50 short answer questions, of which five focused on clinical pharmacology (maximum score 10) and 45 were on internal medicine (maximum score 90). The cut-off level for approval (pass mark) was 60 %.Of the 81 students who wrote the examination, 73 (90.1 %) passed the examination as a whole. When the questions in clinical pharmacology were assessed separately, 62 (76.5 %) students passed the cut-off level of 60 %; the corresponding proportion of students achieving the cut-off level for questions on internal medicine was 90.1 %. There was a significant correlation between the results of the two specialties (p 0.001), but the questions on clinical pharmacology generated lower scores (p 0.001). The correlation coefficient between the results of two randomly chosen questions for clinical pharmacology was greater than that of two randomly chosen questions in internal medicine (p 0.001).Our results confirm that a small specialty like clinical pharmacology may need to be examined separately in order to guarantee a sufficient level of knowledge among students.

Background Spontaneous reporting of adverse drug reactions (ADRs) is an important method for pharmacovigilance, but under-reporting and poor quality of reports are major limitations. The aim of this study was to evaluate if repeated one-page ADR information letters affect (i) the reporting rate of ADRs and (ii) the quality of the ADR reports. Methods All 151 primary healthcare units in the Region Västra Götaland, Sweden, were randomly allocated (1:1) to an intervention (n = 77) or a control group (n = 74). The intervention consisted of one-page ADR information letters administered at three occasions during 2008 to all physicians and nurses in the intervention units. The number of ADR reports received from the 151 units was registered, as was the quality of the reports, which was defined as high if the ADR was to be reported according to Swedish regulations, that is, if the ADR was (i) serious, (ii) unexpected, and/or (iii) related to the use of new drugs and not labelled as common in the Summary of Product Characteristics. A questionnaire was administered to evaluate if the ADR information letter had reached the intended recipient. Results Before the intervention, no significant differences in reporting rate or number of high quality reports could be detected between the randomization groups. In 2008, 79 reports were sent from 37 intervention units and 52 reports from 30 control units (mean number of reports per unit ± standard deviation: 1.0 ± 2.5 vs. 0.7 ± 1.2, P = 0.34). The number of high quality reports was higher in intervention units than in control units (37 vs. 15 reports, 0.5 ± 0.9 vs. 0.2 ± 0.6, P = 0.048). According to the returned questionnaires (n = 1,292, response rate 57%), more persons in the intervention than in the control group had received (29% vs. 19%, P < 0.0001) and read (31% vs. 26%, P < 0.0001) an ADR information letter. Conclusions This study suggests that repeated ADR information letters to physicians and nurses do not increase the ADR reporting rate, but may increase the number of high quality reports.

Background: Knowledge of drug safety is limited in the paediatric population, especially for drugs not used as labelled. Spontaneous reporting of adverse drug reactions (ADRs) may be an important source for increased knowledge, but the extent of the overall rate of reporting in children is not known. Objective: The main objective of the study was to determine the extent of the spontaneous reporting of ADRs in children with a focus on drugs not used as labelled; this involved investigations of reporting rates of individual case safety reports (ICSRs) per 1000 treated individuals for drugs reported in children, to compare these between drugs labelled and not labelled for use in children, and to compare the rates for children with those of adults. Methods: ICSRs (extracted from the Swedish ADR database) and number of treated individuals (extracted from the Swedish Prescribed Drug Register) were analysed for a 2-year period (2006–7). For drugs with one or more ICSR regarding children, rates of ICSRs per 1000 treated individuals were determined and compared between children ( 10% of the volume was sold over-the-counter or for in-hospital use were excluded. The overall reporting ratio of aggregated ICSRs per 1000 treated individuals was calculated between drugs not labelled and drugs labelled for use in children, separately for children and adults. The overall reporting ratio was also calculated between children and adults, separately for drugs labelled and drugs not labelled for use in children. Results: A total of 255 (children) and 1402 (adults) ICSRs concerning 94 drugs were included in the analysis. Seventy-four (29%) and 711 (51%) ICSRs in children and adults, respectively, were registered as serious (p

Background: In the elderly in Scandinavia, multi-dose drug dispensing (MDD) is a common alternative to ordinary prescriptions (OP). MDD patients receive their drugs in unit bags, one for each dose occasion. The prescribing procedure differs between MDD and OP. The aim of the present study was to investigate the association between MDD and quality of drug treatment (QDT). Methodology/Principal Findings: A cross-sectional study was performed of all inhabitants in Region Vastra Gotaland alive on December 31st 2007, aged >= 65 years, with >= 1 prescribed drug and >= 2 health care visits for >= 2 diagnoses for obstructive pulmonary disease, diabetes mellitus, and/or cardiovascular disease in 2005-2007 (n = 24,146). For each patient, drug treatment on December 31st 2007 was estimated from drugs registered in the Swedish Prescribed Drug Register. QDT was evaluated according to established quality indicators (>= 10 drugs, Long-acting benzodiazepines, Drugs with anticholinergic action, >= 3 psychotropics, and Drugs combinations that should be avoided). Logistic regression, with adjustments for age, sex, burden of disease, and residence, was performed to investigate the association between MDD and QDT. Mean age was 77 years, 51% were females, and 20% used MDD. For all quality indicators, the proportion of patients with poor QDT was greater in patients with MDD than in patients with OP (all P < 0.0001). Unadjusted and adjusted odds ratios (95% confidence intervals) for poor QDT (MDD patients vs. OP patients) ranged from 1.47 (1.30-1.65) to 7.08 (6.30-7.96) and from 1.36 (1.18-1.57) to 5.48 (4.76-6.30), respectively. Conclusions/Significance: Patients with MDD have poorer QDT than patients with OP. This cannot be explained by differences in age, sex, burden of disease, or residence. These findings must be taken into account when designing alternative prescribing systems. Further research is needed to evaluate causative factors and if the findings also apply to other dose dispensing systems.

A signal has been raised concerning montelukast and adverse drug reactions (ADRs) in children. The purpose of the present study was to evaluate psychiatric ADRs during treatment with montelukast in children.We analyzed all reports of psychiatric disorders during treatment with montelukast in children (18 years) in the Swedish ADR database SWEDIS (1998-2007). The Bayesian Confidence Propagation Neural Network (BCPNN) method was used to screen for disproportional reporting rates of these reactions. An information component (IC) with a positive 95% lower confidence limit indicates a statistically significant disproportionality between the expected and the reported rate for a drug and an ADR.A total of 48 reports of psychiatric disorders in children during treatment with montelukast were found in SWEDIS. Reports appeared every year after registration. Psychiatric disorders reported more than once included nightmares (n = 15), unspecified anxiety (n = 11), aggressiveness (n = 11), sleep disorders (n = 10), insomnia (n = 3), irritability (n = 3), hallucination (n = 3), hyperactivity (n = 3), and personality disorder (n = 2). In 23 reports (48%), the child experiencing psychiatric ADRs wasor = 3 years old. Time from exposure to ADR was indicated in 35 reports. In 28 of these (80%), the time from exposure to ADR was less than 1 week. A statistical signal for psychiatric disorders appeared in the fourth quarter of 1998 (three reports, IC-value: 2.34, 95% lower confidence limit: 0.62).Psychiatric ADRs can occur during montelukast treatment in children, indicating that attention to this is essential. Further studies are needed to establish the magnitude of the problem.

Purpose To investigate the risk of clinically relevant bleeding in warfarin-treated patients with or without concomitant treatment with selective serotonin reuptake inhibitors (SSRIs). Methods A cohort study was performed in patients treated with warfarin due to atrial fibrillation. Exposed patients were defined as patients treated with SSRI at any time between January 1999 and September 2005 (n = 117). Unexposed patients without SSRI-treatment were randomly selected and matched for age and sex (1:1). The primary endpoint was hospital admission due to bleeding during the same time period. Results Bleeding occurred in 17 exposed patients (totally 23 bleedings) and in two unexposed patients (totally two bleedings) (p = 0.0003). A total of 11 bleedings occurred during treatment with the combination of warfarin and SSRI, and 14 during treatment with warfarin only. The total incidences of bleedings per 1000 treatment years were 51.4 (25.7–92.0) and 23.9 (13.1–40.1), respectively, and the unadjusted incidence rate ratio (IRR) 2.15 (0.88–5.11). Cox regression analysis including first bleedings revealed an adjusted hazard ratio of 3.49 (1.37–8.91) for bleeding during treatment with a combination of SSRI and warfarin compared with treatment with warfarin only. Initiation of SSRI therapy was not associated with a change in dose of warfarin or with a change in international normalized ratio (INR) (p = 0.48 and p = 0.31, respectively). Conclusion Addition of SSRI to warfarin-treated patients may be associated with an increased risk of clinically relevant bleeding. The effect seems not to be associated with a direct influence of SSRI on the anti-coagulant activity of warfarin. Copyright © 2009 John Wiley & Sons, Ltd.

Background In the region of Västra Götaland in Sweden, prescribing guidelines, drawn up by 24 expert groups and determined by the regional board for drugs, are since 2006 available in the form of an annually published booklet. This study investigates, for the first time, the use of and attitudes towards this publication. Methods A questionnaire was administered to doctors working in primary health care in the region of Västra Götaland in Sweden. Questions included characteristics of the responding doctor and use of the prescribing guidelines booklet, as well as attitude questions constructed as statements to which the responder should grade his level of agreement from 1 (total disagreement) to 6 (total agreement). Results Totally 603 filled-in questionnaires were returned (estimated response rate 60%). The majority of the doctors (n = 571, 97%) responded that they use the prescribing guidelines booklet, and when prescribing a drug for a new diagnosis, a drug from the booklet is chosen in most cases [median (25th – 75th percentile) 80 (75–90)]. However, at renewal of a drug prescription, active change to a drug from the prescribing guidelines booklet occurs less often [median (25th – 75th percentile) 50 (20–70)]. The booklet also includes short therapy advice sections, which 231 doctors (42%) use every day and 191 (34%) use every week. The attitudes towards the prescribing guidelines booklet were generally positive. Doctors in privately run primary health care units and doctors running their own business were generally more negative and judged themselves to be less adherent to the prescribing guidelines booklet compared with doctors in publicly run primary health care units. Conclusion The prescribing guidelines booklet is frequently used and is generally appreciated, though differences exist between subgroups of users.

The purpose of this study was to investigate two different feedback alternatives to doctors reporting adverse drug reactions (ADRs) concerning (1) effects on reporting rates and (2) doctors' opinions.When reporting an ADR during January through March 2006, doctors in the western part of Sweden were randomised according to working address to receive feedback I or feedback II. Feedback I consisted of the conventional mode of feedback. Feedback II consisted of the contents of feedback I supplemented with information on the reported drug from the regional drug information centre. A questionnaire was administered 2 weeks after the feedback. The doctors were asked to give their opinion on the feedback concerning amount of information, quality and overall impression on a 6-point scale, where 1 corresponded to too little/very bad and 6 to too much/very good. During the inclusion period and the 6-month follow-up period, additional ADR reports originating from receivers of either feedback I or II were identified and compared.Sixty-six doctors received feedback I, and 49 received feedback II. The number of doctors reporting more than once was greater in the group receiving feedback II (39% vs. 22%; P = 0.039). Feedback II was judged to contain more information than feedback I (4.1 +/- 0.8 vs. 3.6 +/- 0.9; P = 0.014). No difference between the feedback alternatives concerning doctors' opinions on quality and overall impression could be detected. Sixty-five doctors (70%) stated that the content of the feedback letter could affect their willingness to report ADRs.The content of the feedback to doctors reporting ADRs may influence reporting rates.

Use of herbal medicines can result in adverse effects and in interactions with other pharmacological therapies. The hypothesis of the present study was that health professionals overlook use of herbal drugs. Thus, the aims were (i) to examine to what extent hospitalized patient's use of herbal drugs is documented in the files and (ii) to investigate the patients' attitudes concerning effects and adverse effects of herbal drugs in comparison with regular prescription drugs. Eight out of 58 included hospitalized patients in Sahlgrenska University Hospital used herbal drugs regularly before admission, six of which used regular prescribed drugs simultaneously and one of which had the use of herbal drugs documented in the files. The patients considered regular prescription drugs to be more effective and more prone to adverse effects than herbal drugs. In conclusion, health professionals often overlook patients' use of herbal drugs.

Anaemia in patients with chronic kidney disease can be treated with epoetin. An adequate iron status is necessary for an optimal epoetin treatment effect. Guidelines from the Swedish Association of Nephrology recommend that haemoglobin (Hb) and iron status should be investigated every 3 - 6 months. Recommended target values are 110-130 g/l (Hb),20% (transferrin saturation) and100 microg/l (S-ferritin). A cross-sectional study was performed in 173 pre-dialysis patients (GFR20 ml/minx1.73 m2 BSA), 35% of whom received epoetin. In epoetin-treated patients, laboratory investigations as recommended in the guidelines were present for 100% (Hb), 67% (transferrin saturation) and 62% (S-ferritin) of the patients. In these patients, target values were reached for 57% (Hb), 66% (transferrin saturation) and 58% (S-ferritin). Forty percent of the epoetin-treated patients had absolute iron deficiency, 60% of whom received iron therapy. In conclusion, adherence to guidelines concerning epoetin and iron therapy in patients with chronic kidney disease could probably be improved.

The neuropeptide Y (NPY) signal peptide polymorphism T1128C has been linked to several risk factors for cardiovascular disease. The aim of the present study was to evaluate the significance of this polymorphism for cardiovascular and cerebrovascular disease outcome.In a prospective study cohort, 1032 hypertensive patients (174 myocardial infarction and 170 stroke patients and 688 matched controls) were analysed for the T1128C polymorphism in the NPY gene.The dynamic allele specific hybridization (DASH) method was used for genotyping. Serum from the same participants was analysed for total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides.The frequency of the NPY T1128C polymorphism was 8.4% among patients with a myocardial infarction or stroke, as compared to 5.1% in the control group (P = 0.040). The difference remained significant after adjustment for the cardiovascular risk factors age, sex, smoking status, body mass index, systolic and diastolic blood pressure, presence of diabetes, total cholesterol, HDL, LDL and triglycerides.The present study indicates that the NPY T1128C polymorphism is an independent predictor for myocardial infarction and stroke in a Swedish hypertensive population.

The purpose of this study was to determine whether the automated detection of acute myocardial infarction (AMI) by utilizing artificial neural networks was improved by using a previous electrocardiogram (ECG) in addition to the current ECG. A total of 4,691 ECGs were recorded from patients admitted to an emergency department due to suspected AMI. Of these, 902 ECGs, in which diagnoses of AMI were later confirmed, formed the study group, whereas the remaining 3,789 ECGS comprised the control group. For each ECG recorded, a previous ECG of the same patient was selected from the clinical electrocardiographic database. Artificial neural networks were then programed to detect AMI based on either the current ECG only or on the combination of the previous and the current ECGs. On this basis, 3 assessors—a neural network, an experienced cardiologist, and an intern—separately classified the ECGs of the test group, with and without access to the previous ECG. The detection performance, as measured by the area under the receiver operating characteristic curve, showed an increase for all assessors with access to previous ECGs. The neural network improved from 0.85 to 0.88 (p 5 0.02), the cardiologist from 0.79 to 0.81 (p 5 0.36), and the intern from 0.71 to 0.78 (p