Dataset Information

Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study.

ABSTRACT: AIM: To perform a nationwide investigation of paediatric drug use at Swedish hospitals, including an analysis of off-label drug use. METHODS: All paediatric hospitals in Sweden were invited to register all prescriptions to children, aged between 0 and 18, during two separate 2-day-periods in 2008. Data were reported and analysed with respect to licence status and proportion of and reasons for off-label drug use. RESULTS: Data on 11,294 prescriptions to 2947 paediatric patients were received. Drugs associated with pain relief, infection, prematurity, nutrition and surgery or anaesthesia were most commonly used. Paracetamol was the most frequently used drug on-label and also among the most commonly used off-label drugs. Nearly half (49%) of all administered prescriptions concerned unlicensed drugs, off-label drugs or extemporaneously prepared drugs. The corresponding rate among neonates was 69%. Lack of paediatric information in the Summary of Product Characteristics was the main reason for off-label classification. CONCLUSIONS: Paediatric off-label drug use is common at Swedish hospitals, and nearly half of all prescriptions were not documented for use in children. The findings emphasize a need for paediatric clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in infants and neonates.

SUBMITTER: Kimland E

PROVIDER: S-EPMC3437470 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study.

Kimland E E Nydert P P Odlind V V Böttiger Y Y Lindemalm S S

Acta paediatrica (Oslo, Norway : 1992) 20120324 7

<h4>Aim</h4>To perform a nationwide investigation of paediatric drug use at Swedish hospitals, including an analysis of off-label drug use.<h4>Methods</h4>All paediatric hospitals in Sweden were invited to register all prescriptions to children, aged between 0 and 18, during two separate 2-day-periods in 2008. Data were reported and analysed with respect to licence status and proportion of and reasons for off-label drug use.<h4>Results</h4>Data on 11,294 prescriptions to 2947 paediatric patients ...[more]

PMID: 22404126

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Project description:BackgroundPaediatric outpatient prescription (POP) monitoring is pivotal to identify inadequate prescriptions and optimize drug use. We aimed at describing recent trends in POPs in France.MethodsAll reimbursed dispensations of outpatient prescribed drugs (excluding vaccines) were prospectively collected for the paediatric population (<18 years old) in the French national health database in 2010-2011 and 2018-2019 (mean 117,356,938/year). POP prevalence (proportion of children receiving ≥1 drug prescriptions/year) was calculated by age groups and compared by prevalence rate ratios (PRRs). Given the large sample size, 95% confidence intervals of POP prevalences and PRRs did not differ from estimates.FindingsAmong the 14,510,023 children resident in France in 2018-2019, mean POP prevalence was 857‰ children. Most prescribed therapeutic classes were analgesics (643‰), antibiotics (405‰), nasal corticosteroids (328‰), nonsteroidal anti-inflammatory drugs (NSAIDs) (244‰), antihistamines (246‰) and systemic corticosteroids (210‰). POPs decreased with age from 976‰ for infants to 782‰ for adolescents. Children <6 years old were notably more exposed to inhaled corticosteroids (PRR=3.06), non-penicillin beta-lactam antibacterial agents (PRR=3.05) and systemic corticosteroids (PRR=2.11) than older ones. The POP prevalence was slightly higher (PRR=1.04) during 2018-2019 than 2010-2011, with marked increases for anti-emetics (PRR=1.84), vitamin D (PRR=1.49), proton pump inhibitors (PRR=1.42), systemic contraceptives (PRR=1.24) and nasal corticosteroids (PRR=1.21) and decreases for propulsive/prokinetic agents (PRR=0.09), NSAIDs (PRR=0.73) and systemic antibiotics (PRR=0.88).InterpretationPOP remained highly prevalent in France throughout the 2010s, especially for children <6 years old, with only a few improvements for selected therapeutic classes. These findings should prompt clinical guidance campaigns and/or regulatory policies.FundingInternal funding.

Project description:AimsAntipsychotics are primarily labelled for the treatment of severe mental illness and have documented clinical utility in certain neurological disorders or palliative care. However, off-label use of antipsychotics is common and increasing, and prior studies on antipsychotic utilisation have not specifically assessed users in neurology, palliative care or general practice. We aimed to explore diagnoses associated with antipsychotic use, treatment patterns and characteristics of users without diagnoses relevant to antipsychotic treatment.MethodsPopulation-based study identifiying all users of antipsychotics in Denmark (pop 5.7 mio.) 1997-2018 in the Danish National Prescription Register (DNPR). Possible indications for antipsychotic therapy were evaluated using in- and outpatient contacts from the DNPR. Users were divided hierarchically into six groups: severe mental disorders (schizophrenia, bipolar-spectrum disorders), chronic mental disorders (dementias, mental retardation, autism), other mental disorders (depression-spectrum, anxiety and personality disorders, etc.), selected neurological diseases, cancer and antipsychotic users without any of these diagnoses. This last group was characterised regarding demographics, antipsychotic use, health care utilisation and likely antipsychotic treatment initiator in 2018.ResultsAltogether, 630 307 antipsychotic users were identified, of whom 127 649 had filled prescriptions during 2018. Users without diagnoses relevant to antipsychotic treatment comprised of the largest group (37%), followed by schizophrenia and bipolar-spectrum disorders (34%), other mental disorders (15%), dementia, autism and mental retardation (11%), cancer (2.2%) and neurological diagnoses (2.0%). Of 37 478 incident users in 2018, 39% had no diagnosis relevant to antipsychotic treatment, 7.9% had major depression, 7.7% neurotic/stress-related disorders and 7.5% dementia. Quetiapine was most commonly used, both overall (51%) and among users without diagnoses relevant to antipsychotic treatment (58%). Of 14 474 incident users in 2018 without diagnoses relevant to antipsychotic treatment, treatment was most likely initiated by a general practitioner (65%), with only 17% seeing a psychiatrist during the following year. As many as 18% of patients with adjustment disorders and 14% of those without relevant diagnoses for antipsychotic use, remained on antipsychotic treatment 5 years after their first prescription.ConclusionsOver one-third of antipsychotic users in Denmark did not have psychiatric, neurological or cancer diagnoses as possible indications for antipsychotic therapy. Many antipsychotics are initiated or prescribed in general practice, and a concerningly large subgroup without documented diagnoses relevant for antipsychotics continued to receive them. Rational prescribing, adequate side effect monitoring and further research into reasons for the observed antipsychotic use patterns and their risk-benefit ratio are needed.

Project description:Background: The treatment of depression is a main strategy for suicide prevention in older adults. We aimed to calculate suicide rates by antidepressant prescription patterns in persons aged ≥ 75 years. A further aim was to estimate the contribution of antidepressants to the change in suicide rates over time. Methods: Swedish residents aged ≥ 75 years (N = 1,401,349) were followed between 2007 and 2014 in a national register-based retrospective cohort study. Biannual suicide rates were calculated for those with selective serotonin reuptake inhibitor (SSRI) single use, mirtazapine single use, single use of other antidepressants and use of ≥ 2 antidepressants. The contribution of antidepressants to the change in biannual suicide rates was analyzed by decomposition analysis. Results: There were 1,277 suicides. About one third of these were on an antidepressant during their last 3 months of life. In the total cohort, the average biannual suicide rate in non-users of antidepressants was 13 per 100,000 person-years. The corresponding figure in users of antidepressants was 34 per 100,000 person-years. These rates were 25, 42 and 65 per 100,000 person-years in users of SSRI, mirtazapine and ≥ 2 antidepressants, respectively. In the total cohort, antidepressant users contributed by 26% to the estimated increase of 7 per 100,000 in biannual suicide rates. In men, biannual suicide rates increased by 11 suicides per 100,000 over the study period; antidepressant users contributed by 25% of the change. In women, those on antidepressant therapy accounted for 29% of the estimated increase of 4.4 per 100,000. Conclusion: Only one third of the oldest Swedish population who died by suicide filled an antidepressant prescription in their last 3 months of life. Higher suicide rates were observed in mirtazapine users compared to those on SSRIs. Users of antidepressants accounted for only one quarter of the increase in the suicide rate. The identification and treatment of suicidal older adults remains an area for prevention efforts.

Dataset Information

Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study.

Publications

Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study.

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