Drugs In Norway Research Articles

Pharmacological treatment of obesity in adults in Norway 2004-2022.

To describe trends in the use of anti-obesity drugs in Norway during the period 2004-2022. We assessed the annual utilization of any available drug indicated for obesity recorded in the nationwide Norwegian Prescribed Drug Register for adults (age 18-79 years) from 1 January 2004 to 31 December 2022. Prevalence was stratified by sex and age group (18-29 years and 10-year age groups thereafter). Additional analyses were performed in individuals initiating treatment with an anti-obesity drug and on the cost of the anti-obesity drugs since 2017. The prevalence of anti-obesity drug use decreased from 2009, when sibutramine and rimonabant were withdrawn from the market, and increased again after the approval of bupropion-naltrexone in 2017 and liraglutide in 2018. The use of the peripheral-acting anti-obesity drug orlistat decreased from 2004. In 2022, 1.04% of the adult Norwegian population (72.8% women) filled at least one prescription of bupropion-naltrexone, 0.91% used liraglutide (Saxenda; 74.2% women), and semaglutide without reimbursement was used by 0.68% (76.7% women). The prevalence increased with age, peaking in the age group 50 to 59 years, and decreased in older age groups. From 2017 to 2022, 2.8% of the adult residents initiated treatment with an anti-obesity drug. The total sale of those drugs increased from 1.1 million euros in 2017 to 91.8 million euros in 2022. The use of anti-obesity drugs in Norway has increased substantially in recent years, especially among women aged 40 to 59 years. Changes in availability and reimbursement have influenced the use of these drugs in recent years.

“You have to be street smart”: Street capital and the social organisation of risk among people who inject drugs in Norway

This study explores the social organisation of risk among injecting drug users in Norway. Based on qualitative interviews with 80 people who regularly injected drugs, recruited from harm reduction services in five Norwegian cities, the analysis illustrates how users embody various forms of capital in order to mitigate harm. These forms of capital work along three axes that we conceptualise as sociocultural, injecting and structural capital. First, the sociocultural capital highlights how users accounted for a field-specific competence that enabled them to evaluate the trustworthiness of drug dealers, and the quality and purity of the drugs they bought. Second, the injecting capital illustrates the drug-related competence among users, and how they managed their drug use in certain ways to minimise harm. Third, structural capital emphasises how users learned to benefit from various low-threshold agencies and the welfare state. Together, these forms of risk capital illustrate the subtle, and often neglected, forms of capital embedded within marginalised populations and how they ‘do’ harm reduction in their everyday interactions and drug use. If interventions within this population are to succeed, there is need for a greater awareness of such forms of capital and how these are employed within the social environments in which drug-related risks are organised.

The impact of level of documentation on the accessibility and affordability of new drugs in Norway.

Introduction: Over the preceding decade, an increasing number of drugs have been approved by the European Medicines Agency (EMA) with limited knowledge of their relative efficacy. This is due to the utilization of non-randomized, single-arm studies, surrogate endpoints, and shorter follow-up time. The impact of this trend on the accessibility and affordability of newly approved drugs in Europe remains uncertain. The primary objective of this study is to provide insights into the issues of accessibility and affordability of new drugs in the Norwegian healthcare system. Method: The presented study entails an analysis of all reimbursement decisions for hospital drugs in Norway spanning 2021-2022. The included drugs were approved by the EMA between 2014 and 2022, with the majority (91%) receiving approval between 2018 and 2022. The drugs were categorized based on the level of documentation of relative efficacy. Approval rates and costs (confidential net-prices) were compared. Results: A total of 35% (70/199) of the reimbursement decisions were characterized by limited certainty regarding relative efficacy and as a consequence the Norwegian Health Technology Assessment (HTA) body did not present an incremental cost-effectiveness ratio (ICER) in the HTA report. Within this category, a lower percentage of drugs (47%) gained reimbursement approval compared to those with a higher certainty level, which were presented with an ICER (58%). On average, drugs with an established relative efficacy were accepted with a 4.4-fold higher cost (confidential net-prices). These trends persisted when specifically examining oncology drugs. Conclusion: Our study underscores that a substantial number of recently introduced drugs receive reimbursement regardless of the level of certainty concerning relative efficacy. However, the results suggest that payers prioritize documented over potential efficacy. Given that updated information on relative efficacy may emerge post-market access, a potential solution to address challenges related to accessibility and affordability in Europe could involve an increased adoption of market entry agreements. These agreements could allow for price adjustments after the presentation of new knowledge regarding relative efficacy, potentially resolving some of the current challenges.

All-cause and cause-specific mortality among individuals imprisoned for driving under the influence of alcohol and drugs in Norway (2000–2016): a retrospective cohort study

AimsTo describe all-cause and cause-specific mortality and to investigate factors associated with mortality among individuals imprisoned for driving under the influence (DUI) of alcohol and psychoactive drugs in the Norwegian...

Impact of COVID-19 Pandemic on Dispensing of Cardiovascular Drugs in Norway: An Interrupted Time Series Study

The COVID-19 pandemic resulted in changes in prescription patterns and fillings for certain medications, but little is known about its impact on the dispensing of cardiovascular drugs. Trends in dispensing of cardiovascular drugs before and during the pandemic were examined using a population-based cohort in Norway. Using interrupted time series analyses and considering March 1, 2020 as the interruption point, the impact of the pandemic on defined daily dose dispensing of prescribed cardiovascular drugs was estimated in a population of adults with and without pre-existing cardiovascular disease from January 2018 to December 2021. All data were analyzed in 2023. In a total of 4,053,957 adults, 690,910 (17.0%) had pre-existing cardiovascular disease. Prior to the pandemic, there was a significant monthly increase in any cardiovascular drug dispensing among those with pre-existing cardiovascular disease (0.30 defined daily dose per month per adult), including prescription of diuretics, calcium channel blockers, and lipid-modifying agents. After controlling for preinterruption trends, there was a slight decrease in level change immediately after the start of the pandemic (2.5 defined daily dose per month per adult) but an increase in the postinterruption trend (0.06 defined daily dose per month per adult) for dispensing of cardiovascular prescriptions, although these changes were not significant. Although the COVID-19 pandemic did not appear to result in significant changes in patterns of cardiovascular drug dispensing in Norway, continued access to cardiovascular drugs remains important to prevent further related morbidity.

Prescription high-risk polysubstance use among opioid maintenance treatment patients.

Among individuals receiving buprenorphine or methadone as opioid maintenance treatment (OMT), concomitant use of other central nervous system depressants, including prescription drugs, can increase risk of overdose. We aimed to 1) determine the prevalence of use of high-risk prescription drugs (opioid analgesics, benzodiazepines, benzodiazepine-related drugs, and gabapentinoids) among OMT patients, 2) calculate its associations with different mental health and pain-related diagnoses, and 3) compare prevalence of concomitant use with the general population. A national sample comprising all individuals filling at least one prescription of OMT drugs in Norway in 2019 was formed. Healthcare registry data were linked to investigate high-risk prescription drug use and different diagnoses. We calculated one-year prevalence of use, amount dispensed in defined daily doses (DDDs), and the number of prescribers for the different high-risk prescription drugs. Logistic regression was used to determine associations (adjusted odds ratios; aOR, 95% confidence intervals (CIs)) between diagnoses and use. Prevalence of use was calculated both in the OMT patient sample and the general population. Among the OMT patient sample (n=7,299), 47.6% (n=3,476) filled prescriptions for benzodiazepines. For each high-risk prescription drug group, there was a median of 1-2 prescribers. Musculoskeletal diagnoses were the strongest factor for concomitant high-risk prescription drug use for both males (aOR 3.23, CI: 2.72-3.85) and females (aOR 3.07, CI: 2.42- 3.90). The 1-year prevalence of benzodiazepine use was 11.4 times higher for males and 7.1 times higher for females in OMT than the general population. The amount in DDDs was higher for every drug for OMT patients than the general population, particularly for benzodiazepines. OMT patients frequently filled prescriptions for high-risk drugs, and in higher dosages than the general population. However, we found little evidence of 'doctor shopping.' Given that these prescription drugs carry overdose risk, particularly when combined with OMT drugs, our findings emphasize the continued need for education and caution to both prescribers and patients on their concomitant use with OMT.

Cost-effectiveness of integrated treatment for hepatitis C virus (HCV) among people who inject drugs in Norway: An economic evaluation of the INTRO-HCV trial.

The INTRO-HCV randomized controlled trial conducted in Norway over 2017-2019 found that integrated treatment, compared with standard-of-care hospital treatment, for hepatitis C virus (HCV) with direct-acting antivirals (DAAs) improved treatment outcomes among people who inject drugs (PWID). We evaluated cost-effectiveness of the INTRO-HCV intervention. A Markov health state transition model of HCV disease progression and treatment with cost-effectiveness analysis from the health-provider perspective. Primary cost, utility, and health outcome data were derived from the trial. Costs and health benefits (quality-adjusted life-years, QALYs) were tracked over 50 years. Probabilistic and univariate sensitivity analyses investigated DAA price reductions and variations in HCV treatment and disease care cost assumptions, using costs from different countries (Norway, United Kingdom, United States, France, Australia). PWID attending community-based drug treatment centers for people with opioid dependence in Norway. Incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained, compared against a conventional (€70 000/QALY) willingness-to-pay threshold for Norway and lower (€20 000/QALY) threshold common among high-income countries. Integrated treatment resulted in an ICER of €13 300/QALY gained, with 99% and 71% probability of being cost-effective against conventional and lower willingness-to-pay thresholds, respectively. A 30% lower DAA price reduced the ICER to €6 900/QALY gained, with 91% probability of being cost-effective at the lower willingness-to-pay threshold. A 60% and 90% lower DAA price had 36% and >99% probability of being cost-saving, respectively. Sensitivity analyses suggest integrated treatment was cost-effective at the lower willingness-to-pay threshold (>60% probability) across different assumptions on HCV treatment and disease care costs with 30% DAA price reduction, and became cost-saving with 60%-90% price reductions. Integrated hepatitis C virus treatment for people who inject drugs in community settings is likely cost-effective compared with standard-of-care referral pathways in Norway and may be cost-saving in settings with particular characteristics.

Relationship between the Prevalence of Glaucoma (Estimated Through Prescribed Antiglaucomatous Medication) and Access to Ophthalmologists in Norway

Purpose The relationship between supply and demand in health-care is a challenge. The purpose of the present study is to evaluate to what extent glaucoma prevalence is influenced by local access to eye health-care service in Norway. Methods Population-based cross-sectional study. Data from The Norwegian Prescription Database was used to find the number of users of topical glaucoma medication, grouped by age and county, giving an estimate of glaucoma prevalence. The number of registered ophthalmologists and opticians was obtained from The Norwegian Society of Ophthalmologists and The Norwegian Directorate of Health. Results In total, 75733 persons were treated with IOP-lowering drugs in Norway in 2018, suggesting an overall glaucoma prevalence of 1.43%. In the age group 70-89 years, the nationwide prevalence was 7.60%, the lowest prevalence being in Oppland (5.98%) and highest in Aust-Agder (9.28%) counties. The number of ophthalmologists per 100000 inhabitants varied from 2.63 to 14.65 in the various counties. A statistically significant correlation was found between glaucoma prevalence in the age group 70-89 years and access to ophthalmological services. Furthermore, the increase in glaucoma prevalence plateaus at roughly 10 ophthalmologists per 100000 inhabitants, indicating that this could cover population demands. This relationship did not apply for opticians. Conclusions There is a clear correlation between glaucoma prevalence and availability of ophthalmologists in various counties in Norway. Our study indicates a direct relationship between the number of ophthalmologists in the area and the number of people being treated for glaucoma, with prevalence plateauing once a threshold of approximately 10 ophthalmologists per 100000 inhabitants is reached. This finding suggests that low glaucoma prevalence in some regions could be due to limited access to ophthalmological services.

Gaps and discontinuation of statin treatment in Norway: potential for optimizing management of lipid lowering drugs.

In clinical practice, many patients do not reach the recommended treatment targets for LDL-cholesterol levels. We aimed to examine treatment patterns and adherence for patients on lipid lowering drugs in Norway to inform future strategies to improve therapies. We obtained information on all dispensed statins, ezetimibe, and proprotein convertase subtilisin/-kexin 9 (PCSK9) inhibitors 2010-2019 from the Norwegian Prescription Database. Treatment gaps were assessed assuming patients take one tablet per day and were defined to occur if a patient did not refill a prescription when the previous one should have been depleted. Treatment was defined as discontinued when the preceding prescription would have been used and no new subsequent prescription was filled. The mean proportion of days covered (PDC) was calculated by aggregating the total number of tablets dispensed during each calendar year and dividing by 365. Patients 80 years were excluded. A considerable proportion of statin users in Norway had long treatment gaps or discontinuation in treatment. The 19.6% of the patients had treatment gaps of 180 days or more, and 10.8% had gaps or greater than 365 days. Similar results were found for patients on antidiabetics and hypertensives. PDC ranged from 84.9% for simvastatin to 72.2% for ezetimibe (2019). The most common lipid lowering drugs in 2019 were atorvastatin, simvastatin, and ezetimibe. There is a great potential for improving drug adherence and optimizing lipid lowering therapy by switching to more effective statins in greater doses, and more often add ezetimibe and PCSK9 inhibitors to treatment.

THU257 - Cost-effectiveness of integrated treatment for hepatitis C virus among people who inject drugs in Norway: an economic evaluation of the INTRO-HCV trial

THU257 - Cost-effectiveness of integrated treatment for hepatitis C virus among people who inject drugs in Norway: an economic evaluation of the INTRO-HCV trial

A COVID-19 Survey among People Who Use Drugs in Norway.

Background: to combat the COVID-19 pandemic, adherence to COVID-19 recommendations and vaccination against COVID-19 have been important. Among people who use drugs (PWUD), little is known regarding compliance towards COVID-19 recommendations, COVID-19 testing, or attitudes towards COVID-19 vaccination. We aimed to examine these issues in a sample of PWUD. Methods: a cross-sectional study was conducted between January and March 2021. Through users’ organizations and different low-threshold services for substance users, we recruited former drug users and professionals to include participants and perform the interviews. Participants completed an interviewer-administered questionnaire. Any person above 16 years of age who used substances were recruited. Results: 477 Norwegian PWUD participated in the study. The mean age was 43.8 (SD 12.8) years and 77% were males. Thirty-four percent had injected drugs the past four weeks. Alcohol (41%) and cannabis (41%) were the most common drugs used the past four weeks, followed by tranquilizers (37%), central stimulants (35%) and opioids (30%). The majority (90%) had washed their hands frequently, used alcohol sanitizer during the past two weeks, had used face masks, kept one-meter distance to other people and stayed at home if feeling unwell. Fifty-four percent had been COVID-19 tested. More than half the sample (58%) had positive attitudes to COVID-19 vaccination, while 26% were fairly or very unlikely to accept vaccination. Those older (OR = 0.96, 95% CI 0.94; 0.98) and using face masks (OR = 0.49, 95% CI 0.30; 0.79) were more likely to have positive attitudes towards vaccination, while those reporting low life-satisfaction (OR = 3.86, 95% CI 1.43; 10.40), using opioids (OR = 2.97, 95% CI 1.43; 6.18) or almost never staying at home when feeling unwell (OR = 2.76, 95% 1.39; 5.45) expressed more negative attitudes towards vaccination. Conclusion: there was generally a high compliance towards COVID-19 recommendations, but one quarter of the sample was sceptical towards COVID-19 vaccination. This indicates a need for targeted and tailored information and well-designed vaccination roll-out programs to reach all PWUD.

Survival trends for patients with primary metastatic prostate cancer before and after the introduction of new antitumor drugs.

During the past two decades, new antitumor drugs (Abiraterone, Enzalutamide, Radium-223, Cabazitaxel, and Docetaxel) have been introduced for treatment of prostate cancer with distant metastases (mPCa). Each drug have demonstrated a survival gain in studies, but little is known about the impact in a general population of mPCa patients. In this study we assessed survival before and after introduction of the new drugs for Norwegian mPCa patients. Survival was assessed in 5542 patients with primary mPCa. The patients were diagnosed between 2004 and 2018, identified in the Norwegian Cancer Registry. We also analyzed a subgroup of 2738 patients possibly eligible for treatment with new drugs (age <80 years, WHO performance status ≤2 and not dead within 3 months from diagnosis). We estimated overall (OS) and cause-specific survival (CSS) across three diagnostic time periods reflecting to the drugs' introduction in Norway: Before (2004-2009), "in between" (2010-2014) and after the introduction (2015-2018). We used Kaplan-Meier survival analysis and multivariable Cox regression. Median OS increased from 2.3 years in 2004-2009 to 3.3 years in 2015-2018. 3-year OS improved from 41% in 2004-2009 to 51% in 2015-2018. An earlier diagnostic period, a more advanced T stage, higher ISUP grade group, lower WHO status and higher PSA levels were associated with a lower CSS. Similar results was found for the subgroup. Median OS of mPCa has increased by one year since 2004 for mPCa patients in Norway. Survival improvement persisted after adjustment for recognized prognostic factors and may be related to the introduction of new drugs in Norway.

Consumption of oral anticancer drugs in Norway compared by different units of measurements – introduction of new DDDs

Background: Antineoplastic agents (ATC group L01) have not been assigned DDDs due to highly interindividualvariation in dosages. Consumption data has therefore been presented in other measurement units such as grams of active ingredient. However, the protein kinase inhibitors (PKIs) are a rapidly growing drug group that was introduced to the market recently and are administered orally in a fixed dose. DDDs were therefore established for the PKIs in 2020. In this study we aim to assess whether the newly assigned DDDs would better express drug utilisation patterns in Norway than the current units of measurement.Methods: Sales data for PKIs (ATC level L01E) by grams, cost, units and packages for 2019 were collectedfrom the Norwegian Drug Wholesales Statistics and data on number of prescriptions and prevalence for 2019were collected from the Norwegian Prescription Database (NorPD). DDDs were calculated by applying thevalues of the new DDDs.Results: The proportions of the different substances varied according to the unit of measurement. DDDs andpackages had the highest similarity and correlated better than grams with the prevalence of use in theNorwegian population. BCR-ABL tyrosine kinase inhibitors was the largest group accounting for 31% ofthe total consumption (DDD/1000 inhabitants/day) and imatinib was the most sold PKI in all units of measurement except cost.Conclusions: Using an international agreed unit of measurement gives reliability to the study result. Assignment of DDDs to PKIs will improve the quality of drug utilisation studies in this area.

From disease to criminality – changes in how substance dependency is viewed.

The policy on drug use is currently undergoing significant change. This article examines how the view of addiction to illegal drugs changed in the first 30 years after the advent of 'the drug problem' in Norway. We performed a search in Oria, bokhylla.no and various databases on the history of illegal drugs in Norway, with an emphasis on the period from 1960-90, with white papers from 1976 and 1986. Until the mid-1960s, Norway had very few opiate abusers. This generally concerned abuse of medically prescribed drugs, and was perceived as an internal problem for the health services. The youth counterculture in the late 1960s brought the recreational use of illegal substances to Norway, leading to major concern on the part of the public authorities. 'The drug problem' was now perceived as a significant societal problem, with social and societal causal explanations, and was therefore the subject of a white paper (1976). The next white paper (1986) put forward the ideal of a 'drug-free society' for the first time, with the purpose of general deterrence and strict sentencing as important instruments. From the early 1960s until the late 1980s, the 'drug problem' was perceived in different ways. At the start of the period, it was formulated primarily as a medical problem. From the late 1960s, it was seen first and foremost as a social problem caused by changes in society, whereas from the late 1970s until the late 1980s, control measures constituted the most important instrument to address the problem.

Addiction Lives: Ingeborg Rossow.

Addiction Lives: Ingeborg Rossow.

Utilisation and polypharmacy aspects of antiepileptic drugs in elderly versus younger patients with epilepsy: A pharmacoepidemiological study of CNS-active drugs in Norway, 2004-2015

Background and purposeMany patients with epilepsy use antiepileptic drugs (AEDs) in combination. The elderly is a vulnerable group regarding polypharmacy. The purpose of this study was to investigate changes in utilisation of AEDs, and the extent of polypharmacy with other CNS-active drugs in elderly versus younger patients in Norway. MethodsThis pharmacoepidemiological study included all prescriptions of antiepileptic, antidepressant and antipsychotic drugs from Norwegian pharmacies in the Norwegian Prescription Database (NorPD) (2004-2015). Variables included number of patients, utilisation in defined daily doses, age, gender, and diagnosis specific reimbursement codes for AEDs. ResultsThe use of AEDs has increased in all age groups in this population-based study in Norway. In the elderly, AEDs used in neuropathic pain (mainly gabapentin and pregabalin) have increased more than 10-fold (from 0.7 to 9.6 DDDs/1000 elderly/day, 2004-2015), while the prevalence of users is four times more than in younger patients. Polypharmacy between antiepileptic, antidepressant and antipsychotic drugs occurred in 35% of elderly and 38% of younger patients with epilepsy. The use of enzyme-inducers was common, and occurred more often in elderly patients. A total of 42 different interactions that may have clinical implications were identified among these drugs. ConclusionThe use of AEDs in elderly compared to younger patients is increasing, especially in neuropathic pain. Polypharmacy with antiepileptic, antidepressant and/or antipsychotic drugs was documented in more than one third of the patients. Awareness of increased drug utilisation, polypharmacy with potential drug interactions, and focus on elderly patients are important for increased patient safety.

Modelling the burden of hepatitis C infection among people who inject drugs in Norway, 1973\u20132030

BackgroundLack of Hepatitis C virus (HCV) incidence data in (Norwegian) high-risk groups impedes the ability to make informed decisions on prevention measures. Thus we rely on modelling to estimate the incidence and burden of HCV infections.MethodsWe constructed a compartmental model for HCV infections in Norway among active and former people who inject drugs (PWIDs). We based yearly transition rates on literature. The model was fitted to absolute numbers of hepatitis C associated cirrhosis, hepatocellular carcinoma (HCC) and death from national data sources (2000–2013). We estimated the number (95%CI) of HCV infections, cirrhosis, HCC and death and disability adjusted life years (DALYs) due to HCV infections in Norway, 1973–2030. We assumed treatment rates in the projected period were similar to those in 2013.ResultsThe estimated proportion of chronic HCV (including those with cirrhosis and HCC) among PWIDs was stable from 2000 (49%; 4441/9108) to 2013 (43%; 3667/8587). We estimated that the incidence of HCV among PWIDs was 381 new infections in 2015. The estimated number of people with cirrhosis, HCC, and liver transplant was predicted to increase until 2022 (1537 people). DALYs among active PWIDs estimated to peak in 2006 (3480 DALYs) and decrease to 1870 DALYs in 2030. Chronic HCV infection contributes most to the total burden of HCV infection, and peaks at 1917 DALYs (52%) in 2007. The burden of HCV related to PWID increased until 2006 with 81/100,000 DALYs inhabitants and decreased to 68/100,000 DALYs in 2015.ConclusionThe burden of HCV associated with injecting drug use is considerable, with chronic HCV infection contributing most to the total burden. This model can be used to estimate the impact of different interventions on the HCV burden in Norway and to perform cost-benefit analyses of various public health measures.

Psychotropic drug use among 0-17 year olds during 2004-2014: a nationwide prescription database study.

BackgroundTime-trend studies on psychotropic drugs among children and adolescents are scarce, and most of them are outdated. The purpose of this study was to study prevalences of psychotropic drug use during 2004–2014 among Norwegians aged <18 years, overall and in psychotropic sub-groups.MethodsData were obtained from the Norwegian Prescription Database, which covers all dispensed prescription drugs in Norway from 2004 and onwards. Psychotropic drugs included: antipsychotics (ATC-group N05A), anxiolytics (N05B), hypnotic/sedatives (N05C), antidepressants (N06A), stimulants (N06BA), and alimemazine (R06AD01). Period (1-year) prevalence of use, overall and in subgroups of psychotropic drugs, was estimated by identifying individuals <18 years who had at least one psychotropic drug dispensed during each year.ResultsPsychotropic drug use increased in 0–17 year olds over an 11-year period, in which the main contributing drugs were stimulants (boys overall; 15.0 to 20.8/1000, girls overall; 3.8 to 8.5/1000), hypnotic/sedative drugs in adolescents (boys overall; 4.2 to 10.8/1000, girls overall; 2.6 to 8.8/1000) and to some extent antidepressants among adolescent girls (girls overall from 3.1 to 4.0/1000). Psychotropic drug use was, however, reduced by half in the youngest children, attributed to reduction of alimemazine only (1-year olds: boys; from 36.6 to 10.2/1000, girls; 26.9 to 7.2/1000). A higher level of psychotropic drug use was observed among younger boys, but there is a shift towards girls using more psychotropic drugs than boys during adolescence for all psychotropic drugs except for stimulants.ConclusionDifferent trends in psychotropic drug use exist in age and gender subgroups. Psychotropic drug use has decreased among the youngest children, attributed to alimemazine, and increased in older children and adolescents, attributed mainly to stimulants and hypnotics/sedatives.

Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study

Background A wide range of antithrombotic medications can be used in the prevention and treatment of thrombosis. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage may have particularly devastating consequences with high morbidity, disability and mortality rates. The incidence and risks of intracranial hemorrhage in patients on antithrombotic treatments from regular clinical practice outside clinical trials remain largely unknown. It is not known if results from clinical trials can be extrapolated to everyday clinical practice. We will conduct a nationwide study to investigate the risks and incidence rates of intracranial hemorrhage in users oral antithrombotic drugs in Norway from 2008 through 2014. Methods and design The aim of this nationwide study is to investigate the incidence rates of intracranial hemorrhage requiring hospitalization in users of oral antithrombotic drugs. The study will be conducted within the approximately 4.7 million inhabitants of Norway from January 1 st, 2008, to December 31 st, 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database. Trial registration number Clinicaltrials.gov (NCT02481011)

Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study

BackgroundA wide range of antithrombotic medications can be used in the prevention and treatment of thrombosis. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage may have particularly devastating consequences with high morbidity, disability and mortality rates. The incidence and risks of intracranial hemorrhage in patients on antithrombotic treatments from regular clinical practice outside clinical trials remain largely unknown. It is not known if results from clinical trials can be extrapolated to everyday clinical practice. We will conduct a nationwide study to investigate the risks and incidence rates of intracranial hemorrhage in users oral antithrombotic drugs in Norway from 2008 through 2014. Methods and designThe aim of this nationwide study is to investigate the incidence rates of intracranial hemorrhage requiring hospitalization in users of oral antithrombotic drugs. The study will be conducted within the approximately 4.7 million inhabitants of Norway from January 1 (st), 2008, to December 31 (st), 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database. Trial registration numberClinicaltrials.gov (NCT02481011).