Search

Kidney transplant recipients (KTRs) experience increased risk of cardiovascular disease. Guidelines recommend HMG-CoA reductase inhibitor (statin) therapy when tolerated. We aimed to study changes in the prescription of statins and patients’ adherence to treatment over time. A population-based observational study utilizing linked data from the Norwegian Renal Registry (national coverage of 99.9%) and the Norwegian Prescription Database was performed. Data from a total of 2250 first KTRs were included (mean age—54 years, 69% men). Dispensed prescriptions of statins and immunosuppressants for the period 2004–2016 for all first KTRs engrafted in the period 2005–2015 were analyzed. Seventy-two percent received statins the first year after kidney transplantation and the proportion increased with age. The proportion receiving a statin varied according to the time frame of transplantation (77% in 2005–2010 vs. 66% in 2012–2015). Among new users of statins, 82% of the patients were adherent both the second and third year after kidney transplantation, while the corresponding figure for those already receiving statins before transplantation was 97%. Statin continuation rates in KTRs were high. In conclusion, our findings show a slightly lower overall proportion of patients receiving statins after kidney transplants than the national target level of 80%. The proportion of statin users increased with the age of the KTRs but showed a decreasing trend as time progressed.

Objectives To investigate whether infants exposed to antimicrobials in hospital during the first 3 months of life had an increased risk of ambulatory antimicrobial use during the following year compared with infants not exposed to antimicrobials during the first 3 months of life. Methods Norwegian cohort study of infants less than 3 months consisting of one group exposed to antimicrobials recruited during hospitalization and one group not exposed to antimicrobials. Ten unexposed infants were matched with one exposed infant according to county of residence, birth year and month, and sex. The Norwegian Prescription Database was applied to register antimicrobial use from the month after discharge and 1 year onward. We defined comorbidity based on antimicrobials prescribed as reimbursable prescriptions due to underlying diseases. Results Of 95 infants exposed to antimicrobials during the first 3 months of life, 23% had recurrent use compared with 14% use in 950 unexposed infants [relative risk (RR) = 1.7 (95% CI = 1.1–2.5) and comorbidity-adjusted RR = 1.4 (95% CI = 0.9–2.2)]. The recurrence use rate in exposed term infants (≥37 weeks, n = 70) was 27% compared with 12% in their unexposed matches [RR 2.3 = (95% CI = 1.4–3.7) and comorbidity-adjusted RR = 1.9 (95% CI = 1.2–3.2). Of 25 exposed preterm infants, 3 (12%) had recurrent use. The total antimicrobial prescription rate was 674/1000 in the exposed group and 244/1000 in the unexposed group [incidence rate ratio = 2.8 (95% CI = 1.6–4.9)]. Conclusions Infants exposed to antimicrobials during the first 3 months of life had an increased risk of recurrent use during the following year. This increased risk also appeared in term infants without infection-related comorbidity.

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.

Objectives Data on cephalosporin consumption in the community were collected from 30 EU/EEA countries over two decades. This article reviews temporal trends, seasonal variation, presence of change-points and changes in the composition of the main subgroups of cephalosporins. Methods For the period 1997–2017, data on consumption of cephalosporins (i.e. first-, second-, third- and fourth-generation cephalosporins; ATC subgroups J01DB, J01DC, J01DD and J01DE, respectively) in the community and aggregated at the level of the active substance, were collected using the WHO ATC/DDD methodology (ATC/DDD index 2019). Consumption was expressed in DDD per 1000 inhabitants per day and in packages per 1000 inhabitants per day. Cephalosporin consumption was analysed based on ATC-4 subgroup, and presented as trends, seasonal variation, presence of change-points and compositional changes. Results In 2017, cephalosporin consumption in the community expressed in DDD per 1000 inhabitants per day varied by a factor of 285 between countries with the highest (Greece) and the lowest (the Netherlands) consumption. Cephalosporin consumption did not change significantly between the first quarter of 1997 and the last quarter of 2017. Seasonal variation decreased significantly over time. Proportional consumption of second- and third-generation cephalosporins significantly increased over time compared with that of first-generation cephalosporins, and proportional consumption of fourth-generation cephalosporins significantly decreased compared with that of second- and third-generation cephalosporins. Conclusions Despite considerable variation between countries in the composition of cephalosporin consumption and trends over time, a significant shift towards consumption of more broad-spectrum cephalosporins in the community was observed across the EU/EEA during 1997–2017.

Objectives Data on the consumption of macrolides, lincosamides and streptogramins (MLS) in the community were collected from 30 EU/European Economic Area (EEA) countries over two decades. This article reviews temporal trends, seasonal variation, presence of change-points and changes in composition of the main subgroups of MLS. Methods For the period 1997–2017, data on consumption of MLS, i.e. ATC group J01F, in the community and aggregated at the level of the active substance, were collected using the WHO ATC/DDD methodology (ATC/DDD index 2019). Consumption was expressed in DDD per 1000 inhabitants per day and in packages per 1000 inhabitants per day. Consumption of MLS was analysed and presented as trends, seasonal variation, presence of change-points and compositional changes, using a classification based on mean plasma elimination half-life for macrolides. Results In 2017, consumption of MLS in the community expressed in DDD per 1000 inhabitants per day varied by a factor of 13 between countries with the highest (Greece) and the lowest (Sweden) consumption. Consumption of MLS did not change significantly up to 2003, after which it significantly increased up to 2007. No significant change was observed after 2007. Consumption of MLS showed high seasonal variation. The proportional consumption of long-acting macrolides significantly increased over time compared with that of intermediate-acting macrolides, and proportional consumption of the latter increased compared with that of short-acting macrolides. Conclusions Consumption of MLS did not change significantly over time during 2007–2017, while the proportional consumption of long-acting macrolides increased. Seasonal variation remained high, which suggests that MLS are still prescribed inappropriately in many countries.

Background/Aims: The aim was to study the prevalence of use of different drugs prescribed for behavioral and psychological symptoms of dementia in persistent users of acetylcholinesterase inhibitors (AChEIs) before and after AChEI initiation, and to compare with the use in the general population. Methods: Use of antidepressants, antipsychotics, and analgesics in the 4 years before and 2 years after AChEI initiation was studied based on data from the Norwegian Prescription Database 2004–2016. Results: The prevalence of use of antidepressants and antipsychotics the year before AChEI initiation was twice the prevalence in the age-adjusted general population and continued to rise in the first 2 years after initiation of AChEIs. The prevalence of weak analgesics and antipsychotics increased strongly in the last year before AChEI initiation. The increase in the use of antidepressants started at least 4 years before initiation of AChEIs. Opioid use was generally lower than in the general population and was not influenced by AChEI initiation. Conclusion: Increased use of antidepressants and antipsychotics was observed both before and after initiation of AChEIs and may indicate that behavioral symptoms occur in a preclinical or early phase of Alzheimer’s disease. The prescription pattern of analgesics with a low use of opioids may indicate an undertreatment of pain in people with dementia.

Background Clinical activities provided by pharmacists are increasing worldwide, including Europe. However, an overview of clinical pharmacy education and practice is needed. Objective To map clinical pharmacy (CP) education and practice among European countries. Setting: Web-based survey led by the Education Committee of the European Society of Clinical Pharmacy (ESCP). Method Cross-sectional study resorted to a survey sent to ESCP members. The survey comprised three domains focusing on: undergraduate education, postgraduate education, and practice. A multi-phased validation process was undertaken, attributing levels of evidence according to the number of information sources for each country. Triangulation was used to seek within country consensus. Student perceptions on their preparedness to engage in CP and adequacy of learning methods were also explored via the European Pharmaceutical Students' Association (EPSA), representing students from 37 countries. Main outcome measures Number of hours of education in clinical pharmacy; existence of a specialization in clinical pharmacy and activities delivered in practice.Results Data from 40 European countries were included (response rate 95.2%). Most respondents (86.8%) agreed with the definition of CP proposed by the ESCP. Almost every country (94.9%) reported to have CP topics integrated at the undergraduate level [median number=65 hours/semester (IQR: 2.0-5.6)], including practical teaching [median=30.0% (IQR: 17.0-42.0)]. Students from 16 countries were unanimous stating CP practical training to be insufficient and only in one country CP education was perceived as totally fit for practice. At the postgraduate level, 92.5% of countries have PhD programmes including CP and 65.0% specific CP master/diploma degrees. Continuous professional development (CPD) courses were also reported by 63.9% of respondents. More than half of countries (52.5%; n=21) recognize CP as an area of specialization, which for 60.0% of countries is applied solely in the hospital setting. Conclusion Although CP is embedded in education and practice in European countries, students experience a lack of practical training hampering job readiness. Education in CP should be adapted and tailored towards the skills and competences required in practice.

Interest has been shown in the use of antibiotics during the COVID-19 pandemic. In this article we present the consumption of systemic antibiotics in Norway during the period of the pandemic.Total sales of systemic antibiotics in defined daily doses (DDD) were retrieved from the wholesaler-based medicinal product statistics for 2019 and 2020, and sales of antibiotics for use outside of healthcare institutions were retrieved from the Norwegian prescription database. Information was retrieved on the proportion of users (prevalence), doses (measured in DDD) and prescriptions.Total sales of systemic antibiotics increased in March 2020, but sales to persons outside of healthcare institutions did not. Compared to previous years, both total consumption and use of antibiotics outside of institutions fell steeply in the months that followed. The reduction was greatest for antibiotics against respiratory infections and in the youngest age groups.The significant reduction in the use of systemic antibiotics during the COVID-19 pandemic is attributed to infection control measures and reduced contact with the health service. In 2016, the Norwegian government set a goal for a 30 % reduction in antibiotic use by the end of 2020. The pandemic has contributed to the achievement of that goal.

Objectives This article introduces a series of articles on antibiotic consumption in the community between 1997 and 2017, which provide an update of previous articles covering the periods 1997–2003 and 1997–2009. Methods In this article, differences in participating countries, the ATC/DDD classification system, and data collection, validation and analysis between the current and previous series are described. Results In the previous series, 33 European countries provided valid data for further analysis, while the current series focused on 30 countries belonging to the EU or the European Economic Area (EEA). For both series, data were collected in accordance with the WHO ATC classification system. While the previous series reported data in accordance with the ATC/DDD index 2011, the current series employed the ATC/DDD index 2019. Both series focused on consumption of antibacterials for systemic use (ATC J01) and collected data expressed in DDD per 1000 inhabitants per day and packages per 1000 inhabitants per day. When studying consumption expressed in packages per 1000 inhabitants per day, countries reporting total care data, i.e. community and hospital sector combined, were included in the previous series but excluded in the current series. While the previous series used non-linear mixed models to evaluate time trends in antibiotic consumption, the current series allowed for inclusion of change-points with a data-driven location. In addition, both series assessed the composition and quality of antibiotic consumption in the EU/EEA. Conclusions The updated analyses of two decades of ESAC-Net data provide the most comprehensive and detailed description of antibiotic consumption in the community in Europe.

BackgroundColorectal cancer (CRC) screening reduces CRC incidence and mortality. However, current screening methods are either hampered by invasiveness or suboptimal performance, limiting their effectiveness as primary screening methods. To aid in the development of a non-invasive screening test with improved sensitivity and specificity, we have initiated a prospective biomarker study (CRCbiome), nested within a large randomized CRC screening trial in Norway. We aim to develop a microbiome-based classification algorithm to identify advanced colorectal lesions in screening participants testing positive for an immunochemical fecal occult blood test (FIT). We will also examine interactions with host factors, diet, lifestyle and prescription drugs. The prospective nature of the study also enables the analysis of changes in the gut microbiome following the removal of precancerous lesions.MethodsThe CRCbiome study recruits participants enrolled in the Bowel Cancer Screening in Norway (BCSN) study, a randomized trial initiated in 2012 comparing once-only sigmoidoscopy to repeated biennial FIT, where women and men aged 50–74 years at study entry are invited to participate. Since 2017, participants randomized to FIT screening with a positive test result have been invited to join the CRCbiome study. Self-reported diet, lifestyle and demographic data are collected prior to colonoscopy after the positive FIT-test (baseline). Screening data, including colonoscopy findings are obtained from the BCSN database. Fecal samples for gut microbiome analyses are collected both before and 2 and 12 months after colonoscopy. Samples are analyzed using metagenome sequencing, with taxonomy profiles, and gene and pathway content as primary measures. CRCbiome data will also be linked to national registries to obtain information on prescription histories and cancer relevant outcomes occurring during the 10 year follow-up period.DiscussionThe CRCbiome study will increase our understanding of how the gut microbiome, in combination with lifestyle and environmental factors, influences the early stages of colorectal carcinogenesis. This knowledge will be crucial to develop microbiome-based screening tools for CRC. By evaluating biomarker performance in a screening setting, using samples from the target population, the generalizability of the findings to future screening cohorts is likely to be high.Trial registrationClinicalTrials.govIdentifier:NCT01538550.

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 to 406%)—aztreonam, cefpodoxime, ciprofloxacin, levofloxacin, ofloxacin—and decreased for one drug: cefdinir. These changes were sustained two years after. Cefprozil, cefuroxime axetil and clarithromycin had significant increases in trend, but no significant level changes. No consistent pattern for antibiotic use following generic entry in the United States was observed., Generics contribute to increased availability of antibiotics, benefiting healthcare systems but potentially leading to increased consumption with implications for antibiotic stewardship and resistance. Here, the authors found no consistent changes in prescribing patterns of the 13 antibiotics that entered the US market as generics from 2000–2012.

Background Interest has been shown in the use of antibiotics during the COVID-19 pandemic. In this article we present the consumption of systemic antibiotics in Norway during the period of the pandemic. Material and method Total sales of systemic antibiotics in defined daily doses (DDD) were retrieved from the wholesaler-based medicinal product statistics for 2019 and 2020, and sales of antibiotics for use outside of healthcare institutions were retrieved from the Norwegian prescription database. Information was retrieved on the proportion of users (prevalence), doses (measured in DDD) and prescriptions. Results Total sales of systemic antibiotics increased in March 2020, but sales to persons outside of healthcare institutions did not. Compared to previous years, both total consumption and use of antibiotics outside of institutions fell steeply in the months that followed. The reduction was greatest for antibiotics against respiratory infections and in the youngest age groups. Interpretation The significant reduction in the use of systemic antibiotics during the COVID-19 pandemic is attributed to infection control measures and reduced contact with the health service. In 2016, the Norwegian government set a goal for a 30 % reduction in antibiotic use by the end of 2020. The pandemic has contributed to the achievement of that goal.

Objectives This tutorial describes and illustrates statistical methods to detect time trends possibly including abrupt changes (referred to as change-points) in the consumption of antibiotics in the community. Methods For the period 1997–2017, data on consumption of antibacterials for systemic use (ATC group J01) in the community, aggregated at the level of the active substance, were collected using the WHO ATC/DDD methodology and expressed in DDD (ATC/DDD index 2019) per 1000 inhabitants per day. Trends over time and presence of common change-points were studied through a set of non-linear mixed models. Results After a thorough description of the set of models used to assess the time trend and presence of common change-points herein, the methodology was applied to the consumption of antibacterials for systemic use (ATC J01) in 25 EU/European Economic Area (EEA) countries. The best fit was obtained for a model including two change-points: one in the first quarter of 2004 and one in the last quarter of 2008. Conclusions Allowing for the inclusion of common change-points improved model fit. Individual countries investigating changes in their antibiotic consumption pattern can use this tutorial to analyse their country data.

Objectives The quality of antibiotic consumption in the community can be assessed using 12 drug-specific quality indicators (DSQIs) developed by the European Surveillance of Antimicrobial Consumption (ESAC) project. We compared quality in 2009 and 2017 in the EU/European Economic Area (EEA) and evaluated the impact of using different DDD values (ATC/DDD indices 2011 and 2019) for the 2009 quality assessment using these DSQIs and a joint scientific opinion (JSO) indicator. Methods We calculated the 12 DSQIs and the JSO indicator for 2017 and for 2009 for EU/EEA countries able to deliver values. For each of the indicators we grouped the 2017 and 2009 indicator values into four quartiles. To evaluate changes in quality between 2009 and 2017, we used the quartile distribution of the 2009 indicator values in 30 EU/EEA countries as benchmarks. In addition, we compared the quality assessment for 2009 using the ATC/DDD indices 2011 and 2019. Results In 2017, a difference in the quality of antibiotic consumption in the community between northern and southern EU/EEA countries remained, but also several eastern EU/EEA countries shifted towards lower quality. Quality of antibiotic consumption decreased between 2009 and 2017 in particular indicator values for penicillin, quinolone, relative β-lactam and broad- versus narrow-spectrum antibiotic consumption, and seasonal variation. Using different ATC/DDD indices did not substantially change countries’ ranking based on their DSQI values. Conclusions The quality of antibiotic consumption in the community as measured by the DSQIs further decreased between 2009 and 2017, especially in Southern and Eastern European countries. A continuous effort to improve antibiotic consumption is essential to reduce antibiotic consumption in general and the use of broad-spectrum antibiotics in particular.

The use of quinolones is subject to strict conditions, in part because of their known tendency to drive antimicrobial resistance. Use of quinolones in Norwegian hospitals increased dramatically from their launch in the 1980s to a peak in 2012. Since then, usage has decreased and had almost halved by 2019. However, little information is available on whether the use of quinolones in hospitals is in accordance with national guidelines.This study included inpatients over 12 years of age who were prescribed quinolones at a local hospital in the Central Norway Regional Health Authority in the period 1 September-31 December 2018. An expert group of infectious disease specialists evaluated the use of quinolones against the national guidelines for the use of antibiotics in hospitals.The use of ciprofloxacin was considered to have been inconsistent with therapeutic recommendations in 45 out of 49 (92 %) inpatient stays in the medical, surgical and orthopaedic departments.In a local hospital, ciprofloxacin was used all too frequently for indications outside those recommended in the Norwegian guidelines.

Background In order to change antibiotic prescribing behaviour, we need to understand the prescribing process. The aim of this study was to identify targets for antibiotic stewardship interventions in hospitals through analysis of the antibiotic prescribing process from admission to discharge across five groups of infectious diseases. Methods We conducted a multi-centre, observational cohort study, including patients with lower respiratory tract infections, exacerbation of chronic obstructive pulmonary disease, skin- and soft tissue infections, urinary tract infections or sepsis, admitted to wards of infectious diseases, pulmonary medicine and gastroenterology at three teaching hospitals in Western Norway. Data was collected over a 5-month period and included antibiotics prescribed and administered during admission, antibiotics prescribed at discharge, length of antibiotic therapy, indication for treatment and discharge diagnoses, estimated glomerular filtration rate (eGFR) on admission, antibiotic allergies, place of initiation of therapy, admittance from an institution, patient demographics and outcome data. Primary outcome measure was antibiotic use throughout the hospital stay, analysed by WHO AWaRe-categories and adherence to guideline. Secondary outcome measures were a) antibiotic prescribing patterns by groups of diagnoses, which were analysed using descriptive statistics and b) non-adherence to the national antibiotic guidelines, analysed using multivariate logistic regression. Results Through analysis of 1235 patient admissions, we identified five key targets for antibiotic stewardship interventions in our population of hospital inpatients; 1) adherence to guideline on initiation of treatment, as this increases the use of WHO Access-group antibiotics, 2) antibiotic prescribing in the emergency room (ER), as 83.6% of antibiotic therapy was initiated there, 3) understanding prescribing for patients admitted from other institutions, as this was significantly associated with non-adherence to guideline (OR = 1.44 95% CI 1.04, 2.00), 4) understanding cultural and contextual drives of antibiotic prescribing, as non-adherent prescribing differed significantly between the sites of initiation of therapy (between hospitals and ER versus ward) and 5) length of therapy, as days of antibiotic therapy was similar across a wide range of diagnoses and with prolonged therapy after discharge. Conclusions Analysing the process of antibiotic prescribing in hospitals with patient-level data identified important targets for antibiotic stewardship interventions in hospitals.

Background The use of quinolones is subject to strict conditions, in part because of their known tendency to drive antimicrobial resistance. Use of quinolones in Norwegian hospitals increased dramatically from their launch in the 1980s to a peak in 2012. Since then, usage has decreased and had almost halved by 2019. However, little information is available on whether the use of quinolones in hospitals is in accordance with national guidelines. Material and method This study included inpatients over 12 years of age who were prescribed quinolones at a local hospital in the Central Norway Regional Health Authority in the period 1 September-31 December 2018. An expert group of infectious disease specialists evaluated the use of quinolones against the national guidelines for the use of antibiotics in hospitals. Results The use of ciprofloxacin was considered to have been inconsistent with therapeutic recommendations in 45 out of 49 (92 %) inpatient stays in the medical, surgical and orthopaedic departments. Interpretation In a local hospital, ciprofloxacin was used all too frequently for indications outside those recommended in the Norwegian guidelines.

Objective: To describe epidemiology and antimicrobial susceptibility testing (AST) data of bacteria causing invasive infections in Norwegian children (0–18 years). Methods: Population-based observational study using prospectively collected AST data from the Norwegian Surveillance System of Antimicrobial Resistance from 2013 to 2017. We included all clinically relevant bacterial isolates (blood and cerebrospinal fluid), and compared incidence of invasive infections and AST data in isolates from children and adults. Results: We included 1173 isolates from children and 44,561 isolates from adults. Staphylococcus aureus accounted for 220/477 (46.2%, 95% CI: 41.6–50.7) of all isolates in schoolchildren (6–18 years). Compared with Streptococcus pneumonia isolates from adults (N = 2674), we observed higher nonsusceptibility rates to penicillin in isolates from children (N = 151), 11.9% versus 5.8%, P < 0.01; also higher resistance rates to erythromycin (11.3% vs. 4.9%, P < 0.01), clindamycin (9.3% vs. 3.6%, P < 0.001), and trimethoprim/sulfamethoxazole (17.9% vs. 6.4%, P < 0.001). Compared with Escherichia coli isolates in adults (N = 9073), we found lower rates of ESBL in isolates from children (N = 212), 2.4% versus 6.4%, P < 0.05. Conclusion: The study indicates the importance of microbiologic surveillance strategies in children and highlights the need for pediatric AST data. The high rates of nonsusceptibility to commonly used antibiotics among S. pneumoniae in children and the high burden of invasive S. aureus infections in schoolchildren calls for modifications of Norwegian guidelines.

Background/aims The aim was to explore the impact of sex on prevalence, patterns and trends in the prescription of psychotropics and analgesics in users of acetylcholinesterase inhibitors (AChEIs), before and after AChEI initiation, compared to the general population. Methods A prospective study applying data from the Norwegian Prescription Database (NorPD) in the period 2004–2016. Prescription of antidepressants, antipsychotics, analgesics including opioids, benzodiazepines and z-hypnotics in persistent AChEI users was studied in a follow-up period from four years before to two years after AChEI initiation in men and women of four age groups: 37–64, 65–72, 73–80 and 81–88 years. Results Use of antidepressants, antipsychotics and weaker analgesics increased in both sexes during the follow-up period in 11.764 persistent AChEI users. Women with pre-dementia and dementia stages of AD showed a prescription pattern with more use of psychotropics and opioids than men, except for antipsychotics. Conclusion Female sex showed to have a significant influence on the prescriptions of psychotropics and analgesics in AD patients in a pre-dementia and dementia stage. The exception is for antipsychotics, that men used more than women. The prescription pattern showed a higher extent of polypharmacy of psychotropics and/or opioids in women than in men. The total prescription pattern of analgesics could indicate an undertreatment of pain in pre-dementia and dementia stages, most pronounced in men.

To compare antibiotic treatment failure evaluated as switch from one type of antibiotics to another in ambulatory care.Data on all dispensed doxycycline, amoxicillin, phenoxymethylpenicillin and macrolides in Norway June 2013 - May 2015, was retrieved from the Norwegian Prescription Database. We computed switch rates for the selected antibiotics on day 1-28 after initial dispensing, and the corresponding odds-ratios, adjusted for patients´ age and gender, and prescribers´ specialty.Of 1.860.036 dispensed antibiotics, 103.076 (5.5%) were switched within 28 days. Within 10 days after the index date, the switch rate was highest for phenoxymethylpenicillin (4.1%), followed by amoxicillin (2.5%), macrolides and doxycycline (2.2%).The switch rate after initial dispensing of phenoxymethylpenicillin is higher than that of more broad-spectrum antibiotics. However, it is still low, supporting the recommendation of phenoxymethylpenicillin as first line treatment when an antibiotic is indicated for a respiratory tract infection in primary care.

Background/Aims: Reduced clinical effect on cognitive decline in dementia by acetylcholinesterase inhibitors (AChEIs) may be due to concurrent use of drugs with anticholinergic properties. The aim was to analyze the incidence of AChEI use and comedication with drugs with anticholinergic properties and other potential unfavorable effects. Methods: A prospective study applying drug use data from the Norwegian Prescription Database. Anticholinergic Drug Scale (ADS) scores were used as a measure of overall anticholinergic burden. Results: Patients with high ADS scores were more frequently discontinuing treatment early. Coprescribing of antipsychotics was strongly associated with early discontinuation of AChEI treatment. Conclusion: Coprescribing with potentially unfavorable medications was common. A high ADS score was associated with early discontinuation of treatment.

Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial infection, there is little need for newer, more expensive antibiotics whose therapeutic superiority to existing compounds has not been demonstrated. Since resistance begins to emerge as soon as an antibiotic is used, Norway's practice of leaving newer antibiotics on the shelf is consistent with the goal of prolonging the effectiveness of newer antibiotics. An unintended consequence is that the country has signalled to the private sector that there is little commercial value in novel antibiotics, which may nevertheless still be needed to treat rare or emerging infections. Every country aims to improve infection control and to promote responsible antibiotic use. However, as progress is made, antibiotic-resistant bacteria should become less common and, consequently, the need for, and the commercial value of, novel antibiotics will probably be reduced. Nevertheless, antibiotic innovation continues to be essential. This dilemma will have to be resolved through the introduction of alternative reward systems for antibiotic innovation. The DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) research consortium in Europe has been tasked with identifying ways of meeting this challenge.Nous décrivons ici en détail les procédures d'autorisation de mise sur le marché et de remboursement des médicaments en Norvège, en particulier de neuf nouveaux antibiotiques qui ont reçu une autorisation de mise sur le marché entre 2005 et 2015. Cette description montre que, dans les pays comme la Norvège qui ont adopté des politiques d'utilisation raisonnée des antibiotiques et qui affichent ainsi une faible prévalence d'infections bactériennes résistantes aux antibiotiques, il n'est guère besoin de nouveaux antibiotiques plus coûteux dont la supériorité thérapeutique par rapport aux composés existants n'a pas été démontrée. Étant donné que la résistance apparaît dès que l'on commence à utiliser un nouvel antibiotique, la désaffection de la Norvège pour les nouveaux antibiotiques concorde avec l'objectif d’en prolonger l'efficacité. Conséquence inattendue, le pays a signalé au secteur privé que ces nouveaux antibiotiques ne présentaient qu'un faible intérêt commercial mais qu'ils pourraient cependant être nécessaires pour traiter des maladies infectieuses rares ou nouvelles. Tous les pays souhaitent faire avancer la lutte contre les infections et promouvoir l'utilisation responsable des antibiotiques. Cependant, à mesure qu'ils progresseront, les bactéries résistantes aux antibiotiques devraient devenir moins fréquentes et la nécessité ainsi que l'intérêt commercial de nouveaux antibiotiques devraient par conséquent s'en trouver réduits. L'innovation en matière d'antibiotiques reste toutefois essentielle. Ce dilemme devra être résolu avec l'introduction de systèmes de récompenses alternatifs pour l'innovation dans le domaine des antibiotiques. Le consortium de recherche européen DRIVE-AB (En este documento se detallan los procedimientos de autorización de comercialización y compensación para productos medicinales en Noruega, con especial referencia a nueve antibióticos nuevos que recibieron la autorización de comercialización entre 2005 y 2015. La descripción ilustra que, en lugares como Noruega, que cuentan con políticas eficaces de administración de antibióticos y una prevalencia baja relacionada de infecciones bacterianas resistentes a los antibióticos, hay poca necesidad de antibióticos nuevos más caros cuya superioridad terapéutica respecto a los componentes existentes no ha sido demostrada. Dado que la resistencia comienza a surgir tan pronto como se utiliza un antibiótico, la práctica de Noruega de dejar nuevos antibióticos de lado es coherente con el objetivo de prolongar la eficacia de los nuevos antibióticos. Una consecuencia inesperada es que el país ha explicado al sector privado que los antibióticos nuevos apenas tienen valor comercial, los cuales, sin embargo, pueden ser necesarios para tratar infecciones raras o nuevas. Todos los países tratan de mejorar su control de infecciones y fomentar un uso responsable de los antibióticos. No obstante, conforme se va progresando, las bacterias resistentes a los antibióticos deberían ser cada vez menos comunes y, por tanto, es probable que la necesidad y el valor comercial de los antibióticos nuevos se vean reducidos. Sin embargo, la innovación en el campo de los antibióticos sigue siendo fundamental. Este dilema deberá resolverse mediante la introducción de sistemas de recompensa alternativos por innovar con antibióticos. El consorcio de investigación europeo DRIVE-AB, que fomenta la reinversión en investigación y desarrollo y en el uso responsable de los antibióticos, deberá identificar formas de lograr este objetivo.نتناول بالشرح التفصيلي في هذه الوثيقة إجراءات استرداد التكاليف والحصول على تصريح بتسويق المنتجات الدوائية في النرويج، مع الإشارة على وجه التحديد إلى تسعة أنواع من المضادات الحيوية الجديدة التي تم الحصول على تصريح بتسويقها في الفترة بين عامي 2005 و2015. ويبين هذا الشرح أنه في بعض الأماكن مثل النرويج – حيث تسري سياسات الإشراف على المضادات الحيوية وينخفض ما يرتبط بتلك الأدوية من انتشار للعدوى البكتيرية المقاومة للمضادات الحيوية – تقل الحاجة إلى مضادات حيوية جديدة أغلى سعرًا ولم يظهر دليل على تفوق أثرها عن المركبات الدوائية المتواجدة بالأسواق. ونظرًا لبدء ظهور المقاومة بمجرد استخدام المضاد الحيوي، جاءت الممارسات التي اتبعتها النرويج – والتي تتمثل في التخلي عن المضادات الحيوية الجديدة – متسقةً مع الهدف الرامي إلى إطالة فترة فعالية المضادات الحيوية الجديدة. وأدى ذلك إلى نتيجة غير مقصودة حيث أوضحت النرويج للقطاع الخاص انخفاض القيمة التجارية للمضادات الحيوية الجديدة، والتي قد تظل الحاجة إليها قائمة رغم ذلك لعلاج أنواع العدوى الناشئة أو النادرة. وتسعى كل دولة إلى تحسين مكافحة العدوى وتعزيز الاستخدام المسؤول للمضادات الحيوية، غير أنه، مع المضي قدمًا في سبيل تحقيق ذلك، من المفترض أن يقل شيوع البكتريا المقاومة للمضادات الحيوية، وبالتالي، تظهر احتمالية أن تقل الحاجة إلى المضادات الحيوية الجديدة وأن تنخفض قيمتها التجارية. وبالرغم من ذلك، يظل ابتكار المضادات الحيوية يحتل مكانةً رئيسيةً. ويستلزم الأمر حل هذه المشكلة من خلال توفير نظم بديلة لمنح المكافآت فيما يتعلق بابتكار المضادات الحيوية. وقد تم تكليف اتحاد البحوث في أوروبا DRIVE-AB (القائم على توجيه أنشطة إعادة الاستثمار في مجال البحث والتطوير والاستخدام المسؤول للمضادات الحيوية) بمهمة تحديد سبل مواجهة ذلك التحدي.本文中，我们会特别参考 2005 至 2015 年间获得上市许可的九种新型抗生素，详细地描述挪威医疗产品的上市许可及报销流程。该描述证明，像挪威这样拥有有效抗生素管理政策且耐抗生素细菌感染低相关发病率的地方，几乎不需要对现有化合物治疗优势尚未得到证明的更新、更昂贵的抗生素。 自抗生素使用之初耐药性便开始出现，挪威将新型抗生素束之高阁的做法符合延长新型抗生素效果的目标。 一个意料之外的后果是该国曾向私营部门发出这样的信号：新型抗生素毫无商业价值，但仍可能需要其治疗罕见或新型感染疾病。 每个国家都致力于改善感染控制并促进抗生素的负责任使用。 然而，随着不断进展，耐抗生素细菌感染率应有所减少，并且对新型抗生素的需求及其商业价值也可能会减少。 但是，抗生素的创新仍然至关重要。 这种困境必须通过引进替代性抗生素创新奖励机制进行解决。 位于欧洲的推动对抗生素研发及负责任使用再投资 (DRIVE-AB) 研究联合会已承担起寻找应对该挑战的方法的使命。.Здесь мы подробно описываем процедуры получения регистрационного удостоверения и финансового возмещения для лекарственных средств в Норвегии на примере девяти новых антибиотиков, которые получили регистрационное удостоверение между 2005 и 2015 гг. Описание демонстрирует, что в таких местах, как Норвегия, с эффективной стратегией рационального использования антибактериальных препаратов и со связанной с ней низкой распространенностью устойчивых к антибиотикам бактериальных инфекций практически нет необходимости в новых, более дорогих антибиотиках, терапевтическое превосходство которых не было продемонстрировано. Поскольку устойчивость начинает развиваться сразу при использовании антибиотика, практика Норвегии откладывать применение новых антибиотиков согласуется с целью продления эффективности новых антибиотиков. Непреднамеренным последствием является то, что страна дала понять малому бизнесу, что существует малая коммерческая ценность в новых антибиотиках, которые могут быть по-прежнему необходимы для лечения редких или новых инфекций. Каждая страна стремится усовершенствовать борьбу с инфекциями и стимулировать ответственное применение антибиотиков. Однако при достижении определенного прогресса устойчивые к антибиотикам бактерии должны стать менее распространенными и, как следствие, возможно, снизится потребность в новых антибиотиках и их коммерческая ценность. Тем не менее инновации антибиотиков продолжают оставаться значимыми. Эта дилемма должна быть решена за счет внедрения альтернативных систем вознаграждения за инновации антибиотиков. Исследовательскому консорциуму в Европе DRIVE-AB («Введение реинвестирования в научные исследования и разработки и ответственное использование антибиотиков») была поставлена задача определить пути решения этой проблемы.

The objective of this study was to update a 2011 survey, conducted on behalf of the ESCMID Study Group for Antibiotic Policies (ESGAP), studying the availability of old but clinically useful antibiotics in North America, Europe and Australia. This follow-up survey was performed in 2015 in 40 countries among specialists from the pharmaceutical, infectious diseases and microbiology sectors in North America, Europe and Australia in order to assess the availability through usual marketing processes of 36 systemic antibiotics (addition of 3 antibiotics compared with the 2011 survey) selected for their ability to treat infections caused by resistant bacteria and their unique value for specific criteria. The questionnaire was sent by e-mail to national contacts belonging to ESGAP and ReAct networks. In all, 39 of the 40 countries participated in this survey. The number of available antibiotics differed considerably from one drug to another as well as from one country to another (e.g. 7 antibiotics available in Estonia, 24 in France). Overall, 25/36 selected antibiotics were marketed in 20/39 countries or less. From 2011 to 2015 (data available for both periods in 37 countries for 33 antibiotics), the number of available selected antibiotics increased in 13 countries and decreased in 17. In conclusion, despite the ongoing bacterial resistance crisis, the situation regarding the availability of ‘forgotten antibiotics’ has worsened since 2011. Urgent measures are needed to ensure better availability of these antibiotics on a global scale as a conservation measure to ensure sustainable and responsible use of antibiotics., peer-reviewed

BACKGROUND One of the objectives in the action plan to reduce antimicrobial resistance in the health services in Norway is to reduce the use of broad-spectrum antibiotics in Norwegian hospitals. This study describes the use of certain broad-spectrum antibiotics mentioned in the action plan in Norwegian hospitals, and assesses prescribing practices in relation to the Norwegian guidelines for antibiotic use in hospitals.MATERIAL AND METHOD Data were analysed from a nationwide non-identifiable point prevalence survey in May 2016 where all systemic use of antibiotics was recorded.RESULTS Broad-spectrum antibiotics accounted for 33 % of all antibiotics prescribed. Altogether 84 % of all broad-spectrum antibiotics were prescribed as treatment, 8 % were for prophylactic use, and 8 % were classified as other/unknown. Lower respiratory tract infections were the most frequent indication for treatment with broad-spectrum antibiotics, involving 30 % of all broad-spectrum treatment.INTERPRETATION This point prevalence survey in Norwegian hospitals in spring 2016 indicates a possibility for reducing the use of broad-spectrum antibiotics in the treatment of lower respiratory tract infections and for prophylactic use. Reduction of healthcare-associated infections may also contribute.