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BACKGROUND: Despite a lack of conclusive evidence of effect, methenamine hippurate is widely prescribed as preventive treatment for recurrent urinary tract infections (UTIs) in Norway. A national discontinuation of methenamine hippurate treatment due to a 4-month drug shortage in 2019 presented an opportunity to evaluate its preventive effect on UTIs among regular users. OBJECTIVE: To estimate the impact of the methenamine hippurate drug shortage on prescription frequency of UTI antibiotics. METHODS: Data from The Norwegian Prescription Database was analysed using an interrupted time series design. The time series consisted of 56 time periods of 14â days. The model included two naturally occurring interruptions: (i) the methenamine hippurate drug shortage, and (ii) reintroduction of the drug. The study population were 18â345 women ≥50â years receiving ≥2 prescriptions of methenamine hippurate in the study period before the shortage. Main outcome measure was number of prescriptions of UTI antibiotics per 1000 methenamine hippurate users. Prescription rates of antibiotics for respiratory tract infections were analysed to assess external events affecting antibiotic prescribing patterns. RESULTS: We found a significant increase of 2.41 prescriptions per 1000 methenamine hippurate users per 14-day period during the drug shortage (95%CI 1.39, 3.43, Pâ<â0.001), followed by a significant reduction of -2.64 prescriptions after reintroduction (95%CI -3.66, -1.63, Pâ<â0.001). CONCLUSIONS: During the methenamine hippurate drug shortage, we found a significant increase in prescribing trend for UTI antibiotics followed by a significant decrease in prescribing trend after reintroduction. This change in trend seems to reflect a preventive effect of the drug on recurrent UTIs.
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Antibacterianos , Hipuratos , Análisis de Series de Tiempo Interrumpido , Metenamina , Metenamina/análogos & derivados , Infecciones Urinarias , Humanos , Infecciones Urinarias/tratamiento farmacológico , Noruega/epidemiología , Antibacterianos/uso terapéutico , Femenino , Hipuratos/uso terapéutico , Metenamina/uso terapéutico , Persona de Mediana Edad , Anciano , Prescripciones de Medicamentos/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Anciano de 80 o más Años , Utilización de Medicamentos/estadística & datos numéricosRESUMEN
BACKGROUND: Academic detailing (AD) is a one-on-one educational outreach with the goal to improve prescribing. There is insufficient evidence on the difference in impact between AD and group visits to facilitate behavior change among general practitioners (GPs). OBJECTIVE: To compare the impact of individual AD visits and group visits conveying the same content on treatment of type 2 diabetes (T2D). DESIGN: Randomized controlled trial. PARTICIPANTS: GPs in Central Norway, visited September - November 2018. INTERVENTION: A total of 210 GPs were randomized and invited to an individual AD visit lasting 20 min; 193 were visited, of whom 146 were included in the analyses. In addition, 293 GPs were randomized and invited to a group meeting lasting 30-45 min; 261 were visited, of whom 188 were included in the analyses. Finally, 167 GPs were randomized and included in a control group. Visits were conducted by trained pharmacists and physicians. MAIN MEASURES: Changes in prescribing of metformin and other T2D drugs after the intervention. KEY RESULTS: The use of metformin increased with 5.9% the year after AD and with 4.9% the year after group meetings, compared to no change (0.0%) in the control group (p = 0.006 and p = 0.016, respectively). There was no significant difference between the two intervention groups. The only drug group with a statistically significant difference between interventions was insulins, with an increase of 3.2% after AD compared to 19.1% after group visits (p < 0.001). For GLP-1 analogues (p = 0.031) and T2D drugs in total (p = 0.010), we found a significant difference between group intervention and control. Other differences between study groups did not reach statistical significance. CONCLUSIONS: Short educational visits of 20-45 min impact the prescribing of drugs for T2D, either the education is given one-on-one as AD or in a group setting.
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OBJECTIVE: To investigate the effect of an academic detailing intervention on the utilisation of type 2 diabetes medication among general practitioners. DESIGN: We developed an academic detailing campaign based on the revised national treatment guideline for diabetes and the best available evidence. General practitioners were offered a 20-minute one-to-one visit by a trained academic detailer. SETTING AND SUBJECTS: A total of 371 general practitioners received a visit and represented the intervention group. The control group consisted of 1282 general practitioners not receiving a visit. MAIN OUTCOME MEASURES: Changes in prescribing from 12 months before to 12 months after the intervention. The primary endpoint was a change in metformin. Secondary endpoints were changes in other groups of Type 2 diabetes medication and of these drugs in total. RESULTS: Prescribing of metformin increased by 7.4% in the intervention group and 5.2% in the control group (p = .043). Sodium-glucose cotransporter-2 inhibitors increased by 27.6% in the intervention group and 33.8% in the control group (p = .019). For sulfonylureas there was a decrease of 3.6% in the intervention group vs. 8.9% in the control group (p = .026). The total amount of prescribed medications for type 2 diabetes increased by 9.1% in the intervention group and 7.3% in the control group (p = .08). CONCLUSION: Academic detailing initiated a small but statistically significant increase in the prescription of metformin. For a complex subject like type 2 diabetes, we recommend reserving more time in the visit than the 20 min our campaign aimed for.
Academic detailing is a validated method for facilitating changes in prescribing, via interactive one-to-one meetings with a trained academic detailer.General practitioners who received a 20-minute visit on the treatment of type 2 diabetes prescribed more metformin, compared to the control group.For a complex interventions like the present, we recommend setting aside more than 20 minutes, to ensure sufficient time for discussion and reflection.Academic detailing can impact prescribing, even for a complex subject like the treatment of Type 2 Diabetes.
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Diabetes Mellitus Tipo 2 , Médicos Generales , Metformina , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Prescripciones de Medicamentos , Pautas de la Práctica en Medicina , Metformina/uso terapéuticoRESUMEN
OBJECTIVES: To investigate whether infants exposed to antimicrobials in hospital during the first 3â 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 3â months of life. METHODS: Norwegian cohort study of infants less than 3â 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 1â 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 3â 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 (≥37â 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 3â 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.
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Antiinfecciosos , Recien Nacido Prematuro , Antibacterianos/efectos adversos , Estudios de Cohortes , Hospitalización , Humanos , Lactante , Recién Nacido , Alta del PacienteRESUMEN
PURPOSE: To investigate ambulatory antibiotic use in children during 1 year before and 1 year after in-hospital antibiotic exposure compared to children from the general population that had not received antibiotics in-hospital. METHODS: Explorative data-linkage cohort study from Norway of children aged 3 months to 17 years. One group had received antibiotics in-Hospital (H+), and one group had not received antibiotics in-hospital (H-). The H+ group was recruited during admission in 2017. Using the Norwegian Population Registry, 10 children from the H- group were matched with one child from the H+ group according to county of residence, age and sex. We used the Norwegian Prescription Database to register antibiotic use 1 year before and 1 year after the month of hospitalisation. RESULTS: Of 187 children in the H+ group, 83 (44%) received antibiotics before hospitalisation compared to 288/1870 (15%) in the H- group, relative risk (RR) 2.88 (95% confidence interval 2.38-3.49). After hospitalisation, 86 (46%) received antibiotics in the H+ group compared to 311 (17%) in the H- group, RR 2.77 (2.30-3.33). Comorbidity-adjusted RR was 2.30 (1.84-2.86) before and 2.25 (1.81-2.79) after hospitalisation. RR after hospitalisation was 2.55 (1.99-3.26) in children 3 months-2 years, 4.03 (2.84-5.71) in children 3-12 years and 2.07 (1.33-3.20) in children 13-17 years. CONCLUSIONS: Children exposed to antibiotics in-hospital had two to three times higher risk of receiving antibiotics in ambulatory care both before and after hospitalisation. The link between in-hospital and ambulatory antibiotic exposure should be emphasised in future antibiotic stewardship programs.
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Antibacterianos , Programas de Optimización del Uso de los Antimicrobianos , Antibacterianos/efectos adversos , Niño , Estudios de Cohortes , Hospitalización , Humanos , Noruega/epidemiologíaRESUMEN
BackgroundIn 2019, the World Health Organization published the 21st Model list of Essential Medicines and updated the Access, Watch Reserve (AWaRe) antibiotics classification to improve metrics and indicators for antibiotic stewardship activities. Reserve antibiotics are regarded as last-resort treatment options.AimWe investigated hospital-sector consumption quantities and trends of Reserve group antibiotics in European Union/European Economic Area countries and the United Kingdom (EU/EEA/UK).MethodsHospital-sector antimicrobial consumption data for 2010-2018 were obtained from the European Centre for Disease Prevention and Control. Antibacterials' consumption for systemic use (Anatomical Therapeutic Chemical classification (ATC) group J01) were included in the analysis and expressed as defined daily doses (DDD) per 1,000 inhabitants per day. We defined reserve antibiotics as per AWaRe classification and applied linear regression to analyse trends in consumption of reserve antibiotics throughout the study period.ResultsEU/EEA/UK average hospital-sector reserve-antibiotic consumption increased from 0.017 to 0.050 DDD per 1,000 inhabitants per day over the study period (p = 0.002). This significant increase concerned 15 countries. In 2018, four antibiotics (tigecycline, colistin, linezolid and daptomycin) constituted 91% of the consumption. Both absolute and relative (% of total hospital sector) consumption of reserve antibiotics varied considerably (up to 42-fold) between countries (from 0.004 to 0.155 DDD per 1,000 inhabitants per day and from 0.2% to 9.3%, respectively).ConclusionAn increasing trend in reserve antibiotic consumption was found in Europe. The substantial variation between countries may reflect the burden of infection with multidrug-resistant bacteria. Our results could guide national actions or optimisation of reserve antibiotic use.
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Antiinfecciosos , Daptomicina , Antibacterianos/uso terapéutico , Colistina , Utilización de Medicamentos , Hospitales , Humanos , Linezolid , Tigeciclina , Organización Mundial de la SaludRESUMEN
BACKGROUND: Colorectal 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. METHODS: The 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT01538550 .
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Neoplasias Colorrectales/diagnóstico , Detección Precoz del Cáncer/métodos , Microbioma Gastrointestinal , Estilo de Vida , Anciano , Estudios de Casos y Controles , Colonoscopía , Neoplasias Colorrectales/epidemiología , Neoplasias Colorrectales/microbiología , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Noruega/epidemiología , Sangre Oculta , Pronóstico , Estudios Prospectivos , Curva ROCRESUMEN
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.
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Antibacterianos/administración & dosificación , COVID-19 , Prescripciones de Medicamentos/estadística & datos numéricos , Pandemias , Utilización de Medicamentos , Humanos , Noruega/epidemiologíaRESUMEN
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.
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Ciprofloxacina , Quinolonas , Antibacterianos/uso terapéutico , Ciprofloxacina/uso terapéutico , Hospitales , Humanos , Noruega/epidemiologíaRESUMEN
BACKGROUND: Drug consumption increases with age, but there are few comparisons of drug use between old people living at home or in a nursing home. To identify areas of concern as well as in need for quality improvement in the two settings, we compared drug use among people aged ≥70 years living at home or in a nursing home. METHODS: Cross-sectional observational study from Oslo, Norway. Information about drug use by people living at home in 2012 was retrieved from the Norwegian Prescription Database. Drug use in nursing homes was recorded within a comprehensive medication review during November 2011-February 2014. Prevalence rates and relative risk (RR) with 95% confidence intervals were compared between uses of therapeutic groups with prevalence rates of ≥5%. Drug use was compared for the total population and by gender and age group. RESULTS: Older people (both genders) in nursing homes (n = 2313) were more likely than people living at home (n = 48,944) to use antidementia drugs (RR = 5.7), antipsychotics (RR = 4.0), paracetamol (RR = 4.0), anxiolytics (RR = 3.0), antidepressants (RR = 2.8), dopaminergic drugs (RR = 2.7), antiepileptic drugs (RR = 2.4), loop diuretics (RR = 2.3), cardiac nitrates (RR = 2.1) or opioids (RR = 2.0). By contrast, people living in a nursing home were less commonly prescribed statins (RR = 0.2), nonsteroidal antiinflammatory drugs (NSAIDs) (RR = 0.3), osteoporosis drugs (RR = 0.3), thiazide diuretics (RR = 0.4), calcium channel blockers (RR = 0.5) or renin-angiotensin inhibitors (RR = 0.5). Each of the populations had only minor differences in drug use by gender and a trend towards less drug use with increasing age (p < 0.01). CONCLUSIONS: Drug use by older people differs according to care level, and so do areas probably in need for quality improvement and further research. In nursing home residents, this relates to a probable overuse of psychotropic drugs and opioids. Among older people living at home, the probable overuse of NSAIDs and a possible underuse of cholinesterase inhibitors and osteoporosis drugs should be addressed.
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Utilización de Medicamentos/normas , Servicios de Atención de Salud a Domicilio/normas , Hogares para Ancianos/normas , Conciliación de Medicamentos/métodos , Casas de Salud/normas , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/uso terapéutico , Ansiolíticos/uso terapéutico , Antidepresivos/uso terapéutico , Antipsicóticos/uso terapéutico , Estudios Transversales , Femenino , Humanos , Masculino , Noruega/epidemiología , Psicotrópicos/uso terapéuticoRESUMEN
Unnecessary and inappropriate use of antibiotics in human healthcare is a major driver for the development and spread of antimicrobial resistance; many countries are implementing measures to limit the overuse and misuse of antibiotics e.g. through the establishment of antimicrobial use reduction targets. We performed a review of antimicrobial use reduction goals in human medicine in Transatlantic Taskforce on Antimicrobial Resistance partner countries. On 31 March 2017, the European Centre for Disease Prevention and Control sent a questionnaire to National Focal Points for Antimicrobial Consumption and the National Focal Points for Antimicrobial Resistance in 28 European Union countries, Iceland and Norway. The same questionnaire was sent to the TATFAR implementers in Canada and the United States. Thirty of 32 countries replied. Only nine countries indicated that they have established targets to reduce antimicrobial use in humans. Twenty-one countries replied that no target had been established. However, 17 of these 21 countries indicated that work to establish such targets is currently underway, often in the context of developing a national action plan against antimicrobial resistance. The reported targets varied greatly between countries and can be a useful resource for countries willing to engage in the reduction of antibiotic use in humans.
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Antibacterianos/uso terapéutico , Prescripciones de Medicamentos , Farmacorresistencia Microbiana , Prescripción Inadecuada , Prescripciones de Medicamentos/normas , Unión Europea , Política de Salud , HumanosRESUMEN
INTRODUCTION: Targeted testing and treatment of latent TB infection (LTBI) are priorities on the global health agenda, but LTBI management remains challenging. We aimed to evaluate the prognostic value of the QuantiFERON TB-Gold (QFT) test for incident TB, focusing on the interferon (IFN)-γ level, when applied in routine practice in a low TB incidence setting. METHODS: In this large population-based prospective cohort, we linked QFT results in Norway (1 January 2009-30 June 2014) with national registry data (Norwegian Surveillance System for Infectious Diseases, Norwegian Prescription Database, Norwegian Patient Registry and Statistics Norway) to assess the prognostic value of QFT for incident TB. Participants were followed until 30 June 2016. We used restricted cubic splines to model non-linear relationships between IFN-γ levels and TB, and applied these findings to a competing risk model. RESULTS: The prospective analyses included 50 389 QFT results from 44 875 individuals, of whom 257 developed TB. Overall, 22% (n=9878) of QFT results were positive. TB risk increased with the IFN-γ level until a plateau level, above which further increase was not associated with additional prognostic information. The HRs for TB were 8.8 (95% CI 4.7 to 16.5), 19.2 (95% CI 11.6 to 31.6) and 31.3 (95% CI 19.8 to 49.5) times higher with IFN-γ levels of 0.35 to <1.00, 1.00 to <4.00 and >4.00 IU/mL, respectively, compared with negative tests (<0.35 IU/mL). CONCLUSIONS: Consistently, QFT demonstrates increased risk of incident TB with rising IFN-γ concentrations, indicating that IFN-γ levels may be used to guide targeted treatment of LTBI.
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Objectives: To investigate the prescribing of systemic drugs for the treatment of acne in adolescents in the period 2005-15. Methods: The study population consisted of 14-24-year-old users of tetracyclines, isotretinoin or hormonal therapy retrieved from the Norwegian Prescription Database. The 1 year period prevalence was calculated as the number of patients who had redeemed at least one prescription during the year divided by the mean population. If the user had no prescriptions in the preceding 12 months he/she was defined as a new user. The incidence rate was defined by the number of new users during the year divided by the mean population. Results: Increased prescribing rates for systemic tetracyclines and isotretinoin were observed in the period 2005-15, while a decreased prescribing rate for hormonal therapy was observed from 2007. The majority (75%) of the tetracycline prescriptions were prescribed by general practitioner specialists or physicians with no specialty/under training for a specialty. The average durations of treatment in men and women who only used tetracyclines were 3.3 and 2.8 months, respectively. For men and women that switched to isotretinoin, the average durations of treatment were 4.3 and 3.9 months. Conclusions: The increased use of systemic tetracyclines in general, and the prolonged use of tetracyclines in patients who later switch to isotretinoin, raise the question of whether isotretinoin treatment should be considered at an earlier stage to reduce the use of systemic tetracyclines.
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Acné Vulgar/tratamiento farmacológico , Fármacos Dermatológicos/administración & dosificación , Isotretinoína/administración & dosificación , Prescripciones/estadística & datos numéricos , Tetraciclinas/administración & dosificación , Adolescente , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Bases de Datos Farmacéuticas , Fármacos Dermatológicos/uso terapéutico , Vías de Administración de Medicamentos , Femenino , Hormonas/uso terapéutico , Humanos , Isotretinoína/uso terapéutico , Masculino , Noruega , Pautas de la Práctica en Medicina , Tetraciclinas/uso terapéutico , Adulto JovenRESUMEN
OBJECTIVES: To describe the rates of pediatric antibiotic use across 6 countries on 3 continents. STUDY DESIGN: Cross-national analysis of 7 pediatric cohorts in 6 countries (Germany, Italy, South Korea, Norway, Spain, and the US) was performed for 2008-2012. Antibiotic dispensings were identified and grouped into subclasses. We calculated the rates of antimicrobial prescriptions per person-year specific to each age group, comparing the rates across different countries. RESULTS: A total of 74 744 302 person-years from all participating centers were included in this analysis. Infants in South Korea had the highest rate of antimicrobial consumption, with 3.41 prescribed courses per child-year during the first 2 years of life. This compares with 1.6 in Lazio, Italy; 1.4 in Pedianet, Italy; 1.5 in Spain; 1.1 in the US; 1.0 in Germany; and 0.5 courses per child-year in Norway. Of antimicrobial prescriptions written in Norway, 64.8% were for first-line penicillins, compared with 38.2% in Germany, 31.8% in the US, 27.7% in Spain, 25.1% in the Italian Pedianet population, 9.8% in South Korea, and 8% in the Italian Lazio population. CONCLUSIONS: We found substantial differences of up to 7.5-fold in pediatric antimicrobial use across several industrialized countries from Europe, Asia, and North America. These data reinforce the need to develop strategies to decrease the unnecessary use of antimicrobial agents.
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Antibacterianos/uso terapéutico , Infecciones Bacterianas/tratamiento farmacológico , Utilización de Medicamentos/estadística & datos numéricos , Adolescente , Factores de Edad , Niño , Preescolar , Estudios de Cohortes , Estudios Transversales , Femenino , Alemania , Humanos , Incidencia , Lactante , Internacionalidad , Italia , Masculino , Noruega , República de Corea , Estudios Retrospectivos , España , Estados UnidosRESUMEN
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 (Driving re-investment in research and development and responsible antibiotic use) a été chargé de trouver des solutions pour relever ce défi.
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.
Asunto(s)
Antibacterianos/economía , Aprobación de Drogas/organización & administración , Guías de Práctica Clínica como Asunto , Sector Privado/organización & administración , Costos y Análisis de Costo , Farmacorresistencia Bacteriana , Utilización de Medicamentos , Política de Salud , Humanos , Reembolso de Seguro de Salud , Mercadotecnía/organización & administración , NoruegaRESUMEN
BACKGROUND: Residents in nursing homes have a higher risk of developing infections that require antibiotic treatment than elderly people living at home. Use of antibiotics may cause adverse effects and result in the development of antimicrobial resistance. MATERIAL AND METHOD: Data on healthcare-associated infections and antibiotic use in 540 Norwegian nursing homes were retrieved from the Norwegian Institute of Public Health's point prevalence survey in the spring of 2016. Based on information on drug, dosage and indication, we assessed whether the use of antibiotics for the treatment of UTIs was in accordance with the National Guidelines for the Use of Antibiotics in Primary Care. RESULTS: UTI was the most commonly occurring type of infection, with a prevalence of 2.7 %. Prescription of first-line antibiotics accounted for approximately 60 % of the prescriptions for treatment of this illness. Choice of drug, dosage and microbiological testing when treating lower UTIs was not always in accordance with the national guidelines. The study showed widespread use of methenamine in Norwegian nursing homes. INTERPRETATION: The survey indicates that compliance with the national guidelines when treating lower UTIs could be improved with regard to the choice of drug, dosage and microbiological testing. Norwegian nursing home doctors should also consider whether their use of methenamine is in accordance with national and international recommendations.
Asunto(s)
Antibacterianos/uso terapéutico , Infecciones Bacterianas , Infección Hospitalaria , Prescripciones de Medicamentos/estadística & datos numéricos , Casas de Salud , Anciano , Antiinfecciosos Urinarios/uso terapéutico , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/epidemiología , Infecciones Bacterianas/prevención & control , Bacteriuria/tratamiento farmacológico , Bacteriuria/epidemiología , Bacteriuria/prevención & control , Infección Hospitalaria/tratamiento farmacológico , Infección Hospitalaria/epidemiología , Infección Hospitalaria/prevención & control , Estudios Transversales , Prescripciones de Medicamentos/normas , Utilización de Medicamentos , Adhesión a Directriz , Humanos , Metenamina/uso terapéutico , Noruega/epidemiología , Infecciones Urinarias/tratamiento farmacológico , Infecciones Urinarias/epidemiología , Infecciones Urinarias/prevención & controlRESUMEN
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.
Asunto(s)
Antibacterianos/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricos , Revisión de la Utilización de Medicamentos , Hospitales , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/epidemiología , Infecciones Bacterianas/prevención & control , Carbapenémicos/uso terapéutico , Cefalosporinas/uso terapéutico , Infección Hospitalaria/tratamiento farmacológico , Infección Hospitalaria/epidemiología , Infección Hospitalaria/prevención & control , Estudios Transversales , Farmacorresistencia Bacteriana , Adhesión a Directriz , Humanos , Noruega/epidemiología , Piperacilina/uso terapéutico , Quinolonas/uso terapéutico , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Infecciones del Sistema Respiratorio/epidemiología , Infecciones del Sistema Respiratorio/prevención & controlRESUMEN
BACKGROUND: Residents in nursing homes have a heightened risk of developing infections that should be treated with antibiotics. Inappropriate use of antibiotics may generate drug-related problems and increase resistance. In this study, we describe the use of antibiotics in nursing homes on the basis of prevalence surveys and drug sales statistics. MATERIAL AND METHODS: Five nursing homes in Oslo participated in two one-day surveys in 2009. All use of systemic antibiotics was registered. The data collection was undertaken according to a protocol developed by the European Surveillance of Antimicrobial Consumption (ESAC) Network and was part of a European study. The nursing homes' drug sales statistics for systemic antibiotics during 2009, distributed by the number of bed days for each nursing home, were estimated. Information on indications for each antibiotic from the prevalence surveys was collated with sales data to achieve an estimate of how the purchased antibiotics were used. RESULTS: The prevalence surveys showed that more than 8% of the residents received antibiotics. Prophylactic treatment accounted for 33% of the prescriptions. A prevalence of antibiotic use of 10% was estimated from the drug sales statistics. Urinary tract infection was the most frequently registered indication. Pivmecillinam and methenamine were most frequently prescribed and most frequently purchased. Most courses of treatment were prescribed in accordance with the national guidelines for antibiotic use. INTERPRETATION: The results from the drug sales statistics concurred well with the prevalence surveys, and the methods can thus be relevant for purposes of monitoring the use of antibiotics.
Asunto(s)
Antibacterianos/uso terapéutico , Revisión de la Utilización de Medicamentos , Casas de Salud/normas , Amdinocilina Pivoxil/economía , Amdinocilina Pivoxil/uso terapéutico , Antibacterianos/economía , Infecciones Bacterianas/tratamiento farmacológico , Prescripciones de Medicamentos/economía , Prescripciones de Medicamentos/normas , Prescripciones de Medicamentos/estadística & datos numéricos , Humanos , Metenamina/economía , Metenamina/uso terapéutico , Noruega , Casas de Salud/estadística & datos numéricosRESUMEN
PURPOSE: To investigate patterns of initial drug therapy for the treatment of hypertension and to evaluate treatment persistence and change of treatment during a 4-year period in patients receiving thiazides (TZs) and/or angiotensin II-receptor blockers (ARBs) as first-line treatment. METHODS: All initial users of antihypertensive drugs in 2005 and 2009 registered in the Norwegian Prescription Database were included. Treatment on five index dates at 1-year intervals was recorded. A patient was considered to be under treatment on an index date if a drug had been dispensed within the previous 180 days and to have maintained treatment persistence if he/she was on any antihypertensive treatment on the index date and all previous index dates. RESULTS: Among 78,453 new users of antihypertensives in 2005, women started more often with TZs than men (30 vs. 25 %) and less often with ARBs (22 vs. 25 %). In men, the hazard of non-persistence with antihypertensive treatment was significantly lower among initial ARB users than among TZ users (hazard ratio 0.87, 95 % confidence interval 0.81-0.94); in women no significant difference was found. After 4 years, 49 % of the men and 51 % of the women who had started with plain TZs were still using TZs, whereas 65 % of the male ARB users and 60 % of the female ARB users were still using ARBs. CONCLUSION: TZs and ARBs were the most widely used first-line antihypertensives. Among the men enrolled in the study, ARB users had a somewhat better persistence with antihypertensive treatment than TZ users. Among both genders, continuation on ARBs was more common than continuation on TZs.