Dataset Information

Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

ABSTRACT: BACKGROUND:Off-label drug use in children is common and potentially harmful. In most previous off-label use research, authors studied hospitalized children, specific drug classes, or non-US settings. We characterized frequencies, trends, and reasons for off-label systemic drug orders for children in ambulatory US settings. METHODS:Using nationally representative surveys of office-based physicians (National Ambulatory Medical Care Surveys, 2006-2015), we studied off-label orders of systemic drugs for children age <18 based on US Food and Drug Administration-approved labeling for age, weight, and indication. We characterized the top classes and diagnoses with off-label orders and analyzed factors and trends of off-label orders using logistic regression. RESULTS:Physicians ordered ?1 off-label systemic drug at 18.5% (95% confidence interval: 17.7%-19.3%) of visits, usually (74.6%) because of unapproved conditions. Off-label ordering was most common proportionally in neonates (83%) and in absolute terms among adolescents (322 orders out of 1000 visits). Off-label ordering was associated with female sex, subspecialists, polypharmacy, and chronic conditions. Rates and reasons for off-label orders varied considerably by age. Relative and absolute rates of off-label orders rose over time. Among common classes, off-label orders for antihistamines and several psychotropics increased over time, whereas off-label orders for several classes of antibiotics were stable or declined. CONCLUSIONS:US office-based physicians have ordered systemic drugs off label for children at increasing rates, most often for unapproved conditions, despite recent efforts to increase evidence and drug approvals for children. These findings can help inform education, research, and policies around effective, safe use of medications in children.

SUBMITTER: Hoon D

PROVIDER: S-EPMC7286122 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

Hoon Divya D Taylor Matthew T MT Kapadia Pooja P Gerhard Tobias T Strom Brian L BL Horton Daniel B DB

Pediatrics 20190916 4

<h4>Background</h4>Off-label drug use in children is common and potentially harmful. In most previous off-label use research, authors studied hospitalized children, specific drug classes, or non-US settings. We characterized frequencies, trends, and reasons for off-label systemic drug orders for children in ambulatory US settings.<h4>Methods</h4>Using nationally representative surveys of office-based physicians (National Ambulatory Medical Care Surveys, 2006-2015), we studied off-label orders of ...[more]

PMID: 31527173

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Project description:Blood stream infections rank among the top seven causes of death of the general population. The aim of our study was to better understand the epidemiology of BSI in order to improve diagnostics and patient outcome. We used retrospective aggregated laboratory data of blood samples received from all public hospitals in Tyrol, Austria between 2006 and 2015. Microorganisms were categorized into obligatory, facultative, unusual pathogens and contaminants. The distribution, the cumulative incidence and antimicrobial susceptibility patterns were compared between the tertiary (TH) and regional peripheral hospitals (PH). Among 256,364 blood samples, 76.1% were from the TH The incidence of obligatory pathogens was 1.7 fold, and up to 3 times higher for facultative, unusual pathogens and contaminants in the TH and increased mainly due to an increase of E.coli, which was the most common isolated pathogen (n = 2,869), followed by Staphylococcus aureus (n = 1,439), Enterococcus sp. (n = 953) and Klebsiella sp. (n = 816). The distribution of obligatory pathogens differed between the hospital settings: In the TH Enterococcus sp. accounted for 40.8% and E.coli for 70.4%, respectively, whereas in the PH for 25.4% (p<0.0001) and 57.8%, respectively (p<0.0001) Antibiotic resistance of Gram negative bacteria and Staphylococcus aureus did not change during the observation period. Carbapenem resistance of Klebsiella sp. and vancomycin and linezolid resistance of Enterococcus faecium showed a non-significant increase since 2010 in the TH setting. We concluded that the incidence of BSI in TH was higher compared to PH. We observed higher contamination rates in the TH. We could not interpret the data of coagulase negative staphylococci due to lack of clinical data. We strongly recommend enhancement of training on blood culture sampling to decrease the rate of contamination. Due to differences in pathogen distribution and antimicrobial resistance between different hospital settings we recommend separate treatment guidelines for BSI by hospital setting.

Project description:Importance:The use of opioids to treat pain in pediatric patients has been viewed as necessary; however, this practice has raised concerns regarding opioid abuse and the effects of opioid use. To effectively adjust policy regarding opioids in the pediatric population, prescribing patterns must be better understood. Objective:To evaluate opioid prescribing patterns in US pediatric patients and factors associated with opioid prescribing. Design, Setting, and Participants:This cross-sectional study used publicly available data from the National Hospital Ambulatory Medical Care Survey from January 1, 2006, to December 31, 2015. Analysis included the use of bivariate and multivariate models to evaluate factors associated with opioid prescribing. Practitioners from emergency departments throughout the United States were surveyed, and data were collected using a representative sample of visits to hospital emergency departments. The study analyzed all emergency department visits included in the National Hospital Ambulatory Medical Care Survey for patients younger than 18 years. All statistical analysis was completed in June of 2018 and updated upon receiving reviewer feedback in October of 2018. Exposures:Information regarding participants' medications was collected at time of visit. Participants who reported taking 1 or more opioids were identified. Main Outcomes and Measures:Evaluation of opioid prescribing patterns across demographic factors and pain diagnoses. Results:A total of 69?152 visits with patients younger than 18 years (32?727 female) were included, which were extrapolated by the National Hospital Ambulatory Medical Care Survey to represent 293?528?632 visits nationwide, with opioid use representing 21?276?831 (7.25%) of the extrapolated visits. Factors including geographic region, race, age, and payment method were associated with statistically significant differences in opioid prescribing. The Northeast reported an opioid prescribing rate of 4.69% (95% CI, 3.69%-5.70%) vs 8.84% (95% CI, 6.82%-10.86%) in the West (P?=?.004). White individuals were prescribed an opioid at 8.11% (95% CI, 7.23%-8.99%) of visits vs 5.31% (95% CI, 4.31%-6.32%) for nonwhite individuals (P?<?.001). Those aged 13 to 17 years were significantly more likely to receive opioid prescriptions (16.20%; 95% CI, 14.29%-18.12%) than those aged 3 to 12 years (6.59%; 95% CI, 5.75%-7.43%) or 0 to 2 years (1.70%; 95% CI, 1.42%-1.98%). Patients using Medicaid for payment were less likely to receive an opioid than those using private insurance (5.47%; 95% CI, 4.79%-6.15% vs 9.73%; 95% CI, 8.56%-10.90%). There was no significant difference in opioid prescription across sexes. Opioid prescribing rates decreased when comparing 2006 to 2010 with 2011 to 2015 (8.23% [95% CI, 6.75%-9.70%] vs 6.30% [95% CI, 5.44%-7.17%]; P?<?.001); however, opioid prescribing rates remained unchanged in specific pain diagnoses, including pelvic and back pain. Conclusions and Relevance:This research demonstrated an overall reduction in opioid use among pediatric patients from 2011 to 2015 compared with the previous 5 years; however, there appear to be variations in factors associated with opioid prescribing. The association of location, race, payment method, and pain diagnoses with rates of prescribing of opioids suggests areas of potential quality improvement and further research.

Dataset Information

Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

Publications

Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

Similar Datasets

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