Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

scholarly journals Projected spending for brand-name drugs in English primary care given US prices: a cross-sectional study

2020 ◽  
Vol 113 (9) ◽  
pp. 350-359
Author(s):  
Michael Liu ◽  
Brian MacKenna ◽  
William B Feldman ◽  
Alex J Walker ◽  
Jerry Avorn ◽  
...  
Keyword(s):  
Primary Care ◽  
Medicare Part D ◽  
Access To Medicines ◽  
Cross Sectional Study ◽  
Medicare Part ◽  
Brand Name ◽  
Cross Sectional ◽  
Part D ◽  
The Us ◽  
Brand Name Drugs

Summary Objectives To estimate additional spending if NHS England paid the same prices as US Medicare Part D for the 50 single-source brand-name drugs with the highest expenditure in English primary care in 2018. Design Retrospective analysis of 2018 drug prescribing and spending in the NHS England prescribing data and the Medicare Part D Drug Spending Dashboard and Data. We examined the 50 costliest drugs in English primary care available as brand-name-only in the US and England. We performed cost projections of NHS England spending with US Medicare Part D prices. We estimated average 2018 US rebates as 1 minus the quotient of net divided by gross Medicare Part D spending. Setting England and US Participants NHS England and US Medicare systems Main outcome measures Total spending, prescriptions and claims in NHS England and Medicare Part D. All spending and cost measures were reported in 2018 British pounds. Results NHS England spent £1.39 billion on drugs in the cohort. All drugs were more expensive under US Medicare Part D than NHS England. The US–England price ratios ranged from 1.3 to 9.9 (mean ratio 4.8). Accounting for prescribing volume, if NHS England had paid US Medicare Part D prices after adjusting for estimated US rebates, it would have spent 4.6 times as much in 2018 on drugs in the cohort (£6.42 billion). Conclusions Spending by NHS England would be substantially higher if it paid US Medicare Part D prices. This could result in decreased access to medicines and other health services.

Multidisciplinary team decision is rare and decreasing in percutaneous vascular interventions despite positive impact on in-hospital outcomes

VASA ◽  
2019 ◽  
Vol 48 (3) ◽  
pp. 262-269 ◽  
Author(s):  
Christian-Alexander Behrendt ◽  
Tilo Kölbel ◽  
Thea Schwaneberg ◽  
Holger Diener ◽  
Ralf Hohnhold ◽  
...  
Keyword(s):  
Multidisciplinary Team ◽  
Positive Impact ◽  
Cross Sectional Study ◽  
Invasive Treatment ◽  
Cross Sectional ◽  
Hospital Outcomes ◽  
Vascular Intervention ◽  
Medical Specialties ◽  
Team Decision ◽  
The Impact

Abstract. Background: Worldwide prevalence of peripheral artery disease (PAD) is increasing and peripheral vascular intervention (PVI) has become the primary invasive treatment. There is evidence that multidisciplinary team decision-making (MTD) has an impact on in-hospital outcomes. This study aims to depict practice patterns and time changes regarding MTD of different medical specialties. Methods: This is a retrospective cross-sectional study design. 20,748 invasive, percutaneous PVI of PAD conducted in the metropolitan area of Hamburg (Germany) were consecutively collected between January 2004 and December 2014. Results: MTD prior to PVI was associated with lower odds of early unsuccessful termination of the procedures (Odds Ratio 0.662, p < 0.001). The proportion of MTD decreased over the study period (30.9 % until 2009 vs. 16.6 % from 2010, p < 0.001) while rates of critical limb-threatening ischemia (34.5 % vs. 42.1 %), patients´ age (70 vs. 72 years), PVI below-the-knee (BTK) (13.2 % vs. 22.4 %), and rates of severe TASC C/D lesions BTK (43.2 % vs. 54.2 %) increased (all p < 0.001). Utilization of MTD was different between medical specialties with lowest frequency in procedures performed by internists when compared to other medical specialties (7.1 % vs. 25.7 %, p < 0.001). Conclusions: MTD prior to PVI is associated with technical success of the procedure. Nonetheless, rates of MTD prior to PVI are decreasing during the study period. Future studies should address the impact of multidisciplinary vascular teams on long-term outcomes.

The impact of the use of a footrest on the quality of chest compressions. A prospective, randomized, cross-sectional study

2018 ◽  
Vol 31 (3) ◽  
Author(s):  
Jolanta Majer ◽  
Sandra Pyda ◽  
Jerzy Robert Ladny ◽  
Antonio Rodriguez-Nunez ◽  
Lukasz Szarpak
Keyword(s):  
Cross Sectional Study ◽  
Sectional Study ◽  
Chest Compressions ◽  
Cross Sectional ◽  
The Impact

Correlation of Altmetric Attention Scores with Citations in Major Pharmacy Journals (Preprint)

2018 ◽  
Author(s):  
Dave L Dixon ◽  
William L Baker
Keyword(s):  
Citation Count ◽  
Cross Sectional Study ◽  
Scientific Output ◽  
Cross Sectional ◽  
Promotion And Tenure ◽  
Article Type ◽  
Key Factor ◽  
Number Of Citations ◽  
The Impact

BACKGROUND The impact and quality of a faculty members publications is a key factor in promotion and tenure decisions and career advancement. Traditional measures, including citation counts and journal impact factor, have notable limitations. Since 2010, alternative metrics have been proposed as another means of assessing the impact and quality of scholarly work. The Altmetric Attention Score is an objective score frequently used to determine the immediate reach of a published work across the web, including news outlets, blogs, social media, and more. Several studies evaluating the correlation between the Altmetric Attention Score and number of citations have found mixed results and may be discipline-specific. OBJECTIVE To determine the correlation between higher Altmetric Attention Scores and citation count for journal articles published in major pharmacy journals. METHODS This cross-sectional study evaluated articles from major pharmacy journals ranked in the top 10% according to the Altmetric Attention Score. Sources of attention that determined the Altmetric Attention Score were obtained, as well each articles open access status, article type, study design, and topic. Correlation between journal characteristics, including the Altmetric Attention Score and number of citations, was assessed using the Spearman’s correlation test. A Kruskal-Wallis 1-way analysis of variance (ANOVA) was used to compare the Altmetric Attention Scores between journals. RESULTS Six major pharmacy journals were identified. A total of 1,376 articles were published in 2017 and 137 of these represented the top 10% with the highest Altmetric Attention Scores. The median Altmetric Attention Score was 19 (IQR 15-28). Twitter and Mendeley were the most common sources of attention. Over half (56.2%) of the articles were original investigations and 49.8% were either cross-sectional, qualitative, or cohort studies. No significant correlation was found between the Altmetric Attention Score and citation count (rs=0.07, P = 0.485). Mendeley was the only attention source that correlated with the number of citations (rs=0.486, P<0.001). The median Altmetric Attention Score varied widely between each journal (P<0.001). CONCLUSIONS The overall median Altmetric Attention score of 19 suggests articles published in major pharmacy journals are near the top 5% of all scientific output. However, we found no correlation between the Altmetric Attention Score and number of citations for articles published in major pharmacy journals in the year 2017.

scholarly journals Impact of Community-Led Total Sanitation and Hygiene on Prevalence of Diarrheal Disease and Associated Factors among Under-Five Children: A Comparative Cross-Sectional Study in Selected Woredas of Gamo Gofa Zone, Southern Ethiopia

2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Agune Ashole Alto ◽  
Wanzahun Godana ◽  
Genet Gedamu
Keyword(s):  
Drinking Water ◽  
Diarrheal Disease ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Under Five ◽  
Under Five Children ◽  
Sanitation And Hygiene ◽  
The Impact ◽  
Gamo Gofa

Background. Diarrheal diseases are still one of the major causes of morbidity in under-five children in sub-Saharan Africa. In Ethiopia, diarrhea is responsible for 9% of all deaths and is the major cause of under-five mortality. Objective. To assess the impact of community-led total sanitation and hygiene on the prevalence of diarrheal disease and factors associated among under-five children in Gamo Gofa Zone. Methods. Community-based comparative cross-sectional study design was used to compare the impact of community-led total sanitation and hygiene intervention on under-five diarrheal disease. Multistage sampling method was employed. The data were collected by using pretested structured questionnaires. Data quality was ensured by daily supervision completeness and consistency. The data were coded, entered, and cleaned by using Epi Info version 7 and were analyzed by using SPSS version 20. Bivariate and multivariable analyses were carried out by using binary logistic regression. Significance was declared by using p value of <0.05 and AOR with 95% confidence intervals. Results. The response rate of this study was 93.3%. The overall diarrhea prevalence was 27.5% (CI = (24.06, 30.97)) which was 18.9% (CI = (14.94, 23.2)) in implemented and 36.2%. (CI = (30.41, 41.59)) in nonimplemented woredas. Children whose age was between 12 and 23 months (AOR = 1.6) and greater than 24 months (AOR = 5), availability of handwashing facilities (AOR = 4), disposal of waste in open field (AOR = 9.7), unimproved source of drinking water (AOR = 6.5), using only water for handwashing (AOR = 6), children who started complementary feeding less than 6 months (AOR = 5.6) and greater than 6 months (AOR = 5.2), and utensils used to feed children such as bottle (AOR = 3.9) were the factors positively associated with diarrhea. Conclusion. The overall prevalence of under-five diarrhea was 27.5%. The prevalence was low in CLTSH woredas as compared with non-CLTSH woredas. The study showed that handwashing facility, using only water for handwashing, open refuse disposal, and unimproved source of drinking water among under-five had a statistically significant association with diarrhea occurrence in CLTSH nonimplemented areas. Integrated efforts are needed from the Ministry of Health together with the WASH Project in improving drinking water, handwashing facilities, and solid waste disposal practices.

scholarly journals The impact of health literacy on health outcomes in individuals with chronic pain: a cross-sectional study

Physiotherapy ◽  
2019 ◽  
Vol 105 (3) ◽  
pp. 346-353
Author(s):  
Laura M. Mackey ◽  
Catherine Blake ◽  
Maire-Brid Casey ◽  
Camillus K. Power ◽  
Ray Victory ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Health Literacy ◽  
Health Outcomes ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
The Impact

scholarly journals Green Work-Life Balance and Greenwashing the Construct of Work-Life Balance: Myth and Reality

Energies ◽  
2021 ◽  
Vol 14 (15) ◽  
pp. 4556
Author(s):  
Anuradha Iddagoda ◽  
Eglantina Hysa ◽  
Helena Bulińska-Stangrecka ◽  
Otilia Manta
Keyword(s):  
Job Performance ◽  
Employee Engagement ◽  
Cross Sectional Study ◽  
Work Life ◽  
Work Life Balance ◽  
Cross Sectional ◽  
Life Balance ◽  
Theoretical Contribution ◽  
Green Human Resource Management ◽  
The Impact

Some of the frequently used buzz words in the corporate sector include green leadership, green human resource management, green employee engagement and green work-life balance. The intention of this article is to identify and examine the logical reasons that govern “green work-life balance” or, in simple terms, “greenwashing” work-life balance. The paper also aims at providing a comprehensive conceptualization of work-life balance, while thoroughly examining the components of measuring the construct. Based on a cross-sectional study in the banking industry with a sample of 170 managerial employees, this study analyzes the impact of work-life balance on employee job performance mediated by employee engagement. Results support the assumed relationship between work-life balance and employee job performance embedded in employee engagement. The theoretical contribution of this study concerns the application of role behavior theory to describe the mechanisms shaping the relationship between work-life balance and job performance through employee engagement. The practical implications of the paper include recommendations for improving job performance by enhancing the work-life balance and strengthening employee engagement.

scholarly journals The impact of COVID-19 pandemic on training and mental health of residents: a cross-sectional study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eman Alshdaifat ◽  
Amer Sindiani ◽  
Wasim Khasawneh ◽  
Omar Abu-Azzam ◽  
Aref Qarqash ◽  
...  
Keyword(s):  
Mental Health ◽  
Residency Training ◽  
Training Programs ◽  
Cross Sectional Study ◽  
Protective Equipment ◽  
Sectional Study ◽  
Cross Sectional ◽  
Surgical Residents ◽  
Tertiary Center ◽  
The Impact

Abstract Background Residency programs have been impacted by the Coronavirus disease 2019 (COVID-19) pandemic. In this study we aim to investigate and evaluate the impact of the pandemic on residents as well as residency training programs. Methods This was a cross-sectional study including a survey of 43 questions prepared on Google forms and electronically distributed among a convenience sample of residents training at a tertiary center in North Jordan during the COVID-19 pandemic. Data were collected in the period between October 30th and November 8th of 2020. The survey included questions that addressed the impact of the pandemic on residents’ health as well as training programs. The study participants included residents in training at KAUH in 2020 and were stratified according to the type of residency program (surgical residents (SRs) and non-surgical residents (NSRs)). Statistical methods included descriptive analysis, Chi-square or Fisher’s exact test, Mann Whitney U test, and Cramer’s V and r statistics as measures of effect sizes. Results Of all 430 residents, 255 (59%) responded to the survey. A total of 17 (7%) of residents reported being infected with COVID-19 and a significant difference was reported between SRs and NSRs (10% vs 4%, V = .124 “small effect” (95% CI; .017–.229), p = 0.048). Approximately, 106 (42%) reported a decrease in the number of staff working at the clinic and 164 (64%) reported limited access to personal protective equipment during the pandemic. On a 4-point Likert scale for the feeling of anxiety, the median was 2 (2–3 IQR) in the NSRs group, vs 2 (1–2 IQR) in the SRs groups, with the NSRs being more likely to feel anxious (r = 0.13 “small effect” (95% CI; 0.007–0.249), p = .044). Similarly, the proportion of residents who reported feeling anxious about an inadequacy of protective equipment in the work area was significantly greater in the NSRs group (90.3% vs 75.2%; V = .201 “small effect” (95% CI; .078–.313), p = .001), as well as the proportion of residents who reported feeling increased stress and anxiety between colleagues being also significantly higher in the NSRs group (88.1% vs 76%; V = .158 “small effect” (95% CI; .032–.279), p = .012). Conclusion The burden of the ongoing pandemic on the mental health status of residents is very alarming and so providing residents with psychological counseling and support is needed. Also, critical implications on the flow of residency training programs have been noticed. This necessitates adapting and adopting smart educational techniques to compensate for such limitations.

scholarly journals The impact of coronavirus outbreak on breastfeeding guidelines among Brazilian hospitals and maternity services: a cross-sectional study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Walusa Assad Gonçalves-Ferri ◽  
◽  
Fábia Martins Pereira-Cellini ◽  
Kelly Coca ◽  
Davi Casale Aragon ◽  
...  
Keyword(s):  
Cross Sectional Study ◽  
World Health ◽  
Breastfeeding Support ◽  
Cross Sectional ◽  
Maternity Services ◽  
Community Needs ◽  
Care Services ◽  
Skin Contact ◽  
Health Organization ◽  
The Impact

Abstract Background The World Health Organization recognizes exclusive breastfeeding a safe source of nutrition available for children in most humanitarian emergencies, as in the current pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Despite the Brazilian national guideline protecting breastfeeding practices, there are many concerns about protecting infants from their infected mothers. This study aimed to analyze how the Brazilian hospitals and maternity services promote and support mothers suspected or diagnosed with coronavirus disease (COVID-19). Methods This is a descriptive cross-sectional and multicenter study which collected data from 24 Brazilian hospitals and maternity services between March and July 2020. Representatives of the institutions completed a questionnaire based on acts to promote and support breastfeeding, the Baby-Friendly Hospital Initiative, and Brazil’s federal law recommendations. Results The results showed that in delivery rooms, 98.5% of the services prohibited immediate and uninterrupted skin-to-skin contact between mothers and their infants and did not support mothers to initiate breastfeeding in the first hour. On the postnatal ward, 98.5% of the services allowed breastfeeding while implementing respiratory hygiene practices to prevent transmission of COVID-19. Companions for mothers were forbidden in 83.3% of the hospitals. Hospital discharge was mostly between 24 and 28 h (79.1%); discharge guidelines were not individualized. Additionally, a lack of support was noticed from the home environment’s health community network (83.3%). Hospital and home breast pumping were allowed (87.5%), but breast milk donation was not accepted (95.8%). There was a lack of guidance regarding the use of infant comforting strategies. Guidelines specific for vulnerable populations were not covered in the material evaluated. Conclusions In Brazil, hospitals have not followed recommendations to protect, promote, and support breastfeeding during the COVID-19 outbreak. The disagreement between international guidelines has been a major issue. The absence of recommendations on breastfeeding support during the pandemic led to difficulties in developing standards among hospitals in different regions of Brazil and other countries worldwide. The scientific community needs to discuss how to improve maternal and infant care services to protect breastfeeding in the current pandemic.

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