scholarly journals Excluding Orphan Drugs from the 340B Drug Discount Program: the Impact on 18 Critical Access Hospitals

2012 ◽  
Vol 3 (1) ◽  
Author(s):  
Madeline Carpinelli Wallack ◽  
Todd Sorensen
Keyword(s):  
Federal Government ◽  
Orphan Drug ◽  
Orphan Drugs ◽  
Safety Net ◽  
Original Research ◽  
Critical Access Hospitals ◽  
Patient Protection ◽  
High Prevalence ◽  
Safety Net Providers ◽  
The Impact

Purpose: The 340B Drug Pricing Program is a federal program designed to reduce the amount that safety net providers spend on outpatient drugs. The Patient Protection and Affordable Health Care Act of 2010 extended eligibility for 340B to critical access hospitals (CAHs) for all drugs except those designated as "orphan." Because this policy is unprecedented, this study quantifies the gross financial impact that this exemption has on a group of CAHs. Methods: Drug spending for 2010 from 18 CAHs in Minnesota and Wisconsin are reviewed to identify the prevalence of orphan drug purchases and to calculate the price differentials between the 340B price and the hospitals' current cost. Results: The 18 CAHs' purchases of orphan drugs comprise an average of 44% of the total annual drug budgets, but only 5% of units purchased, thus representing a very high proportion of their expenditures. In the aggregate, the 18 hospitals would have saved $3.1 million ($171,000 average per hospital) had purchases of drugs with orphan designations been made at the 340B price. Because CAH claims for Medicare are reimbursed on a cost-basis, the Federal government is losing an opportunity for savings. Conclusion: The high prevalence of orphan drug use and considerable potential for cost reduction through the 340B program demonstrate the loss of benefit to the hospitals, Federal government and the states.   Type: Original Research

scholarly journals Letter from the Editors

2020 ◽  
Vol 2 ◽  
pp. 1
Author(s):  
Editorial Office
Keyword(s):  
Clinical Trials ◽  
Medical Journal ◽  
Open Access ◽  
Drug Development ◽  
Orphan Drug ◽  
Rare Diseases ◽  
Case Reports ◽  
Orphan Drugs ◽  
Original Research ◽  
Orphan Drug Development

Last year we successfully introduced a new journal: The Journal of Rare Diseases and Orphan Drugs (JRDOD) is a peer-reviewed open-access medical journal that publishes original research, reviews, case reports, and letters covering a broad field of its specialty. We intend to publish articles stimulating to read, educate, and inform readers with the most up-to-date research in genetics, rare diseases, and new orphan drug development in different stages of clinical trials. Journal topics are centered on patients living with undiagnosed rare diseases, the importance of a diagnosis, individual approaches to treatments. We hope that this journal will increase awareness of many difficult to diagnosed and treat medical conditions.

Does an Orphan Drug Policy Make a Difference in Access? A Comparison of Canada and Australia

2019 ◽  
Vol 50 (2) ◽  
pp. 166-172
Author(s):  
Joel Lexchin ◽  
Nicholas Moroz
Keyword(s):  
United States ◽  
Federal Government ◽  
Orphan Drug ◽  
Drug Policy ◽  
Review Process ◽  
Orphan Drugs ◽  
The United States ◽  
Regulatory Review ◽  
United States Food ◽  
States Food

Canada has been discussing whether to implement an orphan drug policy for more than 25 years. Recently, the federal government announced funding for orphan drugs starting in 2022, and the Canadian Senate has recommended that the country develop an orphan drug policy. This paper uses a list of orphan drugs approved by the United States Food and Drug Administration between 2008 and 2017, inclusive. It then compares Canada, which has no orphan drug policy, and Australia, which has had such a policy since 1997. There was no difference between the countries in the proportion of orphan drugs approved, the time drugs spent in the regulatory review process, and any delay in marketing the drugs in the respective countries compared to the United States. Both Canada and Australia approved virtually all of the drugs that offered a moderate to significant therapeutic improvement. If Canada hopes to provide faster access to orphan drugs, especially those that are therapeutically innovative, it will need to develop a policy that is significantly different from that in Australia.

scholarly journals Letter of Editor

2020 ◽  
Vol 1 ◽  
Author(s):  
Editorial Office
Keyword(s):  
Rare Disease ◽  
Orphan Drug ◽  
Rare Diseases ◽  
Publishing House ◽  
Orphan Drugs ◽  
New Drugs ◽  
Medical Community ◽  
Great Promise ◽  
Original Research ◽  
Small Contribution

We are pleased to announce a new addition to SciencePower Publishing House, LLC journal collection: Journal of Rare Diseases and Orphan Drugs (JRDOD), a peer-reviewed open-access medical journal that publishes original research, reviews, case reports, and letters covering a broad field of its specialty. Why do we need a new journal? Because the science moves fast all around the Planet and new technology opened new horizons for the prevention and treatment of rare and genetically based disorders. Rare disease and disorders often need a multidisciplinary care team, deep knowledge of healthcare providers, and extensive patients’ and patient families’ support. It may take years until a disease is recognized and/or diagnosed. Spreading knowledge about rare disease conditions among biomedical scientists and physicians from the different subspecialty fields including genetics, pediatrics, cardiology, pulmonary, gastroenterology, rheumatology, neurology, dietary science, and other related disciplines is one of the goals of this journal, which we will be widely advertised within the medical community. Patients with special conditions could be “Rare, but Not Alone” and we want to add our voice to those patient advocacies. We also want to spread knowledge about orphan drugs. Well known fact that an orphan drug is a medication (pharmaceutical) that remains underdeveloped due to the lack of a company to find the drug profitable because the numbers of patients, who will benefit from the treatment, are small and so the potential market for new drugs to treat these rare diseases is also small. This situation fortunately somewhat changed in 1983, when the U.S. Congress passed the Orphan Drug Act. It facilitated and charged the orphan drugs' developmental landscape. Nowadays the FDA established the Office of Orphan Product Development (OOPD) to help with the development of orphan drugs (and other medical products for rare disorders), including FDA support for research grants. The international medical community has recognized the need to increase research and development of orphan drugs. We hope that our journal will be a small contribution to the promotion of wellbeing of people with rare disease conditions. Our publisher motto is "Superbi progressu aspiramus ad maximum" (the proud aspire to great promise). Please, consider submitting your next manuscript to the Journal of Rare Diseases and Orphan Drugs.

S.N.A.P. Today, Medicare Tomorrow

2018 ◽  
pp. 86-108
Author(s):  
Pamela Hampton-Garland
Keyword(s):  
Federal Government ◽  
Vulnerable Populations ◽  
Personal Narrative ◽  
Safety Net ◽  
Safety Nets ◽  
The Social ◽  
Vain Attempt ◽  
Social Safety Nets ◽  
The Impact ◽  
The U.S

Entitlements, social safety nets, benefits and welfare are just a few of the terms used to describe benefits provided to American businesses and individuals by the federal government. For decades since the FDR laws issued post WWII, politicians have been crying reform, in a vain attempt to dismantle the social safety nets that many of the country's most vulnerable populations need to survive. This chapter provides historical and current information on America's safety net programs and provide a deeper understanding of their importance and their beneficiaries. Finally, the chapter provides clarity to the impact that social safety nets have had on poverty in the U.S. and embedded in this chapter is a personal narrative of how the entitlements helped change my life.

Collaboration Across the Safety Net in the Era of Health Reform: Opportunities or Obstacles?

2016 ◽  
Vol 74 (3) ◽  
pp. 286-310 ◽  
Author(s):  
Katherine H. Mead ◽  
Erin Brantley ◽  
Julia Zur ◽  
Debora Goetz Goldberg
Keyword(s):  
Affordable Care Act ◽  
Health Reform ◽  
Safety Net ◽  
Community Action ◽  
System Transformation ◽  
Reform Era ◽  
Patient Protection ◽  
Common Goals ◽  
Safety Net Providers ◽  
Insurance Exchanges

While implementation of the Patient Protection and Affordable Care Act brings significant opportunities for safety net providers (SNP), local systems vary in how well they adapt to the rapidly evolving environment. Collaboration may enhance SNP capacity to leverage opportunities in the health reform era. Our study examines key opportunities and challenges SNPs face under health reform and how providers use collaboration as a strategy to adapt to the new environment. A qualitative study of 78 executives at safety net organizations identified six priorities that pose both opportunities and challenges for SNP, and around which collaboration is used as a strategy to achieve common goals: Medicaid expansion, outreach and enrollment, capacity and access, health system transformation, health insurance exchanges, and reductions in government funding. Three types of collaborations emerged: policy and advocacy, community action, and practice-based. Types of collaborations and stakeholders involved appeared to vary by priority.

Comparing the Impact of Religious Discourse on HIV/AIDS in Islam and Christianity in Africa

2012 ◽  
Vol 8 ◽  
Author(s):  
Sloane Speakman
Keyword(s):  
Social Factors ◽  
Negative Relationship ◽  
Hiv Prevalence ◽  
Religious Discourse ◽  
Prevalence Rates ◽  
The Social ◽  
High Prevalence ◽  
Islam And Christianity ◽  
Sub Saharan ◽  
The Impact

In examining the strikingly high prevalence rates of HIV in many parts of Africa, reaching as high as 5% in some areas, how does the discourse promoted by the predominant religions across the continent, Islam and Christianity, affect the outlook of their followers on the epidemic? This question becomes even more intriguing after discovering the dramatic difference in rate of HIV prevalence between Muslims and Christians in Africa, confirmed by studies that have found a negative relationship to exist between HIV prevalence and being Muslim in Africa, even in Sub-Saharan African nations. Why does this gap in prevalence rates exist? Does Islam advocate participating in less risky behavior more so than Christianity? By comparing the social construction, epidemiological understanding and public responses among Muslim populations in Africa with Christian ones, it becomes apparent that many similarities exist between the two regarding discourse and that, rather than religious discourse itself, other social factors, such as circumcision practices, contribute more to the disparity in HIV prevalence than originally thought.

988 The Prevalence and Incidence of Gender Bias and Sexual Discrimination in Orthopaedics, and Mitigating Strategies: A Systematic Review

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
A Elbayouk ◽  
U Halim ◽  
A Ali ◽  
S Javed ◽  
C Cullen
Keyword(s):  
Systematic Review ◽  
Gender Bias ◽  
Role Models ◽  
Educational Interventions ◽  
Original Research ◽  
Sexual Discrimination ◽  
Orthopaedic Training ◽  
Orthopaedic Community ◽  
Training Programmes ◽  
The Impact

Abstract Background The aim of this systematic review was to outline the prevalence and impact of Gender bias and sexual discrimination (GBSD) in orthopaedics, and to investigate interventions countering such behaviours. Method Original research papers pertaining to the prevalence and impact of gender bias or sexual discrimination, or mitigating strategies in orthopaedics, were suitable for inclusion. PRISMA guidelines were adhered to in this review. Results Of 570 papers, 27 were eligible for inclusion. A total of 13 papers discussed the prevalence of GBSD, whilst 13 related to the impact of these behaviours, and 6 discussed mitigating strategies. GBSD were found to be prevalent in the orthopaedic workplace, with all sources showing females to be the victims. The impact of GBSD includes poor workforce representation, lower salaries, barriers to career progression, and reduced academic output for females in orthopaedics. Mitigating strategies in the literature are focussed on encouraging females to apply for orthopaedic training programmes, by providing female role models, mentors, and educational interventions. Conclusions GBSD are highly prevalent in orthopaedic surgery, impacting females at all stages of their careers. Mitigating strategies have been tested but are limited in their scope. As such, the orthopaedic community as a whole is obliged to do more to tackle GBSD.

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