Decoding gene therapy: Current impact and future considerations for health-system and specialty pharmacy practice

2021 ◽  
Author(s):  
Scott L Canfield
Keyword(s):  
Gene Therapy ◽  
Health System ◽  
Health Systems ◽  
Pharmacy Practice ◽  
The United States ◽  
Gene Therapies ◽  
Novel Treatments ◽  
Engagement Strategies ◽  
Clinical Benefits ◽  
Specialty Pharmacy

Abstract Purpose To provide health systems with baseline knowledge on existing and pipeline gene therapy treatments, including considerations that health-system pharmacies and specialty pharmacy programs may reference when evaluating and implementing services around gene therapies. Summary Advancements in research and biotechnology have recently led to the development and launch of the first commercially available gene therapy treatments in the United States. These treatments have the ability to significantly alter and even effectively cure diseases. Alongside these significant advances and clinical benefits, these therapies present unique challenges due to their cost and complexity. Given the large number of additional gene therapy treatments that are currently in late-stage clinical development, stakeholders across the healthcare industry must increasingly adapt and ready themselves to meet these challenges. The diagnosis and treatment of patients with diseases being targeted by gene therapies largely occurs within health systems, and judging by the gene therapy pipeline, this trend is likely to continue. To prepare for these novel treatments, health systems must understand and consider the methods in which gene therapies are developed, procured, reimbursed, administered, and monitored. Conclusion The future of health-system pharmacy practice must include comprehensive gene therapy services and stakeholder engagement strategies to ensure patients have access to these life-changing treatments.

Valuing Diversity and Inclusion in Healthcare: Pathways to Equip Workforces in the Post-COVID-19 New Normal (Preprint)

2021 ◽  
Author(s):  
Jiban Khuntia ◽  
Xue Ning ◽  
Wayne Cascio ◽  
Rulon Stacey
Keyword(s):  
United States ◽  
Health System ◽  
Health Systems ◽  
The United States ◽  
Mediating Effect ◽  
New Normal ◽  
Diversity And Inclusion ◽  
Healthcare Workforce ◽  
The Us ◽  
Service Oriented

BACKGROUND The COVID-19 pandemic, with all its virus variants, remains a serious situation. Health systems across the United States are trying their best to respond. The healthcare workforce remains relatively homogenous, even though they are caring for a highly diverse array of patients (6-12). It is a perennial problem in the US healthcare workforce that has only been accentuated during the COVID-19 pandemic. Medical workers should reflect the variety of patients they care for and strive to understand their mindsets within the larger contexts of culture, gender, sexual orientation, religious beliefs, and socioeconomic realities. Along with talent and skills, diversity and inclusion (D&I) are essential for maintaining a workforce that can treat the myriad needs and populations that health systems serve. Developing hiring strategies in a post-COVID-19 “new normal” that will help achieve greater workforce diversity remains a challenge for health system leaders. OBJECTIVE Our primary objectives are (1) to explore the characteristics and perceived benefits of US health systems that value D&I; (2) to examine the influence of a workforce strategy designed to balance talent and D&I; and (3) to explore three pathways to better equip workforces and their relative influences on business- and service-oriented benefits: (a) improving D&I among existing employees (IMPROVE), (b) using multiple channels to find and recruit a workforce (RECRUIT), and (c) collaborating with universities to find new talent and establish plans to train students (COLLABORATE). METHODS During February–March 2021, we surveyed 625 health system chief executive officers, in the United States, 135 (22%) of whom responded. We assessed workforce talent and diversity-relevant factors. We collected secondary data from the Agency for Healthcare Research and Quality’s (AHRQ) Compendium of the US. Health Systems, leading to a matched data set of 124 health systems for analysis. We first explored differences in talent and diversity benefits across the health systems. Then, we examined the relationship between IMPROVE, RECRUIT, and COLLABORATE pathways to equip the workforce. RESULTS Health system characteristics, such as size, location, ownership, teaching, and revenue, have varying influences on D&I and business and service outcomes. RECRUIT has the most substantial mediating effect on diversity-enabled business- and service-oriented outcomes of the three pathways. This is also true of talent-based workforce acquisitions. CONCLUSIONS Diversity and talent plans can be aligned to realize multiple desired benefits for health systems. However, a one-size-fits-all approach is not a viable strategy for improving D&I. Health systems need to follow a multipronged approach based on their characteristics. To get D&I right, proactive plans and genuine efforts are essential.

scholarly journals STRENGTH IN AGE-FRIENDLY HEALTH SYSTEMS: AN INNOVATIVE INTEGRATED INTERPROFESSIONAL MODEL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S829-S829
Author(s):  
Teri Kennedy
Keyword(s):  
Older Adults ◽  
Health System ◽  
Baby Boomers ◽  
Health Systems ◽  
Adult Population ◽  
The United States ◽  
Essential Elements ◽  
Conceptual Approach ◽  
American Hospital ◽  
American Hospital Association

Abstract This paper presents an innovative conceptual approach to health care policy for older adults: the Age-Friendly Health Systems Integrated Interprofessional Model. In 2017, the John A. Hartford Foundation and Institute for Healthcare Improvement, in partnership with the American Hospital Association and Catholic Health Association of the United States, advanced the concept of an Age-Friendly Health System. This initiative is designed to respond to the needs of a burgeoning U.S. older adult population, expected to double from 2012 to 2050, largely due to the aging of Baby Boomers and increased life expectancy. These Baby Boomers will demand a well-coordinated, communicative health system responsive to their values and preferences. In an Age-Friendly Health System, all older adults receive the best possible care, without care-related harms, and with satisfaction of care received. Essential elements include what matters, mentation, mobility, and medications, with a focus on patient-directed, family-engaged care. While a solid framework for improving healthcare for older adults, this model is further strengthened by incorporating the essential elements of person-, family-, and community-centered approaches to care; interprofessional team-based competencies, and Quadruple Aim outcomes. This enhanced model, referred to as the Age-Friendly Health System Integrated Interprofessional Model, combines elements essential to quality healthcare within the framework of an Age-Friendly Health System. This paper will present the original Age-Friendly Health System framework, the proposed Age-Friendly Health System Integrated Interprofessional Model, then compare and contrast each model’s essential principles. Implications for adoption of this enhanced model for policy, education, and practice will be explored.

Gene therapy comes of age

Science ◽  
2018 ◽  
Vol 359 (6372) ◽  
pp. eaan4672 ◽  
Author(s):  
Cynthia E. Dunbar ◽  
Katherine A. High ◽  
J. Keith Joung ◽  
Donald B. Kohn ◽  
Keiya Ozawa ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Viral Vectors ◽  
The United States ◽  
Genetically Engineered ◽  
Drug Status ◽  
Hematopoietic Stem ◽  
Gene Therapies ◽  
Engineered T Cells ◽  
Near Future

After almost 30 years of promise tempered by setbacks, gene therapies are rapidly becoming a critical component of the therapeutic armamentarium for a variety of inherited and acquired human diseases. Gene therapies for inherited immune disorders, hemophilia, eye and neurodegenerative disorders, and lymphoid cancers recently progressed to approved drug status in the United States and Europe, or are anticipated to receive approval in the near future. In this Review, we discuss milestones in the development of gene therapies, focusing on direct in vivo administration of viral vectors and adoptive transfer of genetically engineered T cells or hematopoietic stem cells. We also discuss emerging genome editing technologies that should further advance the scope and efficacy of gene therapy approaches.

scholarly journals ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration—2020

2021 ◽  
Author(s):  
Craig A Pedersen ◽  
Philip J Schneider ◽  
Michael C Ganio ◽  
Douglas J Scheckelhoff
Keyword(s):  
Health Systems ◽  
National Survey ◽  
Workflow Management ◽  
Pharmacy Practice ◽  
Drug Distribution ◽  
Mail Survey ◽  
The United States ◽  
Traditional Role ◽  
Mode Method ◽  
Almost All

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Results of the 2020 ASHP national survey of pharmacy practice in hospital settings are presented. Methods Pharmacy directors at 1,437 general and children’s medical/surgical hospitals in the United States were surveyed using a mixed-mode method of contact by email and mail. Survey completion was online. IQVIA supplied data on hospital characteristics; the survey sample was drawn from the IMS hospital database. Results The response rate was 18.7%. Almost all hospitals (92.5%) have a method for pharmacists to review medication orders on demand. Most hospitals (74.5%) use automated dispensing cabinets (ADCs) as their primary method for drug distribution. A third of hospitals use barcodes to verify doses during dispensing in the pharmacy and to verify ingredients when intravenous medications are compounded. More than 80% scan barcodes when restocking ADCs. Sterile workflow management technology is used in 21.3% of hospitals. Almost three-quarters of hospitals outsource some sterile preparations. Pharmacists can independently prescribe in 21.1% of hospitals. Pharmacist practice in ambulatory clinics in 46.2% of health systems and provide telepharmacy services in 28.4% of health systems. Conclusion Pharmacists continue their responsibility in their traditional role in preparation and dispensing of medications. They have successfully employed technology to improve safety and efficiency in performance of these duties and have employed emerging technologies to improve the safety, timeliness, and efficiency of the administration of drugs to patients. As pharmacists continue to expand their role to all aspects of medication use, new opportunities highlighted in ASHP’s Practice Advancement Initiative 2030 have been identified.

Adherence to Choosing Wisely Campaign Guidelines at Three Health Systems

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S119-S119
Author(s):  
A K Windham ◽  
M Whitted ◽  
B Brimhall ◽  
J Buckley ◽  
G Nichols ◽  
...  
Keyword(s):  
Health System ◽  
Health Systems ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Cost Savings ◽  
The United States ◽  
Choosing Wisely ◽  
Variable Cost ◽  
Clinical Laboratory Testing ◽  
Unnecessary Testing

Abstract Introduction/Objective With rising healthcare costs in the United States, there has been a push for lab stewardship to improve the quality of patient care while reducing costs. To optimize the use of clinical laboratory testing, the ASCP working with other medical specialty organizations, developed the Choosing Wisely Campaign to promulgate evidence-based guidelines to optimize clinical laboratory testing. Methods/Case Report We examined adherence to three Choosing Wisely guidelines over a four-year period (2017- 2020), through queries of internal cost accounting databases to return aggregate volumes as well as variable and total costs at three large academic health systems. We measured concurrent orders for: 1) erythrocyte sedimentation rate (ESR) with C-reactive protein (CRP), 2) serum/plasma amylase with lipase, and 3) free thyroxine (FT4) and/or total triiodothyronine (TT3) with thyroid stimulating hormone (TSH) when the TSH is within the reference range (using an frequency estimate of 85% based on other studies). We also examined another guideline for concurrent orders for serum aldolase with creatine kinase (CK). We also quantified aggregate variable costs for the non-recommended test in each Choosing Wisely guideline (amylase, ESR, FT4 and/or TT3), and for serum aldolase when ordered with CK. Results (if a Case Study enter NA) Over the four-year period, there were 322,853 unnecessary tests based on these four guidelines (120,587 ESR and CRP, 30,444 amylase and lipase, 164,818 FT4 and/or TT3 with TSH, and 7,004 aldolase). Overall, unnecessary testing decreased between 2017 and 2020 for amylase with lipase, remained essentially unchanged for aldolase, and increased for the other two test guideline scenarios. The largest changes were concurrent orders for amylase and lipase at one health system (38% decrease), and orders for TT3 with a normal TSH result at another health system (324% increase). The four-year variable cost of these unnecessary tests was $1,215,309 ($303,827 mean annual cost), resulting in potential annual variable cost savings of $101,276 for each health system for the four guidelines we examined. Variable costs for unnecessary testing increased by 16.5% ($45,571) over the four-year period. Conclusion Guideline-based unnecessary testing remains as a target to improve laboratory diagnostic testing. There is potential to realize significant achievable cost savings if guidelines are implemented and maintained.

Integration vs. Collaborative Redesign Strategies of Health Systems’ Supply Chains in the Post-COVID-19 New Normal using Cross-Sectional Survey Across the United States (Preprint)

2021 ◽  
Author(s):  
Jiban Khuntia ◽  
Frances Mejia ◽  
Xue Ning ◽  
Jeff Helton ◽  
Rulon Stacey
Keyword(s):  
United States ◽  
Supply Chain ◽  
Health System ◽  
Supply Chains ◽  
Health Systems ◽  
The United States ◽  
Supply Chain Integration ◽  
Strategic Choices ◽  
New Normal ◽  
Service Outcomes

BACKGROUND How are health systems shaping strategies to restore the supply chain disruptions in 2021? Do they want to improve the supply chain integration? Do they want to collaborate with new start-ups to revamp the supply chain? Given the widespread disruptions to supply chains in 2020 because of the COVID-19 pandemic, these questions are essential to have confidence in health systems’ supply chain model strategies. Plausibly, health systems have an opportunity for redesign, growth, and innovation by utilizing collaborative strategies now, compared to the usual strategies of integrating their existing supply chains to reduce inefficiencies. This study is focused on teasing out the nuance of supply chain integration vs. collaboration strategies for health systems in the post-COVID “new normal.” OBJECTIVE We focus on two research questions. First, we explore the impact of perceived supply chain challenges and disruptions on health systems’ supply chain integration (SC-INTEGRATION) and collaborative redesign (SC-REDESIGN) strategies. Second, we examine the outcomes of integration and collaborative redesign strategic choices on growth and service outcomes. METHODS We surveyed a robust group of health system chief executive officers (CEOs) (N=625) across the United States from February to March 2021. Twenty-two percent of the CEOs (135) responded to our survey. We considered supply chain relevant strategy and outcome variables from the literature and ratified them via expert consensus. We collected secondary data from the AHRQ Compendium of the U.S. Health Systems, leading to a matched data set from the 124 health systems. Then, we employed ordered logit model estimation to examine CEO preferences for partnership strategies to address current supply disruptions and the outcomes of strategy choices. RESULTS Health systems with higher disruptions would choose integration over redesign, indicating that they still trust the existing partners. Integration strategy is perceived to result in better service outcomes while collaborations are perceived to lead to greater growth opportunities; however, the role of integration on growth is not completely ruled out. Plausibly, some health systems would choose both integration and collaborative redesign models, which have a significant relationship with both service and growth, establishing the importance of mixed strategies for health systems. CONCLUSIONS The cost of healthcare continues to rise, and supply-related costs constitute a large portion of a hospital’s expenditure. Understanding supply chain strategic choices are essential for the success of a health system. Although collaborative revamp is an option; but still focusing on and improving existing integration dynamics is helpful to foster both growth and services for health systems.

scholarly journals Evolving AAV-delivered therapeutics towards ultimate cures

2021 ◽  
Author(s):  
Xiangjun He ◽  
Brian Anugerah Urip ◽  
Zhenjie Zhang ◽  
Chun Christopher Ngan ◽  
Bo Feng
Keyword(s):  
Gene Therapy ◽  
Gene Editing ◽  
Treatment Options ◽  
Genetic Diseases ◽  
The United States ◽  
European Medicines Agency ◽  
Gene Therapies ◽  
Therapeutic Modalities ◽  
United States Food

AbstractGene therapy has entered a new era after decades-long efforts, where the recombinant adeno-associated virus (AAV) has stood out as the most potent vector for in vivo gene transfer and demonstrated excellent efficacy and safety profiles in numerous preclinical and clinical studies. Since the first AAV-derived therapeutics Glybera was approved by the European Medicines Agency (EMA) in 2012, there is an increasing number of AAV-based gene augmentation therapies that have been developed and tested for treating incurable genetic diseases. In the subsequent years, the United States Food and Drug Administration (FDA) approved two additional AAV gene therapy products, Luxturna and Zolgensma, to be launched into the market. Recent breakthroughs in genome editing tools and the combined use with AAV vectors have introduced new therapeutic modalities using somatic gene editing strategies. The promising outcomes from preclinical studies have prompted the continuous evolution of AAV-delivered therapeutics and broadened the scope of treatment options for untreatable diseases. Here, we describe the clinical updates of AAV gene therapies and the latest development using AAV to deliver the CRISPR components as gene editing therapeutics. We also discuss the major challenges and safety concerns associated with AAV delivery and CRISPR therapeutics, and highlight the recent achievement and toxicity issues reported from clinical applications.

scholarly journals American and Canadian Health System Overview

2021 ◽  
pp. 32-37
Author(s):  
Ahmad Khan,
Keyword(s):  
United States ◽  
Infant Mortality ◽  
Life Expectancy ◽  
Maternal Mortality ◽  
Health System ◽  
Health Systems ◽  
Healthcare Services ◽  
The United States ◽  
Universal Healthcare ◽  
The World

Scientists have written numerous papers studying different aspects of health systems in the world. Comparing health systems in the world is essential for policymakers to learn from each other to make healthcare services effective with better outcomes and decrease the cost of healthcare services. In the world, countries have different health systems. The difference in the health systems is a combination of components that are specific to each country based on the financial status of healthcare, workforce, and infrastructures. This paper will evaluate the contrast of Canadian and American health systems payment systems, timely access, and healthcare quality outcomes. Both countries are well-developed countries that have a health system with excellent infrastructure and effective healthcare services. However, the system operates differently in both countries. America does not have a universal healthcare plan and spends more money per capita compared to Canada. The United States has a lower rank than its peer, underperforms in maternal mortality, infant mortality, preventable deaths, and life expectancy. On the other hand, Canada has a universal healthcare plan for all Canadian residents and performs better in life expectancy, infant mortality, and maternal mortality. However, waiting for specialized care is longer than in the United States.

scholarly journals Struggling with COVID-19—A Framework for Assessing Health System Performance

2021 ◽  
Vol 13 (20) ◽  
pp. 11146
Author(s):  
Iwona Markowicz ◽  
Iga Rudawska
Keyword(s):  
Health System ◽  
Conceptual Framework ◽  
Health Systems ◽  
System Performance ◽  
Methodological Approach ◽  
The United States ◽  
World Health ◽  
Pilot Test ◽  
Critical Dimensions ◽  
International Agencies

Currently, no guidelines exist on how to evaluate the performance of health systems fighting the SARS-CoV-2 pandemic. Therefore, this study seeks (1) to develop a conceptual framework that would be helpful in the given context, and (2) to test the feasibility of the proposed approach. The framework is conceptualized based on investigating critical dimensions and indicators for the successful design of a method for evaluating the performance of health systems. Subsequently, the taxonomic measure of development is used and a correlational analysis made in order to run a pilot test of the proposed concept. The finalized conceptual framework has five input dimensions (demographical burden, epidemiological burden, health-related quality of life, financial resources, and access) described by 18 indicators, and two output domains (outcomes, productivity) described by six indicators to monitor system performance under the COVID-19 pandemic. The pilot-test conducted in European Union countries and the United States proved the model to be useful and feasible. The proposed framework can be used to assess the performance of health systems fighting novel pathogens, such as SARS-CoV-2, worldwide. Our methodological approach can be used as a benchmark for international agencies such as the World Health Organization in developing their own frameworks. The paper presents the first research exploring the evaluation of a health system during the COVID-19 pandemic. It has the potential to help monitor a health system’s performance during the pandemic by accounting for specific country-related circumstances. In a broader sense, it can contribute to boosting health market competitiveness in terms of quality.

scholarly journals Falling Between the Cracks: Experiences of Black Dementia Caregivers Navigating U.S. Health Systems

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 977-977
Author(s):  
Karah Alexander ◽  
Sloan Oliver ◽  
Fayron Epps
Keyword(s):  
Health System ◽  
Social History ◽  
Health Systems ◽  
Healthcare Providers ◽  
Well Being ◽  
The United States ◽  
Healthcare Management ◽  
Healthcare Outcomes ◽  
Dementia Caregivers ◽  
Black Caregivers

Abstract In addition to numerous care responsibilities, family caregivers are expected to navigate health systems and engage in healthcare management tasks on behalf of their persons living with dementia (PLWD). These challenging tasks pose additional difficulties for Black dementia caregivers. Due to the centuries-old, disadvantaged social history of Black Americans, several unique stressors, vulnerabilities, and resources have emerged which inform and affect Black dementia caregivers’ experiences and well-being. Focus groups were held with Black caregivers (N = 19) from the United States (U.S.) to explore the unique experiences and perspectives of this population navigating the U.S. health system on behalf of their PLWD. Five overarching themes were developed during thematic analysis: Forced Advocacy, Poor Provider Interaction, Payor Source Dictates Care, Discrimination, and Broken Health System. Black dementia caregivers unanimously concurred that the health system that they experience in America is “broken.” Gaps in the health system can lead to people [as one caregiver passionately expressed] “falling between the cracks,” in terms of care, services, and resources needed. Caregivers agreed that class, sex, utilizing public health insurance, and being a “person of color” contribute to their difficulties navigating the health system. Caregivers perceived being dismissed by providers, forcing them to advocate for both themselves and their PLWD. Healthcare providers and researchers can utilize these findings to improve the experiences and healthcare outcomes of Black patients with dementia and their caregivers. Additionally, these findings can lead to the development of culturally tailored caregiver education programs.

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