scholarly journals The Max Access Solution: A 'No Patient Left Behind' Model for Treatment Access

2018 ◽  
Vol 4 (Supplement 3) ◽  
pp. 29s-29s
Author(s):  
Ann K. Novakowski ◽  
Pat Garcia-Gonzalez

Purpose The Max Foundation has led the development and implementation of the widely recognized model for patient assistance programs by which manufacturers make available some of their innovative products to patients in low- and middle-income countries. Recognizing that a limitation of a pharmaceutical patient assistance program is the focus on a particular product while a patient’s cancer need is company agnostic, the Max Access Solution borrows from all the lessons learned from developing and managing access programs while shifting the focus from the drug to the patient. This innovative long-term access approach provides a bridge to treatment to individually identified patients in countries where the treatment is not otherwise locally available. Methods The initiative focuses on the patient and his or her needs across the disease spectrum, harnessing the power of multisector collaborations, including drug manufacturers, international distributors, diagnostics companies, ministries of health, ministries of health hospitals, cancer centers and other public institutions in recipient countries, and local nongovernmental organizations and patient organizations, as well as cancer research centers in the United States. We established the following measurable objectives: identify all treatments approved for a particular cancer, identify the supportive care needed to successfully treat the disease, identify local and international stakeholders for the success of the initiative, develop collaborative agreements with each of them, and establish an end-to-end validated supply chain into each country/cancer institution. Results In the first year of implementation, The Max Foundation delivered more than 700,000 required daily doses of oral cancer medication for CML to more than 10,000 patients in 65 countries, made 2,500 molecular tests available to patients, executed more than 220 collaboration agreements, and established a gross domestic product–validated supply chain into 90 cancer-treating institutions. Conclusion The Max Access Solution is a unique and innovative approach to cancer care access. An aim of The Max Foundation in developing the Max Access Solution for CML was as a proof of concept as well as to develop systems and impact measurements, with the long-term vision of expanding the model to other cancers. This model may be replicated in a variety of noncommunicable disease areas, including breast cancer and other cancers, to reduce health disparities globally. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc . No COIs from the authors.

Author(s):  
Ryan J Hannan ◽  
Margaret K Lundholm ◽  
Dennis Brierton ◽  
Noelle R M Chapman

Abstract Purpose To describe how health systems may respond to sudden changes in operations by leveraging existing resources and to share one organization’s experience responding to the coronavirus disease (COVID-19) pandemic. Summary In a health system based in Illinois and Wisconsin, pharmacy services are provided by a single, integrated department responsible for all aspects of pharmaceutical care within the organization. Hospital, retail, ambulatory care, and population health services are all managed under one leadership team. All pertinent ancillary services are also managed within the department, including informatics, supply chain, and drug policy. During the COVID-19 pandemic, the pharmacy services leadership has successfully managed volume and capacity challenges by redirecting resources to where they are needed. A disaster response framework based on Federal Emergency Management Agency guidance was put in place, and change management principles were used to rapidly operationalize change. Components of the nimble response have included quickly increasing capacity, thoughtful and timely communication to all team members, strategic decision making with available data, creating an agile pool of labor, and maintaining an efficient system supply chain. Well-being and resilience are emphasized alongside reflection on lessons learned. Some changes made in the urgent response to the pandemic are being considered for long-term implementation. Conclusion Organizations have the potential to respond to almost any situation if they are integrated and teams work together to build flexibility. The keys to success are thoughtful maximization of existing resources and strong communication.


2021 ◽  
pp. 875687052110493
Author(s):  
Brandy N. Brewer ◽  
Leah A. Riggs ◽  
Ginevra Courtade ◽  
Timothy J. Landrum

The COVID-19 pandemic has been one of the most dramatic and far-reaching events to impact education in recent years. At the onset of this global crisis, schools were required to pivot, with little warning or planning, to educate the more than 50 million school-aged children in the United States through some form of nontraditional instruction (NTI), which often involved technology-based distance education. While shifts to NTI for short time periods may be feasible for many students, the potential impact of long-term NTI on students with extensive support needs (ESNs) and their families, especially in rural areas, may be particularly acute. In this article, we discuss specific strategies that address and incorporate what we know about extended NTI in rural school districts, including both lessons learned and areas of concern, with particular attention to the role and importance of caregivers. We outline ways that caregivers can be supported and how natural environment teaching provides one useful framework for efforts to reduce skill regression and to increase the overall potential for skill generalization when traditional schooling is interrupted.


2021 ◽  
Author(s):  
Saif Khan

The countries with the greatest capacity to develop, produce and acquire state-of-the-art semiconductor chips hold key advantages in the development of emerging technologies. At present, the United States and its allies possess significant leverage over core segments of the supply chain used to produce these chips. This policy brief outlines actions the United States and its allies can take to secure that advantage in the long term and use it to promote the beneficial use of emerging technologies, such as artificial intelligence.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 160-160
Author(s):  
Rebecca Davis ◽  
Cheryl Monturo ◽  
Maria O'Reilly ◽  
Diana Sturdevant

Abstract The pandemic profoundly affected the care of older adults in long term care communities (LTCC) across the world. More than one third of pandemic deaths were linked to nursing homes. Most nations and states had strict guidelines on visitation, with many, especially in the United States, totally prohibiting visitation for over an entire year. Well-intentioned measures to protect through isolation caused a profound ethical tension between safety and self-determination. The aim of the project was to examine this dilemma using a case study and the Madison Collaborative Ethical Reasoning in Action Framework. Eight key questions of fairness, outcomes, rights, responsibilities, character, liberty, empathy, and authority were applied in the context of federal and state mandates in the US and Australia. Results highlighted issues of ageism, paternalism vs empathy, regulatory vs family authority, a focus on short-term outcomes while forfeiting long-term outcomes, community responsibilities to the resident trumped individual resident rights, the potential loss of community character in lieu of basic care provision, a loss of personal freedoms, and the emphasis of physical well-being over holistic well-being. The results of this analysis can inform future policy and provide lessons learned for the future.


2018 ◽  
Vol 6 (3) ◽  
pp. 91 ◽  
Author(s):  
Linda Amaral-Zettler ◽  
Victor Schmidt ◽  
Katherine Smith

There is broad interest in disease spread through the pet trade, but empirical research on hosts and pathogens in transit along actual trade routes is notably absent. Using next-generation DNA sequencing, and partnering with the ornamental fish industry, we tracked shifts in microbial community and potential pathogen structure associated with Sailfin Tang (Zebrasoma desjardinii) along the United States (U.S.) leg of an international supply chain. We observed striking changes in microbial diversity and composition of potential pathogens, including increased dominance of vibrios of fishes in transit. Our pilot findings suggest that high investment in fishes early in the supply chain may not matter to their long-term health depending on end destination conditions.


2020 ◽  
Vol 12 (14) ◽  
pp. 5858 ◽  
Author(s):  
Guiyang Zhu ◽  
Mabel C. Chou ◽  
Christina W. Tsai

COVID-19 is a highly infectious respiratory virus that has posed a great threat to the general public. In order to prevent its spread, many governments have enacted stringent measures. Supply chains around the world are facing major disruptions and difficulties adjusting to the new demands and needs of a locked down world. In this paper, we will address the relationship between supply chain operations and the ongoing COVID-19 pandemic. Given current global shortages in essential goods such as medication, we explore the connection between said shortage and supply chain issues, such as the lack of supply chain transparency and resilience, as well as unsustainable just-in-time manufacturing. To mitigate the effects of these issues and protect supply chain operations, we propose some recommendations, such as nationalizing the medical supply chains, adopting a plus one diversification approach, and increasing safety stock. These recommendations are given to not only mitigate current consequences in relation to the ongoing crisis, but also to suggest measures that will provide firms the resiliency needed to weather similar potential shortages in the future.


2015 ◽  
Vol 1 (1) ◽  
pp. 37-45 ◽  
Author(s):  
Pat Garcia-Gonzalez ◽  
Paula Boultbee ◽  
David Epstein

Imatinib was the first targeted therapy approved for the treatment of cancer. With its approval, it was immediately clear to Novartis that this breakthrough therapy would require an innovative approach to worldwide access, with special consideration of low- and middle-income countries. Lack of government reimbursement, universal health care, or health insurance coverage, few trained specialty physicians or diagnostic services, and poor health care infrastructure were, and continue to be, contributing barriers to access to treatment in low- and middle-income countries. The Glivec International Patient Assistance Program (GIPAP) is an international drug donation program established by Novartis Pharma AG and implemented in partnership with The Max Foundation, a nonprofit, nongovernmental organization. GIPAP was established in 2001, essentially in parallel with the first approval of imatinib for chronic myeloid leukemia. Since 2001, GIPAP has made imatinib accessible to all medically and financially eligible patients within 80 countries on an ongoing basis as long as their physicians prescribe it and no other means of access exists. To date, more than 49,000 patients have benefited from GIPAP, and 2.3 million monthly doses of imatinib have been approved through the program. GIPAP represents an innovative drug donation model that has set the standard for access programs for other targeted or innovative therapies. The purpose of this article is to describe the structure of GIPAP, as well as important lessons that have contributed to the success of the program. This article may assist other companies with the development of successful and far-reaching patient assistance programs in the future.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 591-591
Author(s):  
Leah Haverhals

Abstract This research describes how home-based long-term care settings in Puerto Rico, connected to the United States Department of Veterans Affairs (VA) and in non-VA settings, prepared for and secured the safety and wellbeing of elderly and disabled persons during and after Hurricane Maria, which struck Puerto Rico on September 20, 2017. I collected data via in-person interviews, home visits, and field observations between January-March 2019. Guided by a social vulnerability and health model, I interviewed a multitude of people connected to and/or caring for elderly and disabled populations in these settings. Results emphasize importance of disaster preparedness, incorporating lessons learned from hardships, and how Puerto Rico’s colonial status and economic realities influenced recovery. VA’s interconnected nature provided a stronger support network compared to non-VA settings that were often independently or family run. Regardless of setting, the resilience and collaborative spirit of Puerto Ricans proved instrumental in recovery and disaster management.


2012 ◽  
Vol 3 (1) ◽  
Author(s):  
Chin-Fun Chu ◽  
Lincy S Lal ◽  
Tisha M Felder ◽  
Pauline Rosenau

One strategy to encourage uninsured and underinsured patients' compliance with medication regimen is to refer them to pharmaceutical industry-sponsored patient assistance programs (PAPs). In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82%) of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62%) were brand name; 29 (26%) were generic, and 13 (12%) had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic) provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001), permanent residency (p < 0.001), and prescription drug coverage (p< 0.001), but not for income limits (p= 0.051). Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.   Type: Original Research


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