Evergreening, patent challenges, and effective market life in pharmaceuticals

Observers worry that generic patent challenges are on the rise and reduce the effective market life of drugs. A related concern is that challenges disproportionately target high-sales drugs, reducing market life for these "blockbusters." To study these questions, we examine new data on generic entry over the past decade. We show that challenges are more common for higher sales drugs. We also demonstrate a slight increase in challenges over this period, and a sharper increase for early challenges. Despite this, effective market life is stable across drug sales categories, and has hardly changed over the decade. To better understand these results, we examine which patents are challenged on each drug, and show that lower quality and later expiring patents disproportionately draw challenges. Overall, this evidence suggests that challenges serve to maintain, not reduce, the historical baseline of effective market life, thereby limiting the effectiveness of "evergreening" by branded firms.     

Embracing Gay, Lesbian, Bisexual, and Transgendered Youth in School-Based Settings

Youth with invisible challenges constitute a special area of concern for child and youth care workers. Youth struggling with gender and sexual orientation are reported to comprise ten percent of our youth population yet they may often be unknown to teachers and other school personnel. These adolescents face unique challenges in developing their identity and gaining social acceptance. This paper explores the challenges faced by these youth, the consequences of underserving this population and proposes some strategies for improving their educational experience.     

Momma, oh Momma, I can't remember

Institutionalized persons with dementia present many challenges to pastoral caregivers. The loss of memory and cognitive functions in these persons requires that caregivers value the immediate moment of pastoral contact and ground their ministry in relevant theological foundations. Examples of these challenges are provided and theological concepts are discussed.     

VHA Chaplains: Challenges,Roles, Rewards,and Frustrations of the Work

Chaplains working in the Veterans Health Administration have numerous roles and challenges. They work closely with other behavioral health professionals, especially social workers, to address the multiplicity of needs of the Veteran population. They are essentially an understudied subset of the military Chaplaincy service (most studies focus on those engaged in combat areas). In this exploratory qualitative study, VHA Chaplains responded to a survey to determine how they defined their role and professional challenges, what they felt were the rewards and frustrations of their work and their unique function within the VHA system. Findings showed that role differences between Chaplains and social workers and other behavioral health providers are clearly defined; rewards and challenges were diverse and frustrations were common to those working in a bureaucratic structure.     

Providers,Unmarried Young Women,and Post‐Abortion Care in Kenya

Young women and girls in Kenya face challenges in access to abortion care services. Using in‐depth and focus group interviews, we explored providers’ constructions of these challenges. In general, providers considered abortion to be commonplace in Kenya; reported being regularly approached to offer abortion‐related care and services; and articulated the structural, contextual, and personal challenges they faced in serving young post‐abortion care (PAC) patients. They also considered induced abortion among young unmarried girls to be especially objectionable; stressed premarital fertility and out‐of‐union sexual activity among unmarried young girls as transgressive of respectable femininity and proper adolescence; blamed young women and girls for the challenges they reported in obtaining PAC services; and linked these challenges to young women's efforts to conceal their failures related to gender and adolescence, exemplified by pre‐marital pregnancy and abortion. This study shows how providers’ distinctive emphasis that young abortion care‐seekers are to blame for their own difficulties in accessing PAC may add to the ongoing crisis of post‐abortion care for young women and adolescent girls in Kenya.     

Returning physicians to the workforce: history, progress, and challenges

There is growing recognition of the need to reeducate clinically inactive physicians seeking to return to practice and in the facilitation of this return. Physicians seeking to return to practice face many challenges: maneuvering the various requirements of licensing, medical, and credentialing boards; finding an appropriate educational program to become up to date in current practice; paying for the program; and overcoming personal obstacles. Educational programs also face challenges: cost of development and maintenance; allocation of staff and faculty time to reeducate returning physicians alongside other learners; provision of emotional counseling and career guidance; interpretation of varied licensing and board guidelines; and the need to tailor one's program to individual trainees. Despite these challenges, some programs are returning physicians to the workforce. To provide perspective, we review why physicians leave medicine and return. We then discuss challenges for returning physicians and program developers and highlight current educational resources and organizational efforts to facilitate return. We close by offering next steps for programs to facilitate return.     

Challenges of combining work and unpaid care,and solutions: A scoping review

The number of people who combine work and unpaid care is increasing rapidly as more people need care, public and private care systems are progressively under pressure and more people are required to work for longer. Without adequate support, these working carers may experience detrimental effects on their well‐being. To adequately support working carers, it is important to first understand the challenges they face. A scoping review was carried out, using Arksey and O’Malley's framework, to map the challenges of combining work and care and solutions described in the literature to address these challenges. The search included academic and grey literature between 2008 and 2018 and was conducted in April 2018, using electronic academic databases and reference list checks. Ninety‐two publications were mapped, and the content analysed thematically. A conceptual framework was derived from the analysis which identified primary challenges (C1), directly resulting from combining work and care, primary solutions (S1) aiming to address these, secondary challenges (C2) resulting from solutions and secondary solutions (S2) aiming to address secondary challenges. Primary challenges were: (a) high and/or competing demands; (b) psychosocial/‐emotional stressors; (c) distance; (d) carer's health; (e) returning to work; and (f) financial pressure. This framework serves to help those aiming to support working carers to better understand the challenges they face and those developing solutions for the challenges of combining work and care to consider potential consequences or barriers. Gaps in the literature have been identified and discussed.     

Stress,Frequency of Challenges,and Coping for Partners of Individuals with Mental Health Conditions

This study applied Lazarus and Folkman’s stress and coping framework to understand how romantic partners cope with the challenges of a significant other’s mental health condition at three levels (i.e., individual, dyadic, and social), how coping at each of these three levels contributes to the association between stress and relational quality for these partners, and how these associations depend upon the frequency of challenges partners experience. We predicted that stress would be negatively associated with relational quality, and that individual (i.e., emotion and problem-focused), dyadic, and social coping would mediate this association. We also posited that the extent to which partners cope would depend on the frequency of challenges they face. We analyzed data from 325 individuals with a moderated multiple-mediation model. Findings provided support for the mediating role of dyadic coping and its positive association with relational quality; partial support for the mediating role of emotion-focused coping and its negative association with relational quality; and partial support for the moderating role of frequency of challenges. We discuss the study’s findings and contributions.     

Vulnerable people, groups, and populations: societal view

Vulnerability, the susceptibility to harm, results from an interaction between the resources available to individuals and communities and the life challenges they face. Vulnerability results from developmental problems, personal incapacities, disadvantaged social status, inadequacy of interpersonal networks and supports, degraded neighborhoods and environments, and the complex interactions of these factors over the life course. The priority given to varying vulnerabilities, or their neglect, reflects social values. Vulnerability may arise from individual, community, or larger population challenges and requires different types of policy interventions--from social and economic development of neighborhoods and communities, and educational and income policies, to individual medical interventions.     

Improving performance using indicators. Recent experiences in the United States, the United Kingdom, and Australia.

This article describes recent national performance improvement initiatives in the United States, United Kingdom, and Australia. This comparison is of particular interest because each of these three countries faces similar challenges in delivering health care and improving health. Each has elevated a focus on safety and quality improvement to a national level. Marked differences in the organization and financing of health care across these three countries provide a unique opportunity to compare and contrast approaches. Drawing on the experience of the authors in each of the three countries and publicly available data sources about specific national initiatives, we describe the national context for improvement and outline recent performance improvement initiatives and emerging issues and challenges. Similarities and differences in the current evolution of national performance initiatives are described and conclusions are drawn about challenges that all three countries face, particularly in terms of developing meaningful sets of national indicators of health system performance. The challenges for future work include the importance of information infrastructure, the paucity of accurate and accessible clinical data, the need for effective performance measurement processes at a local level to capture useful data, and the tensions of balancing accountability and improvement agendas for measurement.     

Future challenges for nuclear power plant development research, and for radiological protection sciences

The promise of the future shines brightly for nuclear energy technology and production, yet also holds many challenges. Focus on new reactor designs is currently aiming at what is termed the fourth generation of reactors, which will come into operation after 2030. The 10 countries participating in the Generation-IV International Forum to develop the new generation of reactors have designated six reactor designs that will be studied. This paper will briefly discuss some of these challenges in new reactor designs in general. In addition to the challenges posed by new reactor designs, radiation protection is also faced with a series of challenges for the future. These are borne from experience with the implementation of the current system of radiological protection, from the evolution of radiation biological research, and from changes in society in the area of radiological risk assessment and management. This paper will address all of these emerging challenges, and point towards approaches to resolve them in the future.     

The effectiveness of community-based animal health workers, for the poor, for communities and for public safety

The development of community animal health (CAH) is an invaluable tool for addressing a series of challenges, particularly for the policy-maker, whose prime concern is public welfare. This paper examines three of the major challenges which confront governments, particularly the governments of less-developed countries, namely, the collapse of government services, the crucial issue of poverty reduction and the misuse of animal drugs. Although CAH is a potentially powerful tool for approaching all of these problems, the authors argue that CAH can only be fully exploited on a macroscopic level by developing strong institutions to support and regulate such community initiatives. In some countries, developing such institutions depends upon accepting the more fundamental and controversial principle of legalising non-professional animal health service providers who work within the private sector. In Section 1, the authors outline the three principal challenges which face governments, particularly in developing countries, and to which CAH offers a potential solution. Sections 2 to 4 investigate the evidence relating to each of these challenges in turn. Section 5 briefly draws on the lessons that have been generated by field experiences over the years, to propose how governments may develop CAH systems to their best advantage.     

Managing clinical research information: a case study in information access, presentation, and analysis

Medical information systems at the NIH must meet the twin challenges of excellent patient care and innovative clinical research. This article describes the approach taken by the clinical center at the NIH to enhance its information systems to meet these challenges. The four key components of this strategy are the standard clinical desktop, the clinical data repository, the repository access package, and protocol mapping. Together, these tools provide significant new capabilities for patient care staff and clinical investigators.     

Assessing the need, use, and developments in mental health/substance abuse care

This overview presents an introduction to the articles published in this issue of the health care Financing Review, entitled "Mental Health Services and Vulnerable Populations." This article discusses the challenges the mental health and substance abuse (MH/SA) care system is confronted with in terms of equity and efficiency and how the system is responding to these challenges. It further addresses research issues in assessing the need and use of mental health services and summarizes recent activities in the research and evaluation of new delivery and payment systems.     

Sensitive topics, survey nonresponse, and considerations for interviewer training

This paper discusses current challenges in achieving higher survey participation rates in random-digit-dial telephone surveys and proposes steps to address them through interviewer training to avoid refusals. It describes features of surveys that contribute to respondent reluctance to participate and offers a brief overview of current refusal aversion training methods to reduce nonresponse. It then identifies what challenges that unique features of random-digit-dial telephone surveys on sensitive topics might contribute to nonresponse. Recommendations are then proposed for changes in refusal aversion training, standard survey introductions, and informed consent procedures. Finally, further research is called for to identify which methods best balance the need to improve response rates with respondent safety and privacy in surveys with sensitive questions.     

Community pharmacists at transition to independent practice: Isolated,unsupported, and stressed

While there is evidence from nursing and medicine that transition to independent practitioner is challenging and has implications for patient care, there is little research exploring novice community pharmacists' (NCPs) transition. This study aimed to identify the challenges faced by NCPs at transition to independent practitioner and perceptions of the relative importance of these challenges. Nominal group discussions were held between November 2015 and April 2016, in North West England, with purposively sampled NCPs, early career pharmacists, work‐based preregistration tutors, and pharmacy support staff. In response to the question “What are the challenges faced by NCPs at transition?” participants individually wrote down and subsequently called out, in round‐robin fashion, then discussed, and broadly categorised challenges before ranking them in order of importance. Discussions were audio‐recorded with consent, transcribed, and analysed thematically. Twenty‐five participants from independent, supermarket, and small and large multiple pharmacies took part in five nominal group discussions. Challenges experienced through interacting with the workplace environment were identified as: (in order of importance) relationship management; confidence; decision‐making; being in charge and accountable; and adapting to the workplace. With the exception of disagreement between pharmacists and pharmacy support staff regarding whether adapting to the team was challenging for NCPs, all participants reported challenges experienced through interacting with the workplace environment. Challenges were described as inducing psychosocial stress, particularly because NCPs acquired immediate professional accountability, worked in isolation from experienced peers, and faced job‐related pressures. Interpretation of the findings suggests that the Karasek job‐demand‐control‐support (JDCS) model of occupational stress provides valuable insight about transition for NCPs. NCPs' jobs are classified as high strain, where high workplace demands coupled with NCPs' lack of control in being able to meet demands, together with isolation and lack of support, result in transition being characterised as causing isostrain, where the workplace becomes a “noxious” environment.     

Expectations,validity, and reality in gene expression profiling

ObjectiveTo provide a critical overview of gene expression profiling methodology and discuss areas of future development.ResultsGene expression profiling has been used extensively in biological research and has resulted in significant advances in the understanding of the molecular mechanisms of complex disorders, including cancer, heart disease, and metabolic disorders. However, translating this technology into genomic medicine for use in diagnosis and prognosis faces many challenges. In addition, gene expression profile analysis is frequently controversial, because its conclusions often lack reproducibility and claims of effective dissemination into translational medicine have, in some cases, been remarkably unjustified. In the last decade, a large number of methodological and technical solutions have been offered to overcome the challenges.Study Design and SettingWe consider the strengths, limitations, and appropriate applications of gene expression profiling techniques, with particular reference to the clinical relevance.ConclusionSome studies have demonstrated the ability and clinical utility of gene expression profiling for use as diagnostic, prognostic, and predictive molecular markers. The challenges of gene expression profiling lie with the standardization of analytic approaches and the evaluation of the clinical merit in broader heterogeneous populations by prospective clinical trials.     

Valuation of Health and Nonhealth Outcomes from Next-Generation Sequencing: Approaches,Challenges, and Solutions

Background

Next-generation sequencing (NGS) technologies have seen variable adoption in the clinic. This is partly due to a lack of clinical and economic studies, with the latter increasingly challenged to examine patient preferences for health and nonhealth outcomes (e.g., false-positive rate).