How Can General Managers Best Leverage Medical Affairs Now and in the Future?

General managers (GMs) play a crucial role as enterprise leaders of the country affiliate of multi-national pharmaceutical companies, balancing needs, objectives and governance across all local functions. One such function, Medical Affairs, has undergone a significant evolution from a support function into a strategic partner and in some organizations a strategic leader supported by the increasing complexity of medications and a shift to more specialized medicines. Although the function has progressed significantly, there is opportunity to elevate Medical Affairs to another level, with GMs and business unit directors (BUDs) recommending increased business acumen, strategic approach, innovation and project management as competencies that could be further cultivated. Examining the current trends in the industry, including the increasing complexity of innovative medicines and patient journeys, a higher burden of evidence for the reimbursement of medicines, innovative data generation opportunities, the changing stakeholder engagement expectations and the focus on corporate reputation, Medical Affairs is positioned as a key to assist in navigating the organization through these complexities. The GM can help to foster the evolving role of Medical Affairs, encouraging lateral moves for broader enterprise mindset, imparting a culture of shared governance responsibilities across functions to encourage innovative thinking and nurture upcoming leaders by investing in training to take advantage of the above trends and deliver best patient and organizational outcomes now and in the future.

Postexposure prophylaxis for occupational exposure to selected pathogens for healthcare personnel.

PURPOSE OF REVIEW: Timely postexposure prophylaxis is important after an occupational exposure. Here we review select organisms, exposure opportunities in the healthcare setting, and postexposure prophylaxis regimens. RECENT FINDINGS: Needlestick injuries pose a risk of exposure to bloodborne pathogens, such as HIV, Hepatitis B, and Hepatitis C. Risk mitigation strategies should be reexamined in light of newer vaccines and therapeutics. Increased vaccine hesitancy and vaccine denialisms may foster the re-emergence of some infections that have become extremely uncommon because of effective vaccines. With increasing occurrences of zoonotic infections and the ease of global spread as evidenced by COVID-19 and mpox, healthcare exposures must also consider risks related to emerging and re-emerging infectious diseases. SUMMARY: Early recognition and reporting of occupational exposures to pathogens with available postexposure prophylaxis is key to mitigating the risk of transmission. Providers should be able to evaluate the exposure and associated risks to provide prompt and appropriate postexposure prophylaxis.

Curriculum development in Liberia's first postgraduate psychiatry training programme.

This paper describes the implementation of curricula for Liberia's first-ever psychiatry training programme in 2019 and the actions of the only two Liberian psychiatrists in the country at the time in developing and executing a first-year postgraduate psychiatry training programme (i.e. residency) with support from international collaborators. It explores cultural differences in training models among collaborators and strategies to synergise them best. It highlights the assessment of trainees' (residents') basic knowledge on entry into the programme and how it guided immediate and short-term priority teaching objectives, including integrated training in neuroscience and neurology. The paper describes the strengths and challenges of this approach as well as opportunities for continued growth.

Validation of an ICD-Code-Based Case Definition for Psychotic Illness Across Three Health Systems.

BACKGROUND AND HYPOTHESIS: Psychosis-associated diagnostic codes are increasingly being utilized as case definitions for electronic health record (EHR)-based algorithms to predict and detect psychosis. However, data on the validity of psychosis-related diagnostic codes is limited. We evaluated the positive predictive value (PPV) of International Classification of Diseases (ICD) codes for psychosis. STUDY DESIGN: Using EHRs at 3 health systems, ICD codes comprising primary psychotic disorders and mood disorders with psychosis were grouped into 5 higher-order groups. 1133 records were sampled for chart review using the full EHR. PPVs (the probability of chart-confirmed psychosis given ICD psychosis codes) were calculated across multiple treatment settings. STUDY RESULTS: PPVs across all diagnostic groups and hospital systems exceeded 70%: Mass General Brigham 0.72 [95% CI 0.68-0.77], Boston Children's Hospital 0.80 [0.75-0.84], and Boston Medical Center 0.83 [0.79-0.86]. Schizoaffective disorder PPVs were consistently the highest across sites (0.80-0.92) and major depressive disorder with psychosis were the most variable (0.57-0.79). To determine if the first documented code captured first-episode psychosis (FEP), we excluded cases with prior chart evidence of a diagnosis of or treatment for a psychotic illness, yielding substantially lower PPVs (0.08-0.62). CONCLUSIONS: We found that the first documented psychosis diagnostic code accurately captured true episodes of psychosis but was a poor index of FEP. These data have important implications for the case definitions used in the development of risk prediction models designed to predict or detect undiagnosed psychosis.

A mixed-methods evaluation of patients' views on primary care multi-disciplinary teams in Scotland.

BACKGROUND: Expanding primary care multi-disciplinary teams (MDTs) was a key component of the 2018 Scottish GP contract, with over 4,700 MDT staff appointed since then. AIM: To explore patients' views on primary care MDT expansion in Scotland. DESIGN AND METHODS: (1) Survey of patients recently consulting a GP in deprived-urban, affluent-urban and remote/rural areas, assessing awareness of five MDT roles and attitudes towards receptionist signposting; (2) 30 individual interviews exploring MDT-care experiences. RESULTS: Of 1,053 survey respondents, most were unaware of the option of MDT rather than GP consultations for three out of five roles (69% unaware of link worker appointments; 68% mental health nurse; 58% pharmacist). Reception signposting was less popular in deprived-urban areas (34% unhappy vs 29% in remote/rural vs 21% affluent-urban; P<0.001), and in patients with multimorbidity (31% unhappy vs 24% in non-multimorbid; P<0.05).Two-thirds of interviewees had multimorbidity and almost all reported positive MDT-care experiences. However, MDT-care was generally seen as a supplement rather than a substitute for GP care. Around half of patients expressed concerns about reception signposting. These patients were more likely to also express concerns about GP access in general. Both of these concerns were more common in deprived-urban areas than in remote/rural or affluent-urban areas. CONCLUSION: MDT-care has expanded in Scotland with limited patient awareness. Although patients understand its potential value, many patients are unhappy with reception signposting to first-contact MDT care, especially those in deprived-urban areas living with multimorbidity. This represents a barrier to the aims of the new GP contract.

Validation of an ICD-code-based case definition for psychotic illness across three health systems.

Background and Hypothesis: Early detection of psychosis is critical for improving outcomes. Algorithms to predict or detect psychosis using electronic health record (EHR) data depend on the validity of the case definitions used, typically based on diagnostic codes. Data on the validity of psychosis-related diagnostic codes is limited. We evaluated the positive predictive value (PPV) of International Classification of Diseases (ICD) codes for psychosis. Study Design: Using EHRs at three health systems, ICD codes comprising primary psychotic disorders and mood disorders with psychosis were grouped into five higher-order groups. 1,133 records were sampled for chart review using the full EHR. PPVs (the probability of chart-confirmed psychosis given ICD psychosis codes) were calculated across multiple treatment settings. Study Results: PPVs across all diagnostic groups and hospital systems exceeded 70%: Massachusetts General Brigham 0.72 [95% CI 0.68-0.77], Boston Children's Hospital 0.80 [0.75-0.84], and Boston Medical Center 0.83 [0.79-0.86]. Schizoaffective disorder PPVs were consistently the highest across sites (0.80-0.92) and major depressive disorder with psychosis were the most variable (0.57-0.79). To determine if the first documented code captured first-episode psychosis (FEP), we excluded cases with prior chart evidence of a diagnosis of or treatment for a psychotic illness, yielding substantially lower PPVs (0.08-0.62). Conclusions: We found that the first documented psychosis diagnostic code accurately captured true episodes of psychosis but was a poor index of FEP. These data have important implications for the development of risk prediction models designed to predict or detect undiagnosed psychosis.

Social domains of poor mental health: A qualitative pilot study of community stakeholders' understanding and demarcation of mental illness and its interpretations in rural Nigeria.

Background and Aims: Although previous studies on mental health/illness in Nigeria have explored knowledge and attitude of community members using quantitative approaches, few studies have engaged stakeholders within rural communities on the issue of mental illness using qualitative approaches. Community stakeholders play a critical role in influencing health behaviors. The objective of this pilot study was to explore community stakeholders' understanding and demarcation of mental illness, and its interpretations in a rural Nigerian town. This is with the aim of shaping stakeholders understanding of people when they experience mental distress within the community. Methods: The study was conducted in Ijebu-Igbo town of Ogun State in south-west Nigeria. In-depth interviews were conducted among two religious' leaders: a Pastor and an Imam, a traditional healer, a medical doctor, and a registered nurse, and a focus group discussion was held in a church with members of its advisory committee. Results: The findings showed that community stakeholders gave multiple interpretations of mental illness and many attribute mental illness to spiritual attack, ancestral curse, anger of the gods, and personal affliction (Ogun-Afowofa). This has been categorized as familial and individual attributes in this study which is part of the main themes derived. The study findings also show that the understanding of community members regarding the root causes of mental illness is somewhat vague based on their poor knowledge of mental illness. This is because of the various interpretations they gave to explain mental health is based on their cultural orientation, socialization, and belief system, and not based on any medical knowledge. Conclusion: This pilot study was conducted to justify the main study. There is therefore a need for health education interventions to enlighten and educate community stakeholders with requisite knowledge for better understanding and interpretation of mental illness. Also, through mental health education interventions, community members will gain clarity on what mental health is and what it is not.

Precision Education: The Future of Lifelong Learning in Medicine.

ABSTRACT: The goal of medical education is to produce a physician workforce capable of delivering high-quality equitable care to diverse patient populations and communities. To achieve this aim amidst explosive growth in medical knowledge and increasingly complex medical care, a system of personalized and continuous learning, assessment, and feedback for trainees and practicing physicians is urgently needed. In this perspective, the authors build on prior work to advance a conceptual framework for such a system: precision education (PE).PE is a system that uses data and technology to transform lifelong learning by improving personalization, efficiency, and agency at the individual, program, and organization levels. PE "cycles" start with data inputs proactively gathered from new and existing sources, including assessments, educational activities, electronic medical records, patient care outcomes, and clinical practice patterns. Through technology-enabled analytics , insights are generated to drive precision interventions . At the individual level, such interventions include personalized just-in-time educational programming. Coaching is essential to provide feedback and increase learner participation and personalization. Outcomes are measured using assessment and evaluation of interventions at the individual, program, and organizational levels, with ongoing adjustment for repeated cycles of improvement. PE is rooted in patient, health system, and population data; promotes value-based care and health equity; and generates an adaptive learning culture.The authors suggest fundamental principles for PE, including promoting equity in structures and processes, learner agency, and integration with workflow (harmonization). Finally, the authors explore the immediate need to develop consensus-driven standards: rules of engagement between people, products, and entities that interact in these systems to ensure interoperability, data sharing, replicability, and scale of PE innovations.

Primary care transformation in Scotland: a qualitative evaluation of the views of patients.

BACKGROUND: The new Scottish GP contract introduced in April 2018 aims to improve quality of care through expansion of the multidisciplinary team (MDT) to enable GPs to spend more time as expert medical generalists with patients with complex needs. AIM: To explore patients' views on the changes in general practice in Scotland since the inception of the new contract. DESIGN AND SETTING: Qualitative study with 30 patients (10 living in urban deprived areas, 10 living in urban affluent/mixed urban areas, and 10 living in remote and rural areas). METHOD: In-depth semi-structured interviews with thematic analysis. RESULTS: Patients were generally unaware of the new GP contract, attributing recent changes in general practice to the COVID-19 pandemic. Ongoing concerns included access to GP consultations (especially face-to-face ones), short consultation length with GPs, and damage to continuity of care and the GP-patient relationship. Most patients spoke positively about consultations with MDT staff but still wanted to see a known GP for health concerns that they considered potentially serious. These issues were especially concerning for patients with multiple complex problems, particularly those from deprived areas. CONCLUSION: Following the introduction of the new Scottish GP contract, patients in this study's sample were accepting of first contact care from the MDT but still wanted continuity of care and longer face-to-face consultations with GPs. These findings suggest that the expert generalist role of the GP is not being adequately supported by the new contract, especially in deprived areas, though further quantitative research is required to confirm this.

Patients' experiences of GP consultations following the introduction of the new GP contract in Scotland: a cross-sectional survey.

BACKGROUND: The new Scottish GP contract commenced in April 2018 with a stated aim of mitigating health inequalities. AIM: To determine the health characteristics and experiences of patients consulting GPs in deprived urban (DU), affluent urban (AU), and remote and rural (RR) areas of Scotland. DESIGN AND SETTING: In 2022, a postal survey of a random sample of adult patients from 12 practices who had consulted a GP within the previous 30 days was undertaken. METHOD: Patient characteristics and consultation experiences in the three areas (DU, AU, RR) were evaluated using validated measures including the Consultation and Relational Empathy (CARE) Measure and Patient Enablement Instrument (PEI). RESULTS: In total, 1053 responses were received. In DU areas, multimorbidity was more common (78% versus 58% AU versus 68% RR, P<0.01), complex presentations (where the consultation addressed both psychosocial and physical problems) were more likely (16% versus 10% AU versus 11% RR, P<0.05), and more consultations were conducted by telephone (42% versus 31% AU versus 31% RR, P<0.01). Patients in DU areas reported lower satisfaction (82% DU completely, very, or fairly satisfied versus 90% AU versus 86% RR, P<0.01), lower perceived GP empathy (mean CARE score 38.9 versus 42.1 AU versus 40.1 RR, P<0.05), lower enablement (mean PEI score 2.6 versus 3.2 AU versus 2.8 RR, P<0.01), and less symptom improvement (P<0.01) than those in AU or RR areas. Face-to-face consultations were associated with significantly higher satisfaction, enablement, and perceived GP empathy than telephone consultations in RR areas (all P<0.05). CONCLUSION: Four years after the start of the new GP contract in Scotland, patients' experiences of GP consultations suggest that the inverse care law persists.

Primary care transformation in Scotland: a qualitative study of GPs' and multidisciplinary team members' views.

BACKGROUND: The Scottish Government's vision to transform primary care includes expansion of the primary care multidisciplinary team (MDT), formalised in the new GP contract in April 2018. AIM: To explore practitioners' views on the expansion of MDT working in Scotland. DESIGN AND SETTING: Qualitative study with GPs and a range of MDT staff working in three different population settings in Scotland. METHOD: In-depth semi-structured interviews were carried out by telephone with 8 GPs and 19 MDT staff between May and June 2022. Interviews were audio-recorded and transcribed verbatim. Thematic analysis was conducted to identify commonalities and divergences in the interviews. RESULTS: Internal challenges facing MDT staff included adapting to the fast pace of primary care, building new relationships, training and professional development needs, line management issues, and monitoring and evaluation of performance. External challenges included the ongoing effects of the COVID-19 pandemic, lack of time, difficulties with hybrid working, and low staff morale. Most GPs reported that expansion of their roles as expert medical specialists had not yet happened because their workload had not decreased (and in many cases had increased). In deprived areas, insufficient resources to deal with the high numbers of patients with complex multimorbidity remained a key issue. Interviewees in remote and rural settings felt the new contract did not take into account the unique challenges of providing primary care services in such areas, and recruitment and accommodation were cited as particular problems. CONCLUSION: Although there has been substantial expansion of the primary care MDT, which most GPs welcome, many challenges to effective implementation remain that must be addressed if transformation of primary care in Scotland is to become a reality.

Lymphodepletion - an essential but undervalued part of the chimeric antigen receptor T-cell therapy cycle.

Lymphodepletion (LD) or conditioning is an essential step in the application of currently used autologous and allogeneic chimeric antigen receptor T-cell (CAR-T) therapies as it maximizes engraftment, efficacy and long-term survival of CAR-T. Its main modes of action are the depletion and modulation of endogenous lymphocytes, conditioning of the microenvironment for improved CAR-T expansion and persistence, and reduction of tumor load. However, most LD regimens provide a broad and fairly unspecific suppression of T-cells as well as other hematopoietic cells, which can also lead to severe side effects, particularly infections. We reviewed 1271 published studies (2011-2023) with regard to current LD strategies for approved anti-CD19 CAR-T products for large B cell lymphoma (LBCL). Fludarabine (Flu) and cyclophosphamide (Cy) (alone or in combination) were the most commonly used agents. A large number of different schemes and combinations have been reported. In the respective schemes, doses of Flu and Cy (range 75-120mg/m2 and 750-1.500mg/m2) and wash out times (range 2-5 days) differed substantially. Furthermore, combinations with other agents such as bendamustine (benda), busulfan or alemtuzumab (for allogeneic CAR-T) were described. This diversity creates a challenge but also an opportunity to investigate the impact of LD on cellular kinetics and clinical outcomes of CAR-T. Only 21 studies explicitly investigated in more detail the influence of LD on safety and efficacy. As Flu and Cy can potentially impact both the in vivo activity and toxicity of CAR-T, a more detailed analysis of LD outcomes will be needed before we are able to fully assess its impact on different T-cell subsets within the CAR-T product. The T2EVOLVE consortium propagates a strategic investigation of LD protocols for the development of optimized conditioning regimens.

Is Scotland's new GP contract addressing the inverse care law?

Scotland, like many countries around the world, has wide health inequalities resulting, in part, from the longstanding 'inverse care law', in which a mismatch between patient needs and provision of care in general practice in deprived areas results in poorer care and worse patient outcomes compared with affluent areas. In early 2018, Scotland embarked on a new GP contract, a stated aim of which was to reduce healthcare inequalities. National data on avoidable mortality showed a 4.8 (2019) and 4.9 (2021)-fold higher rate in the most deprived compared with the most affluent decile of the population. However, the distribution of whole-time equivalent (WTE) general practice clinicians per 10,000 patients, including GPs, and practice-employed practice nurses and other allied healthcare professionals, showed the opposite trend in both 2019 and 2022, with fewer WTE clinicians of all types in GP practices in deprived areas compared with affluent areas. These findings suggest that radical change is needed to reverse the inverse care law in Scotland.

Health inequalities, multimorbidity and primary care in Scotland.

Scotland has an ageing population and the widest health inequalities in Western Europe. Multiple health conditions develop ∼10-15 years earlier in deprived areas than in affluent areas. General practice is central to the effective and safe management of such complex multiple health conditions, but the inverse care law has permeated deprived communities ('Deep End' general practices) for the past 50 years. A new, radical, Scottish GP contract was introduced in April 2018, which has a vision to improve quality of care through cluster working and expansion of the multidisciplinary team (MDT), enabling GPs to deliver 'expert generalism' to patients with complex needs. It states a specific intention to address health inequalities and also to support the integration of health and social care. Here, we discuss recent evidence for whether the ambition of the new GP contract, to reduce health inequalities, is being achieved.

"It Feels Like Being a Real Doctor:" The Virtual Family Approach in Medical Education.

This article was migrated. The article was marked as recommended. The majority of health outcomes are determined by social determinants of health (SDOH) while medical care is responsible for as little as 20% of health outcomes. This article is an introduction to the Virtual Family (VF) approach to case based instruction; a novel strategy for addressing SDOH in medical school. The VF theoretical framework is presented and practical considerations and challenges for implementation of the VF approach at three different medical schools are offered. VFs are defined as representations of families or social groups that are not real. "Virtual," in this instance, refers to people or things that do not physically exist. The VF approach allows students and educators to adjust the "lens" of a case's focus to view the relevant determinants. The VF approach is presented as an extension of the virtual patient approach. Theoretical support for the VF approach is argued drawing on principles from modeling and simulation, effective story design, establishing a sense of human presence, serious gaming, visual design, identity leveraging, and flow theory. Challenges and benefits of the approach are described. Measures of efficacy designed to match learning goals are proposed. The VF approach is presented as practical, accessible, economical, and potentially powerful.

The effects of tropical cyclone Vance on Exmouth

This article examines the effects of Cyclone Vance which hit Exmouth, a small coastal township some 1250 km North of Perth, WA, on the morning of Monday 22nd March, with particular emphasis on damage to housing. Contains colour photographs of damaged buildings and table of wind speeds

Postexposure prophylaxis for occupational exposures to hepatitis B, hepatitis C, and human immunodeficiency virus

Bloodborne pathogens are becoming increasingly prevalent in, and therefore contributing increasing levels of risk to, the health-care workplace environment. This problem is magnified in the blood-intense operating room and obstetric environments. Whereas we will never be able to eliminate such risks entirely from the health-care workplace, a multifaceted approach to the management of these risks throughout the hospital environment and particularly in risk-intense environments will likely create a safer milieu and climate. Such an improved environment will clearly be necessary as we continue to strive to provide optimal care for all patients, irrespective of their bloodborne infection status