Medical Liaison Research Articles

PHP30 - The Impact of Legislative Changes and Regulatory Guidance on Proactive Dissemination of Healthcare Economic Information: Payers’ Experiences Pre and Post Product Approval

To understand how recent legislation and guidance, including the 21st Century Cures Act-Section 3037 and FDA Draft Guidance, has impacted the proactive communication of healthcare economic information (HCEI) and to assess the importance of preapproval information exchange without HCEI (PIE) and with HCEI (PIE/HCEI) from the payer’s perspective. Payers (N=44) were recruited via a web-based platform and completed a 28-item online survey between 12/22/17-1/5/18. The majority of respondents (68%) represented managed care organizations. Post-approval proactive HCEI was rated as somewhat or very important for decision-making (84%); respondents’ perceptions about the importance of PIE/HCEI was more varied (39% very/extremely important; 30% not very/not at all important). More than half (64%) perceived a gap between available and needed post-approval HCEI. A gap between available and needed PIE was noted by 45% of respondents. The majority of payers (80%) reported that they sometimes/rarely received HCEI communications; receipt of PIE was also uncommon (64% rarely or never). An increase in HCEI and PIE communication over the past year was noted by 43% and 39% of respondents, respectively. Regarding type of PIE, payers considered indication sought (82%), clinical trial results (84%), anticipated timeline for FDA approval (80%), and product pricing (86%) as very or extremely important. Almost all (95%) respondents would prefer to receive PIE within 1 year of the product’s anticipated approval. Further, 47% of respondents would most prefer that a medical science liaison communicate PIE. New legislation and regulations pertaining to the proactive communication of HCEI and PIE may have prompted an increase in such communication by manufacturers in the past year. More frequent and relevant communications between manufacturers and population health decision makers may be helpful to improve formulary decision making and ultimately treatment decisions for patients in need of therapy.

PCN228 - A Critical Assessment Of The Role Of Health Outcomes Liaisons: Today And The Future

As payers balance outcomes, quality metrics, and cost of care, demonstration of product value is increasingly material to the competitive evaluation, placement, and reimbursement of treatment alternatives. Health outcomes liaisons (HOLs) are a trusted medical conduit for communicating a product’s value proposition and health outcomes data to US payers. This study investigates the role and value of the HOL today from the US payer perspective and into the future, particularly in oncology. In-depth telephone interviews with 8 US managed care representatives responsible for more than 190 million covered lives. The traditional role of the HOL has evolved to include the combination of duties of an HOL and a medical science liaison (MSL). This evolution demands that the HOL possess a unique skill set, which includes the clinical understanding and experience of an MSL and the health services research expertise of a health outcomes and economics research (HEOR) scientist. The validity and relevancy of information communicated is a top priority in relationships with payers and helps inform impressions of the HOL, product portfolio, and manufacturer. In addition to product-specific information, payers see benefit in providing unbranded information from well-informed, balanced resources such as HOL teams. Although the frequency and types of interactions between HOLs and payers vary, the focus should be on quality and not quantity of interactions. Payers make time for HOLs who can provide value to their business and will provide support internally for regular, extended face-to-face meetings. Payers expect to collaborate with “good” HOLs and have that role serve as an objective, reliable business partner and resource for their plan. The role of the HOL is expected to continue and expand. Manufacturers most successful at payer management strategies are perceived to dedicate HOL teams to provide medical, outcomes, and economic information to payers.

Medical Science Liaisons in Real-World Evidence Studies: Experience of AstraZeneca Russia.

There is no doubt that real-world evidence studies have the potential to improve and accelerate the development and delivery of safe and cost-effective innovative medicines to patients as well as influence the way we approach health and health care. Real-world evidence studies are a great challenge in terms of development and conduct, so there should be a good collaboration between the study team and clinical sites at all times, resulting eventually in timely and efficient enrollment. Engaging the sites and key external experts as early as possible during feasibility and routine visits, as well as highlighting the science rationale behind AstraZeneca's portfolio at investigator meetings and during medical science liaison (MSL) interactions, can create a positive impact on physician perception of a particular study and prioritization of patient recruitment in such studies. Therefore, we would like to underline the important role of MSLs in the risk-based monitoring setting of real-world evidence studies, with special attention to the studies with complicated patient profiles, tough timelines, and/or seasonal factors. This approach will be used further for other real world evidence projects of AstraZeneca Russia MC to ensure timelines and budget deliverables are met for the generation of high-quality evidence and eventually better health care for all of us.

Tracking Student Mistreatment Data to Improve the Emergency Medicine Clerkship Learning Environment.

IntroductionMedical student mistreatment is a prevalent and significant challenge for medical schools across the country, associated with negative emotional and professional consequences for students. The Association of American Medical Colleges and Liaison Committee on Medical Education have increasingly emphasized the issue of mistreatment in recent years, and medical schools are tasked with creating a positive learning climate.MethodsThe authors describe the efforts of an emergency department (ED) to improve its clerkship learning environment, using a multifaceted approach for collecting mistreatment data and relaying them to educators and clerkship leadership. Data are gathered through end-of-rotation evaluations, teaching evaluations, and an online reporting system available to medical students. Mistreatment data are then relayed to the ED during semi-annual meetings between clerkship leadership and medical school assistant deans, and through annual mistreatment reports provided to department chairs.ResultsOver a two-year period, students submitted a total of 56 narrative comments related to mistreatment or unprofessional behavior during their emergency medicine (EM) clerkship. Of these comments, 12 were submitted in 2015–16 and 44 were submitted in 2016–17. The most frequently observed themes were students feeling ignored or marginalized by faculty (14 comments); students being prevented from speaking or working with patients and/or attending faculty (11 comments); and students being treated in an unprofessional manner by staff (other than faculty, 8 comments).ConclusionThis article details an ED’s efforts to improve its EM clerkship learning environment by tracking mistreatment data and intentionally communicating the results to educators and clerkship leadership. Continued mistreatment data collection and faculty development will be necessary for these efforts to have a measurable effect on the learning environment.

Moving Through and Moving Forward.

Moving Through and Moving Forward Suzanne Minor On the five hour drive home after my father–in–law, Mike's, initial hospitalization for renal failure resulting in a diagnosis of aggressive multiple myeloma, my head seemed too tight, the radio too loud, and the DJ's too rambunctious. The tension in my head built, hammering, getting more severe over the evening. I slept fitfully that night, my head pounding every time I rolled over. The headache continued into the next day, when I went into work as I was scheduled to teach a clinical reasoning small group. I was horribly irritable, and didn't understand the headache. Mike was suffering with an illness, and medical school and residency trained me to deal with illness, so why was I so tense? I could deal with any patients' [End Page E10] medical problems. Yet Mike was not just any patient to me, a tiny voice inside whispered. I confirmed with my supervisor that I was back and would cover the small group on clinical reasoning. I naively felt that if I could work, the headache would pass. The first sentence of the case stopped my breath: the chief complaint was a growing lump in the neck. I frantically flipped to the last page, searching for the diagnosis. My grief, packed away for the past week, erupted in chaotic, wracking sobs. I closed my office door so passing students wouldn't see me losing it and tried not to wail too loudly. I sat on the floor in one corner of my office because the walls felt solid to me and I didn't want those in the nursing building who could see into my office to witness my private sorrow. I called my supervisor back and, still crying, said "I just can't do it." I wanted to give him time to find faculty coverage so I called when I was still in tears, thinking that I wouldn't be composed for hours or days or ever. The tears seemed infinite. I pulled myself together as much as I could and made my way to my car, awkwardly accepting kind remarks and dodging faces full of pity. Everything—the air, my body, life, reality—felt too thick, too heavy. I went home, crying the whole way. Slowly, my headache eased and through it, I felt more real than I had since the ordeal began the week before. I understood my crackling irritability and massive headache—I had been suppressing my feelings. Why wasn't I ok with feeling sadness? I hadn't even realized that I had turned that part of me off for the last week. I had been in crisis mode, doing what needed doing, supporting my husband, filtering the medical–ese being spoken by my peers. Besides, I was just the daughter–in–law. What right did I have to be upset? Mike wasn't my father, though he was a principled influence in my life for two decades. I didn't even realize I was avoiding my sadness or trying to reason around it. Looking back, I had some serious issues with sadness. I learned to stuff sadness, as needed, to function, especially in residency at the county safety–net hospital. Working 36 hour shifts with very sick patients, emotions became superfluous; work and marriage and then sleep were the priorities. I didn't feel justified in feeling sad. Even though feeling feelings was actually self–care, it felt indulgent, though in retrospect was entirely necessary. I crave reason and order whereas sadness isn't orderly at all. Sadness can't be scheduled and seems to exist on its own terms. Expressing sadness, crying, is replete with messy secretions. It didn't feel acceptable to not work just for feeling sad. What? Was I going to call in sad? Yet, I couldn't work when I was bawling and incoherent. I also didn't want people to know that I was that sad, feeling defenseless and entirely helpless in my sadness at work. During my father–in–law's many hospitalizations, I acted as the trusted medical interpreter and liaison for the family. The physicians were intelligent, compassionate...

As Fires Raged, Preparation, Teamwork Kept Disaster at Bay

As Fires Raged, Preparation, Teamwork Kept Disaster at Bay

NCI Breast Cancer Steering Committee Working Group (WG) report on meaningful and appropriate endpoints for clinical trials (CT) in metastatic breast cancer (MBC).

1073 Background: There is significant heterogeneity in the natural history of MBC. Several recent randomized CT have yielded statistically significant advantages for the experimental arm, but neither led to regulatory approval nor practice change. Formal guidance for industry on CT endpoints provided by the US FDA in 2007 was not disease-specific. Patient-focused drug development is mandated by Prescription Drug User Fee Act V. Our WG sought to create specific consensus on endpoints for MBC CT focusing on subtype and line of therapy, with sensitivity to various stakeholders. Methods: A WG composed of medical oncologists, statisticians, advocates, FDA and NCI liaisons performed a systematic literature review of MBC natural history, CT endpoints by subtype (HR+/HER2-, HR+/HER+, HR-/HER2-, HR-/HER2+), and line of therapy (n = 146 papers). External expertise was obtained on industry perspectives, big data and real world evidence (RWE), and patient reported outcomes (PROs). WG members voted anonymously on statements and positions generated from deliberation. Results: The WG reached consensus on definitions relevant to contemporary CT endpoints. WG recommendations on the appropriate choice of OS or PFS are sensitive to expected post progression survival (PPS), and proportional and absolute gains. Currently, for HR-/HER2- MBC, OS is preferred as the optimal primary endpoint regardless of line of therapy; PFS is preferred in settings where expected PPS is longer. Toxicity can outweigh modest gains in PFS; scant data exist to gauge how patients value PFS gain vs toxicity. Where new agents may prolong PFS without impacting OS, exploring/validating graphic approaches that capture grade and timing of toxicity and PROs is warranted. An overview of WG Consensus Statements will be presented in detail. Conclusions: CT design for MBC should be sensitive to natural history (PPS), availability of other effective agents, PROs and toxicity burden. As unique subtypes (e.g. AR+) and novel therapies (e.g. immunotherapy) emerge, reassessment of relevant benchmarks is indicated. Rigorous big data approaches providing insights from RWE may inform CT endpoints in the future.

Psychiatric hospitals may enhance holistic care by introducing medical and surgical liaison teams

IntroductionPatients with mental health problems (MHP) are known to have more physical comorbidities compared to the general population.In Malta, Mount Carmel hospital (MCH) which is the main psychiatric hospital (consisting of both acute and chronic wards), is separate from Mater Dei hospital (MDH) which is the general hospital at which medical and surgical care is provided.Such a division in healthcare may result in inadequate focus on physical health amongst patients of high demand in this regard. This subsequently puts an increased strain on the general hospital through repeated referrals.ObjectivesThe purpose of this study is to show that inpatients with MHP have a significant number of comorbidities and require multiple referrals to a general hospital for medical and surgical attention.MethodsThree hundred and ninety-three inpatients at acute and chronic wards of MCH (during the first week of December 2016) were enrolled in the study.Treatment charts and iSOFT (healthcare IT software used in Malta) were used to determine patient's diagnosed comorbidities, number and type of referrals to MDH outpatient clinics (OPC), casualty and admissions at MDH over 1 year.ResultsResults of the audit indicate that a significant number of inpatients at MCH have medical comorbidities and the majority have been referred to MDH for OPC and casualty over the past year.ConclusionsHaving medical and surgical liaison teams in psychiatric hospitals may enhance patient care and reduce the pressure exerted on general hospitals.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Promoting the APS Chapter Program by sharing its history, best practices, and how-to guide for establishing new chapters.

Early establishment of physiological societies in Oklahoma and Ohio demonstrated the benefits of networking physiologists and paved the way for establishing the APS Chapter Program. Designed to promote the general objectives of the APS, the Chapter Program was officially launched in 1995, with Ohio being the first recognized chapter. There are 13 active chapters regularly engaged in numerous activities designed to advance physiology education and research. In the hopes that others will recognize the important offerings of state chapters and consider organizing one, the aims for this paper are to 1) share a brief history, 2) provide rationale for chapter initiation, and 3) describe the process involved in establishing a chapter. In light of current changes in American Medical Association and Liaison Committee on Medical Education guidelines, the present time may be critical in promoting chapters, as they play a vital role in sustaining recognition and support for the discipline.

Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial

BackgroundEarly hospital readmission of patients after discharge is a public health problem. One major cause of hospital readmission is dysfunctions in integrated pathways between community and hospital care that can cause adverse drug events. Furthermore, the French ENEIS 2 study showed that 1.3% of hospital stays originated from serious adverse drug events in 2009. Pharmacy-led medication reviews at hospital transitions are an effective means of decreasing medication discrepancies when conducted at admission or discharge. However, it is difficult to assess the true impact of pharmacist-led medication reviews in specific high-risk populations, such as pediatric and geriatric populations.In such a context, it is important to demonstrate the effectiveness of medication reconciliation as part of a standardized medication review process—in pediatric and elderly populations—on all-cause readmissions in a large randomized controlled clinical trial.The aim of this study is to assess the impact of the pharmacist-led medication review on the rate of readmissions and/or death after hospital discharge and patient treatment satisfaction.Methods/designThe study is a randomized controlled clinical trial. A total of 1400 hospitalized patients will be randomized in two groups: (1) the experimental group (group receiving a pharmacist-led medication review) and (2) the control group (group receiving usual care). The pharmacist-led medication review process includes medication reconciliation, treatment review and medication liaison service. The primary endpoint will be the rate of readmissions and/or death at 30 days following initial hospitalization discharge. The secondary endpoints will be the rate of hospital readmission, the rate of emergency department visits, the rate of mortality, the number of consultations and patient treatment satisfaction at 30 days following initial hospitalization discharge.DiscussionA randomized controlled trial provides the most extensive evidence on the impact of pharmacist-led medication reviews on early hospital readmission for extreme age populations.Trial registrationCurrent Controlled Trials, NCT02734017. Registered on 4 May 2016.

A survey of medical scientific liaisons in the pharmaceutical industry in Spain

This report presents the findings of an online 38-item survey on the emerging role of medical scientific liaison in the pharmaceutical industry in Spain. A total of 44 complete surveys were receive...

Bridging the gap between R and D and commercialization in pharmaceutical industry: Role of medical affairs and medical communications

The launch of a new drug into the market requires a unique and complex process initiating from development (R&D) to its commercialization (marketing authorization and selling of these products). Due to increased burden by regulatory authorities, the medical affairs evolved as separate medical organization to bifurcate medical and commercial functions. It is closely associated with development but works mainly on post-approval activities by providing both the scientific and clinical expertise. The core functional areas of medical affairs (MA) include: medical communications/publications, medical science liaisons (MSLs) and medical information. In the recent years ethical and evidence-based medical communications has attained increasing importance in emerging pharmaceutical markets. A successful product launch is based on both promotional (medico-marketing) and non-promotional (medical information services, publications) material to support the product and to report clinical trials in peer-reviewed international journals. Local clinical or observational studies and medical surveys can provide sufficient information about the product. Besides, a number of medical communication like product monographs, brochures, slide kits, leave behind literature (LBL), continuous medical education (CME) slides, training modules, key opinion leader documents(promotional inputs) and conference posters, abstracts, and journal articles (research based inputs)are other ways to aid in an effective product launch. In the last 10 years medical writers in India have developed the capability to meet this challenge through their training and work experience making India hub for medical communications services. KEYWORDS: Key opinion leaders; Medical affairs; Medical communications; Medical science liaisons; Medical writing.

Digital Doctor-A New Era in Healthcare

Introduction: The Indian healthcare system is under demands due to the massive health services provided to voluminous a patient which is inaccessible sometimes. Recently the new healthcare start-ups started offering concierge medical services connecting doctors, device suppliers, pharmacies, diagnostic labs etc. Materials and methods: The present study uses a case approach to discuss the various issues related to digitalising the doctor’s service in Indian context. Results and Discussion: As per the recent study, currently 930 million cell phone users, 360 million internet users, along with new smart phone users in next five years, India is having the incredible market for digital apps and other medical devices specifically in healthcare. Conclusion: Thus, the robust growth of digital health care system in India has routed a new avadar of digital doctors reachable by a simple click or touch. As the digital -rendezvous era has embark on a new linkage connecting sales reps, medical liaisons, patients and pharma companies via handsets, apps and social media sites, it also develop patient portals and discussion forum among physicians to discuss common issues related to diseases.

The regional medical liaison in Niigata Rheumatic Center

The regional medical liaison in Niigata Rheumatic Center

Advancements in Undergraduate Medical Education: Meeting the Challenges of an Evolving World of Education, Healthcare, and Technology.

Restructuring of undergraduate medical education (UGME) has occurred from time to time over the past century. Many influences, including the persuasive report of Abraham Flexner in 1910, acted to reorganize medical education in the early twentieth century [1, 2]. In his report, Flexner called on American medical schools to enact higher graduation standards and to stringently adhere to the protocols of mainstream science in their teaching. Prior to this report, UGME had changed little over the previous century but over the last several decades, reform within medical education has become routine. This increasing rate of change has been challenging for those within the realm of undergraduate medical education and can be frustrating to those outside this sphere. Today, the Association of American Medical Colleges (AAMC) and Liaison Committee on Medical Education (LCME) are typically the driving forces behind such changes, along with acceleration of advances in medical care and technology. The number of changes in the last decade is significant and warrants review by those interested or involved in education of medical students. This article aims to provide a summary of recent changes within UGME. Within the article, changes in both the pre-clerkship (1st and 2nd years) and clinical years (3rd and 4th) will be discussed. Finally, this review will attempt to clarify new terminology and concepts such as the recently released Core Entrustable Professional Activities (EPAs). The goal of these UGME changes, as with Flexner's reform, is to ensure future physicians are better prepared for patient care.

The PharmD/MD Dual-Degree Program and Its Potential Value in the Pharmaceutical Industry.

The first dual-degree program combining both the doctor of pharmacy (PharmD) and the doctor of medicine (MD) degrees was designed and launched by Rutgers, The State University of New Jersey, in academic year 2013-2014. This joint effort was led by the Ernest Mario School of Pharmacy (EMSOP) and the Robert Wood Johnson Medical School (RWJMS) to combine expertise in both diagnostic and treatment facets of health care and to prepare graduates for leadership roles in providing and managing comprehensive patient care in a variety of settings. One area of potential value of these skill sets is the drug development industry. A survey was conducted among pharmaceutical executive stakeholders associated with a postdoctoral training program to assess the perceived value of this new dual-degree skill set and to identify particular functions where the combined training has its best fit. Results indicate that the combined nature of this training is highly valued in this setting, especially in the areas of clinical pharmacology, drug safety and pharmacovigilance, medical affairs/strategy, and medical science liaisons. Future monitoring of graduates will further define the value of this dual degree in this and other health care settings.

Medical comorbidity and projected survival in patients admitted to a specialist addictions in-patient unit.

Aims and method To investigate the burden of medical comorbidity in a population receiving in-patient treatment for drug and alcohol problems. All patients admitted over a 6-month period were included in the data-set. We recorded diagnostic information on admission that allowed the calculation of predicted 10-year survival using a previously validated comorbidity index.Results Despite the majority of the sample having a predicted 10-year survival chance of greater than 75%, a sizeable minority (16.7%) are carrying a high burden of medical comorbidity, with a predicted 10-year survival chance of less than 50%. More than half (55.2%) of these patients were under the age of 55. Chronic respiratory disease was the most frequent diagnosis.Clinical implications In-patient substance misuse units serve a complicated group of patients, whose needs are met by active medical input, resident medical cover and effective liaison with general hospitals. This is important when planning and commissioning treatment services. The high burden of respiratory disease suggests the utility of robust smoking cessation interventions among this population.

Accreditation Standards for Medical Science Liaison (MSL) Certification Programmes in Japan: A Viewpoint from the Japanese Association of Pharmaceutical Medicine (JAPhMED)

A medical science liaison (MSL) is a field-based professional with advanced training and academic degrees, who focuses on moving forward standards of care and optimising patient outcomes, and also maximising the value of medical products. Recently, in the pharmaceutical industry in Japan, the role and function of MSLs have been rapidly evolving and are attracting increasing importance not only in corporate strategy but also in their acceptance by health care professionals. However, there is variability in individual company MSL training programmes and how to certify their knowledge and skills across the industry in Japan. Lack of standardised training and assessment of MSL capabilities may threaten the robustness and proper expansion of the MSLs’ role, and raises the question of the need to define a set of minimum and common standards among corporate MSL certification programmes. As a solution to this issue, the Japanese Association of Pharmaceutical Medicine (JAPhMED), whose mission is to promote pharmaceutical medicine by enhancing the knowledge, expertise and skills of pharmaceutical professionals, undertook to define and put into practice accreditation standards for corporate MSL certification programmes. For accreditation standards for MSL certification programmes, three domains were considered in establishing the evaluation standards: (1) independence from promotional activities (compliance structure); (2) medical and scientific expertise (skills and competencies); and (3) the educational system (education and training). On the basis of these standards, JAPhMED has started to implement accreditation of corporate MSL certification through an evaluation process comprising system and field audits. In conclusion, a set of accreditation standards for MSL certification programmes is now available for use and can serve as a useful guide for development of MSL programmes in pharmaceutical and related companies.

Status report of the ninth year of ‘Gifu area medical association liaison pathway organization’ concerning reciprocating-type pathways

Status report of the ninth year of ‘Gifu area medical association liaison pathway organization’ concerning reciprocating-type pathways

SY11-2 - Medical liaison for medical practitioners in Miyagi prefecture: a questionnaire survey

SY11-2 - Medical liaison for medical practitioners in Miyagi prefecture: a questionnaire survey