Pharmaceutical Representatives Research Articles

The Insight Meditation Enhanced Stress, Depression, and Anxiety Reduction in Working Professionals Like Medical Representatives Determined by Using Serum Cortisol Level and Electroencephalogram: A Qualitative Study

The Indian pharmaceutical industry is one of the fastest-growing sectors of the Indian economy and ranks among the top 15 drug-manufacturing countries globally. Among the fastest-growing industries in the world, the pharmaceutical industry has increased over the years. A pharmaceutical company appoints a medical representative to make their products easily reach healthcare specialists and then be used by the general public. The medical representatives construct a well- built network with doctors, clinical specialists, medical practitioners, paramedical experts, Dietitians and nutritionists, paediatricians, gynaecologists, psychiatrists, etc. The problem of stress is widespread in every job description, and it may affect directly or indirectly in the form of health issues and low productivity; the demands of achieving targets induced among medical representatives. Much of this credit goes to Medical Sales Representatives or Pharmaceutical Sales Representatives (also known as MR, PSR) who are solely responsible for the promotion of products among Physicians, Hospitals, and pharmacies and are accountable for sales results. They act as the face of the Pharma company contributing to a better quality of life for customers, building goodwill, and increasing the company’s market share. Pharmaceutical sales representatives (PSR) play a large role in helping an industry in a rapidly changing environment to achieve a new corporate vision and normally these medical representatives are in the highest stress position. Most pharmaceutical sales representatives experience significant job stress and unhappiness levels. Stress, depression, and anxiety are the most common psychiatric disorders all over the world. One of India's oldest meditation methods, vipassana also known as Insight meditation, helps a person become aware of things as they are. The goal of the Vipassana method, which aids in self-change via self-observation, is to finally arrive at a condition of inner and exterior peace and mental equilibrium. It is a process of "Self- exploration" to the normal base of the brain and body that removes mental smog and results in a healthier personality filled with love and empathy. Electroencephalography (EEG) is an efficient modality that helps to acquire brain signals corresponding to various states from the scalp surface area. These signals are generally categorized as delta, theta, alpha, beta, and gamma based on signal frequencies ranging from 0.1 Hz to more than 100 Hz. This paper primarily focuses on EEG signals and their characterization for various states of the human body. Beta wave induced the production of cortisol. Also, the beta wave is necessary for our everyday lives, such as thought, communicating, arguing, and problem-solving, during conscious mental work. This Beta wave can also lead to tension, anxiety, and restlessness as they enable us to think properly. Persistently elevated cortisol concentrations are associated with metabolic disorders. Cortisol is a vital hormone sometimes known as the stress hormone in humans, as it is involved in the body's natural response to physical or emotional stress. cortisol has effects on memory, mood, and neurological diseases. Cortisol is best known for mediating the body’s reaction to stress. This study aims to review the existing research and challenges of serum cortisol levels (cortisol is an indicator of stress) and EEG signals with the Insight meditation effect.

ĐÁNH GIÁ ĐỊNH HƯỚNG NGHỀ NGHIỆP CỦA SINH VIÊN NGÀNH DƯỢC NĂM CUỐI Ở TRƯỜNG ĐẠI HỌC Y KHOA VINH NĂM 2023

Survey results on the career orientation of Pharmacy students in courses D1A and D2A show that the majority of students want to become consulting pharmacists at pharmacies and pharmaceutical sales representatives. The main deciding factor when choosing a job is income level, with most expecting an income after graduation of between 8 and 12 million VND. However, students also face great difficulties in applying for jobs due to lack of experience and limitations in foreign languages and information technology. The skills that students want to receive additional training in are mainly sales, communication and presentation skills. The results also show that most students have determined to develop a job search plan in the near graduation period, only a few do not have plans because they have been arranged by their families or attracted by local policies.

"Caught In Each Other's Traps": Factors Perpetuating Incentive-Linked Prescribing Deals Between Physicians and the Pharmaceutical Industry.

Despite known adverse impacts on patients and health systems, 'incentive-linked prescribing', which describes the prescribing of medicines that result in personal benefits for the prescriber, remains a widespread and hidden impediment to quality of healthcare. We investigated factors perpetuating incentive-linked prescribing among primary care physicians in for-profit practices (referred to as private doctors), using Pakistan as a case study. Our mixed-methods study synthesised insights from a survey of 419 systematically samples private doctors and 68 semi-structured interviews with private doctors (n=28), pharmaceutical sales representatives (n=12), and provincial and national policy actors (n=28). For the survey, we built a verified database of all registered private doctors within Karachi, Pakistan's most populous city, administered an electronic questionnaire in-person and descriptively analysed the data. Semi-structured interviews incorporated a vignette-based exercise and data was analysed using an interpretive approach. Our survey showed that 90% of private doctors met pharmaceutical sales representatives weekly. Three interlinked factors perpetuating incentive-linked prescribing we identified were: gaps in understanding of conflicts of interest and loss of values among doctors; financial pressures on doctors operating in a (largely) privately financed health-system, exacerbated by competition with unqualified healthcare providers; and aggressive incentivisation by pharmaceutical companies, linked to low political will to regulate and an over-saturated pharmaceutical market. Regular interactions between pharmaceutical companies and private doctors are normalised in our study setting, and progress on regulating these is hindered by the substantial role of incentive-linked prescribing in the financial success of physicians and the pharmaceutical industry employees. A first step towards addressing the entrenchment of incentive-linked prescribing may be to reduce opposition to restrictions on incentivisation of physicians from stakeholders within the pharmaceutical industry, physicians themselves, and policymakers concerned about curtailing growth of the pharmaceutical industry.

Understanding Canadian stakeholders’ views on measuring and valuing health for children and adolescents: a qualitative study

ObjectiveValuing child health is critical to assessing the value of healthcare interventions for children. However, there remain important methodological and normative issues. This qualitative study aimed to understand the views of Canadian stakeholders on these issues.MethodsStakeholders from health technology assessment (HTA) agencies, pharmaceutical industry representatives, healthcare providers, and academic researchers/scholars were invited to attend an online interview. Semi-structured interviews were designed to focus on: (1) comparing the 3-level and 5-level versions of the EQ-5D-Y; (2) source of preferences for valuation (adults vs. children); (3) perspective of valuation tasks; and (4) methods for valuation (discrete choice experiment [DCE] and its variants versus time trade-off [TTO]). Participants were probed to consider HTA guidelines, cognitive capacity, and potential ethical concerns. All interviews were recorded and transcribed verbatim. Framework analysis with the incidence density method was used to analyze the data.ResultsFifteen interviews were conducted between May and September 2022. 66.7% (N = 10) of participants had experience with economic evaluations, and 86.7% (N = 13) were parents. Eleven participants preferred the EQ-5D-Y-5L. 12 participants suggested that adolescents should be directly involved in child health valuation from their own perspective. The participants were split on the ethical concerns. Eight participants did not think that there was ethical concern. 11 participants preferred DCE to TTO. Among the DCE variants, 6 participants preferred the DCE with duration to the DCE with death.ConclusionsMost Canadian stakeholders supported eliciting the preferences of adolescents directly from their own perspective for child health valuation. DCE was preferred if adolescents are directly involved.

Implementation of state health insurance benefit mandates for cancer-related fertility preservation: following policy through a complex system

BackgroundA myriad of federal, state, and organizational policies are designed to improve access to evidence-based healthcare, but the impact of these policies likely varies due to contextual determinants of, reinterpretations of, and poor compliance with policy requirements throughout implementation. Strategies enhancing implementation and compliance with policy intent can improve population health. Critically assessing the multi-level environments where health policies and their related health services are implemented is essential to designing effective policy-level implementation strategies. California passed a 2019 health insurance benefit mandate requiring coverage of fertility preservation services for individuals at risk of infertility due to medical treatments, in order to improve access to services that are otherwise cost prohibitive. Our objective was to document and understand the multi-level environment, relationships, and activities involved in using state benefit mandates to facilitate patient access to fertility preservation services.MethodsWe conducted a mixed-methods study and used the policy-optimized exploration, preparation, implementation, and sustainment (EPIS) framework to analyze the implementation of California’s fertility preservation benefit mandate (SB 600) at and between the state insurance regulator, insurer, and clinic levels.ResultsSeventeen publicly available fertility preservation benefit mandate-relevant documents were reviewed. Interviews were conducted with four insurers; 25 financial, administrative, and provider participants from 16 oncology and fertility clinics; three fertility pharmaceutical representatives; and two patient advocates. The mandate and insurance regulator guidance represented two “Big P” (system level) policies that gave rise to a host of “little p” (organizational) policies by and between the regulator, insurers, clinics, and patients. Many little p policies were bridging factors to support implementation across levels and fertility preservation service access. Characterizing the mandate’s functions (i.e., policy goals) and forms (i.e., ways that policies were enacted) led to identification of (1) intended and unintended implementation, service, and patient outcomes, (2) implementation processes by level and EPIS phase, (3) actor-delineated key processes and heterogeneity among them, and (4) inner and outer context determinants that drove adaptations.ConclusionsFollowing the midstream and downstream implementation of a state health insurance benefit mandate, data generated will enable development of policy-level implementation strategies, evaluation of determinants and important outcomes of effective implementation, and design of future mandates to improve fit and fidelity.

What happens when private general practitioners receive incentivisation offers from pharmaceutical sales representatives? A qualitative study in Pakistan.

Pharmaceutical incentivisation of physicians for profit maximisation is a well-documented health system challenge. This study examined general practitioners' (GPs) reactions to pharmaceutical incentivisation offers in one region in Pakistan. We used the Standardised Pharmaceutical Sales Representative (SPSR) method and qualitative interviews with GPs. SPSRs were field researchers representing mock pharmaceutical companies who recorded their observations of 267 GPs' responses to pharmaceutical incentivisation offers. We triangulated SPSR data using qualitative interviews with a subset of the same GPs to gather information about how they interpreted different interaction outcomes. We found four major outcomes for GPs being offered incentives by pharmaceutical companies for prescribing medications. GPs might agree to make incentivisation deals, reject incentivisation offers, disallow PSRs to access them, or remain indeterminate with no clear indication of acceptance or rejection of incentivisation offers. GPs rejecting SPSRs' incentivisation offers indicated having active commitments to other pharmaceutical companies, not being able to work with unheard-of companies, and asking SPSRs to return later. The GP-pharmaceutical sales representative interaction that centres on profit-maximisation is complex as offers to engage in prescribing for mutual financial benefit are not taken up immediately. The SPSR method helps understand the extent of distortion of practices impacted by incentivisation. Such an understanding can support the development of strategies to control unethical behaviours.

Japanese physicians' perceptions of conflicts of interest with pharmaceutical companies: Estimating two different questioning approaches.

Despite being one of the world's largest pharmaceutical markets, interactions between Japanese physicians and pharmaceutical companies often remain opaque. Importantly, potential conflicts of interest associated with these interactions can compromise patient care and increase costs. We conducted an online survey of Japanese physicians to elucidate perspectives on pharmaceutical company promotional activities and how these influence physician prescribing patterns. Anticipating that physicians might downplay their reliance on, or the value of, pharmaceutical company-provided information, the survey incorporated a direct questioning method and an unmatched count technique (UCT) to identify hidden perceptions on factors likely to influence prescribing. Overall, 1080 eligible physicians participated. Of these, 105 (9.7%) self-identified as hospital directors or managers. Surprisingly, nearly twice as many participants responding to direct questioning (18.9%) versus those responding to the UCT (10.1%) asserted that information provided by pharmaceutical companies was important when prescribing medicine. Hospital directors or managers (adjusted odds ratio [adjOR] 2.56, 95% confidence interval [95% CI]: 1.00-6.54, reference=physician without title) and frequent interactions with pharmaceutical sales representatives (adjOR 5.96, 95% CI: 1.88-18.9, reference=rare interaction) significantly valued the information from sales representatives and sponsored lectures when considering prescribing decisions. Additionally, 77.1% of respondents believed that sales representatives provide fair, neutral, or relatively honest and unbiased information about their products. Few Japanese physicians acknowledged the influence of industry-provided information on prescribing patterns. Our study uniquely applies two distinct question formats, providing a novel approach to understanding the depth of physician-industry relationships and the effectiveness of various survey methodologies.

The turbulent future of expertise and training markets

PurposeTo explain how technology will replace a great deal of human labor in knowledge markets using a theory of reasoned action applied to demand and theories of procedural rationality, cost structure and system dynamics applied to supply.Design/methodology/approachTwo illustrative scenarios are presented. The first is a third-party Best Treatments site, and its effect on the expert advice pharmaceutical representatives provide doctors. The second scenario is an online higher education business course module with embedded AI.FindingsBoth scenarios demonstrate the advantages of online expertise and teaching platforms over the in-person alternative in variable and marginal cost, ease and convenience of use, quality conformance, scalability, knowledge reach and depth and most importantly, speed of evolutionary adaptability. Despite such overwhelming advantages, a number of reasons why the substitution might be slowed are presented, and some strategies firms might adopt are discussed. Opportunities for service scholars to confirm, challenge and extend the conclusions are presented throughout the paper.Originality/valueIncreasing cost structure and adaptability advantages of online technology and AI over in-person delivery of expertise and training services are demonstrated. It is also demonstrated that the innovation-imitation cycle is accelerating because of exogenous innovation in knowledge access and online influence networks and an endogenous effect where imitators accelerate their innovation that drives innovators to accelerate their innovation, which drives imitators to further accelerate their imitation.

Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study.

Over the years, there has been increasing interest in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders plays a central role in achieving successful implementation. This study aims to identify insights for the design and implementation of a user-friendly, personalized, and long-term eIC application based on a usability study with (potential) research participants and semistructured interviews with stakeholders on the practical integration of such an application into their daily practice. An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. On the basis of a digital literacy questionnaire, a heterogeneous sample of participants was established. Participants needed to complete a series of usability tasks related to personalization and long-term interaction with the research team while using the "think aloud" technique. In addition, usability tests involved completing the System Usability Scale questionnaire and taking part in a semistructured feedback interview. Furthermore, semistructured interviews were conducted with ethics committee members, health care professionals, and pharmaceutical industry representatives active in Belgium and involved in clinical research. Thematic analysis was undertaken using the NVivo software (Lumivero). In total, 3 iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The System Usability Scale scores related to the tasks on personalization and long-term interaction increased after each iteration and reached 69.5 (SD 8.35) and 71.3 (SD 16.1) out of 100, respectively, which represents above-average usability. Semistructured interviews conducted with health care professionals (n=4), ethics committee members (n=8), and pharmaceutical industry representatives (n=5) identified the need for an eIC system that can be easily set up. For example, a library could be established enabling stakeholders to easily provide background information about a clinical study, presented in the second layer of the interface. In contrast, some functionalities, such as informing participants about new studies through an eIC system, were not considered useful by stakeholders. This study provides insights for the implementation of a user-friendly personalized and long-term eIC application. The study findings showed that usability testing is key to assessing and increasing the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, participants with low digital literacy may not be able to use it successfully, highlighting the need for additional support for participants or other alternatives to an eIC system. In addition, key lessons emerging from the interviews included ensuring that the application is easy to implement in practice and is interoperable with other established systems.

Public perceptions of physician-pharmaceutical industry relationships and trust in physicians.

In Japan, as elsewhere, physicians meet with and receive gifts from pharmaceutical representatives (PRs). This study aimed to clarify the Japanese public perceptions of physicians' relationships with PRs, examine the association between these perceptions and their trust in physicians, and compare the public's and physicians' awareness, acceptance, and perceptions of the influence of physician-PR relationships. A cross-sectional, self-administered, anonymous, internet-panel survey was conducted involving 1,000 participants from the general public. The survey implementation was contracted to Cross Marketing Inc. The mean age of the 1000 participants was 44.8 years (standard deviation 18.3). Forty-eight percent were female. Many of our participants were unaware of certain physician-PR relationships. The public was more acceptable with physicians' receiving stationery and/or medical textbooks and attending promotional drug seminars at their workplaces compared with receiving meals at restaurants. Many thought that physicians' involvement in promotional activities influenced their prescribing habits and estimated that the majority of physicians received office stationery and meals from PRs. They were divided as to whether they would like to know about their physicians' relationships with the industry. Factors associated with higher trust in physicians included participants being 65 years or older, having a primary care physician, being in better health, the belief that physicians' involvement in promotional activities is acceptable, and their high estimate that physicians are not receiving gifts from PRs. Compared to the physicians, the public had lower awareness of and was more accepting of physicians' involvement in promotional activities. Meanwhile, the public believed that physician-PR relationships influenced physicians' prescribing habits more than the physicians themselves. Our survey provided insights into Japanese public perceptions of physician-pharmaceutical industry relationships and their impact on trust in physicians. Physicians should be aware of these perceptions and carefully consider how to foster appropriate relationships with the industry.

The impact of COVID-19 on PRO development, collection and implementation: views of UK and Ireland professionals

BackgroundPROs are valuable tools in clinical care to capture patients’ perspectives of their health, symptoms and quality of life. However the COVID-19 pandemic has had profound impacts on all aspects of life, in particular healthcare and research. This study explores the views of UK and Irish health professionals, third sector and pharmaceutical industry representatives and academic researchers on the impact of COVID-19 on PRO collection, use and development in clinical practice.MethodsA volunteer sample took part in a 10 question cross sectional qualitative survey, on the impact of COVID-19, administered online via Qualtrics. Demographic data was descriptively analysed, and the qualitative free text response data was subject to thematic analysis and summarised within the Strengths, Weaknesses, Opportunities and Threats (SWOT) framework.ResultsForty nine participants took part located in a range of UK settings and professions. Participants highlighted staff strengths during the pandemic including colleagues’ flexibility and ability to work collaboratively and the adoption of novel communication tools. Weaknesses were a lack of staff capacity to continue or start PRO projects and insufficient digital infrastructure to continue studies online. Opportunities included the added interest in PROs as useful outcomes, the value of electronic PROs for staff and patients particularly in relation to integration into systems and the electronic patient records. However, these opportunities came with an understanding that digital exclusion may be an issue for patient groups. Threats identified included that the majority of PRO research was stopped or delayed and funding streams were cut.ConclusionsAlthough most PRO research was on hold during the pandemic, the consensus from participants was that PROs as meaningful outcomes were valued more than ever. From the opportunities afforded by the pandemic the development of electronic PROs and their integration into electronic patient record systems and clinical practice could be a lasting legacy from the COVID-19 pandemic.

A Patient Charter for Chronic Urticaria.

Chronic urticaria (CU) is the recurring development of wheals (aka "hives" or "welts"), angioedema, or both for more than 6weeks. Wheals and angioedema occur with no definite triggers in chronic spontaneous urticaria, and in response to known and definite physical triggers in chronic inducible urticaria. Approximately 1.4% of individuals globally will have CU during their lifetime. The itching and physical discomfort associated with CU have a profound impact on daily activities, sexual function, work or school performance, and sleep, causing significant impairment in a patient's physical and mental quality of life. CU also places a financial burden on patients and healthcare systems. Patients should feel empowered to self-advocate to receive the best care. The voice of the patient in navigating the journey of CU diagnosis and management may improve patient-provider communication, thereby improving diagnosis and outcomes. A collaboration of patients, providers, advocacy organizations, and pharmaceutical representatives have created a patient charter to define the realistic and achievable principles of care that patients with CU should expect to receive. Principle (1): I deserve an accurate and timely diagnosis of my CU; Principle (2): I deserve access to specialty care for my CU; Principle (3): I deserve access to innovative treatments that reduce the burden of CU on my daily life; Principle (4): I deserve to be free of unnecessary treatment-related side-effects during the management of my CU; and Principle (5): I expect a holistic treatment approach to address all the components of my life impacted by CU. The stated principles may serve as a guide for healthcare providers who care for patients with CU and translate into better patient-physician communication. In addition, we urge policymakers and authors of CU treatment guidelines to consider these principles in their decision-making to ensure the goals of the patient are achievable.

A descriptive survey of specialty pharmacy team members' perceptions of interactions with field representatives from pharmaceutical companies.

BACKGROUND: It is not well understood in literature what the time spent between health care professionals, including pharmacists and pharmacy technicians, and pharmaceutical field specialists equates to in terms of changes in productivity or lost time, the educational value provided, or the nature of the resources provided in terms of improving patient care. OBJECTIVE: To evaluate the volume of, and time spent in, pharmaceutical field representative (PFR) meetings by members of an integrated specialty pharmacy team at a large academic medical center. METHODS: A 16-item survey tool used skip and branching logic comprising binary, multiple-choice, multiple-select, and open-ended items was distributed to pharmacists and pharmacy technicians at a health-system specialty pharmacy on the south side of Chicago, Illinois. The survey assessed locations of interactions with PFR, who initiated the request, reason for interaction, time spent, whether the participant felt the interaction provided value, and whether it contributed to them working a longer shift or compromising time spent on patient care that day. RESULTS: There were a total of 108 responses. Of those, 44 responses documented having an interaction with a PFR, and the remaining responses indicated no interaction that week. Only 5 (11.4%) of the interactions were pharmacy team member initiated. Among the pharmacy team member-initiated meetings, all respondents stated that the interaction had provided value, and none reported that it led to a longer workday. Conversely, of the 36 pharmaceutical representative-initiated interactions, 15 (41.6%) found value and 5 (13.8%) said that their workday was elongated because of these interactions. CONCLUSIONS: Our findings demonstrate that the majority of encounters taking place between our specialty pharmacy team members and PFRs did not result in knowledge gained or provision of tools and resources to support our patients. The next steps include 3 specific proposed changes to how our team responds to meeting requests from PFRs, specifically aimed at reducing pipeline presentations, reducing meetings pertaining to limited distribution drugs not accessible to the specialty pharmacy, and reducing meetings with the intent of introduction or pass off of contacts between PFRs.

How does online employee training enhance organizational growth? The benefits of integrating educational technology into workplace learning

PurposeOnline learning becomes a trendy format for workplace training, particularly during the pandemic. This study aims to examine the effects of a technology-assisted self-adaptive training camp on employees’ learning process and acquired knowledge, and the relationship between employees’ knowledge gained and organisational growth.Design/methodology/approachThe participants were 213 pharmaceutical representatives from a global pharmaceutical business in the Asia-Pacific branch who enrolled in a 21-day professional training camp. Their knowledge gained was calculated by pre-tests and post-test scores captured from an online training system. The company’s profits gained by employees were indicated by individuals’ quarter-over-quarter growth rates. Specifically, the authors applied a series of quantitative analyses to examine the relationship between employees’ knowledge gained, learning quality and organizational growth brought by individuals.FindingsDuring the online training session, employees obtained increased professional knowledge significantly. The quality of employees’ learning process was a significant predictor of their learning outcomes. In addition, a positive correlation was found between the knowledge obtained by employees and the company’s quarterly growth rates. A followed-up regression analysis indicated that the greater knowledge improvement an individual achieved, the higher quarter-to-quarter growth rate brought by the individual to the organization.Originality/valueThe study provides educational insights for organisations to effectively train employees’ professional competency through online learning. The investigation on the 21-day camp shows that employees received higher-quality training, resulting in increased revenues and greater workplace flexibility. The findings have implications for supporting the integration of educational technology into workplace training to boost the competency development of employees.

Challenges and Solutions in Implementing eSource Technology for Real-World Studies in China: Qualitative Study Among Different Stakeholders.

eSources consist of data that were initially documented in an electronic structure. Typically, an eSource encompasses the direct acquisition, compilation, and retention of electronic information (such as electronic health records [EHRs] or wearable devices), which serves to streamline clinical research. eSources have the potential to enhance the accuracy of data, promote patient safety, and minimize expenses associated with clinical trials. An opinion study published in September 2020 by TransCelerate outlined a road map for the future application of eSource technology and identified 5 key areas of challenges. The background of this study concerns the use of eSource technology in clinical research. The aim of this study was to present challenges and possible solutions for the implementation of eSource technology in real-world studies by summarizing team experiences and lessons learned from an eSource record (ESR) project. After initially developing a simple prototype of the ESR software that can be demonstrated systematically, the researchers conducted in-depth interviews and interacted with different stakeholders to obtain guidance and suggestions. The researchers selected 5 different roles for interviewees: regulatory authorities, pharmaceutical company representatives, hospital information department employees, medical system providers, and clinicians. After screening all consultants, the researchers concluded that there were 25 representative consultants. The hospital information department needs to implement many demands from various stakeholders, which makes the existing EHR system unable to meet all the demands of eSources. The emergence of an ESR is intended to divert the burden of the hospital information department from the enormous functional requirements of the outdated EHR system. The entire research process emphasizes multidisciplinary and multibackground expert opinions and considers the complexity of the knowledge backgrounds of personnel involved in the chain of clinical source data collection, processing, quality control, and application in real-world scenarios. To increase the readability of the results, the researchers classified the main results in accordance with the paragraph titles in "Use of Electronic Health Record Data in Clinical Investigations," a guide released by the US Food and Drug Administration. This study introduces the requirement dependencies of different stakeholders and the challenges and recommendations for designing ESR software when implementing eSource technology in China. Experiences based on ESR projects will provide new insights into the disciplines that advance the eSource research field. Future studies should engage patients directly to understand their experiences, concerns, and preferences regarding the implementation of eSource technology. Moreover, involving additional stakeholders, including community health care providers and social workers, will provide valuable insights into the challenges and potential solutions across various health care settings.

A global neuronopathic gaucher disease registry (GARDIAN): a patient-led initiative

BackgroundGaucher disease (GD) is a rare autosomal recessive lysosomal storage disorder. GD types 2 and 3 are known as neuronopathic Gaucher disease (nGD) because they have brain involvement that progresses over time. Implementing a systematic approach to the collection of real-world clinical and patient-relevant outcomes data in nGD presents an opportunity to fill critical knowledge gaps and ultimately help healthcare providers in the management of this patient population. This paper summarizes the development of a patient-initiated Gaucher Registry for Development Innovation and Analysis of Neuronopathic Disease (GARDIAN).MethodsThe International Gaucher Alliance led the GARDIAN planning, including governance, scope, stakeholder involvement, platform, and reporting. Registry element input was determined in a series of meetings with clinical experts, patients, and caregivers, who identified key clinical variables and the draft content of nGD patient-reported outcomes (PRO) and observer-reported outcomes (ObsRO) focusing on symptoms, patient physical and emotional functioning. These were then tested in cognitive interviews with patients with nGD (> 12 years of age) and caregivers.ResultsCore registry data elements (n = 138) were identified by seven global clinical experts from Egypt, Germany, Israel, Japan, United Kingdom (UK), and United State (US) and reviewed via online Delphi method by 14 additional clinicians with experience of nGD from six countries and three pharmaceutical representatives. The elements were consistent with those identified via interviews with 10 patients/caregivers with nGD from Japan, Sweden, UK, and US. Key domains identified were demographics, diagnostic information, health status, clinical symptomatology, laboratory testing, treatment, healthcare resource utilization, aids/home improvements, and patient/caregiver burden and quality of life, specifically physical functioning, self-care, daily and social activities, emotional impacts, support services, and caregiver-specific impacts. Nine caregivers and six patients from the US, UK, China, Mexico, Egypt, and Japan participated in the cognitive interviews that informed revisions to ensure that all items are understandable and interpreted as intended.ConclusionsThe comprehensive set of clinical and patient relevant outcomes data, developed collaboratively among all stakeholders, to be reported using GARDIAN will bridge the many gaps in the understanding of nGD and align with regulatory frameworks on real-world data needs.

The reality of embedded drug purchasing practices: Understanding the sociocultural and economic aspects of the use of medicines in Bangladesh.

Purchasing drugs with or without prescription from retail drug shops is common practice in Bangladesh. However, what actually takes place between the drug seller and customer during the transaction is under-researched. This study explores the drug purchasing practices which underlie the socio-cultural and economic aspects of a Bangladeshi city. Adopting ethnographic methods, we conducted thirty in-depth interviews (IDIs) with customers, patients, and sales assistants, and ten key informant interviews (KIIs) with drug sellers, experienced sales assistants and pharmaceutical company representatives. Thirty hours were spent observing drug sellers' and buyers' conversations and interactions for medicine. A total of 40 heterogeneous participants were purposively selected from three drug stores. Transcribed data were coded, and analyzed thematically. We found through thematic analysis that some individuals visited the drug store with fixed ideas about the name, brand, and dose of the drugs they wanted. Among the 30 IDIs participants, most individuals come without any preconceived ideas, describe their symptoms, and negotiate purchases with the expectation of quick remedies. Cultural practices of buying medicines in full or partial course of doses, with or without prescription, trust in sellers, and positive previous experiences of medications shape the drug purchasing behavior, regardless of any preconceived ideas concerning brand name, and dose. Few customers (n = 7) sought drugs by trade name, but most drug sellers often offered a generic substitute because selling non-brand drugs is more profitable. Notably, many of the clients (n = 13) bought drugs through installment payments and with loans. Community people choose and purchase the most necessary medicines in a self-medicated way from shortly trained drug sellers that can harm individuals' health and reduce the effectiveness of medication. In addition, the results of buying medicine through installments and loans suggest further research on the financial burden of consumers' purchasing behavior. Policymakers, regulators, and healthcare professionals might implicate the study findings to deliver practical information on the rational use of medicines to sellers and customers.

Factors associated with potentially inappropriate prescribing among older persons in primary care settings: Systematic review

Background Potentially inappropriate prescribing (PIP) is common in primary care and is associated with adverse outcomes. Knowledge of the risk factors of PIP can be critical in designing PIP interventions, especially in guiding our understanding on how PIP occurs in primary care. Objective This systematic review examined factors associated with PIP, specific to primary care. Methods We searched PubMed, Embase, CINAHL, Web of Science, Scopus and PsycINFO for studies related to ‘older persons’, ‘primary care’ and ‘inappropriate prescribing’. Two reviewers conducted study selection, data extraction and quality appraisal. Factors associated with PIP were narratively synthesized. Results Of the 1017 articles identified, we included 25 articles and a total of 2,893,925 participants, with average age of 70.4–84.0 years. Risk factors of PIP could be classified into patient, physician and system factors. Patient factors were related to patient demographics (advanced age, lower education level and lower socioeconomic status), medical comorbidities (polypharmacy and multimorbidity) and lifestyle factors (unhealthy habits and use of over-the-counter medications). Physician and system factors included older, male, solo general practitioner (GP), higher number of visits of pharmaceutical sales representatives to GP, centrally located GP practice, and smaller number of older patients following up with GP, and medication source from public health system. Conclusions The findings provide contextual information to guide our understanding of PIP in primary care. Factors identified in this review can inform the design of complex interventions for PIP, as well as be used to develop risk prediction tools to identify high-risk groups who may require further interventions related to PIP.

Changes in Japanese physicians' relationships with the pharmaceutical industry between 2008 and 2021: A national survey.

A national survey we conducted in 2008 showed that many Japanese physicians interacted with and received gifts from pharmaceutical representatives (PRs) and had a positive attitude toward relationships with PRs. The revised promotion code of the Japan Pharmaceutical Manufacturers Association in 2019 prohibited the provision of non-educational promotional aids including sticky notes, mouse pads, and calendars. During the COVID-19 pandemic in 2020, face-to-face meetings were socially restricted. This study assessed the extent of current Japanese physicians' involvement in pharmaceutical promotional activities and their attitudes toward relationships with PRs and to ascertain any changes between 2008 and 2021. We also examined the factors that predicted positive attitudes toward gifts from PRs. From January to March 2021, we conducted a national mail survey of Japanese physicians in seven specialties: internal medicine, surgery, orthopedics, pediatrics, obstetrics-gynecology, psychiatry, and ophthalmology. There were 1636 participants and the response rate was 63.2%. Most physicians met face-to-face with PRs (78.8%), whereas only a minority received meals outside the workplace (4.5%). PRs were thought to have an important role in continuing medical education (66.1%) and to provide accurate information about new drugs (74.2%). Opinions were divided on the appropriateness of gifts from PRs. Most thought that stationery and meals provided by the industry did not affect prescribing behavior (89.7% and 75.8%, respectively). Factors that predicted a positive attitude toward gifts from PRs were male, orthopedic specialty vs. internal medicine, more interactions with PRs, a positive attitude toward informational value, and no rules banning meetings with PRs. Involvement in pharmaceutical promotional activities is still common among practicing physicians in Japan, although the extent of the involvement had declined. Rules banning meetings with PRs appear to continue being effective at limiting a physician's involvement with promotional activities and their critical attitudes toward gifts from PRs.

Ensuring access to innovative therapies for children, adolescents, and young adults across Canada: The single patient study experience.

Innovative therapeutic approaches are needed to alleviate the burden of life-limiting, rare, and chronic conditions affecting children, adolescents, and young adults (CAYA). This includes a need for improved access to both clinical research and to non-approved or off-label therapies, together with, ultimately, more therapies achieving regulatory approval in Canada. The single patient study (SPS), also known as an open label individual patient (OLIP) study, was introduced by Health Canada to open access to non-marketed drugs where a clinical trial is not readily available, but the drug is considered too investigational to be managed on a standard Special Access Program. SPS is designed for patients who have a serious or life-threatening condition and have exhausted available treatment options. Our report summarizes this relatively new development in the Canadian regulatory environment and highlights the opportunities and challenges as identified by regulators, pharmaceutical representatives, academic researchers, and patient/parent advocates.