UNASSIGNED: An expanded access clinical trials (EACTs) provides exceptional patient access to investigational new drugs for life-threatening diseases for which no effective treatment exists. Based on public information, we have studied EACTs since 2016, when the EACT system was launched in Japan. In this study, we investigated the reality of EACTs by interviewing pharmaceutical companies and clarifying how they view them.
UNASSIGNED: We conducted semi-structured interviews with 10 pharmaceutical companies developing new drugs. This study aims to clarify the status of EACTs, so we selected pharmaceutical companies that develop innovative drugs for which they may perform EACTs (however, experience in conducting EACTs was optional).
UNASSIGNED: All those surveyed were aware of EACTs. Twelve access clinical trials were conducted, and the EACT implementation rate for pivotal clinical trials was 2.5%. The most common reason for implementing an EACT was \"requests from physicians and medical institutions\" (nine companies, 90.0%), and the most common reason for not implementing an EACT was \"the applicability of the system\" (five companies). Improvements to EACTs were identified by eight companies (80.0%); financial assistance by six companies (60.0%); reducing the scope of data to be collected and simplifying the procedure by six companies (60.0%). Seven companies (70.0%) responded that a Single Patient Investigational New Drug Application should be conducted, suggesting that the system should be revised.
UNASSIGNED: An interview survey of ten pharmaceutical companies developing new drugs in Japan regarding expanded access clinical trials indicated that there were issues with the system. Many wished to improve the system by establishing a single patient access system, supporting resources, and simplifying procedures. Based on our interviews with 10 Japanese pharmaceutical companies, it was found that the system needed to be improved by introducing a single patient access system, providing supporting resources, and simplifying procedures. In Japan, about eight years have passed since EACT was established, and it appears a revision of the EACT legislation is due.

暂无摘要。

The Nordic countries are, together with the United States, forerunners in online record access (ORA), which has now become widespread. The importance of accessible and structured health data has also been highlighted by policy makers internationally. To ensure the full realization of ORA\'s potential in the short and long term, there is a pressing need to study ORA from a cross-disciplinary, clinical, humanistic, and social sciences perspective that looks beyond strictly technical aspects. In this viewpoint paper, we explore the policy changes in the European Health Data Space (EHDS) proposal to advance ORA across the European Union, informed by our research in a Nordic-led project that carries out the first of its kind, large-scale international investigation of patients\' ORA-NORDeHEALTH (Nordic eHealth for Patients: Benchmarking and Developing for the Future). We argue that the EHDS proposal will pave the way for patients to access and control third-party access to their electronic health records. In our analysis of the proposal, we have identified five key principles for ORA: (1) the right to access, (2) proxy access, (3) patient input of their own data, (4) error and omission rectification, and (5) access control. ORA implementation today is fragmented throughout Europe, and the EHDS proposal aims to ensure all European citizens have equal online access to their health data. However, we argue that in order to implement the EHDS, we need more research evidence on the key ORA principles we have identified in our analysis. Results from the NORDeHEALTH project provide some of that evidence, but we have also identified important knowledge gaps that still need further exploration.

BACKGROUND: First Contact Physiotherapy Practitioners (FCPPs) provide expert care for patients with musculoskeletal (MSK) conditions in General Practice. Access to FCPPs can facilitate timely care and efficient use of health services. However, there is little evidence about patient experiences of accessing FCPP appointments.
OBJECTIVE: To explore the experiences of patients with MSK conditions who have accessed an FCPP appointment in a General Practice setting in the UK.
METHODS: Exploratory qualitative design.
METHODS: Patients with MSK conditions who had experience of accessing FCPP appointments were recruited via social media. Semi-structured interviews were conducted and recorded via MS Teams. Data were analysed using thematic analysis.
RESULTS: Of 13 patients interviewed, there were 10 females and three males, with an age range between 20 and 80 years. The main themes identified were: (1) Awareness of FCPP, (2) Access routes, (3) Facilitators to access, (4) Barriers to access, (5) Likelihood of re-accessing FCPP. Awareness of FCPP was generally low amongst participants. There were a variety of routes to access FCPP appointments; some were felt to be sub-optimal by participants. Facilitators included quick/easy access to FCPP. Barriers included difficulty contacting General Practitioner (GP) surgeries and public perception of needing to see a GP initially. The likelihood of re-consultation with a FCPP was low when participants had disappointing care experiences.
CONCLUSIONS: This study provides new evidence about patient experiences of accessing FCPP. It explores positive and negative aspects of access from patients\' perspectives. It also highlights areas for improvement in terms of GP staff/patient awareness and understanding of FCPP.

BACKGROUND: Community health centers grapple with high no-show rates, posing challenges to patient access and primary care provider (PCP) utilization.
OBJECTIVE: To address these challenges, we implemented a virtual waiting room (VWR) program in April 2023 to enhance patient access and boost PCP utilization.
METHODS: Academic community health center in a small urban city in Massachusetts.
METHODS: Community health patients (n = 8706) and PCP (n = 14).
METHODS: The VWR program, initiated in April 2023, involved nurse triage of same-day visit requests for telehealth appropriateness, then placing patients in a standby pool to fill in as a telehealth visit for no-shows or last-minute cancellations in PCP schedules.
RESULTS: Post-implementation, clinic utilization rates between July and September improved from 75.2% in 2022 to 81.2% in 2023 (p < 0.01). PCP feedback was universally positive. Patients experienced a mean wait time of 1.9 h, offering a timely and convenient alternative to urgent care or the ER.
CONCLUSIONS: The VWR is aligned with the quadruple aim of improving patient experience, population health, cost-effectiveness, and PCP satisfaction through improving same-day access and improving PCP schedule utilization. This innovative and reproducible approach in outpatient offices utilizing telehealth holds the potential for enhancing timely access across various medical disciplines.

Governments and biopharmaceutical organizations aggressively leveraged expeditious communication capabilities, decision models, and global strategies to make a COVID-19 vaccine happen within a period of 12 months. This was an unusual effort and cannot be transferred to normal times. However, this focus on a single vaccine has also led to other treatments and drug developments being sidelined. Society expects the pharmaceutical industry to provide an uninterrupted supply of medicines. However, it is often overlooked how complex the manufacture of these compounds is and what logistics are required, not to mention the time needed to develop new drugs. The overarching theme, therefore, is patient access and how we can help ensure access and extend it to low- and middle-income countries. Despite unceasing efforts to make medications available to all patient populations, this must never be done at the expense of patient safety. A major fraction of the costs in biopharmaceutical manufacturing are for drug discovery, process development, and clinical studies. Infrastructure costs are very difficult to quantify because they often depend on whether a greenfield facility or an existing, depreciated facility is used or adapted for a new product. To accelerate process development concepts of platform process and prior knowledge are increasingly leveraged. While more traditional protein therapeutics continue to dominate the field, we are also experiencing the exciting emergence and evolution of other therapeutic formats (bispecifics, tetravalent mAbs, antibody-drug conjugates, enzymes, peptides, etc.) that offer unique treatment options for patients. Protein modalities are still dominant, but new modalities are being developed that can be learned from including advanced therapeutics-like cell and gene therapies. The industry must develop a model-based strategy for process development and technologies such as continuous integrated biomanufacturing must be adopted. The overall conclusion is that the pandemic pace was unsustainable, focused on vaccine delivery at the expense of other modalities/disease targets, and had implications for professional and personal life (work-life balance). Routinely reducing development time from 10 years to 1 year is nearly impossible to achieve. Environmental aspects of sustainable downstream processing are also described.

California like many other states is facing a severe shortage of primary care physicians and access to primary care is uneven across the state. It is well documented that California has the highest number of designated primary care health professional shortage areas in the country. Although physician assistants (PAs) and nurse practitioners (NPs) are estimated to make up a large portion of California\'s primary care workforce by 2030, outdated and unnecessary statutory requirements such as the physician-to-PA supervision ratio requirement represent a practice barrier in expanding access to care. Other states have either eliminated or revised their physician-to-PA supervision ratios in favor of expanding access to health care services. Therefore, this editorial represents a call for coordinated actions from local and state entities to address California\'s outdated physician-to-PA supervision ratio requirement. NPs are mentioned briefly as they have achieved a pathway to full practice authority in California.

UNASSIGNED: As the shortage of primary care providers widens nationwide, access to care utilizing non-physician providers is one strategy to ensure equitable access to care. This study aimed to compare community pharmacist-provided care for minor ailments to care provided at three traditional sites of care: primary care, urgent care, and emergency department, to determine if care provided by pharmacists improved access with comparable quality and reduced financial strain on the healthcare system.
UNASSIGNED: Pharmacy data was provided from 46 pharmacies and 175 pharmacists who participated across five pharmacy corporations over a 3-year period (2016-2019). Data for non-pharmacy sites of care was provided by a large health plan, matching episodes of care for conditions seen in the community pharmacy. Cost-of-care analysis was conducted using superiority study design and revisit data analysis was conducted using noninferiority study design.
UNASSIGNED: Median cost-of-care across traditional sites of care was $277.78 higher than care provided at the pharmacies, showing superiority. Noninferiority was demonstrated for revisit care when the initial visit was conducted by a pharmacist compared to traditional sites.
UNASSIGNED: The authors conclude community pharmacist-provided care for minor ailments improved cost-effective access for patients with comparable quality and reduced financial strains on the healthcare system.

BACKGROUND. To implement provisions of the 21st Century Cures Act that address information blocking, federal regulations mandated that health systems provide patients with immediate access to elements of their electronic health information, including imaging results. OBJECTIVE. The purpose of this study was to compare patient access of radiology reports before and after implementation of the information-blocking provisions of the 21st Century Cures Act. METHODS. This retrospective study included patients who underwent outpatient imaging examinations from January 1, 2021, through December 31, 2022, at three campuses within a large health system. The system implemented policies to comply with the Cures Act information-blocking provisions on January 1, 2022. Imaging results were released in patient portals after a 36-hour embargo period before implementation versus being released immediately after report finalization after implementation. Data regarding patient report access in the portal and report acknowledgment by the ordering provider in the EMR were extracted and compared between periods. RESULTS. The study included reports for 1,188,692 examinations in 388,921 patients (mean age, 58.5 ± 16.6 [SD] years; 209,589 women, 179,290 men, eight nonbinary individuals, and 34 individuals for whom sex information was missing). A total of 77.5% of reports were accessed by the patient before implementation versus 80.4% after implementation. The median time from report finalization to report release in the patient portal was 36.0 hours before implementation versus 0.4 hours after implementation. The median time from report release to first patient access of the report in the portal was 8.7 hours before implementation versus 3.0 hours after implementation. The median time from report finalization to first patient access was 45.0 hours before implementation versus 5.5 hours after implementation. Before implementation, a total of 18.5% of reports were first accessed by the patient before being accessed by the ordering provider versus 44.0% after implementation. After implementation, the median time from report release to first patient access was 1.8 hours for patients with age younger than 60 years old versus 4.3 hours for patients 60 years old or older. CONCLUSION. After implementation of institutional policies to comply with 21st Century Cures Act information-blocking provisions, the length of time until patients accessed imaging results decreased, and the proportion of patients who accessed their reports before the ordering provider increased. CLINICAL IMPACT. Radiologists should consider mechanisms to ensure timely and appropriate communication of important findings to ordering providers.

BACKGROUND: In many large health centers, patients face long appointment wait times and difficulties accessing care. Last-minute cancellations and patient no-shows leave unfilled slots in a clinician\'s schedule, exacerbating delays in care from poor access. The mismatch between the supply of outpatient appointments and patient demand has led health systems to adopt many tools and strategies to minimize appointment no-show rates and fill open slots left by patient cancellations.
OBJECTIVE: We evaluated an electronic health record (EHR)-based self-scheduling tool, Fast Pass, at a large academic medical center to understand the impacts of the tool on the ability to fill cancelled appointment slots, patient access to earlier appointments, and clinical revenue from visits that may otherwise have gone unscheduled.
METHODS: In this retrospective cohort study, we extracted Fast Pass appointment offers and scheduling data, including patient demographics, from the EHR between June 18, 2022, and March 9, 2023. We analyzed the outcomes of Fast Pass offers (accepted, declined, expired, and unavailable) and the outcomes of scheduled appointments resulting from accepted Fast Pass offers (completed, canceled, and no-show). We stratified outcomes based on appointment specialty. For each specialty, the patient service revenue from appointments filled by Fast Pass was calculated using the visit slots filled, the payer mix of the appointments, and the contribution margin by payer.
RESULTS: From June 18 to March 9, 2023, there were a total of 60,660 Fast Pass offers sent to patients for 21,978 available appointments. Of these offers, 6603 (11%) were accepted across all departments, and 5399 (8.9%) visits were completed. Patients were seen a median (IQR) of 14 (4-33) days sooner for their appointments. In a multivariate logistic regression model with primary outcome Fast Pass offer acceptance, patients who were aged 65 years or older (vs 20-40 years; P=.005 odds ratio [OR] 0.86, 95% CI 0.78-0.96), other ethnicity (vs White; P<.001, OR 0.84, 95% CI 0.77-0.91), primarily Chinese speakers (P<.001; OR 0.62, 95% CI 0.49-0.79), and other language speakers (vs English speakers; P=.001; OR 0.71, 95% CI 0.57-0.87) were less likely to accept an offer. Fast Pass added 2576 patient service hours to the clinical schedule, with a median (IQR) of 251 (216-322) hours per month. The estimated value of physician fees from these visits scheduled through 9 months of Fast Pass scheduling in professional fees at our institution was US $3 million.
CONCLUSIONS: Self-scheduling tools that provide patients with an opportunity to schedule into cancelled or unfilled appointment slots have the potential to improve patient access and efficiently capture additional revenue from filling unfilled slots. The demographics of the patients accepting these offers suggest that such digital tools may exacerbate inequities in access.