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Matching the supply of medical equipment with soaring demand caused by an epidemic event is a daunting challenge. Focusing on medical equipment manufacturers, this study empirically examines how supply chain management impacts manufacturers' responses to epidemic-driven demand. This study employs novel supply chain data from South Korea collected before and after the MERS (Middle East Respiratory Syndrome) epidemic event. In the results, we show that such an epidemic positively influences the sales performance of medical equipment manufacturers (i.e. a 10.2 percentage-point increase). To identify the mechanism behind this result, we provide evidence that increasing the supply base (i.e. the number of supply channels) enables medical equipment manufacturers to better respond to epidemic-driven demand and ultimately improves their sales performance. More interestingly, we find that medical equipment manufacturers with lower market status (i.e. lower market shares and lower supplier shares) expand their supply bases more extensively than other medical equipment manufacturers with higher market status do. Interpreting these results, we offer managerial insights into how medical equipment manufacturers can effectively manage their supply chains and improve their performance when responding to epidemic-driven demand. [ABSTRACT FROM AUTHOR]

Motivated by the COVID-19 pandemic, this paper explores the supply chain viability of medical equipment, an industry whose supply chain was put under a crucial test during the pandemic. This paper includes an empirical network-level analysis of supplier reachability under Random Failure Experiments (RFE) and Intelligent Attack Experiments (IAE). Specifically, this study investigates the effect of RFE and IAE across multiple tiers and scales. The global supply chain data was mined and analysed from about 45,000 firms with about 115,000 intertwined relationships spanning across 10 tiers of the backward supply chain of medical equipment. This complex supply chain network was analysed at four scales, namely: firm, country-industry, industry, and country. A notable contribution of this study is the application of a supply chain tier optimisation tool to identify the lowest tier of the supply chain that can provide adequate resolution for the study of the supply chain pattern. We also developed data-driven-tools to identify the thresholds for breakdown and fragmentation of the medical equipment supply chain when faced with random failures or different intelligent attack scenarios. The novel network analysis tools utilised in the study can be applied to the study of supply chain reachability and viability in other industries. [ABSTRACT FROM AUTHOR]

Background and Objectives: Key opinion leader (KOL) interviews were conducted by the Benefit–Risk Assessment Planning (BRAP) Taskforce to seek expert opinion mainly from industry and regulatory bodies, about the current status and future direction of benefit–risk assessment (BRA) planning in the lifecycle of medical product development. The findings from these interviews are intended to help communication concerning planning for BRA between industry and regulators and shape future guidance. Methods: Key opinion leader interviews consisted of 5 questions related to BRA planning, which were administered to volunteers (mainly clinicians and statisticians) within a pool of experienced pharmaceutical and medical device professionals representing academia, industry, regulatory agencies and a patient group. The interviewees' responses to the 5 questions were summarized. To analyze the qualitative data, a Coding System was developed to label themes arising from the interviews. The key findings from the interviews were summarized into a Master Template. A quantitative analysis based on descriptive statistics was also conducted. Results: Of the 27 interviewees, there were 11 professionals from regulatory agencies, 11 from industry, 4 from academia and 1 from a patient advocacy group. Key findings based on the comments provided by 48% of the interviewees indicated the need of incorporating BRA into other (e.g., existing) processes with the importance of alignment between processes being stressed in the comments provided by 59% of the interviewees. Commencing BRA early in the product lifecycle was emphasized in comments provided by 44% of the interviewees. Among other needs identified were an appropriate contextualization of benefits and risks (based on comments provided by 41% of interviewees) through adoption of an integrated approach with structured support by regulatory agencies and a need for understanding the audience with better communication of benefit–risk (BR) among all stakeholders (based on comments provided by 44% of the interviewees). Almost all comments provided by interviewees (96%) highlighted the importance of utilizing patient experience/preference to guide new product development and BRA. Comments provided by 74% of the interviewees expressed the need to understand patient tolerance for risk and trade-offs, with a majority (78%) of interviewees highlighting how to gather information, and 59% stressing the need for the selection and development of appropriate methodologies as important considerations for enhancing the quality and relevance of the data collected from patients. Conclusions: Interviewees indicated that BRA should commence early in the medical product development and inform decision-making throughout the product lifecycle. Better planning and integration of BRA into existing processes within industry would be valuable. The importance of incorporating the patient voice into BRA and medical product development was emphasized. Other key findings from the KOL interviews included a need for improved communication of BR information, and establishment of methodologies for performing BRA and soliciting patient input. [ABSTRACT FROM AUTHOR]

Purpose In high-acuity situations such as cardiac arrest, clinicians rely on prepared medications stocked in code carts to provide timely and accurate pharmacotherapy. We examined shortage trends for medications commonly used in code carts. Methods Drug shortage data from 2001 to 2022 were retrieved from the University of Utah Drug Information Service (UUDIS) to characterize shortages reported for commonly used code cart medications. Data extracted included the number of shortages, shortage duration, drug characteristics, and reason for the shortage. Results From 2001 to 2022, 71 drug shortages for code cart medications were reported. The number of new shortages peaked in 2010, and the number of total shortages peaked in 2010. At the end of the study period, 61 (84.7%) shortages had been resolved. For resolved shortages, the mean shortage duration was 18.2 months. The drug with the greatest number of reported shortages was dextrose (10 total), the drug with the longest resolved shortage was calcium chloride injection (116 months), and the drug with the longest active shortage was atropine injection (165 months at the end of the study period). Throughout the entire study period, only 2 suppliers provided commercially available prefilled syringes of dextrose for stocking on code carts. The most common reason for shortages, when reported, was manufacturing delays. Conclusion Medications commonly used in code carts were frequently impacted by drug shortages, which have the potential to impact patient care. Institutional protocols for mitigation and larger efforts to promote a more resilient drug supply chain are critical to ensure patient safety and quality care. [ABSTRACT FROM AUTHOR]

Public procurement is crucial for effective crisis responses, but is also prone to corruption. To ensure a swift provision of medical supplies in the COVID-19 pandemic, the public procurement regulations were dramatically relaxed. However, the implications for corruption require attention. This paper analyses how the regulatory responses to the crisis affected the risks and perceptions of corruption, by changing public-private interactions and the regulatory environment for public procurement. We compare the contrasting cases of Italy and Germany and triangulate legal analyses, secondary contract and survey data, and an online survey of public administrations (N = 445) and businesses (N = 175). Unexpectedly, in both countries, objective risks of corruption increased similarly. Sector-specific corruption perceptions stem from a low competitiveness of procedures, rule ambiguity, and a politicised bureaucracy. To avoid wasting resources and losing trust, regulatory responses to the crisis should include clear rules that safeguard competitive public procurement procedures and preserve bureaucratic independence. [ABSTRACT FROM AUTHOR]

Introduction: Real-world evidence is receiving considerable attention as a way to evaluate the efficacy and safety of medical products for substance use disorders (SUDs). However, the feasibility of using real-world data (RWD) to emulate clinical trials evaluating treatments for SUDs is uncertain. The aim of this study is to identify the number of clinical trials evaluating treatments for SUDs with reported results that could be feasibly emulated using observational data from contemporary insurance claims and/or electronic health record (EHR) data. Methods: In this cross-sectional study, all phase 2–4 trials evaluating treatments for SUDs registered on ClinicalTrials.gov with reported results were identified. Each trial was evaluated to determine if the indications, interventions, at least 80% of eligibility criteria, comparators, and primary end points could be ascertained using contemporarily available administrative claims and/or structured EHR data. Results: There were 272 SUD trials on ClinicalTrials.gov with reported results. Of these, when examining feasibility using contemporarily available administrative claims and/or structured EHR data, 262 (96.3%) had indications that were ascertainable; 194 (71.3%) had interventions that were ascertainable; 21 (7.7%) had at least 80% of eligibility criteria that were ascertainable; 17 (6.3%) had active comparators that were ascertainable; and 61 (22.4%) had primary end points that were ascertainable. In total, there were no trials for which all 5 characteristics were ascertainable using contemporarily available administrative claims and/or structured EHR data. When considering placebo comparators as ascertainable, there were 6 (2.2%) trials that had all 5 key characteristics classified as ascertainable from contemporarily available administrative claims and/or structured EHR data. Conclusions: No trials evaluating treatments for SUDs could be feasibly emulated using contemporarily available RWD, demonstrating a need for an increase in the resolution of data capture within a public health system to facilitate trial emulation. [ABSTRACT FROM AUTHOR]

It is impossible to eliminate the potential for transmission of donor‐derived infections (DDI) when using medical products of human origin (MPHO). However, a thoughtful and systematic approach to donor evaluation can mitigate the risk. Prevention is a key issue, and physicians must maintain a high index of suspicion and remain vigilant in evaluating MPHO donors or recipients, as well as stay current on emerging infections. Biovigilance is the systematic monitoring of serious adverse reactions and events (SARE) that ensures the quality and safety of MPHO in transplantation. The Notify Library with its 2808 references is an available didactic tool that could support physicians in donor or recipient evaluation, inform biovigilance activity, and benefit the international scientific community. It provides free access to a large collection of many different types of SARE, identified mainly through the review of published articles and case reports from national or regional surveillance programs. The Notify Library includes many well‐documented records of SARE in the field of DDI, representing a useful tool for assessing SARE associated with transplantation. It is continuously updated with new records, especially when a new type of incident is first reported. All types of described incidents may have educational value while guiding detection, investigation, or risk management. Sharing the lessons learned from these incidents represents an important educational opportunity that can help improve organ donation processes and achieve higher standards of quality and safety. [ABSTRACT FROM AUTHOR]

Background: The attainment of global health security goals and universal health coverage will remain a mirage unless African health systems are adequately funded to improve resilience to public health emergencies. The COVID-19 pandemic exposed the global inequity in accessing medical countermeasures, leaving African countries far behind. As we anticipate the next pandemic, improving investments in health systems to adequately finance pandemic prevention, preparedness, and response (PPPR) promptly, ensuring equity and access to medical countermeasures, is crucial. In this article, we analyze the African and global pandemic financing initiatives and put ways forward for policymakers and the global health community to consider. Methods: This article is based on a rapid literature review and desk review of various PPPR financing mechanisms in Africa and globally. Consultation of leaders and experts in the area and scrutinization of various related meeting reports and decisions have been carried out. Main text: The African Union (AU) has demonstrated various innovative financing mechanisms to mitigate the impacts of public health emergencies in the continent. To improve equal access to the COVID-19 medical countermeasures, the AU launched Africa Medical Supplies Platform (AMSP) and Africa Vaccine Acquisition Trust (AVAT). These financing initiatives were instrumental in mitigating the impacts of COVID-19 and their lessons can be capitalized as we make efforts for PPPR. The COVID-19 Response Fund, subsequently converted into the African Epidemics Fund (AEF), is another innovative financing mechanism to ensure sustainable and self-reliant PPPR efforts. The global initiatives for financing PPPR include the Pandemic Emergency Financing Facility (PEF) and the Pandemic Fund. The PEF was criticized for its inadequacy in building resilient health systems, primarily because the fund ignored the prevention and preparedness items. The Pandemic Fund is also being criticized for its suboptimal emphasis on the response aspect of the pandemic and non-inclusive governance structure. Conclusions: To ensure optimal financing for PPPR, we call upon the global health community and decision-makers to focus on the harmonization of financing efforts for PPPR, make regional financing mechanisms central to global PPPR financing efforts, and ensure the inclusivity of international finance governance systems. [ABSTRACT FROM AUTHOR]

Introduction: Health policy and systems research (HPSR) is a multi-disciplinary approach of generating health system and policy-level evidence. Setting HPSR agendas is considered as an efficient strategy to map and identify policy and cost-effective research topics, but its practice in developing countries is limited. This paper aimed to conduct a collaborative health policy and system research priority-setting exercise in Ethiopia. Method: The WHO's plan, implement, publish, and evaluate (PIPE) framework and the Delphi technique were used to conduct the priority-setting exercise. The PIPE model was used to lead the priority-setting process from planning to evaluation, while the Delphi technique was used to run the rating and ranking exercise with the aim of reaching a consensus. Two rounds of expert panel workshops supplemented with an online survey were used for the HPSR agenda setting, rating and ranking purposes. Groups were formed using the WHO health system building blocks as a base framework to identify and prioritize the HPSR topics. Result: Under 8 themes, 32 sub-themes and 182 HPSR topics were identified. The identified research themes include leadership management and governance, health policy, health information system, healthcare financing, human resource for health, medical products and supply, service delivery and cross-cutting issues. Conclusions: Priority HPSR topics focussing on national health priority issues were identified. The identified topics were shared with policymakers and academic and research institutions. Evidence generation on the identified priority topics will guide future research endeavours and improve evidence-informed decision-making practice, health system performance and national health goals and targets. [ABSTRACT FROM AUTHOR]

The paper examines the implications of COVID-19 pandemic on multi-level governance (MLG) in Ghana. Adopting a qualitative document analysis approach supported by 18 key informant interviews, the findings revealed four enablers of recentralization: COVID-19-induced legislations for centralized decision, centralized distribution of relief packages and medical supplies, centralized institutional response, and centralized government communication strategies. Despite the use of centralized policy making, the management of pandemic is fraught with institutional inefficiencies, rigidities, and ambiguities. The paper argues that the recentralization of COVID-19 management is symptomatic of a long period of neglect of MLG in Ghana. Since, local governments are perceived as inept and ill-equipped, there is a mistaken believe that recentralized decisions are more effective during emergencies. To ensure an effective response to public emergencies, its mitigation and post-crisis recovery in developing countries, a MLG approach – where central, local, and other non-state actors work together in equal partnership is crucial. [ABSTRACT FROM AUTHOR]

The article focuses on the importance of expanding and coordinating global regulatory capacity to better prepare for future pandemics. Topics include the need for equitable access to essential medical products; the challenges posed by the concentration of regulatory capacity in high-income countries; and the benefits of decentralizing regulatory review to accelerate access to diagnostics, therapeutics and vaccines.

Importance: The US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated. Observations: Payers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation. In addition, payers have a stake in improving evidence generation because the kinds of evidence needed to inform health care and coverage decisions are often not available when a product enters the market and may not be generated without their involvement. Here, we describe several key steps payers could take to improve evidence generation, including participating in efforts to reduce administrative and financial barriers to the conduct of clinical trials, directly incentivizing evidence generation on high-priority questions by funding potential cost-saving trials, increasing engagement with the medical products industry on evidentiary needs for coverage decisions, and improving usability of claims data by reducing data lags and routinely recording unique device identifiers. Broad payer engagement with US Food and Drug Administration recommendations regarding evidence generation will ensure that the opportunities to participate in clinical research are extended to all communities and that evidence needed to inform care is generated in trials and surveillance systems that reflect the clinical reality across the US. Conclusions and Relevance: Increasing payer involvement in evidence generation can benefit all participants in the medical innovation ecosystem. The importance of payers in these efforts will continue to grow in response to imperatives to increase integration of care and research, engage a diverse set of communities in clinical research, and move toward alternative payment models. This Special Communication discusses the current clinical trials system, examines why payers should support evidence generation, and suggests potential avenues for collaboration. [ABSTRACT FROM AUTHOR]

Chimeric antigen receptor (CAR) T-cell therapy has shown promise in patients with late-line refractory multiple myeloma, with response rates ranging from 73 to 98%. To date, three products have been approved: Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which are approved by the US Food and Drug Administration, the European Medicines Agency, Health Canada (ide-cel only), and Brazil ANVISA (cilta-cel only); and equecabtagene autoleucel (eque-cel), which was approved by the Chinese National Medical Products Administration. CAR T-cell therapy is different from previous anti-myeloma therapeutics with unique toxic effects that require distinct mitigation strategies. Thus, a panel of experts from the International Myeloma Working Group was assembled to provide guidance for clinical use of CAR T-cell therapy in myeloma. This consensus opinion is from experts in the field of haematopoietic cell transplantation, cell therapy, and multiple myeloma therapeutics. [ABSTRACT FROM AUTHOR]

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Outsourcing of health-commodity supplies to third-party logistics providers is one of the ways of reducing costs and/or improving service levels in the public sector. This paper evaluates three forms of outsourcing: full outsourcing of inventory management, partial outsourcing of specific activities, and contingent partial outsourcing of specific logistics activities. It notes that, in Africa, contracting-out supply logistics has mostly taken the form of partial outsourcing of transportation only or storage and transportation of specific health commodities to all or selected geographical regions. Partial outsourcing offers limited benefits since it cannot provide adequate pressures on public-sector logistics to be efficient or maintain uninterrupted supplies in times of catastrophes. Improvements in logistics performance achieved through partial outsourcing should not mask the need for more expansive arrangements that support not only partial outsourcing but also full outsourcing in situations of inefficiency and in times of supply-disruption catastrophe. [ABSTRACT FROM AUTHOR]

Objective: Both camrelizumab plus paclitaxel and carboplatin (CTC) and sintilimab plus gemcitabine and cisplatin or carboplatin (SGP) have been approved by the National Medical Products Administration of China (NMPA) for the first-line treatment of local advanced or metastatic sqNSCLC. However, the comparison of the two treatments as first-line treatments in efficacy or pharmacoeconomics has barely been studied. To deeply understand the costs and outcomes of the two treatments, this work directly compared the cost-effectiveness for the first-line treatment of local advanced or metastatic squamous NSCLC in the Chinese mainland. Methods: A network meta-analysis was first performed based on the three clinical trials, namely, CameL-Sq, ORIENT-12, and C-TONG1002, to compare the clinical benefits of the two treatments. The Weibull approximation was applied to further calculate the life expectancy of the two treatments. The partitioned survivalmodel (PSM) was next established, and one-way sensitivity analysis and probabilistic sensitivity analysis were also performed to evaluate the stability of the underlying parameter values and assumptions within the model. Results: CTC treatment gained 0.68 QALYs and cost $14,764. SGP treatment gained 0.54 QALYs and cost $14,584. The CTC arm gained 0.14 additional QALYs and cost $179 more than the SGP arm, and the ICERs was $1,269/QALY, which was lower than one-fold GDP per capita in the Chinese mainland ($12,734 GDP per capita in 2022). In probabilistic sensitivity analysis, when the WTP ranged from $12,734-38,202 (1-3 folds, 2022 GDP per capita in China), the CTC group had higher probabilities than the SGP group for being cost effective, which ranged from 85.65% to 88.38%. Conclusion: From the perspective of the payers, camrelizumab plus chemotherapy was cost-effective compared with sintilimab plus chemotherapy for the first-line treatment of local advanced or metastatic squamous NSCLC in the Chinese mainland. [ABSTRACT FROM AUTHOR]

3D printing technology has revolutionized product development in numerous industries. Due to 3D printing, innovative ways of directly giving drugs to patients, anatomical models for surgical planning and training, and tailored prosthetics and other medical equipment are all within the realm of possibility in the medical industry. 3D printing in healthcare has sparked a paradigm shift in creating medical implants and prosthetics. As a result of their exceptional mechanical, thermal, electrical, and optical qualities, polymers and composites made of them have gained widespread use in the medical industry. In this review article, we look at the most recent and cutting-edge benefits of 3D printing technology to create medical products out of polymers and composites. This article summarizes recent findings in patient-specific medical device and prosthesis design and manufacture and anatomical model development for surgical training and planning. Various 3D printing techniques, i.e., stereolithography, fused deposition modeling, and selective laser sintering methods, were examined, along with the pros and cons. Finally, we discuss the importance of 3D printing, which could significantly alter how medical devices are designed and produced, enhancing healthcare services and improving patient outcomes. [ABSTRACT FROM AUTHOR]

Crossing the early modern Pacific Ocean presented many challenges. This chapter seeks to provide some insights into the food provisions, diseases, and medical supplies found on board galleons. I will also discuss some aspects of transcultural medical knowledge transfer and introduce some results of our ongoing ERC AdG project TRANSPACIFIC. [ABSTRACT FROM AUTHOR]

In response to the COVID-19 pandemic, the Red Cross Society of China played a crucial role in distributing medical donations, but the initial efforts were inefficient and neglected medical personnel’s welfare. This study proposes a time-sensitive humanitarian distribution model that optimizes the social costs by integrating logistics and deprivation costs that cares about human suffering. We ues the Gini coefficient to evaluate delays in distribution, aiding trade-off analysis between logistics efforts and social welfare. Our findings show that the proposed model improves the Gini coefficient by an average of 33.96% across 500 scenarios. Additionally, investing 23.7% more in logistics costs reduces the Gini coefficient by 0.1, enhancing the social welfare of medical supplies distribution. Sensitivity analysis examines the impact of time delay and cost investment on the Gini coefficient, offering insights into balancing logistics investments and social welfare. [ABSTRACT FROM AUTHOR]

Cell and gene therapy poses evolving challenges. The current article summarizes the discussions held by European Regional Committee of the International Society for Cell & Gene Therapy and the European Society for Blood and Marrow Transplantation (EBMT) on the current challenges in this field, focusing on the European setting. This article emphasizes the imperative assessment of real-world cell and gene therapy activity, advocating for expanded registries beyond hematopoietic transplantation and chimeric antigen receptor–T-cell therapy. Accreditation's role in ensuring standardized procedures, as exemplified by JACIE (The Joint Accreditation Committee of ISCT-Europe and EBMT), is crucial for safety. Access to commercial products and reimbursement variations among countries underscore the need for uniform access to advanced therapy medical products (ATMPs). Academic product development and point-of-care manufacturing face barriers to patient access. Hospital Exemption's potential, demonstrated by some initial experiences, may increase patient accessibility in individual situations. Regulatory challenges, including the ongoing European ATMPs legislation review, necessitate standardized criteria for Hospital Exemption and mandatory reporting within registries. Efforts to combat unproven therapies and fraud involve collaboration between scientific societies, regulatory bodies and patient groups. Finally, is important to highlight the vital role of education and workforce development in meeting the escalating demand for specialized professionals in the ATMP field. Collaboration among scientific societies, academic institutions, industry, regulatory bodies and patient groups is crucial for overcoming all these challenges to increase gene and cell therapy activity in Europe. [ABSTRACT FROM AUTHOR]

Integrated skincare combines clinically proven skincare products with professional medical aesthetics to provide a comprehensive solution for beauty pursuers. Studies have demonstrated that a combination of medical aesthetic procedures and maintenance therapies is more effective than either treatment alone. This review outlines the current applications of integrated skincare, including different regimens of energy‐based aesthetic devices and active ingredients in cosmeceuticals or chemical peels. Additionally, the benefits and limitations of integrated skincare are discussed. Lastly, this review highlights the potential for improved satisfaction and long‐term maintenance of the desired outcomes through appropriate integrated skincare procedures. [ABSTRACT FROM AUTHOR]

This article shares the personal account of the author who is living with double incontinence, and the impact this condition can have on the individual and their carers. [ABSTRACT FROM AUTHOR]

Adebrelimab, a novel anti‐PD‐L1 antibody, has been approved by the National Medical Products Administration of China as an intravenous infusion for use in combination with carboplatin and etoposide as first‐line treatment for extensive‐stage small‐cell lung cancer in 2023. A two‐compartment model with empirical time‐varying CL for adebrelimab was established based on data from 263 patients receiving body weight‐based doses from two clinical studies. Significant covariate effects of baseline body weight, albumin levels, tumor size, neutrophil counts, and presence of anti‐drug antibodies were identified on CL of debrelimab, none of which were clinically significant or warranted dose adjustment. The degree of decrease in CL was higher in patients who responded to treatment with adebrelimab than in non‐responders. Adebrelimab exposures (AUC, Ctrough, or Cmax) were not identified as a statistically significant factor related to efficacy or safety endpoint in the exposure–response analysis. Distribution of simulated exposure metrics from the flat dose regimen (1200 mg q3w) was similar to the marketed weight‐based dosing regimen (20 mg/kg q3w), supporting the alternative flat dose regimen in the clinic. [ABSTRACT FROM AUTHOR]

To mitigate losses from public health emergencies, promptly choosing an emergency medical supply distribution center is essential. The success of rescues hinges on the center's location. Location decision for such centers is fraught with uncertainty and risk, complicating the task for decision makers (DMs). Often, DMs operate under bounded rationality in urgent situations. In response, this paper introduces a novel fuzzy multicriteria decision-making approach, integrating interval-valued intuitionistic fuzzy numbers, interval intuitionistic trapezoidal fuzzy numbers, not-in-my-backyard (NIMBY) effect, and cumulative prospect theory, to address the uncertainty and risk in decision-making. The method begins by introducing the NIMBY effect to construct the evaluation criteria system of emergency medical supply distribution centers. Next, the alternative under the evaluation criteria is evaluated by fuzzy linguistic terms and interval intuitionistic trapezoidal fuzzy numbers. The interval-valued intuitionistic fuzzy numbers are used to determine the weight of each DM by calculating the relative scores of advantage and disadvantage. The criteria weight is determined via a combination of fuzzy network analysis and the entropy weight method. Cumulative prospect theory is then employed to rank site selections, factoring in DM risk preferences. The approach is tested on an emergency medical supply distribution center location for sensitivity and comparative analysis, proving its efficacy and stability. This research presents an innovative fuzzy model for evaluating emergency medical supply distribution center site selection in uncertain conditions, suggesting the need to incorporate multiple dimensions such as realistic criteria systems, uncertain decision information, and variable environments in such decision-making processes. [ABSTRACT FROM AUTHOR]

Purpose: Ineffective management inventory of medical products such as blood and vaccines can create severe repercussions for hospitals, clinics or medical enterprises, such as surgery delays and postponements. Inventory sharing is a form of horizontal collaboration that can provide solutions to key actors of the healthcare supply chain (HSC), yet no prior study reviewed this topic. Design/methodology/approach: This study conducts a systematic literature review of thirty-nine inventory-sharing studies in the context of HSCs published from 2012 until early 2022. The descriptive and thematic analyses include chronological distribution, geographical location, comparison between developed/developing regions, stakeholder and incident analysis. Findings: Thematic analysis classified inventory sharing among five product supply chains (blood, medical supplies, medicines, vaccines and generic medical products). Benefits include shortage reduction, cost minimisation, and wastage mitigation. Barriers include (1) IT infrastructure, (2) social systems, (3) cost and (4) supply chain operations. Perishable inventory policies include Fresher-First (FF), Last-Expire-First-Out (LEFO), First-In-First-Out (FIFO) and First-Expire-First-Out (FEFO). The analysis also showed differences between developed and developing countries. The study identifies several future research opportunities that include (1) product utilisation rate, (2) cost reductions, (3) shortage mitigation and (4) waste reduction. Originality/value: No prior study has systematically reviewed inventory sharing in HSCs to reveal benefits, barriers, patterns and gaps in the current literature. It makes five propositions and develops a research model to guide future research. The study concludes with theoretical and managerial implications. [ABSTRACT FROM AUTHOR]

There is a growing demand for the use of high‐quality real‐world evidence (RWE) to support regulatory decision‐making worldwide and in China, which highlights the need for conducting literature reviews to evaluate the available data and evidence. This study aims to review the use of RWE in Chinese regulatory decisions and to summarize relevant regulatory and methodological considerations to inform the future use of RWE in China. We identified policy documents, technical guidance documents, and cases on official Chinese government websites and extracted their contents separately. We consulted experts from the National Medical Products Administration (NMPA) and academic institutes and searched case‐related articles for enrichment. We also searched and included articles related to the use of RWE/Real‐world data in Chinese regulatory decisions. Six trial versions of technical guidance documents, 7 case studies, and 40 articles related to the Chinese regulatory decisions were included in this study. Based on the technical guidance, data quality, and appropriate study design and statistical analysis are the main concerns for RWE generation. The cases and articles related to regulatory decisions revealed 9 main concerns, including data sources and applicability, data quality, strength of existing evidence, appropriate study design and statistical analysis, regulated and transparent process for analysis and evidence generation, product safety and efficacy, product characteristics and clinical needs, ethical considerations and data security, and communicate adequately with regulatory authorities. Among these concerns, data issues are central. Preliminary attempts have been made by the NMPA to promote the use of RWE, but substantial challenges still remain. [ABSTRACT FROM AUTHOR]

RTV 10A silicone rubber composites have many applications in forming many medical products and one of the recent applications is for orthotic insoles. This is because the RTV silicon rubber has excellent flexibility, elasticity, and resistance against splitting. However, these mechanical properties still need improvement when applied in certain medical applications. One way to improve mechanical properties is by adding talc. The process of mixing silicon rubber with talc requires special techniques to prevent the formation of porosity that may lead to unexpected mechanical properties. This porosity occurs due to trapped air during the mixing process or pouring into molds. Efforts to eliminate this porosity include vacuum die casting (VDC) techniques. This study presents the mechanical properties improvement of RTV 10A silicon rubber composite with the addition of using 30% talc. The objective is to achieve a more convenient orthotic insole to reduce the pain in human foot joints during walking due to planar stress. This study aims to reduce the porosity and minimize the trapped air by adding 30% talc into RTV 10A silicone rubber composite using VDC. In the experiment, the pressure variation was determined at -0.04 MPa, -0.06 MPa, -0.08 MPa, and -0.1 MPa through a mold size of 45 mm in diameter and thickness of 7 mm. Fluidity, density, porosity, and hardness were tested during the experiment. The results show that by decreasing vacuum pressure, the density and the hardness increase. This is because the size and distribution of porosity are decreased and more homogeny. Furthermore, it also produces higher fluidity. However, the porosity of the specimen after vacuum casting is not partially filled. [ABSTRACT FROM AUTHOR]

Platform business models are upending the value proposition of the companies in traditional industries, such as healthcare, through competitively pricing value-added services and products. In this study, we consider a unique, but important, on-demand two-sided service platform: a monopolistic online healthcare platform, which not only provides medical services to patients by connecting them with doctors, but also sells medical products to patients. A crucial operational decision for the platform is to set up a pricing scheme to encourage enough doctors and patients to participate on the platform. We consider two common pricing schemes in this study: fixed and linear pricing, in an empirically-grounded optimisation model that considers medicine pricing decisions together with network externalities. Our results show that the fixed pricing scheme almost always dominates the linear pricing scheme by providing the platform with higher expected profit. Our results also reveal the strong interdependence between the optimal doctor service pricing decision and optimal medicine pricing decision. However, these decisions are often made independently by different functional units of a firm, which could cause suboptimal platform financial performance. These results indicate the importance of pricing products and services in an integrated manner for maximising the profit of a product/service platform. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has highlighted the salience of different supply networks merging together to provide critical products in short supply. The automotive supply network and the medical device supply network, for instance, became intertwined to meet rising demands for ventilators. As such, coming to the fore is a search mechanism, based on recombination of multiple components, conceptualized as jury-rigging behavior. Designing and changing the interdependencies across firms/supply chains become relevant. Drawing on complex adaptive systems and Ashby’s law of requisite variety, we use a computational model to examine these mechanisms’ isolated and combined effect on supply chain network resiliency. Our results show statistically significant difference in the adaptiveness and mortality rate between a jury-rigged supply chain network and a non-jury-rigged one. In particular, the effect of jury-rigging is diminished by the level of coupling among the supply chains. [ABSTRACT FROM AUTHOR]

Context: Although pharmaceutical equipment and medical supplies play a vital role in the quality of traditional medicines, they have not received much attention from stakeholders and researchers nationally and internationally. Objective: this study assesses traditional healers' knowledge and utilization of pharmaceutical equipment and medical supplies in the amhara region, North West ethiopia. Materials and methods: A quantitative cross-sectional study was conducted on 70 traditional healers. the data were collected using an interview-based questionnaire. the collected data were checked and entered into statistical Package for social sciences version 25.0 for analysis. the results were presented as percentages. the association between socio-demographic characteristics and traditional healers' knowledge of pharmaceutical equipment and medical supplies was examined using Pearson's chi-squares test. Results: About 90% of traditional healers had information about pharmaceutical equipment and medical supplies, and currently 80% of them used different pharmaceutical equipment and medical supplies individually and in combination with traditional equipment. although most traditional healers used different pharmaceutical equipment and medical supplies, only 13.3% of them used equipment and supplies a day. Only 15% of traditional healers continuously cleaned their equipment. None of the socio-demographic variables were significantly associated to the knowledge of pharmaceutical equipment and medical supplies. Discussion and Conclusions: Pharmaceutical equipment and medical supplies used by traditional healers was inconsistent, mainly associated with their habit of using self-prepared and home-available equipment. Moreover, the checkup status of compounding equipment was poor. as traditional healers provide high-patient care services, emphasis should be given to improving their preparation and treatment strategies. [ABSTRACT FROM AUTHOR]

High-speed railways are “lifeline projects” that shoulder the heavy responsibility of transporting relief supplies and medical forces for the first time after earthquakes. To ensure the train’s safety after earthquakes, it is of great urgency to ascertain a post-earthquake speed threshold. To that end, a target model for seismic irregularity emerges as a key parameter. In this paper, a null phase assumption-based technique for the mutual conversion between evolutionary power spectral density and non-stationary signal was proposed. Taking a high-speed railway track-bridge system as the research object, the target model of seismic irregularities was constructed based on the proposed technique. The rationality of the target model of seismic irregularities was verified, and the construction parameter settings were discussed. Moreover, a simplified frequency-domain fitting method for the target model of seismic irregularities was proposed based on the spectral decomposition theory. According to the research findings, the null phase assumption-based technique is capable of performing interconversion between seismic irregularity and its evolutionary power spectral density with satisfactory accuracy. It is recommended to set the minimum number of seismic irregularities, spatial sampling interval, hop size, and length of window function as 50, 0.25m, 1, and 40 to 100, respectively. [ABSTRACT FROM AUTHOR]

Introduction: In the big data era, where corporations commodify health data, non-fungible tokens (NFTs) present a transformative avenue for patient empowerment and control. NFTs are unique digital assets on the blockchain, representing ownership of digital objects, including health data. By minting their data as NFTs, patients can track access, monetize its use, and build secure, private health information systems. However, research on NFTs in healthcare is in its infancy, warranting a comprehensive review. Methods: This study conducted a systematic literature review and thematic analysis of NFTs in healthcare to identify use cases, design models, and key challenges. Five multidisciplinary research databases (Scopus, Web of Science, Google Scholar, IEEE Explore, Elsevier Science Direct) were searched. The approach involved four stages: paper collection, inclusion/exclusion criteria application, screening, full-text reading, and quality assessment. A classification and coding framework was employed. Thematic analysis followed six steps: data familiarization, initial code generation, theme searching, theme review, theme definition/naming, and report production. Results: Analysis of 19 selected papers revealed three primary use cases: patientcentric data management, supply chain management for data provenance, and digital twin development. Notably, most solutions were prototypes or frameworks without real-world implementations. Four overarching themes emerged: data governance (ownership, tracking, privacy), data monetization (commercialization, incentivization, sharing), data protection, and data storage. The focus lies on user-controlled, private, and secure health data solutions. Additionally, data commodification is explored, with mechanisms proposed to incentivize data maintenance and sharing. NFTs are also suggested for tracking medical products in supply chains, ensuring data integrity and provenance. Ethereum and similar platforms dominate NFT minting, while compact NFT storage options are being explored for faster data access. Conclusion: NFTs offer significant potential for secure, traceable, decentralized healthcare data exchange systems. However, challenges exist, including dependence on blockchain, interoperability issues, and associated costs. The review identified research gaps, such as developing dual ownership models and data pricing strategies. Building an open standard for interoperability and adoption is crucial. The scalability, security, and privacy of NFT-backed healthcare applications require further investigation. Thus, this study proposes a research agenda for adopting NFTs in healthcare, focusing on governance, storage models, and perceptions. [ABSTRACT FROM AUTHOR]

Health emergency outbreaks such as the COVID-19 pandemic make it challenging for healthcare systems to ration medical resources and patient care. Such disastrous events have been increasing over the past years and are becoming inevitable, necessitating the need for healthcare to be well-prepared and resilient to unpredictable rises in demand. Quantitative and qualitative based decision support systems increase the effectiveness of planning, alleviating uncertainties associated with the crisis. This study aims to understand how the COVID-19 pandemic has affected the performance of healthcare systems in different areas and to address the associated disruption. A cross-sectional online survey was conducted in the Kingdom of Saudi Arabia and the United Arab Emirates among healthcare workers who worked during the pandemic. The pandemic-related disruption and its psychometric properties were assessed using Structural Equations Modeling (SEM) with 5 latent factors: Staff Mental Health, Communication Level, Planning and Readiness, Healthcare Supply Chain, and Telehealth. Responses from highly qualified participants with many years of experience in hospital settings were collected and analyzed. Results show that the model satisfactorily fits the data with a CLI of 0.91 and TLI of 0.88. The model indicates that enhancing supply chain management, planning, telehealth usage, and communication level across the healthcare system can mitigate the disruption. However, the lack of mental health management for healthcare workers can significantly disrupt the quality of delivered care. Staff mental health and healthcare supply chain, respectively, are the highest contributors to varying degrees of disruption in healthcare delivery. This study provides a direction for more research focusing on determinants of healthcare efficiency. It also provides decision-makers insights into the main factors leading to disruptions in healthcare systems, allowing them to shape their outbreak response and better prepare for future health emergencies. [ABSTRACT FROM AUTHOR]

Purpose of the study: the creation of a dextran coating on cerium oxide crystals using different ratios of cerium and dextran to synthesize nanocomposites, and the selection of the best nanocomposite to develop a nanodrug that accelerates quality wound healing with a new type of antimicrobial effect. Materials and methods: Nanocomposites were synthesized using cerium nitrate and dextran polysaccharide (6000 Da) at four different initial ratios of Ce(NO3)3x6H2O to dextran (by weight)—1:0.5 (Ce0.5D); 1:1 (Ce1D); 1:2 (Ce2D); and 1:3 (Ce3D). A series of physicochemical experiments were performed to characterize the created nanocomposites: UV-spectroscopy; X-ray phase analysis; transmission electron microscopy; dynamic light scattering and IR-spectroscopy. The biomedical effects of nanocomposites were studied on human fibroblast cell culture with an evaluation of their effect on the metabolic and proliferative activity of cells using an MTT test and direct cell counting. Antimicrobial activity was studied by mass spectrometry using gas chromatography–mass spectrometry against E. coli after 24 h and 48 h of co-incubation. Results: According to the physicochemical studies, nanocrystals less than 5 nm in size with diffraction peaks characteristic of cerium dioxide were identified in all synthesized nanocomposites. With increasing polysaccharide concentration, the particle size of cerium dioxide decreased, and the smallest nanoparticles (<2 nm) were in Ce2D and Ce3D composites. The results of cell experiments showed a high level of safety of dextran nanoceria, while the absence of cytotoxicity (100% cell survival rate) was established for Ce2D and C3D sols. At a nanoceria concentration of 10−2 M, the proliferative activity of fibroblasts was statistically significantly enhanced only when co-cultured with Ce2D, but decreased with Ce3D. The metabolic activity of fibroblasts after 72 h of co-cultivation with nano composites increased with increasing dextran concentration, and the highest level was registered in Ce3D; from the dextran group, differences were registered in Ce2D and Ce3D sols. As a result of the microbiological study, the best antimicrobial activity (bacteriostatic effect) was found for Ce0.5D and Ce2D, which significantly inhibited the multiplication of E. coli after 24 h by an average of 22–27%, and after 48 h, all nanocomposites suppressed the multiplication of E. coli by 58–77%, which was the most pronounced for Ce0.5D, Ce1D, and Ce2D. Conclusions: The necessary physical characteristics of nanoceria–dextran nanocomposites that provide the best wound healing biological effects were determined. Ce2D at a concentration of 10−3 M, which stimulates cell proliferation and metabolism up to 2.5 times and allows a reduction in the rate of microorganism multiplication by three to four times, was selected for subsequent nanodrug creation. [ABSTRACT FROM AUTHOR]

Cannabis-based products have gained attention in recent years for their perceived therapeutic benefits (with cannabinoids such as THC and CBD) and widespread availability. However, these products often lack accurate labelling regarding their cannabinoid content. Our study, conducted with products available in Portugal, revealed significant discrepancies between label claims and actual cannabinoid compositions. A fully validated method was developed for the characterisation of different products acquired from pharmacies and street shops (beverages, herbal samples, oils, and cosmetic products) using high-performance liquid chromatography coupled with a diode array detector. Linearity ranged from 0.4 to 100 µg/mL (0.04–10 µg/mg) (THC, 8-THC, CBD, CBG, CBDA, CBGA), 0.1–100 µg/mL (0.01–10 µg/mg) (CBN), 0.4–250 µg/mL (0.04–25 µg/mg) (THCA-A), and 0.8–100 µg/mL (0.08–10 µg/mg) (CBCA). Among sampled beverages, none contained detectable cannabinoids, despite suggestive packaging. Similarly, oils often differed from the declared cannabinoid compositions, with some containing significantly higher CBD concentrations than labelled. These inconsistencies raise serious concerns regarding consumer safety and informed decision-making. Moreover, our findings underscore the need for stringent regulation and standardised testing protocols to ensure the accuracy and safety of cannabis-based products. [ABSTRACT FROM AUTHOR]

Icaritin is a prenylflavonoid derivative of the genus Epimedium (Berberidaceae) and has a variety of pharmacological actions. Icaritin is approved by the National Medical Products Administration as an anticancer drug that exhibits efficacy and safety advantages in patients with hepatocellular carcinoma cells. This study aimed to evaluate the inhibitory effects of icaritin on UDP‐glucuronosyltransferase (UGT) isoforms. 4‐Methylumbelliferone (4‐MU) was employed as a probe drug for all the tested UGT isoforms using in vitro human liver microsomes (HLM). The inhibition potentials of UGT1A1 and 1A9 in HLM were further tested by employing 17β‐estradiol (E2) and propofol (PRO) as probe substrates, respectively. The results showed that icaritin inhibits UGT1A1, 1A3, 1A4, 1A7, 1A8, 1A10, 2B7, and 2B15. Furthermore, icaritin exhibited a mixed inhibition of UGT1A1, 1A3, and 1A9, and the inhibition kinetic parameters (Ki) were calculated to be 3.538, 2.117, and 0.306 (μM), respectively. The inhibition of human liver microsomal UGT1A1 and 1A9 both followed mixed mechanism, with Ki values of 2.694 and 1.431 (μM). This study provides supporting information for understanding the drug–drug interaction (DDI) potential of the flavonoid icaritin and other UGT‐metabolized drugs in clinical settings. In addition, the findings provide safety evidence for DDI when liver cancer patients receive a combination therapy including icaritin. [ABSTRACT FROM AUTHOR]

Background and Objectives Covid-19 was declared a public health emergency by World Health Organization in jan 2020. Public fear, quarantine, and shutdown created an unpredictable situation for healthcare services worldwide, which created a great challenge for blood transfusion services. Materials and Methods In a cross-sectional study, the data about the request, distribution, and waste of blood products were collected and compared in two time periods (March and February 2019 and March and February 2020) before and at the time or Covid-19 pandemic with test of proportion. The poisson regression test was used to compare the amount of waste, request, and distribution of blood products in two consecutive years. Results The request for red blood cells before the pandemic was 920,591 units, but it decreased by 18% to 754,052 units, and the distribution of red blood cells decreased by 17.3% at the time of pandemic, because of the cancellation of surgeries and general quarantine. The RBC wastage decreased from 25878 to 12837 units, a reduction of 50.3% (p = 0.03). However, the demand for leukoreduced red blood cells rose by 10.8%, yet wastage also increased by 8.8%. Waste in red blood cell bags for infants quadrupled during the pandemic. Plasma requests decreased by 4.9%, with a 7.2% decline in distribution, yet plasma waste increased by 6.8%. At pandemic time, Platelet requests decreased by 19%, distribution decreased by 15.6%, and waste decreased by 32.3%. Conclusions During the COVID-19 pandemic, the waste of RBCs and platelets was reduced. The distribution-to-demand ratio remained relatively stable throughout the pandemic time. [ABSTRACT FROM AUTHOR]

The aim of this review is to present the potential application of camphor—a bicyclic monoterpene ketone—in the prevention of skin infections. Skin diseases represent a heterogeneous group of disorders characterized by prolonged symptoms that significantly diminish the quality of life. They affect the dermis, the epidermis, and even subcutaneous tissue. They very often have a bacterial or fungal background. Therapy for dermatological skin disorders is difficult and long-term. Therefore, it is important to find a compound, preferably of natural origin, that (i) prevents the initiation of this infection and (ii) supports the skin's repair process. Based on its documented anti-inflammatory, antibacterial, antifungal, anti-acne, anesthetic, strengthening, and warming properties, camphor can be used as a preventative measure in dermatological infectious diseases and as a component in medical and cosmetic products. This work discusses the structure and physicochemical properties of camphor, its occurrence, and methods of obtaining it from natural sources as well as through chemical synthesis. The use of camphor in industrial preparations is also presented. Additionally, after a detailed review of the literature, the metabolism of camphor, its interactions with other medicinal substances, and its antimicrobial properties against bacteria and fungi involved in skin diseases are discussed with regard to their resistance. [ABSTRACT FROM AUTHOR]

Background: Volume overload (VO) is common in the intensive care unit (ICU) and associated with negative outcomes. Approaches have been investigated to curtail VO; however, none specifically focused on medication diluent volume optimization. Objective: Investigate the impact of a pharmacist-driven medication diluent volume optimization protocol on fluid balance in critically ill patients. Methods: A prospective, pilot study was conducted in a medical ICU during October 2021 to December 2021 (pre) and February 2022 to April 2022 (post). A pharmacist-driven medication diluent volume optimization protocol focusing on vasopressor and antimicrobial diluent volumes was implemented. Demographics and clinical data were collected during ICU admission up to 7 days. The primary outcome was net fluid balance on day 3. Secondary outcomes were medication volumes administered, net fluid balance, ICU length of stay, and mortality. Results: Supply chain shortages caused the study to stop at the end of February 2022. Overall, 152 patients were included (123 pre group, 29 post group). The most common admission diagnosis was acute respiratory failure (35%). Vasopressors and antimicrobials were utilized in 47% and 66% of patients, respectively. Net fluid balance on day 3 was greater but not significant in the post group (227.1 mL [−1840.3 to 3483.7] vs 2012.3 mL [−2686.0 to 4846.0]; P =.584). Antimicrobial diluent volumes were significantly less in the post group. No differences were seen in other secondary outcomes. Protocol group assignment was not associated with net fluid balance on day 3. Conclusion: Despite decreasing antimicrobial volume contributions, optimizing diluent volumes alone did not significantly impact overall volume status. Future studies should focus on comprehensive approaches to medication diluent optimization and fluid stewardship. [ABSTRACT FROM AUTHOR]

Polypropylene (PP) is a commonly used material in medical supplies. However, its lack of antibacterial properties has led to a frequent occurrence of healthcare-associated infections that need to be addressed. This study extensively investigates the antibacterial effects of bisphenol A-type benzoxazine (BA-a), revealing a relationship between the curing degree of BA-a and its antibacterial performance. A lower degree of curing corresponds to stronger antibacterial activity. At the processing temperature of 170 °C, the curing degree of BA-a reached only 14.6%, and it had strong antibacterial activity. Based on this relationship, a melt blending method at 170 °C is determined to prepare PP/BA-a composite material, aiming to enhance the antibacterial properties. The antibacterial performance of PP/BA-a is evaluated by plate coating method. The results demonstrate that PP/0.8BA-a exhibits an antibacterial rate as high as 99.99% against E. coli and S. aureus. Migration experiments confirm the stability of the antibacterial effect. The extracts from PP/BA-a show no toxicity towards mouse fibroblast cells (L929). Furthermore, compared to pure PP, the addition of BA-a improves the thermal stability of PP/BA-a, with an increase of 56 °C in the onset thermal decomposition temperature (T5%), enabling PP to better adapt to the high-temperature environment of moist heat sterilization. This study presents a novel method for obtaining highly antibacterial medical polymer materials (PP/BA-a) with broad application prospects. [ABSTRACT FROM AUTHOR]

The European Commission has presented a draft for a comprehensive reform of pharmaceutical law in order to promote innovation and access to medicines. However, the reform is facing criticism from the innovative pharmaceutical industry, which is concerned that the new rules could jeopardize Europe's competitiveness as a research location. In particular, the planned weakening of data protection is seen as innovation-hostile. The European Parliament has adopted its position on the EU Pharma Package and partially withdrawn some planned changes, but industry criticism remains. The article deals with the European Commission's proposal to shorten data protection for medicines. The proposal suggests shortening data protection from six to two years, followed by a two-year market protection. Critics argue that it is not possible in many countries to obtain a decision on the reimbursement eligibility of a medicine within two years. The European Parliament proposes a data protection period of seven and a half years, followed by a two-year market protection. The extension of data protection for products marketed in all member states is seen as an insurmountable hurdle for many companies. There is also discussion of extending data protection by six months for medicines that fill a medical supply gap. However, critics argue that the definition of "medical supply gap" is too narrow. The article describes the proposed changes in EU pharmaceutical law. The European Parliament has proposed extending data protection for medicines by twelve months, while market protection can only be granted once. It is also proposed to shorten market exclusivity for medicines for rare diseases from ten to nine years, with the possibility of an extension to eleven years in the case of a "major medical supply gap". Measures to address medicine shortages are also proposed, such as the introduction of an EU-wide list of critical medicines and the tightening of obligations for marketing authorization holders and wholesalers. The Parliament has largely supported the Commission's proposal but has tightened the obligations related to supply shortages. The article describes the proposed regulations for addressing medicine shortages in the EU. Marketing authorization holders must explain reasons for interruptions or suspensions of supply and report them at least six months in advance. Wholesalers must report shortages and provide information on available stocks. The European Commission has proposed measures to strengthen supply chains and minimize supply interruptions. An alliance for critical medicines is also being created to develop coordinated actions against the shortage of critical medicines. The industry has positively evaluated the proposed measures. [Extracted from the article]

Background and Objective: Azithromycin is the first azalide antibiotic that is related to the macrolide family of antibiotics. Bioequivalence studies in China are initiated by the National Medical Products Administration (NMPA), which supports a generic consistency evaluation program for ensuring that generic products manufactured in China meet the required standards and provide equivalent therapeutic effects to their reference products. This study aimed to assess the bioequivalence of two azithromycin tablets under both fasting and fed conditions in healthy Chinese volunteers. Methods: This was a single-center, open-label, single-dose, randomized, three-way crossover trial with two independent groups (fasting group and fed group). A total of 72 healthy Chinese subjects (36 subjects in the fasting state and 36 subjects in the fed state) were enrolled and randomized to treatment. Blood samples were collected from 0 to 120 h after a single oral dose of a 250-mg generic azithromycin tablet (test, T) or branded azithromycin tablet (reference, R). The plasma concentrations of azithromycin were determined by high-performance liquid chromatography–tandem mass spectrometry (HPLC‒MS/MS). A non-compartmental analysis method was used to estimate the pharmacokinetic parameters. Adverse events were documented. Results: In a fasting state, the bioequivalence of maximum plasma concentration (Cmax) was evaluated using the reference-scaled average bioequivalence (RSABE) approach (within-subject standard deviation, SWR > 0.294), and the bioequivalence of area under the concentration–time curve from time 0 to the time of the last measurable plasma concentration (AUC0–t) and area under the concentration–time curve from time 0 extrapolated to infinity (AUC0–∞) were evaluated by the average bioequivalence (ABE) method (SWR < 0.294). The geometric mean ratio (GMR) of T/R for Cmax was 106.49%, while the 95% upper confidence bound was < 0. The GMRs of AUC0–t and AUC0–∞ were 103.34% and 101.28%, and the 90% confidence intervals (CIs) of the test/reference were 95.90–111.35%/94.85–108.15%, respectively. In the fed state, the RSABE approach was applied to estimate the bioequivalence of Cmax (SWR >0.294), and the ABE approach was applied to estimate the bioequivalence of AUC0–t and AUC0–∞ (SWR < 0.294). The GMR for Cmax was 99.80%, while the 95% upper confidence bound value was < 0. The GMRs of AUC0–t and AUC0–∞ were 97.07% and 98.15%, and the 90% CIs of the T/R were 90.02–104.68% and 90.66–106.25%, respectively. All adverse events were mild and transient. Conclusions: The trial indicated that the test and the reference azithromycin tablets were bioequivalent and well tolerated in healthy Chinese volunteers under both fasting and fed conditions. Trial Registration: Clinicaltrials, ChiCTR2300071630 (retrospectively registered in 19/05/2023). [ABSTRACT FROM AUTHOR]

Recently, Unmanned Aerial Vehicles (UAVs) have been used in many fields, including the field of health care, especially in delivering the necessary medical equipment and supplies, due to the many advantages they have compared to other traditional methods and the presence of different types of UAVs, to improve healthcare and provide it with the medical supplies and equipment necessary to save the lives of patients. Choosing the appropriate UAV for a specific situation represents a problem facing decision-makers, which is considered a multi-criteria decision-making problem. Since the decision-making process is cumbersome and complex, and deals with uncertainty and ambiguity. In this research, we proposed multi-criteria decision-making (MCDM) model using CRITERIA (Criteria Importance through Intercriteria Correlation) and MARICA (Multi-Attribute Rating Analysis with Ideal Concepts) methods integrated with neutrosophic logic, which is considered a powerful tool in dealing with uncertainty and ambiguity. The CRITIC method calculates the weight of criteria, whereas it takes into account the correlations and relationships between the criteria, whether they are positive or negative, unlike other methods that consider the criteria separately, which allows for a more accurate and comprehensive analysis of the decision problem. The MARICA method is used also to rank the alternatives. It allows decision-makers to evaluate alternatives according to how well they perform across multiple criteria by considering several factors at once. This helps increase the effectiveness of judgments by taking into account all relevant factors. Moreover, MARICA is a user-friendly method that doesn't require complex mathematical calculations, making it accessible to anyone who wants to make sound choices. The UAV with the highest ranking is the one that will be chosen and represents the best among the alternatives. The proposed model proved its effectiveness by applying it to an experimental case. [ABSTRACT FROM AUTHOR]

The use of data analytics has seen widespread application in fields such as medicine and supply chain management, but their application in occupational safety has only recently become more common. The purpose of this scoping review was to summarize studies that employed analytics within establishments to reveal insights about work-related injuries or fatalities. Over 300 articles were reviewed to survey the objectives, scope and methods used in this emerging field. We conclude that the promise of analytics for providing actionable insights to address occupational safety concerns is still in its infancy. Our review shows that most articles were focused on method development and validation, including studies that tested novel methods or compared the utility of multiple methods. Many of the studies cited various challenges in overcoming barriers caused by inadequate or inefficient technical infrastructures and unsupportive data cultures that threaten the accuracy and quality of insights revealed by the analytics. [ABSTRACT FROM AUTHOR]

US-based drone service provider Zipline International Inc. (Zipline) delivered critical medical supplies to citizens living in remote and hard-to-reach areas of Rwanda, saving many lives in the process. Rwanda, with its challenging terrain and limited infrastructure, faced significant problems in reaching timely medical supplies to all parts of the country. Zipline started its operations in Rwanda in 2016 in collaboration with the Rwandan government. By 2022, Zipline had flown more than 30 million autonomous miles and delivered more than 450,000 parcels containing 4.5 million different medical supplies. In December 2022, the government of Rwanda signed a new agreement with Zipline, with an aim to fly Zips over 200 million autonomous kilometers and do about 2 million instant deliveries by 2029. Scalability and sustainability, however, proved to be significant obstacles in a nation with unfavorable geographic and climatic characteristics. Will Keller Rinaudo, CEO of Zipline, be able to collaborate closely with the local government to secure the necessary infrastructure given the goal of tripling delivery volume? Will he be able to successfully negotiate intricate regulatory frameworks? Will Zipline be able to make enough money to manufacture enough Zips to meet the increasing need for medical supply drone delivery? [ABSTRACT FROM AUTHOR]

Analysis of international public-sector contributions to Food and Drug Administration (FDA)-approved drugs and vaccines allows for a more thorough examination of the global biomedical innovation ecosystem by institution of origin. Using new and existing methods, we have identified 364 FDA-approved drugs and vaccines approved from 1973 to 2016 discovered in whole or in part by Public Sector Research Institutions (PSRIs) worldwide. We identified product-specific intellectual property contributions to FDA-approved small molecule and biologic drugs and vaccines from the FDA Orange Book, our peer network, published studies, and three new sources: reports of medical product manufacturers' payments to physicians and teaching hospitals under The Sunshine Act of 2010, a paper by Kneller and 64 royalty monetization transactions by academic institutions and/or their faculty that one of us (AS) maintains. We include a total of 293 drugs discovered either wholly by a US PSRI or jointly by a U.S. and a non-U.S. PSRI. 119 FDA-approved drugs and vaccines were discovered by PSRIs outside the U.S. Of these, 71 were solely discovered outside the US, while 48 also involved intellectual property contributions by US PSRIs. In the context of the global public sector landscape, the US dominates drug discovery, accounting for two-thirds of these drugs and many of the important, innovative vaccines introduced over the past 30 years. Contributions by Canada, UK, Germany, Belgium, Japan, and others each amount to 5.4% or less of the total. [ABSTRACT FROM AUTHOR]

Analysis of functional products for medical textiles indicates that there are plenty of different classifications of this group. Requirements for compression generated by compression garments differ depending on the application area, and even more, sometimes are contradictory and can be fulfilled in very different ways. The effectiveness of such products depends on mechanical and physical properties as well as psychological barriers. Currently, there is no uniform classification of compression classes, furthermore, there is no uniform standard, test method or technic for evaluation of the product' compression. Knitted compression fabrics are made by knitting together at least two types of yarns: a ground yarn which ensures stiffness and thickness and an elastomeric yarn which generates compression. Knitted compression products can be produced on both flat and circular knitting machines, though parameters and usage of production are different. Additional elements used in the structure of the compression product can significantly change the generated compression. Purposes and number of additional details depend on the application and functionality of the compression support, nevertheless, all rigid elements must be taken into account at the designing stage. Additional functionality like antimicrobial activity or thermal therapy can also be provided for compression knits. It is highly important to ensure the longevity of all functional properties. [ABSTRACT FROM AUTHOR]

In recent years, there has been significant focus on China's new drug lag, but relevant research is limited. This study explores the reasons for drug lag by assessing the impact of reforms in China's drug review system, particularly focusing on the influence of clinical development strategies. This study selected drugs first launched in the United States between 2017 and 2022, examining absolute and relative lag between China and the first‐launch country (including submission and review lag). These delays with drugs approved in the European Union and Japan during the same period were compared with uncover the roots of delays in China, further identifying potential factors that could reduce these delays. The results indicate that the National Medical Products Administration (NMPA) has a longer relative lag compared with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA). The submission lag time of the NMPA significantly surpasses that of the EMA and PMDA, whereas the review lag time of the NMPA exceeds that of the PMDA but falls short of the EMA. Focusing on clinical trial strategies, bridging trials and multiregional clinical trials (MRCTs) are typically required by the NMPA in East Asia, resulting in longer clinical delay time. Whereas the EMA and PMDA primarily require international MRCTs in Europe and America, with a clinical delay of < 5 months. It is evident that there is a significant gap in clinical trial durations between China and other countries. Further optimization of clinical trial management is necessary to address the lag for new drugs in China. [ABSTRACT FROM AUTHOR]