The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards.

Advanced therapy medicinal products (ATMPs) are rapidly evolving to offer new treatment options. The scientific, technical, and clinical complexities subject drug regulatory authorizes to regulatory challenges. To advance the regulatory capacity for ATMPs, the National Medical Products Administration in China made changes to the drug regulatory system and developed regulatory science with the goal of addressing patient needs and encouraging innovation. This study aimed to systematically identify the regulatory evidence on ATMPs in China under the guidance of an overarching framework from the World Health Organization Global Benchmarking Tool. It was found that China's administrative authorities at all levels have issued a number of policy documents to promote the development of ATMPs, covering biopharmaceutical products research and development (n = 14), biopharmaceutical industry development (n = 9), high-quality development of medical institutions (n = 1), specific development plans/projects (n = 6) and specific regional development (n = 4). The legal and regulatory framework of ATMPs in China has been established and is subject to continuous adjustment in various aspects including regulations (n = 3), departmental rules or administrative normative documents (n = 22), and technical guidance (n = 15). As the regulatory reform continues, the drug review processes have been revised, and various technical standards have been launched, which aim to establish a regulatory approach that oversees the full life-cycle development of ATMPs in the country. The limited number of investigational new drug applications and approved ATMPs suggests a lag remains between the translation of advanced therapeutic technologies into clinically available medical products. To accelerate the translational research of ATMP in countries such as China, developing and adopting real-world evidence generated from clinical use in designated healthcare facilities to support scientific decision-making in ATMP regulation is warranted. The enhancement of regulatory capacity building and multi-stakeholder collaborations should also be encouraged to facilitate the timely evaluation of promising ATMPs to meet more patient needs.

Could pharmacy technicians play a role in supporting the appropriate and safe use of traditional and complementary medicines?

Across the world traditional and complementary medicine (T&CM) product use is prevalent with some countries reporting greater than 50% of the population using these products. T&CM products are primarily self-selected through retail outlets including pharmacies. Pharmacists across the world generally agree they should play a role in ensuring the appropriate and safe use of T&CM products but report being time and resource poor to do so. In this commentary, it is proposed that pharmacy technicians as members of the pharmacy workforce, who with adequate education, and supportive technologies could support pharmacists in providing guidance to consumers and patients about the appropriate and safe use of T&CM products. Pharmacy technicians play a crucial role in the pharmacy workforce, serving as integral members of healthcare teams fulfilling a wide array of tasks essential for the efficient functioning of pharmacies and ensuring the safe dispensation of medications. They have been described by pharmacists as the "the face of the pharmacy" in the community setting and relied on not only for mitigating and triaging problems, but also be primarily responsible for developing rapport, eliciting trust and even loyalty from pharmacy patrons. As such, there is a momentous opportunity for pharmacy technicians to play a role in providing T&CM advice and triaging the need for pharmacists' intervention where harm, or risk of is identified.

Pharmacoeconomic evaluation of anti-obesity drugs for chronic weight management: a systematic review of literature.

Introduction: Pharmacological therapy is recommended as a second-line alternative to reverse obesity. Currently, five anti-obesity drugs (AODs) have been approved by the U.S. Food and Drug Administration (FDA) for chronic weight management. The aim of this paper is to investigate the pharmacoeconomic evaluation of AODs through a systematic review with a special focus on methodological considerations. Methods: We searched the general and specific databases to identify the primary pharmacoeconomic evaluation of AODs. Results: A total of 18 full-text articles and three conference abstracts were included in this review. Most of the economic assessments were still about Orlistat. And the observations we could make were consistent with the previous systematic review. A few studies were on the combined therapies (i.e. PHEN/TPM ER and NB ER) compared to different comparators, which could hardly lead to a generalized summary of the cost-effectiveness. Most recently, pharmacoeconomic evidence on the newest GLP 1 RA approved for the indication of obesity or obesity with at least one comorbidity emerged gradually. Modelling-based cost-utility analysis is the major type of assessment method. In the modelling studies, a manageable number of the key health states and the state transitions were structured to capture the disease progression. In particular, the principal structure of the decision model adopted in the three studies on the newly approved drug was nearly the same, which enables more in-depth comparisons and generalizations of the findings. Conclusion: This study provided an up-to-date overview of the strengths and areas for improvement in the methodological design of the pharmacoeconomic evaluation of the licensed drugs for chronic weight management. Future modelling evaluations would benefit from a better understanding of the long-term weight loss effects of the current therapeutic options and the weight rebound process after the discontinuation of treatment. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302648, identifier CRD42022302648.

Is there a role for traditional and complementary medicines in managing chronic fatigue? a systematic review of randomized controlled trials.

Introduction: Chronic fatigue syndrome (CFS) is an increasingly common condition that is challenging to treat due to unclear etiology and a lack of consensus on clinical diagnosis and treatment guidance. Many affected people resorted to using traditional and complementary medicines (T&CMs). However, the evidence for T&CMs for CFS has been inconclusive and continues to evolve. The study aims to identify, summarize and assess the most recent evidence on the efficacy and safety of T&CMs for CFS. Methods: Randomized controlled trials (RCTs) investigating T&CMs for CFS published in English of Chinese between 1 January 2013 and 31 December 2022 were searched from 7 databases. RCTs comparing T&CMs with no treatment, placebo, or pharmacological medicine were included, irrespective of language or blinding. The Consolidated Standards of Reporting Trials Statement extensions for Chinese herbal medicine Formulas (CONSORT-CHM) and the Cochrane Collaboration's Risk of Bias tool were used to evaluate the quality and risk of bias of included studies. Results: A total of 62 RCTs investigating 43 types of T&CMs and involving 5,231 participants with CFS were included in this review. The primary outcome measures mainly included the scoring of fatigue symptoms using the validated tool Fatigue Scale-14 (FS-14) or the TCM syndrome score. The main interventions showing overall efficacy were Chaihu Guizhi Decoction and Buzhong Yiqi combined with Xiao Chaihu Decoction, and 148 ingredients were identified, including Astragali Radix, Glycyrrhizae Radix et Rhizoma, Atractylodis Macrocephalae Rhizoma, and Bupleuri Radix. The most significant effect was the improvement of fatigue, followed by TCM-diagnosed symptoms and other psychological conditions. No serious adverse effect had been reported. However, the quality of the RCTs included RCTs were found to be suboptimal, and the risk of bias remained uncertain. Conclusion: Some evidence from RCTs supported the efficacy and safety of T&CM in CFS. However, given the methodological and quality heterogenicity of the included studies, the recommendations of T&CMs in treating CFS remain inconclusive. To develop better quality evidence about T&CMs for CFS, future studies should employ more objective diagnosis standards and outcome measurements, larger sample size, and better bias control, and ensure the compliance with the corresponding reporting guidelines. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022362268, identifier CRD42022362268.

Digital Medical Information Services Delivered by Pharmaceutical Companies via WeChat: Qualitative Analytical Study.

BACKGROUND: Social media has become one of the primary information sources for medical professionals and patients. Pharmaceutical companies are committed to using various social media platforms to provide stakeholders with digital medical information services (DMISs), which remain experimental and immature. In China, WeChat tops the list of popular social media platforms. To date, little is known about the service model of DMISs delivered by pharmaceutical companies via WeChat. OBJECTIVE: This study aims to explore the emerging service model of DMISs delivered by pharmaceutical companies via WeChat in China. METHODS: This study applied a qualitative research design combining case study and documentary analysis to explore the DMISs of 6 leading pharmaceutical companies in China. Materials were collected from their official WeChat platforms. Thematic analysis was conducted on the data. RESULTS: The DMISs of 6 pharmaceutical companies were investigated. Themes emerged regarding 2 essential information services delivered by pharmaceutical companies via WeChat: business operation services and DMISs (ie, public information services, professional services, science and education services, and e-commerce services). Business operation services mainly function to assist or facilitate the company's operations and development trends for general visitors. Public-oriented information services are realized through health science popularization, academic frontiers, product information, and road maps to hospitals and pharmacies. Internet hospital and pharmacy services are the main patient-oriented professional services. Medical staff-oriented science and education services commonly include continuing education, clinical assistance, academic research, and journal searching. Public-oriented e-commerce services include health products and health insurance. CONCLUSIONS: Pharmaceutical companies in China use WeChat to provide stakeholders with diversified DMISs, which remain in the exploratory stage. The service model of DMISs requires more distinct innovations to provide personalized digital health and patient-centric services. Moreover, specific regulations on the DMISs of pharmaceutical companies need to be established to guard public health interests.

Efficacy and safety of traditional Chinese medicine for cancer-related fatigue: a systematic literature review of randomized controlled trials.

BACKGROUND: Cancer-related fatigue (CRF) is an extremely common and long-term condition that affects the physical and mental health of oncology patients. While the treatment for CRF with western medicine and non-pharmacological therapy remains uncertain and challenging, traditional Chinese medicine (TCM) has become a trending option for the patients. Based on the findings from randomized controlled trials (RCTs), this study aims to identify and evaluate the evidence about the efficacy and safety of TCM for CRF. METHODS: A systematic literature search was conducted according to the PRISMA literature research guidelines. Seven electronic databases including PubMed, the Cochrane Library, Embase, Web of Science, Scopus, China National Knowledge Infrastructure (CNKI) and Wanfang database were searched to identify RCTs which investigated TCM in the treatment of CRF published since inception to December 2022. RCTs comparing TCM with no treatment, placebo, or pharmacological interventions were considered eligible for this review. The Consolidated Standards of Reporting Trials Statement extensions for Chinese herbal medicine Formulas (CONSORT-CHM) and the Cochrane Collaboration's Risk of Bias tool were used in this review to evaluate the quality and the risk of bias of all included trials. RESULTS: A total of 82 RCTs were included in this review, regardless of whether they were published in English or Chinese. After data extraction and results evaluation, 78 trials demonstrated overall efficacy in using TCM for CRF patients compared with the control group, in which 33 trials showed that the efficacy rate was statistically significant (p < 0.05 or p < 0.01). TCM was also shown to be beneficial in improving the scores of relevant scales (e.g., PFS, QoL, TCM syndrome score, other fatigue scales etc.) or physical tests indicators (e.g., cytokines, blood test etc.). The most common herbs found in Chinese medicine were Astragali Radix, Ginseng Radix and Codonopsis Radix. Some TCM products, such as Kangai Injection, Buzhong Yiqi Decoction and Shenqi Fuzheng Injection could provide a reference for medication in this review. A range of non-serious, reversible adverse effects associated with the use of TCM was also reported. However, the result of evaluation showed that none of the trials fully met all the CONSORT-CHM criteria, the quality of included trials was generally poor and the risk of bias was mostly uncertain. CONCLUSION: There is some evidence supporting the efficacy and safety of TCM in managing CRF in this systematic review. However, no clear conclusion can be made due to the inadequate reporting of efficacy and adverse reactions. In view of some concerns about the existing evidence after the evaluation, it is essential to standardize the comprehensive identification and efficacy measurement standards, improve the quality of RCTs and conduct more multicomponent therapies to provide an updated reference for CRF patients medication in the future. The protocol of this systematic review has been registered on PROSPERO (CRD42023413625). [ https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023413625 ].

Comparative analysis of disease modelling for health economic evaluations of systemic therapies in advanced hepatocellular carcinoma.

BACKGROUND: The objective of this study was to systematically analyse methodological and structural assumptions utilised in model-based health economic evaluations of systemic advanced hepatocellular carcinoma (HCC) therapies, discuss the existing challenges, and develop methodological recommendations for future models in advanced HCC. METHODS: We performed literature searches using five databases (Embase, PubMed, Web of Science, Econlit, and CNKI) up to December 4, 2022. Technology appraisals from Canada, England, Australia, and the United States were also considered. Model-based full economic evaluations of systemic advanced HCC therapies in English or Chinese met the eligibility criteria. The reporting quality was assessed by using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. RESULTS: Of 12,863 records retrieved, 55 were eligible for inclusion. Markov model (n = 29, 53%) and partitioned survival model (n = 27, 49%) were the most commonly used modelling techniques. Most studies were based on health-state-driven structure (n = 51, 93%), followed by treatment-line-driven structure (n = 2, 4%) and combination structure (n = 1, 2%). Only three studies (5%) adopted external real-world data to extrapolate the overall survival or calibrate the extrapolation. Few studies reported the assumptions of transition probabilities. Utility modelling approaches were state-based (n = 51, 93%) and time-to-death (n = 1, 2%). Only 13 studies (24%) reported five types of model validation. Economic evaluation results of specific treatment strategies varied among studies. CONCLUSIONS: Disease modelling for health economic evaluations of systemic therapies in advanced HCC has adopted various modelling approaches and assumptions, leading to marked uncertainties in results. By proposing methodological recommendations, we suggest that future model-based studies for health economic evaluation of HCC therapies should follow good modelling practice guidelines and improve modelling methods to generate reliable health and economic evidence.

Pharmacist intervention for pediatric asthma: A systematic literature review and logic model.

BACKGROUND: Asthma is highly prevalent in children. Evidence about pharmacist-led interventions in the management of pediatric asthma is emerging. OBJECTIVE: To summarize empirical evidence of pharmacist-led interventions for pediatric asthma patients, and to identify the components of a logic model, which can inform evidence-based pharmacy practice. METHODS: PubMed, Web of Science, Embase Scopus, ScienceDirect, Medline and CNKI were searched. Studies concerning pharmacist-led interventions for pediatric asthma patients with an interventional design published between January 2013 and February 2023 were selected for analysis. Literature was searched and retrieved according to PRISMA guidelines. Components of pharmacist-led interventions were compiled into a logic model comprising input, activity, output, outcome and contextual factors. RESULTS: The initial search retrieved 2291 records and 35 were included in the analysis. The main interventional activities included optimising medicines use and prevention and control of asthma. Commonly reported outputs were medication adherence, knowledge and inhaler technique. The main economic outcomes included cost of medication and hospitalization; clinical outcomes included Childhood Asthma Control Test/Asthma Control Test scores and lung function in FEV1% and PEF%; humanistic outcomes included patients' quality of life and satisfaction. Social, economic, political, and technological factors were identified as contextual factors. CONCLUSION: The logic model summarized components of interventions evaluated in literature. It provides a blueprint for pharmacist-led management of pediatric asthma. Further research can focus on the pharmacists' role in a multidisciplinary healthcare professional team and transition of care in patient-centered management of pediatric asthma.

Defining and supporting a professional role for pharmacists associated with traditional and complementary medicines: a cross-country survey of pharmacists.

Introduction: An estimated 80% of the world's population use traditional and complementary medicine (T&CM) products as part of their healthcare, with many accessed through pharmacy. This cross-cultural study posed a set of professional practice responsibilities and actions to pharmacists related to T&CM products, with a view toward developing consensus, safeguarding, and promoting the health of the public. Methods: Data were collected from 2,810 pharmacists across nine countries during 2022 via a cross-sectional online survey reported in accordance with the guidelines of STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) and the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). Results: Of the 2,810 participants from nine countries, 2,341 completed all sections of the survey. Of these, most agreed (69%) that T&CM product use was common in the community they served, but most did not have adequate training to support consumer needs. Over 75% acknowledged that there were known and unknown safety risks associated with T&CM use. Of 18 professional responsibilities posed, 92% agreed that pharmacists should be able to inform consumers about potential risks, including T&CM side effects and drug-herb interactions. The provision of accurate scientific information on the effectiveness of T&CM products, skills to guide consumers in making informed decisions, and communication with other healthcare professionals to support appropriate and safe T&CM product use were all ranked with high levels of agreement. In order to effectively fulfill these responsibilities, pharmacists agreed that regulatory reforms, development of T&CM education and training, and access to quality products supported by high-quality evidence were needed. Conclusion: General agreement from across nine countries on eighteen professional responsibilities and several stakeholder actions serve as a foundation for the discussion and development of international T&CM guidelines for pharmacists.

A systematic review of self-medication practice during the COVID-19 pandemic: implications for pharmacy practice in supporting public health measures.

Introduction: Since the COVID-19 pandemic, self-medication had become highly popular due to the risk of virus infection and overwhelming medical resources. Pharmacists are well-positioned to provide public health education and disease prevention. This study aims to provide an overview of the research about self-medication during COVID-19 and the role of pharmacists in ensuring the drug safety related to self-medication. Methods: Databases (PubMed, Google Scholar, Scopus, EBSCO host, and Web of Science) were searched for published studies on the practice of self-medication in COVID-19 pandemic without restriction in population and location. Primary search terms were "self-medication," "self-care," "self-management," "non-prescription drugs," "2019nCoV," and "COVID-19." Studies conducted during the pandemic but not exclusively for COVID-19 disease were eligible for inclusion. Results: The database search yielded a total of 4,752 papers. After appropriate screening, 62 articles met the inclusion criteria. Most of the studies were cross-sectional in nature. The review highlighted a very high prevalence of self-medication during COVID-19, ranging from 7.14 to 88.3%. The purpose of self-medication was mainly to treat and prevent COVID-19; fever, body aches, cough, headache, and sore throat were the most frequently mentioned indications. Categories of drugs commonly used in self-medication included antibiotics, herbs, vitamins, and analgesics, most of which came from pharmacies. Information about self-medication usually obtained from relatives and friends, social networks and health care professionals. Common reasons for self-medication included saving money and time, prior experience and mild illness; reasons associated with COVID-19 were mainly fear of contracting the virus and poor access to doctors. Gender, age, education, marital status, and concern about COVID-19 were the most usual associated factors. The role of pharmacists in self-medication included sources of information, advice on medication use, and management of adverse reactions. Conclusion: During the COVID-19 pandemic, self-medication practices were widespread and varied across countries and populations. Self-medication has emerged as an important component of health care, but also as a huge global challenge. The engagement of healthcare administrators and policy makers are essential to regulate self-medication practices. The expertise and favorable conditions of pharmacists make them positioned as key roles in public health interventions for self-medication. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=395423, identifier CRD42023395423.

Policy analysis of system responses to addressing and reversing the obesity trend in China: a documentary research.

BACKGROUND: The obesity epidemic and its established consequences on population health and the economy call for a vigorous fight against excess weight. The primary aim of this study is to investigate China's responses to address and reverse the obesity trend by analysing the official documents and guidelines issued or coordinated by the central government through the lens of the WHO Health System Six Building Blocks. METHODS: This study is based on the method of document research. We screened the official documents obtained through the initial search on databases. The basic information of the included documents was tabulated, and the relevant content was mapped onto the analytical framework for further analysis. RESULTS: The screening process finally rendered 55 out of 152 official documents. The temporal distribution of these documents issued between 2003 and 2022 concentrated in the period starting 2016 until now. The State Council and its affiliated ministries were found to play an instrumental role in the efforts to tackle the obesity epidemic. The results from further analysis based on the framework revealed that the current government responses to the obesity epidemic were mainly oriented towards strengthening governance, promoting healthcare delivery to prevent obesity, and improving access to interventions. The components of financing, information system, and workforce are currently absent in the relevant documents. CONCLUSIONS: Our analysis indicated that China's health system has taken action in response to the unprecedented obesity prevalence in recent years. In preventing and managing obesity and overweight in the population, the government affirmed its central place in governing and coordinating different recourses. The promotion of healthcare service delivery and access to medical products and technologies have been reflected gradually in the relevant policy documents. An integrated endeavour should be made in the future from all six aspects of the health system to halt the further rise in overweight and obesity.

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities.

Introduction: The purpose of developing and adopting regulatory science (RS) for drug regulatory authorities (DRAs) is to enhance regulatory capacity by advancing the scientific approach for the evaluation of health-related products. While many DRAs around the world advocate the concept of RS, the implementation approaches of RS vary according to local needs and have not been systemically examined. This study aimed to systematically identify the evidence about how RS was developed, adopted, and advanced by the selected DRAs, and analyzed and compared the implementation experiences of RS development under the guidance of an implementation science framework. Methods: Documentary analysis of government documents and a scoping literature review were conducted, and data analysis was performed under the guidance of the PRECEDE-PROCEED Model (PPM). DRAs in the United States, the European Union, Japan, and China had officially launched RS initiatives and were therefore selected as the target countries in this study. Results: There is no common consensus on the definition of RS among the DRAs. However, these DRAs shared the same goal of developing and adopting RS, which was used to develop new tools, standards, and guidelines that could improve the effectiveness and efficiency of the risk and benefit assessment of the regulated products. Each DRA had decided its own priority areas for RS development and thus set specific objectives that might be technology-based (e.g., toxicology and clinical evaluation), process-based (e.g., partnership with healthcare systems and high-quality review/consultation services), or product-based (e.g., drug-device combination products and innovative emerging technologies). To advance RS, considerable resources had been allocated for staff training, advancing information technology and laboratory infrastructure, and funding research projects. DRAs also took multifaceted approaches to expand scientific collaborations through public-private partnerships, research funding mechanisms, and innovation networks. Cross-DRA communications were also reinforced through horizon scanning systems and consortiums to better inform and assist the regulatory decision-making process. The output measurements might be scientific publications, funded projects, DRAs interactions, and evaluation methods and guidelines. Improved regulatory efficiency and transparency leading to benefits to public health, patient outcomes, and translation of drug research and development as the key primary outcomes of RS development were anticipated but not yet clearly defined. Conclusion: The application of the implementation science framework is useful for conceptualizing and planning the development and adoption of RS for evidence-based regulatory decision-making. Continuous commitment to the RS development and regular review of the RS goals by the decision-makers are important for DRAs to meet the ever-changing scientific challenges in their regulatory decision-making process.

Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design.

BACKGROUND: Non-alcoholic steatohepatitis (NASH) is a liver disease currently lacking an approved therapy, resulting in significant clinical demand. Traditional Chinese medicines (TCMs) have been commonly used to manage NASH. This study aimed to systematically analyse the randomised controlled trials (RCTs) using TCMs for NASH management. METHODS: A systematic literature review was performed by following PRISMA guidelines 2020 in six electronic databases: PubMed, Web of Science, Scopus, Embase, the Cochrane Library, and China National Knowledge Infrastructure, from inception until August 2022. RCTs using TCMs for NASH were included in the analysis, irrespective of language or blinding. RESULTS: 112 RCTs were included in this review, with 10,573 NASH participants. 108 RCTs were conducted in China, and 4 RCTs were in other countries. Herbal medicine decoction was the major dosage form used for treating NASH (82/112). 11 TCMs products have been approved for NASH treatment (8 in China, 2 in Iran, and 1 in Japan). Classic prescriptions, such as "Huang Lian Jie Du decoction", "Yin Chen Hao decoction", and "Yi Guan Jian" were used in some studies. The TCMs treatment of NASH involved the use of 199 different plants, with the top 5 herbs being Salviae Miltiorrhizae Radix Et Rhizoma, Alismatis Rhizoma, Bupleuri Radix, Poria, and Curcumae Radix. "Salviae Miltiorrhizae Radix Et Rhizoma + Bupleuri Radix/Alismatis Rhizoma" were the mostly common drug-pair in the herbs network analysis. Nowadays, "Bupleuri Radix/Alismatis Rhizoma + Atractylodis Macrocephalae Rhizoma" are increasingly applied in herbal formulas for NASH. Based on the PICOS principles, the included studies varied in terms of the population, intervention, comparator, outcomes, and study design. However, some studies reported unstandardised results and failed to report diagnostic standards, inclusion or exclusion criteria, or sufficient patient information. CONCLUSION: Adopting Chinese classic prescriptions or drug-pair may provide a basis for developing new drugs of NASH management. Further research is needed to refine the clinical trial design and obtain more convincing evidence for using TCMs to treat NASH.

Modelling 30-day hospital readmission after discharge for COPD patients based on electronic health records.

Chronic Obstructive Pulmonary Disease (COPD) is the third most common chronic disease in China with frequent exacerbations, resulting in increased hospitalization and readmission rate. COPD readmission within 30 days after discharge is an important indicator of care transitions, patient's quality of life and disease management. Identifying risk factors and improving 30-day readmission prediction help inform appropriate interventions, reducing readmissions and financial burden. This study aimed to develop a 30-day readmission prediction model using decision tree by learning from the data extracted from the electronic health record of COPD patients in Macao. Health records data of COPD inpatients from Kiang Wu Hospital, Macao, from January 1, 2018, to December 31, 2019 were reviewed and analyzed. A total of 782 hospitalizations for AECOPD were enrolled, where the 30-day readmission rate was 26.5% (207). A balanced dataset was randomly generated, where male accounted for 69.1% and mean age was 80.73 years old. Age, length of stay, history of tobacco smoking, hemoglobin, systemic steroids use, antibiotics use and number of hospital admission due to COPD in last 12 months were found to be significant risk factors for 30-day readmission of CODP patients (P < 0.01). A data-driven decision tree-based modelling approach with Bayesian hyperparameter optimization was developed. The mean precision-recall and AUC value for the classifier were 73.85, 73.7 and 0.7506, showing a satisfying prediction performance. The number of hospital admission due to AECOPD in last 12 months, smoke status and patients' age were the top factors for 30-day readmission in Macao population.

Burnout among healthcare providers: Its prevalence and association with anxiety and depression during the COVID-19 pandemic in Macao, China.

INTRODUCTION: Burnout in healthcare providers (HPs) might lead to negative consequences at personal, patient-care and healthcare system levels especially during the COVID-19 pandemic. This study aimed to investigate the prevalence of burnout and the contributing variables, and to explore how, from health workforce management perspective, HPs' experiences related to carrying out COVID-19 duties would be associated with their burnout. METHODS: A cross-sectional, open online survey, informed by physical and psychological attributes reportedly related to burnout, the Copenhagen Burnout Inventory (CBI) and the Hospital Anxiety and Depression Scale (HADS), was completed by HPs in Macau, China during October and December 2021. Factors associated with burnout were analysed using multiple logistic regressions. RESULTS: Among the 498 valid responses, the participants included doctors (37.5%), nurses (27.1%), medical laboratory technologist (11.4%) and pharmacy professionals (10.8%), with the majority being female (66.1%), aged between 25-44years (66.0%), and participated in the COVID-19 duties (82.9%). High levels of burnout (personal (60.4%), work-related (50.6%) and client-related (31.5%)), anxiety (60.6%), and depression (63.4%) were identified. Anxiety and depression remained significantly and positively associated with all types of burnout after controlling for the strong effects of demographic and work factors (e.g. working in the public sector or hospital, or having COVID-19 duties). HPs participated in COVID-19 duties were more vulnerable to burnout than their counterparts and were mostly dissatisfied with the accessibility of psychological support at workplace (62.6%), workforce distribution for COVID-19 duties (50.0%), ability to rest and recover (46.2%), and remuneration (44.7%), all of which were associated with the occurrence of burnout. CONCLUSIONS: Personal, professional and health management factors were found attributable to the burnout experienced by HPs during the COVID-19 pandemic, requiring actions from individual and organizational level. Longitudinal studies are needed to monitor the trend of burnout and to inform effective strategies of this occupational phenomenon.

The use of herbal and dietary supplements for COVID-19 prevention: A survey among the public in a Malaysian suburban town.

Introduction: The spread of the novel coronavirus disease (COVID-19) may lead people to seek preventative measures. The use of herbal and dietary supplements (HDS) may have become prevalent during the COVID-19 pandemic. This study aims to identify the prevalence, predictors, and patterns of HDS use for COVID-19 prevention in a sample of the general public in a suburban town in Malaysia. Methods: An online cross-sectional survey was conducted between May and June 2021 involving adults ≥ 18 years old. Data on the self-reported use of HDS for COVID-19 prevention were collected. Logistic regression analysis was conducted to determine the predictors of HDS use. Results: Overall, 41.9 % (168/401) reported using HDS to prevent COVID-19. Multivariate analysis showed that HDS users were more likely to be individuals ≥ 40 years old (adjusted odds ratio [aOR] = 1.774, 95 % confidence interval [CI] = 1.016 - 3.098), and to have had a history of HDS use prior to the pandemic (aOR = 19.378, 95 % CI = 5.901 - 63.639). Most HDS users referred to social media or websites (66.7 %, 112/168) for HDS information. Approximately half of them had consulted either pharmacists or doctors about their HDS use. Conclusion: HDS use to prevent COVID-19 was common among the respondents. Several issues - such as the concurrent use of HDS with conventional medications, the use of unreliable sources of information, and the lack of consultation with healthcare providers (HCPs) - indicate that HCPs should be more proactive in their consultative and information-providing roles regarding HDS use.

Adopting an electronic medication administration system in long-term care facilities: a key stakeholder interview study in Macao.

To improve medication safety for residents in long-term care facilities (LTCFs), electronic medication administration records (eMARs) are widely adopted in Macao. This study aimed to (1) develop a logic model for adopting eMAR in LTCFs and (2) explore the contextual factors relevant to the implementation. Semi-structured interviews were conducted with key stakeholders (managers, doctors, nurses, pharmacy staff and other frontline workers) experienced with eMAR in LTCFs in Macao between February and March 2021. Purposive sampling was used for recruitment and thematic analysis followed the theoretical framework of the logic model. All 57 participants were positive about eMAR. Financial and nonfinancial resources were critical to adopting eMAR. eMAR was mostly used for its functions in documentation, e-prescribing and monitoring. Immediate output included simplified working process, reduced errors, closer monitoring of residents' conditions, and timely communication among staff. The outcomes mainly related to efficiency, safety and quality of care, workload redundancy, and data unification. Key influencing factors included eMAR flexibility, stability, and technical support. Adopting eMARs is highly consuming and the benefits in improving quality of care can only be realized with appropriate implementation, precise execution, regular evaluation and responsive adjustment. The proposed logic model framework serves as a roadmap for LTCFs, both current and future users of eMAR.

Real-world clinical effectiveness of once-weekly semaglutide in patients with type 2 diabetes: a systematic literature review.

INTRODUCTION: The efficacy of once-weekly (O.W.) semaglutide for the treatment of type 2 diabetes mellitus (T2DM) has been demonstrated in clinical trials. The aim of this systematic literature review was to summarize real-world evidence for O.W. semaglutide. METHODS: A comprehensive search of PubMed, Web of Science, Embase, and Scilit databases was performed from January 2017 to June 2022 to identify eligible real-world studies examining O.W. semaglutide in T2DM. RESULTS: Thirty-one records (18 full-text and 13 abstracts) were identified. The general characteristics of studies and included patients were summarized. Changes in glycated hemoglobin (HbA1c) and body weight were analyzed across studies and according to patient characteristics: baseline HbA1c/weight level, GLP-1 RA-naïve/ GLP-1RA-experienced. The effectiveness of O.W. semaglutide compared with dulaglutide, and the dose of O.W. semaglutide in the real world were also summarized. CONCLUSIONS: This systematic literature review provided complementary evidence to findings from the clinical trials and provided a more comprehensive picture of the use of O.W. semaglutide in routine clinical practice. Results of the review suggested that O.W. semaglutide therapy was associated with improving glycemic control and weight loss in both T2DM patients naïve to GLP-1RA and those previously treated with other GLP-1RA in routine clinical practice. PROSPERO REGISTRATION: CRD42022306164.

Long-Term Cost-Effectiveness of Subcutaneous Once-Weekly Semaglutide Versus Polyethylene Glycol Loxenatide for Treatment of Type 2 Diabetes Mellitus in China.

OBJECTIVE: This study aimed to evaluate the long-term cost-effectiveness of once-weekly subcutaneous semaglutide versus polyethylene glycol loxenatide (PEG-loxenatide) in patients with type 2 diabetes uncontrolled on metformin, from a Chinese healthcare systems perspective. METHODS: The study applied the Swedish Institute of Health Economics Diabetes Cohort Model to evaluate the long-term clinical and economic outcomes of once-weekly treatment of semaglutide at 0.5 mg and 1.0 mg, respectively, versus PEG-loxenatide 0.2 mg, over a 40-year time horizon. Baseline cohort characteristics were collected from the SUSTAIN China trial. A network meta-analysis was conducted to obtain comparative treatment effects of once-weekly semaglutide and PEG-loxenatide based on two phase 3a clinical trials. Drug costs were sourced from the national bidding price of China. Outcomes were discounted at 5.0% per annum. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to assess the uncertainty of the base-case results. RESULTS: When compared with PEG-loxenatide 0.2 mg, the projections of outcomes over the 40-year time horizon in patients with type 2 diabetes uncontrolled on metformin showed that treatment with once-weekly semaglutide 0.5 mg and 1.0 mg were associated with improved discounted life expectancy by 0.08 and 0.12 years, and improved discounted quality-adjusted life expectancy by 0.16 and 0.22 quality-adjusted life-years, respectively. Once-weekly semaglutide 0.5 mg and 1.0 mg were achieved at lifetime cost savings of 19,309 China Yuan (CNY) and 10,179 CNY, respectively. Sensitivity analyses verified the robustness of the results. CONCLUSION: From the perspective of Chinese healthcare systems, treatment with once-weekly subcutaneous semaglutide represents a dominant option versus PEG-loxenatide for patients with type 2 diabetes uncontrolled on metformin.