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.

Exploring the implementation of an outreach specialist program for nursing home residents in Macao: A multisite, qualitative study.

Background: The "Specialist Medical Outreach Project (SMOP)" involving inter-disciplinary hospital-based healthcare professionals is a government initiative that aims to provide integrative specialist care to high-risk residents at the nursing homes. However, research exploring the implementation and impact of SMOP is lacking. This study aimed to evidence the impact of SMOP on the quality of care at the nursing home and the key contextual determinants influencing SMOP outcomes. Method: Semi-structured key informant audio-recorded face-to-face interviews were conducted with eight managers, six doctors, 28 nursing staff, and seven pharmacy staff at the nursing homes participating in the SMOP to collect insights about how SMOP was operated and performed, and the impact of SMOP as observed and expected. Participants were recruited with purposive sampling. A thematic analysis approach was employed and key themes were identified using open coding, grouping, and categorizing. Results: Forty-nine interviews were conducted. Thematic analysis identified three principal themes: the overall perception about SMOP, the benefits as observed; and the areas of improvement. Together with the 10 subthemes, the results highlighted the expectations for SMOP to address the unmet needs and promote patient-centered care, and the benefits of SMOP in supporting effective use of resources for the nursing home, reducing the risks of adverse events for the residents, promoting communication and capacity building for the healthcare providers and facilitating efficient use of healthcare resources for the health system. Requests for more frequent visits by a larger inter-disciplinary specialist team were raised. Careful staff and workflow planning, and mechanisms for data-sharing and communication across care settings were deemed the most important actions for improvement. Conclusion: It is a general perception that the SMOP is beneficial in enhancing the quality of care for high-risk residents in the nursing home in Macao. Cross-sector inter-disciplinary collaboration and efficient data-sharing and communication mechanism play a crucial role in ensuring the success of the program. A robust assessment framework to monitor and evaluate the cost-effectiveness of the program is yet to be developed.

Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use.

BACKGROUND: An appropriate regulatory system to ensure and promote the quality, safety, and efficacy of the products of traditional medicine (TM) and complementary medicine (CM) is critical to not only public health but also economic growth. The regulatory approach and evaluation standards for TM/CM products featured with a long history of use are yet to be developed. This study aims to investigate and compare the existing regulatory approaches for TM/CM products with a long history of use. METHOD: A mixed approach of documentary analysis involving official and legal documents from official websites, as well as a scoping review of scholarly work in scientific databases about regulatory systems of TM/CM products in China, Hong Kong, Taiwan, Japan, and Korea, was employed in this study and used for comparison. RESULTS: For registration purposes, all five regulatory systems recognized the history of use as part of the totality of evidence when evaluating the safety and efficacy of TM/CM products with a long history of use. Generally, the list of classic formulas is predefined and bound to the formulas recommended in the prescribed list of ancient medical textbooks. Expedited pathways are usually in place and scientific data of nonclinical and clinical studies may be exempted. At the same time, additional restrictions with the scope of products constitute a comprehensive approach in the regulation. Quality assurance and postmarketing safety surveillance were found to be the major focus across the regulatory schemes investigated in this study. CONCLUSION: The regulatory systems investigated in this study allow less stringent registration requirements for TM/CM products featured with a long history of use, assuming safety and efficacy to be plausible based on historic use. Considering the safety and efficacy of these products, regulatory standards should emphasize the technical requirements for quality control and postmarket surveillance.

Quality Evaluation of Randomized Controlled Trials of Rhodiola Species: A Systematic Review.

BACKGROUND: Rhodiola is a worldwide used medicinal plant for its various medicinal functions, and the number of randomized controlled trials (RCTs) of Rhodiola is increasing in recent years. This study aims to evaluate the reporting quality and risk of bias of the current RCT reports of different Rhodiola species. METHODS: Six databases including Embase, PubMed, Web of Science, the Cochrane Library, ClinicalTrial.gov, and China National Knowledge Infrastructure were searched to identify RCTs that used Rhodiola as a single intervention and were published in English or Chinese from inception to December 2020. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement was used as the checklist for assessment, and a scoring system was applied to the evaluation of RCTs. Score 0 represents no reporting or inadequate reporting, and score 1 represents adequate reporting. The risk of bias of the included studies was also assessed using the Cochrane Risk of Bias tool. RESULTS: A total of 39 RCTs were included in this study, including 23 RCTs of Rhodiola rosea (R. rosea), 8 RCTs of Rhodiola crenulata (R. crenulata), and 8 RCTs of Rhodiola wallichiana (R. wallichiana). None of the included studies met all the CONSORT statement criteria, and the reporting quality of RCTs of the three Rhodiola species was all generally poor. Based on the risk of bias assessment, the majority of included studies were judged to have an unclear risk of bias in most domains due to inadequate reporting. CONCLUSIONS: There is inadequate reporting among the included RCTs of different Rhodiola species, and RCTs of Rhodiola with higher reporting quality and better methodological quality are needed.

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model.

Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little systematic documentary analysis about how RWE was integrated for the use by the DRAs in evaluating new treatment approaches and monitoring post-market safety. This study aimed to analyze and discuss the integration of RWE into regulatory decision-making process from the perspective of DRAs. Different development strategies to develop and adopt RWE by the DRAs in the US, Europe, and China were reviewed and compared, and the challenges encountered were discussed. It was found that different strategies on development of RWE were applied by FDA, EMA, and NMPA. The extent to which RWE was adopted in China was relatively limited compared to that in the US and EU, which was highly related to the national pharmaceutical environment and development stages. A better understanding of the overall goals, inputs, activities, outputs, and outcomes in developing RWE will help inform actions to harness RWD and leverage RWE for better health care decisions.

Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications.

BACKGROUND: The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of traditional Chinese medicines (TCMs) with the adoption of regulatory science (RS). However, the priority of actions at the interface of RS and TCMs were yet to be defined. This research aims to identify the priority areas and summarize core actions for advancing RS for traditional medicines in China. METHODS: A mixed approach of documentary analysis of government policies, regulations and official information about TCMs regulation in China, and a scoping review of literature using 4 databases (PubMed, ScienceDirect, Scopus and CNKI) on major concerns in TCMs regulation was employed. RESULTS: Ten priority areas in the development of TCM-related regulatory science in China have been identified, including: (1) modernizing the regulatory system with a holistic approach; (2) advancing the methodology for the quality control of TCMs; (3) fostering the control mechanism of TCMs manufacturing process; (4) improving clinical evaluation of TCMs and leveraging real world data; (5) re-evaluation of TCMs injection; (6) developing evaluation standards for classic TCMs formula; (7) harnessing diverse data to improve pharmacovigilance of TCMs; (8) evaluating the value of integrative medicine in clinical practice with scientific research; (9) advancing the regulatory capacity to encourage innovation in TCMs; and (10) advancing a vision of collaboration for RS development in TCMs. CONCLUSIONS: RS for TCMs in China encompasses revolution of operational procedures, advancement in science and technology, and cross-disciplinary collaborations. Such experiences could be integrated in the communications among drug regulatory authorities to promote standardized and scientific regulation of traditional medicines.

Efficacy and safety of traditional Chinese medicines for non-alcoholic fatty liver disease: a systematic literature review of randomized controlled trials.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a common liver disease that may progress into, in the absence of proper treatment, severe liver damage. While the optimal pharmacotherapy for NAFLD remains uncertain and the adherence to lifestyle interventions is challenging, the use of herbal medicines such as traditional Chinese medicines (TCMs) to manage the condition is common. The evidence about TCMs in the management of NAFLD is continuously developing through randomized controlled trials (RCTs). This study aims to identify and evaluate the emerging evidence about the efficacy and safety of TCMs for NAFLD. METHODS: A systematic literature search was conducted to identify RCTs which investigated TCMs in the management of NAFLD published in 6 electronic databases including PubMed, the Cochrane Library, EMBASE, Web of Science, Scopus and China National Knowledge Infrastructure since inception to September 2020. RCTs comparing TCMs with no treatment, placebo, non-pharmacological and/or pharmacological interventions were included irrespective of language or blinding. The quality of reporting was evaluated using the Consolidated Standards of Reporting Trials Statement extensions for Chinese herbal medicine Formulas (CONSORT-CHM). Risk-of-bias for each study was assessed using the Cochrane risk of bias tool. RESULTS: A total of 53 RCTs involving 5997 participants with NAFLD were included in this review. Each included RCT tested a different TCMs giving a total of 53 TCMs identified in this study. Based on the evaluation of the RCT results, TCMs might have various beneficial effects such as improving TCM syndrome score, liver function, and body lipid profile. A range of non-serious, reversible adverse effects associated with the use of TCMs were also reported. However, no conclusion about the efficacy and safety of TCMs in NAFLD can be made. The quality of reporting was generally poor and the risks of bias was mostly uncertain in all trials. CONCLUSIONS: There is some evidence from RCTs that supported the effectiveness and safety of TCMs for NAFLD. However, no conclusive recommendations can be made due to the questionable quality of the RCTs. Improvement in the RCT protocol, the use of a larger sample size, a setting of multicenter, and a more focused approach in selecting TCMs are recommended for developing high quality evidence about the use of TCMs in managing NAFLD.

An evaluation of randomized controlled trials on nutraceuticals containing traditional Chinese medicines for diabetes management: a systematic review.

BACKGROUND: Nutraceuticals containing traditional Chinese medicine (TCM) are promoted for use in the management of diabetes. The evidence to support such use is largely unknown. This study aimed to summarise and evaluate the literature reporting the results of randomized controlled trials (RCTs) investigating the effects of nutraceuticals in people living with diabetes. METHODS: Literature from four electronic databases (PubMed, Scopus, CINAHL and Web of Science) was searched following PRISMA guidelines to yield RCT publications on nutraceutical for diabetes management published since 2009. The quality of reporting was assessed using the CONSORT 2010 checklist statement. Risk-of-bias for each study was assessed using the Cochrane risk of bias tool. RESULTS: Out of 1978 records identified in the initial search, 24 randomized, double/triple-blinded, controlled trials that investigated the effect of nutraceuticals covering 17 different TCM herbs for diabetes management were selected. Participants included people who were diabetic (n = 16), pre-diabetic (n = 3) or predisposed to diabetes (n = 5). Sample sizes ranged between 23 and 117 for 2 arms, or 99-165 for 3 arms. Comparisons were made against placebo (n = 22), conventional medicine (n = 1), or regular diet (n = 1) for a duration between 4 and 24 weeks. All but one study tested the effect on fasting blood glucose levels (n = 23) or glycated haemoglobin levels (n = 18), and/or postprandial 2-h blood glucose levels (n = 4) as the primary outcomes. Nineteen studies reported some statistically significant reductions in the respective measures while 5 studies showed no effect on primary or secondary outcomes. None of the included studies met all the criteria for the CONSORT guidelines. Incomplete reporting about randomization and blinding, and a lack of ancillary analyses to explore other influential factors and potential harms associated with the use were repeatedly noted. Based on the Cochrane risk-of-bias tool, 19 studies were deemed to have a high risk of bias mainly attributed to sponsor bias. CONCLUSIONS: There is some evidence to suggest positive clinical outcomes in response to the administration of a range of nutraceuticals containing TCM in the management of diabetes. However, these results must be interpreted with caution due to the overall low quality of the trials.

[Study on germination characteristic of seed of Dendranthema indicum].

OBJECTIVE: To find out the optimum condition for the germination of seed of Dendranthema indicum by studying the effects of pretreatment,phytohormone and temperature on it, and offer the basis for its standardized culture. METHODS: The seed purity, weight per 1000 seeds, seed moisture content and seed viability were determined. The germination of D. indicum seed was tested under following conditions: pretreatment (acid, base, warm water, boiling water), phytohormone (IBA, 6-BA, NAA) and treatments under different temperature (10, 20, 25, 30 degrees C). RESULTS: The seed purity was 99.4%; The weight per 1000 seeds was 0.2941 g; The seed moisture content was 4.39%; The seed viability was 85.3%; The tests of pretreatment couldnt increase the germination of D. indicum seed; Phytohormone had limited effect on the germination of the seed; Temperature condition showed significant effects on the germination. CONCLUSION: The optimum condition for the germination of the seed of D. indicum is 25 degrees C on filter paper.