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

IntroductionThe 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.MethodsDocumentary 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.ResultsThere 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.ConclusionThe 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

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

IntroductionPharmacological 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.MethodsWe searched the general and specific databases to identify the primary pharmacoeconomic evaluation of AODs.ResultsA 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.ConclusionThis 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 registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302648, identifier CRD42022302648

Community pharmacists’ understanding, attitudes, practice and perceived barriers related to providing pharmaceutical care: a questionnaire-based survey in Macao

Purpose: To explore the knowledge, attitudes, practice and perceived barriers of community pharmacists regarding provision of pharmaceutical care as well as provide recommendations on how to advance the service during the early stage of development in Macao.Methods: A questionnaire comprising 10 items was used to collect respondents’ demographic information and to evaluate their understanding of pharmaceutical care, attitude towards service provision, current practice and perceived barriers. Descriptive and comparative analysis of the results was conducted.Results: While 95 % of the participating pharmacists agreed that patients’ health was their primary responsibility, only 57 % believed that they can provide better pharmaceutical care in the future. The majority spent most of their work time counselling patients (90 %) and checking prescription (70 %). Only a small portion monitored adverse drug reaction and drug compliance (44 %), engaged in health screening or drug safety promotion (20 %) or maintained patient medication records (4 %). Insufficient communication with physicians (90 %), lack of time (79 %) and lack of physical space at the pharmacy (76 %) were considered the most significant barriers.Conclusion: A suboptimal level of pharmaceutical care is provided by pharmacists in Macao. Considering the barriers identified and integrating other country experiences, establishing an enabling atmosphere using policy and regulatory measures is the fundamental element for advancing pharmaceutical care by community pharmacists.Keywords: Community pharmacist, Community Pharmacy, Pharmaceutical care, Maca

The short-term associations of chronic obstructive pulmonary disease hospitalizations with meteorological factors and air pollutants in Southwest China: a time-series study

Chronic obstructive pulmonary disease (COPD) is the fourth major cause of mortality and morbidity worldwide and is projected to be the third by 2030. However, there is little evidence available on the associations of COPD hospitalizations with meteorological factors and air pollutants in developing countries/regions of Asia. In particular, no study has been done in western areas of China considering the nonlinear and lagged effects simultaneously. This study aims to evaluate the nonlinear and lagged associations of COPD hospitalizations with meteorological factors and air pollutants using time-series analysis. The modified associations by sex and age were also investigated. The distributed lag nonlinear model was used to establish the association of daily COPD hospitalizations of all 441 public hospitals in Chengdu, China from Jan/2015–Dec/2017 with the ambient meteorological factors and air pollutants. Model parameters were optimized based on quasi Akaike Information Criterion and model diagnostics was conducted by inspecting the deviance residuals. Subgroup analysis by sex and age was also performed. Temperature, relative humidity, wind and Carbon Monoxide (CO) have statistically significant and consistent associations with COPD hospitalizations. The cumulative relative risk (RR) was lowest at a temperature of 19℃ (relative humidity of 67%). Both extremely high and low temperature (and relative humidity) increase the cumulative RR. An increase of wind speed above 4 mph (an increase of CO above 1.44 mg/m3) significantly decreases (increases) the cumulative RR. Female populations were more sensitive to low temperature and high CO level; elderly (74+) populations are more sensitive to high relative humidity; younger populations (< = 74) are more susceptible to CO higher than 1.44 mg/m3. Therefore, people with COPD should avoid exposure to adverse environmental conditions of extreme temperatures and relative humidity, low wind speed and high CO level, especially for female and elderly patients who were more sensitive to extreme temperatures and relative humidity

Key stakeholder perspectives on the barriers and solutions to pharmacy practice towards complementary medicines: an Australian experience

Abstract Background Although pharmacists are entrusted to play a role in ensuring the safe and appropriate use of all medicines, in general, the inclusion of complementary medicines (CMs) into their professional practice has not been observed. The purpose of this study was to explore the perceptions and opinions of pharmacists and 8 key stakeholder leaders regarding the barriers that hinder pharmacists from providing care related to the use of CMs by patients/consumers and to identify solutions that would support pharmacists’ in extending their role in this area. Methods Semi-structured key informant interviews were conducted with 2 practicing pharmacists, 1 pharmacy owner, 1 key representative of a pharmacist professional organization, 1 key representative of a consumer advocacy group, 1 key representative of a medical professional organization, 1 key representative from a complementary medicine practitioner professional organization, 1 leader within a pharmacy school, 2 senior staff from a regulatory authority, and 1 key representative of the complementary medicine industry in Australia. Results A total of 9 barriers were identified in this study. Barriers including a lack of CMs knowledge, doubts about the evidence-base, a lack of research skills and access to reliable and reputable information dominated the discussions. A total of 7 solutions were proposed. Of those, the integration of CMs curricula into under-graduate and professional pharmacy education, and defining a clearer role for pharmacists’ standard of practice were considered the most important. Apposing opinions about the role of naturopaths in pharmacies were identified.. Conclusion It is anticipated that pharmacists will be required to formalise a role in ensuring the safe and appropriate use of complementary medicines to fulfil their professional and ethical responsibilities. However, pharmacists in general are not ready to take up this extended role. Individual key stakeholder groups have considered the existing barriers and have proposed solutions that are isolated measures. To facilitate further developments related to CMs and the professional practice of pharmacy, collaborative efforts between key stakeholders are needed to strategically plan and execute an extended role in a unified manner

Living with COVID-19 and Sustaining a Tourism Recovery—Adopting a Front-Line Collaborative Response between the Tourism Industry and Community Pharmacists

While the COVID-19 pandemic evolves and new variants emerge, destinations and cities look to tourism recovery, cautiously rebooting and re-opening borders. Since the start of the pandemic, dramatic lockdowns have been employed, resulting in dire economic and social consequences to the tourism and hospitality industry and creating the need for a more feasible and sustainable response in the post-pandemic era. Pandemic vigilance and resilience at the societal level have become key in pandemic preparedness. However, due to the complexity of managing COVID-19, no clear cross-disciplinary collaborative framework for tourism recovery has been developed. Cross-sector collaboration to collectively integrate resources, capabilities, and experiences should be prioritised to spearhead tourism recovery plans. With insight on public health, pandemic preparedness, and community access, we hypothesised that cross-industry collaboration between the tourism industry and the pharmacist profession is relevant to the measures adopted for recovery from the COVID-19 pandemic. To examine this hypothesis, this study aimed to explore perceptions from key stakeholders in the tourism and the pharmacist sectors on cross-industry collaboration towards COVID-19 management and the “know-how” in developing, adopting, and advancing such a partnership. This exploratory study adopts and advances the ‘Four Cs’ conceptual framework of communication, cooperation, coordination, and collaboration. In terms of our hypothesis, interview responses with tourism executives and CPs confirm the framework’s suitability and the importance of an interdisciplinary collaborative approach between CPs and the tourism sector to craft a sustainable pathway to recovery from COVID-19 and future pandemic measures as borders re-open and international mobility increases. A tourism recovery strategy from this pandemic can occur more judiciously through a collaborative partnership with an extensive network of pharmacists within communities and popular tourism sites, as CPs have valuable healthcare resources and the ability to track and communicate healthcare alerts to tourism destination recovery efforts

Physicians’ and Pharmacists’ Experience and Expectations of the Roles of Pharmacists: Insights into Hospital Setting in Macau

Purpose: To investigate physicians’ and pharmacists’ experience and expectations of the roles of pharmacists in hospital setting in Macau for the development of physician-pharmacist collaborative working relationship (CWR). Methods: A survey was conducted to address the research questions. The study population included the physicians and pharmacists working in hospitals in Macau. A self-administered survey was designed correspondingly to physicians and pharmacists with same series of questions, which composed of 4 parts: demographics, collaboration status, roles of pharmacist based on experience, and roles of pharmacist based on expectations. Results: Sixty six out of the 120 physician surveys and 18 out of the 30 pharmacist surveys were returned, giving a response rate of 55.00% and 60.00% respectively. 33.33% of physicians and 77.8% of pharmacists claimed they collaborated with the other professional at least once a week. The main reason for collaboration was prescription order queries. Both professionals indicated that “medication dispensing” and “identification and prevention of prescription errors” were currently the top responsibilities of pharmacists. It was anticipated by the physicians that pharmacists would remain focused on “medication dispensing” but should put in more effort. Pharmacists, on the other hand, would like to develop their role in direct patient care such as “patient counseling”. Conclusion: There were discrepancies in physicians’ and pharmacists’ expectations of the roles of pharmacists. The 6 most important responsibilities of pharmacists were determined in consultation with physicians’ opinions. Capacity building of pharmacists, communication between the two professionals and administrative co-ordinations were considered important elements in developing CWR

Towards consensus: defining and supporting a professional role for pharmacists associated with traditional and complementary medicines – a protocol of implementing an international e-survey

Introduction Traditional and complementary medicines (T&amp;CM) are predominantly self-selected from retail outlets including pharmacies as part of self-care practices. Concerns about the appropriate and safe use of T&amp;CM products raises questions about ‘should’ and ‘how’ pharmacists could adopt professional responsibilities. There lacks a consensus about the scope of these responsibilities, or the initiatives required to execute them. The aim of this study is to identify an international set of core responsibilities that support pharmacists’ contribution to ensuring the quality and safe use of T&amp;CMs to promote public health.Methods and analysis An international cross-sectional e-survey of pharmacists representing the six WHO regions will be conducted over a 12-month period. Pharmacists will be invited via representative organisations and professional networks within their respective country. Survey responses to statements about the relevance of T&amp;CM to day-to-day practice; opinions about the bioethical and practice responsibilities; and support required to build their scope of practice associated with T&amp;CM will be collected centrally via the online survey platform Survey Monkey and analysed using the Statistical Package for Social Sciences V.27 software for Windows. Bivariate statistical analysis will be conducted to examine the associations between agreement to statements within each section with key demographic variables, country of practice, pharmacy type, age, gender, qualification and years in practice. Cronbach’s alpha will be used to test the internal consistency of items from certain sections of the survey and evince their clarity to respondents of the questionnaire.Ethics and dissemination Ethics approval has been obtained from the University of Macau (approval number SSHRE21-APP068-ICMS-01). The results of this survey will be used to inform key discussion points in a consensus process and a step towards developing an agreed and defined professional role for pharmacists in T&amp;CMs

Prevalence and trend of major transfusion-transmissible infections among blood donors in Western China, 2005 through 2010.

BACKGROUND: The prevalence of transfusion-transmissible infections (TTIs) in blood donations is important for evaluating blood safety and potential risks to the population. This study investigated the prevalence of TTIs among blood donors in Western China and suggested measures for policy-makers. METHODS: The screening results of 66,311 donations between 2005 and 2010 from a central blood center in Western China were analyzed. The prevalence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and syphilis infections were expressed in percentages for the entire study group as well as groups by demographic characteristics and donation frequency, with differences analyzed using Fisher's exact or Chi-square test. Logistic regression was performed to identify the influencing factors of the detected results. RESULTS: 1,769 (2.67%, 95% CI 2.55-2.79%) of the donated blood had serological evidence of infection with at least one pathogen and 44 (0.07%, 95% CI 0.05-0.09%) showed evidence of multiple infections. The seroprevalence of HBV, HCV, HIV, and syphilis infections was 0.87% (95% CI 0.80-0.94%), 0.86% (95% CI 0.79-0.93%), 0.31% (95% CI 0.26-0.35%), and 0.70% (95% CI 0.64-0.76%) respectively. Trend analysis for the prevalence of TTIs showed a significant increase from 2.44% to 3.71% (χ2 = 100.72, p = 0.00) over this 6-year period. The positive rates for TTIs varied along demographic lines. The top three risk factors in test-positive donors were identified as age, education level and donation frequency. The older age group and lower educated group were linked to a higher prevalence of TTIs. A decreasing prevalence was associated with an increasing frequency of blood donations (χ2 = 562.78, p = 0.00). CONCLUSIONS: Hepatitis B and C were found most, and often in conjunction with syphilis. These were the primary threats to blood safety. The high positivity rate and the increasing prevalence of TTIs among blood donors in Western China call for further actions