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.

Efficacy and safety of direct-acting antiviral regimen for patients with hepatitis C virus genotype 2: a systematic review and meta-analysis.

BACKGROUND: Direct-acting antivirals (DAAs) show high cure rates in treating chronic hepatitis C virus (HCV). However, the effect of DAAs on patients infected with genotype 2 (GT2) is difficult to determine despite the availability of several DAA regimens. METHODS: A systematic search of six databases (PubMed, Embase, Cochrane Library, Web of Science, CNKI, and Clinicaltrial.gov) was conducted through April 20, 2022. We considered the sustained virological response 12 weeks after treatment (SVR12) as the efficacy outcome, and adverse events (AEs) as the safety outcome. By calculating the mean SVR12 and the proportion of AEs among patients, we considered the intervention effect for each DAA regimen. The random effect model was then used in all meta-analyses. This systematic review and meta-analysis aimed to summarize the evidence on efficacy and safety of DAAs in patients infected with HCV GT2. The Bayesian Markov Chain Monte Carlo (MCMC) network metanalysis was used to indirectly compare regimen in GT2 patients. RESULTS: Among 31 articles included (2,968 participants), consisting of 1,387 treatment-naive patients and 354 patients with cirrhosis. The overall pooled SVR12 rate was 94.62% (95% CI: 92.43-96.52%) among the participants who received all doses of treatment. Meta-analysis results of AEs revealed that fatigue was the most common AE (14.0%, 95% CI: 6.4-21.6%), followed by headache (13.1%, 95% CI: 9.2-17.1%), whereas death and serious adverse events were uncommon. CONCLUSIONS: We compared DAA-based treatments indirectly using meta-analysis and found the combination of Sofosbuvir plus Velpatasvir and Glecaprevir plus Pibrentasvir, each administered over a 12-week period, were identified as the most effective and relatively safe in managing chronic hepatitis C virus genotype 2 (HCV GT2) infection. Both treatments achieved a SVR12 of 100% (95% CI 99-100%).

Safety and efficacy of phosphodiesterase-5 (PDE-5) inhibitors in fetal growth restriction: a systematic literature review and meta-analysis.

Introduction: Fetal growth restriction (FGR) is associated with a higher risk of perinatal morbidity and mortality, as well as long-term health issues in newborns. Currently, there is no effective medicine for FGR. Phosphodiesterase-5 (PDE-5) inhibitors have been shown in pre-clinical studies to improve FGR. This study aimed to evaluate the latest evidence about the clinical outcomes and safety of PDE-5 inhibitors for the management of FGR. Methods: Eight databases (PubMed, Embase, Medline, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Database and WangFang Database) were searched for English and Chinese articles published from the database inception to December 2023. Randomized controlled trials (RCTs) reporting the use of PDE-5 inhibitors in FGR were included. The quality of the RCTs was assessed using the Cochrane Risk of Bias Tool. Odds ratio and mean difference (MD) (95% confidence intervals) were pooled for meta-analysis. Results: From 253 retrieved publications, 16 studies involving 1,492 pregnant women met the inclusion criteria. Only sildenafil (15 RCTs) and tadalafil (1 RCT) were studied for FGR. Compared with the control group (placebo, no treatment, or other medication therapies), sildenafil increased birth weight, pregnancy prolongation and umbilical artery pulsatility indices. However, it also increased the risk of pulmonary hypertension in newborns, as well as headache and flushing/rash in mothers. There were no significant differences in gestation age, perinatal mortality or major neonatal morbidity, stillbirth, neonate death, infants admitted to neonatal intensive care unit, intraventricular hemorrhage and necrotizing enterocolitis in infants, as well as pregnancy hypertension and gastrointestinal side effects in mothers between the treatment and the control groups. Discussion: Sildenafil was the most investigated PDE-5 inhibitors for FGR. Current evidence suggests that sildenafil can improve birth weight and duration of pregnancy but at the same time increase the risk of neonatal pulmonary hypertension. It remains uncertain whether the benefits of sildenafil in FGR outweigh the risks and further high-quality RCTs are warranted. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=325909.

Patterns of self-medication and intention to seek pharmacist guidance among older adults during the COVID-19 pandemic in Macao: a cross-sectional study.

INTRODUCTION: Self-medication was remarkably popular during the COVID-19 pandemic. In older populations, the risk of self-medication is higher. Pharmacists are well positioned to provide public health education and disease prevention. This study aims to explore the self-medication patterns and intention to seek pharmacist guidance among older adults in Macao. METHODS: A face-to-face cross-sectional survey was subsequently performed in March-April 2023 among older adults in Macao. The questionnaire was designed based on the Theory of Planned Behavior (TPB) framework. Multiple logistic regression was used to analyze predictors of self-medication behavior and multiple linear regression analysis to determine whether the TPB construct was the predictor of older adults' intention to seek guidance from pharmacists. RESULTS: A total of 412 participants completed the questionnaire. The self-medication rate among older adults in Macao was 64.2%. The most commonly used types of medications were over-the-counter and traditional Chinese medicine, mainly from government anti-pandemic packages. The majority of individuals engaged in self-medication to treat COVID-19 symptoms or prevent COVID-19 infection. The prevalent reasons for self-medication were the perceived non-seriousness of the illness. 85 years old or older and university degree were significantly associated with self-medication behavior. Older adults had moderate intention to seek pharmacist guidance on medication use. The average scores (standard deviation) were 3.43 (1.10) for Attitude, 2.69 (0.99) for Subjective Norm, 3.56 (1.04) for Perceived Behavioral Control, and 3.07 (1.43) for Intention. Attitude, Subjective Norm, and Perceived Behavioral Control were all strong predictors of intention, which explained 53% of the variance in intention. In demographic factors, age was identified as a significant predictor of intentions. CONCLUSIONS: Self-medication was widely practiced in Macao during the COVID-19 pandemic. To better control the risks associated with self-medication, the role of pharmacists is paramount. Enhancing the recognition and trust of pharmacists within society, modifying pharmacy management models, and strengthening pharmacists' self-perception of their profession are all pivotal directions areas to further enhance their role.

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.

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.

Investigating the intention to receive the COVID-19 vaccination in Macao: implications for vaccination strategies.

BACKGROUND: Understanding the intention of receiving COVID-19 vaccines is important to inform effective vaccination strategies. This study aimed to investigate such intention, identify the key influencing factors, and determine the most important intention predictors using a theoretically principled model. METHODS: An online, cross-sectional survey method was implemented in Macao in May 2021. People aged 18 years or above and residing in Macao for 12 months prior to the study were recruited through social media. Intention to receive COVID-19 vaccines and the main constructs of the protection motivation theory and the health belief model were the main measures encompassing threat appraisal, intrapersonal characteristics, cues to action, coping appraisal, past experiences and information seeking behavior. Descriptive statistics, Pearson correlation and multiple linear regression were used for data analysis. RESULTS: A total of 552 valid responses were received. Among the respondents, 79.5% aged between 25 and 54 years old, 59.4% were female, and 88% had a bachelor degree or above; 62.3% of the respondents indicated their intention to receive COVID-19 vaccination while 19.2% were hesitant and 18.5% did not have any intention. While 67.0% believed COVID-19 infection was life-threatening, only 19.0% thought they were at risk of getting infected. Control variables such as age, gender, education level, and having travel plans were significantly correlated with intention. Significant associations between intention with perceived severity, perceived susceptibility, maladaptive response reward, self-efficacy, response-efficacy, response cost, social attitude, social norm, past experience and information seeking behavior were identified (P < 0.05). The most important positive predictors of intention were "being able to make arrangement to receive the vaccine" (ß = 0.333, P < 0.001), "a sense of social responsibility" (ß = 0.326, P < 0.001), and "time off from work after vaccination" (ß = 0.169, P < 0.001), whereas "concerns over vaccine safety" (ß = - 0.124, P < 0.001) and "relying on online resources for vaccine information" (ß = - 0.065, P < 0.05) were negative predictors. Perceived severity in terms of COVID-19 being a life threatening illness was not a predictor of intention. CONCLUSION: This study reaffirmed that intention to receive COVID-19 vaccination is an ongoing concern in the combat of the pandemic. Multi-component strategies to enhance health literacy that supports well-informed decision-making, increase vaccination convenience, promote social responsibility, and provide time-off incentives are among the key considerations in designing and improve vaccination campaigns in Macao.

Viral etiology among children hospitalized for acute respiratory tract infections and its association with meteorological factors and air pollutants: a time-series study (2014-2017) in Macao.

BACKGROUND: The associations between viral etiology of acute respiratory infections (ARI) with meteorological factors and air pollutants among children is not fully understood. This study aimed to explore the viral etiology among children hospitalized for ARI and the association of meteorological factors and air pollutants with children hospitalization due to viral ARI. METHODS: Electronic health record data about children (aged between 1 month and 14 years) admitted for ARI at Kiang Wu Hospital in Macao between 2014 and 2017 was analyzed retrospectively. xMAP multiplex assays were used to detect viruses in the nasopharyngeal swab and distributed-lag nonlinear model (DLNM) was used to evaluate associations. RESULTS: Among the 4880 cases of children hospitalization due to ARI, 3767 (77.2%) were tested positive for at least one virus and 676 (18%) exhibited multiple infections. Enterovirus (EV)/rhinovirus (HRV), adenovirus (ADV), respiratory syncytial virus (RSV) and influenza virus (IFV) were the most common viral pathogens associated with ARI and human bocavirus (hBOV) exhibited the highest multiple infection rates. Meteorological factors and air pollutants (PM10, PM2.5 and NO2) were associated with the risk of viral ARI hospitalization. The relative risk of viral infection increased with daily mean temperature but plateaued when temperature exceeded 23 °C, and increased when the relative humidity was < 70% and peaked at 50%. The effect of solar radiation was insignificant. Air pollutants (including PM10, PM2.5, NO2 and O3) showed strong and immediate effect on the incidence of viral infection. CONCLUSIONS: The effects of mean temperature, relative humidity and air pollutants should be taken into account when considering management of ARI among children.

Health technology assessment-informed pricing negotiation in China: higher negotiated price for more effective targeted anticancer medicines?

BACKGROUND: In China, health technology assessment (HTA) has recently been adopted in pricing negotiation for medicine listing in the National Reimbursement Drug List. At present, how HTA is applied to inform the decision-making process remains underreported. In order to explore how the adoption of HTA was translated into listing and price negotiation results in light of the confidential nature of the negotiating process, this study aimed to compare the negotiated price and the clinical benefit of selected targeted anticancer medicines (TAMs) involved in the 2019 negotiation. MAIN TEXT: Among 16 TAMs successfully negotiated, only four TAMs representing four indication groups had appropriate reference medicines for comparison and were, therefore, included in the analysis. The price and clinical benefit of the four TAMs were compared against one or two reference medicines with the same initial indications. The sales prices for nine TAMs before and after the negotiation were extracted from the centralized medication procurement system. Clinical benefits were evaluated based on evidence from published articles and clinical guidelines. The results suggested that, despite the application of HTA, both rational and irrational decisions had been made about the reimbursement of TAMs in the 2019 negotiation, warranting further investigation. CONCLUSION: While the development and adoption of HTA has seen significant progress in China, actions are needed to ensure that the adoption of HTA is effectively applied in decisions on the reimbursement of medicines.

Viral etiology and epidemiology of pediatric patients hospitalized for acute respiratory tract infections in Macao: a retrospective study from 2014 to 2017.

BACKGROUND: Acute respiratory infections (ARIs) are among the leading causes of hospitalization in children. Understanding the local dominant viral etiologies is important to inform infection control practices and clinical management. This study aimed to investigate the viral etiology and epidemiology of respiratory infections among pediatric inpatients in Macao. METHODS: A retrospective study using electronic health records between 2014 and 2017 at Kiang Wu Hospital was performed. Nasopharyngeal swab specimens were obtained from hospitalized children aged 13 years or younger with respiratory tract diseases. xMAP multiplex assays were employed to detect respiratory agents including 10 respiratory viruses. Data were analyzed to describe the frequency and seasonality. RESULTS: Of the 4880 children enrolled in the study, 3767 (77.1%) were positive for at least one of the 13 viral pathogens tested, of which 2707 (55.5%) being male and 2635 (70.0%) under 2 years old. Among the positive results, there were 3091 (82.0%) single infections and 676 (18.0%) multiple infections. The predominant viruses included human rhinovirus/enterovirus (HRV/EV 27.4%), adenovirus (ADV, 15.8%), respiratory syncytial virus B (RSVB, 7.8%) and respiratory syncytial virus A (RSVA, 7.8%). The detection of viral infection was the most prevalent in autumn (960/1176, 81.6%), followed by spring (1095/1406, 77.9%), winter (768/992, 77.4%), and summer (944/1306, 72.3%), with HRV/EV and ADV being most commonly detected throughout the 4 years of study period. The detection rate of viral infection was highest among ARI patients presented with croup (123/141, 87.2%), followed by lower respiratory tract infection (1924/2356, 81.7%) and upper respiratory tract infection (1720/2383, 72.2%). FluA, FluB and ADV were positive factors for upper respiratory tract infections. On the other hand, infection with RSVA, RSVB, PIV3, PIV4, HMPV, and EV/RHV were positively associated with lower respiratory tract infections; and PIV1, PIV2, and PIV3 were positively associated with croup. CONCLUSIONS: This is the first study in Macao to determine the viral etiology and epidemiology of pediatric patients hospitalized for ARIs. The study findings can contribute to the awareness of pathogen, appropriate preventative measure, accurate diagnosis, and proper clinical management of respiratory viral infections among children in Macao.

Policy Interventions, Development Trends, and Service Innovations of Internet Hospitals in China: Documentary Analysis and Qualitative Interview Study.

BACKGROUND: Internet hospitals have been encouraged by the Chinese government to develop an innovative medical service model that mainly uses new internet-based technologies to increase access to health care and improve the quality and efficiency of health care delivery. However, the academic exploration of the institutional and sectoral development of internet hospitals in China is scarce in the existing literature. OBJECTIVE: This study aimed to investigate the policy interventions, development trends, and service innovations of internet hospitals in China. It is expected that the findings from this study will contribute to the further innovation of internet hospitals in China and provide references for the international development of internet hospitals for personalized digital health and patient-centric services. METHODS: This study analyzed official policies related to internet hospitals that were implemented by the government in China since 2005. The data of formally approved internet hospitals were collected from official websites to analyze development trends. In-depth semistructured interviews were conducted with 58 key stakeholders who represented comprehensive viewpoints about the service innovations of internet hospitals between March and November 2019. RESULTS: In total, 25 policies that promoted the development of internet hospitals in China were identified. These policies encompassed informatization infrastructure construction, medical resource integration, development model design, service model design, and payment model design. Of the 268 internet hospitals that had received an official license from the government, 153 public internet hospitals had been built mainly by medical institutions. Public tertiary hospitals were the main actors in founding internet hospitals that were created to provide services that targeted patients with common diseases or chronic diseases or patients living in remote and rural areas. Promoting convenient access to high-quality medical resources and saving patients' and their families' time were the key values of internet hospitals. CONCLUSIONS: The policy interventions strongly promoted the development of internet hospitals in China. Public tertiary hospitals led the development of internet hospitals. However, internet hospitals in China have mainly played roles that are complementary to those of physical medical institutions. The service model of internet hospitals needs more distinguished innovations to provide personalized digital health and patient-centric services.

Drug Utilization for Pain Management during Perioperative Period of Total Knee Arthroplasty in China: A Retrospective Research Using Real-World Data.

Background and Objective: Total knee arthroplasty (TKA) is one of the most painful procedures and perioperative pain usually requires the use of many analgesics to relieve it. The appropriate use of analgesics to relieve patient pain is an important issue of TKA. To characterize the drug utilization for pain management during perioperative period of TKA in China using real-world data of electronic medical records. Materials and Methods: This research used the data of all inpatients who received TKA at 145 hospitals covered 31 provinces in China from 1 January 2016 to 31 December 2018. The exclusion criteria included pregnancy and cancer diagnosis. In the analysis of drug utilization mode (DUM), medicines were classified into 5 groups: non-steroidal anti-inflammatory drugs (NSAIDs), opioids, non-opioid central analgesics, acetaminophen and others. Results: Among the 2017 patients included in this study, there were 1537 (76.20%) female and 480 (23.80%) male, aged 65.77 ± 7.73 years. Regarding the surgery characteristics, 1658 (82.20%) were unilateral; 1220 (60.49%) was graded Level 4; 1312 (65.05%) used local anesthesia as the main anesthesia method, and 1450 (71.89%) lasted for more than 2 h. The most common DUM was "NSAIDs + opioids" (55.92%), followed by "NSAIDs only" (17.85%), and "NSAIDs + Opioids + Non-opioid central analgesics" (17.15%). The results of the Chi-square test showed that differences in DUM were associated with surgery types, surgery levels, surgery duration, and types of anesthesia used. Up to 81.14% of the total drug expenses for pain management was spent on NSAIDs. Due to the limitation of database, this study could not subdivide operation stages, anesthesia methods, dosage forms of drugs. Conclusion: In China, the use of analgesics in perioperative period of TKA was diversified and influenced by a number of surgery characteristics. The rational use of analgesics should be considered in combination with surgery type, surgery level, surgery duration and anesthesia method.

Involving systems thinking and implementation science in pharmacists' emerging role to facilitate the safe and appropriate use of traditional and complementary medicines.

The use of traditional and complementary medicines (TM/CMs) has become an increasingly popular part of healthcare and self-care practices across the world. While the benefits and risks of many TM/CMs are yet to be fully evaluated, their prevalent use without consistent oversight has not been fully addressed by the public health sector. Pharmacists play an integral role in contributing to public health. Discussion about integrating TM/CMs into the professional practice of the pharmacist began over two decades ago. Nevertheless, TM/CMs are predominantly managed as "retail products" and are not integrated into pharmaceutical care and practice. While some isolated measures towards integration have been proposed, there remains no consensus on how to deliver pharmaceutical care in a coordinated, systematic manner. Systems thinking approaches are needed to formulate and implement strategies that change pharmacists' practice related to TM/CMs. Such approaches will ultimately reduce risk, optimize patient care, and result in better health outcomes.

Evaluation of the association between presenteeism and perceived availability of social support among hospital doctors in Zhejiang, China.

BACKGROUND: This study investigated the association between presenteeism and the perceived availability of social support among hospital doctors in China. METHODS: A questionnaire was administered by doctors randomly selected from 13 hospital in Hangzhou China using stratified sampling. Logit model was used for data analysis. RESULTS: The overall response rate was 88.16%. Among hospital doctors, for each unit increase of the perceived availability of social support, the prevalence of presenteeism was decreased by 8.3% (OR = 0.91, P = 0.000). In particular, if the doctors perceived availability of appraisal support, belonging support and tangible support as sufficient, the act of presenteeism was reduced by 20.2% (OR = 0.806, P = 0.000) 20.4% (OR = 0.803, P = 0.000) and 21.0% (OR = 0.799, P = 0.000) respectively with statistical differences. CONCLUSION: In China, appraisal support, belonging support and tangible support, compared to other social support, had a stronger negative correlation with presenteeism among hospital doctors. The benefits of social support in alleviating doctors' presenteeism warrant further investigation.

Safety of medication use during pregnancy in mainland China: based on a national health insurance database in 2015.

BACKGROUND: Medication safety during pregnancy has drawn global attention, little of which has been reported about the Chinese population. This study aims to describe patterns and risks of medication use among pregnant women in mainland China with reference to the U.S. Food and Drug Administration (FDA) pregnancy risk category. METHODS: Hospital diagnostic and drug dispensing information of a national representative sample of basic medical insurance (BMI) beneficiaries was obtained from the China Health Insurance Association (CHIRA) database in 2015. Prevalence of use and number of medicines involved in each risk category were calculated. Most commonly used medicines from each risk category were illustrated. Factors associated with the use of category D/X medicines were evaluated through multiple logistic regression. RESULTS: Out of 11,373 women who had singleton deliveries in 2015, there were 2896 women with records covering their entire pregnancies, 5377, and 7946 women with records through the 2nd, and the 3rd trimester, respectively. It was found that 11.1% pregnant women used at least one medication and a total of 321 medications had been used during pregnancy. Most pregnant women used medicines which were classified FDA category C (66.2%), followed by category B (57.8%), category A (16.8%), category X (7.5%) and category D (5.0%). The most commonly used medicines from category D and X were anxiolytics and hormonal preparations respectively. Women who were from mid-western area (p = 0.045) or used four or more medications (p < 0.001) were more likely to use category D/X medicines. CONCLUSIONS: This study revealed that about one in ten pregnant women used at least one medication during pregnancy in China and a significant number of them used FDA Category D or X medicines. The usage patterns identified in the present study indicate that sub-optimal medicine use might exist warranting further evaluation and intervention in future studies. More efforts are needed to uncover the safety concerns about medication use during pregnancy and improve current information system for clinical practice.

Consumers' Perceptions About Pharmaceutical Care Provided by Community Pharmacists in China in Relation to Over-the-Counter Drugs: A Qualitative Study.

While patient-centered care is highly anticipated nowadays, investigation of consumers' perceptions and expectations about pharmacist's pharmaceutical care when providing over-the-counter (OTC) drugs is sparse. This article aimed to explore consumers' perceptions regarding the pharmaceutical care that community pharmacists provide in relation to OTC drugs. Semistructured interviews were conducted with consumers recruited (N = 97) in Yinchuan City, China. The 4 main themes that emerged were expectations on pharmaceutical care, attitude toward pharmacist's competence, experience of self-medication, and suggestions for improving pharmaceutical care. Most participants had high expectations on community pharmacists to recommend the right medicines, to advise them about the effective use of drug, to advise them about the safe use of drug, and to recommend economic drugs. However, their previous experiences at community pharmacy were far from satisfaction reportedly, leading to a general distrust in pharmacist's certification and qualification, knowledge, communication skills, and attitude. As a result, the participants turned to self-medication based on their personal experiences, their relatives' experiences, the information on drug label, and the information distributed in the mass media. Realizing the need to improve pharmaceutical care, the participants also made improvement suggestions specific to community pharmacist, community pharmacy, and the government.

Obstacles and opportunities in Chinese pharmaceutical innovation.

BACKGROUND: Global healthcare innovation networks nowadays have expanded beyond developed countries with many developing countries joining the force and becoming important players. China, in particular, has seen a significant increase in the number of innovative firms and research organizations stepping up to the global network in recent years. Nevertheless, the intense Research and Development input has not brought about the expectable output. While China is ascending at a great speed to a leading position worldwide in terms of Research and Development investment, scientific publications and patents, the innovation capabilities in the pharmaceutical sector remain weak. DISCUSSION: This study discusses the challenges and opportunities for pharmaceutical innovation in China. One hand, academic, industrial, institutional and financial constraints were found to be the major and inevitable barriers hindering the development of drug innovation. On the other hand, unique advantages had been observed which included growing pharmaceutical market, Research and Development funding, distinctive source, and international cooperation. The most important thing for China's pharmaceutical sector to leap forward is to break though innovation barriers and integrate own advantages into global value-chain of healthcare product development.

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

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.

Community pharmacists' perceptions about pharmaceutical service of over-the-counter traditional Chinese medicine: a survey study in Harbin of China.

BACKGROUND: This study aims to investigate community pharmacist's perception on the provision of over-the-counter (OTC) traditional Chinese medicine (TCM) pharmaceutical services; focusing on the areas of their attitude, general practice, perceived barriers and suggested improvements. METHODS: Questionnaire survey targeting community pharmacists in Harbin of China was applied in this study. Questionnaires were distributed and collected at community pharmacies. Data was analyzed by combining descriptive analysis and Chi-test. RESULTS: 280 valid questionnaires were collected, giving a response rate of 78%. Respondents generally showed positive attitude towards OTC TCM pharmaceutical services. However, they were uncertain about whether such pharmaceutical services should be considered as their primary responsibility. Respondents indicated that they acted proactively to find out all the medicines taken by their patients and to remind consumers of possible OTC TCM adverse reactions. However, they were less keen on recommending or re-directing consumers to suitable OTC TCM. The three main barriers hindering the provision of OTC TCM pharmaceutical service identified in this study were "insufficient professional knowledge" (54.6%), "ambiguity of the professional role of pharmacists" (54.6%) and "lack of scientific evidence of OTC TCM" (45.4%). The three main actions considered most relevant to improving pharmaceutical service of OTC TCM were "formulating or refining legislation to clarify the legal and professional role of pharmacists with respect to TCM" (60.7%), "strengthening training of pharmacists with respect to TCM" (57.9%), and "promoting public awareness of the pharmacist's role" (53.6%). According to the results of Chi-test, respondents' perceptions about the attitude, practice, perceived barriers, and improvement suggestions were significantly different depending on the education levels, certificate types and workloads of western medicine. CONCLUSIONS: The community pharmacists in Harbin, China were positive about the provision of OTC TCM pharmaceutical services. However, they were less certain about taking this duty as their primary responsibility. Insufficient knowledge and lack of role definition in the area of OTC TCM were found to be the major factors discouraging the provision of pharmaceutical service on OTC TCM by community pharmacists.

Naturally Occurring Diterpenoid Dimers: Source, Biosynthesis, Chemistry and Bioactivities.

Diterpenoid dimers are rare in nature and mainly found in higher plants including the families Acanthaceae, Annonaceae, Asteraceae, Calceolariaceae, Chrysobalanaceae, Cupressaceae, Euphorbiaceae, Fabaceae, Lamiaceae, Liliaceae, Meliaceae, Rhizophoraceae, Taxaceae, Velloziaceae, and Zingiberaceae. In addition, a few diterpenoid dimers have been also reported from fungi (Psathyrellaceae), liverworts (Scapaniaceae), and a gorgonian (Gorgoniidae). They feature a wide variety of structures due to different core skeletons, linkage patterns, substituents, and configurations. Accordingly, diterpenoid dimers exhibit a broad range of bioactivities, including cytotoxic, anti-inflammatory, antimicrobial, antimalarial, and antifouling properties, which have attracted more and more research interests in the past decades. This review with 176 metabolites from 109 references provides a comprehensive and up-to-date overview of the source, biosynthesis, structure, synthesis, and bioactivities of diterpenoid dimers.