Research Progress and Suggestions on China’s Drug Registration Management Based on CiteSpace Knowledge Maps

Objective To analyze the research status and hot spots in the field of drug registration in China,and to provide some suggestions for the follow-up research.Methods CiteSpace was used to conduct literature quantitative analysis on 684 related articles from 2012 to 2022,and the knowledge map was drawn.Based on this,the main characteristics and development trends of the related studies were summarized.Results and Conclusion The number of articles published was closely related to the regulatory policy of drug registration reform.The authors of these articles did not have good continuity.Besides,research hot spots were closely related to the actual work,which was mainly around the improvement of the review and approval policy,encouraging innovative drug research and development,improving the level of new drug development and other directions.The follow-up studies should further strengthen the continuity of research and inter-agency collaboration.In addition,biomedical registration may become a new research focus in the future.

Factors Affecting the Knowledge and Practice of Drug Management among Healthcare Workers in Primary Health Centers in South-East, Nigeria

The knowledge of health workers regarding their management of drugs is very important in ensuring good health. One of the major indices of the performance of primary health care (PHC) remains improved access to essential drugs as they are the link between patients and health services. Consequently, their availability or absence will contribute to a positive or negative impact on health. This was a quasi-experimental study, carried out in Anambra state, which compared the intervention and control groups following the training and provision of drug management tools to PHC workers in the intervention group. A multi-stage sampling technique was used to select 264 health workers from 132 health centers from two senatorial zones in the State, one acting as a control group and the other as an intervention group. Data was collected using a pre-tested in-depth interview guide and semi-structured interviewer administered questionnaire. Statistical analysis was conducted using SPSS at a statistical significance level of p value less than 0.05, while qualitative data was analyzed using N-Vivo. Several factors such as age, sex, educational qualification, cadre of staff, years of practice and PHC workers’ previous training were identified as affecting the knowledge and practice of drug management. The majority (72.0% and 71.2%) in intervention and control groups respectively said inadequate information or lack of knowledge was the main reason for poor practices while the proportion with low interest of health workers for drug management was (38.5%) for intervention and (59.8%) for the control group and the difference between the groups was statistically significant (p = 0.034). In conclusion, this study has shown that age, sex, educational qualification, cadre of staff, years of practice and PHC workers’ previous training were factors associated with health workers’ knowledge and practice of drug management. The study recommends the development of Aide Memoire and conduct of training and retraining on drug management to improve both knowledge and practice of drug management in PHCs in Nigeria.

Risk management of drug products in FDA: the development and implication

This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages： the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.

An overview of management of narcotics and psychotropic drugs in China

Narcotics and psychotropic drugs are known as controlled drugs with special management and super vision due to their psychic and physiological dependence. Based on the literature review, experts interview and policy comparative analysis, our study summarized and reviewed the status of related legislation and regulations since the enactment of the Narcotics and Psychotropic Drugs Regulations in 2005. We found the problems of legal loopholes, the complexity of supervision system and the irrational use of narcotics in the treatment of chronic non-cancer. Our analysis suggested that China should reinforce legislation, strengthen the cooperation among departments, establish the information network and improve the guideline of narcotics and psychotropic drugs for clinical treatment as quickly as possible.

STATUS AND CONTROL POLICY OF MAIN CHRONIC DISEASES IN COMMUNITY HEALTH MANAGEMENT BASES IN SHANGHAI AND GUANGDONG

Objective To investigate the current conditions of the main chronic diseases and to make the control policy in community health management base in China. MethodsThe questionnaire consisting of prevalence, awareness rate, management rate, behavior correct rate, control rate, and medicine obey was used to survey the chronic disease condition in 2009. A total of 809 736 residents were randomly selected from Shanghai and Guangdong, China. ResultsThe hypertension prevalence was 17.81%. From sex analysis, the female has higher rate than male in hypertension prevalence, understand rate, management rate, behavior correct rate, control rate, and medicine obey rate. From age analysis, the prevalence, understand rate, management rate, control rate, and medicine obey were increasing along with the age, but behavior correct rate was not in this condition. The diabetes prevalence was 6.92%. To compare with Shanghai and Guangzhou in 5 aspects, the prevalence of chronic diseases was alike. Except lower behavior correct rate in Shanghai, management rate, behavior correct rate, control rate, and medicine obey rate were higher in Shanghai. ConclusionThe government must take main principle in chronic disease control. Base construction of community health management and increase management level of chronic diseases should be enhanced and practitioner's knowledge of chronic disease management should also be enhanced.