Study On Current Situation Of Drug Use Safety For Children In China And Its Influencing Factors

[Objective] This study aims to identify the migration pathway of policies on children’s medication-related.Summarize the current status of pediatric medicine,clarify the knowledge and needs of medical staff for pediatric medicine,and explore the influencing factors based on the perspective of medical personnel.Propose the safety management strategy for children’s medication from the characteristics and laws of children’s ADR in Hubei Province from 2014 to 2018.With a view to providing a reference for the country to improve policies and management strategies related to children’s medication.[Methods](1)Literature review.Cite Space software was used to analyze Web of Science and CNKI database search results.(2)Empirical research.Snowball sampling method was used to conduct a baseline survey of pediatric medical staff from August to October 2019.(3)Retrospective research.Analysis of all reported ADR cases of 0-14 years in Hubei Province from January 2014 to December 2018.(4)Data analysis.Epidata was used to establish the corresponding database,and SPSS25.0,Microsoft Excel(2016),SPSSAU(Version 20.0)were used for mathematical statistical analysis.The main analysis methods include reliability analysis,validity analysis,chi-square test,mean value comparison Meta-Logistic regression analysis,multiple response analysis,etc.[Results](1)Cognitive status of medical staff: the overall average score is 9.93 points(<60% scoring rate).Relative to medical staff with a working period of ">10 years",the recognition level of knowledge of "<5 years" and "5-10 years" are lower.The level of knowledge of medical staff in first-level hospitals and second-level hospitals is lower than that of tertiary hospitals.The level of knowledge of medical staff with higher familiarity with the guidance of children’s medication standards or norms is higher.(2)Half of the respondents think that the children’s special medicines provided by the unit cannot meet the clinical drug demand,of which 81.62% are due to the lack of children’s special medicine varieties,80.88% are due to the lack of children’s special dosage forms,and 70.59% are the lack of children’s special specifications medicines.The medical staff’s medication basis is mainly the drug instructions,the relevant drug administration system formulated by the state,and the medication guidelines.(3)After experiencing adverse drug reactions,nearly 90% of the medical staff will fill in the adverse reaction reporting system,and 23% of the respondents are still not familiar with the adverse reaction reporting system.Whether the hospital where you are responsible for adverse drug reaction reporting and monitoring,the number of adverse reaction reports,and the familiarity of the adverse reaction reporting system are the main factors affecting the reporting.(4)Medical staff have a high familiarity with the standard drug administration system formulated by the department,the standard drug administration system developed by the hospital,the instruction database,the "Administrative Measures for the Report and Monitoring of Adverse Drug Reactions",the national guidelines such as the "National Antimicrobial Treatment Guidelines".(5)Lack of special drugs for children and nonstandard instructions(lack of items,too general expression and unspecified usage and dosage)are the most important factors affecting the safety of drug use for children.[Conclusions](1)There are differences in the cognition level of children’s medication safety among medical staff in different levels of hospitals,and the training for level I and level II hospitals should be strengthened;(2)Long-term encouragement of pharmaceutical enterprises to develop special drugs for children,and improvement of drug instructions for children by conducting prospective post-market safety re-evaluation of drugs and introducing similar pediatric research programs;(3)Medical staff is not familiar with the adverse reaction reporting system,and relevant training on reporting system operation can be appropriately increased during relevant training on adverse reaction monitoring;(4)In the future,further research can be conducted on the reporting mechanism and channels of consumer adverse reactions to expand the reporting scope of adverse reactions.