Résumé
OBJECTIVE：To provide sugge stions for improving the variety of pediatric drugs and ensuring the safety of pediatric drug use in China. METHODS ：The historical evolution of laws and regulations on the marketing approval of pediatric drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation of the development of pediatric drugs in China ，some suggestions were put forward to ensure the accessibility and safety of pediatric drug use in China. RESULTS & CONCLUSIONS ：Since 1994，the United States had issued a series of laws and regulations to encourage the development of pediatric drugs. At present ，the marketing approval of pediatric drugs were mainly based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act （PREA）. From 1998 to 2019，the amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of April 2020，854 kinds of drugs had been modified in pediatric instructions ，792 of which had been carried out post marketing pediatric clinical research ，and the problem of incomplete pediatric instructions had also been greatly improved. At present ，China’s policies on pediatric drugs mainly included encouraging R&D innovation ，giving priority to review and approval ，and strengthening R&D technical guidance. Although certain achievements had been made ，there were still some problems ，such as imperfect policies and regulations ，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons from the American regulations on pediatric drugs ，pediatric research and the catalogue of pediatric drugs ，and establish a system and catalogue of ped iatric drug use suitable for China ’s national conditions ，so as to improve the effectiveness ，safety and accessibilityof pediatric drugs.
Résumé
Objective:To discuss the management norms for the rational use of potassium chloride injection in neurosurgery department of a hospital.Methods:A special review of the medical advice including potassium chloride injection from January to June in 2016 in neurosurgery department was carried out.Results:In the 2 596 prescriptions including potassium chloride injection,the irrational drug use rate was 17.87%,and among them,92.67% were irrational compatibility,which showed serious risk of drug use.Conclusion:Some defects still exist in the application management of potassium chloride injection in neurosurgery department of this hospital.In order to avoid the risk of clinical medication,it is necessary to establish standardized management norms for the use of potassium chloride injection in this hospital to further promote the management of high-risk drugs with intravenous administration commonly used in clinics.
Résumé
OBJECTIVE:To provide reference for the rational use of Potassium chloride injection and the management of high-risk drugs. METHODS:A total of 1 065 prescriptions containing Potassium chloride injection during the first half year of 2014 were analyzed retrospectively according to“Rules for Comment on Prescriptions”. RESULTS:The qualification rate of pre-scription was 95%. The irrational prescriptions accounted for 5%. The main problems included unreasonable route of administra-tion,unreasonable selection of solvent,incompatibility with TCM injection and other types of injections as well as the risk of Potas-sium chloride injection combined with a few oral drugs. CONCLUSIONS:The defect still exist in the management of high-risk drug aspotassiam chloride injection in our hospital,so that the hospital should set up high-risk drug prescription special review sys-tem and emergency plan which is the effective way for avoiding the drug risk of high-risk drugs.