Résumé
OBJECTIVE:To investigate and perfect the pilot work of medicine marketing authorization holder system in China. METHODS:The problems of medicine marketing authorization system in China and the features of medicine marketing licensing system in USA and EU were analyzed. The legal authority and content of pilot medicine marketing authorization holder system in China were summarized so as to propose related policy recommendation. RESULTS & CONCLUSIONS:There are many problems in the medicine authorization system in China which is the combination of“production license”and“marketing license”,for exam-ple,the obsolete definition of“new drugs”,the serious waste of drug resources,the insufficient research and development of new drugs. The“production license”and“marketing license”are separated in the USA and EU. There are many new drugs,high capaci-ty utilization and perfect system of drug safety,quality control and risk management. In order to ensure the effective implementa-tion of the pilot work,it is suggested to enhance and improve the quality authorization management,the pharmacovigilance system and drug injury relief related to drug safety management.
Résumé
Objective:To understand the basic situation of pharmacy staff in the hospitals in Beijing Xicheng district. Methods:Totally 12 hospitals in Xicheng district were investigated by a questionnaire( including the age,educational degree and professional title of phama-cists) , and the obtained information was classified, gathered and counted, and the evaluation and recommendation were also performed after the combination with regulations and actual work. Results:There were 385 persons working in the pharmacies of the 12 hospitals, which accounted for 7. 56 % of the total health professionals. Among them, 67. 02% were under the age of 40, 83. 11%were undergraduates or specialists, 84. 93% had primary or intermediate titles, 3. 38% had finished standardized training, and 4. 68%were clinical pharmacists. Conclusion:The composition of pharmacy staff can not match the national requirements. It is necessary to optimize the structure of pharmacy staff, improve the level of education, and strengthen the standardized training and clinical pharma-cist training in order to promote the career competence of pharmacists.
Résumé
OBJECTIVE:To study the effect of canceling the maximum retail price limit on the accessibility of low-cost drugs in our hospital. METHODS:Based on the policies of canceling the maximum retail price,the low-cost drugs in the hospital man-agement system were extracted to adjust the relevant data of price,compare the drug supply changes before and after the price ad-justment and summarize the effect of canceling the maximum retail limit on the accessibility of low-cost drugs in our hospital. RE-SULTS:The price of 19 kinds of low-cost drugs in our hospital were adjusted,which were raised,for 1-4 times,the average daily cost increased to 0.06-2.51 yuan,with an increase proportion of 11%-309%. 16 varieties of order delivery rate increased,with in-crease proportion of 2%-100%,1 variety decreased,with decrease proportion of 32%,2 varieties showed the same distribution rate. CONCLUSIONS:Canceling the maximum retail price limit can promote the accessibility of low-cost drugs in our hospital.