OBJECTIVE:To provide references for Chinese drug distribution reform.METHODS:The drug distribution model in USA was briefly introduced and compared with that in China.The difficulties and orientations in Chinese drug distribution reform were put forward.RESULTS &CONCLUSIONS:Drug distribution reform should be carried out cautiously.Our government should deal well with the relationships between different interested parties and set up a reimbursement mechanism in medical institutions in order to facilitate the reform.

OBJECTIVE:To further perfect the discipline theory of pharmaceutical administration in China.METHODS:The processes and methods of the discipline theory construction of pharmaceutical administration was studied by deductive theory and‘taking root’theory.RESULTS&CONCLUSION:The pharmaceutical administration theory is characterized by diverse and empirical,to make it improved,more research work needs to be done.

OBJECTIVE:To facilitate the construction of Chinese pharmaceutical profession associations. METHODS: We analyzed the current situation and problems existing in Chinese pharmaceutical profession association as well as the developmental experience of foreign pharmaceutical associations then put forward suggestions for the development of pharmaceutical profession associations in China. RESULTS & CONCLUSIONS: The sound development of pharmaceutical profession associations calls for the cooperated efforts of government, profession association and pharmaceutical enterprises, meanwhile its function as bridge and tie between pharmaceutical enterprises and government should be brought into full play.

This article introduces the classifications of medical devices by FDA and EU and compares them with the situation in China. Towards the problems found, several reasonable advices are put forward.
China ; Durable Medical Equipment ; classification

OBJECTIVE:To provide suggestions for dealing with public emergency in China. METHODS:Through consulting the FDA guidelines for emergency management,the study was done by reviewing literature and comparison study. RESULTS:USA has established complete legal system for emergency management. FDA has established complete organization chart of emergency response with the emergency operation center as its focal point and various centers and offices providing support to resolve all kinds of emergencies. CONCLUSIONS:A complete legal system for emergency management is required in China,the most importance of which is to set up an emergency operation center in SFDA with a set of supporting departments. It is urgent to establish practical emergency response plans.

OBJECTIVE:To provide references for the accountability of civil liability induced by different causes.METHODS:Literature retrieval and case study were applied to analyze the civil liability of pharmaceutical manufacturers and medical institution in medication misadventures.RESULTS & CONCLUSIONS:At present it is difficult for patients who suffered from medication misadventures caused by drug quality defects,drug adverse reaction or medication errors to claim.The main reasons are imperfect relevant law system and the vacancy of compensation mechanism of drug-induced injury events.It is suggested to establish technology institution for evaluating medication misadventures,state relief and compensation system and encourage pharmaceutical manufacturers to buy products liability insurance.

OBJECTIVE:To put forward some suggestion to improve drug bidding system in China.METHODS:The process of drug bidding system reform and its common problems were analyzed.Game theory and information asymmetry theory were adopted to analyze the root of the problems and to put forward suggestions.RESULTS:Governments indiscriminately expanded the goals of bidding policy and strengthen price factor.They neglected important steps such as logistics distribution.Current single evaluation system can not count the medication order exactly.Delayed received payment of medical institution resulted in many problems of drug purchase.CONCLUSION:Centralized drug bidding system should be improved and enhanced.It also should be connected with relevant medical system reform to standardize drug circulation channels,reduce drug price and reduce the burden of patient.

OBJECTIVE:To provide suggestions for the revision of regulations on drug import and export stated in Pharmaceutical Management Law.METHODS:The Federal Food,Drug and Cosmetic Act(FD&CA) and regulations and procedures on drug import & export were reviewed.Then literature analysis and comparison research were adopted in study.RESULTS:Complete legal system for drug import and exports were established in USA.With multiple revision and supplement,items in FD&CA were comprehensive and explicit,which standardized the behavior of import and export and increased sales.CONCLUSIONS:The management for drug import and export should further be strengthened in China with a focus on improving Pharmaceutical Management Law.The most important thing is to implement full supervision on drug imports with flexible import procedure and regulations,and enhance the management for exporting drugs and specific medicines.

OBJECTIVE:To provide suggestions for the development of training mode for pharmaceutical monitoring personnel in China.METHODS:The training mode of Office of Regulatory Affair University(ORA U) was introduced to analyze the difference of training mode for pharmaceutical monitoring personnel between China and America.RESULTS & CONCLUSIONS:America has established a systematic,continuous and uniform pharmaceutical monitoring personnel training system,which is more flexible and advanced than that in China.Our country could draw experiences from the training mode of FDA personnel to develop uniform and diversified training system with suitable budget mechanism.

Objective To investigate the effect of being waked up on bispectral index (BIS) and auditory evoked potential index (AEPI) during emergence from propofol administered by TCI.Methods Twenty ASAⅠorⅡpatients aged 31-63 yrs weighing 52-70 kg undergoing elective cholecystectomy using fiberoptic laparoscope under propofol anesthesia administered by TCI were enrolled in the study. During induction of anesthesia the initial target effect-site concentration of propofol was set at 1.0?g?ml-1 and was increased by 1.0?g?ml-1 until 6.0?g?ml-1 step by step. The BIS and AEPI values and hemodynamic variables were recorded at each target effect-site concentration during induction of anesthesia. At the end of operation the infusion of propofol was stopped and the name of the patient was called loudly every minute asking the patient to open his/her eyes. The BIS and AEPI values were recorded 1 minute before and after the eyes opened on command. Results Both BIS and AEPI correlated closely with target effect-site concentration of propofol during induction of anesthesia. During emergence from propofol at the end of operation the BIS value was 69?7 and 72?10 at 1 min before and after the patients opened eyes on command; while the mean AEPI value was 29.8?6.0 and 73.9?5.9 respectively. The increase in AEPI value was significantly larger than the increase in BIS value. Conclusion Both BIS and AEPI correlate closely with target effect-site concentration of propofol during induction of anesthesia. During emergence from propofol the AEPI is more sensitive to being waked up on command.