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OBJECTIVE：To construct China ’s Insurance Mode for ADR injury compensation model under marketing authorization holder （MAH）system，and to provide reference for reducing the medical disputes caused by ADR damage and protecting the rights and interests of patients. METHODS ：Using the methods of recommendation and “snowball”，the interviewers were invited to conduct semi-structured interviews to obtain qualitative data ，and the results were analyzed by thematic analysis. According to the results of subject analysis ，the ADR injury compensation model was designed from three aspects of insurance type setting，insurance level division and compulsory insurance protection objects ，and the Fuzzy comprehensive evaluation method based on AHP was used to evaluate the model ；questionnaire and multiple factor Logistic regression analysis was adopted to analyze the influential factors of whether drug related institutions were willing to establish ADR injury compensation system. RESULTS：A total of 40 experts were invited and 34 of them completed the interview ，with a response rate of 85.0％. At present ， the problems of ADR injury compensation in China mainly included the difficulties of third-party identification and adducing evidence of ADR injury ，the difficulty of timely and fair settlement of medical disputes caused by ADR injury ，the high cost and long time of handling ADR injury disputes ，and the uncertainty of compensation mode. More than half of the experts interviewed agreed with the compensation mode of insurance . The overall score of established model was 89.50. A total of 640 questionnaires were distributed and 559 valid questionnaires were recovered （204 drug manufacturers ，172 drug distributors and 183 medical institutions）. The effective rate of the questionnaire was 87.3％. Multiple Logistic regression analysis showed that the factors positively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system in China included the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies （β＝1.697，P＜0.05），the types of drugs operated by pharmaceutical companies （β＝2.987， P＜0.05），the cognitionlevel of medical staff on ADR （β＝ 2.800，P＜0.05）. The working years of medical staff were negatively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system （ β ＝－ 2.544，P＜0.05）. CONCLUSIONS ：ADR injury compensation model designed in this study is feasible. It has reference value for reducing the economic burden of ADR patients ， treating patients ’health problems caused by ADR injury in time ，and promoting the development of China ’s drug insurance. Main influential factors for the establishment of ADR injury compensation model under MAH system contain the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies ，the types of drugs operated by pharmaceutical companies ，the cognitionlevel of medical staff on ADR ，the types of drugs operated by pharmaceutical companies ，the cognitionlevel of medical staff on ADR.
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OBJECTIVE：To analyze th e risk factors of marketing authorization holder （MAH）pharmacovigilance outsourcing and propose risk management and control strategies ， and to provide reference for MAH to successfully implement pharmacovigilance outsourcing and regulatory authorities to formulate corresponding regulatory strategies. METHODS ：Based on the principal-agent theory and brainstorming method ，the risk factors were preliminarily determined ，and a questionnaire was designed. The questionnaire survey was carried out among pharmacovigilance staff of 200 MAH in Guangdong province by random sampling. The factor analysis method was used to statistically analyze the questionnaire data ，and the comprehensive risk factors and their respective factor scores were summarized. RESULTS & CONCLUSIONS ：A total of 200 questionnaires were distributed ， and 154 valid questionnaires were returned ，with effective recovery rate of 77.00％. The results of factor analysis method showed that there were 4 comprehensive risk factors involved in MAH pharmacovigilance outsourcing activities ，which were service providers and outsourcing management factor （3.792 score），MAH factor （3.766 score），regulations factor （3.626 score）and market factor （3.610 score）from high to low. In view of the above factors ，it is suggested that MAH should focus on improving outsourcing contract ，establishing information communication mechanism with service providers ，strengthening auditing and management，strengthening pharmacovigilance ability and personnel building ，defining appropriate pharmacovigilance outsourcing business contents ， and fully doing pre-service investigation of service providers ， when MAH conducts outsourcing of pharmacovigilance. It is suggested that relevant departments should formulate pharmacovigilance entrusted quality management specifications or guidelines as soon as possible and strengthen the supervision of service providers. It is suggested to try to establish a pharmacovigilance outsourcing industry associa tion， andstandardize the industry behavior by giving full play to the influence of the association ，so as to avoid the outsourcing risk.
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OBJECTIVE：To provide assistance for the smooth implementation of classification management policies of retail pharmacies in Guangdong province and the scientific supervision of retail pharmacies by relevant departments. METHODS ：In this study，key interviews were conducted among 68 interviewees，involving experts from Guangdong drug regulatory department ，head of retail pharmacies and research experts on relevant policies of universities. The current situation ，problems and suggestions of the classification management policy of retail pharmacies in Guangdong province were summarized. RESULTS & CONCLUSIONS ： The implementation of the classification management policies for retail pharmacies in Guangdong province operated well. Drug regulatory authorities at all levels could conduct daily supervision in accordance with policy requirements. Retail pharmacies operated in strict accordance with the classification management policy and established a relatively complete quality management system. However ，there were still problems such as difficulty in policy implementation ，insufficient policy clarity ，increased regulatory pressure and regulatory risks from government regulatory agencies ，rising operating costs and increasing pressure in retail pharmacies，the large gap of licensed pharmacists ，difficult to investigate and deal with “affiliation of certificate ”behavior，and difficult survival for remote pharmacies ，and the impact on the convenience of drug use of the public. It is suggested to improve the content of the policy ，introduce related supporting measures ，strengthen the construction of the supervisory team ，increase policy publicity，improve the ways and methods to investigate and deal with the “affiliation of certificate ”behavior of licensed pharmacists， and help retail pharmacies to diversify their operations and chain operations. It is recommended that relevant government departments should further improve the content of the policy and actively adjust the supervision methods to make the policy better implemented.
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OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under MAH system.
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OBJECTIVE:To study influential factors for retail chain drugstore undertaking the pharmacy function of community health center based on the perspective of retail chain drugstore pharmacist. METHODS:The stratified sampling method was used to conduct questionnaire survey among pharmacists in retail chain drugstores from Pearl River Delta(Guangzhou,Foshan, Dongguan),eastern Guangdong,western Guangdong and northern Guangdong. Multivariate analysis of variance was performed to study main effects of independent variables,pairwise comparison and interaction,with social demographic characteristics(gender, age,educational level,major,profession at title,working life,location)as independent variables,using fear of workload increase,inadequate pharmaceutical care,lower wages,inadequate electronic prescription acceptance and change in the work model as dependent variable. RESULTS:A total of 242 questionnaires were sent out,involving 239 valid questionnaires with effective recovery rate of 98.8%. The results of multivariate analysis of variance showed that majors of main effect and the interaction between major and professional title affected the fear of increase in the workload;age,education and working years of main effect,and the interaction between age and location affected the fear of inadequate pharmaceutical care;professional title of main effect affected the fear of electronic prescription acceptance;age and location of main effect,and the interactions between age and professional title influenced the fear of change in work model. CONCLUSIONS:It is suggested to strengthen pharmaceutical care and electronic prescription acceptance of pharmaceutical staff in retail chain drugstore,increase the number of professional pharmaceutical staff,allocate pharmaceutical staff reasonably and consider about regional differences.
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OBJECTIVE:To understand the public cognitive status about the adverse drug reaction(ADR),and provide refer-ence for improving the ADR reporting system. METHODS:Field to fill out and recycling questionnaire on the spot were conducted to investigate the cognition of ADR about 1 379 people from the Pearl River Delta,Eastern,Western and Northern region of Guangdong Province,and analyze related influential factors. RESULTS:Totally 1 500 questionnaires were sent out and 1 379 were effective with effective rate of 91.9%. Among the respondents,931(67.5%)could correctly answer the question of ADR concept, the correct rate showed lowest in the people lived in Northern region and with no less than 40 years old and low education;only 36.1% could correctly know the cause of ADR;only 388 (28.1%) knew the individuals can report ADR;723 (52.4%) thought hospital should be held responsible for ADR;once the ADR appeared,62.2% of respondents would choose to report to the hospi-tal. The main causes of discourage individual report of ADR were due to less know about where,how and which relevant depart-ments could report,and the report way was not convenient and the procedures were cumbersome. CONCLUSIONS:The public awareness of the ADR concept is not high and the enthusiasm of report is relatively low. Therefore,the propaganda of public aware-ness of ADR should be strengthened to encourage the public to participate in the ADR report actively,and broaden the channels of ADR personal report.
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Vitamin C (VC) and vitamin K3 (VK3) are widely used in the fields of antioxidant,immunity improvement and hemostasis,etc.In the 1 940 s,the antitumor effect of these two vitamins was found.Research shows that the combination regimen of VC and VK3 with a ratio of 100:1 produces a maximum of synergistic anti-tumor effect.Such combination reduces the overall dose of drugs,thus avoiding the increase in their adverse effects.The combination of VC and VK3 effectively kills a variety of tumor cells,such as breast cancer,ovarian cancer,prostate cancer,bladder cancer and leukemia,etc.This combined therapy has been patent and is in phase Ⅰ and Ⅱ clinical trials.The clinical studies show that it prolongs the survival time of patients with terminal cancer,while its adverse reactions is mild.Therefore,VC in combination of VK3 is of broad application prospect.This paper reviews the synergistic anti-tumor effects of VC combined with VK3.