| With the implementation of the announcement on the direct reporting of adverse reactions by drug listing license holders(hereinafter referred to as the announcement),the state has further clarified the main responsibilities of drug listing license holders in the monitoring and reporting of adverse reactions(ADRs).In order to understand the current situation and existing problems of ADR monitoring and reporting in pharmaceutical enterprises,this study took a Chinese patent medicine enterprise in Jiangsu Province as the research site,and systematically carried out a study on ADR monitoring and reporting of Chinese patent enterprises by means of retrospective analysis,questionnaire survey and qualitative research.Part ?:Retrospective Analysis of ADR of a Chinese Patent Medicine Enterprises from 2013 to 2019Objective:To understand the current situation of ADR monitoring and reporting in this enterprise and the characteristics of ADR of Chinese patent medicine.Methods:Based on the ADR monitoring data of Chinese patent medicine enterprises in 2013-2019(January to November),the age,sex ratio,administration route,clinical manifestations,involved organs,drug types and reporter of ADR patients were analyzed and evaluated.Results:Through the analysis of 1699 ADR events,1060 ADR reports from 2013 to 2016 were not reported from sources.In the ADR reports with obvious sources from2017 to 2019(January to November),the reporting proportion of production enterprises increased from 5.6%in 2017 to 17.24%in 2019(January to November).In 1699 ADR cases,there were 900 male patients and 799 female patients,with a male-to-female ratio of 1:0.89.The most common adverse reactions were new general adverse reactions(75.93%),most of them occurred in people over 60 years old(33.49%),the main organ involved was digestive system(50.53%),the main outcome of ADR was"recovery"(54.21%),and the statistical results of ADR causality evaluation were the most"possible"(49.26%).Conclusion:From 2013 to 2019(January to November),the annual ADR report of the pharmaceutical enterprise shows an upward trend.Since 2015,the number of ADR reports has increased rapidly.Influenced by the implementation of the announcement,the proportion of manufacturers as the source of ADR report has increased significantly.The Chinese patent medicine ADR in this enterprise is characterized by a high incidence of new adverse reactions,a high incidence of elderly people,and a large proportion of ADR involving the digestive system.In addition,in terms of reporting problems,the number of ADRs reported by the pharmaceutical enterprise in the past 7years is not high,and some of the reports are inaccurate and incomplete.Part ?:The Analysis of Cognition and Influencing Factors of Marketing Personnel to ADRObjective:To understand the cognition status and influencing factors of ADR of marketing personnel in pharmaceutical enterprises,and to find out the existing problems,so as to facilitate the internal improvement measures of enterprises,give full play to the active participation of marketing personnel in the work of ADR,and provide scientific theoretical basis for the effective implementation of the announcement.Methods:A simple random sampling method was used to investigate 50%of the marketing staff of the pharmaceutical company with a self-administered questionnaire,covering the basic concepts,the cognition of ADR reporting regulations,reporting procedures and drug safety.The frequency and composition ratio were used to describe the results of the survey.The factor analysis of ADR awareness was performed by?~2 Analysis and multi factor Logistic regression analysis.Results:A total of 498 people were surveyed and 480 valid questionnaires were collected,with an effective recovery rate of 96.39%.The average age was 35.81±7.26years,and 56.45%of the marketing personnel were male.The vast majority of marketing personnel know ADR(93.54%),75.63%know that ADR reporting system is implemented in China,but only 61.25%think that manufacturing enterprises also need to report ADR,and 21.67%cannot accurately determine what kind of ADR should be reported.According to the correct answers of 10 objective questions,the average score of marketing personnel was 5.75,which was at a low level.The results of univariate and multivariate analyses showed that the factors of education level and professional title were related to the level of cognition(P<0.05).The higher the education level or professional title of marketing personnel was,the better their cognition level would be.Conclusion:The marketing personnel of the interviewed pharmaceutical enterprise have poor cognition of ADR,and they do not know the responsibility of the pharmaceutical enterprise as one of the reporting subjects,and they are not clear about what kind of ADR should be reported.If marketing personnel are to be taken as the main channel for pharmaceutical enterprises to report ADR,it is very necessary to strengthen the training of ADR professional knowledge for marketing personnel with low education level and low professional title,to improve the ADR reporting rate of pharmaceutical enterprises.Part ?:The Qualitative Study on the Monitoring and Management of ADRs in Pharmaceutical EnterprisesObjective:To understand the implementation,problems and challenges of adverse reactions reporting monitoring after the implementation of the announcement,and to provide countermeasures and references for further improvement of ADR monitoring.Methods:A semi-structured,one-to-one in-depth interview was used to conduct a qualitative study on the managers of enterprises and the personnel related to adverse reaction monitoring.QSR NVivo 8.0 software was used to analyze the interview content with the help of colaozzi seven step method,so as to form the opinions on adverse reaction monitoring of the personnel related to pharmaceutical enterprises and analyze the reasons.Results:The pharmaceutical enterprise's 6 active managers and 12 ADR monitoring post-related personnel,whether they are managers or ADR monitoring post personnel,attach great importance to ADR monitoring and reporting work,.In order to coordinate with the implementation of the announcement to sort out the problems existing in the internal ADR monitoring and reporting of the enterprise,a special monitoring organization was established with full-time staff to implement the responsibilities and clear division of labor.However,there are still some problems and challenges,such as the gap with the requirements of the announcement,the weak awareness of ADR monitoring and reporting of relevant personnel,the unwillingness of enterprises to invest too much in ADR monitoring and reporting,and the concern that ADR monitoring will bring patients'disputes to enterprises.Conclusion:The implementation of the announcement further strengthened the main responsibility consciousness of pharmaceutical enterprises and promoted the direct reporting of ADR by pharmaceutical enterprises.However,the state should formulate and improve the ADR monitoring and reporting guidelines,popularize the knowledge of safe drug use for patients,and establish laws and regulations related to ADR relief as soon as possible.Pharmaceutical enterprises should also strengthen the training of ADR monitoring personnel to ensure the sustainability of ADR monitoring.Through the systematic research of the above three parts,aiming at the problems existing in ADR monitoring of Chinese patent medicine enterprises,this study puts forward six countermeasures:first,according to the characteristics of ADR of Chinese patent medicine,formulate ADR reporting standards and strengthen the quality of ADR reports;second,make full use of the marketing personnel to set up the reporting network,strengthen the training related to ADR and improve the number of reports;third,actively carry out the analysis of ADR reports,Enhance the awareness of drug risk management and drug safety;strengthen the supervision and inspection of daily work,strengthen the work training of enterprises,and enhance the awareness of the main responsibility of enterprises;formulate technical guidance documents and supporting incentive policies to give enterprises clearer ADR monitoring guidance;strengthen the publicity of drug safety knowledge of the whole people,establish ADR relief laws and regulations,and eliminate the afterthought of enterprises worry. |
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