摘要
目的:了解药品生产企业营销人员对药品不良反应(ADR)的认知及其影响因素,发挥营销人员主动参与ADR的上报,更好地配合《关于药品上市许可持有人直接报告不良反应事宜的公告》的实施。方法:采用单纯随机抽样方法,对某药企营销人员进行自填式问卷调查,内容涉及基本概念、上报及用药安全,采用频数及构成比描述调查结果,影响因素分析采用χ~2检验及多因素Logistic回归分析。结果:共调查498人,回收有效问卷480份,有效回收率为96.39%。56.45%的营销人员为男性,平均年龄(35.81±7.26)岁。绝大多数营销人员知晓ADR(93.54%),75.63%的被调查者知道我国实行ADR报告制度,但只有61.25%的人认为生产企业也要上报ADR,而且21.67%无法准确判断何种情况的ADR应该上报。依据10道客观题回答正确情况,营销人员平均得分为5.75分,处于较低水平。单因素和多因素分析结果均显示,文化程度、职称等因素与认知程度高低有关(P<0.05),营销人员的文化程度或职称越高,认知程度越好。结论:受访的药企营销人员对ADR认知程度欠佳,对于生产企业作为报告主体之一的责任还不了解,而且对何种ADR该上报并不清晰。加强对低文化程度和低职称营销人员开展ADR专业知识的培训,对于提高生产企业ADR报告率显得非常必要。
Objective:To understand the cognition status of adverse drug reactions(ADR)and its influencing factors among the marketing personnel in a drug manufacturing enterprise of Jiangsu,and to improve their enthusiasm in ADR reporting and cooperate with the implementation of the Notice on Adverse Drug Reactions Reported directly by the Holder of Drug Listing License.Methods:A self-administered questionnaire survey was conducted among the marketing personnel of a drug manufacturing enterprise using simple random sampling method.The contents involved basic concepts,reporting and medication safety.The results were described by frequency and percentage.The influencing factors were analyzed usingχ~2 test and logistic regression model.Results:A total of 498 people were surveyed and 480 valid questionnaires were collected,with an effective response rate of 96.39%.56.45%of the marketing personnel were male,with an average age of 35.81 years.The majority of marketing personnel knew ADR(93.54%)and 75.63%knew that ADR reporting system was implemented in our country,but only 61.25%thought that drug manufacturing enterprises also need to report ADR,and 21.67%cannot accurately judge what kind of ADRs should be reported.According to the correct answers of 10 objective questions,the average score in marketing personnel was 5.75,which was at a low level.Univariate and multivariate analysis showed that educational level and professional title were related to cognitive level(P<0.05).The higher educational level or professional title the marketing personnel were,the better their cognitive levels were.Conclusion:The marketing personnel in a drug manufacturing enterprise have a poor understanding of ADR,and do not know the ADR reporting responsibility of the manufacturing enterprise and understand what kind of ADR should be reported.It is necessary to strengthen the training of ADR knowledge for marketing personnel with low educational level and low professional title to improve the ADR reporting rate in drug manufacturing enterprises.
作者
陈孟基
高明贤
陈家进
孙立娟
陶必林
唐少文
Chen Mengji;Gao Mingxian;Chen Jiajin;Sun Lijuan;Tao Bilin;Tang Shaowen(School of Public Health,Nanjing Medical University,Nanjing 211166,China;Nanjing Tongrentang Pharmaceutical Co.,Ltd.)
出处
《药物流行病学杂志》
CAS
2020年第4期237-241,共5页
Chinese Journal of Pharmacoepidemiology
基金
江苏高校品牌专业建设工程资助项目(编号:PPZY2015A067)。
关键词
药品生产企业
营销人员
药品不良反应
认知度
问卷调查
Drug manufacturing enterprise
Marketing personnel
Adverse drug reactions
Cognition status
Influencing factor
