Study Of The Management Mechanism Of Drugs With Dual Legal Status

In a broad sense,drugs with dual legal status are a kind of drug that has both prescription and over-the-counter status.Due to the special status of the drugs,the drugs’ risks of abuse and misuse are higher,and the industry has disputes over the necessity and rationality of drugs with dual legal status.In 2010,NMPA(National Medical Products Administration)posted a notice on the prescription drugs switch to non-prescription drugs,which stated that NMPA will further study the management mode of drugs with dual legal status,and carry out the related work of drugs with dual legal status conversion after the management mode is clear.So far,drugs with dual legal status conversion is still in suspension.The problem of management of drugs with dual legal status in China has become an urgent problem to be solved in the field of drug regulation.There is no report of management mechanism of drugs with dual legal status in China through researching.First of all,this paper sorts out the situation of drugs with dual legal status in America,Europe,Japan and Chinese Taiwan.At the same time,this project systematically investigated the management measures of drugs with dual legal status in the United States,Europe,Japan and Chinese Taiwan.Then we systematically studies the marketing routes,management measures and terminal control means for drugs with dual legal status in the United States,Europe,Japan,and Chinese Taiwan,and based on the concept of drug Life-cycle management,the key elements of Life-cycle risk management to avoid the confusion of drugs with dual legal status were extracted,including the drugs approval number/application number,the drugs trade name,instructions and package labels,advertising management,surveillance of adverse reactions,consumer education and licensed pharmacist training.Then,through expert interviews and consumer interviews,we can get a preliminary understanding of the current status of our country’s management and major problems in supervision of drugs with dual legal status,as well as a preliminary understanding of the public’s understanding of drugs with dual legal status.Next,based on the interviews,a survey questionnaire was designed.The questionnaire survey method was used to investigate the problems existing in China’s management of drugs with dual legal status,and we used statistical methods to analyze the data that collected based on questionnaire survey.Finally,combined with the management experience of drugs with dual legal status in the United States,Europe,Japan,or Chinese Taiwan and investigation results,the problems of management of drugs with dual legal status were sorted out,and suggestions for improving our management mechanism of drugs with dual legal status were put forward.The research result show that drugs with dual legal status is an inevitable product of the classification management of medicines and has its rationality.In order to meet the public’s drug demand,it is suggested that the regulatory authorities should start the transformation work as soon as possible after further improving drugs with dual legal status regulatory measures.At the same time,in order to avoid confusion and reduce the risk of abuse and misuse,for drugs with dual legal status,they should adopt their respective management mechanisms and measures according to the classification of drugs,and improve the management measures of approval number/application number,trade name,instructions and package labels,and advertising,etc.