Situation Comparison and Enlightenment of ADR Collection by Social Media between European and American Countries and China / 中国药房

ABSTRACT

OBJECTIVE：To c ompare the situation of adverse drug reaction （ADR） collection by social media between European and American countries and China ，so as to provide reference for the improvement of corresponding work in China. METHODS：By retrieving relevant literatures from CNKI ，Web of Science ，Elsevier ScienceDirect ，SpringerLink and so on ， referring to the official website of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH），the current situation of ADR collection by social media in European and American countries（organizations）such as the United States ，the European Union ，the United Kingdom ，France was introduced ，and compared with the corresponding work in China. The advantages and possible problems of using social media to collect ADR were analyzed so as to put forward some suggestions on how to use social media to collect ADR in China. RESULTS & CONCLUSIONS：Since 2013，many countries in Europe and the United States have started to collect ADRs using social media （such as Twitter ，Facebook），such as the draft on drug safety issues on social media issued by the Pharmaceutical Research and Manufacturers of America （PhRMA），and the EU organization ’s Innovative Medicines Initiative （IMI）network to identify adverse drug reaction in web media （WEB-RADR）projects. Through this way ，it is more convenient for patients to report ADR ，and helpful for the pharmacovigilance department to collect ADR information in time ，and can be used as an important supplement to the traditional drug safety information report. However ，there are some advantages ，such as mismatch between the health vocabulary spontaneously reported by patients and medical professional vocabulary ，the challenges of balancing the relationship between public health maintenance and patient privacy protection ，and various deviations affecting the reporting rate and quality of ADR collected by social media. When using social media （such as Wechat ，microblog，QQ and other social media or tools ，as well as applications and small programs ）to collect ADR information in China ，it is suggested to ensure the ease of use and security of reporting ADR applications ，and improve the design of applications to comply with E 2B （R3） data elements and information specifications of ICH guidelines for the electronic transmission of individu al security reports. At the same time ，we should give full play to the supervisory role of regulatory department ，consider non-regulatory factors ，and take privacy protection measures to make it conform to ethics.