关键词: 药品不良反应, 药品说明书, 数据标准化, 不良反应信息数据库, 监测与评价

Abstract: Objective Construct the database of the adverse drug reaction information and explore the methods and significance which strengthen the efficiency and levels of the adverse drug reaction monitoring and promote it more legislative, more scientific and more transparent. Methods The researched objects are 26,000 pieces of package insert which were approved by SFDA. We dealed with the adverse drug reaction of the package insert in order that the information was more standardized and more structured. Results & Conclusion We obtained the criteria and procedures about constructing the database of the adverse drug reaction information and construct our database on the basis of them. That Database will actively promote and propel drug monitoring and evaluation or work quality and efficiency.

Key words: adverse drug reaction(ADR), package insert, data standardization, database of adverse drug reaction information, monitoring and evaluation