王渊琦 彭陈万里 曹萌

    摘 要 根据法规要求，使用计算机管理并进行电子记录已基本覆盖药品经营企业的业务各主要环节。电子记录的普及，提高了药品流通的规范性，加强了用药安全保障，也在新冠疫情的应急防控方面发挥了重要作用。虽然电子记录在药品流通领域的应用已较为成熟，但在系统验证、数据安全、技术革新等方面仍有待完善。本文综述了药品经营电子记录的应用、进展与挑战以及对监管工作的影响，讨论了新时代对药品流通和监管的数字化要求，分析了流通与生产环节可相互借鉴的方向，并展望了数字QA等质量理念在药品流通领域的应用前景。

    关键词 药品经营 电子记录 数字化 智慧监管 进展与挑战 数字QA

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2021)17-0056-04

    Progress of the application of electronic records in drug distribution

    WANG Yuanqi1， PENG Chenwanli2， CAO Meng1

    (1. Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China； 2. Shanghai University of Engineering Science， Shanghai 201620， China)

    ABSTRACT The use of computer management and electronic records has basically covered all major links of the business of drug distribution companies according to the requirements of regulations. The standardization of the management of drug distribution has been greatly improved since the popularization of electronic records， which has enhanced the safety of drug use and played an important role in the emergency supplies for major public health incidents such as COVID-19. Although electronic records have been widely used in drug distribution ......