CAJ | 학술논문

药品未注册用法是世界医药学界都十分关注的重要议题。通过对药品说明书意义与药品未注册用法含义的阐述，介绍了国外对药品未注册用法的政策与规定，指出我国应规范和解决药品未注册用法问题，加强药品的物流管理，药品由药学部门统一管理，药师应认真审核医师处方或用药医嘱的适宜性。同时，提出了几点意见，即药品生产企业要积极参与药品未注册用法的管理、政府有关部门应调整政策，规范药品未注册用法、建议制定公布《药品未注册用法管理办法》、医疗机构应制定药品未注册用法的规章制度。
약품미주책용법시세계의약학계도십분관주적중요의제。통과대약품설명서의의여약품미주책용법함의적천술，개소료국외대약품미주책용법적정책여규정，지출아국응규범화해결약품미주책용법문제，가강약품적물류관리，약품유약학부문통일관리，약사응인진심핵의사처방혹용약의촉적괄의성。동시，제출료궤점의견，즉약품생산기업요적겁삼여약품미주책용법적관리、정부유관부문응조정정책，규범약품미주책용법、건의제정공포《약품미주책용법관리판법》、의료궤구응제정약품미주책용법적규장제도。
Drug off label use is an important theme over the world. Based on the discussion of the conception of drug package insert and off label use, the policy and regulation on drug off label use in foreign counties are introduced. It shows that drug off label use should be regulated, drug logistics management should be strengthened and drug should be integrated managed by pharmacy department. Clinical pharmacists should check prescription and assess its suitability. Suggestions such as drug manufacturers need to actively participate in off label use regulation, government needs to standardize off label use regulation and make Drug Off Label Use Management Regulation and medical institutes need to obey the regulations.