The Probe into the Necessity of the Safety Monitoring of Over-the-Counter Drug in China

Abstract

Abstract: Objective To probe into the necessity of the safety monitoring of OTC drug in China. Methods From the point of view of the combination of drug classification management system and adverse reaction monitoring status, discuss the main problems with the use and adverse reaction monitoring of OTC drug. Results and Conclusion It is urgent to establish a mode of drug safety monitoring which is suitable for OTC drug's characteristics and use on Chinese drug classification management system, which could lay the foundation for the further research on OTC drug safety supervision in the future.

Key words: OTC, safety, monitoring, necessity, probe into

CLC Number:

R951

XIA Dong-sheng ,TIAN Chun-hua ,WANG Ao, SONG Qiu-jie, LI Lan, DU Xiao-xi. The Probe into the Necessity of the Safety Monitoring of Over-the-Counter Drug in China [J]. Chinese Journal of Pharmacovigilance, 2013, 10(2): 80-83.

References

[1] 国家食品药品监督管理局.关于印发《实施处方药与非处方药分类管理 2004-2005年工作规划》的通知（国食药监安[2004] 262号）[EB/OL].[2012-10-06](2004-06-10).http://www.sda.gov.cn/WS01/CL0844/10172.html.
[2] 陈易新,李少丽,曹立亚,等.西方发达国家药品不良反应监测体系现状[J].药物流行病学杂志,2004,13（3）：113-116.
[3] 潘晓,马爱霞.中外药品不良反应监测体系的比较分析[J].药学进展,2005,29（4）：183.
[4] 国家食品药品监督管理局药品安全监管司,国家药品不良反应监测中心《.国家药品不良反应监测年度报告》（2011年）[R]. 2012.4.
[5] 杜晓曦《.药品不良反应报告和监测管理办法》培训教材[M].北京：中国医药科技出版社,2012.4.
[6]国家食品药品监督管理局.全国药品流通行业发展规划纲要（2011－2015年）[EB/OL].[2012-10-06](2012-03-10). http://www.sfda.gov.cn/WS01/CL0900/69670.html.
[7] 卫生部统计信息中心.2010年全国医疗服务情况[EB/OL]. [201210-06](2011-03-04).http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohwsbwstjxxzx/s7967/201103/50847.htm.
[8] 国家药品不良反应监测中心.药品不良反应知识100问[EB/OL].[2012-10-06] (2011-06). http://www.cdr.gov.cn.
[9] 夏东胜.非处方药合理使用与不良反应规避策略探讨[J].中国药物警戒,2010,7（6）343.
[10]吴晓松,王欢,徐珍霞,等.自我药疗与风险防范[J].中国药房,2003,14（5）：315.
[11] NortierJ L,MartinezM C,SchmeiserH H,et al.Urothelial carcinoma associated with the use of Chinese herb(Aristolochia fangchi)[J].N Engl J Med,2000,342:1686.
[12]国家食品药品监督管理局.关于加强广防己等 6种药材及其制剂监督管理的通知（国食药监注[2004]379号）[EB/OL].[2012-1006](2004-08-05)http://www.sda.gov.cn/WS01/ CL0844/10242.html.
[13] Substance Abuse and Mental Health Services Administration.Misuse of Over-the-Counter Cough and Cold Medications among Persons Aged 12 to 25[EB/OL].[2008-01-10](2010-01-22). http://oas.samhsa.gov/2k8/cough/cough.pdf.
[14]夏东胜,程刚.非处方药的风险与管理探讨[J].中国药物警戒,2008,5（1）:15-17.
[15]牛淑乔,俞海亮,米光明.我国城乡居民自我药疗行为及影响因素的文献研究[J].中国药房,2012,23(29):2782-2784.
[16]孙新,颜敏,王兰明,等.药品上市后安全性监测的现状与展望[J].中国新药杂志,2001,10（6）：401.