2010Traditional Chinese Drug Research and Clinical PharmacologyRequires access

Key Point and Methods of Designing Spontaneous Adverse Drug Reaction Reporting System Form of Chinese Medicine

Yan‐Ming Xie

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Abstract

Adverse Drug Reaction(ADR)form has been used as an important tool to report the reaction of post-market pharmacovigilance and security monitoring.The current ADR form can not satisfactorily meet the needs of the ADR report after Chinese Medicine going on the market.Based on the foreign management of herbal medicine and on the conformations of foreign ADR forms,we defined the reasons and the characteristics of ADR of Chinese medicine,and then designed the spontaneous ADR reporting system form of Chinese Medicine.Finally we verified the feasibility of the scientific highlights of the spontaneous ADR reporting system form of Chinese Medicine.The construction of the spontaneous ADR reporting system form of Chinese Medicine will have great significance to the post-marketing Chinese medicine pharmacovigilance and security monitoring.

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What this paper is about

Adverse Drug Reaction(ADR)form has been used as an important tool to report the reaction of post-market pharmacovigilance and security monitoring.The current ADR form can not satisfactorily meet the needs of the ADR report after Chinese Medicine going on the market.Based on the foreign management of herbal medicine and on the conformations of foreign ADR forms,we defined the reasons and the characteristics of ADR of Chinese medicine,and then designed the spontaneous ADR reporting system form of Chinese Medicine.Finally we verified the feasibility of the scientific highlights of the spontaneous ADR reporting system form of Chinese Medicine.The construction of the spontaneous ADR reporting system form of Chinese Medicine will have great significance to the post-marketing Chinese medicine pharmacovigilance and security monitoring.

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Available abstract

Adverse Drug Reaction(ADR)form has been used as an important tool to report the reaction of post-market pharmacovigilance and security monitoring.The current ADR form can not satisfactorily meet the needs of the ADR report after Chinese Medicine going on the market.Based on the foreign management of herbal medicine and on the conformations of foreign ADR forms,we defined the reasons and the characteristics of ADR of Chinese medicine,and then designed the spontaneous ADR reporting system form of Chinese Medicine.Finally we verified the feasibility of the scientific highlights of the spontaneous ADR reporting system form of Chinese Medicine.The construction of the spontaneous ADR reporting system form of Chinese Medicine will have great significance to the post-marketing Chinese medicine pharmacovigilance and security monitoring.

Key concepts: Pharmacovigilance, Traditional Chinese medicine, Adverse drug reaction, Medicine, Drug reaction, Alternative medicine, Pharmacology, Drug

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