Research On The Safety Monitoring And Risk Management Of Danshen Injection After Marketing

Objective:To assess relevant factors of ADR/ADE of Traditional Chinese Medicine Injections(TCMI)Injections,this paper selected the safety monitoring of Danshen injection as an example through metrological evaluation and retrospective analysis of Danshen injection.The paper summarized the features of ADR/ADE induced by Danshen injection,fond out the risk in clinical application.The paper also put forward suggestions for the National Drug Adverse Reaction Monitoring System and future risk management work,and provids reference and reference for the current drug regulatory work.Methods:(1)Literature analysis:51 ADR/ADE reports of Danshen collected from China Knowledge Network and Wanfang database from 1977 to 2017 for metrological analysis;(2)The retrospective analysis on ADR reports reported by Jiangsu area in Jiangsu area from 2006 to 2016 in National Drug Adverse Reaction Monitoring System was carried out to provide reasonable suggestions on report quality and regulatory work;(3)The paper analyzed the basic procedures of risk management in the production process of Danshen injection,and put forward suggestions on establishing medicine risk management mechanism.Results:(1)434 cases were collected in 51 papers involved 43 kinds of journals;the incidence of male ADR was significantly higher than that of females,and ADR had higher incidence rate on people over 59 years old;the main original disease was coronary heart disease(21.51%),hypertension(19.89%),cerebral infarction(10.22%).Patients with allergic history or allergic constitution are more likely to affect the occurrence of ADR.The ADR involved multiple systems and organs,most of which were seen in skin and its accessories,multiple in 30min.The inappropriate administration route,excessive dose administration,rapid drop speed,improper solvent selection,improper combination of drugs,long duration of continuous administration may affect the occurrence of ADR.(2)1583 ADR cases of Danshen injection in Jiangsu Province from 2006 to 2016 involved 44 production enterprises.The main report object was level I medical institution,accounting for 44.54%;ADR mainly occurred in people over 50 years old,accounting for 68.35%;the original disease was mainly coronary heart disease(17.73%),cerebral infarction(16.62%),hypertension(15.38%),people with previous ADR history may be prone to ADR;ADR/ADE involved multiple organism system was mainly caused by damage to the skin and its attachments,systemic damage and immune dysfunction,accounting for 24.69%,21.01%and 12.98%,respectively.(3)Through the FMEA method,the risk factor of the production process was analyzed,and risk point will be continuous improved.Conclusion:(1)The clinical application aspect:ADR induced by Danshen injection can involve multiple organ systems,the clinical manifestation is complex and diverse,and it is mainly rapid type allergic reaction;the clinical application needs to be treated based on TCM theory and syndrome,and it is strictly forbidden to use drugs irrationally.The patients with high sensitivity needs to be closely observed during the skin test and clinical use,pay attention to the interval of drug delivery,drug delivery rate;clinical pharmacists should participate in clinical examinations to guide physician medication;(2)Monitoring system:add online quality assessment system and perfect the various modules of the National Adverse Drug Reaction Monitoring System to improve the value of data utilization;(3)Supervision:regulatory authorities should promote the consistency evaluation and re-evaluation of TCMI actively,establish laws and regulations of risk management,improve the state social drug safety compensation and relief mechanism to protect the rights and interests of victims.