Adverse drug reaction reports of traditional chinese materia medica injection in National Essential Medicines List (2002 edition) by systematic analysis

Objective Find out and analyse the adverse drug reaction reports of Traditional Chinese Materia Medica(TCMM) Injection in List of National Essential Drugs by Systematic Review. Method The papers were searched and collected from the CBMdisc(1981～Dec.2002) and TCMLRS(1981～Dec.2002) using the names of 72 TCMMS as the. Data were extracted and evaluat-ed by two reviewers indepen-dently with a designed extraction form. Results No published papers of 5 kinds of TCMM in 72 TCMMs in List of National Essential Drugs were searched. Among 4156 cases of ADRs/AEs reported in 34 TCMMs, 4146 cases(99.76%) were from TCMM injection, only 7 cases and 3 cases were from solution and capsule respectively. Conclusion The great majority of ADRs/AEs cases occurs in TCMM injection, but few of ADRs/AEs cases occurs in other dosage forms(such as solution, granule, capsule, tablet, etc.). There are shortage in the reporting of ADRs/AEs cases aboved, such as without regard to the GCP guide-line and government regulations, lack of standardization of ADR reports, absence of causality assessment, without conducting the prospective study on ADR, and no incidence of ADRs/AEs. Great efforts should be made to strengthen the safety surveillance of TCMM injection in the postmarketing reevaluation of TCMM.