ABSTRACT
To enhance the scientific and fair evaluation about proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs, and to ensure those medicines to be used safely by the public in their self-medication. Combined with current research status of toxic herbs, the experience and knowledge accumulated in the practical work of selection and switch of OTC Chinese medicines for years, thinking about the feasible standards about evaluation and management of proprietary Chinese medicines containing toxic herbs at this stage. Initially established ideas and methods about evaluation of proprietary Chinese medicines containing toxic herbs during the switch process of non-prescription drugs. Basically solved the main problem currently faced by toxic herbs during the OTC switch process of proprietary Chinese medicines, effectively promoted the work on OTC switch, and had the important significance in making consumers use non-prescription drugs conveniently and safely.
Subject(s)
Humans , Medicine, Chinese Traditional , Methods , Nonprescription Drugs , Classification , Plants, Toxic , Classification , Quality Control , ResearchABSTRACT
In this retrospective study, 56 cases of adverse reactions caused by Niuhuang Jiedu tablet (pill) were statistically analyzed in respects of genders, ages, routes of administration, clinical manifestations, etc. We pinpointed that the main factors related to safety problems of Niuhuang Jiedu tablet (pill) are irrational drug use and drug quality, and put forward suggestions for strengthening the surveillance and administration of Niuhuang Jiedu tablet (pill) and improving clinical rational use.
Subject(s)
Adolescent , Adult , Child , Child, Preschool , Female , Humans , Infant , Male , Middle Aged , Young Adult , Age Factors , Drug Therapy , Reference Standards , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal , Retrospective Studies , Risk Factors , Sex Factors , TabletsABSTRACT
OBJECTIVE:To improve the efficiency and quality of adverse drug reaction(ADR)monitoring in China.METHODS:The current situation,existing difficulties,as well as problems yet to be solved in the construction of informa-tionalized reporting system of ADR in our country were discussed.RESULTS&CONCLUSION:The management software at national,provincial and individual levels should be developed.Also,The data collection should be improved for variety,quickness,and timeliness as well as modularization and expansion.