| ABSTRACT Objective: To investigate the status of the leaflets of domestic Chinese patent drugs, and put forward our views and suggestions to improve them. Methods:1 618 leaflets of domestic Chinese patent drugs were collected by fieldwork and literature retrieving. According to the relevant regulation of drug leaflets, all information of 25 items of prescription drugs and 18 items of over the counter drugs (OTC) were extracted and analyzed by bibliometric and classification statistics. Results:1 618 leaflets were included, 1 000 of which were from prescription drugs, which the other were OTC. No matter the prescription or OTC drugs, the information for describing drugs and guiding patient medication was relatively complete, which labeling rate was 100%, such as name, composition, function, usage, while the information for clinical trials, pharma toxicology, pharmacokinetic and drug interactions was deficit. The safety related information, such as warmings, adverse drug reactions, contraindications and others, has deficiencies and incomplete statements, which may lead to medication risks. Conclusion: The leaflets of domestic Chinese patent drugs were rather important to ratimal drug use in clinic, its revision and improvement was urgent, which could be proceeded from many aspects. |
