| ABSTRACT Objective:To investigate the status of the leaflets of imported Chinese patent drugs, and put forward suggestions to improve them. Methods:The origin and domestic leaflets of 40 imported Chinese patent drugs were collected， which were listed on the official website of China Food and Drug Administration. By using the comparison and bibliometric methods, the differences of drug property and leaflet describing between origin and domestic, and that between domestic leaflets and relevant regulations, were explored.Results:64 leaflets of imported Chinese patent drugs were collected, including 24 origin ones and 40 domestic ones. In the terms of drug property, 3 of 40 imported Chinese patent drugs were products for health care in the origin, while others were for treatment. Comparing the origin and domestic leaflets, the statements in the items of indication, dosage, contraindication and precaution were presented inconsistencies. And the analysis of 40 domestic leaflets demonstrated that the descriptions of warning, adverse drug reaction, contraindication and precaution were missing or inappropriate.Conclusion:The leaflets of imported Chinese patent drugs needed to be revised and improved, which could ensure rational drug use. |
