| ABSTRACT Objective:Investigating the statement status of “adverse drug reactions” in the leaflets of Chinese patent drugs, and putting forward our views and recommendations to improve them.Methods:First, 1 618 varieties of Chinese patent drugs leaflets were obtained through field collection and literature search. Making statistics and comparative analysis on the setting rate and content of “adverse drug reactions”. Then aiming at the species containing chemical or toxic ingredients, comparing the differences between leaflets of the same species from different manufacturers. Results: All of 1 618 leaflets set the “adverse drug reactions” item. There were 19.2% of all varieties with the content, 0.6% said no adverse drug reactions accounted, and the other was “unclear”. The annotation content of “adverse drug reactions” mainly consisted of clinical features, proportion, frequency or probability of occurrence, rescue and prevention methods, special populations and combination warning information, and the high risk component. A total of 3 562 leaflets that with the same species from different manufacturers were collected. There exist 25.6% and 20.5% variances, respectively.Conclusion:Contents of “adverse drug reactions” in some leaflets didn’t update in time and have standardized writing. To improve “adverse drug reactions” items, our study puts forward some views and suggestions from three aspects including data source, data transformation path and writing model. |
