Analysis of Medication Information Labeling for Pregnant and Lactating Women in the Instructions of Traditional Immunosuppressants
Objective To analyze the labeling of medication information for pregnant and lactating women in the instructions of traditional immunosuppressants.Methods The information of immunosuppressant instructions were collected from the medlive.cn and checked by the db.Yaozhi.com,medicine helper App and paper-based drug instructions in October 31,2022.The medication labeling information for pregnant and lactating women in the instructions of traditional immunosuppressants was extracted and summarized based on the Specification Rules on Instructions of Chemical Drugs and Biological Products for Therapeutic Use.Results A total of 123 drug instructions were collected.There were 100 and 96 drug instructions(81.30%and 78.05%)were labeled with medication information for pregnant and lactating women respectively,of which 95 and 93 drug instructions(77.24%,75.61%)contained medication guidance respectively.A total of 26 drug instructions had different medication information for pregnant women due to different dosage forms and manufacturers,involving fluorouracil,ciclosporin,hydroxycarbamide and tacrolimus,while their medication information for lactating women was consistent,that was lactation or medication was not allowed.Conclusion There are some problems in the labeling of medication information for pregnant and lactating women in the instructions of some traditional immunosuppressants in China such as missing information,unclear guidance,inconsistent labeling in some drug instructions and delayed medication labeling for lactating women.Drug regulatory departments and marketing authorization holders should pay attention to these problems,and strengthen continuously the management and standardization of drug instructions.
pregnancylactationtraditional immunosuppressantdrug instructionmedication information
万方数据
维普
