Investigation and Analysis of Medication Information Labeling in 157 Package Inserts of Anticancer Drugs
- VernacularTitle:157份抗肿瘤药物说明书用药信息标注情况的调查分析
- Author:
Jing MA
1
;
Yan WANG
1
;
Bo LU
2
;
Shouxiang TANG
1
;
Lihua YUAN
3
;
Xuemin ZHOU
4
Author Information
1. Dept. of Pharmacy，Dachang Hospital of Nanjing/Jiangbei District of the Affiliated Zhongda Hospital of Southeast University，Nanjing 210044，China
2. Dept. of Radiology and Functional Examination，Nanjing Prevention and Treatment Center for Occupational Diseases，Nanjing 210042，China
3. Dept. of Pharmacy，Nanjing Children’s Hospital，Nanjing 210000，China
4. School of Pharmacy，Nanjing Medical University，Nanjing 211166，China
- Publication Type:Journal Article
- Keywords:
Anticancer drug;
Package inserts;
Medication information;
Label;
Investigation and analysis
- From:
China Pharmacy
2019;30(7):985-990
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To investigate and analyze medication information labeling in package inserts of anticancer drugs， and to provide reference for clinical rational use. METHODS： The package inserts of anticancer drugs were collected from drug catalogues of 3 Third Grade Class A hospitals in Nanjin. Common problems of drug package inserts （whether the main contents arweree contradictory or not and whether the contents were fully expressed， etc.）， complete specific labeling items （detailed contents of “ADR” “contraindication” “precautions” and other items）， detailed intravenous injection dispensing guidance （solvent selection， precautions during dispensing， etc.）， package insert labeling difference of drugs with same general name and route of administration were evaluated according to Drug Package Inserts and Label Management Regulation，Regulations for Chemical Drugs and Biological Products for Treatment. RESULTS： A total of 157 package inserts for anticancer drugs were collected and divided into domestic drugs （80 pieces） and imported drugs （77 pieces） according to the source as well as also divided into oral preparation （44 pieces） and injection （113 pieces）. The common problems of package inserts for anticancer drugs contained contradictory main contents， incomplete description， Chinese character errors， missing items and simple description of drug interactions， etc. Compared with domestic or oral anticancer drugs， the labeling rate of each item in the import or injection anticancer drug package inserts was higher， but specific labeling items such as prevention and treatment of vomiting （＜20％） under “precautions” and interference of drugs on clinical tests （＜40％） were lower. The labeling rate of serious ADR after large dose or long-term use was all less than 41％ under the item of “drug overdose” （except for imported drugs）. The labeling rate of intravenous dispensing guidance of imported anticancer drug injection package inserts about preparations was higher than that of domestic ones. There were differences in labeling items as “precautions” （30/56，53.57％）， “pharmacological toxicology” （29/56，51.79％）， “contraindication” （26/56，46.43％） among 56 groups of drug package inserts with same general name and route of administration. CONCLUSIONS： The labeling items for drug package inserts of anticancer drugs need to be further standardized and improved. It is recommended that the relevant departments force pharmaceutical manufacturers to regularly supplement the deficiencies in the package inserts to improve the safety of drug use in clinic.
