Analysis of 313 Instructions for Injectable Drugs

doi:10.19803/j.1672-8629.2021.07.15

Abstract

Abstract: Objective To investigate the labeled information in the instructions of injectable drugs and provide reference for the improvement of instructions. Methods A total of 313 instructions for injectable drugs used in the First Affiliated Hospital of Xinxiang Medical University from January 2018 to November 2019 were collected before the items and contents in the instructions were statistically analyzed. The labeling rates were compared between imported drugs and home-made ones, and the difference in the specifications of the same type of injectable drug by different manufacturers was also studied. Results The labeling rate of drug interactions, drug overdose and toxicology in the instructions of imported drugs was higher than that of domestic drugs, with statistically significant differences (P<0.05). The difference rate in the specifications of the same type of drug produced by different enterprises was 42.86% (9/21). Conclusion The labeling rate of instructions of imported drugs is higher than that of home-made drugs. There are differences in the specifications of the same type of injectable drug produced by different enterprises.

Key words: injection, instructions of drugs, integrity, difference, rational use of drugs

CLC Number:

ZHANG Yongheng, HAN Chen, YANG Xiao, HAN Xiuqi, YUAN Hongchang, DENG Zhijian. Analysis of 313 Instructions for Injectable Drugs[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 669-673.

References

[1] Shah TJ, Moshirfar M."Doctor, I have a sulfa allergy": clarifying the myths of cross-reactivity[J]. Ophthalmology and Therapy, 2018, 7(2): 211-215.
[2] Mcconeghy KW, Caffrey AR, Morrill HJ, et al.Are non-allergic drug reactions commonly documented as medication“allergies”? a national cohort of veterans' admissions from 2000 to 2014[J]. Pharmacoepidemiology and Drug Safety, 2017, 26(4): 472-476.
[3] He XJ, Ji Y, Li XB, et al.Safety information for pregnant women in drug instructions and drug information databases[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床), 2018, 21(9): 1077-1080.
[4] Wang XY, Su WW, Ding H, et al.Problems of clinical use in pediatric drug and countermeasures analysis in China[J]. Chinese Pharmacy(中国药房), 2019, 30(2): 149-153.
[5] Wang RQ, Huo YF, Xie YJ, et al.Retrospective analysis of 530 cases of new/severe pediatric adr in shandong province during 2016~2017[J]. Chinese Pharmacy(中国药房), 2019, 30(1): 115-119.
[6] Su XD, Fang S, Fu XD.Practice and enlightenment of patient medication guide in foreign Countries such as Europe and America[J]. Herald of Medicine(医药导报), 2018, 37(2): 265-267.
[7] Fu SY, Yang Y, Yu JR.Comparison of laws and regulations of drug instructions management between China and the United States of America[J]. Herald of Medicine(医药导报), 2018, 37(10): 1291-1294.
[8] Wu TT.Retrospective analysis of adverse drug reaction of shuxuening injection in Xi'an from 2013 to 2017[J]. Herald of Medicine(医药导报), 2019, 38(1): 49-53.
[9] State Food and Drug Administration of the People's Republic of China. Provisions on the administration of drug instructions and labels [EB/OL].(2006-03-16)[2019-11-20]. http://www.gov.cn/ziliao/flfg/2006-03/16/ content_228465.htm.
[10] State Food and Drug Administration of the People's Republic of China. Notice concerning the issuance of specifications and rules for the specifications of chemical drugs and biological products(National Food and Drug Administration notes[2006]202号)[EB/OL].(2006-05-10)[2019-11-20].http://www.nmpa.gov.cn/ WS04/CL2196/323547.html.
[11] Zhang H, Gu YX.Literature review of 141 cases of adverse drug reactions induced by simvastatin[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(8): 487-491.
[12] Zhang SZ, Huang WJ.Clinical efficacy and adverse reaction of torasemide combined with bisoprolol in the treatment of patients with essential hypertension complicated with systolic heart failure[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(8): 467-472.
[13] Wei J, Cai J, Li M, et al.Statistical analysis of sulfonamide allergy item annotation in drug instructions of commonly-used sulfonylureas at home and abroad[J]. Chinese Pharmacy(中国药房), 2019, 30(4): 538-541.
[14] Xu J, Zheng XX, Liu HF, et al.A survey on attention about drug labels among outpatients[J]. Chinese Remedies & Clinics(中国药物与临床), 2019, 19(4): 543-545.
[15] Herber OR, Gies V, Schwappach D, et al.Patient information leaflets: informing or frightening? a focus group study exploring patients’emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices[J]. BMC Family Practice, 2014, 15(1): 1-8.
[16] Sato T.What is a medication guide suits patients' needs?[J]. Journal of the Pharmaceutical Society of Japan, 2015, 135(2): 297-306.
[17] Benjamin B, Thomas V, Carole L, et al.Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen: a comparative cohort study[J]. International Clinical Psychopharmacology, 2015, 30(1): 49-53.
[18] Rolland B, Deheul S, Danel T, et al.Temporary recommendation for use on off-label baclofen: viewpoint of prescribers of the CAMTEA System[J]. Therapies, 2015, 70(2): 235-238.