Interpretation and insights from the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications”

doi:10.19803/j.1672-8629.20240349

Abstract

Abstract: Objective To guide the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications” (referred to as the “Guidelines”), providing a reference for standardizing pharmacovigilance activities and clinical practices related to topical traditional Chinese medicines (TCMs) in China. Methods Summarize the traditional formulations of topical TCMs mentioned in the “Guidelines”, and provide a detailed interpretation of the potential risks and control measures in the clinical application of topical TCMs. Results The Guidelines highlight the safety of medications containing mineral Chinese medicinal materials, toxic Chinese medicinal materials, and the use of TCMs in special populations such as pediatric, elderly, and pregnant patients. Comprehensive risk assessment and control measures are provided. Conclusion The irrational clinical application of topical TCMs increases the risk of medication-related adverse events. The guidelines offers valuable reference and guidance for better standardizing pharmacovigilance activities in the clinical application of topical TCMs.

Key words: external TCM preparations, adverse reactions, risk control, drug safety monitoring, interpretation

CLC Number:

R994.11

LU Zhenkai, YANG Dingquan, XIE Zhennian, WANG Lianxin, LI Yuanyuan, WANG Zhifei, CUI Xin, XIE Yanming. Interpretation and insights from the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications”[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1029-1033.

Add to citation manager EndNote|Ris|BibTeX

URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240349

https://zgywjj.magtechjournal.com/EN/Y2024/V21/I9/1029

References

[1] LIU SY.Three Interpretations of Shennong’s Herbal Classic(神农本草经三解)[M]. Beijing: China Traditional Chinese Medicine Publishing House, 2022.
[2] QIAO J, ZHAO Y.An explanation of external treatment methods of pediatric medicine in“Qianjin Yao Fang”[J]. Journal of Traditional Chinese Medical Literature(中医文献杂志), 2020, 38(4): 11-14.
[3] FANG FQ, HUANG GH.An overview of Qian Yi’s strategy of using “Toxins” in pediatrics as reflected in Xiao’er Yaozheng Zhijue[J]. Global Traditional Chinese Medicine(环球中医药), 2022, 15(10): 1850-1853.
[4] WANG P, SHEN J, SHI SJ, et al.History and development of external treatment methods in traditional Chinese medicine and modern research progress[J]. Journal of Nanjing University of Traditional Chinese Medicine(南京中医药大学学报), 2022, 38(11): 990-999.
[5] SHI L, LIU X, ZHANG B.Research on the toxic alert thought of medicinal herbs in Bencao Gangmu[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(6): 347-351.
[6] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People’s Republic of China(中华人民共和国药典)[M]. Beijing: China Medical Science Press, 2020
[7] LI LF, WEN H, GU H, et al.Evaluation standards for adverse skin reactions induced by topical traditional Chinese medicine preparations[C]. Changchun: Proceedings of the 19th Annual Conference of the CSTPCD-Forum on Standard-led Innovative Development of Traditional Chinese Medicine Academic Achievements, 2017.
[8] HUANG HS, FAN JW, NI SZ, et al.Research on heavy metal pollution-related issues in traditional Chinese medicine[J]. Microelements in Health and Diseases(微量元素与健康研究), 2022, 39(5): 34-36.
[9] CHANG XH, LI J.The relationship between traditional Chinese medicine and heavy metals[J]. Traditional Medicine(传统医药), 2011, 20(10): 79.
[10] LIU GY, BAI L, MIAO MS.Analysis of characteristics of 42 toxic traditional Chinese medicines for external use in the 2020 edition of Chinese Pharmacopoeia[J]. Chinese Pharmacology and Clinical Pharmacology(中国药理与临床), 2024, 40(04): 115-120.
[11] DU C, HUANG Y.Clinical analysis of 48 cases of contact dermatitis caused by Bai Guo[J]. Dermatology and Venereology(皮肤病与性病), 2015, 37(5): 301-302.
[12] YANG X, XIA D, TIAN C, et al.Literature analysis of adverse reactions to Fuzi in 508 cases[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(10): 615-621.
[13] LIU H, MEI W, GUAN M, et al.Research progress on photosensitizers in traditional Chinese medicine[J]. Chinese Community Physicians(中国社区医师), 2023, 39(1): 9-11.
[14] LIU C.Issues to be aware of and preventive measures in pediatric medication[J]. Primary Medical Forum(基层医学论坛), 2013, 17(19): 2571.
[15] DONG JX, WANG LP, LI JR, et al.Study on target organs of toxicity and safe medication range of Zhu Hong Gao[J]. Chinese Journal of Traditional Chinese Medicine(中华中医药杂志), 2011, 26(6): 1293-1295, 1449.
[16] ZHOU B, ZHU CJ, LYU JK, et al.Reflections on the development of new topical traditional Chinese medicines containing mercury[J]. Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2017, 33(18): 1847-1849, 1852.
[17] ZHANG KQ, LI X, MA X, et al.Death caused by arsenic poisoning due to external application of realgar: a case report[J]. Journal of Forensic Medicine(法医学杂志), 2017, 33(4): 435-436.
[18] SHANG H, MA GY, ZHU JB, et al.Clinical experience in the diagnosis and treatment of one case of acute severe arsine poisoning[J]. Occupational Health and Emergency Rescue(职业卫生与应急救援), 2017, 35(6): 590-592.
[19] WANG DS, ZHENG G, WANG T, et al.Lead exposure induces copper accumulation and oxidative stress in neurons of mice[J]. Journal of Neuroanatomy(神经解剖学杂志), 2022, 38(4): 367-373.
[20] GE W, XIE CY, YE MQ, et al.Safety considerations of toxic mineral drugs[J]. Journal of Jiangxi University of Traditional Chinese Medicine(江西中医药大学学报), 2020, 32(6): 1-5.
[21] YANG X, XIA D, TIAN C, et al.Literature analysis of adverse reactions to Fuzi in 508 cases[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(10): 615-621.
[22] Health Canada warns of serious adverse events risk of diphenhydramine in children and adolescents[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(7): 812.
[23] ZHENG YL, MEI QX, DAI WB, et al.Overview of research on contraindications of traditional Chinese medicine in pregnancy[J]. China Pharmacy(中国药房), 2018, 29(03): 421-424.
[24] ZHANG Y, ZHANG XH, WANG LL, et al.Research progress on the treatment of primary dysmenorrhea with angelica sinensis and its active components[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine(现代中西医结合杂志), 2023, 32(23): 3339-3344.
[25] ZHANG MT, WANG JX, LIANG XD, et al.Research progress on the chemical constituents and pharmacological effects of hyoscyamus niger[J]. Chinese Traditional Patent Medicine(中成药), 2024, 46(07): 2321-2326.
[26] WU Z, WU SG.Survey and analysis of safety-related projects for topical traditional Chinese medicines[J]. Journal of Traditional Chinese Medicine and Pharmacy Management(中医药管理杂志), 2022, 30(16): 109-111.