Construction of prescription review standard of Chinese patent medicine
10.3760/cma.j.cn114015-20240830-00021
- VernacularTitle:中成药处方审核标准的构建
- Author:
Juan LI
1
;
Guohan YANG
;
Hong ZHANG
;
Huanhuan ZHOU
;
Min HOU
;
Chengying XU
;
Xiaofeng LUO
;
Haiyan XING
Author Information
1. 中国人民解放军陆军特色医学中心药剂科，重庆 400042
- Publication Type:Journal Article
- Keywords:
Drugs, Chinese herbal;
Formularies;
Review standard;
Pharmacy administration;
Safety;
Chinese patent medicine
- From:
Adverse Drug Reactions Journal
2025;27(9):559-567
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To formulate the audit standards of Chinese patent medicine prescriptions, and provide reference for rational prescriptions of Chinese patent medicine.Methods:A three-level evidence system for prescription review of Chinese patent medicine was established according to the national regulatory documents, drug labels, relevant guidelines, and expert consensuses. The catalog of Chinese patent medicines in Army Medical Center of the People′s Liberation Army was integrated and classified, preliminary review criteria including indications, drug selection, usage and dosage, and combination drugs was established and submitted to clinical experts of traditional Chinese medicine for review and revision, and finally the prescription review standard was confirmed.Results:The Chinese patent medicine catalog of the Medical Center contained 218 drugs, which were divided into 23 kinds according to efficacy and 17 kinds according to dosage forms. The prescription review standards of Chinese patent medicine were as follows. (1) Indications: both traditional Chinese medicine and Western medicine diagnosis were required. (2) Drug selection: 37 kinds of Chinese patent medicines were marked as forbidden for pregnant women in the labels, and 16 kinds were not marked but contained forbidden ingredients; 4 kinds were marked with caution for patients with liver dysfunction, and 24 kinds were not marked but contained ingredients with caution; 2 kinds of Chinese patent medicines were marked with caution for patients with renal insufficiency, and 9 kinds were not marked but contained ingredients with caution. (3) Usage and dosage: the usage and dosage rules of Chinese patent medicines for children, the elderly and patients with liver and kidney dysfunction were formulated. (4) Combined medication: 5 and 21 kinds of Chinese patent medicines were marked as "highly toxic" and "toxic" in the labels, respectively, 11 kinds of Chinese patent medicines contained incompatible ingredients of "Shibafan" (eighteen antagonisms) and "Shijiuwei (nineteen incompatibilities), and a new review scale for repeated use of Chinese patent medicine was developed.Conclusions:Based on the existing evidence-based medicine, the evidence system of prescription review of Chinese patent medicine is established, the prescription review standards of Chinese patent medicine prescription based on the pharmaceutical interaction mode is formulated and constructed.
