5 032 例东莞市国家集中带量采购药品的药品 不良反应报告分析.

张 莉; 罗 伟; 刘 仔; 陈桂香; 李凤仪

OBJECTIVE: To investigate the characteristics and rules of adverse drug reactions (ADR) of drugs in national centralized volume-based procurement in Dongguan, so as to provide reference for clinical rational drug use. And to identify the high-risk drug categories with the highest number of severe ADR cases, so as to initially screen out the primary suspected drugs for the signal mining. METHODS: Through the spontaneous reporting system of the National Adverse Drug Reaction Monitoring Platform, 5 032 reports of ADR of drugs in national centralized volume-based procurement in Dongguan from 2020 to 2023 were collected for statistics, analysis and evaluation. RESULTS: Among the 5 032 reports of ADR of drugs in national centralized volume-based procurement, there were more females than males, with a gender ratio (males: females) of 0. 93: 1. The proportion of patients aged from >15 to 45 years was the highest (41. 34%, 2 080 cases). Totally 45. 81% (2 305 cases) of patients had a history of ADR, and 58. 03% (2 920 cases) had unknown family history of ADR. The main route of administration was oral administration (2 982 cases, 59. 26%), followed by injection (1 888 cases, 37. 52%). ADR occurred mainly within 1 h (1 475 cases, 29. 31%), >1 to 3 d (1 077 cases, 21. 40%) and >12 to 24 h (921 cases, 18. 30%) after administration. The types of drugs involved in ADR were mainly chemical drugs (4 973 cases, 98. 83%). The top 2 drug categories ranked by the number of ADR reports were anti-infective drugs (2 438 cases, 48. 45%) and cardiovascular system drugs (599 cases, 11. 90%). The top 2 drug categories ranked by the number of severe ADR reports were anti-infective drugs (719 cases, 14. 29%) and tumor drugs (83 cases, 1. 65%). A total of 5 838 cases of organs and (or) systems were involved, mainly skin and subcutaneous tissues (2 380 cases, 40. 77%). After treatment, 97. 71% of the patients (4 917 cases) were improved or recovered. CONCLUSIONS: It is necessary to carry out ADR monitoring of drugs in national centralized volume-based procurement, strengthen the analysis and evaluation of surveillance data, and focus on new and severe ADR, as well as ADR of anti-infective drugs, cardiovascular system drugs, and antitumor drugs.

DRUG side effects; ORAL drug administration; CARDIOVASCULAR agents; ANTINEOPLASTIC agents; DRUG monitoring

Evaluation & Analysis of Drug-Use in Hospitals of China / Zhongguo Yiyuan Yongyao Pingjia yu Fenxi, 2024, Vol 24, Issue 12, p1527

1672-2124

Academic Journal

10.14009/j.issn.1672-2124.2024.12.025