某哨点医院基于中国医院药物警戒系统(CHPS)开展药品不良反应监测的研究分析

Research and Analysis of Adverse Drug Reaction Monitoring Based on Chinese Hospital Pharmacovigilance System( CHPS) in a Sentinel Hospital

目的 通过对某哨点医院上线中国医院药物警戒系统(CHPS)前后开展药品不良反应(ADR)监测工作进行对比分析,体现国家哨点医院基于CHPS开展ADR监测工作的优越性。方法 回顾性方法收集运行CHPS前后ADR监测情况,应用鱼骨图对运行CHPS前ADR监测工作存在的问题进行根因分析,应用统计学对ADR监测中报告的新的、严重的、药品种类、零报告科室、占出院人数比例、累及系统及主要临床表现、给药途径及ADR病例监测进行对比分析。结果 运行CHPS前年上报348例ADR报告,其中新的/严重的91例(26.14%),涉及药品品种146种,其中西药141种(340例占比97.70%)、中成药5种(13例占3.74%),零报告科室10个(占比29.41%),占出院人数比例0.67%。运行CHPS后年上报771例,其中新的/严重的256例(33.20%),涉及药品品种214种,其中西药189种(754例占97.80%),中成药13种(22例占2.85%),零报告科室1个(占比2.56%),占出院人数比例1.21%,开展主动监测筛出29858例特征病例,提醒医师上报123例,占报告总数(771)的16.00%。结论 运行CHPS后提高了哨点医院ADR上报的效率、报告质量、上报率,减少漏报,ADR上报更加及时、准确、高效;提高了药师工作的技术含量,把ADR的危害降到最小,以此保障患者用药安全。

OBJECTIVE Through a comparative analysis of the adverse drug reaction(ADR) monitoring before and after the launch of the Chinese Hospital Pharmacovigilance System(CHPS) in a sentinel hospital, it reflects the superiority of the national sentinel hospital in carrying out ADR monitoring based on CHPS.METHODS The ADR monitoring situation before and after running CHPS was collected retrospectively.The fishbone diagram was used to analyze the root cause of the problems existing in the ADR monitoring work before running CHPS.The departments with zero reporting, the proportion of discharged patients, the system involved and the main clinical manifestations, the route of administration and the monitoring of ADR cases were compared and analyzed.RESULTS 348 cases of ADR were reported the year before running CHPS,of which 91 were new/severe cases(26.14%),involving 146 kinds of drugs, including 141 kinds of western medicines(340 cases accounted for 97.70%),5 kinds of Chinese patent medicines(13 cases 3.74%),10 departments with zero reporting(accounting for 29.41%),accounting for 0.67% of the discharged patients.After running CHPS,771 cases were reported, including 256 new/severe cases(33.20%),involving 214 kinds of drugs, including 189 kinds of western medicines(754 cases accounting for 97.80%) and 13 kinds of Chinese patent medicines(22 cases accounting for 2.85%),1 department with zero reporting(2.56%),accounting for 1.21% of the number of discharged patients, and carried out active monitoring to screen out 29,858 characteristic cases, and reminded doctors to report 123 cases, accounting for 16.00% of the total number of reports(771).CONCLUSION After running CHPS,the efficiency, quality and rate of ADR reporting in sentinel hospitals have been improved, omissions have been reduced, and ADR reporting has become more timely, accurate and efficient;the technical content of pharmacists′ work has been improved, and the harm of ADR has been minimized.This ensures patient safety.