论文部分内容阅读
目的评价2008年至2010年西安市医疗机构上报的药品不良反应(adverse drug reaction,ADR)报告表的质量。方法根据《“药品不良反应/事件报告表”规范分级标准》和《WHO药品不良反应病例报告分级标准》对报告表的完整性进行评价;对报告表的基本信息缺项进行统计;评估新的和严重的ADR病例报告比例以及报告表提交的时效性等。结果护士填报的报告表完整性3或4级的占72.29%,显著低于医生和药师(分别为95.01%和98.52%);报告表基本信息的缺失主要存在于患者病历号/门诊号(30.55%)、联系方式(23.55%)以及药品商品名(8.19%);药师报告的新的和严重的ADR病例构成比显著高于医生和护士;护士在ADR发生后超过3个月才上报的比例最低(2.29%),其次是医生和药师(分别为4.16%和8.30%)。结论不同专业医务人员对ADR的关注角度以及对报告过程的掌握程度并不一致,应该采取各种措施有针对性地提高药品不良反应报告表的质量。
Objective To evaluate the quality of ADR reports submitted by medical institutions in Xi’an from 2008 to 2010. Methods The report forms were evaluated according to the Adverse Drug Reaction / Incident Report Form, Standard Classification Criteria and the WHO Drug Adverse Reaction Case Report Grading Standard. Statistical results were reported on the lack of basic information in the report form. The proportion of new and serious cases of ADR cases reported, and the timeliness of submission of reports. Results The nurses reported 72.29% completeness level 3 or 4, which was significantly lower than that of doctors and pharmacists (95.01% and 98.52% respectively). The lack of basic information in the report form mainly existed in patients’ medical records / outpatients (30.55 %), Contact information (23.55%) and drug product name (8.19%). The proportion of new and serious cases of ADR reported by pharmacists was significantly higher than that of doctors and nurses. The percentage of nurses reporting more than 3 months after ADR Lowest (2.29%), followed by doctors and pharmacists (4.16% and 8.30% respectively). Conclusion The different professional medical staff’s attention angle on ADR and the mastery of the reporting process are not consistent. Various measures should be taken to improve the quality of adverse drug reaction reports.