發(fā)布時間：2018-10-20 13:35

【摘要】：目的:了解河南省和河北省藥品不良反應(yīng)(ADR)報告單位的工作開展現(xiàn)狀,為ADR監(jiān)測工作的完善提供依據(jù)。方法:通過查閱文獻了解國內(nèi)外關(guān)于ADR監(jiān)測工作的概況,以河南省和河北省ADR報告單位(藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機構(gòu))為研究對象進行整群抽樣,發(fā)放調(diào)查問卷,運用描述性統(tǒng)計分析等方法對調(diào)查結(jié)果進行處理和分析。結(jié)果:共回收有效問卷186份。河南省和河北省受訪ADR報告單位專門建立ADR監(jiān)測部門的分別有58家和62家,且全部專門配備了人員負責(zé)ADR工作;ADR監(jiān)測工作在藥品生產(chǎn)、經(jīng)營企業(yè)中絕大多數(shù)隸屬于質(zhì)量管理部門,在醫(yī)療機構(gòu)大多隸屬于藥劑科;大多數(shù)配備了計算機、打印機、電話等基本辦公設(shè)備;大多數(shù)受訪ADR報告單位工作職責(zé)仍不夠明確;有專門用于ADR監(jiān)測工作的預(yù)算的分別為24家和2家;與當(dāng)?shù)谹DR監(jiān)測中心有交流溝通的分別占95.7%和96.8%,但信息反饋情況不理想;對工作人員進行了相關(guān)培訓(xùn)的分別占86.7%和98.9%;建立標準工作流程的情況河北省較好;發(fā)現(xiàn)ADR后會立即上報的分別占96.7%和98.9%,會對上報的ADR進行備份記錄的分別占92.3%和97.8%;上報形式均以網(wǎng)絡(luò)報告形式為主;工作滿意度評價方面,河南省的平均分高于河北省。結(jié)論:針對調(diào)查結(jié)果,建議通過明確ADR監(jiān)測工作職責(zé),優(yōu)化工作條件,保證工作經(jīng)費,加強工作反饋等措施促進其ADR監(jiān)測工作的開展。
[Abstract]:Objective: to understand the status quo of (ADR) reporting units of adverse drug reactions in Henan and Hebei provinces, and to provide basis for the improvement of ADR monitoring. Methods: the general situation of ADR monitoring at home and abroad was investigated by consulting the literature. Cluster sampling was conducted with ADR reporting units (drug manufacturing enterprises, drug trading enterprises, medical institutions) in Henan Province and Hebei Province, and questionnaires were distributed. The method of descriptive statistical analysis is used to deal with and analyze the survey results. Results: 186 valid questionnaires were collected. In Henan Province and Hebei Province, 58 and 62 ADR monitoring departments were established by ADR reporting units interviewed in Henan Province and Hebei Province respectively, and all of them were specially staffed to take charge of ADR work. Most of the enterprises belong to the quality management department, most of the medical institutions belong to the pharmacy department; most of them are equipped with basic office equipment such as computer, printer, telephone, etc. There were 24 and 2 special budgets for ADR monitoring, 95.7% and 96.8% of them had communication with local ADR monitoring center, but the information feedback was not satisfactory. 86.7% and 98.9% of the staff were trained respectively. It was found that 96.7% and 98.9% of the ADR would be reported immediately, 92.3% and 97.8% of the reported ADR would be backed up and recorded, respectively. The main form of the report was in the form of network report, and the average score of Henan Province was higher than that of Hebei Province in terms of job satisfaction evaluation. Conclusion: in view of the investigation results, it is suggested that the work of ADR monitoring should be promoted by clarifying the duties of ADR monitoring, optimizing the working conditions, ensuring the work expenses and strengthening the work feedback and so on.
【作者單位】： 西安交通大學(xué)醫(yī)學(xué)部藥學(xué)院;
【基金】：國家社會科學(xué)基金資助項目(No.13BGL132)
【分類號】：R951

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