The Norwegian Knowledge Centre for the Health Services, PO Box 7004, St, Olavsplass, 0130 Oslo, Norway.
BMC Med Inform Decis Mak. 2013 Dec 5;13:133. doi: 10.1186/1472-6947-13-133.
The objective was to find evidence to substantiate assertions that electronic applications for medication management in ambulatory care (electronic prescribing, clinical decision support (CDSS), electronic health record, and computer generated paper prescriptions), while intended to reduce prescribing errors, can themselves result in errors that might harm patients or increase risks to patient safety.
Because a scoping search for adverse events in randomized controlled trials (RCTs) yielded few relevant results, we systematically searched nine databases, including MEDLINE, EMBASE, and The Cochrane Database of Systematic Reviews for systematic reviews and studies of a wide variety of designs that reported on implementation of the interventions. Studies that had safety and adverse events as outcomes, monitored for them, reported anecdotally adverse events or other events that might indicate a threat to patient safety were included.
We found no systematic reviews that examined adverse events or patient harm caused by organizational interventions. Of the 4056 titles and abstracts screened, 176 full-text articles were assessed for inclusion. Sixty-one studies with appropriate interventions, settings and participants but without patient safety, adverse event outcomes or monitoring for risks were excluded, along with 77 other non-eligible studies. Eighteen randomized controlled trials (RCTs), 5 non-randomized controlled trials (non-R,CTs) and 15 observational studies were included. The most common electronic intervention studied was CDSS and the most frequent clinical area was cardio-vascular, including anti-coagulants. No RCTS or non-R,CTS reported adverse event. Adverse events reported in observational studies occurred less frequently after implementation of CDSS. One RCT and one observational study reported an increase in problematic prescriptions with electronic prescribing
The safety implications of electronic medication management in ambulatory care have not been established with results from studies included in this systematic review. Only a minority of studies that investigated these interventions included threats to patients' safety as outcomes or monitored for adverse events. It is therefore not surprising that we found little evidence to substantiate fears of new risks to patient safety with their implementation. More research is needed to focus on the draw-backs and negative outcomes that implementation of these interventions might introduce.
本研究旨在寻找证据，以证实电子应用程序在门诊药物管理（电子处方、临床决策支持 (CDSS)、电子病历和计算机生成的纸质处方）中虽然旨在减少处方错误，但也可能导致危害患者或增加患者安全风险的错误的说法。
由于针对随机对照试验 (RCT) 中不良事件的范围搜索产生的相关结果很少，我们系统地搜索了九个数据库，包括 MEDLINE、EMBASE 和 The Cochrane Database of Systematic Reviews，以获取针对广泛设计的系统评价和研究报告，这些研究报告了干预措施的实施情况。纳入了具有安全性和不良事件作为结局、对其进行监测、报告不良事件或其他可能表明对患者安全构成威胁的事件的报道的研究。
我们没有发现专门研究组织干预措施引起的不良事件或患者伤害的系统评价。在筛选出的 4056 个标题和摘要中，有 176 篇全文文章被评估是否纳入。排除了 61 项具有适当干预措施、设置和参与者但没有患者安全、不良事件结局或风险监测的研究，以及 77 项其他不符合条件的研究。纳入了 18 项随机对照试验 (RCT)、5 项非随机对照试验 (非 RCT) 和 15 项观察性研究。研究最多的电子干预措施是 CDSS，最常见的临床领域是心血管，包括抗凝剂。没有 RCT 或非 RCT 报告不良事件。在 CDSS 实施后，观察性研究报告的不良事件发生频率较低。一项 RCT 和一项观察性研究报告称，电子处方的问题处方增加。
本系统评价纳入的研究结果并未确定门诊电子药物管理的安全性。只有少数研究将这些干预措施的患者安全威胁作为结局或监测不良事件。因此，我们发现几乎没有证据可以证实实施这些干预措施会带来新的患者安全风险。需要开展更多研究，重点关注这些干预措施实施可能带来的缺点和负面结果。
