Thiyagu Rajakannan, Mallayasamy Surulivel R, Rajesh Valakkathala, Muralidhar Varma, Smitha Prabhu, Sudha Vidyasagar, Laxminarayana Bairy K
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India;
Drug Healthc Patient Saf. 2010;2:95-100. doi: 10.2147/dhps.s11222. Epub 2010 Jun 30.
Adverse drug events (ADEs) are drug-related events which continue to pose serious challenges to the safety of patients. There are a number of ways to monitor ADEs, and the use of indictors to screen them provides an alternative method for detecting them. This method helps to assess the safety of drugs by the manual record review technique. The aim of this work was to develop a list of indicators to use in medical units of the study hospital to identify ADEs.
Tertiary care teaching hospital in India.
An initial list of ADE indicators based on published literature was developed by a panel of three experts. The list of indicators was subjected to review by a Delphi panel of five members. The Delphi panel reviewed the list of valid indicators and also suggested an addition of new indicators. The final list of indicators was used to review 100 previously documented ADE case reports. The case reports were screened for the presence of any of the indicators from the list. Parameters studied included number of indicators per case report and the most used indicators.
From the literature, a 72 item indicator list was initially prepared which was further narrowed down to a list of 63 items. The Delphi panel conducted a review with these 63 items. At the end of review, and after addition and deletion of indicators, a 49 item indicator list was finalized. When this list of indicators was used for the review of ADE case reports, 42 indicators were identified. On average, three indicators were present in the reviewed case reports.
An indicator list was developed for identification of ADEs in the study setup. The relevance of this indicator list was demonstrated by the presence of these indicators in the previously documented ADE reports. This is the first study from India to report on the development of ADE indicators, which might provide an alternative method to detecting ADEs in the setup of future studies.
药物不良事件（ADEs）是与药物相关的事件，继续对患者安全构成严峻挑战。监测ADEs有多种方法，使用指标对其进行筛查提供了一种检测它们的替代方法。这种方法有助于通过人工记录审查技术评估药物安全性。这项工作的目的是制定一份指标清单，用于研究医院的医疗单位以识别ADEs。
印度的三级护理教学医院。
由三位专家组成的小组根据已发表的文献制定了一份ADE指标初始清单。该指标清单由一个五人德尔菲小组进行审查。德尔菲小组审查了有效指标清单，并还建议增加新的指标。最终的指标清单用于审查100份先前记录的ADE病例报告。对病例报告筛查清单中任何指标的存在情况。研究的参数包括每份病例报告的指标数量和最常用的指标。
从文献中，最初编制了一份72项指标清单，进一步缩减至63项清单。德尔菲小组对这63项进行了审查。在审查结束时，经过指标的增减，最终确定了一份49项指标清单。当使用这份指标清单对ADE病例报告进行审查时，识别出了42项指标。在审查的病例报告中平均存在三项指标。
为在研究机构中识别ADEs制定了一份指标清单。先前记录的ADE报告中存在这些指标证明了这份指标清单的相关性。这是印度第一项报告ADE指标制定情况的研究，可能为未来研究机构中检测ADEs提供一种替代方法。
