Thürmann P A
Philipp Klee-Institute of Clinical Pharmacology, Hospital Wuppertal GmbH, University of Witten/Herdecke, Wuppertal, Germany.
Drug Saf. 2001;24(13):961-8. doi: 10.2165/00002018-200124130-00003.
Detection of adverse drug reactions (ADRs) in hospitals offers the chance to detect serious ADRs resulting in hospitalisation and ADRs occurring in hospitalised patients, i.e. patients with high comorbidity and receiving drugs that are administered only in hospitals. The most commonly applied methods involve stimulated spontaneous reporting of doctors and nurses, comprehensive collection by trained specialists and, more recently, computer-assisted approaches using routine data from hospital information systems. The different methods of ADR detection used result in different rates and types of ADRs and, consequently, in different drug classes being responsible for these ADRs. Another factor influencing the results of surveys is the interpretation of the term ADR, where some authors adhere to the strict definition of the World Health Organization and many others include intended and unintended poisoning as well as errors in prescribing and dispensing, thus referring to adverse drug events. Depending on the method used for screening of patients, a high number of possible ADRs and only few definite ADRs are found, or vice versa. These variations have to be taken into account when comparing the results of further analyses performed with these data. ADR rates and incidences in relation to the number of drugs prescribed or patients exposed have been calculated in only a few surveys and projects, and this interesting pharmacoepidemiological approach deserves further study. In addition, the pharmacoeconomic impact of ADRs, either resulting in hospitalisation or prolonging hospital stay, has been estimated using different approaches. However, a common standardised procedure for such calculations has not yet been defined. Although detection of ADRs in hospitals offers the opportunity to detect severe ADRs of newly approved drugs, these ADRs are still discovered by spontaneous reporting systems. The prospects offered by electronic hospital information systems as well as implementation of pharmacoepidemiological approaches increases the possibilities and the value of ADR detection in hospitals.
医院中药物不良反应(ADR)的监测为发现导致住院的严重ADR以及住院患者中发生的ADR提供了机会,即共病率高且使用仅在医院给药药物的患者。最常用的方法包括医生和护士的自发报告、由训练有素的专家进行全面收集,以及最近使用医院信息系统常规数据的计算机辅助方法。所采用的不同ADR检测方法会导致不同的ADR发生率和类型,进而导致对这些ADR负责的药物类别不同。影响调查结果的另一个因素是ADR这一术语的解释,一些作者遵循世界卫生组织的严格定义,而许多其他作者则将有意和无意的中毒以及处方和配药错误包括在内,因此指的是药物不良事件。根据用于筛查患者的方法,会发现大量可能的ADR和仅少数明确的ADR,反之亦然。在比较使用这些数据进行的进一步分析结果时,必须考虑这些差异。仅在少数调查和项目中计算了与所开药物数量或暴露患者数量相关的ADR发生率和发病率,这种有趣的药物流行病学方法值得进一步研究。此外,已使用不同方法估计了ADR导致住院或延长住院时间的药物经济学影响。然而,尚未定义用于此类计算的通用标准化程序。虽然医院中ADR的监测为发现新批准药物严重ADR提供了机会,但这些ADR仍通过自发报告系统发现。电子医院信息系统提供的前景以及药物流行病学方法的实施增加了医院中ADR检测的可能性和价值。