Zernikow B, Michel E, Fleischhack G, Bode U
Department of Paediatric Heamatology/Oncology, University Children's Hospital, Bonn, Germany.
Drug Saf. 1999 Jul;21(1):57-74. doi: 10.2165/00002018-199921010-00005.
Drug errors are quite common. Many of them become harmful only if they remain undetected, ultimately resulting in injury to the patient. Errors with cytotoxic drugs are especially dangerous because of the highly toxic potential of the drugs involved. For medico-legal reasons, only 1 case of accidental iatrogenic intoxication by cytotoxic drugs tends to be investigated at a time, because the focus is placed on individual responsibility rather than on system errors. The aim of our study was to investigate whether accidental iatrogenic intoxications by cytotoxic drugs are faults of either the individual or the system. The statistical analysis of distribution and quality of such errors, and the in-depth analysis of contributing factors delivered a rational basis for the development of practical preventive strategies.
A total of 134 cases of accidental iatrogenic intoxication by a cytotoxic drug (from literature reports since 1966 identified by an electronic literature survey, as well as our own unpublished cases) underwent a systematic error analysis based on a 2-dimensional model of error generation. Incidents were classified by error characteristics and point in time of occurrence, and their distribution was statistically evaluated. The theories of error research, informatics, sensory physiology, cognitive psychology, occupational medicine and management have helped to classify and depict potential sources of error as well as reveal clues for error prevention.
Monocausal errors were the exception. In the majority of cases, a confluence of unfavourable circumstances either brought about the error, or prevented its timely interception. Most cases with a fatal outcome involved erroneous drug administration. Object-inherent factors were the predominant causes. A lack of expert as well as general knowledge was a contributing element. In error detection and prevention of error sequelae, supervision and back-checking are essential. Improvement of both the individual training and work environment, enhanced object identification by manufacturers and hospitals, increased redundancy, proper usage of technical aids, and restructuring of systems are the hallmarks for error prevention.
Errors follow general patterns even in oncology. Complex interdependencies of contributing factors are the rule. Thus, system changes of the working environment are most promising with regard to error prevention. Effective error control involves adapting a set of basic principles to the specific work environment. The work environment should allow for rectification of errors without penalty. Regular and ongoing intra-organisational error analysis needs to be an integral part of any error prevention strategy. However, it seems impossible to totally eliminate errors. Instead, if the environment guarantees timely error interception, most sequelae are avoided, and errors transform into a system-wide learning tool.
用药错误十分常见。其中许多错误只有在未被发现时才会造成危害，最终导致患者受到伤害。细胞毒性药物的错误尤其危险，因为所涉药物具有高毒性。出于法医学原因，细胞毒性药物导致的医源性意外中毒事件每次往往只调查1例，因为重点放在个人责任而非系统错误上。我们研究的目的是调查细胞毒性药物导致的医源性意外中毒是个人的过错还是系统的过错。对这类错误的分布和性质进行统计分析，并深入分析促成因素，为制定切实可行的预防策略提供了合理依据。
基于二维错误产生模型，对总共134例细胞毒性药物医源性意外中毒事件（来自电子文献检索确定的1966年以来的文献报告以及我们自己未发表的病例）进行系统的错误分析。根据错误特征和发生时间对事件进行分类，并对其分布进行统计评估。错误研究、信息学、感觉生理学、认知心理学、职业医学和管理学理论有助于对潜在错误源进行分类和描述，并揭示预防错误的线索。
单因错误是例外情况。在大多数情况下，不利情况的汇合要么导致了错误，要么阻碍了对错误的及时发现。大多数导致致命后果的病例涉及用药错误。药物本身的因素是主要原因。缺乏专业知识和一般知识也是一个促成因素。在错误检测和预防错误后果方面，监督和复查至关重要。改进个人培训和工作环境、制造商和医院加强对药品的识别、增加冗余、正确使用技术辅助工具以及系统重组是预防错误的关键。
即使在肿瘤学领域，错误也遵循一般模式。促成因素之间复杂的相互依存关系是常态。因此，就预防错误而言，改变工作环境的系统最有前景。有效的错误控制需要根据具体工作环境调整一套基本原则。工作环境应允许对错误进行纠正而不受到惩罚。定期且持续的组织内部错误分析需要成为任何预防错误策略的一个组成部分。然而，似乎不可能完全消除错误。相反，如果环境能够保证及时发现错误，大多数后果是可以避免的，错误会转化为全系统的学习工具。
