Hartmann K, Kuhn M, Gartmann J
Schweizerische Arzneimittel-Nebenwirkungs-Zentrale SANZ.
Schweiz Med Wochenschr. 1992 Sep 19;122(38):1409-13.
The Swiss Drug Monitoring Center SANZ operates the spontaneous reporting system in Switzerland. Spontaneous reporting schemes represent the systematic approach to the collection of individual case reports on suspected adverse drug reactions (ADR). ADR spontaneous reporting systems are an important component of the postmarketing surveillance of drugs. Spontaneous reporting systems are primarily designed to detect new and unexpected ADR; they generate signals about possible ADR and create hypotheses to be tested in pharmaco-epidemiological studies. Besides collecting, analyzing and evaluating single case reports it is important to extract those cases from the data pool which can be used to produce signals. A computer-assisted early warning system enables SANZ to detect cases with signal function and thus to track down new, rare and unexpected ADR. Carefully selected parameters can help to identify important new hazards. However, the detection of new and unexpected ADR depends to a large extent on the minds of alert physicians and the practicing clinician's awareness of and cooperation with ADR reporting.
瑞士药品监测中心（SANZ）负责瑞士的自发报告系统。自发报告计划是收集疑似药物不良反应（ADR）个案报告的系统方法。ADR自发报告系统是药品上市后监测的重要组成部分。自发报告系统主要用于检测新的和意外的ADR；它们生成有关可能的ADR的信号，并创建有待在药物流行病学研究中检验的假设。除了收集、分析和评估单个病例报告外，从数据池中提取可用于产生信号的病例也很重要。计算机辅助预警系统使SANZ能够检测具有信号功能的病例，从而追踪新的、罕见的和意外的ADR。精心选择的参数有助于识别重要的新危害。然而，新的和意外的ADR的检测在很大程度上取决于警觉的医生的意识以及临床执业医生对ADR报告的认识和合作。
