Strandberg K, Wiholm B E
Med Toxicol. 1986;1 Suppl 1:137-49.
Effective post-marketing surveillance of drugs calls for an approach tuned to the individual problem. In Sweden, the combined use of spontaneous adverse drug reaction (ADR) reporting data and different registers has yielded much valuable information on safety problems with different drugs. However, the raw data must be interpreted with care and often be supplemented by in-depth studies. The advantage with registers is that they comprise the whole or a random sample of the population and that the reporting routines are fairly simple. Since much of the information is collected primarily for other purposes (like health care planning or budgeting) the cost of the information is low. The potential of spontaneous ADR reporting for detecting new rare ADRs is exemplified by the zimeldine case. Limitations of the system besides low and selective reporting are that the physicians must suspect the clinical manifestation to be drug-induced and that patient compliance is unknown. The greatest disadvantage with the patient- and disease-oriented registers is the frequent inaccuracy of the diagnoses and the delay in the appearance of the data. Improved education and more resources for updating the registers are required. The ICD-code should be adapted to the needs of drug monitoring. Since the registers contain sensitive information about individual patients, the confidentiality of the data must be secured. As a logical complement to these sources of information, systems for case control studies, to be adopted ad hoc when problems arise, should be instituted. Moreover, for certain kinds of long term drug reactions, record-linkage systems are probably the only means to disclose risks (e.g. of cancer) after long term drug exposure. In this respect, the computerisation of Swedish pharmacies offers unique possibilities for the retrieval of prescription data on individual patients.
有效的药品上市后监测需要针对具体问题采取相应方法。在瑞典，将自发的药品不良反应（ADR）报告数据与不同的登记系统相结合，已经产生了许多关于不同药物安全性问题的宝贵信息。然而，原始数据必须谨慎解读，并且常常需要通过深入研究加以补充。登记系统的优势在于它们涵盖了全部人群或随机样本，而且报告程序相当简单。由于许多信息主要是为其他目的（如医疗保健规划或预算编制）收集的，所以信息成本较低。齐美利定事件例证了自发ADR报告在发现新的罕见ADR方面的潜力。除了报告率低和报告具有选择性之外，该系统的局限性还在于医生必须怀疑临床表现是药物所致，而且患者的依从性情况不明。以患者和疾病为导向的登记系统最大的缺点是诊断经常不准确以及数据出现延迟。需要加强培训并增加更新登记系统的资源。国际疾病分类代码应适应药物监测的需求。由于登记系统包含有关个体患者的敏感信息，所以必须确保数据的保密性。作为这些信息来源的合理补充，应建立在出现问题时临时采用的病例对照研究系统。此外，对于某些类型的长期药物反应，记录链接系统可能是揭示长期药物暴露后风险（如癌症风险）的唯一手段。在这方面，瑞典药房的计算机化提供了获取个体患者处方数据的独特可能性。
