Härmark Linda, van Hunsel Florence, Grundmark Birgitta
Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre in Pharmacovigilance for Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands,
Drug Saf. 2015 Apr;38(4):337-47. doi: 10.1007/s40264-015-0264-1.
Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the same as for healthcare professional reporting; the message in the reports, not the type of messenger, is what is of importance. Studies have established the significant contribution of consumer reporting to ADR signal detection. Combining all reports regardless of reporter type is recommended since it yields the largest critical mass of reports for signal detection. Examples of signals where consumer reports have been of crucial importance for signal detection are electric shock-like sensations associated with the use of duloxetine, and persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors. An example of consumer reporting significantly strengthening a detected signal is Pandemrix(®) (influenza H1N1 vaccine)-induced narcolepsy. Raising public awareness of ADR reporting is important, but time- and resource-consuming. The minimum effort taken should be to passively inform consumers, e.g. via stakeholders' homepages and via drug product information leaflets. Another possibility of reaching out to this target group could be through co-operation with other (non-government) organizations. Information from consumer reports may give a new perspective on ADRs via the consumers' unfiltered experiences. Consumers' views may change the way the benefit-harm balance of drugs is perceived and assessed today, and, being the ultimate users of drugs, consumers could have a relevant influence in the regulatory decision-making processes for drugs. All stakeholders in pharmacovigilance should embrace this new valuable source of information.
几十年来，一些国家一直存在消费者报告药品不良反应（ADR）的情况，但在整个欧洲，直到最近消费者作为药品不良反应信息来源的作用才得到充分认可。在欧洲，荷兰和瑞典是最早实施消费者报告的国家之一，远早于整个欧盟依法强制实施这一举措。消费者报告是荷兰和瑞典自发报告系统的一个组成部分，报告数量逐年不断增加。消费者报告表格和处理程序与医疗专业人员报告基本相同；报告中的信息而非报告者类型才是重要的。研究已证实消费者报告对药品不良反应信号检测有重大贡献。建议合并所有报告，无论报告者类型如何，因为这样能产生用于信号检测的最大报告量。消费者报告对信号检测至关重要的信号示例包括使用度洛西汀时出现的电击样感觉，以及停用选择性5-羟色胺再摄取抑制剂后持续存在的性功能障碍。消费者报告显著强化已检测信号的一个例子是帕纳单抗（Pandemrix，®）（甲型H1N1流感疫苗）诱发的发作性睡病。提高公众对药品不良反应报告的认识很重要，但耗时且耗费资源。应付出的最小努力是被动告知消费者，例如通过利益相关者的主页和药品信息传单。接触这一目标群体的另一种可能性是与其他（非政府）组织合作。消费者报告中的信息可能通过消费者未经筛选的经历为药品不良反应提供新视角。消费者的观点可能会改变如今对药物利弊平衡的认知和评估方式，而且作为药物的最终使用者，消费者可能会对药品监管决策过程产生相关影响。药物警戒的所有利益相关者都应接纳这一宝贵的新信息来源。
