A new patient-centered classification system for adverse drug reactions

F. Rahaghi, S. Tunnicliffe, Vianca Reeves, Starlet Harrimon, William Kernan
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Abstract

Introduction: Long term medication adherence is often determined by patients’ perceptions of a drug’s effectiveness and potential adverse reactions. Adverse drug reactions are now listed in manufacturing package inserts in a manner that does not emphasize either the expected incidence or risk level. Aims and Objectives: We discuss and propose a new format for listing adverse drug reactions to be in a more patient centered classification system. Methods: We explored a variety of communication methods observed for illustration of risk in medical literature. Results: We found the methodology of risk disclosure used by many institutional review boards designed for full disclosure of potential presenting adverse effects in research may be generalized to clinical communication of approved medications. This takes the form of grid with risk and probability as the axis (Table1). Providers and patients should be more aware of what adverse reactions would be expected or likely to occur versus a simple listing of reactions with incidences. This allows to focus on discussing interventions to protect against the likely/expected adverse effects, while allaying fears of occurrence of less likely effects. Conclusions: We believe this would lead to improved provider and patient understanding of a medications adverse reactions and ultimately to improved patient adherence and outcomes.
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一种新的以患者为中心的药物不良反应分类系统
长期服药依从性通常取决于患者对药物有效性和潜在不良反应的认知。药品不良反应现在在药品说明书中以一种既不强调预期发生率也不强调风险水平的方式列出。目的和目标:我们讨论并提出了一种新的格式列出药物不良反应是在一个更以患者为中心的分类系统。方法:我们探讨了医学文献中观察到的各种沟通方法,以说明风险。结果:我们发现,许多机构审查委员会所使用的风险披露方法,旨在充分披露研究中潜在的潜在不良反应,可以推广到已批准药物的临床交流中。这采用以风险和概率为轴的网格形式(表1)。提供者和患者应该更多地了解预期或可能发生的不良反应,而不是简单地列出发生率。这样可以集中讨论干预措施,以防止可能/预期的不利影响,同时减轻对不太可能发生的影响的恐惧。结论:我们相信这将提高提供者和患者对药物不良反应的理解,并最终提高患者的依从性和结果。
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