Lane D A, Hutchinson T A
J Chronic Dis. 1987;40(6):621-5. doi: 10.1016/0021-9681(87)90023-3.
This paper presents a definition of "acceptable risk" that is based on the concept of utility. The adverse effects of a specific use of a drug pose an acceptable risk if no alternative treatment has a higher cumulated expected utility in the relevant patient population than that associated with the use of the drug. The implications of this definition for postmarketing management of drugs are explored. In particular, postmarketing surveillance should be expanded to include the quantification of patients' values, a drug's beneficial effects, and its adverse effects. Management actions should be targeted at specific drug uses with unacceptable risks rather than at drugs themselves. This may require the use of education and service action options, as well as regulatory actions aimed at prescribers and dispensers.
本文提出了一种基于效用概念的“可接受风险”定义。如果在相关患者群体中，没有其他替代治疗方法具有比使用该药物更高的累积预期效用，那么药物特定用途的不良反应就构成可接受风险。探讨了这一定义对药物上市后管理的影响。特别是，上市后监测应扩大到包括对患者价值观、药物有益效果及其不良反应的量化。管理行动应针对具有不可接受风险的特定药物用途，而不是针对药物本身。这可能需要使用教育和服务行动选项，以及针对开处方者和配药者的监管行动。
