Postmarketing surveillance and adverse drug reactions - Current perspectives and future needs
Postmarketing surveillance and adverse drug reactions - Current perspectives and future needs
复制标题
DOI：
10.1001/jama.281.9.824
复制
发表时间：
1999-03-03
影响因子：
120.7
通讯作者：
Colditz, GA
中科院分区：
文献类型：
--
作者：
Brewer, T;Colditz, GA
像MEDWATCH这样的自发报告系统可以有效地揭示与药物使用有关的不寻常或罕见的不良事件，此类报告通常足以确定因果关系。然而，自发报告不能可靠地检测药物不良反应（adr），这些不良反应发生的时间与最初使用药物的时间相差很大，或者在未接触药物的人群中常见的不良事件风险增加。在这些情况下，自发报告本身并不能提供足够的证据来得出不良事件是ADR的结论，识别与慢性疾病药物长期服用相关的ADR也仍然存在问题。必须开发利用临床试验、医疗记录以及药物使用者和非药物使用者计算机数据库的数据来评估adr的方法，以补充自发报告系统。如果没有这些方法，潜在的重要不良反应将不会被发现，不良后果与药物或器械之间的虚假关联将不会受到质疑。
Spontaneous reporting systems like MEDWATCH can be effective in revealing unusual or rare adverse events that occur with the use of medications, and such reports may often be sufficient to assign causality. However, spontaneous reports do not reliably detect adverse drug reactions (ADRs) that occur widely separated in time from the original use of the drug or that represent an increased risk of an adverse event that occurs commonly in populations not exposed to the drug. In these situations, spontaneous reports alone do not provide sufficient evidence to conclude that the adverse event was an ADR, identification of ADRs associated with long-term administration of drugs for chronic diseases also remains problematic. Methods to evaluate ADRs using data from clinical trials, medical records, and computerized databases of medication users and nonusers must be developed to complement spontaneous reporting systems. Without these methods, potentially important ADRs will remain undetected, and spurious associations between adverse outcomes and medications or devices will remain unchallenged.