Impact of safety alerts on measures of disproportionality in spontaneous reporting databases - The notoriety bias
Impact of safety alerts on measures of disproportionality in spontaneous reporting databases - The notoriety bias
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DOI：
10.2165/00002018-200730100-00007
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发表时间：
2007-01-01
期刊：
影响因子：
4.2
通讯作者：
Moore, Nicholas
中科院分区：
文献类型：
--
作者：
Pariente, Antoine;Gregoire, Fleur;Moore, Nicholas
背景：自发报告的歧化分析越来越多地被使用，但它可能以未知的方式受到安全警报（恶名偏见）的影响。目的：探讨安全警报对报告不相称性的影响。方法：在法国国家药物警戒数据库中，使用报告优势比（ROR）及其95%置信区间，在四个安全警报之前和之后，对报告的不比例性进行检验：培高利特的瓣膜病变；英夫利昔单抗治疗肺结核；卒中伴非典型抗精神病药物；和使用HMG-CoA还原酶抑制剂（他汀类药物）进行横纹肌溶解[停伐他汀后]。结果：培高利特安全警报前未报告与瓣膜病变相关的病例，警报后报告了63例（ROR 9400; 95% CI 4300, 20000），其中5例发生在警报前。25篇报道提到了在安全警报之前他汀类药物（不包括cerivastatin）相关的横纹肌溶解（ROR 5.8; 95% CI 3.8, 9.0）， 63篇报道在警报之后（ROR 9.4; 95% CI 7.0, 13.0）。撤下头孢伐他汀后，大约报告了280例涉及头孢伐他汀的病例。预警前有2例与英夫利昔单抗相关的结核病报告（ROR 1500; 95% CI 130, 18 000），预警后有7例（ROR 430; 95% CI 110, 1700）。在安全警报之前，有1例卒中与非典型抗精神病药物治疗相关（ROR 0.10; 95% CI 0.01, 0.63），警报之后有16例卒中（ROR 1.10; 95% CI 0.70, 1.90）。排除抗凝剂治疗相关事件后，卒中与非典型抗精神病药物治疗相关的RORs在预警前为0.14 (95% CI 0.02, 1.00)，预警后为2.0 （95% CI 1.2, 3.4）。结论：在安全警报后，自发报告数据库中的不相称性增加，因为感兴趣事件的报告增加，包括警报前发生的此类事件的报告。这可能会导致与其他药物相关的事件报告增加。
Background: Disproportionality analysis of spontaneous reporting is increasingly used, but it may be influenced in unknown ways by safety alerts (notoriety bias).Objective: To explore the consequences of safety alerts on reporting disproportionality.Methods: Within the French national pharmacovigilance database, disproportionality of reporting was tested, using the reporting odds ratio (ROR) and its 95% confidence interval, before and after four safety alerts: valvulopathies with pergolide; tuberculosis with infliximab; strokes with atypical antipsychotics; and rhabdomyolysis with HMG-CoA reductase inhibitors (statins) [after cerivastatin withdrawal].Results: No cases of valvulopathy were reported in association with pergolide before the safety alert and 63 cases were reported after the alert, (ROR 9400; 95% CI 4300, 20 000), of which five had occurred before the alert. Twenty-five reports mentioned rhabdomyolysis associated with statins (not including cerivastatin) before the safety alert (ROR 5.8; 95% CI 3.8, 9.0), and 63 did so after the alert (ROR 9.4; 95% CI 7.0, 13.0). Approximately 280 cases involving cerivastatin were reported after its withdrawal. There were two reports of tuberculosis associated with infliximab before the alert (ROR 1500; 95% CI 130, 18 000) and seven after the alert (ROR 430; 95% CI 110, 1700). There was one report of a stroke in association with atypical antipsychotic treatment before the safety alert (ROR 0.10; 95% CI 0.01, 0.63) and 16 after the alert (ROR 1.10; 95% CI 0.70, 1.90). After excluding events involving treatment with anticoagulant agents, the RORs for stroke in association with atypical antipsychotic treatment were 0.14 (95% CI 0.02, 1.00) before the alert and 2.0 (95% CI 1.2, 3.4) after the alert.Conclusion: Disproportionality in spontaneous reporting databases increases after a safety alert because of increased reporting of the event of interest, including reports of such events that occurred before the alert. This may overflow to increased reporting of the event in association with other drugs.