POWER AND WEAKNESS OF SPONTANEOUS REPORTING - A PROBABILISTIC APPROACH

被引：46

作者：

TUBERT, P ^{[1
]}

BEGAUD, B ^{[1
]}

PERE, JC ^{[1
]}

HARAMBURU, F ^{[1
]}

LELLOUCH, J ^{[1
]}

机构：

[1] HOP PELLEGRIN,CTR PHARMACOVIGILANCE,SERV PHARMACOL CLIN,F-33076 BORDEAUX,FRANCE

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 1992年 / 45卷 / 03期

关键词：

PHARMACOEPIDEMIOLOGY; PHARMACOVIGILANCE; SPONTANEOUS REPORTING; DETECTION; UNDERREPORTING; POISSON MODEL;

D O I：

10.1016/0895-4356(92)90088-5

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

It has been clearly demonstrated that spontaneous reporting remains one of the best ways for picking up new adverse drug reactions (ADRs) once a drug is on the market. The probability of revealing a new ADR by spontaneous reporting was studied as a function of reporting rate, strength of drug-event association (relative risk), background incidence of the event and number of patients treated. The model included determination of (i) the probability of reporting at least one drug-event association case and (ii) the overall probability of concluding that the drug-event association is not coincidental. Both probabilities were generally low. The results suggest that the identification of a new risk by spontaneous reporting implies a strong association between the drug treatment and the occurrence of the event.

引用

页码：283 / 286

页数：4

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