Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindole

Abstract

Proportional reporting ratios indicate differential reporting of possible reactions, not necessarily differential occurrence. There was no indication of an actual increase of risk of all causes or cardiac deaths during sertindole treatment, but only an increased risk of its being reported. The suspension of sertindole was rescinded by Committee on Proprietary Medicinal Products (CPMP) in October 2001.

Relationship Between Structural Alerts in NSAIDs and Idiosyncratic Hepatotoxicity: An Analysis of Spontaneous Report Data from the WHO Database

“…In addition, ADR spontaneous reports may be subject to various forms of bias and confounding, so the correlation between reported ADRs and the suspected drug does not necessarily have to be based on a truly causal relationship. Beside these limitations, adverse event identification and reporting rates may be higher if there have been warnings about a drug ('notoriety bias') or specific surveillance recommendations [16]. The impact of the withdrawal of bromfenac and lumiracoxib from the market on the disproportionality of the associations of these drugs is unknown.…”

Quantitative Signal Detection and Analysis in Pharmacovigilance

“…Another approach to examining the magnitude of underreporting is the use of the capturerecapture method to estimate the actual number of cases, or the degree of underreporting, when several separate and near-independent systems of case collection are available to the same population, such as in the UK spontaneous reporting and prescription-event monitoring (e.g., see Moore et al (2003)), or potentially spontaneous reports to national systems and to industry, if duplicate reports can be identified.…”

“…The DAs application to the particular context of spontaneous reporting does not protect them from the classical biases encountered in epidemiology (Moore et al, 1997(Moore et al, , 2003. To better understand how these might occur, it is important to know the content of a suspected ADR report, of a spontaneous reporting database, and the mechanism by which a report happens to be recorded in a spontaneous reporting database.…”

Antipsychotikainduzierte QT-Verlängerung

“…Sertindol wurde 1998 vom Hersteller vom Markt zurückgenommen, nachdem gehäuft unklare Todesfälle und Arrhythmien aufgetreten waren. Inzwischen wurde die Suspendierung von den Europä-ischen Zulassungsbehörden aufgehoben, nachdem eine erneute Auswertung der Daten keinen Hinweis auf eine erhöhte Sterblichkeit oder Morbidität unter Sertindol ergeben hatte [33]. Die Wiederzulassung wird abhängig gemacht von dem Ergebnis einer gerade angelaufenen Mortalitätsstudie, in die 10.000 Patienten einbezogen werden.…”