An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies

Miguel-Angel Maciá-Martínez (), Francisco J. Abajo, Gilly Roberts, Jim Slattery, Bharat Thakrar and Antoni F. Z. Wisniewski
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Miguel-Angel Maciá-Martínez: AEMPS (Spanish Agency for Medicines and Medical Devices)
Francisco J. Abajo: University of Alcalá
Gilly Roberts: GlaxoSmithKline
Jim Slattery: European Medicines Agency
Bharat Thakrar: Roche
Antoni F. Z. Wisniewski: AstraZeneca

Drug Safety, 2016, vol. 39, issue 1, No 4, 29-43

Abstract: Abstract Introduction Although it seems reasonable to suppose that a drug that increases the risk of an adverse event might tend to show increased disproportionality statistics in spontaneous reporting databases, that relationship is not clear. Therefore, an empirical approach was taken to investigate the relationship between proportional reporting ratios (PRRs) and relative risk (RR) estimates from formal studies in a set of known adverse drug reactions (ADRs). Methods Drug-event pairs that were the subject of pharmacovigilance-driven European regulatory actions from 2007 to 2010 were selected. Only pairs having RR derived from formal studies and where it was considered that there was well-established evidence supporting the actions were included. A best estimate of the RR for each ADR was chosen based on pre-specified rules. PRRs were then calculated in Eudravigilance using only those cases reported before the date of first recognition of the ADR in the medical community. An additional analysis was carried out in FEDRA, the Spanish spontaneous reports database. A descriptive analysis and an orthogonal regression model were performed. Results From an initial dataset of 78 drug-event pairs, 15 were selected. The regression model (ln RR = 0.203 + 0.463 × ln PRR) showed a significant (p

Date: 2016
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DOI: 10.1007/s40264-015-0351-3

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