Adverse Drug Reaction Risk Measures: A Comparison of Estimates from Drug Surveillance and Randomised Trials
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ORIGINAL RESEARCH ARTICLE
Adverse Drug Reaction Risk Measures: A Comparison of Estimates from Drug Surveillance and Randomised Trials Raphaelle Beau‑Lejdstrom1 · Sarah Crook1 · Alessandra Spanu1 · Tsung Yu1,2 · Milo A. Puhan1 Published online: 15 June 2019 © Springer Nature Switzerland AG 2019
Abstract Background Most drug regulatory agencies and pharmaceutical companies hold databases of spontaneous reports of suspected adverse drug reactions (ADRs). Detection systems for ADR signals have been created by specialists to analyse such reports, based on the concept of disproportionality, in order to support safety decision making. However, these measures are often misinterpreted by non-specialists in pharmacovigilance. Objectives Our aim was to assess agreement between estimates of risk from spontaneous reports of suspected ADRs and estimates of risks of ADRs from randomised controlled trials (RCTs). Methods From 150 drugs randomly selected from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS), we identified drugs where FAERS provided reporting odds ratios (RORs) and corresponding systematic reviews from the Cochrane database gave (pooled) odds ratios (ORs) for the same drugs and adverse reactions. We assessed agreement between (ln) RORs and (ln) ORs using the Pearson correlation coefficient and the Bland–Altman agreement method, and performed sensitivity analyses. Results We identified 6 drugs and 125 ADRs. Overall, there was a weak correlation (r = 0.20) between RORs (FAERS) and ORs (RCTs). However, we observed a stronger correlation (r = 0.78) between RORs and ORs for one drug (roflumilast) that received market approval relatively recently (2011). Conclusions Spontaneous reporting of suspected ADRs is an important tool for regulatory agencies and pharmaceutical companies in making decisions and detecting drug safety signals. Although there was moderate-to-strong agreement between ADR risk estimates from drug surveillance and RCTs for one drug, this study illustrates the current recommendations not to use disproportionality measures as valid proxies for risk estimates.
1 Introduction
Key Points
Databases of spontaneous adverse drug reaction (ADR) reports contain hundreds of thousands of case reports of suspected ADRs from patients all over the world. Thanks to these databases, patients, manufacturers and healthcare providers have the opportunity to send a report signaling an ADR potentially related to a medication, directly or indirectly to their local health authority. Most drug regulatory agencies hold such databases including the US Food and
The analysis of adverse drug reactions (ADRs) in spontaneous reporting systems is important for the regulatory surveillance of marketed drugs.
* Raphaelle Beau‑Lejdstrom [email protected]
Stronger correlations may be found in some specific cases, such as newer and well-studied drugs, although these also could be due to chance.
1
Department of Epidemiology, Epidemiology, Biostatistics and Prevention Institute, University of
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