Journal ArticleDOI
Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
TLDR
The process of generating ‘signals’ of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack but statistical approaches to the data have been underutilised.Abstract:
BACKGROUND: The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised. METHODS: Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4. FINDINGS: The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation. IMPLICATIONS: Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.read more
Citations
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Journal ArticleDOI
Under-reporting of adverse drug reactions : a systematic review.
Lorna Hazell,Saad A. W. Shakir +1 more
TL;DR: Evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs is provided.
Journal ArticleDOI
Quantitative signal detection using spontaneous ADR reporting.
TL;DR: The role of Bayesian shrinkage in screening spontaneous reports, the importance of changes over time in screening the properties of the measures and some suggestions as to where emerging research is likely to lead are given.
Journal ArticleDOI
Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine.
Barbara A. Slade,Laura Leidel,Claudia Vellozzi,Emily Jane Woo,Wei Hua,Andrea Sutherland,Hector S. Izurieta,Robert Ball,Nancy Miller,M. Miles Braun,Lauri E. Markowitz,John K. Iskander +11 more
TL;DR: Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events.
Journal ArticleDOI
Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).
TL;DR: Fundamental vaccine safety concepts are described, an overview of VAERS is provided for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and how CDC and FDA analyze VAERS data are explained.
Journal ArticleDOI
Understanding vaccine safety information from the Vaccine Adverse Event Reporting System.
Frederick Varricchio,John K. Iskander,Frank DeStefano,Robert Ball,Robert Pless,M. Miles Braun,Robert T. Chen +6 more
TL;DR: The Vaccine Adverse Event Reporting System is useful in detecting adverse events related to vaccines and most recently was used for enhanced reporting of adverse events in the national smallpox immunization campaign.
References
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Journal ArticleDOI
False‐positives in spontaneous reporting: should we worry about them?
TL;DR: For rare events, reports of coincidental drug-event associations are too unlikely to be considered as an important limitation of spontaneous reporting, and the proposed method based on the Poisson distribution is suggested.
Journal ArticleDOI
Regulatory pharmacovigilance in the United Kingdom: current principles and practice.
Journal ArticleDOI
Adverse drug reactions : finding the needle in the haystack
TL;DR: Britain thus joins 36 other countries in the World Health Organisation's programme on international drug monitoring that accept reports from pharmacists, and shows that reporting by pharmacists can make a difference to the number of meaningful reports from hospitals.