Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports


Evans, SJW; Waller, PC; Davis, S; (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and drug safety, 10 (6). pp. 483-486. ISSN 1053-8569 DOI: https://doi.org/10.1002/pds.677

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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.

Item Type: Article
Keywords: Adverse Drug Reaction Reporting Systems, statistics & numerical data, Data Interpretation, Statistical, Databases, Factual, Software
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
PubMed ID: 11828828
Web of Science ID: 173426600001
URI: http://researchonline.lshtm.ac.uk/id/eprint/18379

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