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Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483-6.

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

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  • 1Post-Licensing Division, Medicines Control Agency, Market Towers, 1, Nine Elms Lane, London SW8 5NQ.

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.

PMID:
11828828
[PubMed - indexed for MEDLINE]
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