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

Pharmacoepidemiology and Drug Safety - Tập 10 Số 6 - Trang 483-486 - 2001
Stephen Evans1, P.J. Waller1, Sarah Davis1
1Post‐Licensing Division, Medicines Control Agency, Market Towers, 1, Nine Elms Lane, London SW8 5NQ

Tóm tắt

AbstractBackgroundThe 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 underutilised.MethodsUsing 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 × 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.FindingsThe 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.ImplicationsProportional 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. © Crown copyright 2001. Reproduced with the permission of Her Majesty's Stationary Office. Published by John Wiley & Sons, Ltd.

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Tài liệu tham khảo

10.1002/(SICI)1099-1557(199611)5:6<363::AID-PDS249>3.0.CO;2-7

Wood SM, 1993, Adverse Drug Reactions On‐line Information Tracking (ADROIT), Pharmaceutical Medicine, 7, 203

10.1111/j.1365-2125.1994.tb04373.x

10.1136/bmj.315.7107.500

Speirs CJ, 1986, Iatrogenic Diseases, 93

Grant EM, 1998, Electronic Communication Technologies‐Techniques and Technologies for the 21st Century, 551

Finney DJ, 1974, Systematic signalling of adverse reactions to drugs, Meth Inf Med, 13, 1, 10.1055/s-0038-1636131

10.1002/(SICI)1099-1557(199912)8:7<535::AID-PDS456>3.0.CO;2-D

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Pharmacoepidemiology and Drug Safety

Tập 10 Số 6

483-486

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