Comparison of hospital episodes with 'drug-induced' disorders and spontaneously reported adverse drug reactions.
OBJECTIVE
To compare Hospital Episode Statistics for 'drug-related' admissions with spontaneously reported adverse drug reactions (ADRs) using UK Yellow Card data for the period 1996-2000.


METHODS
This was a descriptive study for which we matched the relevant datasets in respect of time, place, evidence of hospitalization and disease terminology. The principal outcome was the ratio of ADRs leading to hospitalization which had been reported spontaneously during the whole study period.


RESULTS
Twenty types of ADR were included and between them there was a wide spread of overall ratios (range 0-130%). The general tendency was for under-reporting on Yellow Cards but for ADRs with a fatal outcome this appeared to be less (range 7-168%).


CONCLUSIONS
This study provides some broad indications of the degree of under-reporting of ADRs that occurs despite a clinical diagnosis of a serious ADR being made and recorded.
Barrow
Paul
P
Post-Licensing Division, Medicines and Healthcare products Regulatory Agency, London, UK. paul.barrow@mhra.gsi.gov.uk
Waller
Patrick
P
Wise
Lesley
L
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D003937:Diagnosis, Differential; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000453:epidemiology*; D017052:Hospital Mortality; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D011361:Professional Competence; D012189:Retrospective Studies; D006113:United Kingdom / Q000453:epidemiology