Longitudinal medical records as a complement to routine drug safety signal analysis.

PURPOSE

To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database.

METHODS

Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination.

RESULTS

Of 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre-prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post-prescription period that, after review of individual patient histories, did not support an association.

CONCLUSIONS

Longitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions.