Objective To determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting.

Design Retrospective chart review of clinical events following observed medication administration errors.

Background Medication errors are common at the medication administration stage for inpatients. While many errors can cause harm, it is unclear exactly how often.

Methods In a previous study where 14 041 medication administrations were directly observed, 1271 medication administration errors were discovered, of which 133 had the potential to cause serious or life-threatening harm and were considered serious or life-threatening potential adverse drug events. As a follow-up, clinical reviewers conducted detailed chart review of serious or life-threatening potential ADEs to determine if they caused an ADE. Reviewers assessed severity of the ADE and attribution to the error.

Results Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% (95% CI 2.12 to 3.6)) of serious or life threatening potential ADEs led to serious or life threatening ADEs. Half of the ADEs were caused by dosage or monitoring errors for anti-hypertensives.

Conclusions Unintercepted potential ADEs at the medication administration stage can cause serious patient harm. At hospitals where 6 million doses are administered per year, about 4000 preventable ADEs would be attributable to medication administration errors annually.