Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

This analysis of 75 observational studies (mainly retrospective) found 25-50% received off-label DOAC doses. Only three directly correlated DOAC dose adjustment with clinical outcome; both under-dosing and over-dosing were associated with an increased risk for adverse events.

SPS commentary:

The authors note that their review supports that most people treated with DOACs for stroke prevention in atrial fibrillation receive doses approved in the relevant country; however there is a significant use of off-label dosing in clinical practice. They discuss the numerous limitations to their research and note that pharmacists, doctors and other healthcare professionals have an important role in ensuring that patients with AF receive the appropriate dosage of DOAC, and in detecting problems such as inadequate dose, non-adherence, inadequate follow-up of patients, and stopping DOAC too soon before a surgical procedure.

British Journal of Clinical Pharmacology