Characteristics of gadolinium-based contrast media cancellation at the point of care: a 15-month assessment of FDA-inspired medication guides on gadolinium retention.

2020 
PURPOSE To assess the effect of United States Food and Drug Administration (FDA)-inspired patient handouts, regarding gadolinium retention, on the frequency of patient-initiated cancellations of gadolinium-based contrast media (GBCM) at the point of care. METHODS This is a single center retrospective cohort review of MRI examinations protocolled to receive GBCM but performed without GBCM from October 2017 to January 2019. The study period spans an FDA-inspired safety intervention (December 2017 to May 2018) to provide patients with a handout on gadolinium retention. Examinations were coded according to rationale for GBCM cancellation. Process control charts were created to statistically evaluate trends in GBCM cancellations over time. RESULTS From October 2017 to January 2019, GBCM was canceled at the point of care for 0.22% (131/58,837; 95% CI 0.19-0.26) of examinations in which GBCM was indicated. This did not significantly vary during the study period. No cancellations (0/131) were due to stated concern for gadolinium retention. However, 38% (50/131; 95% CI 30-47) were canceled due to kidney impairment and 21% (28/131; 95% CI 13-30) were canceled for an unknown reason. CONCLUSION FDA-inspired handouts informing patients about gadolinium retention did not significantly change the frequency of GBCM cancellation. GBCM cancellations at the point of care remain uncommon.
    • Correction
    • Source
    • Cite
    • Save
    • Machine Reading By IdeaReader
    14
    References
    0
    Citations
    NaN
    KQI
    []