Implementing Black Box Warnings (BBWs) in Health Information Systems

Journal: Applied Clinical Informatics
ISSN: 1869-0327
Issue: Vol. 3: Issue 1 2012
Pages: 124-134

Implementing Black Box Warnings (BBWs) in Health Information Systems

An Organizing Taxonomy Identifying Opportunities and Challenges

Research Article

M. Ikezuagu (1, 2), E. Yang (4), A. Daghstani (4), D. C. Kaelber (1, 2, 3, 5, 6)

(1) Departments of Information Systems; (2) Internal Medicine; (3) Pediatrics, Epidemiology, and Biostatistics; (4) Pharmacy; (5) Center for Clinical Informatics Research and Education; (6) The MetroHealth System and School of Medicine, Case Western Reserve University, Cleveland OH


Health Information Systems, Patient safety, clinical decision support, HIS, Taxonomy, CDS, Black box warning, BBW


Objective: To develop a practical approach for implementing clinical decision support (CDS) for medication black box warnings (BBWs) into health information systems (HIS).

Methods: We reviewed all existing medication BBWs and organized them into a taxonomy that identifies opportunities and challenges for implementing CDS for BBWs into HIS.

Results: Of the over 400 BBWs that currently exist, they can be organized into 4 categories with 9 sub-categories based on the types of information contained in the BBWs, who should be notified, and potential actions to that could be taken by the person receiving the BBW. Informatics oriented categories and sub-categories of BBWs include – interactions (13%) (drug-drug (4%) and drug-diagnosis (9%)), testing (21%) (baseline (9%) and on-going (12%)), notifications (29%) (drug prescribers (7%), drug dispensers (2%), drug administrators (9%), patients (10%), and third parties (1%)), and non-actionable (37%). This categorization helps identify BBWs for which CDS can be easily implemented into HIS today (such as drug-drug interaction BBWs), those that cannot be easily implemented into HIS today (such as non-actionable BBWs), and those where advanced and/or integrated HIS need to be in place to implement CDS for BBWs (such a drug dispensers BBWs). 

Conclusions: HIS have the potential to improve patient safety by implementing CDS for BBWs. A key to building CDS for BBWs into HIS is developing a taxonomy to serve as an organizing roadmap for implementation. The informatics oriented BBWs taxonomy presented here identified types of BBWs in which CDS can be implemented easily into HIS currently (a minority of the BBWs) and those types of BBWs where CDS cannot be easily implemented today (a majority of BBWs).

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