Assessment of inpatient boxed warning compliance

Purpose: Boxed warnings (BWs) are the most serious type of safety warning mandated by the United States Food and Drug Administration. Prescriber compliance to BWs was assessed to determine how often general medicine patients are prescribed a medication that is non-compliant to a BW, to evaluate reasons for prescriber non-compliance, and to assess the possibility of a consequential adverse drug reaction (ADR).

Methods: Approval was obtained for this evaluation as a quality improvement project by the Total Quality Council at our institution. For 10 weeks, general medicine patients were evaluated for medication orders with an actionable BW, defined as a warning that allowed for intervention by a pharmacist. When BW non-compliance occurred, the physician was contacted and a reason for non-compliance was determined. Patients that received a medication non-compliant to a BW were monitored for an ADR until discharge, and causality analysis was performed with published tools to determine if a suspected reaction was related to the BW non-compliance.

Results: A total of 224 patients were evaluated for non-compliance of 149 actionable BWs. There were 175 drugs with BWs prescribed, of which 107/175 (61%) were medications restarted from home. A total of 23 BW non-compliances occurred in 18 patients, and 13/23 (57%) occurred with home medications. Non-steroidal anti-inflammatories (NSAIDs) were the most common BW medication involved (81%), and the reasons for non-compliance were equally split between knowledge deficit and risk-to-benefit ratio. One possible ADR occurred related to a drug-drug interaction with ritonavir and antiarrhythmic co-administration.

Conclusion: This project illustrates BW non-compliance is a problem in the general medicine population, specifically in patients with high cardiovascular risk that are prescribed NSAIDs. Over half of BW non-compliance occurred in medications restarted from home, which emphasizes the need for improved transitions of care.