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Prospective Assessment of Inpatient Boxed Warning Prescriber Adherence

Kloet, Megan A. PharmD, BCPS; Lohr, Brian R. PharmD; Smithburger, Pamela L. PharmD, BCPS; Seybert, Amy L. PharmD, FASHP, FCCP; Kane-Gill, Sandra L. PharmD, MSc, FCCM, FCCP

doi: 10.1097/PTS.0000000000000101
Original Articles

Objective To evaluate medication boxed warning nonadherence in the inpatient setting.

Methods This was a prospective cohort quality improvement project approved by our institution’s Total Quality Council. General medicine and ICU patients 18 years and older were included if they were cared for by a prescriber-led multidisciplinary team that included a pharmacist. Patients were evaluated for medication orders with an actionable boxed warning; if boxed warning nonadherence occurred, the physician’s reason was determined. Patients with boxed warning nonadherence were monitored for adverse drug reactions until discharge.

Results A total of 393 patients (224 general medicine and 169 ICU) were evaluated for nonadherence to 149 actionable boxed warnings. There were 293 drugs (175 general medicine and 118 ICU) with boxed warnings prescribed, and more than 50% of these were medications restarted from home. A total of 23 boxed warning nonadherences occurred in general medicine patients, and NSAIDs accounted for 81% of these events. ICU patients experienced 11 boxed warning nonadherences, with nearly 54% from anti-infectives and immunosuppressants. Antipsychotics were the most commonly ordered boxed warning medication class in ICU patients. Reasons for nonadherence included knowledge deficit and an acceptable risk-to-benefit ratio. Two adverse drug reactions occurred from boxed warning nonadherences, both because of a drug-drug interaction.

Conclusions Boxed warning nonadherence is a concern in the inpatient setting, specifically with NSAID use in general medicine patients and antipsychotic use in ICU patients. More than half of boxed warning nonadherence occurred in medications restarted from home, which emphasizes the need for medication evaluation during transitions of care.

*From the PGY2 Critical Care Resident, †Critical Care Pharmacist, University of Pittsburgh Medical Center; ‡Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy; Department of Pharmacy and Therapeutics; Critical Care Pharmacist, Medical Intensive Care Unit, §Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy; Director, Critical Care Pharmacy Specialty Residency, University of Pittsburgh Medical Center; and ∥Pharmacy and Therapeutics, Clinical Translational Science Institute and Critical Care Medicine, Schools for Pharmacy and Medicine, University of Pittsburgh; Critical Care Medication Safety Officer, Department of Pharmacy, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Correspondence: Sandra L. Kane-Gill, PharmD, MSc, FCCM, FCCP, University of Pittsburgh, School of Pharmacy, 918 Salk Hall, 3501 Terrace St., Pittsburgh, PA 15261 (e-mail:

Conflicts of Interest and Source of Funding: The authors have no conflicts of interest to report.

No financial support was obtained for this project.

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