799

Abstract

Introduction: Medication boxed warning (BW) compliance has been evaluated for outpatients, but inpatient compliance rates have not been determined. The goal of this project was to determine BW compliance rates, assess prescribers’ reasons for noncompliance, and evaluate adverse drug reactions (ADRs) as a result of noncompliance in the intensive care unit (ICU). Hypothesis: BW noncompliance occurs in the ICU due to a lack of awareness of medication warnings, which may lead to ADR development. Methods: A group of four pharmacists evaluated over 400 BWs, with 150 actionable BWs deemed appropriate for inclusion. “Actionable” BWs were those that allowed for a pharmacist intervention to promote patient safety (i.e. drug-induced abnormal lab values). All medication orders for patients admitted to the medical and surgical ICUs were reviewed for BWs for 10 weeks. After a noncompliant episode occurred, the prescriber was notified to address the noncompliance. The pharmacist inquired as to the reason for noncompliance, and the prescriber’s response was documented. ADR monitoring occurred if a patient received a medication noncompliant to a BW. Causality analysis was performed with a published instrument to determine if an association existed between noncompliance and ADR development. Results: Data was collected for 169 patients. Overall, 84 patients (49.7% of all patients) were exposed to 118 medications with BWs. Antipsychotics (27%) were the most common medication class with a BW ordered. Noncompliance occurred 11 times for 10 patients (5.9% of all patients) and occurred most commonly with anti-infectives (27.3%) and immunosuppressants (27.3%). Risk-to-benefit ratio was the most common reason cited for BW violations (54.5%). One probable ADR occurred related to the coadministration of an aminoglycoside and vancomycin. Conclusions: These findings indicate medications with BWs are commonly prescribed within ICU settings, noncompliance is approximately 6% and resultant ADRs are infrequently encountered. BW noncompliance for antipsychotics may be of particular concern due to their increasing off-label use for delirium and potential adverse effects. Health care professionals should remain vigilant concerning BW and ADR monitoring.