Abstract

Introduction: USP general chapter < 800> establishes comprehensive guidelines for safe handling of hazardous drugs, including some antiepileptics, by healthcare personnel. This guidance increases the number of steps required to safely compound and deliver medications, potentially resulting in a delay of care for time-sensitive medications. The aim of this study is to assess the impact that implementation of USP < 800> had on the timeliness of administration of antiepileptic medications at an academic medical center. Methods: A single center, retrospective study of time from verification to administration pre- and post-USP < 800> implementation of adult one-time orders of intravenous (IV) fosphenytoin (FOS), phenytoin (PHT), and valproic acid (VPA) was conducted. The study period includes 10 months immediately prior to adoption of USP < 800> and five months post adoption. One-time orders were included if scheduled administration time was within 90 minutes of verification. The primary outcome was time in minutes from order verification to medication administration. Subgroup analyses compared the results based on method of medication delivery (pneumatic tube system (PTS) vs hand delivery) and if orders were designated as “STAT”. Results: A total of 248 orders met inclusion criteria: 33 FOS, 12 PHT, and 203 VPA, (pre: 176, post: 72). Time from verification to administration was 15 minutes longer in the post-implementation group for aggregate antiepileptic orders (54 [35-72] vs 69 [48-90], p=0.0013). This increase in time to administration post-implementation was comparable across each of the medications assessed. Subgroup analysis of orders marked as “STAT” showed a similar increase in median time to administration (43 [28-65] vs 56 [34-86], p=0.0406). There was no difference in time to administration comparing PTS to hand delivery (71 [46-109] vs 68 [51-88], p=0.6603). Conclusions: Implementation of USP < 800> increased the median time from order verification to administration for three hazardous IV antiepileptic medications. In patients with status epilepticus, a 15 minute delay could prolong time to seizure termination resulting in worse clinical outcomes. Institutions will need to develop alternative methods for compounding and delivery to ensure timely administration while maintaining safety.

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