Deviations From Best Practice: Findings From a Certified Patient Safety Organization Remote-Verification Observational Study of Intravenous Compounding of Chemotherapeutic and Ancillary Drugs

Abstract

Background Chemotherapeutic and immunomodulatory medications can pose a serious risk to patient and healthcare provider safety because of complex processes, cytotoxicity, and prevalent medication use. Objective To evaluate chemotherapeutic and ancillary medication compounding in hospital pharmacies using a remote verification system, focusing on pharmaceutical deviations from best practice, compounding time, medication waste, and cost. Methods This retrospective, blinded observational study used a remote intravenous (IV) workflow verification system to examine IV chemotherapeutic compounding errors in large hospital systems. A Patient Safety Organization securely obtained >5000 compounding records and photos from the IV workflow system. Blinded pharmacists evaluated IV chemotherapy preparations using picture slide viewers to assess any deviations from best practice. Time variables, medication waste, STAT vs non-STAT orders, and cost were also evaluated. Results The most frequently reported deviations from best practice included medications exceeding the >10% additive volume guideline (35.9%) and inaccurate dose labels (28.3%). Time flow analyses demonstrated a substantial increase in total compounding time per vial for 1 vs 2 vials. Most medications in this analysis had an average waste ranging from 0-.36 vials. STAT orders, accounting for 38.4% of all orders, wasted more medication than non-STAT orders. Gemcitabine cost analyses showed an association for number of vials and compounding time with overall cost per dose. Conclusion Substantial inconsistencies between workflow stations were observed—highlighting the lack of standardization across chemotherapeutics, volume of medication waste during preparation, and the need to establish improved quality controls to safeguard patient and health care provider safety.