In 1999, the Institute of Medicine (now the National Academies of Science, Engineering and Medicine) published the report “To Err Is Human,” in which they warned that up to 98,000 hospitalized patients die per year due to a medical error. Further, they point out that the medication process is an example where implementing better systems will yield better human performance.

With patient safety in mind, in 2005 Congress passed the Patient Safety and Quality Improvement Act authorizing the creation of Patient Safety Organizations (PSOs), which conduct safety research to improve patient safety, quality of patient care, and provide education on improving safety practices in clinical practice.

Researchers from a PSO conducted a retrospective, blinded, observational study using a remote IV workflow verification system to monitor deviations from best practices and/or errors in the compounding of IV chemotherapeutic agents in two large U.S. hospital pharmacies over a 90-day period during January through April 2019. This paper is the report of findings of the certified PSO study that was designed to identify undetected errors or deviations in best practice not found by the IV workflow system. Time variables were assessed that involved IV preparation, review and approval times using time stamps, identification and analysis of medication waste, and cost assessments. Safety assessments were conducted on 5,656 images of 77 different chemotherapeutic agents obtained from the remote IV workflow verification system.

The PSO investigators reported on safety assessments, time flow and medication waste assessments, and cost assessments.

For safety assessments, investigators found that only 42.6% of images obtained demonstrated acceptable verification of the compounded medication. A major issue involved medications that exceeded the Institute for Safe Medication Practices’ (ISMPs’) >10% additive volume guidelines. Parenteral solution bags contain volumes of solution that are larger than the amount intended for administration (i.e., overfill) to account for loss that may occur during storage, due to container permeability, related to the specific contents, or because of the ratio of fluid volume to the container surface area. According to ISMP’s guidelines, during the preparation of IVs the voluntary rule of 10% is used to determine whether fluid should be removed from the solution container prior to adding the prescribed drug. If the volume of the additive medication will be >10% of the volume listed on the solution container, the volume of the additive, and sometimes the volume of the overfill, will be removed to assure that the patient receives the appropriate drug concentration. This is essential when dealing with chemotherapy.

Researchers found that in over one-third of doses (35.9%), the ISMP >10% guideline was not followed. Other deviations included inaccurate label dosing information (28.3%), inability to verify medications (10.4%), missing vials or syringes (6.9%), failure to use a closed-system drug transfer device when appropriate (5.7%), and use of inappropriate syringe size to accurately measure medication volume (4.0%).

Time flow and medication waste assessment revealed that it took 7.6-13.8 minutes to compound most medications. As the number of vials needed to compound an IV increased, so did compounding time. For medications using more than one vial, each additional vial added about 51 seconds to the total time. Iron, methotrexate, and obinutuzumab had the highest total compounding time, averaging >30 minutes. It was also observed that most IV chemotherapeutic agents were ordered between 11 a.m. and 2 p.m. Medication waste averaged <9 mL of waste per dose. However, bortezomib and dexamethasone were associated with the most drug waste. Stat (compared with non-Stat) orders were associated with more medication waste (9-15 mL versus 3-6 mL, respectively).

Unfortunately, one of the weakest parts of this paper is the cost assessment, as it was only based on one chemotherapeutic agent, gemcitabine. It also utilized data from a national purchasing contracting organization, and it estimated oncology pharmacists’ salaries. The authors report on gemcitabine cost based on the number of vials of drug used, the number of vial protectors needed, and the prorated cost of the pharmacist’s salary to compound the oncologic agent.

The report concludes by offering recommendations to enhance patients’ safety during the preparation and administration of parenteral chemotherapeutic agents. Among the suggestions are to utilize ready-to-administer formulations and robotic medication compounding technology.

This paper offers an in-depth analysis of deviations in best practices when compounding IV chemotherapeutic agents and serves as a blueprint for pharmacists involved in quality improvement in this area.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

« Click here to return to Infusion Pharmacy Update.