Use of a Lipid Screening Tool to Identify Patients at Greater Risk of Infusion Reactions to Lipids in the Home Setting

Background Parenteral nutrition (PN) containing lipid has potential for causing hypersensitivity related reactions due to the components that make up the intravenous lipid emulsions (ILE). There are 5 different brands of lipids approved in the U.S. for use in PN: Intralipid® (Fresenius Kabi) and Nutrilipid® (B. Braun), SMOF® (Fresenius Kabi), Clinolipid® (Baxter), and Omegaven® (Fresenius Kabi). As reported in the literature, rates of infusion reactions increase in patients with higher risk of hypersensitivity to fish, egg, soybean, or peanut protein. At present, there is limited clinical guidance specific to the home setting for monitoring and administration of the first dose of lipid. Due to this, home infusion organizations have traditionally imposed strict protocols, including required nursing observation time, when administering new ILE formulations. A lipid risk screening tool was previously implemented by this organization to ascertain patients at minimal risk for reaction and allow greater flexibility in patient care surrounding first doses of lipids. Secondary benefits of the lipid risk screening tool included the optimization of limited nursing time available and decreased costs and waste associated with unused anaphylaxis kits. The lipid risk screening tool assesses the potential level of risk the patient may experience based on previous use of ILE products; history of reaction to components such as eggs, soybean products, peanuts, and fish; history of anaphylaxis reactions to ILE or components; history of mild to moderate reactions or no history of reactions to ingredients or potential ingredients. Although there is high potential for hypersensitivity, the reporting shows low incidence of hypersensitivity reactions from previous published literature. Purpose The primary objective of this study was to compare the resources utilized when using a lipid risk screening tool versus the resources utilized previously without the use of a lipid risk screening tool. Specifically, this study assessed nursing time and drug costs related to the dispensing of anaphylaxis kits. The secondary objective was to assess the tolerability of ILE first doses in the home. It was hypothesized that ILE first doses in the home would be well tolerated after clinical review of patients using the lipid risk screening tool. Methods This was a multi-center, retrospective chart review and analysis. Data was collected from electronic medical records and internal surveillance software. Inclusion criteria were patients with whom the lipid risk screening tool was utilized over a period of 12 months. Exclusion criteria included patients less than 18 years of age, and ILE conversion that did not meet risk stratification (i.e., soy-based product conversion to soy-based product). A cost analysis was completed to assess nursing time reduced, and medication dispenses avoided as a result of utilizing the lipid risk screening tool, as compared to the previous process. The patient charts were reviewed for infusion reactions of ILE first dose administration. Results During the 12-month period reviewed, there was a reduction in resources utilized as a result of the lipid risk assessment tool. Drug utilization related to anaphylaxis kit usage decreased, which resulted in a 99.3% drug cost reduction. There was also a 98.2% reduction in nursing time with the use of the lipid risk screening tool versus the previous method. For the secondary objective of ILE first dose tolerability, the percentage of patients determined to be at any level of risk for ILE infusion reactions was 1.2%. The at-risk population for infusion reactions was determined to have 66.7% of patients at low risk, 11.1% at mild-moderate risk and 22.2% at high risk (see Figure 2). There were no hypersensitivity reactions reported with the at-risk population. The types of allergies for the at-risk population are shown in Figure 3. Discussion Hypersensitivity to the components of parenteral nutrition (PN) is a rare but important complication of PN. Resources used in connection with hypersensitivity reaction were expected to be lower when utilizing the lipid assessment tool prior to first doses of ILEs in the home. As hypothesized the results showed lower cost utilization and nursing time with the lipid assessment tool. A limitation of the study was voluntary reporting and manual documentation of adverse events. Conclusions This study demonstrated the utility of the lipid risk screening tool in appropriately assessing level of risk and potential need for additional resources. The lipid risk screening tool significantly reduced cost as well as time required by nurses to monitor patients for potential reactions. This study shows there is an opportunity to develop further training, education, and insight for optimal usage of the lipid risk screening tool.