Implementation and Pilot Evaluation of A Pharmacist-Led Optimization Tool for Subcutaneous Immune Globulin Administration in the Home Setting
Katie Laskin, PharmD, BCSCP, FNHIA, IgCP, CBSC Yale New Haven Health Home Infusion Katie.laskin@ynhh.org
Jill Yusko, RPh. Yale New Haven Health Home Infusion
Jennifer Bunk, PharmD Yale New Haven Health Home Infusion
Gene B. Decaminada BS Pharm, RPh, FNHIA, FCPA Yale New Haven Health Home Infusion
Nicholas LaRiviere PharmD, MBA, BCGP Yale New Haven Health Home Infusion
Abstract
Background
This study aimed to develop a standardized method and timeline for home infusion pharmacists to assess subcutaneous immune globulin (SCIG) regimens and perform interventions to optimize infusions based on patient tolerance and preference. A tool was built within the electronic patient management platform at a health system-affiliated home infusion pharmacy to aid in standardizing patient assessments and capturing interventions. This tool was tested over a period of 2 months.
Methods
Two patient assessment questionnaires were created and embedded within the home infusion pharmacy’s patient management platform. The first was an initial assessment to review current SCIG infusions and patient interest in infusion optimization and the second was a follow-up assessment 30 days following changes to SCIG regimen. These questionnaires were used by the pharmacist to assess adherence, tolerance, infusion optimization preferences, and patient satisfaction. Tasks within the patient management platform were designed to automatically trigger outreach tasks for the pharmacist to assess new SCIG patients. To identify patients who might benefit from SCIG infusion optimization, a review of the current census was performed. The pharmacist attempted to contact all patients receiving SCIG therapy dispensed by the health system home infusion pharmacy.
Results
During the 2-month period from November 2024 to January 2025, 35 patients were contacted and assessed using the tool. Of the patients contacted, 29 (83%) were interested in pharmacist-led interventions to optimize their SCIG infusions. Patient infusion optimization preference was divided between reducing the number of needles, reducing infusion time, and reducing both the number of needles and infusion time. Nineteen patients completed 30 days of their optimized SCIG infusions during the study period and were contacted for follow-up assessment. Of these, 18 patients (94.7%) reported no new systemic or local reactions and were satisfied with the changes made. No patients reported a change in adherence.
Discussion
The use of tasks and questionnaires embedded in the EMR assisted in identification of patients who were likely to benefit from SCIG infusion optimizations. The majority of patients contacted by the pharmacist were interested in implementing changes to optimize their SCIG infusions. After pharmacist interventions to optimize infusions, a majority of SCIG patients reported no new drug-related reactions and expressed satisfaction with the changes.
Conclusions
The testing of this tool demonstrated the substantial opportunity for home infusion pharmacist-led interventions to optimize SCIG infusions according to patient preferences, resulting in high patient satisfaction rates. Embedding this tool in the patient management platform provided an efficient method for identifying patients receiving SCIG and facilitated assessment by a pharmacist.
Key Words: Subcutaneous immune globulin, immunoglobulin, SCIG, infusion optimization
Introduction
Immune globulin (Ig) therapy is used for the treatment of many complex disease states, including primary immunodeficiency and a variety of immune-mediated disorders. There are more than a dozen Ig products available on the U.S. market and different formulations allow for administration of Ig intravenously, intramuscularly, and/or subcutaneously.1 Preferred administration methods in most cases are intravenous (IVIG) and subcutaneous (SCIG).2 Several advantages to subcutaneous administration include fewer systemic adverse events and the independence self-administration affords the patient.3
Common SCIG regimens range from administration daily to once every 2 weeks.4 Typically, administration is done utilizing a syringe pump, rate-specific tubing, and multibranch needle sets to allow for multiple infusion sites at once. When initiating a patient on SCIG, the pharmacist is often tasked with determining the rate and number of infusion sites for administration. This is based on product labeling, which contains more conservative volume and rate recommendations for the initial 1-2 infusions. After the patient has tolerated the first infusion(s), subsequent infusions can be customized according to patient tolerance and preference by adjusting the number of infusion sites and/or infusion rates within a wider established range.5-7 Without a protocol for assessing and adjusting infusions, patients may continue with the initial infusion regimen indefinitely.
An opportunity exists to develop a standardized method and timeline for home infusion pharmacists to assess SCIG regimens and perform interventions to optimize infusions. These infusion customizations should be based on patient tolerance and preference with a goal of increasing both patient satisfaction and adherence.
The purpose of this study was to develop a tool embedded within the electronic patient management platform to standardize home infusion pharmacist SCIG infusion assessments and interventions. The tool was then tested over a period of 2 months at a health system-owned home infusion pharmacy.
Methods
Tool Design
The first step in designing the tool was to create an initial patient questionnaire (Figure 1) for use by the home infusion pharmacist to assess a patient’s tolerance and compliance with the current SCIG therapy. The questions are used to identify any potential adverse reactions to SCIG that could be alleviated by adjusting needles, rate, or number of infusion sites. The questionnaire also aims to identify any potential barriers to adherence such as scheduling, forgetfulness or delivery coordination issues. If barriers to adherence are identified, the pharmacist would be able to counsel the patient on strategies to increase adherence or address operational issues within the pharmacy.
If the patient expresses interest in optimizing infusions, the questionnaire goes on to identify patient’s preferences for infusion optimizations. Patients are asked if they would prefer to shorten their infusion, reduce number of needles used, or if they would like to explore reducing both time and needles.
The questionnaire was embedded within the home infusion pharmacy’s patient management platform for easy access and documentation by the pharmacist. Use of the questionnaire made it possible to collect discreet data.
A second follow-up questionnaire was also embedded in the patient management platform to be administered by the pharmacist at least 30 days after any changes in infusion regimen were implemented (Figure 2). The 30-day time frame was chosen for 2 reasons. First, it would allow the patient to administer at least 2 doses of the updated regimen and second, it would align with the next refill coordination call to minimize patient outreach. The goal of the follow-up assessment was to assess any changes in patient tolerance or adherence, as well as to determine patient satisfaction with the updated SCIG regimen.
Outreach tasks were built within the pharmacy’s patient management platform and designed to automatically trigger for each new patient enrolled in the home infusion program receiving SCIG therapy. These outreach tasks prompt both the pharmacist’s initial assessment of SCIG infusions and pharmacist follow-up assessment of SCIG infusions after intervention following the cadence outlined in Figure 3.
Inclusion Criteria
To identify active patients who might benefit from SCIG infusion optimization, a review of the current patient census was performed. All patients receiving SCIG therapy dispensed by the health system home infusion pharmacy were manually assigned the assessment tasks by the pharmacy team. The tool was used to assess these active patients during regularly scheduled delivery coordination phone calls.
After go-live of the tool within the patient management platform, all new SCIG patients enrolled in the home infusion program were automatically assigned the outreach tasks and were contacted by the pharmacist approximately 30 days after initiating SCIG therapy for assessment.
The questionnaire in Figure 1 was administered by the home infusion pharmacist to all patients who were able to be contacted. The pharmacist then reviewed the patient’s current regimen and coordinated with the ordering prescriber to make changes to the infusion based on patient questionnaire response and product labeling recommendations.
The research involved secondary data analysis where the data set was deidentified before analysis and recorded in a manner where the resulting data contained no information that could be linked directly or indirectly to the identity of the patients. This study was therefore exempted from IRB review.
Results
During the 2-month period from November 2024 to January 2025, 35 patients were contacted and assessed using the tool. Demographics (Table 1) of the patients were a mean age of 55.7 years, including 2 pediatric patients. 80% (n=28) of the population was female. The mean days since SCIG initiation for the study group was 377.34. The predominant diagnosis was primary immunodeficiency (80%, n=28). The remaining 20% diagnosis included autoimmune encephalitis, optic neuritis, chronic granulomatous disease, small fiber neuropathy, monoclonal gammopathy, and mast cell activation syndrome.
Of those contacted, 11 patients reported experiencing local site reactions including leakage, lumps, and pain/ tenderness with their current regimen. Six patients reported systemic side effects such as headache, fatigue, and nausea.
During the assessments 29 (83%) expressed interest in pharmacist-led interventions to optimize their SCIG infusions. Patient infusion optimization preference (Figure 4) was divided between reducing the number of needles, reducing infusion time, and reducing both the number of needles and infusion time.
Pharmacist-led interventions to optimize infusions were captured based on the patient adjustment preference stated in the initial assessment. For patients who preferred a reduction in the number of needles, a mean reduction of 1.46 needles per infusion (37.3% reduction) in needles used was seen (Figure 5). For those patients preferring to reduce infusion time, a mean reduction of 27 minutes (33.3% reduction) in infusion time was seen (Figure 6). Finally, for the patients who requested a reduction in both the number of needles and the infusion time, a mean reduction of 1.09 needles per infusion (29.7% reduction) used and a reduction of 13.2 minutes (18.3% reduction) in infusion time was seen (Figure 7).
Out of the 29 patients who had SCIG infusion adjustments, 19 patients completed 30 days of the updated regimen and were able to be contacted by the pharmacist within the study period for follow-up assessment. Of the 19 patients contacted for follow-up assessments 18 (94.7%) reported no new systemic or local reactions. Eighteen of the 19 patients (94.7%) responded that they were satisfied with their updated SCIG infusions. No patients reported a change in adherence. One patient reported new local site reaction of increased redness and requested to return to the previous regimen.
Limitations
Not all the patients who had interventions performed to optimize infusions were contacted during the study period for follow-up assessment. Ten of the 19 patients with infusion changes did not receive 30 days of the new regimen prior to the end of the study period.
The assessments themselves had several limitations. First, the initial assessment did not specifically ask patients to rate their satisfaction with their initial infusion regimen. Future research could assess this prior to intervention and compare satisfaction rates following infusion changes. Additionally, the follow-up assessment only captured new systemic or local site reactions following infusion adjustments. There is opportunity to also capture improvements in systemic or local site reactions after interventions that existed previously.
Discussion
The use of questionnaires embedded in the home infusion pharmacy’s patient management platform created a standardized approach to identify and monitor patients who were likely to benefit from pharmacist interventions to optimize SCIG infusions. The pharmacist was able to utilize the questionnaires to gather information regarding the patient’s SCIG history, tolerance, and adherence, and apply that along with patient preferences to recommend a customized infusion regimen.
Pharmacists found that upon the initial assessment, most patients (83%) were interested in making changes to their SCIG infusions. This high rate of patient reception to pharmacist-led interventions highlights the impact home infusion pharmacists can have on the patient infusion experience.
Outreach tasks within the patient management platform acted as reminders for the pharmacist to perform patient assessments and to streamline ongoing management of SCIG patients. Assigning these tasks to all new SCIG patients will allow for closer pharmacist monitoring of this patient population going forward and eliminate the need to place manual reminders to track these patients.
After pharmacist interventions to optimize infusions, 18 of the 19 (94.7%) patients who completed 30 days of their optimized SCIG infusions reported no new drug-related reactions and expressed satisfaction with the changes. Although there was no reported change in adherence for the study patients, we expect there is a population of patients who find infusion time or number of infusion sites burdensome and for whom optimizations will help to increase adherence.
It is important to note that the patients included in this study had been on SCIG therapy for an average of 377 days. In some cases, patients were receiving infusions for many months as originally established upon initiating therapy without adjustment. Pharmacists were able to customize SCIG infusion experience by considering what was important to the patient for infusion optimization.
Conclusions
Through high satisfaction rates following pharmacist interventions, this study demonstrated the substantial opportunity for home infusion pharmacists to optimize SCIG infusions according to patient preferences. Embedding this tool in the patient management platform provided prompts to ensure each patient receiving SCIG is assessed by a pharmacist and receive standardized ongoing management to continuously evaluate infusion tolerance and adherence.
References
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3. Moore ML, Quinn JM. Subcutaneous immunoglobulin replacement therapy for primary antibody deficiency: advancements into the 21st century. Annals of Allergy, Asthma & Immunology. 2008;101(2):114-21. doi: 10.1016/s1081- 1206(10)60197-4.
4. Epland K, Suez D, Paris K. A clinician’s guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. Allergy, Asthma & Clinical Immunology. 2022;18(1). doi: 10.1186/s13223-022-00726-7.
5. Cutaquig (Immune Globulin Subcutaneous (Human) – hipp). [Package Insert]. Pfizer Laboratories; New York, NY. March 2025.
6. Hizentra (Immune Globulin Subcutaneous (Human). [Package Insert]. CSL Behring; Kankakee, IL. April 2023.
7. Xembify (Immune Globulin Subcutaneous (Human) – klhw). [Package Insert]; Grifols USA; Research Triangle Park, NC. July 2024.
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