Quality improvement project - Implementation of subcutaneous immunoglobulin in patients with haematological disorders and secondary immunodeficiency

Abstract

Background

Immunoglobulins (Ig) play a crucial role in the immune system’s ability to fight infections. In incidences when their production and function is disrupted, such as in secondary immunodeficiency (SID), patients often face increased frequency and severity of infection, particularly respiratory tract infections. Ig replacement therapy administered intravenously (IVIG) or subcutaneously (SCIG) is recommended for treatment of SID, including SID caused by haematological malignancies. Subregional Ig assessment panels (SRIAPs) and prefilled syringes (PFS) for SCIG may positively impact services across the Trust and wider National Health Service (NHS) and increase patient satisfaction and treatment outcomes.

Objectives

Investigate the improvement in service delivery and patient satisfaction following the switch from IVIG to SCIG PFS manual push in patients with SID following an East of England Immunoglobulin Assessment Panel (EOE IAP) review.

Design

Following establishment of the EOE IAP, three cohorts of patients with haematological disorders and SID, currently receiving IVIG across the Mid and South Essex NHS Foundation trust, were reviewed before switching to SCIG PFS. This manuscript reports the findings from one of the three cohorts, based at Broomfield Hospital.

Methods

Following clinical screening, patients were reviewed by the local SRIAP to assess Ig use and suitability for transfer from IVIG to SCIG PFS. Patient outcomes and satisfaction, financial measurements, and prescribing information after transition were recorded.

Results

SRIAP review of Ig prescribing for ten patients resulted in six transitioning from IVIG to SCIG PFS. Patients reported improved infection rates and satisfaction with home-based SCIG PFS treatment. Service outcomes reported savings in prescribing, pharmacy, and nursing time, as well as an increase in therapy chair capacity.

Conclusion

SRIAP reviews and switching to SCIG PFS can improve patient satisfaction and outcomes, help clinically vulnerable patients shield via home-based treatment, improve service efficacy and lower total treatment costs, whilst promoting Ig stewardship.

Introduction

Immunoglobulins (Ig) play a critical role in the linking of humoral and cellular immune responses, and an individual’s ability to combat infections. ¹ These heterodimeric proteins are diversely expressed and produced by B cells in response to the presence of foreign antigens, such as bacteria or viruses. Immunoglobulins act directly by virus and toxin neutralisation, and indirectly by specific binding and marking of antigens and subsequent destruction by other immune cells. ¹

Secondary immunodeficiency (SID) is an impairment of immune response, including disruption in Ig production and/or function, due to factors extrinsic to the immune system.^2–4 Such factors include underlying conditions such as haematological malignancy, medical treatments including chemotherapy, and environmental conditions and infectious agents.^2–4 SID is characterised by low immunoglobulin G (IgG) levels, referred to as hypogammaglobulinaemia (IgG <6 g/L) and an increased frequency of recurrent, prolonged, or severe infections.^2–4

Ig replacement therapy (IgRT) involves the administration of Ig products, helping to provide antibodies to reduce the risk of severe or frequent infections.^2,3,5 IgRT may be used in cases of SID with low IgG levels (IgG <6 g/L) to supplement immune function.^5,6 IgRT may be particularly useful for patients with respiratory comorbidities such as chronic obstructive airway disease. ⁷ IgRT use is recommended for treatment of SID in patients with haematological malignancies where patients have severe hypogammaglobulinaemia (IgG levels <4 g/L), or experience severe, recurrent or persistent infections despite anti-infective treatment. ⁸ IgRT can be administered intravenously (IVIG), typically in a hospital setting, or subcutaneously (SCIG). ⁹ SCIG can be self-administered at home following comprehensive training from a reliable and experienced healthcare provider, followed by a clear competency assessment of patients and/or carers. ⁹ Both routes of administration display acceptable safety profiles, with comparable protection against infections in patients with SID. ¹⁰ Prefilled syringes (PFS) offer an additional method of SCIG delivery to traditional vial and syringe administration.^11,12 PFS may improve access to IgRT for patients with poor dexterity, coordination issues or visual difficulties, and are associated with an overall improvement to patient quality of life and treatment satisfaction. ¹²

Whilst both routes of administration have benefits, SCIG is often associated with a range of advantages when compared with IVIG. Treatment-related benefits include shorter infusion preparation times, shorter infusion times, and no requirement for venous access.^13,14 SCIG use is also associated with fewer systemic adverse events (AEs) compared with IVIG, due to slower absorption. ¹⁴ Additional benefits include better patient satisfaction, as measured by treatment satisfaction questionnaire for medication, version II (TSQMII), and better perception of overall health. ¹⁵ The simplicity and flexibility of SCIG is amplified by PFS, further reducing treatment burden and increasing patient independence. ¹⁶ The clinical and lifestyle needs of individual patients should be evaluated when considering each route of administration. ⁹

Over recent years, Ig product supply has been reduced and unstable due to international market forces, and regulatory and technical issues with product manufacture and supply chains.^17–21 This is compounded by international plasma shortages, partly by decreased plasma donations throughout the coronavirus disease 2019 (COVID-19) pandemic, and further amplified by an increase in approved indications and global access to Ig products. ¹⁹ This supply and demand imbalance has significantly impacted patients with primary (PID) and SID and their treatment options.^19,22 During the COVID-19 pandemic, individuals across the United Kingdom (UK) receiving long-term IgRT experienced dose reductions or even the withholding of treatments, if clinically appropriate, to help conserve Ig supply. ²² Additionally, shielding advice reduced hospital visits, limiting infusions and Ig monitoring. ²² This conservation of supply naturally impacted specific cohorts of patients who were reliant on Ig therapy, reducing access to optimal therapeutic doses.

To address this issue, Ig stewardship has become increasingly important. This stewardship involves clear commissioning guidelines to ensure effective and efficient Ig use, prioritising patients with no alternative treatment options.^20,23,24 Subregional Ig assessment panels (SRIAPs), such as the East of England Immunoglobulin Assessment Panel (EOE IAP), have been set up to monitor and control prescribing practices, optimise dosing regimens, and promote alternative treatments where clinically appropriate.^24,25 Implementation of these panels allows healthcare providers to ensure that Ig products are used appropriately and sustainably, thereby reducing the risk of shortages, and ensuring that patients receive the care they need.

Aim

Prior to quality improvement (QI) process initiation, patients receiving IVIG received only sporadic review by their specialist team and lacked routine therapeutic monitoring. In addition, some patients were receiving inappropriate dosing, leading to sub-clinical treatment.

The development of the EOE IAP provided an opportunity to review the haematology cohort of patients receiving long-term IVIG across three sites (Broomfield Hospital, Basildon University Hospital and Southend University Hospital) and implement dosing and regimen changes as clinically appropriate.

Following the establishment of the EOE IAP, three cohorts of patients with haematological malignancies and SID, currently receiving IVIG across the Mid and South Essex NHS Foundation Trust, were reviewed before switching to SCIG PFS. The Trust, which was formed in April 2020 following the merger of Mid Essex, Southend and Basildon Hospital trusts, is one of the largest trusts in the UK and delivers services to a population of around 1.2 million across Mid and South Essex.

Here, we present the initial findings of switching patients from IVIG to SCIG PFS manual push following EOE IAP review at Broomfield Hospital. Similar schemes are currently underway at the Basildon and Southend University Hospital sites.

Methods

Design

All patients receiving IVIG for SID due to haematological malignancy at Broomfield Hospital were clinically reviewed by a haematologist and senior clinical pharmacist before they were submitted to the EOE IAP for further clinical evaluations and approval for use of Ig therapy (Figure 1). Patients were included whether or not they were receiving treatment for their haematological malignancy. The full list of inclusion and exclusion criteria are shown in Table 1. Once patients were reviewed and dosing was optimised, patients were screened for suitability to change to SCIG PFS.

Figure 1.

Flow chart to show patient’s progress from clinical review to transfer to homecare. EOE IAP, East of England Immunoglobulin Assessment Panel; IVIG, intravenous immunoglobulin; PFS, prefilled syringe; SCIG, subcutaneous immunoglobulin.

Table 1.

Inclusion and exclusion criteria.

Inclusion criteria	Exclusion criteria
Adult patients above 18 years old	Patients younger than 18 years old
Patients with confirmed SID	Patients with haematological malignant diagnosis but no evidence of SID (IgG >6 g/L)
Patients who are either on Ig replacement or about to be started	Patients with confirmed neuromuscular disorders impairing dexterity in absence of family support
Patients with adequate dexterity	Patients who were not willing to switch to SCIG
Patients with adequate eyesight

Ig, immunoglobulin; SCIG, subcutaneous immunoglobulin; SID, secondary immunodeficiency.

Screening

Each patient underwent a detailed review of their haematological diagnosis, previous treatments, trough Ig levels, and infection and anti-microbial treatment history. In addition, several factors were measured and recorded including patient co-morbidities (e.g. bronchiectasis), therapeutic monitoring (e.g. Ig levels), and up-to-date dose determining weight (DDW; a computerised algorithm that adjusts weights up/down to an ideal body weight for patients who are under/overweight). Infection history, including type of infection, use of prophylactic and therapeutic antimicrobials, microbiology cultures and immunisation history, was also recorded.

Dosing

Patients’ treatment doses were previously optimised based on their most recent DDW and Ig levels. However, following clinical approval for SCIG, patients with haematological malignancies were dosed on actual body weight (400 mg/kg body weight for a 4-week period; 100 mg/kg per week). Therefore, in cases where patients were overweight, there was an increase in Ig dose. Patient clinical outcomes in terms of infection history were also considered. To align with vial/pre-filled syringe sizes and make administration practical, weekly doses could be alternated to get an average (i.e. if a patient required 7 g/week, they could be prescribed 6 g in week one and 8 g in week two which best fits pre-filled syringe volumes.)

Switch from IVIG to SCIG

Following clinical approval for Ig use from EOE IAP, patients were reviewed to assess their suitability to switch from IVIG to SCIG. This decision considered the clinical appropriateness, as well as the patients’ ability to manage home-based therapy. Contributing factors to this decision included manual dexterity, visual acuity, and the ability/capacity to self-administer treatment and store substantial quantity of medication, as tasks such as opening packaging and preparing the medication require fine motor skills and coordination. Eligible patients and carers were then trained by in-house nurses to self-administer SCIG treatment and received a supply of SCIG through the pharmacy. All training was undertaken at Broomfield Hospital, conducted by a band 7 nurse. Training included two to six sessions, each a week apart. Each session was 45–60 minutes in length, which involved training in how to administer SCIG injections, signing-off competencies and training the patient and/or carer regards managing the home-based treatment and possible drug reactions. Patients were also informed of the routine monitoring (Ig trough levels, infection rates, culture results, computed tomography and chest x-ray reports) they would now need to undertake before being transferred to receive their treatment via homecare. The number of sessions provided was based on the confidence of each patient and/or their caregiver to administer their treatment at home. Once patients and/or their caregivers were confident, the hospital pharmacy Clinical Homecare team and the Community Pharmacy Patient Services team worked together with the Specialist Haematology team, including the prescriber, to ensure that patients who administer their own treatment at home got a bespoke service and receive the necessary drugs and ancillaries that are needed to be able to carry out the treatment successfully. A repeat prescription (usually for 6 months) was generated for each patient using the prescribing template from the Homecare team. Once reviewed clinically by the pharmacist for suitability it was passed on to the internal pharmacy homecare team who were responsible for doing the appropriate administration and sending the prescription to the homecare provider. The homecare provider then supplied pre-filled SCIG along with all necessary ancillary items such as butterfly needles, cleaning wipes, cotton wool and a sharps bin for safe sharps disposal. They also support continuity of care by contacting the patient about stock levels and next drug delivery date and sending reminders to the hospital-based homecare team when repeat prescriptions were due for renewal (6 months). Clinical reassessment schedules varying by regional guidelines and patient needs.

Data collection

Data were collected via a range of patient-reported and quantitative assessments. These included patient satisfaction from anecdotal communication and an emailed in-house developed survey (Supplementary Material 1), financial records, and prescribing, dispensing and administration times data.

Chair time was calculated by asking nurses in the infusion day unit to record the total duration each patient spent in the chair. This encompassed clinical observations, collection of relevant blood samples, documentation of infection history, preparation and administration of the immunoglobulin infusion, nursing documentation, and the required post-infusion observation period. The mean chair time was then determined and extrapolated across the cohort of patients who underwent the treatment switch to estimate the annual time saving.

Nursing time was based on time to schedule an appointment for infusion, the actual infusion time, time to take bloods, waiting for drugs, writing up notes, and discussing and implementing rate adjustments. The mean time was then applied across the pilot cohort to estimate the corresponding annual saving.

Prescribing time was calculated as the average duration required to generate a clinically safe immunoglobulin prescription for a patient. For pharmacy staff this involves clinically screening the prescription (including reviewing blood results, infection history, and any updates from the EOE IAP panel regarding dosing), the dispensing and checking process, as well as uploading the batch numbers and other information onto the Ig database for each patient. The SCIG PFS prescribing time involved processing a bespoke prescription consisting of one new and one repeat prescription, twice a year, and screening by the pharmacy staff before sending to the homecare pharmacy via the Clinical Homecare team. The mean time was then applied across the pilot cohort to estimate the corresponding annual saving.

Pharmacy time was estimated using data from the pharmacy prescription tracking system. A cohort of prescriptions was monitored over the course of one month to generate an average time per prescription. This included the interval from receipt of the prescription in pharmacy through clinical screening, dispensing, assembly of the product, and final accuracy check prior to release. The mean time was then applied to the relevant patient numbers to calculate the projected annual saving.

Results

Patients

In total, ten patients receiving, or in need of starting IVIG for haematological malignancies at Broomfield Hospital were clinically reviewed. Of these patients, nine were submitted to the EOE IAP resulting in three patients having their IVIG treatment discontinued due to lack of clinical benefit. The remaining six patients, reviewed by the EOE IAP, were deemed eligible for SCIG PFS. However, one patient was unable to complete a switch from IVIG to SCIG due to visual impairment. Of these eligible patients, three had their doses optimised to a clinically therapeutic dose for optimal effect and tolerability. Of the five patients who started SCIG (Table 2), all were trained in-house by a nurse to self-administer, including two patients who received SCIG PFS by caregiver administration. Of the five patients who initiated SCIG treatment, two had only recently been prescribed Ig but had not yet received any infusions; they therefore commenced directly on SCIG. The remaining three patients had been receiving IVIG for several years and transitioned to SCIG following appropriate training. An average of four training sessions were required to enable patients and/or their caregiver to feel confident with home treatment practices. Post-training, one patient remained receiving SCIG within a hospital healthcare professional (HCP) setting as they needed weekly blood tests, however she has since now converted to home SCIG administration. Patients received 20–30 g of SCIG per four-week period (400 mg/kg/4 weeks), divided into a weekly dose (Table 2).

Table 2.

Demographics and clinical characteristics of the five patients who switched from IVIG to SCIG PFS.

​	Total (N=5)
Age (years)
Mean (SD)	74.8 (6.94)
Sex, n (%)
Female	3 (60)
Male	2 (40)
Ethnicity, n (%)
Caucasian	5 (100)
Secondary antibody deficiency, n (%)
Chemotherapy/immunotherapy for treatment e.g. CLL, AML, myeloma	5 (100)
Dose range, g (mg/kg) for a 4-week period *	20–30 (400)
Number of patients receiving prophylactic antibiotics, n (%)	4 (80)
Number of patients with a history of bronchiectasis, n (%)	5 (100)
Patients reporting infection history, n (%) †
Requiring antibiotics/hospitalisation prior to SCIG PFS	3 (60)
Patients managing to self-inject, n (%)
No dependence on family support, carers, or district nurses	3 (60)

AML, acute myeloid leukaemia; CLL, chronic lymphocytic leukaemia; SCIG PFS, subcutaneous immunoglobulin prefilled syringe; SD standard deviation.

^*Patients who previously received IVIG were dosed according to an up-to-date DDW, where a computerised algorithm adjusted weights up/down for patients who were under/overweight, to provide an ideal body weight. After switching to SCIG, patients were dosed according to actual body weight.

^†Patients were encouraged to maintain an infection history diary, documenting the type of infections they experienced, whether treatment was needed, and if hospitalisation occurred. This information was reviewed periodically during assessments with the EOE IAP to help determine whether the current dosage was appropriate, needed adjustment, or if the patient might benefit from prophylactic antibiotics to help reduce their risk of future infections. This information was shared with the team on a monthly basis.

Benefits

The introduction of EOE IAP review of Ig prescribing demonstrated improvements in both clinical and service outcomes. Improved infection rates were observed via regular (3-month) reviews of a patient-recorded ‘infection diary’, with no infections being reported throughout the QI process period. Regular reviews of Ig trough levels also demonstrated a slight improvement. These reviews resulted in appropriate dose adjustments to find individualised optimal dose regimens for each patient.

Improved patient outcomes were observed in terms of quality-of-life aspects reported during HCP/patient communications. Such improvements included increased patient satisfaction due to no longer having to attend hospital for lengthy infusions, an increased shielding of clinically vulnerable patients, and provision of clinically therapeutic doses to increase efficacy.

A total of four patients considered for SCIG PFS responded to a patient satisfaction survey. Patients were asked how they perceived their SCIG PFS experience using a four-point scale from strongly agree to strongly disagree. A total of 75% (n=3/4) of patients strongly agreed that during training, the nurse explained the process well and answered any questions they had, resulting in 75% (n=3/4) of the patients strongly agreeing that they felt they had become competent enough to start therapy at home. Overall, 75% (n=3/4) strongly agreed that the Day Therapies staff could help them with any concerns and questions, with 75% (n=3/4) of patients strongly agreeing that their haematology consultant provided sufficient information. All patients strongly agreed or agreed (25% [n=1/4] and 75% [n=3/4], respectively) that they benefitted from home-based treatment rather than attending hospital and that the homecare pharmacy and deliveries worked well. All patients strongly agreed (50%, n=2/4) or agreed (50%, n=2/4) that the process of giving themselves weekly injections was easy, and most patients strongly agreed that SCIG was just as effective in terms of feelings of wellness as IVIG (75%, n=3/4) (Figure 2). No patient reported any local side effects, such as local injection site reactions.

Figure 2.

Patient satisfaction survey results. IVIG, intravenous immunoglobulin; SCIG, subcutaneous immunoglobulin.

Improvements in service outcomes included an annual saving of 14 hours of prescribing time and 42 hours of pharmacy time, as well as a decrease in dispensing time through patients moving into homecare. An annual saving of 336 hours in therapy chair capacity was also observed, as well as an annual re-distribution of 126 hours of nursing time to be focused into other clinical services such as monitoring and varying infusion rates (Figure 3).

Figure 3.

Annual benefits of SCIG PFS at Broomfield Hospital. Ig, immunoglobulin; SCIG PFS, subcutaneous immunoglobulin prefilled syringe.

Several financial benefits were observed including an annual saving of 600 g of Ig product through optimisation of dosage by dose adjustments per weight and clinical response to treatment, no hospital transport costs due to patients receiving treatment in their homes and in-house training of self-administration rather than relying on external providers. The nursing staff were trained in-house by an Ig clinical nurse specialist who is part of the EOE IAP.

Cost saving of these measures as extrapolated across the entire Trust are shown in Figure 4.

Figure 4.

Projected annual benefits of SCIG PFS across the Trust. Ig, immunoglobulin; SCIG PFS, subcutaneous immunoglobulin prefilled syringe.

Discussion

As the supply and demand of plasma-derived Ig is in fine balance, appropriate use of IgRT is essential to ensure appropriate patient access.^17–19 A European expert consensus previously recommended that regular follow-up for recurrence of infections and hypogammaglobulinaemia after initiation of IgRT in patients with haematological malignancies is necessary, and that dose adjustments and discontinuation should be determined on a per-patient basis. ⁸ However, despite these recommendations, haematology patients receiving IVIG at Broomfield Hospital have historically received only sporadic review by their specialist team and lacked routine monitoring, which has the potential for inappropriate IgRT use or sub-optimal dosing. In this QI process, following the establishment of EOE IAP, a third of patients in a cohort with haematological malignancies receiving IVIG at Broomfield Hospital had their IgRT discontinued following panel review due to lack of clinical benefit, and a third of patients had their IgRT dose adjusted to improve efficacy and tolerability. These findings demonstrate that through the implementation of SRIAPs, a regular and frequent review of therapeutic response to IgRT (monitoring infection frequency and Ig levels) can ensure patients receive optimal dose regimens and prevent unnecessary IgRT use.

Previous studies have demonstrated increased patient satisfaction with SCIG treatment regimens when compared with IVIG due to shorter infusion times, the lack of requirement for venous access, improved convenience and flexibility, and reduced incidence of AEs.^{13,14,16,26–29} In this QI process, patients (or their carers) were taught to self-administer their SCIG infusions within two to six sessions, and a large majority of patients strongly agreed they were satisfied by their training experience and the aftercare support provided. A previous study demonstrated that favourable training characteristics (such as high confidence post-training and no training barriers) can substantially increase the probability of patients experiencing higher treatment satisfaction and quality of life. ³⁰ Similarly, we observed an improvement in patient outcomes following a transition from hospital-based IVIG to home-based SCIG. Patient-recorded improvements included increased simplicity of administration and convenience to prepare, greater patient independence, and reduced treatment burden covering no longer having to attend lengthy infusions at the hospital. Furthermore, studies have demonstrated that SCIG home use can increase shielding of clinically vulnerable patients, further highlighting the benefit of home-based treatment.^27,28 All patients agreed that their SCIG was as efficaceous as their previous IVIG; anecdotal evidence that is well supported by studies demonstrating that IVIG and SCIG are both effective and well-tolerated treatment options.^9,13

In addition to improvements in clinical outcomes for patients, service improvements were also observed following a switch from IVIG to SCIG PFS. Using a homecare service significantly improved efficiency across multiple areas of the care pathway. A key benefit was that repeat prescriptions were now generated every six months, eliminating the need for monthly prescribing and reducing the administrative burden on the clinical team. Pharmacy involvement was also been streamlined, with prescriptions requiring clinical verification only twice a year, and dispensing responsibilities outsourced to the homecare provider. This reduced pressure on the dispensary, freeing up capacity to focus on time-sensitive tasks and support for other clinics. Additionally, chair capacity and nursing time in the hospital were freed up, as patients now received treatment in the comfort of their own homes. We observed an annual saving of 336 hours of day therapy chair capacity following a switch from IVIG to SCIG. This has the potential to allow movement of services currently carried out in the Same Day Emergency Care clinic to the day therapy unit, improving the flow of patients through the emergency floor. Services that could benefit from this switch include iron infusions, blood product transfusions, electrolyte replenishment and intravenous antibiotics. This is in line with current studies that have shown a switch to SCIG from IVIG could lessen nursing burden and may increase clinic-based capacity for others. ³¹

We also observed financial benefits associated with a transition from IVIG to SCIG in line with current literature.^32,33 These included saving of already limited Ig product of up to 600 g annually, and a removal of hospital transport costs associated with clinic visits for IVIG. A further financial benefit was seen with the utilisation of in-house training of self-administration, removing the reliance on external training providers. A Canadian study also found a switch to SCIG from IVIG to be less costly from a healthcare payer perspective. ³¹ This lower cost per-patient-year included the cost of initial training for self-administration of SCIG, ambulatory care clinical visit costs for IVIG, and preparation and dispensation costs for both routes of administration. This QI process also analysed available data to demonstrate that a switch of 50% of patients from in-clinic IVIG administration to self-administration of SCIG would result in an estimated $19.4 milllion (95% CI: $18.1–$20.2) cost-reduction for the Canadian healthcare system. ³¹ Studies of other therapies have shown significant cost savings following transition from vials to PFS, including a study that showed a 61% reduction in treatment costs associated with the use of thiopental PFS compared with thiopental vials in a UK hospital. ³⁴ Together, these studies suggest that switching patients from IVIG to SCIG PFS could have significant cost savings for healthcare systems.

Since the initiation of the QI process described in this report, additonal patients have been added to the cohort due to increased use of novel cellular therapies that are associated with a risk of developing SID, including bispecific antibodies and chimeric antigen receptor T cell (CAR T) therapy.^35–37 Two other Trust sites have also joined the data collection and standardisation process. We anticipate further cost reductions at mass level despite increased referrals.

This QI process was limited by available sample size and therefore any conclusions of the broader impact on the NHS must use extrapolated data compounded against current literature. The data presented in purley observational and there was no randomisation as all patients eligible to receive IgRT were given the option of IVIG or SCIG. As this was pilot QI project, the primary aim was to assess feasibility, patient satisfaction, and service-level outcomes rather than to test a specific hypothesis. Therefore, a formal power analysis was not conducted. However, the findings from this pilot will inform the design and sample size calculations of a larger Trust-wide study. Additionally, the large cost saving shown across this Trust, by implementing a switch to SCIG from IVIG, represents the potential financial and resource saving that could be achieved if this swap was employed across the wider NHS. This data will be further confirmed following full analysis of the Basildon and Site 3 cohort results. This full, Trust-wide experience is planned to be published once all data collection and analysis is complete.

Conclusion

Patients deemed eligible for a switch from IVIG to SCIG PFS reported a greater overall satisfaction with their treatment, from increased independence and treatment convenience. Patients also reported a reduced treatment burden, with no requirement to visit the hospital for administration of treatment and a reduction in personal costs associated with these clinics. Health service outcomes also improved with the transition of patients to home self-administration of SCIG, with reduced overall treatment costs, reduced nursing time and an overall increase in the capacity of the haematology department. The switch of patients from IVIG to SCIG was facilitated by the introduction of SRIAPs, which play an important role in Ig stewardship and appropriate use of IgRT.

ORCID iD

Shereen Elshazly https://orcid.org/0000-0003-4732-9412

Ethical considerations

As this was a quality improvement process, ethics approval was deemed not necessary.

Consent to participate

All respondents provided written or verbal informed consent to participate prior to initiation of the survey.

Data Availability Statement

The data that support the findings of this QI process are not openly available but can be made available from the corresponding author upon reasonable request.*