The impact of a specialist nurse-led oral food challenge and penicillin de-labelling service in a secondary care hospital in Ireland

With the high prevalence of allergy worldwide, this paper highlights a solution to reduce the impact on patients, families, and healthcare services

Food allergy affects one in every 25 children in Ireland.¹ Early recognition and intervention are vital when it comes to successful identification and management of food allergy in children. Research has shown that only 50 per cent of oral food challenges (OFCs) are positive in patients suspected of having food allergies.² This figure suggests that half of these patients were living under the assumption of an allergy and were unnecessarily avoiding certain foods before their OFC.

Penicillin allergies are reported in 10 per cent of the population internationally,³ with 95 per cent of these penicillin allergy labels deemed incorrect when tested.⁴ Misdiagnosis of penicillin allergy must be addressed since it increases the risk of antibiotic-resistant infections, the duration of hospital admissions, and significantly impacts healthcare costs.⁵

Despite the increasing presentation of penicillin and food allergy cases, penicillin and OFC testing is scarce in Ireland. Multiple factors contribute to this testing shortage, including a scarcity of day case beds, an overburdened healthcare system, and a lack of adequately trained medical and administrative staff to support the running of a robust allergy service.

OFCs are also widely considered to be cumbersome. In their 2021 study, Byrne et al described OFCs as labour-intensive, time-consuming, and in need of adequately trained and experienced staff at all times.⁶ Such inconveniences should not impede their usage – however, delaying OFCs results in an increased economic burden on the healthcare system and a diminished quality of life for families living with allergies.⁷

Historically in the Irish public sector, few tertiary centres with specialist allergy teams performed oral challenges, culminating in huge service demand and lengthy waiting lists. Since penicillin de-labelling and OFCs remain the gold standard for the diagnosis of a penicillin or food allergy,⁷ appropriately skilled healthcare professionals must provide a safe and effective service in which to conduct these challenges outside of tertiary centres.

Due to the development of advanced practitioner and specialist nursing roles, as well as the introduction of the MSc in Allergy and Clinical Immunology in Ireland, a secondary care hospital – Midland Regional Hospital Portlaoise (MRHP) – was able to establish a nurse-led OFC and low-risk penicillin de-labelling service in a safe environment.

The literature surrounding the practice and safety of nurse-led oral food and penicillin challenges is limited. This paper aims to explore and document the effects and safety of a specialist nurse-led OFC and penicillin de-labelling service in MRHP. Ultimately, it is hoped that this small-scale piece of research, and its associated findings, will provide sufficient evidence to support further specialist nurse-led OFCs and penicillin de-labelling initiatives throughout Ireland.

Planning

In January 2022, a business case was put forward to the senior management team at MRHP requesting the allocation of beds on the adult day ward two days per week during the summer months – when in-patient activity is typically lower. This service would be specialist nurse-led by an advanced nurse practitioner (ANP) and a clinical nurse specialist (CNS) in paediatric respiratory and allergy, and supported by a general paediatrician with an interest in allergy.

For efficiency, the ANP and CNS were required to manage all aspects of the service. All safety protocols (including the Children First programme, paediatric emergency supplies, and risk assessment) were put in place to ensure the safe management of children on an adult ward. The paediatric medical team and the anaesthetics team were informed of the schedule for food and penicillin challenges, and were available to attend the day ward if requested. All qualifying children for the challenges had met inclusion criteria (Tables 1 and 2) outlined by international and local guidelines.^3,8,9

TABLE 1: Inclusion and exclusion criteria for low-risk penicillin de-labelling³

TABLE 2: Inclusion and exclusion criteria for OFC

Preparation

In the absence of clerical support, the ANP and CNS were responsible for managing all administrative aspects of running this service. A food challenge waiting list was created on Excel, comprising 120 children awaiting at least one food challenge, with an anticipated wait time of 14 months. Simultaneously, a penicillin waiting list was drawn up, comprising 60 children awaiting a low-risk penicillin challenge with a waiting period of up to two years.

Before service commencement, pro formas were developed for each challenge to facilitate pre-assessment, GP, and medical note correspondence, communication via parent, and discharge information leaflets and assessment documents. All documentation was approved by the local documentation committee and the senior management team at MRHP.

Appointment notifications and parent information leaflets were sent via post and email three to four weeks before the child’s allocated challenge date. Patient medical charts were requested and prepped with documentation.

As per the hospital-based OFC dosing schedule,⁸ foods being challenged were prepped the day before the appointment and offending penicillin was made available by the hospital pharmacy. Day ward bed spaces were prepared and all safety and infection control and prevention precautions were observed.

Challenges

Non-double-blinded, open challenges were performed across a six-bedded day ward space. The ANP and CNS carried out advanced physical assessments on the patients before the commencement of the challenges to ensure they were medically fit. The ratio of nurse to patient was 3:1. The The OFCs followed the PRACTALL guidelines of incremental dosing with 20-minute intervals between doses.¹

Each interval concluded with a clinical assessment from the CNS/ANP to assess for signs of reaction. Challenged foods were prepared by the CNS/ANP with the exception of a mixed cookie, where the child’s parents received a strict recipe to follow and clear instructions to bring this food item with them on the day of the challenge. Six OFCs were offered every Tuesday.

The child and parent were advised to arrive to the day ward at 08.30 with an estimated discharge time of 15.00. Parents were instructed to bring a light lunch and some books/low-impact games for the child to distract them during the challenge. Food challenge outcomes were documented in the child’s medical notes and correspondence was forwarded to their GP.

On Wednesdays, non-double-blinded, open penicillin challenges were performed as per the British Society for Allergy and Clinical Immunology guideline.² Once the child was assessed and deemed medically fit by the supervising specialist nurse, one dose of the offending penicillin was given and the patient was monitored for one-hour post-administration for signs of an anaphylactic reaction.

Some patients were given a three-day course of penicillin if their initial offending reaction was on a subsequent dose. These patients were directed to update the CNS /ANP after completion of the three-day course so the documentation and GPs could be updated on the challenge results. A total of 12 penicillin challenges were offered every Wednesday, with six arriving at 9am and six arriving at 2pm. Before leaving, patients were given a discharge information sheet which advised on signs of a delayed reaction and contact numbers to call if a reaction occurred.

Outcomes

Over a five-month period between July and December 2022, 120 OFCs were offered, with an uptake of 86 appointments. Of the 86 food challenges performed, 56 passed their challenge, 28 failed, and two were deemed inconclusive. Sixty-five per cent of children did not react, a figure that is in keeping with Byrne et al’s study,⁶ whereby 474 OFCs were carried out in a vacant Covid-19 step-down facility and 69 per cent of patients did not react.

A 65 per cent OFC pass rate far exceeds the 50 per cent rate generally cited in the research.² Of the 86 children who presented for OFC, only 35 per cent had a positive reaction to the tested/suspected allergen, suggesting that the number of children with proven allergies may be significantly lower than anticipated.

In terms of age range, 40 per cent of participating patients were under five years old, while the remaining 60 per cent were between five and 15 years at the time of the challenge.

Forty per cent (35) of the OFCs were peanut; 50 per cent (43) were tree nut, and the remaining 10 per cent (8) were fish, sesame, oat, tomato, kiwi, and wheat. Of the 28 failed challenges, nine were peanut, with one requiring adrenaline. Six (7%) patients were treated as per the anaphylaxis protocol; this is also similar to the results found by Byrne et al, whereby 5 per cent were treated with the anaphylaxis protocol.⁶

Four patients required one dose of adrenaline, with two reacting to walnut, one to hazelnut, and one to peanut. In all instances, the ANP and CNS assessed, treated, and managed the anaphylaxis safely, and the patient was discharged home that evening four hours after the treatment had been given with no adverse effects. Two patients required two doses of adrenaline (cashew x 1 and almond/pine nut mixed cookie x 1).

These were the only two patients who required medical review by the paediatric registrar for intravenous cannulation, fluids, and admission for overnight observation to the paediatric ward. They were discharged early the following morning. No child received advanced airway interventions. A total of 18 patients who failed their challenge recovered with antihistamines, while two did not require any treatment, only observation.

Moving to results of the penicillin challenge, there were 72 low-risk penicillin de-labelling appointments offered between July and September 2022 (two-month period), with an uptake of 55, and a total of 53 of these patients passed their penicillin challenge. Two patients failed – one developed three hives at home that evening, and one developed a rash the following day – non urticarial or itchy.

Due to the success of the service, the senior management team extended the day ward facility from a summer-time service to six bed spaces per week, and six OFCs were offered up until December 2023.

Subsequently, the OFC waiting list was reduced from 14 months to five months. The waiting list for a low-risk penicillin de-labelling appointment was cleared after the summer of 2022. Due to its success, the senior management team offered these beds again in the summer of 2023 for any new penicillin de-labelling appointments.

The efficient response of the respiratory and allergy team at MRHP to service needs and patient safety ensured the prompt issuing of appointments and appropriate diagnosis of all children participating in the OFC and low-risk penicillin de-labelling clinics. With 96 per cent passing their penicillin challenge and 65 per cent passing their OFC, the impact of these results is far-reaching, culminating in enhanced quality of life, reduced anxiety for the child and their families, and greater health outcomes.

The confirmation of a food allergy resulted in the patient being trained appropriately on food avoidance and effective management of an allergic reaction. Demonstrating that a patient was not allergic to penicillin reduced the impact of second-line antibiotics on the individuals, such as antibiotic resistance and longer hospital stays, thus improving safety outcomes and compatible treatment options for individuals attending the paediatric respiratory and allergy service at MRHP.

Discussion

At MRHP, the allergy and respiratory team adopted the model of care rolled out by Byrne et al⁶ where empty day case beds were used in a vacant Covid-19 step-down facility during periods of pandemic-related inactivity to decrease waiting lists. A similar approach was taken in this study – during quieter periods of the year when winter-time respiratory illnesses are typically lower, vacant day case beds were reassigned to maximise an exceptional opportunity to decrease waiting lists for both OFCs and low-risk penicillin de-labelling clinics at MRHP.

Of the 86 OFCs performed at MRHP during the five-month period, only 35 per cent of children had a positive reaction to their suspected allergen. These results indicate that the rate of verified food allergy in children may be significantly lower than anticipated² and further strengthen the case for increased specialist nurse-led initiatives to expedite OFC testing nationwide and reduce the number of children who are avoiding foods unnecessarily.

The 96 per cent pass rate achieved in the 55 low-risk penicillin de-labelling appointments mirrors the findings of Blumenthal et al.⁵ With less than 5 per cent of allergy labels being deemed correct when tested, this signals an alarmingly high rate of current penicillin allergy misdiagnosis in Ireland.

The addition of a highly skilled team with specialist training in food allergy management was instrumental in the success of the initiative to reduce paediatric waiting times for OFCs and low-risk penicillin de-labelling appointments at MRHP.

Advanced practice nursing is defined as the ability to practice at a higher level of capability as an independent, autonomous, and expert practitioner, and the CNS’s role encompasses a major clinical focus on patients and their families in hospital, providing expert care, education, and training to the patients in their care.¹⁰

A publication titled the ‘Final Evaluation Report on the Impact of Implementing the Policy on Graduate, Specialist and Advanced Nursing Practice’¹⁰ demonstrated the positive impact on patients and services through the addition of advanced nurse practitioner and specialist roles.

It also highlighted the central role that ANPs and other specialist nursing roles play in creating positive change for patients and services.¹⁰ Significantly, the report identified that each ANP removes 3.9 patients per week on average from specialist waiting lists.

By combining their knowledge and skillsets, the ANP and CNS significantly impacted paediatric waiting lists and patient outcomes at MRHP.

Considering the impact on challenge lead times alone at the hospital, the OFC waiting list was reduced from 14 months to five, while the low-risk penicillin de-labelling appointment list was reduced from two years to 0 months. Further allocation of dedicated bed spaces to the OFC offering at MRHP would ensure that waiting lists remain at less than six months at all times.

The OFC and penicillin de-labelling service at MRHP was nurse specialist-led with support from the paediatrician with an interest in allergy and respiratory.

By increasing the specialist nursing allergy services within the hospital in the past five years, the allergy and respiratory service has been able to double the number of oral challenges conducted. The positive outcome of this initiative advocates for further collaboration between specialist nursing roles in secondary care facilities nationwide.

This paper establishes the safety of OFCs and low-risk penicillin de-labelling tools when administered by trained and experienced clinicians,⁶ in this case, nursing specialists. The appropriate training of nursing staff plays a critical role in the safety of the initiative, ensuring that nursing specialists can deliver a safe, efficient service with the autonomy to make key decisions regarding patient care.

With appropriately trained personnel and a safe environment, these challenges and associated outcomes can be replicated in other secondary care facilities across Ireland.

This initiative could act as a blueprint for transforming the way that hospital management and nursing specialists address the OFC and low-risk penicillin waiting list issue in hospitals nationwide. By adopting the model of care demonstrated by Byrne et al,⁶ the specialist nursing team at MRHP rolled out an innovative OFC and penicillin de-labelling service, facilitated by short-term access to day case beds during a quieter period.

This solution maximised the hospital’s existing resources which ensured the rapid approval and deployment of the service within the hospital. A nationwide roll-out of this initiative would significantly reduce waiting lists, demands on allergy services, and the burden on patients living with allergies.

A limitation of this study was its small sample size – 86 OFCs and 55 low-risk penicillin de-labelling challenges. When compared to the more robust sample sizes of Byrne et al,⁶ the significance of the results was impacted by the limited scale of the study.

Additionally, the lack of available research prevents comparison with other specialist nurse-led challenges, further emphasising a need for significant time and resource investment to encourage more specialist nurse-led initiatives in this area. Only when there is a wealth of robust research demonstrating the effectiveness of specialist nurse-led challenges, will specialist nurse-led solutions be established as reputable, scientifically sound, and trusted routes to addressing these waiting lists and testing issues.

Conclusion

This paper demonstrates the feasibility and safety of a specialist nurse-led challenge in a secondary hospital setting in Ireland. Its ability to deliver a full circle of care – encompassing assessment, diagnostics, challenges, and appropriate support following discharge – positions this nurse-led initiative as a new and innovative approach to tackling excessive waiting times for OFC and penicillin de-labelling appointments in Ireland.

This project has shown that it is possible to safely and efficiently reduce OFC and penicillin de-labelling appointment lead times via a specialist nurse-led strategy. The success of this initiative calls for reformed thinking in hospitals across Ireland. This will ensure that nursing specialists are situated at the heart of safe, effective solutions that will address the OFC and penicillin de-labelling service waitlist issue nationwide.

The success of this study can be partially attributed to the positive collaboration between nursing specialists and senior management at MRHP. For successful simulation of these results, senior management must foster a supportive environment, empowering specialist nursing staff through the provision of resources, education, and time.

The completion of this research paper would not have been possible without the support and guidance of the senior management team in MRHP. We would also like to express our deepest gratitude to our work colleagues for their continuous support. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article.