Title: Removing Erroneous Penicillin Allergy Labels (REPeAL)
Funder: Health Education England

Abstract: Background Penicillins are the preferred antibiotic therapy for many infections due to their lower potential for driving antibiotic resistance, have fewer side effects, a lower acquisition cost, and greater efficacy compared to alternative antibiotics. Approximately 10% of the UK population have a recorded penicillin allergy and are denied penicillins in favour of less desirable second or third line antibiotics. Ninety percent of patients with a penicillin allergy record are able to safely take penicillin for one of the following reasons: they have grown out of their allergy; the symptoms were misdiagnosed as an allergy; or, what they describe is a mild side effect or intolerance to the antibiotic that wouldn't necessitate avoidance of penicillins in the future. Identifying all 90% of incorrectly labelled penicillin allergy patients would require allergy expertise and skin testing. Many hospitals in England do not have access to allergy expertise. However approximately 50% of patients with a penicillin allergy record give a history not in keeping with a penicillin allergy and can safely be de-labelled by ward doctors, nurses and pharmacists using a structured set of questions and a decision support aid. This would enable a significant number of patients to be safely exposed to penicillin. My aim is to design, develop and implement an intervention that will help clinicians remove incorrect penicillin allergy records for selected patients admitted to hospital, without the use of skin allergy testing. Work Package 1 (WP1). Systematic review I will conduct a systematic review of non-skin allergy testing methods used by healthcare organisations and healthcare systems to identify and de-label patients with an incorrect penicillin allergy diagnosis and to report the benefits and the potential risks to patients and the benefits and potential risks to the wider health-care system. WP2. Qualitative studyI will explore the barriers and enablers, perceived by health professionals and patients, to the introduction of a penicillin allergy de-labelling intervention to acute hospital inpatient medical and surgical admitting areas. WP3. Complex Intervention DesignI will develop a complex intervention using the findings from both the systematic review (WP1) and the qualitative study (WP2) that will facilitate safe de-labelling of patients with incorrect penicillin allergy records and that is acceptable to both patients and healthcare workers. WP4. A feasibility study to test implementation of the complex interventionI will test implementation of the complex penicillin allergy de-labelling intervention in the acute surgical and medical admitting patient pathway. The feasibility of collecting healthcare resource data and other expected outputs as a consequence of this intervention (identified in the systematic review and will likely include such measures as patient length of stay and antibiotic treatment failure), will be explored and used to inform outcome measures in a post fellowship step wedge trial with health outcome and process evaluation of this complex intervention in the NHS. Dissemination. The findings for each work package will be disseminated via; medical journals, conference presentation, professional and patient social media groups and pharmacy, nursing and medical professional networks.

Lay abstract: Background to the researchPenicillins are a large group of antibiotics. Therefore, patients with penicillin allergy records have reduced antibiotic options. In addition, penicillin is the preferred antibiotic for many infections. Patients with a penicillin allergy are given 'second choice' antibiotics which can be less effective, more likely to cause side effects, and put people at risk of superbugs. One in ten people have a record of penicillin allergy. Most of these patients can safely take penicillin. This is because the 'allergy' described is not a true allergy but instead a mild side effect, also known as an intolerance or they may have grown out of their allergy. A large number of patients therefore are unnecessarily denied penicillin, often the best antibiotic, and unnecessarily put at risk of the harms associated with 'second choice' antibiotics. The process for assessing patients and removing incorrect penicillin allergy labels is called 'de-labelling.' Patients safe to take penicillin can be identified through taking an 'allergy history'. This involves talking to patients and also checking GP records to find out what happened when they took penicillin. About half of patients with a penicillin allergy record can be identified in this way without the use of penicillin skin testing which is not available to most hospitals. Removing these incorrect allergy records will enable many more patents to safely take penicillin antibiotics instead of the second choice antibiotics which will benefit patients and the NHS. Ward doctors, nurses and pharmacists are able to discuss the benefits of removing the penicillin allergy record with patients if this does not pose a risk to patients. Design, methods and Patient and Public Involvement (PPI) I will review the medical literature to learn how hospitals in other countries have removed incorrect penicillin allergy records from patient medical records. I will look at the effect of this on the amount of penicillin and the amount of second choice antibiotics hospitals used in my hospital as well as patients' infection outcomes and any side effects experienced by patients. Penicillin allergy de-labelling is not currently routine practice in the UK (although it is sporadically undertaken by some healthcare staff in UK hospitals). Asking healthcare workers to work in new ways and patients to accept and act on new advice requires careful thought. I will work with healthcare workers and with patients to identify how to support healthcare workers to incorporate de-labelling into routine practice and also to develop education material that will help patients understand the benefits of de-labelling. Working with patients will ensure the de-labelling process is acceptable to patients and the information and reassurance needed is available at the time of de-labelling.I will monitor patients for any potential harm caused as a consequence of being de-labelled and will measure the success of the study. Dissemination. This work will be shared through publication in medical journals and through the southwest Antimicrobial Pharmacist and Medical Microbiology networks and wider through the national professional networks such as the UK Clinical Pharmacy Association and the British Infection Association, as well as infectious diseases, microbiology and immunology conferences. I will use social media (Twitter and Facebook) to promote the findings of the research I do in this fellowship and link these posts to patient support groups such as Allergy UK. The final phase of my research will be the planning of a multi-centre implementation study to see if this work is replicable in other hospitals in the NHS.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INFECTION