Could penicillin allergy de-labelling lead to better outcomes?

Implementation of penicillin allergy de-labelling calls for an understanding of the key barriers and enablers in healthcare systems – topics that the iNAAN and ALABAMA studies address, explains Neil Powell, Consultant Antimicrobial Pharmacist, Royal Cornwall Hospital.

It is estimated that up to four million people in the UK could be incorrectly labelled as having an allergy to penicillin. Neil Powell’s research is exploring the implementation of penicillin allergy de-labelling as a standard of care for hospitalised patients. In Australia hospitals are already expected to risk-assess ‘penicillin allergic’ patients and de-label, if appropriate whereas in the UK this is currently an ambition, he says.  “My fellowship looks at what the potential barriers to implementation of the penicillin allergy de-labelling tool might be and what the enablers are …… and then trying to work out how we remove barriers and bring in the enablers”, he explains.  This is part of a wider project involving other hospitals in England (including Imperial, King’s, Papworth and Bristol) as part of the iNAAN study that is being coordinated from Australia. As part of his work Mr Powell has interviewed many patients who have undergone de-labelling and many healthcare workers to find out more about their concerns and the barriers to behaviour change.

The International Network of Antibiotic Allergy Nations (iNAAN)

Some 39 hospitals in Australia have signed up to the iNAAN project. Five hospitals in the UK are participating, with the Royal Cornwall Hospital playing a central role. In addition, hospitals in Canada, South Africa and The United Arab Emirates are participating. Each hospital implements penicillin allergy de-labelling according to its own, approved local guidelines and procedures. “They’ll be delivered differently in each hospital – it might be pharmacist doing it, it might be nurses doing it, it might be one enthusiast doing it – how it’s done is up to the hospital with their own guidelines. …..It’s a data collection study where patients who are identified with the penicillin allergy record are risk-assessed and from that point onwards their data is collected”, explains Mr Powell.

The data will then be analysed centrally by the investigators in Melbourne, Australia.  One key aspect of the study is to interrogate the data “to see whether if you undo the label, does that change prescribing? does it change the types of antibiotics used? ….. but more importantly, does it change patient outcomes? does it change mortality? does it change length of stay? Penicillin allergy records are associated with increased mortality [and] increased length of stay; if you undo the label, does it bring about the change?”, he says.   A randomised, controlled study would require vast numbers of patients but this type of study is the next best thing, “to see whether undoing the label undoes the harms”, he notes.  Data collection is expected to continue for 10 years.

ALABAMA – ALlergy AntiBiotics And Microbial resistAnce

The ALABAMA study has now finished recruiting and results are expected soon. It is a multicentre, randomised, pragmatic trial and the Royal Cornwall Hospital was one of the participating sites.  “The main aim is to identify patients from GP records who have got a penicillin allergy record, identify which of those are low-risk, randomise them to ‘allergy-testing’ or ‘not allergy-testing’ (usual care) and then to follow patients up to see whether those that have been de-labelled have different health outcomes from those that haven’t been de-labelled”, explains Mr Powell.

The ALABAMA study also incorporates a “a big behavioural component …. where they’ve looked at [the] patient perspective and GP perspectives around penicillin allergy records and penicillin allergy testing and ……. investigated what the potential barriers might be for GPs referring patients for allergy testing. … Also, what patients understand and what healthcare workers understand about what a negative penicillin allergy test means and whether they believe that test and whether or not they would continue to avoid penicillin in the future even if they have a negative penicillin allergy test. So, as part of that, they’ve come up with a behavioural package which helps remove some of the barriers”, he says.  Part of this is designed to optimise the intervention to ensure that both GPs and patients understand what has been done and that once a patient has been de-labelled, they change their behaviour i.e., prescribe or consume penicillin “and to not continue avoiding it, otherwise the intervention of de-labelling is lost”, says Mr Powell.

About Neil Powell

Neil Powell is a consultant antimicrobial pharmacist at the Royal Cornwall Hospital. As Associate Director of Antimicrobial Stewardship (or two days a week) he is responsible for ensuring that the hospital is delivering on its antibiotic stewardship program of work. In addition, outside of the hospital he is responsible for ensuring that antibiotic prescribing is appropriate in primary care and the community hospitals. The remaining three days each week are devoted to research – Mr Powell is an NIHR and Health Education England (NIHR/HEE) funded clinical doctoral research fellow.

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