RAFT3: DALES Drug Allergy Labels in the Elective Surgical population

Timescales Site / Trust / Board registration of interest (March - April 2018) The Local Information Pack will include all information required to confirm capability to run at each Trust / Board; will be sent out April 2018 Formal Trust / Board R&D approvals to take part (April-May 2018) Main data collection period will be three locally agreed days between: 21st May - 2nd July 2018

Background Allergy labels are encountered frequently Can be harmful e.g. beta-lactam allergy label Interpreted by anaesthetists on the day of surgery DALES explores prevalence & nature of allergy label plus anaesthetist’s knowledge & attitudes Periop prescribing is reviewed via same-day follow up in two patient subgroups Drug allergy labels are of particular interest to anaesthetists, given the wide range of drugs which a patient may require or be exposed to during the perioperative period. It is widely accepted that many allergy labels are incorrect, with side effects incorrectly labelled as allergy, & that these incorrect labels can themselves cause harm through avoidance of drugs & use of alternatives. Penicillin allergy labels are an example of this: 90-98% of labels are incorrect, & the label associated with increased risk of Clostridium difficile, MRSA, longer hospital stay & other poor outcomes1. Work in other countries has investigated the incidence of drug allergy labels & the nature of the reaction described, however this has not been looked at in the UK elective surgical population.   Current Literature The prevalence of drug allergy label from studies in other countries varies widely depending on the study design & population. In Canada, of 1818 adult & paediatric patients interviewed, 28.1% claimed to have one or more drug allergies. More women than men claimed to have drug allergies (60.3% vs 39.7%) & there was a positive correlation between age, number of medications & reported drug allergies. Antibiotics (50%), opioids (27%), non-steroidal anti-inflammatory agents (10%), & sedatives (5%) accounted for 92% of all claimed drug allergies. Overall, 50% of claimed allergies had a high probability of true allergic reactions2. In Spain, a prospective study of 1439 patients undergoing a surgical intervention were asked about drug allergy. The prevalence of self-reported drug allergies was 8.3% (119/1439). 3.6% considered themselves allergic to β-lactams & 2.4% to non-steroidal anti-inflammatory drugs3. In Serbia, 1126 surgical patients were questioned. 434 (38.5%) reported drug reactions. The most common allergy claim was to antibiotics (68%), nonsteroidal anti-inflammatory drugs (16.4%) & iodine (3.9%). Women, urban residents & herbal drug consumers were more likely to state an allergy. The majority of reported reactions were cutaneous (72%) & respiratory (34%), while anaphylaxis was reported by 3.2% of patients. Only 38 (8.7%) patients had previously undergone any formal allergy testing. Retrospective chart review revealed that 26 (6%) patients were administered the drug to which they had reported allergic reaction in the past, with no adverse effects4. In this study we aim to identify the prevalence of drug allergy labels, & to categorise these reactions on the basis of history into high or low risk of true allergy (as opposed to recognised side effect). References Macy E, Contreras R. Health care use & serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol 2014; 133 (3): 790-6. Hung OR, Bands C, Laney G et al. Drug allergies in the surgical population. Can J Anaesth 1994; 41(12):1149-55. Tamayo E et al. Self-reported drug allergies & the diagnostic work-up in the surgical population. J Eval Clin Pract 2010; 16 (5): 902–4. Velicković J, Palibrk I, Miljković B et al. Self-reported drug allergies in the surgical population in Serbia. Acta Clin Croat 2015; 54(4): 492-9.

Patient study Explores prevalence & nature of allergy labels All elective patients ≥18 undergoing elective surgery Exclusions: Emergency surgery, unable to consent, prisoners All patients are consented including those without allergy labels Demographic & baseline data collected from all patients Follow up of patient notes for β-lactam & opioid allergy label patients were penicillins or opioids given incidence of unexpected adverse events Follow up is designed to be carried out on the day of surgery for ease of access to notes. We know that our defined list of unexpected adverse events (unanticipated use of adrenaline, chlorpheniramine, hydrocortisone & critical care admission) does not define anaphylaxis, but it allows us to review the group in which these were not required & conclude that nothing untoward occurred peri-operatively.

Patient study

Anaesthetist survey Paper copies preferred Takes ~10 min to complete Completed by all anaesthetists working on the 3 study days Each anaesthetist completes the survey once only All anaesthetists on a list complete it Include prescribing anaesthetic practitioners Exclusions: those not working as anaesthetists during the three study days, i.e. intensivists excluded if not covering a list, non-prescribing anaesthetic practitioners. The survey asks about knowledge of how likely certain reported allergy label reactions are to represent true allergy. We ask whether the anaesthetist would give a beta-lactam in a variety of situations.

Progress REC & HRA approvals obtained AAGBI/NIAA grant secured NIHR Portfolio status confirmed Pilot ran in Leeds 6th/7th March Following final minor amendments which are being made in response to the pilot, sites will be sent a Local Information Pack which includes all documents required for each Trust / Board R & D to undertake their capability & capacity assessment. Once this assessment is returned to the Sponsor, Leeds Teaching Hospitals R & d department, participating sites will be ‘green-lighted’ to start data collection.

Technical aspects Patient survey is paper-free; upload of information is via secure link to REDCap / Anaesthesia.Audit via a portable device or Trust / Board computer Consent is verbal but confirmed on the device by the patient Links for each data collector are generated during site sign-up process The SOP & interactive FAQs programme explain all aspects of running DALES The device used for collecting data has to be moved between patients. There is an infection control policy which appears in the SOP.

What to do next Identify your local investigators Decide on your three study days between 21st May - 2nd July Local investigators will need to book study leave for the days they are taking part Identify PI (permanent consultant) in each Trust / Board Liaise with research nurses who may be assisting Ensure all involved have valid GCP training Locally-agreed study days may be non-consecutive

Contacts & questions DALES study email is Leedsth-tr.dales@nhs.net Please email us to be added to DALES Basecamp group To join the DALES WhatsApp group, please follow https://chat.whatsapp.com/LQ35ZL0oLLB7yCT2tcWECv Information & documents on DALES section of RAFT website & can be downloaded via https://www.raftrainees.com/dales-files.html Questions? Currently available documentation is via the download link above. Also available via the RAFT website at www.raftrainees.com via the DALES files section.