Standard Operating Procedure for Allergies and Sensitivities
Version: V4
Ratified by: Quality and Safety Committee
Date ratified: 18/12/2025
Job Title of author: Director Pharmacy, Medicines and AHP
Reviewed by Committee or Expert Group Medicines Governance and Safety Group
Related procedural documents
MMPOL30 Medicines Management Policy
IGPOL63 Health Record Keeping Policy
IGPOL34 Records Management Strategy
IGPOL35 Records Management Policy
Review date: 18.12.2028
It is the responsibility of users to ensure that you are using the most up to date document template – i.e. obtained via MyCompliance.
In developing/reviewing this procedure Provide Community has had regard to the principles of the NHS Constitution.
Version Control Sheet
Version Date
V1 March 2018 Head of Medicines Management
V2 January 2020 Community Health Specialist Pharmacist Update
V3 Sept 22 AD Pharmacy and Medicines Review
V4 October 2025 Community Health Services Pharmacist Review
1. Introduction
If a patient receives a drug, food or other substance that they have an allergy or other sensitivity to, it poses a significant risk to their wellbeing. Drugs have the potential to cause side effects, also known as ‘adverse drug reactions’ but not all of these are allergic in nature. Other reactions are idiosyncratic, pseudo-allergic or caused by drug intolerance.
By ensuring allergies and sensitivities are recorded, this can contribute to improvements in the following outcomes:
• Patient experience of care
• Patient safety incidents
• Reported mortality from causes considered preventable
• Patient exposure to unnecessary broad-spectrum antibiotics
• Antibiotic prescribing and antimicrobial resistance rates
A person-centred integrated approach to providing services is fundamental to delivering high quality care to people, including children and young people, with allergies and sensitivities. In line with the National Institute for Health and Care Excellence (NICE) Quality Standard for drug allergy (QS97) and NICE Clinical Guideline on drug allergy (CG183), patients with suspected allergies and sensitivities must have this information recorded in various forms to ensure this information is shared across the care pathway.
After a person experiences a specific allergic reaction or sensitivity, it is important that full and accurate information is recorded so that prescribing of the associated drug can be avoided in the future. Accurate recording will also support healthcare professionals when assessing a patient to ensure that allergies and sensitivities are taken into account when treating a patient, e.g. a patient with severe nut allergy.
A healthcare professional can achieve this by following the structured assessment guide when recording the allergic reaction and its severity. The structured assessment guide is also important for educating patients about signs, patterns and timings of allergic reactions. This should help prevent morbidity and improve health outcomes.
2. Purpose
The purpose of this Standard Operating Procedure is to:
• Ensure patient allergy and sensitivity status is known and appropriately recorded before any medication is administered to the patient
• Outline how to ascertain allergy and sensitivity information.
• Describe how the status should be documented.
• Define who can ascertain and document allergy and sensitivity information.
• Describe good practice that should be followed to reduce the risk of a patient being administered a drug to which they are allergic or have a sensitivity to
• To describe what should happen when a patient is administered a drug or exposed to an allergen to which they have a documented allergy or sensitivity
3. Scope
All clinical staff who provide clinical care to patients within Provide should ascertain and record allergies and sensitivities in accordance with this procedure. This includes those who should record allergy/sensitivity status, prescribe or administer drugs using paper or electronic prescribing, and administration systems.
4. Definitions/Glossary
Drug allergy – any reaction due to a drug that has clinical features compatible with hypersensitivity (immune response).. Mild drug allergies cause a rash or cough, while more severe reactions may cause trouble breathing, low blood pressure or a change in heartbeat.
Drug sensitivity (intolerance) – an adverse effect from a drug that does not involve the immune system.
Non-drug allergy – a reaction to food or other substance (e.g. excipient in a drug or material) that has clinical features compatible with hypersensitivity (immune response). It can cause a range of symptoms, and in some cases an allergic food reaction can be severe or life-threatening.
Non-drug sensitivity – a reaction to food or other substance (e.g. excipient in a drug or material) that does not involve the immune system. Symptoms are generally less serious and results from an elevated response, often triggered by the digestive system.
5. Ownership and Responsibilities
• All clinical staff who provide clinical care to patients within Provide are responsible for establishing and recording allergy and sensitivity status
• All clinical staff who provide clinical care to patients within Provide are responsible for ensuring that patient safety is considered where the patient is known to have drug, food or substance allergies
• All staff are responsible for reporting non-adherence to this SOP via Datix, and for reporting patient safety incidents as a result of non-adherence to this SOP via Datix
• All persons administering drugs are responsible for not administering any drug to a patient if the prescription or accompanying information, whether written or electronic, does not have the patient’s allergy and sensitivity status recorded.
6. Standards and Practice
Establishing allergy and sensitivity status
Before any treatment can be administered, allergy and sensitivity status must be established.
The three categories of patient allergy status are:
• No known allergies
• Drug sensitivity
• Other allergy
Note: Allergy status on Inform is displayed as either ‘no allergies or adversedrug reactions’ or the recorded allergy itself.
ACTION
No known allergies – when confirmation has been received from a combination of the patient, the medical records and (where appropriate) the patient’s carer or guardian, that the patient has not previously had a reaction to a drug, food or latex.
Drug sensitivity or other allergy – when confirmation has been received from a combination of the patient, the medical records and (where appropriate) the patient carer or guardian, that the patient has previously had a reaction to a drug, food or latex.
Allergy and sensitivity status should be reconfirmed with the patient and recorded at each episode of care.
RATIONALE
No treatment can be administered safely if the allergy and sensitivity status of a patient has not been established.
Allergy and sensitivity status can change over time and therefore it is necessary to reconfirm allergy and sensitivity status at each episode of care.
Allergies and sensitivities need to be recorded on the ‘Provide Ethnicity, Language, Religion and Allergies’ template on the clinical tree on SystmOne or the allergies section of the main template on Inform. This is a mandatory requirement.
Once allergy and sensitivity status has been checked and confirmed, it must be recorded in the patient’s record.
Recording allergy and sensitivity status
The allergy and sensitivity status must be clearly documented in the medical notes and on SystmOne. This needs to be completed at the following times:
• Point of entry into service;
• Point of prescribing and/or PGD supply; and
• Yearly review
Note: additional entry may be required if the patient/service users condition or health changes to ensure no new allergies or sensitivities
Allergies and sensitivities need to be recorded on the ‘Provide Ethnicity, Language, Religion and Allergies’ template on the clinical tree on SystmOne. Once status has been checked and confirmed, it is important to tick the ‘Patient allergies/sensitivities currently recorded on patient record checked and confirmed with patient/carer’ on the template, BEFORE prescribing medication and at each patient contact Reconfirming the allergy status of an allergy status of an individual at each contact is required as part of the Inform template.
The clinical system template provides support and help to clinicians before prescribing a drug, as well as providing assurance and evidence that allergy and sensitivity status has been checked and confirmed with the patient/carer before prescribing
It is the clinician’s responsibility to ensure the clinical system template is accurately filled and the tick box has been ticked prior to prescribing medication (SystmOne)
ACTION
When the patient or carer reports a reaction to a medication or other substance, the recorder should attempt to ascertain whether the reaction(s) are immunologically modulated or not.
Immunological-based reactions should be recorded as ‘allergies’ and other reactions should be recorded as ‘sensitivities’.
When recording an allergen or sensitising agent, the healthcare professional must, wherever possible, document the nature of the reactions e.g. rash, swollen lips, etc. as well as the date when the reaction occurred (if known).
When recording a drug allergy or sensitivity, care should be taken to ensure the correct drug is selected, particularly with drugs that look or sound alike. Be particularly aware of penicillin / penicillamine as per National Patient Safety Alert for harm from incorrect recording of a penicillin allergy as a penicillamine allergy
RATIONALE
To make it as clear as possible to all those involved in the patient care pathway, of the allergy and sensitivity status of the patient.
Patients frequently report being allergic to a medication or other substance but this can often not be an allergy but rather a sensitivity. It is important to differentiate as sensitivities wrongly marked as allergies can limit treatment options for the patient
So that prescribers and those administering are aware of the nature of the reaction that the patient experienced. Who can ascertain and document allergy and sensitivity status ACTION
• All registered healthcare professionals
RATIONALE
All members of the multidisciplinary team involved in the prescribing, administration and supply of medication should be allowed and encouraged to ascertain and document allergy and sensitivity status.
Good practice to reduce the risk of allergic reactions
RATIONALE
The healthcare professional will not be able to prescribe any treatment until the allergy andsensitivity status is known and recorded on the electronic clinical record
No drug will be administered to a patient until the allergy and sensitivity status is known and recorded.
Healthcare professionals should be clear which category of drug they are prescribing, and the potential for crosssensitivity with other drugs of the same group (e.g. penicillins, contrast agents).
Allergy and sensitivity status should be reconfirmed and documented for every admission/episode of care/patient contact.
It is not possible to prescribe safely without establishing allergy and sensitivity status.
To reduce the risk of a patient receiving a drug to which they are allergic or have a sensitivity.
Patient experiencing a new allergic reaction
ACTION
When a patient experiences a new reaction to a drug during admission, or as a result of a drug prescribed at an outpatient appointment, the reaction should be clearly recorded in the notes and clinical system, e.g. SystmOne (if applicable)
The signs, symptoms and severity of the reaction should be documented as well as the date when the reaction occurred.
The patient’s GP practice should be informed of the newly documented reaction.
Consider stopping any drug suspected of causing a reaction
A Yellow Card should be completed for all serious adverse drug reactions and any adverse drug reactions for a Black Triangle drug (see BNF and Yellow Card reporting site for further information).
The patient should be referred to a specialist allergy service if they have had:
• A suspected anaphylactic reaction OR
• A severe non-immediate cutaneous reaction (e.g. drug reaction with eosinophilia and systemic symptoms [DRESS], Stevens-
RATIONALE
To reduce the chance of the patient receiving the drug again
This is in line with NICE CG183
To ensure the GP practice can keep their records up-to-date.
To ensure reactions are appropriately reported to the relevant national organisations who share this information.
This is in line with NICE CG183
Johnston syndrome, toxic epidermal necrolysis)
After a suspected anaphylactic reaction in adults or young people aged 16 or older, take timed blood samples for mast cell tryptase testing, as follows:
• A sample as soon as possible after emergency treatment has started
• A second sample, ideally within 1-2 hours (but not later than 4 hours) from the onset of symptoms
The patient must be thoroughly counselled on the details of the reaction and the implications of further treatment. This counselling must include:
• The name of the drug implicated
• The name of the class of drugs implicated (if applicable)
• Details on whether this reaction means they are more prone to allergic reactions with other classes of drug, e.g. penicillins and cephalosporins
• The nature of the reaction
• An explanation that although an initial reaction might be mild, a second exposure to the same drug/food may trigger a much more severe reaction
• The importance of the patient informing other healthcare professionals of their allergy before they are prescribed, administered or dispensed a drug
• Where an allergy is severe, the options of carrying adrenaline , etc.
• The advice to check with a pharmacist before taking any ‘over the counter’ medicines
Information to the patient regarding a newly discovered allergy should also be provided in writing. This should include details of the person providing the information and when.
This is in line with NICE CG183 and CG134.
To reduce the chance of the patient receiving the drug or class of drugs again
When a patient is administered a drug to which they have a documented allergy in error
ACTION
The patient should be monitored very closely.
RATIONALE
To ensure the patient receives appropriate intervention.
If required, QSPOL15 Resuscitation and Anaphylaxis Policy should be followed.
If the patient doesn’t have an allergic reaction to a drug they are documented as being allergic to, re-visit the history of the allergy with the patient, as it may be the patient was never allergic to the drug in the first place. Amend the records as necessary.
Note: It may not be possible to change an allergy and sensitivity status on the electronic clinical record as usually the organisation which added the allergy / sensitivity is the only organisation that can change it. In this case, contact the initiating organisation (usually the patient’s GP) for amendments
A Datix report MUST be completed for any incident when a patient is administered a medicine to which they have a documented allergy, even when no reaction occurs.
The patient’s Primary Care provider should be informed that the patient was administered a drug to which they have a documented allergy.
It is very important that the organisation learns from any incidents relating to allergy to inform policy and procedure development.
To ensure the appropriate transfer of information to primary care.
How to document if allergy status changes (e.g. following successful desensitisation or a previous documented allergy is subsequently found to be a sensitivity only)
ACTION
The allergy status on the electronic clinical record (e.g. SystmOne) and in the patient case notes needs to be amended.
If the amendment is that a new allergy or sensitivity has been identified, this should be added as detailed above, taking care to include the date of the amendment
If the amendment is to remove an allergen or sensitising agent from the allergy status (e.g. patient has had successful desensitisation treatment and can now safely be prescribed that medication) then the electronic clinical record should be updated and an ‘Allergy’ note should be used to record a more detailed explanation for the change.
A contemporaneous record should also be made in the patient’s clinical notes.
RATIONALE
To ensure information is contemporaneous.
To reduce the chance of the patient receiving the drug again.
It is important to have a clear audit trail showing what the allergy status of the patient was at what time. It is equally important that allergy and sensitivity status be accurate.
Note: It may not be possible to change an allergy and sensitivity status on the electronic clinical record as usually the organisation which added the allergy / sensitivity is the only organisation that can change it. In this case, contact the initiating organisation (usually the patient’s GP) for amendments.
For documented allergies relating to penicillin, consider de-labelling – refer to Mid and South Essex ICB Penicillin Allergy Assessment in Primary Care or Community or Mental Health Services guidance. (Link to be embedded once guidance has been approved by Mid and South Essex ICS).
Note: For SystmOne users, utilise SystmOne template for patient questionnaire and GP letter; for Inform users, GP letter will need to be printed and posted, following obtaining patient consent
For documented allergies relating to penicillamine, follow National Patient Safety Alert for harm from incorrect recording of a penicillin allergy as a penicillamine allergy
7. Monitoring
Incidents relating to this SOP will be reported via Datix. Incidents will be reviewed as they are reported and monitored through Medicines Governance Safety Group (MGSG)
Within the inpatient setting, clinical pharmacists will check allergy status as part of the clinical screen of a drug.
8. References
• Royal Cornwall Hospitals NHS Trust. Allergies or sensitivities to medicines procedure Version 4.0, December 2022. Accessible via https://doclibraryrcht.cornwall.nhs.uk/DocumentsLibrary/RoyalCornwallHospitalsTrust/Clinical/Pha rmacy/AllergiesOrSensitivitiesToMedicinesProcedure.pdf
• NICE Drug Allergy QS97 (2015) https://www.nice.org.uk/guidance/qs97
• NICE Food Allergy QS118 (2016) https://www.nice.org.uk/guidance/qs118
• NICE Drug Allergy Diagnosis and Management CG183 (2014) https://www.nice.org.uk/Guidance/CG183
• NICE Food Allergy in Under 19s: Assessment and Diagnosis CG116 (2011) https://www.nice.org.uk/Guidance/CG116
• NICE Anaphylaxis QS119 (2024) https://www.nice.org.uk/guidance/qs119
• NICE Anaphylaxis: Assessment and referral after emergency treatment CG134 (2020) https://www.nice.org.uk/guidance/cg134
• National Patient Safety Alert: Harm from incorrect recording of a penicillin allergy as a penicillamine allergy (2025) https://www.england.nhs.uk/long-read/nationalpatient-safety-alert-harm-from-incorrect-recording-of-a-penicillin-allergy-as-apenicillamine-allergy/
