Standard Operating Procedure for Allergies and Sensitivities to Medicines
Version: V3
Ratified by: Quality and Safety Committee
Date ratified: 20/10/2022
Job Title of author: AD Pharmacy and Medicines
Reviewed by Committee or Expert Group Medicines Governance and Safety Group
Related procedural documents
MMPOL30 Medicines Policy
IGPOL63 Health Record Keeping Policy
IGPOL34 Records Management Strategy
IGPOL35 Records Management Policy
Review date: 20/10/2025
It is the responsibility of users to ensure that you are using the most up to date document template – ie obtained via the intranet.
In developing/reviewing this procedure Provide Community has had regard to the principles of the NHS Constitution.
Version Control Sheet
Version
V1 March 2018 Head of Medicines Management New
V2 January 2020 Community Health Specialist Pharmacist Update
V3 Sept 22 AD Pharmacy and Medicines Review
1. Introduction
If a patient receives a medicine, food or other substance that they have an allergy or other sensitivity to, it poses a significant risk to their wellbeing. Medicines 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 we record allergies and sensitivities we 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. Within the NICE Quality Standards for allergies, 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 has a specific allergic reaction or sensitivity, it is important that full and accurate information is recorded so that prescribing errors for drug allergies and sensitivities and adverse drug reactions 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 drug reaction and its severity. Theguide 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 of this Standard Operating Procedure
The purpose of this Standard Operating Procedure is to:
• Ensure patient allergy and medication sensitivity status is known and appropriately recorded before any medication is administered to the patient
• Outline how to ascertain allergy and medication sensitivity information
• Describe how the status should be documented
• Define who can ascertain and document allergy and medication 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 medication sensitivity 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 – a rare condition in which the body’s immune system responds to a drug and causes adverse health effects. Mild drug allergies cause a rash or cough, while more severe reactions may cause trouble breathing, low blood pressure or a change in heartbeat.
True Allergy – Severe allergic reactions can be life-threatening and may cause serious reactions, including anaphylaxis (a life-threatening condition that affects multiple body systems.
Drug Sensitivity (Intolerance) – refers to an inability to tolerate the adverse effects of a medication, generally at therapeutic or sub-therapeutic doses. Conversely, a patient is said to be ‘tolerating’ a drug when they can tolerate its adverse effects.
Non-Drug Allergy – a reaction to food or other substance (e.g. excipient in a medicine or material), which causes an immune system reaction that affects numerous organs in the body. It can cause a range of symptoms, and in some cases an allergic food reaction can be severe or life-threatening.
Non-Drug Sensitivity – symptoms are generally less serious and results from an elevated response, often triggered by the digestive system.
5. Ownership and Responsibilities
• The Medication Governance & Safety Group (MGSG), in collaboration with the Clinical Excellence Group (CEG) will monitor the implementation and compliance with this SOP
• All clinical staff are responsible for establishing and recording allergy and sensitivity status
• All clinical staff are responsible for ensuring that patient safety is considered where the patient is known to have 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
• Medicines Management staff are responsible for ensuring supplies of any medicines on a prescription are not made if the allergy and medicine sensitivity
status is not recorded on the prescription or accompanying information, whether written or electronic
• All persons administering medicines are responsible for not administering any medicine to a patient if the prescription or accompanying information, whether written or electronic, does not have the patient’s allergy and medicine sensitivity status recorded
6. Standards and Practice
Establishing Allergy Status
Before any treatment can be administered, allergy and medicine sensitivity status must be established.
The three categories of patient allergy status are:
• None Known
• Drug Allergy Status Undetermined
• Allergy or Sensitivity known
ACTION
None Known – 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 medicine, food or latex.
Drug Allergy Status Undetermined –when the allergy and medicine sensitivity status of the patient cannot be confirmed as the patient may be unconscious and no medical records are available. Further attempts to establish allergy and medicine sensitivity status should be made as soon as possible, and the status updated accordingly. This should be recorded as ‘Drug Allergy Status Unknown’.
Allergy or Sensitivity Known – 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 medicine, food or latex.
Allergy and medicine 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 medicine sensitivity status of a patient has not been established.
There will be occasions when it is impossible to confirm the allergy status of a patient. In this case a decision will need to be made depending on whether this is a lifesaving intervention or whether the drug can be administered after the allergy/sensitivity status has been confirmed.
Allergy and medicine sensitivity status can change over time and therefore it is necessary to reconfirm allergy 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. This is a mandatory requirement.
Once allergy or sensitivity has been checked and confirmed, it is important to record this in the patient records.
Recording Allergy Status
The allergy and medicine 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 (please 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.
This template provides support and help to clinicians before prescribing medicines, as well as providing assurance that allergy status has been checked and confirmed with the patient/carer. This tick box evidences the confirmation of allergy/sensitivities with the patient/carer before prescribing, and will therefore help to check compliance.
It is the clinician’s responsibility to ensure this template is accurately filled and the tick box has been ticked prior to prescribing medication.
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.
RATIONALE
To make it as clear as possible to all those involved in the patient care pathway, of the allergy and medicine sensitivity status of the patient.
Patients frequently report being allergic to a drug but this can often not be a ‘true’ allergy. It is important to differentiate as it can limit treatment options.
So that prescribers and administers are aware of the nature of the reaction that the patient experienced.
Who can ascertain and Document Allergy and Medicine Sensitivity Status
• Doctors
• Nurses
ACTION RATIONALE
All members of the multidisciplinary team involved in the prescribing, administration and supply of medication
• Pharmacists
• Pharmacy Technicians competent in Medicines Management
• Healthcare Professionals
should be allowed and encouraged to ascertain and document allergy and medication sensitivity status.
Good Practice to Reduce the Risk of Allergic Reactions
ACTION
The healthcare professional will not be able to prescribe any treatment until the allergy and medication sensitivity status is known and recorded on SystmOne
Pharmacy staff will not agree to supply any medication directly to a named patient, unless patient allergy and medication sensitivity status is known and recorded.
No medicine will be administered to a patient until the allergy and medication 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 medication sensitivity status should be reconfirmed and documented for every admission/episode of care/patient contact.
Review as soon as possible when a patient’s allergy status is ‘Drug Allergy Status Undefined’.
RATIONALE
It is impossible to prescribe safely without establishing allergy and medication sensitivity status.
To reduce the risk of a patient receiving a medicine 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 medicine prescribed at an outpatient appointment, the reaction should be clearly recorded in the notes and on SystmOne (if applicable)
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 for details)
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. Stevens-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
RATIONALE
To reduce the chance of the patient receiving the medication again
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 complies with NICE guidance CG183
This complies with NICE Guidance CG183
10% of patients allergic to penicillin will also be allergic to cephalosporins.
Including risk of a biphasic reaction (recurrence of symptoms within 72 hours)
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 an adrenaline syringe etc.
• The advice to check with a pharmacist before taking any ‘over the counter’ medicines
Good Practice
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.
When a Patient is Administered a Medicine to which they have a Documented Allergy
ACTION
The patient should be monitored very closely.
Ensure immediate availability of injectable adrenaline, Chlorphenamine and hydrocortisone in case they are required.
If required, the Provide resuscitation guidelines 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.
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 of the allergy
RATIONALE
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 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 SystmOne should be altered 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
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 status be accurate.
7. Dissemination and Implementation
This document is available on MyCompliance. Significant updates will be communicated via email.
Training for this SOP will be set out in the Medicines Management Training Matrix.
8. Monitoring Compliance and Effectiveness
Element to be monitored
Lead
Tool
Incidents of patients administered medications they are allergic to or have a documented sensitivity to.
The lead pharmacist for clinical services will coordinate an audit that encompasses allergy on an annual basis.
The clinical pharmacists will also check allergy status as part of the clinical screen of a drug.
Incidents will be reviewed by the senior nurse for the area and the Lead Pharmacist.
An audit tool will be used to collect data on allergy. This tool will vary depending on which audit it is being used to collect the data, e.g. the documentation audit, the antibiotic audit, prevalence audit or a specific allergy audit.
Frequency An audit reporting on completion of allergy status will occur annually.
Reporting Arrangements
Acting on Recommendations
Change in practice and lessons to be shared
Incidents will be reviewed as they are reported.
The allergy audit will be reported to the MGSG via the Quarterly Medicines Management and Safety report.
Incidents are reported to the MGSG via the lead pharmacist.
The MGSG will sanction recommendations from MGSG for them to act upon.
Required changes to practice will be identified and actions within the time frame outlined in the action plan. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with the relevant stakeholders.
9. References
• Policy on Allergies and Sensitivities, Royal Cornwall Hospital NHS Trust May 2016
• British Society for Allergy and Clinical Immunology (BSACI) http://www.bsaci.org/publications/allergy-update
• NICE Drug Allergy QS97 (2015) https://www.nice.org.uk/guidance/qs97
• NICE Food Allergy QS118 (2016) https://www.nursinginpractice.com/sites/default/files/nice/Online%20NICE_QS118 _Food_Allergy.pdf
• 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 (2016) https://www.nice.org.uk/guidance/qs119
• Provide: How to Prescribe and Print Prescription on SystmOne Guide
