GROUP PROTOCOL FOR THE MANAGEMENT OF SIMPLE MOUTH ULCERS. Version 4 December 2017

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1 GROUP PROTOCOL FOR THE MANAGEMENT OF SIMPLE MOUTH ULCERS Version 4 December 2017 RATIFYING COMMITTEE Drugs and Therapeutics Group DATE RATIFIED MAUP EXPIRES December 2020 EXECUTIVE SPONSOR Chief Nurse MAUP ORIGINAL AUTHOR Louise Noble - Pharmacist REVIEWED BY Mel Stubbs Pharmacy Technician KEY POLICY ISSUES: Key indication for the use of Bonjela oral gel Staff eligible to work under the protocol If you require this document in an alternative format, ie easy read, large text, audio, Braille or a community language please contact the Pharmacy Team on

2 GROUP PROTOCOL FOR THE MANAGEMENT OF SIMPLE MOUTH ULCERS Version : 4 December 2017 Group Protocol drawn up by: Name Title Louise Noble Pharmacist Group Protocol authorised by: (on behalf of the Trust). Chief Medical Officer Chief Nurse Chief Pharmacist Rick Fraser Diane Hull Ray Lyon Appointed Practitioner in Charge (on behalf of the ward) Date Protocol agreed December 2017 Proposed review date December 2020 Date Protocol expires December 2020 Ward Protocol relates to

3 GROUP PROTOCOL FOR THE MANAGEMENT OF SIMPLE MOUTH ULCERS 1. CLINICAL CONDITION 1.1 Clinical condition Mouth ulcer or denture sore (as assessed using nurse s clinical judgement) warranting treatment with Bonjela oral gel. 1.2 Inclusion Criteria Patients with a mouth ulcer or denture sore - (adults and children over 16 years of age). 1.3 Exclusion Criteria First ever mouth ulcer If the ulcer is deep and has an uneven discolouration If the ulcer is not causing any pain or discomfort If the ulcer has been present for more than three weeks If the ulcer is greater than 1cm across If the patient has a stomach ulcer If the patient is allergic to salicylates e.g. aspirin If the patient is under 16 years of age If the patient is pregnant If the patient has known sensitivity to Bonjela oral gel If the patient has an intolerance or hypersensitivity to ethanol.

4 1.4 Action to be taken if patient is excluded from treatment under protocol Consult with ward Medical Officer 9.00 am 5.00 pm Monday to Friday. Contact duty Medical Officer out of hours if persistent or extreme discomfort warrants. 1.5 Action to be taken if patient refuses treatment under protocol Discuss with the Ward Medical Officer if pain persists and nursing staff have significant concerns. 2. STAFF AND LOCATION 2.1 Location 2.2 Staff Inpatient units - Trustwide. Qualified nursing staff that have been signed off as competent by the Appointed Practitioner in Charge of the ward following training and successful completion of the 'Key Aspects of Pharmacy' questionnaire for Bonjela oral gel. 2.3 Continued Training Requirements. It should be highlighted to medical and nursing staff that Bonjela oral gel should not be given to children under 16 years of age. This is because there is a possible association between salicylates (contained in Bonjela oral gel) and Reye s syndrome, when given to children. Reye s syndrome is a rare, potentially fatal disease that affects the brain and liver. 3 TREATMENT 3.1 Name of medicine Bonjela oral gel 3.2 Legal status (POM, P or GSL) GSL (General sales list) 3.3 Dose or dose range and criteria for determining dose Massage approximately 1cm of gel onto the sore area. If using for denture sores then leave at least 30 minutes before reinserting the dentures. (Do not apply Bonjela oral gel directly to the dentures). 3.4 Method of route of administration Topical application

5 3.5 Frequency of administration Every three hours as needed. Maximum period of continuous treatment must not exceed seven days without a medical review of the underlying symptoms. NB. Bonjela tubes should not be shared amongst patients. There must be one tube in use per patient. This should be labelled with their name and the date of opening and must be disposed of when treatment is complete. 3.6 Follow up treatment None 3.7 Side effects and potential drug interactions Side effects are rare. Glycerol may cause headache, stomach upset and diarrohea in high doses. 3.8 Instruction on identifying and managing possible adverse outcomes Normal ward observations. If there is a decline in the patient s physical condition or the nurse suspects an adverse reaction, contact the ward Medical Officer or duty Medical Officer. Document concerns in patients notes. 3.9 Arrangement for referral to medical advice Contact ward Medical Officer in normal working hours. Contact duty Medical Officer outside working hours. 4. INFORMATION AND DOCUMENTATION 4.1 Advice (including written advice) to be given to patient or carer before or after treatment. Confirm no history of sensitivity to Bonjela oral gel or salicylates. Verbal instruction on drug being administered. Offer leaflet patient information on mouth ulcers if appropriate. See appendix. 4.2 Details of treatment records required Completion of MAUP section on the patient s drug chart.

6 Record entry in Carenotes. This should record the presence of a mouth ulcer, and administration of Bonjela oral gel in line with MAUP (or equivalent statement). 5. MANAGEMENT AND MONITORING 5.1 Advisory group approving the protocol Drugs and Therapeutics Group. 5.2 Lines of accountability Clinical Service Managers. 5.3 Method to report any adverse drug reactions to the doctor Normal ward policy for communicating with the Medical Officer. 5.4 Audit Arrangements Pharmacy supervision. Clinical audit. 5.5 Review Date and by Whom Every two years by the Drugs and Therapeutics Group, or earlier if significant new evidence or manufacturers advice on use of Bonjela oral gel becomes available.

7 6. Staff authorized to work under the Group Protocol I have read the group protocol and agree to use it: - Nurses agreeing to and authorized to work under the protocol Appointed Practitioner in Charge assessing competence Name Signature Name Signature Date

8 KEY ASPECTS OF PHARMACY QUESTIONNAIRE (To be completed without access to the Protocol or drug text books, eg BNF.) Key aspects of pharmacy for Bonjela oral gel Professional's name: Grade: 1. Symptoms/criteria under which the patient will be eligible for treatment under the Protocol 2. Forms and strengths available 3. Mode of action 4. Exclusion criteria 5. Dose 6. Route of administration 7. What potentially significant side effects and drug interactions are there? 8. What written/verbal advice must be given to the patient/carer on the identification and management of significant potential side effects? I confirm that at the time of completion the answers provided showed an acceptable level knowledge. Name: Designation: Signature: Date:

9 Patient Information on mouth ulcers A mouth ulcer is a painful sore in the mouth. They can occur singly or in clusters, causing a lot of discomfort or pain. Mouth ulcers normally heal within 7 to 10 days. They are different from cold sores that appear on the outer lips due to a viral infection. Symptoms Mouth ulcers may be round or oval with shallow, white, grey or yellow spots with an inflamed border. They cause discomfort or pain, particularly in response to eating certain foods. The most painful stage lasts for three or four days and then the symptoms settle until the ulcers heal. In severe attacks you may feel sick and have a slight fever. You may have painful, enlarged lymph glands around your jaw in the upper part of your neck. Causes Recurrent mouth ulcers cannot be caught by kissing or by sharing drinks/utensils because they are not caused by an infectious agent (they are not contagious). Recurrent mouth ulcers may be due to stress, generalised infections, hormonal changes, too little iron or a lack of vitamins in the diet (especially B12 and C), sensitivity to foods containing some preservatives and flavouring agents, bowel diseases or skin diseases. Some medicines can also cause mouth ulcers. Treatment Treatment involves reducing pain caused by the ulcer. Keep your mouth clean. Avoid foods that are spicy, acidic, salty or particularly hot or cold. Eat a healthy diet. Gargle with warm salt water. Various products are available without a prescription (e.g. Bonjela oral gel which helps to relieve pain caused by the ulcer). Not all products are suitable for the treatment of children. You can obtain more advice from your doctor or nurse, or from a member of the pharmacy team. If the ulcer does not heal either after seven days of continuous treatment or within three weeks if untreated, then speak to a doctor or dentist to check there is not an underlying medical cause. If you require this document in an alternative format, ie easy read, large text, audio, Braille or a community language please contact the Pharmacy Team on Reviewed unchanged 2017

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