2 Yearly update to new PGD template.

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2 Revision History: Date of change Approval date of PGD that is being superseded Summary of Changes 2 Yearly update to new PGD template. Section heading NHS Grampian Identifier: NHSG/PGD/lido_cet_endo/MGPG907 Replaces: NHSG/PGD/lido_cet_endo/MGPG734, Version 1 Keyword(s): PGD patient group direction nurse endoscopy lidocaine cetrimide Xylonor anaesthesia Policy Statement: It is the responsibility of individual nurse and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. The lead author is responsible for the review of this PGD and for ensuring the PGD is updated in line with any changes in clinical practice, relevant guidelines, or new research evidence. Review date: The review date for a PGD needs to be decided on a case-by-case basis in the interest of patient safety. The expiry date should not be more than 3 years from the date the PGD was authorised. Document: Drafted: June 2017 Completed: September 2017 Approved: September 2017 (published October 2017) UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG907 - i -

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4 Patient Group Direction For The Administration Of Lidocaine/Cetrimide (Xylonor ) Spray For Oropharyngeal And Nasopharyngeal Surface Anaesthesia To Patients Undergoing Upper GI Investigations/Bronchoscopy By Registered Nurses Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition This Patient Group Direction (PGD) will authorise nurses to administer lidocaine/cetrimide (Xylonor ) spray to individuals aged 16 years of age and over who wish to have local anaesthetic/antiseptic throat spray for their upper GI investigation/bronchoscopy. Xylonor is not licensed to be given via the oropharyngeal and nasopharyngeal route and the use within Endoscopy is offlabel. This PGD should be used in conjunction with the recommendations in the current British National Formulary (BNF) and individual Summary of Product Characteristics (SPC). Inclusion criteria Patients aged 16 years and over, that are American Society of Anaesthesiologists (ASA) classification l or ll, or grade lll on discussion with medical supervisor (Appendix 3). Any patient attending for Upper Gastrointestinal Endoscopy (UGIE). Any patient attending for bronchoscopy. Patients with whom upper GI endoscopy/bronchoscopy are clearly indicated. Exclusion criteria Patients may be administered Xylonor spray under this PGD unless: They are under 16 years of age. They have previously had an adverse reaction/hypersensitivity to lidocaine/cetrimide (Xylonor ) spray. ASA classification is out with the nursing staff selection criteria. They have a hypersensitivity to local anaesthetics of the amide type or any of the components of Xylonor spray. UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

5 Precautions and special warnings Xylonor spray should be used with caution if there is sepsis or extremely traumatised mucosa in the area of application, since under such conditions there is potential for rapid systemic absorption of both lidocaine and cetrimide. Before administering Xylonor spray in the following cases/patient groups, discussion with the relevant consultant must take place and all decisions must be documented in the appropriate patients notes: Epilepsy Hepatic impairment Severe renal impairment Respiratory impairment Impaired cardiac conduction Pregnancy and breastfeeding Cardiovascular disease and heart failure Bradycardia Porphyria Traumatised mucosa and/or sepsis in the oropharyngeal region In the elderly, acutely ill or debilitated the dose should be reduced Patients treated with antiarrhythmic drugs class lll (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. Referral criteria Patients who fall into the categories detailed in the exclusion criteria. Action if excluded from treatment Medical advice should be sought refer to General Practitioner/Consultant (relevant medical practitioner). The reason why the patient was excluded under the PGD will be documented in the appropriate patient record. Action if patient declines treatment The patient should be advised of the risks and consequences of not receiving treatment. Refer to General Practitioner/Consultant (relevant medical practitioner). Record outcome in Patient Medication Record if appropriate, or relevant patient record. UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

6 Consent Prior to the administration of the drug, valid consent must be obtained. Consent must be in line with current NHSG consent policy. Description of treatment available under the PGD Name of medicine Lidocaine/cetrimide (Xylonor ) spray Legal status Xylonor is a Prescription-only Medicine (PoM). N.B. Xylonor spray is not licensed to be given via the oropharyngeal and nasopharyngeal route and the use for this indication is off-label. It is however accepted clinical practice to administer Xylonor spray via the oropharyngeal and nasopharyngeal route for upper GI Investigations/Bronchscopies. Form/Strength Xylonor spray containing lidocaine base 10mg, which is a local anaesthetic and cetrimide 0.10mg, which is an antiseptic, in a metered dose aerosol. Route/Method of administration The tip of the nozzle should be placed at about 2cm from the area to be anaesthetised. The actuation of the valve emits a dose of spray covering an area of about 1cm in diameter. Care must be taken to avoid contact with the eyes. A new nozzle must be used for each patient. Nozzles are available to order from the company. 1 metered dose containing 10mg of lidocaine and 0.10mg cetrimide is usually sufficient to achieve anaesthesia on a particular site; two may be used if required but no more than 3 doses should be applied. The onset of action occurs within 2-5 minutes, and persists for approximately minutes. Dosage/Total Dose 1 metered dose containing 10mg of lidocaine and 0.10mg cetrimide. Maximum dose allowed under this PGD is 3 metered doses (30mg of lidocaine and 0.30mg cetrimide). UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

7 Duration of treatment N/A Storage requirements Store below 25 C. Follow-up (if applicable) Patients should not leave if they are feeling unwell without speaking to the registered nurse or medical staff first. If necessary the patient should contact a doctor or the patient s GP should be contacted for advice. If out of hours or at the weekend the patient should be advised to contact NHS 24. Advice to patient (Verbal) Advice should be given on what to expect and what to do for major and minor reactions. The patient must be advised that Xylonor spray is not licensed to be given via the oropharyngeal and nasopharyngeal route and the use is off-label. Patients undergoing upper GI endoscopy will be informed that they should not eat or drink anything for 1 hour post procedure unless a successful 'sip test' has been carried out. A tepid drink and/or food may be offered after a successful 'sip test'. Patients will also be informed to observe for signs of adverse effects such as dizziness and drowsiness which may affect their ability to drive or operate machinery. Numbness of the tongue and buccal mucosa may increase the danger of biting trauma and may also interfere with swallowing, increasing the risk of aspiration. Advice to patient (Written) Patients will be given discharge information leaflets with advice and contact details. The Patient Information Leaflet (PIL) contained in the medicine(s) should be made accessible to the patient, parent, guardian, or person with parental responsibility. Where this is unavailable, or unsuitable, sufficient information should be given in a language that they can understand. Copies of PIL and SPCs for all medicines can be found at or UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

8 Concurrent Medications/Drug Interactions Cimetidine may inhibit the hepatic metabolism of lidocaine, leading to an increased risk of lidocaine toxicity, in particular with large doses. Concurrent use of beta-adrenergic blocking agents may slow metabolism of lidocaine because of decreased hepatic blood flow, leading to increased risk of lidocaine toxicity, in particular with large doses, repeated administration, or oral use (especially if swallowed) of lidocaine. Identifying and managing possible adverse reactions Adverse effects may include: CNS effects including confusion, respiratory depression which may lead to respiratory arrest, convulsions, dizziness, blurred vision, tremors and unconsciousness. Hypotension and bradycardia may lead to cardiac arrest. Hypersensitivity. Local irritation at site of application. This list is not exhaustive. Please also refer to current BNF/BNFC and manufacturers SPC for details of all potential adverse reactions. BNF: SPCs/PILs and risk minimisation materials: If an adverse reaction does occur give immediate treatment and inform relevant medical practitioner as soon as possible. Report the reaction to the MHRA using the Yellow Card System. Treatment of overdose The normal application of Xylonor spray according to its directions for use is very unlikely to result in an overdose. However, in the event of an overdose, the endoscopist in charge of the list should be contacted for advice. Facilities and supplies required The following should be available at sites where the medication is to be administered: UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

9 Appropriate storage. An acceptable level of privacy to respect patient s right to confidentiality and safety. Resuscitation equipment. Immediate access to Epinephrine (Adrenaline) 1 in 1000 injection. Access to medical support (this may be via the telephone). Approved equipment for the disposal of used materials. Clean and tidy work areas, including access to hand washing facilities. Copies of the current PGD for the medicine specified in the PGD. Characteristics of staff authorised to administer medicine under PGD Professional qualifications Registered Nurses as recognised by the Nursing and Midwifery Council (NMC). Specialist competencies As above and approved by the organisation as; Nurse endoscopists who have completed a recognised course in Endoscopy Skills and background knowledge incorporating a sedation module. Endoscopy nursing staff and respiratory clinical support nurses who have completed a set of agreed competencies and been signed off by senior nursing staff/practice educator/nurse endoscopist. GI specialist nurse who has completed a set of agreed competencies and be signed off by senior nursing staff/practice educator/nurse endoscopist. Be competent to assess the patient s capacity to understand the nature and purpose of the administration in order for the patient to give or refuse consent. Has undertaken appropriate training to carry out clinical assessment of patients leading to a diagnosis that requires treatment according to the indications listed in the PGD. Be aware of current treatment recommendations and be competent to discuss issues about the drug with the patient. Is competent in the administration of the drug. UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

10 Ongoing training and competency All professionals working under this PGD must; Have attended basic life support training which is required to be updated annually. Have undertaken the NHS e-anaphylaxis training session or equivalent (including annual updates) which covers all aspects of the identification and management of anaphylaxis. This can be accessed via eksf, or the AT Learning tool/learnpro. Maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. Must be familiar with the SPC for all medicines administered in accordance with this PGD. Professional managers/lead Nurses will be responsible for: Ensuring that the current PGD is available to staff providing care under this direction. Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. Maintain up to date record of all staff authorised to administer drug specified in PGD. Documentation Authorisation of administration Nurses working within endoscopy units in NHS Grampian can be authorised to administer the drug specified in this PGD by their Nurse Manager/Consultant. All authorised staff are required to read the PGD and sign the Agreement to Administer Medicines Under PGD (Appendix 1). A Certificate of Authorisation (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual practitioners records, or as agreed locally. Record of administration/ supply An electronic or paper record for recording the screening of patients and the subsequent administration of the drug specified in this PGD must be completed in order to allow audit of practice. This should include: UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

11 Name and address of patient. Patient CHI No and date of birth. Details of parent/guardian, or person with parental responsibility where applicable. Consultant/General Practitioner details. Risk group, if appropriate. Findings of physical examination, if appropriate. Exclusion criteria, record why the drug was not administered. Reason for giving. Consent to the administration (if not obtained elsewhere). Signature and name in capital letters of practitioner who administered the drug. Date drug given. Record of any adverse effects (advise patient s doctor). These records should be retained: For children and young people, retain until the patient's 25th birthday or 26th if the young person was 17 at the conclusion of treatment. For 17 years and over retain for 6 years after last date of entry, for 3 years after death, or in accordance with local policy, where this is greater than above. Audit All records of the drug(s) specified in this PGD will be filed with the normal records of medicines in each practice/service. A designated person within each H&SCP/practice/service will be responsible for auditing completion of drug forms and collation of data. References Medicines and Healthcare Products Regulatory Agency Xylonor spray Date of revision of text 13/12/12, accessed 15/06/17. British National Formulary accessed 15/06/17. UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

12 Appendix 1 Health Care Professional Agreement to Administer Medicines Under Patient Group Direction I: (Insert name) Working within: e.g. H&SCP, Practice Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Administration Of Lidocaine/Cetrimide (Xylonor ) Spray For Oropharyngeal And Nasopharyngeal Surface Anaesthesia To Patients Undergoing Upper GI Investigations/Bronchoscopy By Registered Nurses Working Within NHS Grampian I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor out with the recommendations of the Patient Group Direction. Signed: Print Name: Date: Professional Registration No: UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

13 Appendix 2 Health Professionals Authorisation to Administer Medicines Under Patient Group Direction The lead nurse/professional of each clinical area is responsible for maintaining records of their clinical area where this PGD is in use, and to whom it has been disseminated. The manager who approves a healthcare professional to supply and/or administer medicines under the patient group direction, is responsible for ensuring that he or she is competent, qualified and trained to do so and for maintaining an up-to-date record of such approved persons in conjunction with the Head of Profession. The healthcare professional who is approved to supply and/or administer medicines under the direction is responsible for ensuring that he or she understands and is qualified, trained and competent to undertake the duties required. The approved person is also responsible for ensuring that administration or supply is carried out within the terms of the direction, and according to his or her code of professional practice and conduct. Patient Group Direction For The Administration Of Lidocaine/Cetrimide (Xylonor ) Spray For Oropharyngeal And Nasopharyngeal Surface Anaesthesia To Patients Undergoing Upper GI Investigations/Bronchoscopy By Registered Nurses Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

14 Patient Group Direction For The Administration Of Lidocaine/Cetrimide (Xylonor ) Spray For Oropharyngeal And Nasopharyngeal Surface Anaesthesia To Patients Undergoing Upper GI Investigations/Bronchoscopy By Registered Nurses Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG

15 Appendix 3 American Society Of Anaesthesiologists Classification Of Physical Status. Class I The patient has no organic, physiological, biochemical or psychiatric disturbance. The pathological process for which surgery is to be performed is localised and does not entail a systemic disturbance. Examples: a fit patient with an inguinal hernia, a fibroid uterus in an otherwise healthy woman. Class II Mild to moderate systemic disturbance caused either by the condition to be treated surgically or by other pathophysiological processes. Examples: non or slightly limiting organic heart disease, mild diabetes, essential hypotension or anaemia. The extremes of age may be included in here, even though no discernible systemic disease is present. Extreme obesity and chronic bronchitis may be included in this category. Class III Severe systemic disturbances or disease from whatever cause, even though it may not be possible to define the degree of disability with finality. Examples: severely limiting organic heart disease, severe diabetes with vascular complications, moderate to severe degrees of pulmonary insufficiency, angina pectoris or healed myocardial infarction. Class IV Severe systemic disorders that are already life threatening, not always correctable by operation. Examples: patient with organic heart disease showing marked signs of cardiac insufficiency, persistent angina, or active myocarditis, advanced degrees of pulmonary, hepatic, renal or endocrine insufficiency. Class V The moribund patient who has little chance of survival but is submitted to operation in desperation. Examples: the burst abdominal aneurysm with profound shock, major cerebral trauma with rapidly increasing intracranial pressure, massive pulmonary embolus. Most of these patients require operation as a resuscitative measure with little if any anaesthesia. UNCONTROLLED WHEN PRINTED Review Date: September 2019 Identifier: NHSG/PGD/lido_cet_endo/MGPG