SAMPLE. This direction was authorised on 4/5/2007. The direction will be reviewed by 4/5/2009

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1 Patient Group Direction for the Supply and Administration of Flumazenil 100microgram Injection To Patients requiring reversal of oversedation due to midazolam in association withendoscopy attending Endoscopy Unit of the Borders General Hospital This document authorises the supply or administration of Flumazenil 100microgram injection by Endoscopy Nurse Specialists to patients requiring reversal of midazolam induced sedation after endoscopy who meet the criteria for inclusion under the terms of the document The Endoscopy Nurse Specialists seeking to supply and administer Flumazenil 100microgram Injection must ensure that all clients have been screened and meet the criteria before supply takes place The purpose of this Patient Group Direction is Patients requiring Endoscopy timely access to treatment in the absence of a Gastro- Intestinal Consultant. This direction was authorised on 4/5/2007 The direction will be reviewed by 4/5/2009 Clinician Responsible for Training and Review: Morag Henderson

2 Patient Group Direction for Administration of Flumazenil 100microgram injection without a Prescription for a Named Individual by Endoscopy Nurse Specialists employed by NHS Borders in Endoscopy Unit of the Borders General Hospital 1. This Patient Group Direction relates to the following specific preparation: Name of medicine, Strength,Formulation Legal status Flumazenil 100microgram Injection (5ml ampoules) Prescription Only Medicine (POM) Storage Do not store above 30 C Dose Route/method Frequency Security-Ampoules are stored in the locked medicine cupboard, within the endoscopy treatment room 200 microgram of Flumazenil should be administered over 15 seconds, if the desired level of consciousness is not observed after sixty seconds then 100mcg can be at repeated at sixty second intervals until the patient is fully awake. The normal dose required to rouse the patient is mcg. The maximum dose to be administered is 1mg of Flumazenil Slow Intravenous Injection through pre-sited cannula One treatment course per Endoscopy Total dose Quantity (Maximum/Minimum) Advice to Patients Follow up Arrangements Relevant Warnings 200microgram-1mg (10ml) Patients should be advised of the requirement to have suitable supervision and must be warned not to drive or operate machinery for 24 hours. Patients should be observed in a recovery area for a minimum of one hour. If after an hour there has been no further evidence of the sedative effects of the benzodiazepine, the patient may be discharged.

3 The patient must be accompanied by a responsible adult who will remain with them for 24 hours. If sedative effects recur, medical assistance should be sought and the patients admitted to a ward for further observation. They should also be advised to be aware of possible side effects, including: nausea, vomiting or flushing. 2. Clinical condition Clinical Condition to be treated Criteria for inclusion Criteria for exclusion Action if excluded Action if declines Interactions with other medicaments and other forms of interaction Adult patients who have undergone an endoscopic examination under benzodiazepine sedation (such as midazolam) and who require reversal of sedative effects Patients who have respiratory depression and/or bradycardia and/or are difficult to rouse following sedation from the use of a benzodiazepine for undergoing an endoscopic examination Patients with known hypersensitivity to benzodiazepines, flumazenil or any constituent of the injection. Patients in whom a benzodiazepine is used to control a potentially life threatening condition. (e.g. control of raised intercranial pressure or status epilepticus) Patients who are epileptic and have been receiving benzodiazepine treatment for a prolonged period. Patients who are pregnant. Refer to appropriate medical personnel Document In Patient s notes refusal offer of reversal of sedation. If refused consult medical personnel Flumazenil blocks the central effects of benzodiazepines by competitive interaction at the receptor level; the effects of non-benzodiazepines acting via the benzodiazepine receptor, such as zopiclone, are also blocked by flumazenil. However, flumazenil is ineffective when unconsciousness is due to other substances. Interaction with other central nervous system depressants has not been observed. The pharmacokinetics of benzodiazepines are unaltered

4 in the presence of flumazenil and vice versa.

5 3. Records-Entries should be made in Patient Case Notes and on Endoscopy Database a. The following information should be kept in records The patient name and CHI number The medicine name, dose, route, time of dose(s), and where appropriate, start date, number of doses and or period of time, for which the medicine is to be supplied or administered Drug batch number and expiry The signature and printed name of the approved healthcare professional who supplied or administered the medicine The patient group direction title Whether patient met the inclusion criteria and whether the exclusion criteria were assessed Quantity supplied and current stock balance b. Audit trail, data collection and reconciliation of stock Pharmacy receipts to be kept in Endoscopy for 6 months. Endoscopy Nurse Specialist is responsible for ensuring current stock balance coincides with ampoule stock after every patient treatment c. Storage Do not store ampoules above 30 C. Keep ampoules in outer carton Security-Ampoules are stored in the locked medicine cupboard, within the endoscopy treatment room 4. Professional Responsibility PGD will be for Endoscopy Specialist Nurse, that is a person who is educated to a minimum of degree level and has carried out an approved Endoscopy course which allows them to perform upper GI Endoscopy / Colonoscopy procedures in the Endoscopy unit. All Health Professionals will ensure he/she has the relevant training and is competent in all aspects of medication, including contra-indications and the recognition and treatment of adverse effects. He/she will attend training updates as appropriate. Nurses will have due regard for the NMC code of Professional Conduce: standards for conduct, performance and ethics(0704) NMC Guidelines for administration of medicines (0104) Sources of Reference: Summary of Characteristics Anexate Injection BP 500mcg/5ml Roche Products Limited updated September British Society of Gastro-enterology- Safety and Sedation during Endoscopic Procedures 2003 BNF v 52 September 2006

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