PATIENT GROUP DIRECTION (PGD) SUPPLY OF NALOXONE HYDROCHLORIDE INJECTION BY REGISTERED NURSES TO CLIENTS BEING RELEASED FROM HMP FORD Version Number: 01HMP Patient Group Direction originally drawn up by: Name: Daniel Barry Position: Lead Pharmacist Mental Health Chichester Locality Name: Dr Davie Robertson Position: General Practitioner, HMP Ford Name: Stacey Brewis Position: DART Nurse, HMP Ford Patient Group Direction authorised by: Name: Dr Tim Ojo Position: Medical Director, on behalf of the organisation Name: Jed Hewitt Position: Chief Pharmacist Name: Diane Hull Position: Director of Nursing Standards & Safety Date Protocol agreed January 2017 Proposed review date September 2018 Date Protocol expires January 2019 1
PATIENT GROUP DIRECTION DETAILS Staff characteristics Professional qualification: NMC Registered Nurse At least 3 months post registration experience in a substance misuse team Evidence of training in basic life support and anaphylaxis, updated annually Has attended a PGD foundation course Has successfully completed the 'Key topics of Pharmacy' questionnaire for Supply of naloxone hydrochloride injection Has read the HMP Ford Standard Operating Procedure for Takehome Naloxone Hydrochloride CLINICAL DETAILS Aims Diagnosis / condition treated Criteria for inclusion Criteria for exclusion Cautions Clinical features of an This patient group direction (PGD) will allow registered nurses the authority to supply naloxone to named clients who are being released and have been identified as being at future risk of opioid overdose The aim of supply is to reduce the occurrence of drug related deaths in this client group Supply of naloxone to treat actual or suspected overdose due to an opioid substance, to reverse the action of opioids such as heroin, methadone, morphine (inc MST ), pethidine, dihydrocodeine (DF118 ) or buprenorphine (Temgesic, Subutex ) It does not matter which opioid was taken or whether it was legal or not If overdose is suspected then naloxone should be given Naloxone can be used even if evidence of an opioid overdose is lacking, so should be used if there is a suspicion that an individual s respiratory depression or impaired level of consciousness is due to an excess of opioid Clients at risk of opioid overdose, who have demonstrated awareness and understanding of naloxone supply Clients must have undertaken appropriate training in the use of Prenoxad 1mg/1ml injection Clients must successfully complete the Take-away Naloxone Hydrochloride (Prenoxad 1mg/1ml injection 2ml syringe) Competence Questionnaire for Clients Naloxone will not be supplied to clients: Who have not undertaken the approved training Where valid consent for supply is not obtained Note: There are no clinical exclusions from treatment where opioid overdose is suspected Exclusion may result in the death of the patient The client must understand the short acting nature of naloxone and an apparently successful outcome after injection of naloxone may be followed later by a return to respiratory depression and overdose The client should be advised of the requirement to contact the emergency services wherever opioid overdose is suspected For the purposes of the PGD, the injection may only be administered by intramuscular injection Naloxone may cause hypersensitivity reactions in a small number of susceptible individuals Medical advice must be sought as soon as possible from a doctor if a recipient develops any signs of hypersensitivity Suspected or actual opioid overdose is indicated by symptoms, such as 2
actual or suspected overdose due to an opioid substance Actions to be taken for patients who are excluded from supply or do not wish to receive a supply of naloxone under the PGD pinpoint pupils, respiratory depression and reduced level of consciousness In addition the individual may be difficult to rouse, unresponsive to painful stimuli, unconscious, snoring, have shallow slow breathing, blue lips; or may present very drowsy When spoken to they may be difficult, and then some minutes later may be unable to respond to questions He/she may be a known drug user or there may be evidence that they are using opiates or are an injecting drug user (eg injection sites, track marks, drug paraphernalia or collateral reports) Refer to current edition of British National Formulary wwwbnforg for latest information on cautions If a client is excluded from treatment under this PGD it will be explained to them that naloxone can only be supplied under the PGD following completion and demonstration of understanding of the approved training The client should be provided with details of how to access training Clients who are not eligible to receive a supply of naloxone may still attend basic life support and naloxone administration training Advice should be given on alternative treatment strategies including harm reduction and overdose prevention The client should be advised of the requirement to contact the emergency services wherever overdose is suspected The client should be referred to an appropriate healthcare professional and / or advised on available treatment services if appropriate Any action or referral should be noted in the client s SystmOne record Generic name Formulation and route Strength Dose(s) and frequency of administration Duration of treatment Legal status Storage DESCRIPTION OF TREATMENT Naloxone Hydrochloride 2mL pre-filled syringe for intramuscular injection 1mg/mL A single dose of 04 mg (04mL) should be administered immediately upon an individual being suspected of having taken an opioid overdose The dose should be administered intramuscularly into the outer thigh or muscles of the upper arm It may be administered through clothing if necessary If the patient has not responded or if respiratory function deteriorates a further dose of 04 mg (04mL) should be administered; this can be repeated at 2-3 minute intervals Clients should be advised not to exceed 5 doses Prescription Only Medicine (POM) Store below 25 C After use, any unused solution should be discarded immediately Any unused product or waste material (including needles) should be disposed of in accordance with local requirements 3
Adverse effects Advice to be given to the client Procedure to follow on issue of Prenoxad 2mg/2ml injection Administration of naloxone in opioid overdose is a life-saving intervention and should not be delayed However abrupt reversal of opioid effects by the administration of naloxone may cause the following reactions: In patients who are physically dependent on opioids, rapid reversal of opioid effects may precipitate an acute withdrawal syndrome, inducing nausea, vomiting, sweating, tachycardia, hyperventilation, hypertension and tremor Common reactions include hypotension, hypertension, ventricular tachycardia, dizziness and headache In patients with pre-existing cardiac disease or in those taking potentially cardiotoxic drugs, serious adverse effects have been reported such as pulmonary oedema, myocardial ischaemia, hypotension, hypertension, ventricular tachycardia and fibrillation The client should be informed of importance of contacting ambulance services by dialling 999 at the earliest opportunity where opioid overdose is suspected Clients must understand the short acting nature of naloxone and an apparently successful outcome after injection of naloxone may be followed later by return of respiratory depression and overdose On arrival of the ambulance, individuals are instructed to advise ambulance staff of how the patient has responded and details of any adverse effects Ensure the client has undertaken an approved Take Home Naloxone Training Programme Explain treatment and course of action Highlight information included in the Manufacturers Patient Information Leaflet Where this is unavailable, or unsuitable, sufficient information should be given to the client in a language that they can understand Store the product in a cool, dry place Protect from light Keep syringes in a sealed container Use within expiry date on product Clients will be trained in the safe storage and handling of the product and safe disposal of needles following naloxone injection Advise client on procedures to obtain resupplies of naloxone after their current supply has been used, lost or expired Advice given will be recorded in the client s SystmOne record Advice should be given on what to expect and what to do for major and minor reactions The Prenoxad injection pack already contains needles Label the Prenoxad injection with a pre-printed HMP Ford label, completing the Patient name and Issue date sections on the label 4
AUDIT TRAIL Records required for a documented audit trail Authorisation Nurses can be authorised to supply Naloxone by an Authorised Person, namely a Clinical Nurse Manager, Substance Misuse Service Team Lead or Pharmacist working for or on behalf of Sussex Partnership NHS Foundation Trust Reason for giving or record why drug not supplied SystmOne patient record including exclusion criteria Scanned, completed copy of the Client Consent and Record Form for the Supply of the Prenoxad 2mg/2ml injection to Take Home Scanned copy of the Take-away Naloxone Hydrochloride (Prenoxad 1mg/1ml injection 2ml syringe) Competence Questionnaire for Clients after the client has successfully completed it Trust Incident Form To be completed in the event of a suspected adverse drug reaction The incident must be reported immediately to the relevant member of staff Report on suspected Adverse Drug Reactions (Yellow form in back of the BNF) To be completed for a significant adverse event by a doctor, pharmacist or nurse 5
COMPETENCY Designation (tick appropriate box) NMC Registered Nurse Competency/Qualifications (tick when checked) Professional qualification: NMC Registered Nurse At least 3 months post registration experience in a substance misuse team Evidence of training in basic life support and anaphylaxis, and to remain updated annually Has attended a PGD foundation course Has successfully completed the 'Key topics of Pharmacy' questionnaire for Supply of naloxone hydrochloride injection Has read the HMP Ford Standard Operating Procedure for Take-home Naloxone Hydrochloride Evidence checked by: Name Designation Signature Review of competency Two years or following a significant change in the Patient Group Direction Competency expires Two years or following a significant change in the Patient Group Direction 6
AUTHORISATION OF PROFESSIONAL TO USE THE PATIENT GROUP DIRECTION SUPPLY OF NALOXONE HYDROCHLORIDE INJECTION BY REGISTERED NURSES TO CLIENTS BEING RELEASED FROM HMP FORD Date valid from: Date of expiry: This confirms that I: Name: understand the PGD have received the necessary education and training am of the opinion I am competent to implement the PGD effectively agree to work within the PGD SIGNATURE OF AUTHORISED PERSON Name: REFERENCES 1 Patient Group Direction (PGD) for the Supply and/or Administration of Naloxone Hydrochloride Injection by Registered Nurses Working in Community and Inpatient Substance Misuse Teams Helen Manuell Sussex Partnership NHS Foundation Trust 2013 2 Patient Group Direction for the Supply of Naloxone Injection by Appropriately Registered Nurses and Pharmacists to Individuals at Risk of Opioid Overdose in NHS Grampian NHS Grampian 2013 3 http://wwwmedicinesorguk/emc/medicine/27616 accessed 08/07/2016 4 https://wwwmedicinescompletecom/mc/bnflegacy/current/php33748- prenoxadhtm?q=prenoxad&t=search&ss=text&tot=1&p=1#php33748-prenoxad accessed 08/07/2016 7
KEY ASPECTS OF PHARMACY QUESTIONNAIRE Supply of naloxone hydrochloride injection (To be completed without access to the PGD or drug text books, eg BNF) Professional's name: Job Title: 1 Symptoms/criteria under which the patient will be eligible for treatment under the PGD 2 Forms and strengths available 3 Mode of action 4 Exclusion criteria 5 Doses per injection 6 Maximum doses per episode 7 Repeat dose frequency 8 Route of administration 9 What potentially significant side effects are there? 10 What potentially significant drug interactions are there? 11 What written/verbal advice must be given to client? I confirm that at the time of completion the answers provided showed an acceptable level knowledge Name: Designation: 8
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Take-away Naloxone Hydrochloride (Prenoxad 1mg/1ml injection 2ml syringe) Competence Questionnaire for Clients 1 What is Naloxone used for? 2 How does Naloxone work? 3 How long does Naloxone last once it has been administered? 4 What are the risks of using Naloxone? 5 What are a person s symptoms when they have overdosed on opioid drugs? 10
6 What should you do before you administer Naloxone? 7 Describe how to administer naloxone 8 What is the route of administration for Naloxone? 9 How much is a single dose of Naloxone? 10 How much time should have passed before you administer another dose? 11 What is the maximum number of doses that you can administer? 11
12 What should you do after you administer Naloxone? 13 Describe how to put someone into the recovery position 12