Version Number: 5. Patient Group Direction originally drawn up by: Reviewed by: Patient Group direction authorised by: Medical Lead

Transcription

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 Version Number: 5 Patient Group Direction originally drawn up by: Name Helen Manuell Dr Anthony Glasper Cris Allen Reviewed by: Helen Manuell Title Clinical Pharmacist Consultant Psychiatrist Deputy Director of Nursing (No longer working for the Trust). Clinical Pharmacist Dr Anthony Glasper Consultant Psychiatrist Patient Group direction authorised by: Medical Lead Executive Medical Director On behalf of the organisation Chief Pharmacist Director of Nursing Dr Anthony Glasper Dr Tim Ojo Jed Hewitt Helen Greatorex Date Protocol agreed July 2013 Proposed review date May 2016 Date Protocol expires July 2016 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 (Text Relay calls welcome) 1

2 PLAN OF CARE Condition treated 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. Clinical criteria under which the client will be eligible for treatment under the PGD Clients with suspected or actual opioid overdose as indicated by symptoms, such as pinpoint pupils, respiratory depression, and reduced level of consciousness. In addition the client 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 resentful/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 (e.g. injection sites, track marks, drug paraphernalia or collateral reports). Refer to current edition of British National Formulary for latest information on cautions. Clients, or representatives of a named client, can also be supplied with naloxone injections to take home for use in suspected opioid overdose in the community. Aims of treatment or care To reverse opioid-induced respiratory depression due to overdosage with opioids. Criteria under which the client will be excluded from care within the protocol including contraindications There are no exclusions from treatment with naloxone where opioid overdose is suspected. A decision often has to be made as to the severity of symptoms and whether or not these are likely to be due to an overdose. If in doubt always give naloxone. Not giving naloxone could result in the death of the client. However, care should be exercised in the case of actual or suspected pregnancy as naloxone may well precipitate withdrawal symptoms, which could adversely affect the foetus. Nevertheless, it should be recognised that failure to administer naloxone in an emergency could result in the death of both the mother and the foetus. Caution: naloxone may cause cardiac irritability, and as naloxone is short-acting, repeated doses may need to be given until sustained recovery is certain. Seek medical assistance for all affected. Refer to current edition of British National Formulary for latest information on cautions. 2

3 Actions to be taken for clients who are excluded from treatment under the protocol and arrangements for referral Seek urgent medical attention. Advise an alternative treatment strategy such as calling emergency services. Record all decisions and actions in client notes. Actions to be taken for clients who do not wish to receive, or do not adhere to, care under the protocol and arrangements for referral If appropriate, acknowledge the client s right to decline treatment under this PGD, ensuring they understand the risks involved in delaying treatment and the alternative treatments available. If the client argues that they do not need naloxone, do not argue with them but watch and wait if you think that their condition may deteriorate. If their level of consciousness or respiratory function deteriorates then further attempts to administer naloxone should be made. Seek medical attention. Review with medical staff and document all decisions and actions in the client s notes. Follow-up treatment which may be required Reassure the client, and explain the procedure and course of action if appropriate. Contact doctor. Contact emergency services. Record an accurate account of what has happened, including what doses have been given etc. All information relating to the action taken and the doses given and the times that they were given must accompany the client if they are transferred to hospital. Evaluation of treatment/care Observe and record response to treatment (including any adverse reactions) in client notes. MEDICINE Generic name and form(s) Naloxone injection 400 micrograms/ml as either non-proprietary naloxone ampoules, (or prefilled syringe 400mcg/ml as1ml or 2ml or 2mg/2ml if available) or 1 ml or 2 ml Minijet Naloxone (Celltech) can be used by nurses. 1ml naloxone 400micrograms/ml Minijet or Prenoxad injection can be supplied to approved clients once trained. Mode of action Naloxone is a specific opioid antagonist that acts competitively at opioid receptors. Legal status of medicine Prescription Only Medicine Potentially significant drug interactions None significant. 3

4 Method or route of administration Subcutaneous or intramuscular injection (not intravenous). Note that the onset of action following intramuscular or subcutaneous injection is similar for both routes (2 to 5 minutes) One naloxone Minijet 1mL or Prenoxad 2mg/2ml injection may be supplied by the nurse to clients for use in the event of overdose, once these clients have satisfactorily completed training. Clients should be given advice on how to recognise an opiate overdose, how to put clients in the recovery position, how to administer naloxone injection and the importance of calling an ambulance. Dose(s) and where a range criteria for deciding on a dose Naloxone 400micrograms per dose. (0.4ml Prenoxad 2mg/2ml injection) Maximum of 10mg naloxone in an overdose situation if administered by a nurse. Clients should be advised that a maximum of 5 doses should be used. Frequency of administration The injection may need to be repeated more than once if the desired degree of improvement in respiratory function and level of consciousness is not achieved. Higher doses may be needed, especially if non-opioids or buprenorphine contribute to the clinical condition. Naloxone 400micrograms may be repeated at 2 to 3 minute intervals up to a maximum of 10mg in any single treatment episode. A new needle can be used when multiple doses are used. However, needles may need to be reused in the treatment episode of one client. 4

5 Minimum and maximum period over which the medicine should be administered If no improvement in respiratory function or consciousness is observed after a total quantity of 10mg of naloxone has been administered, the diagnosis of opiate induced or partial opiate induced toxicity should be questioned, and overdose with buprenorphine and/or benzodiazepines and/or other sedative-hypnotics should be considered. Procedure to follow on issue of Minijets or Prenoxad 2mg/2ml injection Open the Minijet box and add an appropriate needle for intramuscular injections. The Prenoxad injection pack already contains needles. Label the minijets or Prenoxad injection with a preprinted dispensing label, completing the patient name and date section on the label. Written advice to be given to the client/carer on the identification and management of significant potential side effects Provide the client/ carer with the manufacturer s Patient Information leaflet. Indications for follow up and actions to be taken Monitor for side effects such as increased or decreased BP, ventricular tachycardia and fibrillation, pulmonary oedema (has occurred in post-operative patients with pre-existing cardiac disease, hypertension and patients receiving ß2 agonist therapy), opiate withdrawal symptoms (nausea, vomiting, sweating, tremor), hyperventilation, depression, and myocardial ischaemia (in patients with pre existing cardiac disease), aggression in response to onset of significant opioid withdrawal symptoms. Refer to current edition of British National Formulary for latest information on sideeffects. 5

6 AUDIT TRAIL Records required for a documented audit trail A completed naloxone injection PGD administration form or supply form, as appropriate To be completed for each treatment episode and a copy kept by the Designated Practitioner. Record the administration or the supply To be recorded in the client s notes. Trust Incident Form To be completed in the event of a suspected adverse drug reaction. The incident must be reported immediately to the relevant doctor or pharmacist. Report on suspected Adverse Drug Reactions (Yellow form in back of the BNF) To be completed for a significant adverse event by the doctor or pharmacist. 6

7 COMPETENCY Designation 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 the Trust's PGD foundation course Has successfully completed the 'Key topics of Pharmacy' questionnaire for naloxone injection. Evidence checked by: Name Designation Signature Review of competency 21months or following a significant change in the patient group direction. Competency expires Two years or following a significant change in the patient group direction. 7

8 AUTHORISATION OF DESIGNATED PRACTITIONERS TO USE THE PATIENT GROUP DIRECTION FOR SUPPLY AND/OR ADMINISTRATION OF NALOXONE 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: Date: SIGNATURE OF LOCALITY OR UNIT MANAGER Name: Date: SIGNATURE OF SERVICE MANAGER Name: Date: REFERENCES 1. BNF 65 March Naloxone Hydrochloride Injection, Minijet. (International Medication Systems Ltd) Summary of Product Characteristics October Prenoxad SPC April 2013 Martindale Pharma 8

9 Naloxone Injection administration form Designated Practitioner Client s Name Route of Injection Naloxone Product used Dose administered Batch Number Expiry Date Time Dose administered Batch Number Expiry Date Time TOTAL Dose Administered Record of adverse reactions: If an adverse reaction has occurred I confirm that: o The details have been recorded in the client s notes o The details have been forwarded to the client s general practitioner Signed by Date 9

10 Client Consent and Record Form for the Supply of Naloxone Minijet 400 micrograms/1ml to Take Home Client s name: Address: Consultant: Tel: DoB: Tel: Mobile: Referrer: Keyworker: Naloxone 400microgram/ml 1ml Minijet Issued By Date Batch Number Expiry date I confirm I have been given instruction and training on how to recognise opiate overdose, put someone in the recovery position and appropriately administer a Naloxone Minijet. The importance of calling an ambulance has been explained to me. I agree to be contacted at a later date to assess my knowledge and/or use of overdose training and Naloxone. Client s signature Date: I authorise my representative (representative s name) to collect, hold and use the Naloxone Minijet on my behalf. Client s signature Date: I confirm I have been given instruction and training on how to recognise opiate overdose, put someone in the recovery position and appropriately administer a Naloxone Minijet. The importance of calling an ambulance has been explained to me. I am willing to collect, hold and use the Naloxone Minijet on behalf of (client s name). I agree to be contacted at a later date to assess my knowledge and/or use of overdose training and Naloxone Representative Date: (Please print name and sign) The client / representative (delete as appropriate) demonstrated sufficient understanding of the treatment of opiate overdose and the use of naloxone in order to be issued with the Naloxone Minijet Signature of Issuing Practitioner Date: 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 (Text Relay calls welcome). Modified with permission from documents produced by Dr Michael Kelleher, Professor John Strang and Dr David Best for the South London and Maudsley NHS Trust, by Dr Fergus Law (Consultant Psychiatrist in Substance Misuse, Fergus.Law@awp.nhs.uk) for Avon and Wiltshire Mental Health Partnership NHS Trust, Dec

11 Client Consent and Record Form for the Supply of the Prenoxad 2mg/2ml injection to Take Home Client s name: Address: Consultant: Tel: DoB: Tel: Mobile: Referrer: Keyworker: Prenoxad 2mg/2ml injection Issued By Date Batch Number Expiry date I confirm I have been given instruction and training on how to recognise opiate overdose, put someone in the recovery position and appropriately administer a Prenoxad 2mg/2ml injection. The importance of calling an ambulance has been explained to me. I agree to be contacted at a later date to assess my knowledge and/or use of overdose training and Naloxone. Client s signature Date: I authorise my representative (representative s name) to collect, hold and use the Prenoxad 2mg/2ml injection on my behalf. Client s signature Date: I confirm I have been given instruction and training on how to recognise opiate overdose, put someone in the recovery position and appropriately administer a Prenoxad 2mg/2ml injection. The importance of calling an ambulance has been explained to me. I am willing to collect, hold and use the Prenoxad 2mg/2ml injection on behalf of (client s name). I agree to be contacted at a later date to assess my knowledge and/or use of overdose training and Naloxone Representative Date: (Please print name and sign) The client / representative (delete as appropriate) demonstrated sufficient understanding of the treatment of opiate overdose and the use of naloxone in order to be issued with the Prenoxad 2mg/2ml injection. Signature of Issuing Practitioner Date: 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 (Text Relay calls welcome). Modified with permission from documents produced by Dr Michael Kelleher, Professor John Strang and Dr David Best for the South London and Maudsley NHS Trust, by Dr Fergus Law (Consultant Psychiatrist in Substance Misuse, Fergus.Law@awp.nhs.uk) for Avon and Wiltshire Mental Health Partnership NHS Trust, Dec

12 KEY ASPECTS OF PHARMACY QUESTIONNAIRE (To be completed without access to the PGD or drug text books, eg BNF.) Key aspects of pharmacy for injectable naloxone Professional's name: Job Title: 1. Symptoms/criteria under which the client will be eligible for treatment under the PGD 2. Forms and strengths available 3. Mode of action 4. Exclusion criteria 5. Dose per injection 6. Maximum dose 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 the client/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: Signature: Date: 12

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