NHS Grampian Westholme Woodend Hospital Queens Road ABERDEEN AB15 6LS

NHS Grampian

Date 27th Sep 2018 Our Ref FANaloxone_MGPG/September18 Enquiries to Frances Adamson Extension 56689 Direct Line 01224 556689 Email f.adamsonnhs.net

Dear Colleague

This letter authorises the extended use of the following PGD until 1st April 2019:

Patient Group Direction For The Administration Of Naloxone Injection In Suspected Or Known Opioid Overdose For Patients Aged 12 Years And Over By Nurses And Midwives Working Within NHS Grampian, Version 8

This PGD is currently under consideration to be withdrawn from use as Naloxone can be administered under exemption within Medicines Legislation. This letter provides permission to continue using the PGD to a new expiry date of 1st April 2019 and should be kept with the PGD records, and brought to the attention of the individual nurses and other healthcare professionals who operate under the PGD currently.

If you have any queries regarding this please do not hesitate to contact the Pharmacy and Medicines Directorate.

Yours sincerely

Lesley Thomson Chair Medicines Guidelines and Policies Group

NHS .......„...... Grampian

Patient Group Direction For The Administration Of Naloxone Injection In Suspected Or Known Opioid Overdose For Patients Aged 12 Years

And Over By Nurses And Midwives Working Within NHS Grampian

Lead Author:

Medicines Management Specialist Nurse

Consultation Group:

See relevant page in the PGD

Approver:

Medicine Guidelines and Policies Group

Signature:

Atleartsin elf -

Signature:

41L1 Identifier:

NHSG/PGD/Naloxone/ MGPG828

Review Date:

October 2018

Date Approved:

October 2016

Expiry Date:

October 2019

A Patient Group Direction is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn

up locally by Doctors, Pharmacists and other appropriate professionals, approved by the Employer and advised by the relevant professional advisory

committees. In most cases, appropriate clinical care is provided on an individual basis by a specific prescriber to a specific individual patient. Patient Group

Directions should only be considered where they offer a benefit to patient care without compromising patient safety in any way.

Uncontrolled when printed

Version 8

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - i - PGD for the administration of naloxone by nurses and midwives – Version 8

This document is also available in large print and other formats and languages, upon request.

Please call NHS Grampian Corporate Communications on (01224) 551116 or (01224)

552245. Revision History: Date of change

Approval date of PGD that is being superseded

Summary of Changes

Section heading

June 2016

July 2014 Two yearly update onto new PGD template.

June 2016

July 2014 Removed additional unnecessary information under definition of situation.

Definition of Situation.

June 2016

July 2014 Added information regarding further emergency treatment of patients.

Inclusion Criteria/Exclusion Criteria/If Patient Excluded or Declines treatment.

June 2016

July 2014 Clean and tidy work areas, including access to hand washing facilities and statement regarding provision of an acceptable level of privacy removed as not applicable in an emergency.

Facilities and Supplied Required.

Subject: Patient Group Direction Identifier: NHSG/PGD/Naloxone/MGPG828 Replaces: NHSG/PGD/nalox/MGPG656, Version 7 Keyword(s): PGD patient group direction nurse midwife opioid opiate

overdose opioid induced naloxone Policy Statement: It is the responsibility of individual nurse, midwife 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.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - ii - PGD for the administration of naloxone by nurses and midwives – Version 8

The lead author is responsible for the review of this PGD as well as its dissemination. Pharmacy and Medicines Directorate is responsible for ensuring registration of this document. 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: November 2000 Completed: November 2000 Approved: November 2000, August 2003, January 2006,

January 2008, May 2010, July 2012, July 2014, October 2016 (published – November 2016)

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 1 - PGD for the administration of naloxone by nurses and midwives – Version 8

Patient Group Direction For The Administration Of Naloxone Injection In Suspected Or Known Opioid Overdose For Patients Aged 12 Years And Over By Nurses And Midwives Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition

This Patient Group Direction (PGD) will authorise nurses and midwives to administer naloxone to individuals aged 12 years and over for reversal of coma and respiratory depression caused by suspected or known opioid overdose. Where child protection concerns come to light in the course of treating opioid overdose, the Child Protection Guidelines available from the Child Protection Partnership website should be followed. See link below. http://www.childprotectionpartnership.org.uk/nmsruntime/saveasdialog.asp?lID=414&sID=182 This PGD should be used in conjunction with the recommendations in the current British National Formulary (BNF), British National Formulary for Children (BNFC), and individual Summary of Product Characteristics (SPC).

Inclusion criteria

Patients 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. These patients should be managed using standard resuscitation procedures and then considered for naloxone injection. 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). This direction is for the immediate needs of the patient to prevent death and does not replace the need to call for immediate medical attention and if in the community setting an ambulance transfer to A&E within 30 minutes.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 2 - PGD for the administration of naloxone by nurses and midwives – Version 8

Exclusion criteria

Due to the serious nature of the condition it is appropriate to administer naloxone to any patient over 12 years of age exhibiting significant symptoms suggestive of opioid overdose, rather than risk the patient’s life. Under this PGD, for individuals aged 12 years and under, medical intervention is required. Call (9) 999 Emergency services and/or refer to doctor as appropriate. If within the acute hospital setting dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. Ensure all actions/decisions are documented.

Precautions and special warnings

Due to the life saving nature of this intervention, naloxone administration should not be delayed, however the following points should be noted: • Administer gradually or in small increments to patients

who have received large doses of opioids or to those physically dependent on opioids since too rapid reversal may precipitate an acute withdrawal syndrome in such patients. When naloxone is used in the management of acute opioid overdosage, other resuscitation measures should be readily available.

• Naloxone may cause hypersensitivity reactions in

susceptible individuals. Medical advice must be sought as soon as possible from a doctor if a recipient develops any signs of hypersensitivity.

• Patients who have responded to naloxone should be

carefully monitored since the duration of action of some opioids may exceed that of naloxone.

N. B. The following groups require caution when naloxone is administered. However, the conditions covered may not be known about before administration: • Patients with pre-existing cardiovascular disease or in

those receiving potentially cardiotoxic drugs, since serious adverse cardiovascular effects may occur.

• Pregnant women who are known or suspected to be

opioid-dependent. Risk benefit must be considered before administration of naloxone since maternal dependence may be accompanied by foetal dependence. The neonate should be monitored for respiratory rate and signs of opioid withdrawal.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 3 - PGD for the administration of naloxone by nurses and midwives – Version 8

• Lactating women, it is not known whether naloxone is

distributed into breast milk.

Referral criteria

Patients who fall into the categories detailed in the exclusion criteria.

Action if excluded from treatment

Not considered likely however; Call (9) 999 Emergency services and/or refer to doctor as appropriate. If within the acute hospital setting dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. Ensure all actions/decisions are documented. If necessary, medical advice should be sought - refer to a doctor. The reason why the patient was excluded under the PGD will need to be documented in the patient’s medical notes.

Action if patient declines treatment

Not considered likely however; Call (9) 999 Emergency services and/or refer to doctor as appropriate. If within the acute hospital setting dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. Ensure all actions/decisions are documented. An attempt should be made to communicate with the patient. If appropriate, acknowledge the right of the patient to decline treatment under this PGD ensuring they understand the risks involved in delaying treatment. N.B. The ability of a patient to consent or decline treatment is largely theoretical. If the patient is able to decline they would be classified as responsive which should act as an indicator that naloxone is not required. Treatment should not be delayed by attempts to gain patient consent. Continue to observe and to check for deterioration of condition. If the levels of consciousness or respiratory function deteriorate, administer naloxone.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 4 - PGD for the administration of naloxone by nurses and midwives – Version 8

Consent

Patients who require naloxone are unlikely to be in a state to give consent to its administration. In an emergency where the patent is unable to give or withhold their consent, it is acceptable for treatment to proceed provided treatment is a necessity and does no more than is reasonably required in the best interests of the patient. The circumstances should be documented in the clinical record and the treatment given must be no more than the immediate situation requires. NHSG “Staff Policy for Obtaining Consent for Clinical Procedures and Healthcare Interventions”. See link below. http://intranet.grampian.scot.nhs.uk/ccc_nhsg/15692.html?pMenuID=460&

Description of treatment available under the PGD Name of medicine

Non-proprietary naloxone 400 micrograms/mL solution for injection. Naloxone Hydrochloride Minijet 400 micrograms/mL, solution for injection.

Legal status

Naloxone is a Prescription-only Medicine (PoM).

Form/Strength

Solution for Injection/400 micrograms per mL.

Route/Method of administration

Naloxone injection is available for subcutaneous (SC), intramuscular (IM), or intravenous injection (IV) or for intravenous infusion. For the purpose of this PGD Naloxone injection should be given SC or IM injection. N.B. The Hameln brand is not suitable for SC administration.

Dosage/Total Dose

Child over 12 years and adults: 400 micrograms. • 400 micrograms as a starting dose to ascertain effect.

The extent of precipitated withdrawal caused by administration of naloxone is dose related.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 5 - PGD for the administration of naloxone by nurses and midwives – Version 8

• Naloxone has an onset of action within 2 to 5 minutes

following SC or IM administration. • If respiratory function does not improve the dose may be

repeated at intervals of 2 to 3 minutes to a maximum of 10mg.

Since the effects of opioids can outlast the effect of naloxone, close monitoring and repeated injections are necessary according to the respiratory rate and depth of coma.

Duration of treatment

Dose may be repeated at 2 to 3 minute intervals up to a maximum of 10mg (25mL).

Storage requirements

Keep the ampoules in the outer carton in order to protect from light. Keep the glass syringe in the outer carton to protect from light (Minijet). Store below 25°C.

Follow-up (if applicable)

Any patient treated with naloxone injection under this PGD should be referred to a doctor as soon as possible. If the patient is transferred to hospital, a written record of the treatment already given should accompany the patient.

Advice to patient (Verbal)

Where patients have been admitted due to illicit opioid use they will often discharge themselves at the earliest opportunity, before being seen by a doctor. The patient should be advised of the risk of leaving the hospital before being seen by a doctor. For patients in contact with NHS substance misuse services advise patient to contact their CPN or doctor. A community programme is now available in Grampian which provides basic life support training and a personal naloxone supply to those at risk of opioid overdose. Patients should be provided with the approved leaflet advertising the service (available from Health Information Resource Centre) and/or signposted to the organisation which provides the service in their area. Aberdeen City, Aberdeenshire Central and South: Alcohol and Drugs Action (ADA) Helpline 01224 594700 or 01224 577120.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 6 - PGD for the administration of naloxone by nurses and midwives – Version 8

Aberdeenshire North: Northern Horizons (Turning Point Scotland): 01779 470490. Moray: Arrows: 01343 610500. Helpline 07812 228547. Several community pharmacies are also participating, ask your pharmacist for information. NHS Grampian substance misuse pharmacists co-ordinate the programme and can be contacted on 01224 557694 for more information.

Advice to patient (Written)

In the case of naloxone administration it is unlikely that written information will be able to be provided to the patient. However, the patient information leaflet contained in the medicine(s) should be made accessible where available 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 Patient Information Leaflets and SPCs for all medicines can be found at: http://www.medicines.org.uk or http://www.mhra.gov.uk/spc-pil/index.htm

Concurrent Medications/Drug Interactions

Opioid overdose is life-threatening. Naloxone should be administered regardless of other medication the patient may have taken.

Adverse effects and managing possible adverse reactions

Common adverse effects to naloxone administration include dizziness, headache, tachycardia, hypotension, hypertension and vomiting. Nausea is also very common. The signs and symptoms of opioid withdrawal in a person physically dependent on opioids may include but are not limited to the following; body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, nausea, vomiting, nervousness, restlessness, irritability, shivering, trembling, abdominal cramps, weakness and increased blood pressure. Abrupt reversal of opioid effects can cause acute withdrawal syndrome. Resulting in: nausea, vomiting, sweating, tachycardia, hyperventilation, hypertension, and tremulousness and violent behaviour. Cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 7 - PGD for the administration of naloxone by nurses and midwives – Version 8

Seizures have occurred on rare occasions following the administration of naloxone. This list is not exhaustive. Please also refer to current BNF and manufacturers SPC for details of all potential adverse reactions. BNF: https://www.medicinescomplete.com/mc/bnf/current/ https://www.medicinescomplete.com/mc/bnfc/current/ SPCs/PILs: https://www.medicines.org.uk/emc/ http://www.mhra.gov.uk/spc-pil/index.htm 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. https://yellowcard.mhra.gov.uk/ Medical advice in cases of anaphylaxis Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should this occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. (Refer to Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals). http://www.nhsgrampian.com/grampianfoi/files/PGD_Adrenaline.pdf MHRA Patient Safety Alerts for risk of distress and death from inappropriate doses of naloxone in patients on long-term opiate treatment can be found here; https://www.england.nhs.uk/wp-content/uploads/2014/11/psa-inappropriate-doses-naloxone.pdf https://www.england.nhs.uk/patientsafety/wp-content/uploads/sites/32/2015/10/psa-naloxone-stage2.pdf

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 8 - PGD for the administration of naloxone by nurses and midwives – Version 8

Facilities and supplies required

The following should be available at sites where the medication is to be administered: • Appropriate storage facilities • Resuscitation equipment • Access to medical support (this may be via the telephone). • Approved equipment for the disposal of used materials. • Copies of the current PGD for the medicine specified in

the PGD. • PGD for the administration of Adrenaline (epinephrine) in

cases of suspected anaphylactic reactions by qualified health professionals.

Characteristics of staff authorised to supply/administer medicine under PGD Professional qualifications

Registered nurses and midwives as recognised by the NMC.

Specialist competencies

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. The practitioner must be familiar with the SPC for all medicines supplied in accordance with this 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.

Ongoing training and competency

Have attended basic life support training which is required to be updated annually. Have undertaken the NHS e-anaphylaxis training session (and annual updates) which covers all aspects of the identification and management of anaphylaxis. This can be accessed via eKSF, or the AT Learning® tool. Maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct.

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 9 - PGD for the administration of naloxone by nurses and midwives – Version 8

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 and midwives working within NHS Grampian can be authorised to administer the drug specified in this PGD by their nurse or midwifery manager/consultant/practice GP. 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: • 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 drug not administered • Reason for giving • Consent to the administration (if not obtained elsewhere) • Drug manufacturer, batch number and expiry date

(Vaccines and injectable medicines) • Site where drug administered, dose and route of

administration • Signature and name in capital letters of practitioner who

administered the drug

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 10 - PGD for the administration of naloxone by nurses and midwives – Version 8

• 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 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

Electronic Medicines Compendium http://www.medicines.org.uk Naloxone (Hameln Pharmaceuticals) – Date of revision of text 11/11/2014, accessed 08/06/16 Naloxone (Minijet, International Medication Systems Ltd) – Date of revision of text 26/11/2015, accessed 08/06/16 British National Formulary https://www.medicinescomplete.com/mc/bnf/current/ accessed 08/06/16 British National Formulary for Children https://www.medicinescomplete.com/mc/bnfc/2011/ accessed 08/06/16

Management and Monitoring of Patient Group Direction

PGD Consultative Group

The consultative group is legally required to include a medical practitioner, a pharmacist and a representative of the professional group who will provide care under the direction.

Frances Adamson Dr Steve Beason Eunice Chisholm Dr Karen Cranfield Dr James Ferguson Elaine Ho!berry Dr Fiona Mair

Elaine Neil Catherine Noble Fiona Raeburn Lucy Skea Aifric Twomey

Medicines Management Specialist Nurse Speciality Doctor in Psychiatry, Timmermarket Head of Nursing, Aberdeenshire H&SCP Consultant Anaesthetist, Head of Acute Pain Services Consultant in Accident and Emergency, ARI Substance Misuse Nurse Medical Professional: Associate Specialist in Accident and Emergency, ARI Pharmacist: North Aberdeenshire H&SCP Lead Pharmacist Ward Manager, Casualty, Fraserburgh Hospital Specialist Pharmacist in Substance Misuse Specialist Pharmacist in Substance Misuse Nurse Practitioner, Accident and Emergency, ARI

Authorising Managers

Dr Nick Fluck Medical Director, NHS Grampian

A

Mr David Pfleger

Director of Pharmacy and Medicines Management, NHS Grampian

Ms Amanda Croft G.L.Cra-

Executive Director of Nursing, Midwifery and AHPs, NHS Grampian

Identifier: NHSG/PGD/Naloxone/MGPG828 - 1 - UNCONTROLLED WHEN PRINTED Review Date: October 2018 PGD for the administration of naloxone by nurses and midwives — Version 8

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 12 - PGD for the administration of naloxone by nurses and midwives – Version 8

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 Naloxone Injection In Suspected Or Known Opioid Overdose For Patients Aged 12 Years And

Over By Nurses And Midwives 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 outwith the recommendations of the Patient Group Direction. Signed:

Print Name:

Date:

Professional Registration No:

UNCONTROLLED WHEN PRINTED Review Date: October 2018 Identifier: NHSG/PGD/Naloxone/MGPG828 - 13 - PGD for the administration of naloxone by nurses and midwives – Version 8

Appendix 2

Certificate Of Authorisation To Administer Medicines Under Patient Group Direction This authorises:

Working within:

e.g. H&SCP, Practice

To administer medicines under the following Patient Group Direction

Patient Group Direction For The Administration Of Naloxone Injection In Suspected Or Known Opioid Overdose For Patients Aged 12 Years And

Over By Nurses And Midwives Working Within NHS Grampian The above named person has satisfied the training requirements and is authorised to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed:

Authorising Manager/Doctor

Print Name:

Date: