clinical guideline for the administration of naloxone

CLINICAL GUIDELINE FOR THE ADMINISTRATION OF NALOXONE HYDROCHLORIDE INJECTION TO

ADULTS WITH OPIOID OVERDOSE OR SUSPECTED OPIOID OVERDOSE AND THE

CLINICAL MANAGEMENT OF THE NALOXONE TAKE HOME PROGRAMME

CLINICAL GUIDELINE REFERENCE NUMBER:

CG82

VERSION NUMBER: 1

REPLACES SEPT DOCUMENT CG82

REPLACES NEP DOCUMENT CG/Management of Naloxone Take Home Programme/05/16

KEY CHANGES FROM PREVIOUS VERSION

Not applicable

AUTHOR: Pharmacy Manager, North Essex

CONSULTATION GROUPS: Medicines Management Group (MH & LD)

IMPLEMENTATION DATE: October 2017

AMENDMENT DATE(S): Not applicable

LAST REVIEW DATE: Not applicable

NEXT REVIEW DATE: September 2020

APPROVAL BY CLINICAL GOVERNANCE AND QUALITY SUB COMMITTEE:

September 2017

CLINICAL GUIDELINE SUMMARY

This guideline aims to ensure that staff are familiar with the procedure for the emergency management of opioid overdose with naloxone within Community Drug and Alcohol Services (CDAS) and the supply of naloxone to service users and carers within the naloxone take home programme.

The Trust monitors the implementation of and compliance with this clinical guideline in the following ways;

This guideline will be monitored by through the trust audit programme and via Datix incident reporting.

Services Applicable Comments

Trustwide

Essex MH&LD

CHS

The Director responsible for monitoring and reviewing this Clinical Guideline is the Executive Medical Director

CLINICAL GUIDELINE FOR THE ADMINISTRATION OF NALOXONE HYDROCHLORIDE INJECTION TO ADULTS WITH OPIOID OVERDOSE OR

SUSPECTED OPIOID OVERDOSE AND THE CLINICAL MANAGEMENT OF THE

NALOXONE TAKE HOME PROGRAMME – CG82

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ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST


SUSPECTED OPIOID OVERDOSE AND THE CLINICAL MANAGEMENT OF THE NALOXONE TAKE HOME PROGRAMME

CONTENTS

THIS IS AN INTERACTIVE CONTENTS PAGE, BY CLICKING ON THE TITLES BELOW YOU WILL BE TAKEN TO THE SECTION THAT YOU WANT

1.0 INTRODUCTION

2.0 SCOPE

3.0 DEFINITIONS

4.0 RESPONSIBILITIES

5.0 UNDERPINNING PRINCIPLES

6.0 TRAINING

7.0 DRUG USED FOR THE PHARMACOLOGICAL TREATMENT OF OPIOID OVERDOSE

8.0 MONITORING THE USE OF NALOXONE

9.0 REMEDIAL MEASURES

10.0 NALOXONE TAKE HOME PROGRAMME

11.0 IMPLEMENTATION

12.0 CLINICAL GUIDELINE REVIEW

13.0 REFERENCES

14.0 REFERENCE TO OTHER TRUST POLICIES/PROCEDURES




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APPENDICES

APPENDIX 1 – STAFF TRAINING FOR NALOXONE COMPETENCE ASSESSMENT FORM

APPENDIX 2 – NALOXONE HYDROCHLORIDE (PRENOXAD) TRAINING CHECKLIST

FOR SERVICE USERS

APPENDIX 3 – REFUSAL OF NALOXONE TRAINING – HMP & YOI CHELMSFORD

APPENDIX 4 – REFUSAL OF NALOXONE TRAINING APPENDIX 5 – OVERDOSE MONITORING CLINICAL MONITORING CHART

APPENDIX 6 – TAKE HOME NALOXONE RECORDING FORM

APPENDIX 7 – SAFE STORAGE OF NALOXONE KITS AGENCY STATEMENT

APPENDIX 8 – ADMINISTRATION OF NALOXONE (PRENOXAD) FEEDBACK FORM




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ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST


SUSPECTED OPIOID OVERDOSE AND THE CLINICAL MANAGEMENT OF THE NALOXONE TAKE HOME PROGRAMME

Assurance Statement

These guidelines aim to ensure that staff are familiar with the procedure for the emergency management of opioid overdose with naloxone within Community Drug and Alcohol Services (CDAS)

1.0 INTRODUCTION

1.1 Mortality due to opioid overdose remains high worldwide and a priority for public health to reduce the number of deaths due to opioid overdose. According to the National Office of Statistics, in 2016, there were 3,744 drug poisoning deaths involving both legal and illegal drugs in England and Wales. This is an increase of 2% from 2015 and the highest number since comparable statistics began in 1993. Of these 3,744 deaths, over half (54%) related to drug poisoning involving an opiate (mainly heroin and/or morphine). It is a priority to make every effort to reduce the death rate due to opioid overdose. The provision of a take-home naloxone service has been commissioned as part of efforts to prevent opioids related deaths.

1.2 A primary cause of mortality after an overdose of natural and synthetic opioid drugs

is respiratory depression. National Institute of Health and Clinical Excellence (NICE 2004) guidelines names Naloxone as the first line intervention in the diagnosis and treatment of opiate overdose. Naloxone Hydrochloride blocks opioid receptors to counteract the effects of opioid drugs such as heroin, methadone, fentanyl and morphine. It reverses the life-threatening effects of an overdose such as respiratory depression. Naloxone has no psychoactive properties and has no intoxicating effects or misuse potential. When administered by injection it can rapidly reverse the effects of opioid drugs and improve respiratory function.

1.3 Naloxone is the only licenced medicine in the UK for the treatment of overdose and

toxicity. In October 2015, The Human Medicines (Amendment) (No. 3) Regulations 2015 (2015/1503) came into force allowing Naloxone to be supplied by: Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies– a) an NHS body; (b) a local authority;(c) Public Health England; or (d) Public Health Agency without the need for a prescription, a Patient Group Direction (PGD) or Patient Specific Direction (PSD): https://www.gov.uk/government/publications/widening-the-availability-of-naloxone/widening-the-availability-of-naloxone




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1.4 CDAS have developed an overdose prevention strategy that involves suppling Naloxone directly to patients and carers along with overdose prevention training. Opioid overdose training and take-home Naloxone for outpatients have been proposed as one possible method for reducing drug related deaths caused by opioid overdose, and is recommended in the 2011 report by the National Treatment Agency for Substance Misuse.

1.5 This guideline extends the strategy described in section 1.4 to staff, both qualified

and unqualified, working in CDAS so that they too may treat the overdose. Dose schedules for administration by staff are different from those used by patients and carers. The differences are documented here.

2.0 SCOPE

2.1 This clinical guideline applies to all employees (both permanent and temporary) of the Trust. It also applies to all staff within CDAS (including Essex STaRS) that have been trained and authorised to train service users and issue “Take-Home Naloxone Kits”.

2.2 Administration of Naloxone for the management of overdose will only be used on

CDAS and Integrated Drug T re a t m e n t S ys t e m ( IDTS) p r e m i s e s a n d p a r t n e r agencies within CDAS such as Phoenix Futures, and Open Road.

2.3 The clinical guideline compliments all professional and ethical rules, guidelines and

codes of professional conduct. 2.4 This clinical guideline must be read in conjunction with the following policies:

CLP6 Policy on advance directives

CLP14 Policy for cardio-pulmonary resuscitation (CPR)

CLP13 & CLPG13 Policy and Procedural Guidance on the Safe and Secure Handling of Medicines.

and the relevant section of the Trust Formulary and Prescribing Guidelines on the Management of Alcohol, Opioid and Benzodiazepine Dependence.

3.0 DEFINITION

3.1 The management of opioid overdose is a pharmacological strategy used to reverse respiratory depression.

3.2 All medicines given in the urgent management of opioid overdose should be

administered from an agreed protocol.




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4.0 RESPONSIBILITIES

4.1 The Director of Clinical Governance and Quality will ensure:

Clinical Guidelines are embedded into clinical practice as well as the best

practice framework and ensure that these are updated regularly

the identification and implementation of training and educational needs arising from any relevant documentation

4.2 Directors and Senior Management will:

monitor the implementation of this clinical guideline via clinical audit and

supervision

ensure that the Trust Risk Management team is appropriately notified of all incidents

Be able to evidence that EPUT Clinical Guidelines have been followed 4.3 Lead Nurses will:

ensure that these clinical guidelines are followed

ensure that all patient safety incidents are reported on the Datix form in line with the requirements of Trust policy

ensure staff receive appropriate and correct training in line with Trust requirements

Monitor the use of treatment of opioid overdose as an essential part of managing their clinical area. They will collate reports to relevant groups and committees ensuring individual instances are objectively reviewed and audit undertaken

ensure that patients who have received treatment for opioid overdose are supervised/monitored by staff in line with this procedural guideline

ensure issues relating to treatment of opioid overdose are discussed during clinical supervision

4.4 Individual staff will:

adhere to this procedural guideline

undertake appropriate and approved training

ensure treatment is documented in line with the requirements of the procedural guideline

5.0 UNDERPINNING PRINCIPLES

5.1 The need for treatment of opioid overdose requires careful clinical judgement. 5.2 The dose of medication must be individualised for each patient.

5.3 In the event of any respiratory compromise an ambulance should be requested via

the normal ‘999’ route.




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5.4 All staff need to be aware of the legal framework that authorises the use of

naloxone for the treatment of opioid overdose.

6.0 TRAINING

6.1 All staff in areas where treatment of opioid overdose is undertaken are expected to undertake training relevant to its use, including:

The use of Naloxone

Cardio-Pulmonary Resuscitation

Enhanced Clinical Care including management of anaphylaxis

Medicines Management 6.2 Training for staff:

Treatment should be administered by EPUT staffs who have received

appropriate training to carry out clinical assessment and naloxone administration. Staff training must be recorded using the “Staff Training for Naloxone Competence Assessment Form” Appendix 1.

6.3 The training will include:

I. Identification of patients at risk of overdose

At the end of the training session, staff will: o Understand the causes of opiate overdose

II. Recognising the signs of overdose

At the end of the training session, staff will:

o Know how to recognise overdoses and respiratory arrest o Know what action to take in the event of an overdose

III. Management of overdose

At the end of the training session, staff will:

o Know what naloxone is and how it is used o Have had myths and misconceptions about overdose and its treatment

dispelled o Feel more confident in dealing with an overdose o Know what to do if they see an overdose o Be confident they can respond appropriately, including:

Phoning 999 and asking for an ambulance Performing rescue breathing if needed Putting someone in the recovery position Knowing when to use naloxone.




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IV. Administering naloxone

At the end of the training session, staff will know: o Where to keep naloxone o How to prepare a naloxone injection

o How and where to give naloxone o How much naloxone to give and when to give another dose o What to do when the patient comes around, and what to do if they don’t

A simple video at www.harmreductionworks.org.uk/2_films/overdose_and_naloxone.html should also be used as a training tool.

V. Monitoring outcomes

6.4 Training for Service Users (in Overdose Management):

6.4.1 All patients on the Naloxone Take Home Programme must be trained on:

How to recognise opioid overdose, overdose management and the

administration of Naloxone injection.

Training must be conducted as a group or on an individual basis.

The Naloxone Take Home Kit must be explained and demonstrated to the patient and /or representative and an assessment checklist (Appendix 2) must be completed post training to ensure understanding.

6.4.2 Within the Integrated Drug Treatment System (IDTS) team in HMP

Chelmsford, training of Service Users on the Administration of Naloxone will be provided in partnership with Phoenix Futures Full Circle Team.

6.4.3 Refusal of training by a service user must be documented on the Refusal of

Naloxone Training form (Appendix 3 or 4).

7.0 NALOXONE HYDROCHLORIDE - DRUG USED FOR THE PHARMACOLOGICAL TREATMENT OF OPIOID OVERDOSE

7.1 Identification of patients at risk of overdose All patients dependent on opioids are potentially at risk of overdose but the following patients would be considered at increased risk:

Recent history of injecting heroin.

Using opiate on top of their prescribed methadone and buprenorphine

(“Subutex”).

Using heroin with other illicit substances, alcohol or prescribed opiates.

Chaotic lifestyle which can increase the risk.

Potentially any patient who is not currently stable on substitute medication or

still using regular heroin/opiates.

http://www.harmreductionworks.org.uk/2_films/overdose_and_naloxone.html




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7.2 Recognising the signs of overdose

7.2.1 Inclusion criteria for treatment

Patients over 16 years with suspected or actual opioid overdose

indicated by the following:

1. Pinpoint pupils

2. Respiratory depression (respiratory rate below 8/ minute)

3. Reduced level of consciousness

The patient may be difficult to rouse, shows no response to painful

stimuli, exhibits unusual breathing, which may be laborious or shallow,

the patient may be snoring, or presenting with blue lips or other signs of

cyanosis.

7.2.2 Exclusion criteria for treatment

There are no exclusion criteria for treatment but the medication should be administered with caution in case of actual or suspected pregnancy due to the risk of withdrawal and spontaneous abortion. In a life threatening situation naloxone should be given regardless of the pregnancy status.

The medication should be administered with caution in the elderly

and physically frail. A lower dose range of 0.2mg - 0.4 mg is recommended for this patient group. If the treatment response is inadequate, administer subsequent dose of 100 micrograms every two minutes. The maximum dose should not exceed 5mg.

7.3 Management of overdose

Call 999

Check airway and breathing

If breathing, place the patient in the recovery position

If not breathing, administer CPR starting with two rescue breaths and then

place the patient in the recovery position

7.4 Administering Naloxone

Naloxone can induce rapid onset of withdrawal symptoms, such as nausea,

vomiting and sweating. A relatively low first dose of naloxone (typically 0.4mg)

will have a treatment effect but reduce the risk.

Depending on the severity of presentation between 0.4 mg to 2 mg to be

administered intramuscular (to outer thigh) immediately if a patient is identified

as likely to have taken an opioid overdose.




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Repeat 0.4mg- 2 mg dose at two to three minutes intervals depending on the

response, up to the maximum dose of 10mg. The pharmacological effect of

naloxone is short-lived compared to heroin or other opioids, therefore the

overdose can re-occur very rapidly if the number of treatments is insufficient.

Reassure the patient and explain the procedure if appropriate

Call the ambulance regardless of the outcome of the procedure, as the patient will require a period of observation in hospital.

8 Monitoring of outcomes

9 Record vital signs on the Clinical Monitoring Chart (See Appendix 5)

8.0 MONITORING THE USE OF NALOXONE

8.1 A database will be used to monitor outcomes, and for audit and research purposes. This will include:

Number of naloxone injections used

Number of incidents prevented due to use of Naloxone

Number of reported overdoses

Number of reported deaths

9.0 REMEDIAL MEASURES

Reduced respiratory rate (<10/minute)

or oxygen saturation <90%

Maintain airway; ensure patient is not lying face down and recovery position is maintained

Irregular or slow pulse (<50/minute)

Refer to specialist medical care immediately

Fall in blood pressure as measured (>30mmHg orthostatic drop or <50mmHg diastolic) or as observed

Maintain recovery position Monitor closely




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10.0 Naloxone Take Home Programme – Under the supervision of the CDAS Team

10.1 Identify Appropriate Service User/Carer

Named patients 18 years and above identified at risk of opioid overdose should

be offered training and supply of Naloxone.

Adult representatives nominated by the named patient at risk of opioid overdose who have not attended the approved training. Consent must be obtained from

the named representatives to attend training and receive supplies of Naloxone on behalf of the patient.

10.2 Exclusion Criteria

Caution should be exercised in case of actual or suspected pregnancy due to the risk of withdrawal and spontaneous abortion. In a life threatening situation naloxone should be given regardless of the pregnancy status (7.2.2).

Patients who are hypersensitive to Naloxone and /or any component of the preparation should not be given a supply.

Patients who decline training and supply or are excluded. Such patients should be referred to the appropriate medical practitioner or non-medical prescriber.

10.3 Supply of Take Home Naloxone Kit to Service Users

10.3.1 Take Home Naloxone Kit is supplied as “Prenoxad” pre-packs and contains:

1 x 2mls pre-filled syringe (Naloxone Hydrochloride – Prenoxad –

1mg/ml)

2 x 23G 1.25” needles for Intramuscular (IM) injection.

Patient Information Leaflet

10.3.2 Each 2ml syringe is marked out with 5 x 0.4mg doses.

10.3.3 For every Naloxone Take Home Kit issued to a Service User in the

community, record of supply must be captured on the Take Home Naloxone Recording Form (Appendix 6). The Service User must also be issued with a signed copy of “Safe Storage of Naloxone Kits Agency Statement (Appendix 7).

10.3.4. Supply of Naloxone Take Home Kits to Service Users being released from

prison will be issued by trained IDTS Nursing Staff at reception prior to service user’s release following completion of their training. Record of supply will be captured in process as stated in section 10.3.3.




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10.4 Storage and Stock Control

10.4.1 Storage

Storage of Naloxone in all designated premises must be in line with Trust Policy for the Safe and Secure Handling of Medicines (CLPG13).

Service Users must be advised to keep the Take Home Naloxone Pre-packs out of the reach of children and pets and encouraged to return kits to their CDAS teams for a replacement pack should the medication be used, lost or expired. The safe disposal of needles following the use of Naloxone pre-pack must be emphasised to service users.

10.4.2 Supply

Stock supply should only be ordered as needed from the Trust Pharmacy Departments.

10.5 Record Keeping

The supply of Naloxone must be recorded onto the Naloxone Training Checklist (Appendix 2) and the Take Home Naloxone Recording Form (Appendix 6).

When a client returns for subsequent supplies, the “Administration of Prenoxad feedback form” for recording the use and replenishment of Naloxone (See Appendix 8) must be completed to facilitate audit.

11.0 IMPLEMENTATION

11.1 This clinical guideline will be made available across the organisation via the Trust intranet.

11.2 All incidents of opioid overdose must be reported in line with Trust policy on

adverse incidents.

12.0 CLINICAL GUIDELINE REVIEW

12.1 The Director of Clinical Governance and Quality will be responsible for the overall monitoring and review of this clinical guideline.

12.2 This clinical guideline will be reviewed every three years taking into account

emerging national guidance, local audit recommendations and lessons learnt from reports, inquiries and positive practice initiatives.

12.3 Any amendments to this clinical guideline will be submitted for consideration and

endorsement prior to being ratified to:

Medicines Management Committee




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12.4 Effectiveness of this Clinical Guideline will be monitored through the Trust Clinical

Governance department. The results will be presented to Clinical Advisory Group (CAG) for review and identification of any actions required.

12.5 Training requirements will be monitored by the CDAS Quality Group.

13.0 REFERENCES

1. The NTA overdose and Naloxone training programme for families and carers. The National Treatment Agency for Substance Misuse, 2011.

2. Office of National Statistics 2016:

https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2016registrations

3. The Human Medicines (Amendment) (No. 3) Regulations 2015 (2015/1503) http://www.legislation.gov.uk/uksi/2015/1503/pdfs/uksiem_20151503_en.pdf

4. https://www.gov.uk/government/publications/widening-the-availability-of-naloxone/widening-the-availability-of-naloxone

5. http://www.nta.nhs.uk/uploads/phetake- homenaloxoneforopioidoverdoseaug2017.pdf

14.0 REFERENCE TO OTHER TRUST POLICIES/PROCEDURES

EPUT Formulary and Prescribing Guideline Section 10: Management of alcohol, opioid and benzodiazepine dependence.

END

http://www.legislation.gov.uk/uksi/2015/1503/pdfs/uksiem_20151503_en.pdf

http://www.nta.nhs.uk/uploads/phetake-

clinical guideline for the administration of naloxone

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