Public Health Dorset Prenoxad (Naloxone) Supply Standard Operating Procedure (SOP)

Transcription

1 Public Health Dorset Prenoxad (Naloxone) Supply Standard Operating Procedure (SOP) 1 Introduction 1.1 Purpose This SOP aims to provide guidance on the supply of take home naloxone, in the form of Prenoxad prefilled syringe pack, to service users, family members, hostels, carers and other groups for the purpose of temporarily reversing opioid overdose. It is intended as a framework for the supply of naloxone injections by specialist services operating pan-dorset. This applies to all staff, volunteers and peers within Substance Misuse services who have direct contact with service users. 1.2 Background Britain continues to have a high number of drug-related deaths with opiate overdose remaining a major cause of death among injecting drug users. In England and Wales 765 deaths were registered in 2013 in which heroin or morphine were mentioned on the death certificate: An average of two every day, and a significant increase of 32% compared to those registered in This increase brings the number of deaths relating to heroin and/or morphine to similar levels to Naloxone is a drug which temporarily reverses the effects of opioids such as heroin, methadone and morphine. For many years, naloxone has been used within emergency medical settings to reverse the effects of opioid overdose and prevent death. UK Guidelines on Clinical Management of Drug Misuse fully endorses the use of naloxone in overdose management and prevention. On the first of October 2015 The Human Medicines (Amendment) (No. 3) Regulations 2015 (2015/1503) comes into force. This allows 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. It can be supplied to anyone in the course of lawful drug treatment services and only where required for the purpose of saving life in an emergency. For explanatory memorandum see: 2 Policy Public Health Dorset will facilitate overdose awareness and use of naloxone training to staff, hostel workers and appropriate others in line with local and national guidelines 1

2 to help reduce the numbers of local drug related deaths from opioid overdose. This training will be delivered by Martindale, manufacturers of Prenoxad. Trained staff will then disseminate the training within their teams and to service users and their concerned others who take supply. Service users and concerned others will sign a responsibility deal agreeing to appropriate use. 2.1 Staff competence Staff supplying naloxone should have been appropriately trained. All staff should complete the SMMGP online learning package (available at: and have attended overdose awareness and use of naloxone training. All staff will also be signed off as competent by the service Naloxone Lead, or relevant service line manager. A record of staff trained will be sent to the PHD Naloxone lead and maintained and updated by the specialist service involved. The Naloxone Lead will be responsible for keeping a register of staff/volunteers appropriately trained in supply of naloxone. 2.2 Eligibility criteria Naloxone can be supplied to anyone: Currently using illicit opiates, such as heroin Receiving opioid substitution therapy Leaving prison with a history of drug use Who has previously used opiate drugs (to protect in the event of relapse) 2.3 Training service users, carers and identified others in overdose management Training on how to recognise opioid overdose, overdose management, and administration of naloxone injection must be given before naloxone is supplied. The training may be delivered on an individual or group basis. The training is not time consuming, taking five to ten minutes, but must cover recognition of an opioid overdose and that the procedure is to: Ensure personal safety first Call an ambulance Place the casualty in the recovery position, or on their side if breathing Place the casualty on their back if not breathing Commence chest compressions and rescue breaths if not breathing Inject naloxone into the thigh or upper arm muscle Repeat chest compressions and rescue breaths until breathing commences 2

3 Repeat naloxone injections at 2 minute intervals in doses of 0.4mg until breathing commences. If patient is still non-responsive and ambulance services have not arrived Naloxone can continue to be given at 2 minute intervals if there are other kits available to use. Wait with the casualty until the ambulance arrives and safely dispose of the naloxone kit to paramedics The process of using the naloxone kit must be explained and demonstrated and a Consent, Agreement and Data Collection Form for the Supply of Take- Home Naloxone (see appendix 2) must be completed post training, and given to the Naloxone Lead. This should be done each time a kit is given out or replaced. One naloxone pre-filled syringe/pack for intramuscular use will be supplied. Should there be an identified need for more than one kit, this should be discussed with Public Health Dorset Naloxone Lead. Each pack will include one naloxone injection 1mg/ml as a 2ml pre filled syringe. Each 2ml syringe is marked out with 5 x 0.4mg doses - the minimum effective dose which can be given in an attempt to reverse the effects of opioid overdose. The used syringe and needle should be replaced in cradle in the yellow Naloxone kit box when no longer required and the box shut to become a temporary sharps container. Used or partially used kits should be given to the emergency services attending (police, ambulance, fire) for safe disposal. If no emergency services attend then used kits should be returned to the service of issue for bearer re-supply and recording of details of use. Naloxone can be issued to pregnant women where the potential benefit is deemed to outweigh the risk Naloxone can be issued to young people under 18 by an appropriately acting professional acting within a suitable clinical governance framework after careful consideration and on a case by case basis. Account should be taken of Fraser guidelines and the mental capacity of the young person to understand the issues involved, together with adherence to guidance relating to consent and safeguarding in children and young people. 2.4 Collection and audit The supply of naloxone must be recorded on the HALO Naloxone Management programme. A paper record must also be securely kept of the supply including; to whom it was supplied; the batch number of the product; the expiry date; and the name of the person supplying the kit. If it is a replacement kit, details should be recorded on the Take Home Naloxone Replenishment Recording Form (see appendix 5). This will record valuable information about the use of the naloxone kit and the situation in which it was used. This should also be recorded on HALO. Staff may need to record re-issue the same day if replenishing. A spread sheet of this data is held by Public Health Dorset. 3

4 Those who have used naloxone should be encouraged to share and record their story with appropriate specialist staff, which can then be transcribed. Stories of people who have used naloxone to save a life provide useful learning for staff, carers and service users and can be helpful in evidencing the effectiveness of take home naloxone. 2.5 Supply, storage and stock control On 30th June 2015, naloxone was reclassified under article 7 of Prescription Only Medicines Order, by Parliament. Naloxone is now on the list of prescription only medicines that can be administered parentally (by injection) by anyone for the purpose of saving a life. Take home naloxone will be supplied as pre-packed Prenoxad kit containing: 1 x 2ml pre-filled syringe ( Naloxone Hydrochloride (Prenoxad) 1mg/1ml) 2 x 23G 1.25 needles for intramuscular injection Product instruction sheet/s Naloxone has been subjected to stability studies at 40 degrees centigrade which showed the product shelf life was fully compliant at this temperature for up to 6 months however it should be protected from light. Inappropriate storage and handling may shorten the shelf life. Service users must be advised to keep the take home naloxone out of reach of children and pets and encouraged to return for replacement dose should they have used or lost the medication or when it has expired. Service users must be advised of the safe disposal of needles following the use of the take home naloxone. Prenoxad kits have a low potential for misuse however carriers should be discouraged from opening kits to use needles for other purposes, understanding that police will remove unsealed kits from service users if found during searches. Used sharps and syringes should be replaced in the Naloxone kit box and shut before being given to attending emergency services or returned to the specialist service of issue for safe clinical waste disposal. Un-used, unwanted, used or partially used, found and expired stock should also be returned to service of issue or handed to the ambulance service staff who attend a suspected overdose situation for safe disposal. Supplies of Naloxone can be drawn from the Public Health Dorset purchase order placed with Frontier Medical and stored in a secure place until issued. In cases such as hostels Prenoxad should be stored safely but accessible to staff and trained others. On drawing from the purchase order each service will provide Frontier with a named contact, address and telephone number. Each specialist issuing service will attach a self-adhesive label to the kit when issued stating name of issuing service, trained bearers name and date of issue. Care should be taken over the placement of this label to ensure it does not obscure the product expiry date pre-fixed label. Stock can be delivered in minimum quantities of 10 kits and maximum orders of 30 kits should be placed as required with awareness that there is up to one week delivery time. Stock should be requested Monday to Wednesday. Requests should not be placed on Thursdays (as this may lead to a special delivery cost being incurred in order to supply by Friday which will be passed on to the ordering service) and orders placed on Fridays will not be dispatched until Monday due to Naloxone being classed as a 4

5 medicine and therefore cannot sit in mailing warehouses and sorting offices over a weekend. Services should avoid holding more stock than they need as held stock expiry dates will be eroding. Budget for Naloxone supplies is not finite and services are requested to carefully consider the appropriateness of issue to a service user. Naloxone is designed to help save the lives of opiate users, many of whom will be known to services to be at high risk of overdose through chaotic behaviour or to have overdosed before and for service users in known high risk situations such as recent exit from custody or discharge from inpatient stay. It is not necessary or appropriate for all injecting drug users such as NPS or steroid users to be issued with it unless they are known to also be using opiates. Services are asked to order and issue Naloxone with caution, given financial constraints, and only to service users where they identify it will be beneficial and effective. 2.6 Expired supplies Naloxone has a maximum shelf life of 3 years. When naloxone is supplied this should be explained to the client and the expiry date noted and told to them. Recipients of take home naloxone should be encouraged to return the naloxone to the service before the expiry date to collect a further supply. Recipients should be made aware of stock recall procedures should a product recall be issued for a specific batch. Expired supplies should immediately be placed in sharps collection bins for clinical waste collection and disposal. Returned sealed kits can be used for demonstration or staff training purposes. 2.7 Product Recall Should a product recall alert be received from the supplier to the Public Health Dorset Naloxone lead, the lead officer will cascade the alert and notify batch numbers to the specialist services who issue the product. Specialist services are responsible for making every attempt possible to contact the bearer of the recalled batch and encouraging them to return their supply. Recalled supplies should be stored separate to other stock. Returned stock is to be labelled appropriately and quarantined, awaiting supplier collection and replacement, in line with MHRA guidance 0/A_guide_to_defective_medicines.pdf. The specialist service is responsible for contacting the supplier direct for pick up and replacement of such stock. Record should be made of quantity of recalled stock received and batch numbers and of the new batch number of supply issued to replace that recalled. Re-issue should otherwise follow standard procedure. 5

6 Appendix 1 Naloxone Provision Flow Chart Individual presents needing naloxone for purposes of saving a life in emergency Presenting individual is trained in overdose awareness and use of naloxone by a certified and competent member of staff/volunteers. Appendix 1 completed, naloxone supplied with accompanying fact sheets, wrist band and online training reminder. HALO Naloxone programme records to be updated. Naloxone kit is used; lost; or expires Appendix 2 completed and naloxone replaced. HALO Naloxone programme records to be updated. 6

7 Appendix 2 Consent, Agreement and Data Collection Form for the Supply of Take-home Naloxone Complete this form every time you issue take-home Prenoxad Injection Recipient Name Needle Exchange No. (if relevant) Recipient Address Recipient Type Engaged Service User Non-Engaged User Harm Min Client Carer Hostel/Community Service Worker Specialist Drug Worker Family Member/Friend Date of Birth Male Female GP (for engaged service user & non engaged user) Home Telephone Mobile Telephone Supply Status Initial Supply Re-supply Re-supply Reason batch recall out of date Recipient Training Date Closed Date Closure Reason confiscated kit lost Recipient deceased Re-supplied used for overdose (If yes please complete Naloxone Used form) other please state: Recipient lost to contact other please state: By signing the form I confirm that: I have been given training in the dangers of opiate overdose, basic resuscitation and the appropriate intramuscular administration of Prenoxad Injection (naloxone hydrochloride) I am aware of online Prenoxad Injection resources and have been advised to revisit them for a review 7

8 I have been given printed guidance about Prenoxad Injection I am aware that Prenoxad Injection is to be administered in suspected opiate overdose only I am aware that the Prenoxad pre-filled syringe has an expiry date on the yellow box label and that it is my responsibility to return it before this date and collect a new kit. I agree that my participation at the training and the issuing and use of Prenoxad Injection (naloxone hydrochloride) may be audited I confirm that I am to my knowledge not allergic to naloxone hydrochloride (Prenoxad ) Injection I understand that all medicine should be kept in a safe place, i.e. out of reach of children. Your details will be held confidentially by commissioned providers of substance misuse services and shared with Public Health Dorset for the purpose of data analysis e.g. measuring programme uptake and monitoring outcomes. If you require further information about how your information will be used or shared, please discuss this with your Naloxone issuer. I understand and consent to my details being used for these purposes and understand that I may withdraw this consent at any time. I am aware that doing so may result in my not being able to participate in the Naloxone programme. Name: Signature: Date: Batch Number: Expiry date: Name recorded on label Name of person supplying Prenoxad: Signature of person supplying Prenoxad: Date of issue recorded on label 8

9 Appendix 3 Drug Service Worker Training Checklist Prenoxad (naloxone hydrochloride 1mg/ml solution for injection) Training Name of Drug Service Worker: Signature: Job Role: Agency: Base: 1 What are the signs of suspected opioid overdose? 2 Name some overdose myths. 2 What is Prenoxad Injection? 3 When to call 999? 4 When should you use the recovery position? 5 How and when to perform chest compressions and rescue breaths? 6 How do you assemble Prenoxad injection? 7 How do you inject Prenoxad? 8 How often should you administer doses of Prenoxad? 9 Should you stay with the casualty? I confirm that the above Drug Service Worker can demonstrate an understanding of the appropriate use of Prenoxad Injection and is competent to train service users and carers. Trainer s name: Trainer s signature: Date: Agency: 9

10 Appendix 4 Public Health England Take Home Naloxone Guidance: Changes in legislation 1 st October 2015 As of 1 st October 2015 changes to the way naloxone can be supplied by Local Authority and NHS commissioned drug treatment agencies come into effect. This document will outline how naloxone can be supplied and by whom. 1. Background In 2012 the Advisory Council on the Misuse of Drugs (ACMD) recommended that take-home naloxone should be made more widely available. Naloxone is also recommended by the World Health Organization In 2014 the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on a proposal to make naloxone more widely available. Responses were almost unanimously in favour of the proposal. On 1 October 2015, new legislation will come into force that will enable naloxone to be supplied to individuals by drug services without prescription 2. Before October 2015 Naloxone is a prescription-only medicine and could only be prescribed directly to a named patient, or supplied to an individual by means of a patient specific direction (PSD) or a patient group direction (PGD) It could therefore be supplied using these mechanisms to anyone currently using illicit opiates; receiving opioid substitution therapy; leaving prison with a history of drug use; or who has previously used opiate drugs (to protect in the event of relapse). With the agreement of someone to whom naloxone could be supplied, it could also be provided to their family members, carers, peers and friends. 3. As of October 2015 The law governing the supply remains the same as above and naloxone remains a prescription only medication. In addition, as of 1 st October 2015 naloxone can be supplied by a drug treatment service commissioned by a local authority or the NHS to any individual needing access to naloxone for saving a life in an emergency. It can now be supplied without prescription (or PGD or PSD) to someone who is using or has previously used opiates (illicit or prescribed) and is at potential risk of overdose; a carer, family member or friend liable to be on hand in case of overdose; a named individual in a hostel (or other facility where drug users gather and might be at risk of overdose), which could be a manager or other staff There is no need for the usual Prescription Only Medicine requirements, just a requirement that the supply is suitably recorded [see section 8- Record Keeping]. 4. What can be supplied Currently Prenoxad (naloxone hydrochloride 1mg/1ml solution for injection) is the only product that is to be supplied under these guidelines. This is subject to review and may change if other products are considered for the supply for the purpose of saving life in an emergency. 10

11 5. Which services can supply naloxone A drug treatment service commissioned by a local authority or the NHS. Other drug treatment services receiving funding from elsewhere are not eligible to supply naloxone Services are not defined in legislation but are generally understood to include: Specialist drug treatment services Primary care drug services Needle and syringe programmes, including those provided from pharmacies A pharmacy providing supervised consumption of opioid substitute medication 6. Who can supply naloxone These guidelines enable specialist staff members who have undergone Take-Home Naloxone training and had their competencies accredited [see Appendix 1] to supply naloxone to individuals as set out in Section 7. Organisations participating in the supply of naloxone will need to keep up-to-date staff training records and ensure that only those evaluated as competent are able to provide the drug. 7. Who can be supplied Eligible staff can supply individuals for the purpose of saving life in an emergency. These individuals will be: someone who is using or has previously used opiates (illicit or prescribed) and is at potential risk of overdose; a carer, family member or friend liable to be on hand in case of overdose; a named individual in a hostel (or other facility where drug users gather and might be at risk of overdose), which could be a manager or other staff Eligible staff are not able to supply stock to another service or organisation for onward supply under this change to legislation. Organisations not covered by the new legislation will need to seek advice on prescribing options available to them if they wish to provide naloxone to their clients. 8. Record keeping I Records must be kept of all naloxone supplied. As a minimum this needs to include: The identity of the staff member supplying naloxone (including their role) The actual location the supply took place The identity of the individual being supplied naloxone Whether the person being supplied is someone using opiates (illicit or prescribed); someone who has previously used opiates (illicit or prescribed); a carer, family member or friend; or an individual working in a hostel (or another named facility where there is a risk of overdose) and their role The product being supplied (currently this is only Prenoxad) The batch number of the naloxone supplied The expiry date of the naloxone supplied See Appendix 2 11

12 It will be necessary to record other information in cases where naloxone has been used and needs to be replenished, such as: circumstances of the overdose: who, when, where, etc whose naloxone was used by whom how many naloxone doses were given and to what effect the response of emergency services (time to ambulance arrival, additional naloxone administered, person taken to hospital, etc) advice given to the overdosed person outcome of the overdose and its treatment See Appendix 3 12

13 Date Naloxone used Appendix 5 Details of Use of Prenoxad Injection Name of person who administered Naloxone (if available) Relationship to casualty Naloxone administered to (name if known) Date of birth (if known) Please confirm if engaged service user Whose naloxone kit(s) was /were used? (if known) Batch number(s) (if known) Into which part of the body was Naloxone injected? How many doses of naloxone were administered? Given in Did the patient experience withdrawal symptoms? Was 999 emergency service called? Recovery position used? Was CPR / BLS used? Did patient attend A&E? Friend Relative Carer Yes Outer thigh Upper arm Single dose increments Random increments Yes Yes Yes Yes Yes Unknown individual Community Service Worker Specialist Drug Worker No Other (please state where) 1st ½ then 2nd ½ Whole syringe No No No No No 13

14 Overdose suspected of: Where did the overdose take place? Were specialist services staff at scene of overdose? What was the outcome? Heroin Methadone Home address Public Place Hostel Yes Survived Unknown Other (please specify): Friends/Relatives/Partners House Not Known Other (please specify): No Deceased Please remember to issue a new dose and complete a new Naloxone issue form. 14