Expanded Access to Take-Home Naloxone Without Prescription

Introduction

Naloxone is an emergency antidote for overdoses caused by opioids such as heroin, methadone, morphine, nitazenes, and fentanyl. It works by reversing the life-threatening effects of opioids, particularly respiratory depression. While naloxone remains a prescription-only medicine, certain services and professionals are now permitted to supply it without a prescription to save lives in emergencies.

Legislative Framework

Under The Human Medicines (Amendment) (No. 3) Regulations 2015, individuals working for drug treatment services were authorised to supply naloxone without a prescription. Amendments in February 2019 included nasal naloxone.

In December 2024, The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 further expanded the scope, allowing a wider range of professionals and services to supply take-home naloxone under two routes:

• Route 1: Named professionals and services
• Route 2: Others registered to supply naloxone

These individuals and services can supply naloxone provided they are suitably trained and choose to do so.

Authorised Suppliers

Professionals and services authorised to supply naloxone without a prescription under Route 1 include:

• Drug treatment services
• Medical services of the armed forces
• Police forces and services, including commissioned drug treatment workers
• Prison services
• Probation and youth justice services
• Registered nurses and midwives
• Pharmacists and pharmacy technicians
• Registered paramedics

These entities can supply naloxone to individuals at risk of overdose, their family members or friends, outreach workers, and others in positions to assist during an overdose emergency.

Registration for Non-Named Professionals (Route 2)

A new registration service is being established to enable professionals and services not explicitly named in the legislation to supply take-home naloxone. These individuals must undergo appropriate training and register accordingly. Further information on this registration process will be provided in due course.

Forms of Naloxone Available

Authorised suppliers can provide naloxone in the following forms:

• Prenoxad intramuscular injection
• Nyxoid nasal spray
• Naloxone 1.26 mg nasal spray

Training is required to ensure proper understanding of the product, its administration, and safe storage.

Eligibility for Receiving Naloxone

Naloxone can be supplied to:

• Individuals at risk of opioid overdose
• Carers, friends, or family members of at-risk individuals
• Outreach workers and hostel managers
• Individuals working in environments where overdoses may occur

While anyone can administer naloxone in an emergency, those supplied with it are not permitted to redistribute it to others for future use.

Considerations for Children and Young People

There are no legal restrictions on supplying naloxone to individuals under 18. However, decisions to provide naloxone to children or young people should be made on a case-by-case basis, considering clinical principles, the individual’s needs, potential benefits and risks, and their capacity to consent.

Product licensing varies:

• Nyxoid nasal spray is authorised for individuals aged 14 and over
• Prenoxad injection and naloxone 1.26 mg nasal spray are authorised for adults aged 18 and over

Off-label use in younger individuals is permissible with appropriate care and governance.

Governance and Training

Services supplying naloxone should implement protocols covering:

• Eligibility criteria for recipients
• Product selection
• Training requirements
• Storage and record-keeping

Training should be provided for:

1. Individuals supplying naloxone, focusing on stock management and record-keeping
2. Those providing naloxone to others, ensuring they can train recipients effectively
3. Recipients of naloxone, covering overdose recognition, emergency response, and naloxone administration

Data Collection and Record-Keeping

Accurate records of naloxone supply are essential for:

• Stock management and reordering
• Demonstrating appropriate supply practices
• Monitoring distribution and training coverage
• Replacing naloxone approaching its expiry date

Acquisition and Storage

Authorised services can obtain naloxone from pharmaceutical wholesalers:

• Prenoxad is available from AAH Pharmaceuticals and Alliance Healthcare
• Nyxoid and naloxone 1.26 mg nasal spray are available from AAH Pharmaceuticals

Proper storage protocols should be established, including considerations for quantity needed, safe storage conditions, and record-keeping.

Dosing and Side Effects

While side effects are rare, they may include nausea, tremors, sweating, rapid heartbeat, blood pressure changes, pulmonary oedema, and seizures.

In emergencies, the benefits of administering naloxone outweigh potential risks. Careful, graduated dosing can minimise withdrawal symptoms and other side effects.

Citation:
Department of Health and Social Care. (2025, April 23). Supplying take home naloxone without a prescription. GOV.UK.