UK law around naloxone changed on 1st October 2015, the main change is that now any worker in a commissioned drug service can now distribute naloxone without prescription .
You can see details of the changes in 'The Human Medicines (Amendment) (No. 3) Regulations 2015' and it's supporting documents.
Public Health England have produced a helpful slideset that explains the changes in the law and how they impact drug services.
Existing Laws Still in Effect
The October 2015 law changes only apply to drug services, any other services wishing to deliver naloxone interventions are still covered under exisiting laws, because of this we have left the original content of this page below for reference.
Like all medicines in the UK, naloxone sale and supply is regulated under the Medicines Act of 1968. This act brought together most of the previous legislation on the regulation of medicines but also introduced some new legal provisions for the control of medicines.
When thinking about the regulation of medicines, it's important to recognise that medicines (broadly) fall into one of four categories;
- GSL. General Sales List Medicines sold or supplied direct to the public in an unopened manufacturer's pack from any lockable premises
- P. Pharmacy Medicines sold or supplied from registered premises by, or under the supervision of a pharmacist
- POM. Prescription Only Medicines sold or supplied to named patients by prescription. Applies to all injectable preparations, including Naloxone
- POM (CD). Controlled Drugs
As stated above, injectable naloxone is a POM and can therefore only be SUPPLIED to a person identified as 'at risk' of potential future opiate related overdose. It can be supplied to the friends/loved ones of those identified as at risk, but only with the written consent from the person for whom it's to be supplied.
Who can administer naloxone?
Anyone can administer naloxone for the purpose of saving a life. In November 2005 naloxone was added to the list of injectable drugs in Article 7 of the Medicines Act, this is the part of the act that covers drugs like insulin for diabetics (and adrenaline, atropine, snake anti-venom etc).
Who can supply naloxone?
Naloxone can be prescribed by any medical doctor, but can also be prescribed by some other registered medical staff using a Patient Group Direction (PGD). This means that naloxone can be given out via drug projects that don't necessarily have a doctor on their staff.
What's covered by a PGD?
A PGD is a written agreement that in the case of naloxone allows nurses or pharmacists to distribute the drug to people at risk of overdose. It's important to note that a PGD is only related to the supply of the drug and has nothing to do with administration (as we've stated above anyone can legally administer naloxone to save a life). A PGD should contain the following information:
- The name of the business to which the direction applies
- The date the PGD comes into force and the date it expires
- A description of the medicine(s) to which the direction applies
- The class of health professionals able to supply or administer the medicine (as named individuals)
- Signature of a doctor or dentist, as appropriate, and a pharmacist
- Signature by a representative of an appropriate health organisation
- The clinical condition to which the direction applies
- A description of those patients excluded from treatment under the direction (if applicable)
- A description of the circumstances in which further advice should be sought from a doctor and the arrangements for referral
- Details of the appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or maximum period over which the medicine should be administered. Legal status of the drug should also be indicated
- Relevant warnings, including potential adverse reactions
- Details of any necessary follow-up action and the circumstances
- A statement of records to be kept for audit purposes
Taken from the Royal College of Nursing Guide to PGD
We have a sample PGD you can use as a foundation for developing your own available here.