Supply and administration of P and GSL medicines
Medicines that are classified as Pharmacy (P) or General Sales List (GSL) medicines can be administered without the need for a Patient Group Direction (PGD) or Patient Specific Direction (PSD), and pre-packed GSL medicines can be supplied without a PGD.
The supply of a P medicine requires a PGD or PSD, unless:
- an exemption under the Human Medicines Regulations 2012 applies
- the supply is made from a registered pharmacy premises under the supervision of a pharmacist
- the supply is made by a registered midwife in the course of their professional practice
P medicines
PGDs should not be used for the administration of a P medicine but can be used for the supply of a P medicine to an individual.
Administration
For the administration of a P medicine to an individual, a locally developed and approved protocol can be used to support the administration, which may be a standalone policy or incorporated within a broader medicines policy. Protocols can be used in all healthcare settings.
Local processes for record keeping, staff training and competency assessments, audit, incident reporting and medicines storage and requisition must all be considered when operating under protocols.
When a P medicine is administered under a local protocol and where the legal classification of the medicine is based on the pack size (for example fluconazole), SPS has been advised by the MHRA that administration of single doses can be made from a POM or P pack which has been legally obtained by the organisation.
Supply
A registered pharmacy can legally supply/sell P medicines without a PGD or prescription. In addition, a P medicine can be sold/supplied by a registered midwife in the course of their professional practice or by other healthcare professionals where an exemption exists. Therefore a PGD is not required where supply is made by these healthcare professionals.
A PSD or PGD is required for the supply of P medicines in other circumstances.
GSL medicines
PGDs should not be used for a GSL medicine administration or supply. A locally developed and approved protocol can be used to support these tasks, which may be a standalone policy or incorporated within a broader medicines policy. Protocols can be used in all healthcare settings.
Local processes for record keeping, staff training and competency assessments, audit, incident reporting and medicines storage, labelling and requisition must all be considered when operating under protocols.
Administration
When a GSL medicine is administered under a local protocol and where the legal classification of the medicine is based on the pack size (for example paracetamol), SPS have been advised by the MHRA that administration of single doses can be made from a POM, P or GSL pack which has been legally obtained by the organisation.
Supply
A PGD is not necessary to supply a GSL medicine, provided the supply takes place from lockable premises and the GSL medicine supplied is in an original pre-packed GSL labelled pack only.
If the dosage instructions on the GSL pack reflect the dose required to be administered under the protocol then over-labelling is not required. It is good practice to add the individual’s name/date supplied and address of the supplying unit to any medicine supplied. This information can be as a pre-printed label to which the individual’s name and date of supply is added at the time of supply. Any additional label should be added in such a way that it does not obscure manufacturer’s information on the pack.
Legislation relating to the supply of GSL medicines (Regulation 221 of the HMR 2012) must be adhered to unless an exemption is made within the legislation. All GSL medicines must be supplied from a premises which is able to be closed as to exclude the public. Only where there is an exemption to this with the legislation (namely under HMR 2012 Schedule 17, for registered midwives as detailed in HMR 2012 Regulation 223 or under the directions of a prescriber) can a GSL be supplied outside of this legal requirement.
Promote self-care
Refer to the NHS England policy guidance on conditions for which over-the-counter items should not routinely be prescribed in primary care when considering if a GSL medicine should be supplied. Integrated Care Boards will usually have their own local policy based on this guidance. Whilst the guidance was written to support policy development for primary care services, all NHS services should be mindful of it and practitioners should advise individuals to buy over the counter medicines for self-care in line with the guidance/local policy.
Where a medicine is supplied under an NHS commissioned service, the regulations require that a prescription charge is made unless the individual is exempt from such charges. In most cases it would not be cost effective for an individual to pay a prescription charge for a GSL medicine to be supplied, which they can purchase. If any GSL medicines are supplied and a prescription charge levied, the organisation should have a mechanism in place for collecting these charges.
Template protocol
SPS have developed a template protocol for the administration of GSL/P medicines or the supply of GSL medicines.
This can be locally adapted by organisations noting that it is a template for local adaptation and organisations are responsible for ensuring the clinical and pharmaceutical content is appropriate. Any templates used in practice must be approved for use through appropriate local governance processes.