SPS, NHS England, the Royal College of Radiologists (RCR) and the Society and College of Radiographers (SCoR), with the support of specialists working within NHS clinical practice, have produced PGD templates for contrast agents commonly used in radiology services for use in NHS England commissioned services.
The aim of these templates is to produce a consistent presentation which has been reviewed by specialists within radiology. They have ensured that the legislative and clinical parameters have been fully considered and addressed, but have been mindful of the SPS advice on the use of PGDs for contrast agents.
The PGD templates require local adaptation to reflect local policies and populations – the areas of each PGD requiring local adaptation are highlighted in blue throughout each PGD.
The PGDs contain advisory text (highlighted in yellow) intended to support the adoption of the PGD – all text in yellow highlight should be removed from final versions of the PGDs.
Each organisation using these PGD must ensure that it is formally signed by a senior pharmacist, a senior doctor and any other professional group representatives involved in its review and that it is reviewed in line with the organisation’s PGD governance system. The organisation’s governance lead (or nominated deputy) must sign to authorise the PGD on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD. See SPS website or NICE guidance for further guidance on signatories.
It is envisaged that until legislative changes occur these templates will be reviewed and re-released prior to reaching their valid to date. If any relevant changes occur to the product SPC or other guidance then an earlier review will be undertaken. Any decision to locally extend a stated valid to date needs to be locally assessed and agreed as per the organisation’s local policy
The following PGD templates are available:
- Iomerprol (Iomeron®)
- Iopamidol (Niopam®)
- Iohexol (Omnipaque®)
- Ioversol (Optiray®)
- Iodixanol (Visipaque®)
- Gadoteric acid meglumine (e.g. Dotarem®, Clariscan®, Dotagraf®, Cyclolux®)
- Gadobutrol (e.g. Gadovist®)
- Gadobenate dimeglumine (e.g. MultiHance®)
- Gadoteric acid disodium (e.g. Primovist®)
- Gadoteridol (e.g. ProHance®)
Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division