Patient group direction
PGDs are often used for routine vaccination clinics. The view of the Department of Health (as expressed in the Green Book) is that this should not normally be necessary. The argument is that practices will know who is coming for vaccination (which in practice may not always be the case), and that a "patient specific direction" or PSD is therefore more appropriate.
Black triangle drugs and medicines used outside the terms of the Summary of Product Characteristics
Some people believe that you cannot have a PGD for Black Triangle Drugs and medicines used outside the terms of the Summary of Product Characteristics (aka product license). This is not strictly true. For the [catch-up vaccination programme] starting in 2007, for example, the products used are not licensed for use in some of the age groups involved in the catch-up programme; but the JCVI has recommended their use, and the Department of Health has endorsed this recommendation in a CMO letter; so the products can be used in a PGD, despite being used outside their product license, and despite being black triangle drugs.
HSC 2000/026 states:
- "Black Triangle Drugs and medicines used outside the terms of the Summary of Product Characteristics.
- "13. Black triangle drugs (ie, those recently licensed and subject to special reporting arrangements for adverse reactions) and medicines used outside the terms of the Summary of Product Characteristics (eg, as used in some areas of specialist paediatric care) may be included in PGDs provided such use is exceptional, justified by current best clinical practice (eg, NICE guidance) and that a direction clearly describes the status of the product. Black triangle vaccines used in immunisation programmes may be included in PGDs, provided they are used in accordance with the schedules recommended by the Joint Committee on Vaccination and Immunisation. Where the medicine is for children, particular attention will be needed to specify any restrictions on the age, size and maturity of the child. Each PGD should clearly state when the product is being used outside the terms of the SPC and the documentation should include the reasons why, exceptionally, such use is necessary."
- Guidance on PGDs from the National Prescribing Centre
- Flowchart "To PGD or not to PGD" from Druginfozone
- PGDs from DH, for use in situations where there has been a deliberate release of a nerve agent or bioterrorism agent
- The Health Service Circular (HSC 2000/026) establishing PGDs
- PGD portal of National Electronic Library of Medicine
- MHRA PGD portal