Advice on the use of Patient Group Directions (PGDs) to supply or administer a medication which is part of a clinical trial, study or pilot

Permitted use of PGDs

There is nothing in legislation that prevents the use of PGDs in clinical trials, studies or pilots if the medicine has a UK product licence and all other legal and good practice requirements relating to PGDs are met.

Often medicines administered or supplied under a PGD as part of a clinical trial, study or pilot are not actually part of the investigation which is more commonly focused on the service design, delivery or patient group. Examples include use of a vaccine in a population outside the national immunisation schedule or the supply of a medicine as part of a clinical  programme pilot (e.g. in the community pharmacy setting).

Licensing considerations

The UK licensing status of the medications involved must be considered.

If the medication use is off label this is permitted under a PGD, but this must be acknowledged within the PGD as stated within the NICE guidance and must be clearly justified by best clinical practice.

Unlicensed medicines

Unlicensed medications (those without a UK licence or Market Authorisation) cannot be supplied or administered under a PGD in any circumstance. SPS provide further advice in Unlicensed medicines and use of PGDs.

Further information

Organisations may wish to seek advice and support from their local Clinical Trials team or the commissioner of the proposed service.

Other useful resources include:

Update history

  1. Minor formatting updates. Link to SPS article on unlicensed medicines and use of PGDs added.
  1. Content reviewed - no changes or updates required.
  1. Published

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