This guideline provides good practice recommendations for the systems and processes used when commissioners and providers of public‑funded services are considering the need for, developing, authorising, using and updating patient group directions (PGDs). It also covers governance arrangements to ensure that patients receive safe and appropriate care, and timely access to medicines, in line with legislation.

The guideline incorporates medicines legislation and takes into account the range of organisations providing public-funded services. This includes NHS organisations, local authorities (in England), and any public-funded services provided by non-NHS organisations, such as:

  • independent organisations (for example, independent hospitals)

  • independent contractors (for example, community pharmacies)

  • voluntary and charitable agencies (for example, hospices).

Legislation establishing PGDs was introduced in 2000, and the Health Service Circular (HSC 2000/026) provided additional guidance. The current legislation for PGDs is included in The Human Medicines Regulations 2012, which came into force in August 2012. This legislation was amended in April 2013 to reflect changes to NHS organisational structures in England, as a result of the Health and Social Care Act 2012 (see The National Treatment Agency [Abolition] and the Health and Social Care Act 2012 [Consequential, Transitional and Saving Provisions] Order 2013).

PGDs provide a legal framework that allows the supply and/or administration of a specified medicine(s), by named, authorised, registered health professionals, to a pre-defined group of patients needing prophylaxis or treatment for a condition described in the PGD, without the need for a prescription or an instruction from a prescriber.

A PGD is defined in Health Service Circular (HSC 2000/026) as 'written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment'. This definition should not be interpreted as indicating that the patient should not be identified. Patients may or may not be known to the service provider.

The Health Service Circular (HSC 2000/026) states that 'the majority of clinical care should be provided on an individual, patient-specific basis'. Supplying and/or administering medicines under PGDs should be reserved for situations in which this offers an advantage for patient care without compromising patient safety, and there are clear governance arrangements and accountability. Using a PGD is not a form of prescribing.