NICE's latest good practice guidance for those involved in providing medicines to patients without a prescription under a Patient Group Direction (PGD) must clearly benefit the patient, not compromise safety and only happen when clear processes and lines of accountability are in place.

PGDs provide a legal framework that allows some medicines to be supplied and/or administered by named, authorised, registered health professionals, to a pre-defined group of patients needing preventative treatment or treatment for a condition without the need for a prescription. PGDs may be appropriate when medicine use follows a predictable pattern, such as for patients attending for contraception, or where patients seek unscheduled care, such as for a minor ailment in a community pharmacy or walk-in centre.

On occasion, Patient Group Directions are used when other forms of medicines prescribing or supply would be more appropriate as Professor Mark Baker, Director of the Centre for Clinical Practice at NICE explains:

“This guidance provides an opportunity for organisations to review whether their process for authorising PGDs is in line with current legislation, and to ensure that they are not used by healthcare professionals who are not authorised to do so. In addition, the Guidance Development Group considered that the risks of including medicines such as anticoagulants or insulin that need frequent individual adjustment of dosage or frequent or complex monitoring in a PGD outweigh the benefits, and agreed that prescribing would be a more appropriate option.

“The majority of clinical care should be provided on an individual, patient-specific basis. Prescribing to a named patient after the prescriber has assessed the patient on an individual basis remains the preferred option for the majority of care - PGDs should not be seen as a direct substitute for prescribing.”

The NICE good practice guidance on PGDs has been developed to help individuals and organisations who are considering the need for, developing, authorising, using and/or updating PGDs to ensure they are appropriate, legal and that relevant governance arrangements are in place within commissioning and provider organisations.

“Check whether a PGD is the best way to deliver the service and if it is, ensure your processes are in line with this guidance,” Professor Baker added. “Barriers to developing non-medical prescribing, such as a lack of funding or staff commitment, may have contributed to the unnecessary or inappropriate development of PGDs. The guidance therefore recommends that consideration should be given to investing in the training of additional non-medical prescribers to redesign services if necessary, as part of a wider development or review of local medicines policy.

“PGDs often involve significant resources and are time‑consuming to produce. The good practice guidance therefore recommends there should be a robust and transparent process for obtaining the agreement of the authorising body before proceeding to develop a PGD.”

Antimicrobial resistance and healthcare‑associated infections are matters of major public health importance and the good practice guidance recommends organisations should not jeopardise local and national strategies to combat these threats. Organisations should only include an antimicrobial in a PGD when it is clinically essential and clearly justified by best clinical practice, and when a specialist in microbiology has agreed that a PGD is needed. It also recommends that the use of a PGD for an antimicrobial is monitored and reviewed regularly.

Ends.

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Notes to editors

1. The good practice guidance on Patient Group Directions is available.

2. The NICE good practice guidance on Patient Group Directions is aimed at NHS organisations, local authorities (in England), and any NHS-commissioned services provided by non-NHS organisations, such as independent organisations (for example, independent hospitals), independent contractors (for example, community pharmacies) and voluntary and charitable agencies (for example, hospices).

3. The PGD website contains example PGDs and the guidance and implementation section of the guidance landing page will link to this. Additionally, the guidance development team plan to develop a template PGD containing prompts for information and detail which needs to be included in accordance with the guidance recommendations. Whether this will be presented as an appendix in the guideline or a separate implementation tool is currently being discussed.

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