This article relates to the CQC key questions: Is your practice safe? and Is your practice effective?
The majority of clinical care should be provided on an individual, patient-specific basis. If a care pathway can include the issue of a prescription or a written patient specific direction by a doctor or non-medical prescriber so that the patient receives the medicine in a timely manner, then a patient group direction (PGD) should not be required.
What are patient group directions (PGDs)?
These are written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment. Organisations should have policies and processes in place to consider all options before a service is designed or commissioned using PGDs. Before a PGD is developed, the organisation must ensure that PGDs are appropriate, legal and that relevant governance arrangements are in place.
Who can write a PGD?
PGDs should be drawn up by a multi-disciplinary group involving a doctor (or dentist when in a dental practice), a pharmacist and a representative of any professional group expected to supply medicines under the PGD. It is good practice to involve local Drug and Therapeutics Committees, Area Prescribing Committee and similar advisory bodies
PGD documents must be signed by:
- each member of the multi-disciplinary group
- the representative of the appropriate authorising body, and
- the individual health professionals working under the direction.
Generally, a PGD should be reviewed every two years. That review should include clinical governance arrangements and an assessment of whether the PGD remains to most effective way of providing the relevant services.
Who can operate under a PGD?
PGDs allow specified health professionals to supply and / or administer a medicine directly to a patient with an identified clinical condition without the need for a prescription or an instruction from a prescriber. The health professional working within the PGD is responsible for assessing that the patient fits the criteria set out in the PGD.
The specified health professionals who may supply and/or administer medicines under a patient group direction are nurses, midwives, health visitors, optometrists, pharmacists, chiropodists, radiographers, orthoptists, physiotherapists, ambulance paramedics, dietitians, occupational therapists, speech and language therapists, prosthetists, orthotists, dental hygienists and dental therapists. They can only do so as named individuals. Healthcare assistants cannot administer/supply medicines under a PGD.
The specified health professional who carries out the assessment under the PGD cannot delegate the supply and administration to a person who is not a specified health professional.
What information must a PGD contain?
A PGD must contain:
- the name of the business to which the direction applies
- the date the direction comes into force and the date it expires
- a description of the medicine(s) to which the direction applies
- class of health professional who may supply or administer the medicine
- signature of a doctor (or dentist, as appropriate)
- signature of a pharmacist
- signature of an appropriate organisation
- the clinical condition or situation to which the direction applies
- a description of those patients excluded from treatment under the direction
- a description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral
- details of appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength (if a brand is specified then the PGD would only apply to the particular product), route and frequency of administration, and minimum or maximum period over which the medicine should be administered
- relevant warnings, including potential adverse reaction
- details of any necessary follow-up action and the circumstances
- a statement of the records to be kept for audit purposes.
What about adopting the PGD for use within the service?
When the PGD has been signed by the appropriate people and is authorised for use, clear local arrangements are needed that outline the ownership of, and responsibility for, delivering the service.
The PGD may need to be 'adopted' by the provider organisation(s) if they have not been involved in developing and authorising the PGD. For example, when a PGD is developed and authorised by a CCG for use across multiple GP practices, a process would need to be in place for each GP practice to adopt the PGD for use in their practice.
Organisations should publish final signed versions of PGDs on an intranet to allow named, authorised health professionals using the PGD to be able to access the most up-to-date version.
The health professionals who will be using the PGD must be named and authorised to practise under it. Provider organisations should designate an appropriate person (for example, a clinical supervisor, line manager or GP) to be responsible for authorising these health professionals in each service.
A record of all the health professionals authorised to practise under the PGD must be maintained in the service. In addition, authorised health professionals must sign the appropriate documentation as an agreement to practise within the requirements of the PGD and provide assurances that they are trained and competent to do so.
What if the practice wants to develop their own PGD for NHS patients?
A GP practice can develop their own PGDs to use in the practice for their NHS patients but they need to have a formal agreement in place. When the employing provider organisation (for example a GP practice) is not the authorising body (for example the CCG or NHS England), the responsibility for authorising health professionals to practise under the PGD requires a formal agreement between the commissioner (in this case the CCG or NHS England) and provider (in this case the GP practice).
This may be outlined in a service level agreement or contract specification. Clear governance arrangements should be in place to ensure that only health professionals who have been trained and assessed as competent are authorised to practise under a PGD.
What about labelling and leaflets for medicines supplied under a PGD?
Single dose medicines (including those which are not injectables) supplied by a healthcare professional under a PGD and then immediately self-administered or administered by another person, such as a carer, healthcare worker or healthcare professional in the same room or clinic, do not require labelling.
Medicines supplied and taken away by the patient for self-administration or administration by a carer/ another healthcare worker at a later time must be labelled.
A patient information leaflet must be supplied in every case, whether or not the medicine has to be labelled.
It is important that the medicines are used in accordance with the Summary of Product Characteristics for the relevant product and any relevant authoritative good practice guidance.
Can PGDs be used for private practice?
A GP practice can, in law, develop their own PGDs for use in their private practice (non NHS work), for example for the administration of travel vaccines (such as yellow fever, rabies and Japanese B Encephalitis). When doing this they will need to make sure that they involve the appropriate people in the development of the PGD, and follow the information in the sections above about writing, operating, information contained and labelling.
What are patient specific directions (PSD)?
A PSD is the traditional written instruction, signed by a doctor, dentist, or non-medical prescriber (hereafter referred to as "the prescriber") for medicines to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis.
In practice, a PSD is may be referred to as a 'prescription' by those who write and follow them because this indicates that it is written by a prescriber. But this should not be confused with an FP10 or other written prescription given to the patient for supply from a pharmacy or dispensary.
Does a PSD need to be written?
Yes. A PSD must be written and signed by the prescriber - this can be by hand or electronically.
A PSD is an instruction to administer/supply a medicine written in the patient’s notes (this also includes an electronic record made in the notes where it is identifiable to the prescriber). In acute care, this might be an instruction written on an inpatient’s medicine chart. Careful consideration needs to be given to how the instruction is incorporated in the patient record to ensure the medicine is given safely and in a timely manner.
A PSD can also be an instruction to administer a medicine to a list of named patients where each patient on the list has been individually assessed by that prescriber. The prescriber must have knowledge of the patient's health, and be satisfied that the medicine to be administered serves the individual needs of each patient on that list. For example, a healthcare assistant may be running an influenza immunization clinic so the prescriber reviews the patients planned to attend the clinic and produces a list of those that they authorize to be immunized.
During inspections we have observed a number of instances where staff have mistakenly believed they were administering/supplying a medicine with the authority of a PSD. Whilst it is not possible to list them all, the following are examples that do not meet the requirements of a PSD and are therefore not a legal authority for the administration or supply of medicines:
- A patient group direction (PGD) template that has been renamed a "PSD" and used to instruct healthcare staff.
- A generic instruction to be applied to any patient who may be seen by a healthcare professional or who has an appointment on any particular day, for example, an instruction to administer a "flu vaccine" to any patient who fits the criteria attending clinics on a specific day.
- A verbal instruction.
How long is a PSD valid for?
There is no legally valid period for a PSD for administration of a medicine, but good practice dictates that the prescriber should include a start and finish date in the direction to ensure it is acted on within a time frame appropriate to the needs of the patient.
Local procedures should be agreed to address any delay and action to be taken by the person who may be supplying and/or administering the medicine.
Appropriate measures should be taken to ensure that the supply and administration of that medicine remains safe to the point of administration and beyond, for example following local guidelines on the correct administration and monitoring for medicines supplied or administered.
What are the responsibilities and accountabilities of the prescriber who writes the PSD?
The prescriber has a duty of care and is professionally and legally accountable for the care he/she provides, including tasks delegated to others.
The prescriber must be satisfied that the person to whom a task is delegated has the qualifications, experience, knowledge and skills to provide the care or treatment involved.
What are the accountabilities and responsibilities of the delegated staff?
A person who supplies or administers a medicine is accountable for their own practice and must be trained and competent to undertake such tasks.
They must act according to their level of competence and in accordance with the directions of the prescriber.
What clinical governance arrangements should be in place?
In law, anyone whom the prescriber has assessed as competent, has the necessary knowledge and skills, and has been delegated the task may follow a PSD. Some organisations, however, may extend or limit those who are authorised to supply or administer medicines under a PSD within their local medicines policies and governance arrangements.
The employing organisation has a duty of care to both the patient and to the staff and is responsible for ensuring that the staff it employs are properly trained and undertake only those responsibilities specified in agreed job descriptions. If expecting non-regulated staff, for example healthcare assistants, to administer medicines, those delegating the duty must ensure that these staff are competent to do so safely.
PSDs may need to be supported by a locally approved procedure or guideline to support safe administration of the medicine by an appropriately trained and competent healthcare professional.
Prescribers and anyone administering or supplying medicines must ensure that they adhere to clinical governance policies and procedures and associated arrangements.
What if a patient brings in prescribed medicines that have been dispensed for them elsewhere?
There may be some occasions when the practice issues a prescription to a patient for them to have the medicine dispensed to them at a pharmacy or dispensary which requires administration at the practice. For example the patient may obtain their Zoladex from their community pharmacy through an FP10 then return to the practice for it to be administered by the practice nurse. In these circumstances the accountabilities and responsibilities of the prescriber and the delegated member of staff administering the medicine will be same as above for PSDs.
For further information please see
- National Institute for Health and Care Excellence (NICE) Guideline (MPG2) Patient Group Directions
- NHS Patient Group Directions (PGD) website
Sarah Billington is head of medicines management at the CQC
More CQC resources
- View the full CQC Essentials series on Medeconomics
- CQC's recommended reading to help practices meet regulations and prepare for an inspection