There have been no changes to the legislation relating to PGDs during the COVID-19 pandemic.
Organisations will need to consider local governance arrangements and perform local risk assessments if there is any divergence from their usual PGD related processes during a pandemic to ensure that PGD use remains within the legislation and that patient safety is protected.
COVID-19 Guidance has been provided by the Specialist Pharmacy Service for use of PGDs in pandemics (for example COVID-19).
Staff who administer and/or supply prescription only medicines should have appropriate authorisation. Full details are listed in the information sources below. Providers should be aware of the requirements, but some of the key points are:
Patient Group Directions (PGDs)
PGDs are governed by the Human Medicines Regulations 2012 and later amendments. They allow specified health professionals to supply and/or administer medicine without a prescription or an instruction from a prescriber. The majority of clinical care should be provided on an individual basis using prescriptions or patient specific directions.
PGDs in commissioned NHS services
- Most PGDs are authorised before they are supplied to the practice for use in a commissioned service.
- These include PGDs authorised by the NHS England regional team to support the national immunisation programme.
- PGD is not valid until signed by a senior member of staff to adopt it for use by the provider.
Who can operate under a PGD?
Health professionals who may supply and/or administer medicines under a PGD are listed in the regulations. They include registered nurses, paramedics and pharmacists.
Examples of staff groups who cannot work under a PGD are:
- healthcare assistants
- nurse associates and
- physician associates.
The health professional who carries out the assessment under the PGD cannot delegate supply and/or administration to another member of staff.
Health professionals who will be using the PGD must be named and authorised before they use it to provide care. An appropriate member of staff, for example GP, practice manager or lead nurse should be responsible for authorising the health professionals in each organisation. Practitioners should keep a copy of their individual authorisation and have the current authorised PGD available for reference.
PGDs in Primary Care Networks (PCNs)
Where using patient group directions across primary care networks, each practice should adopt the PGD and authorise their staff to use it. Each practice is responsible for making sure their staff are trained, competent and complete necessary records.
There must be an agreement in place across the network to set out responsibilities and governance arrangements. Staff can then provide care under the PGD to patients of other practices covered by the agreement.
The provider must keep a record of all the health professionals authorised to practise under the PGD. Authorised health professionals must record an agreement to follow the PGD. They must provide assurances they are trained and competent to do so.
Electronic systems may be used to record authorisation, agreement and declarations of competence. If buttons or tick boxes are used it must be clear what the individual is confirming or signing up to. There must be a record of who has made the entry, the date and the time and an audit trail of any alterations.
Labelling and leaflets
- Medicines administered by the person operating under the PGD do not need to be labelled.
- Medicines do not need to be labelled if supplied under a PGD for immediate administration. For example, a flu vaccine nasal spray administered in the clinic to a child by their parent.
- Medicines supplied and taken away by the patient must be labelled in line with the regulations.
- Patient information leaflet must be supplied in every case, whether or not the medicine has to be labelled.
Developing PGDs for NHS or private services
A GP practice can develop their own PGDs to use for their NHS patients. There must be a formal agreement in place between the commissioner (the CCG or NHS England) and provider (the GP practice). This may be outlined in a service level agreement or contract specification.
GP practices and other providers can use PGDs in their private practice. For example, for the administration of travel vaccines such as yellow fever, rabies and Japanese B encephalitis. They can develop their own PGDs or buy authorised PGDs from an external organisation.
When developing their own PGDs providers should make sure they are aware of and follow the regulatory requirements for all areas of development, authorisation and use. Guidance is available in NICE MPG2 Patient group directions.
When buying a PGD the provider should make sure the organisation supplying the PGD has developed it in line with:
- national guidance
- current clinical practice and
- is legally able to authorise the PGD.
Patient Specific Directions (PSDs)
A PSD is an instruction to supply and/or administer a medicine written and signed by the prescriber. It could be an electronic record made in the patient notes where it is identifiable to the prescriber.
A PSD can also be an instruction to administer a medicine to a list of patients. Each patient on the list must be individually assessed by that prescriber. The prescriber must have knowledge of the patient's health and be satisfied the medicine meets the individual needs of each patient on that list. For example, a healthcare assistant may be running an influenza immunisation clinic. The prescriber must review the patients attending the clinic and sign a list of those who they authorise to be immunised.
The PSD must include the:
- name(s) of patient(s) and/or other individual patient identifiers including age if a child
- name, form and strength of medicine
- route of administration
- date of treatment/number of doses/frequency/date treatment ends as applicable
- signature of prescriber.
During inspections we have seen cases where staff have mistakenly believed they were administering/supplying a medicine with the authority of a PSD. While it is not possible to list them all, the following are examples that do not meet the requirements of a PSD. They are not a legal authority for the administration or supply of medicines:
- a Patient Group Direction (PGD) template 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.
Responsibilities and accountabilities
- The prescriber is responsible for assessing the patient and making the decision to allow the supply or administration of the medicine.
- The prescriber must be satisfied that the person to whom administration is delegated has relevant qualifications, experience, knowledge and skills.
- A person supplying or administering medicine must be trained and competent.
- They must act in line with their level of competence and 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 may extend or limit those who are authorised to supply or administer medicines under a PSD. This must be documented in their local medicines policies and governance arrangements.
The practice has a duty of care to the patient and staff. They are responsible for making sure staff are properly trained and undertake only those responsibilities written in agreed job descriptions. If expecting non-regulated staff, for example healthcare assistants, to administer medicines, those delegating the duty must make sure these staff are competent to do so safely.
A locally approved procedure or guideline would support the safe administration of medicines by a suitably trained and competent healthcare professional.
What if a patient brings in prescribed medicines that have been dispensed for them elsewhere?
The practice may issue a prescription to a patient to have the medicine dispensed at a pharmacy or dispensary for administration at the practice. For example, the patient may obtain an injection such as vitamin B12 or Zoladex from a community pharmacy. The patient returns to the practice for it to be administered by the practice nurse. In these circumstances the responsibilities of the prescriber and the delegated member of staff administering the medicine are the same as for a PSD.