Note: This article refers to guidance published on 5 December. A letter from NHS England on 7 December to designated sites that are taking part in the first wave of the vaccination programme in primary care says that a patient group direction will be in place ahead of GPs and their teams starting vaccination.
A document published at the weekend setting out the legal mechanisms for administering the COVID-19 vaccines said that, until the PGD is published and approved, GPs will be expected to authorise vaccinations under a patient specific direction (PSD). As a result, each vaccination could take an additional three minutes longer than initially thought, the document said.
There could also be a knock-on effect on workforce as NHS England said that more prescribers would need to staff vaccination centres than originally planned.
'Business continuity risks may need to be considered if large numbers of doctors are required to support in large numbers of vaccination centres as they would be removed from normal work,' the document said.
The news comes as NHS England confirmed that designated sites in primary care would start vaccinating patients from 14 December. Some 280 PCN-led sites are expected to be up and running in the first wave.
Patient specific direction
A PSD requires a GP or independent nurse or pharmacist prescriber to give 'authorised instruction' to administer a vaccine to an individually named patient. Each patient should be assessed by the authorising prescriber before they are vaccinated.
'The prescriber must have adequate 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,' the document said.
There are no restrictions on who can administer the vaccine, but the prescriber 'takes full accountability and responsibility for the patient and the members of staff administering the vaccine', the document added.
It said that vaccination clinics may need to be staffed by 'additional prescriber roles'. The prescribers must also be 'suitably trained with experience in immunisation', which would 'limit the number of staff' who could take on this role.
'In practice professions are only likely to take on responsibility for others when that person is known to them and they are aware of their skills and training. It is therefore essential that prescriber is content with taking on this responsibility and that there is no suggestion of expectation for them to take on this role. This should be confirmed with each prescriber at the start of a vaccination session,' the document added.
The requirements also meant that there would also be 'a decrease in productivity', NHS England said. 'Volumes are lower than expected due to the need for each prescriber to review each individual patient before they can be added to the PSD and are able to have the vaccine,' the document said.
The rapid authorisation of the Pfizer/BioNTech jab has meant that a PGD would not be available for the start of the programme because a detailed summary of product characteristics was not yet available.
NHS England said it was 'supporting the relevant organisations to complete the development of the PGD or National Protocol'. However, it added that the use of a PSD would be necessary as 'a short-term interim step to support the delivery of vaccines until the relevant legal documents are available'.
NHS England has provided a template PSD that prescribers can use to authorise vaccination.