Considerations when using PGDs
The need for a PGD in an NHS or Local Authority (LA) occupational health service (OHS) needs to be carefully considered, especially as NICE guidance (MPG 2 2017) recommends that PGDs should not be used where they are not required, irrespective of care setting. The Human Medicines Regulations (HMR) 2012 provides a legal framework with alternative exemptions in Schedule 17, specifically for the delivery of an OHS.
For example, the need for a PGD in an NHS or LA OHS for the influenza and coronavirus vaccines is unlikely, due to the introduction of occupational health vaccinators (further information is available in Seasonal influenza vaccination and occupational health services).
It would be the responsibility of the NHS or LA organisation to develop and authorise the PGD in accordance with HMR 2012 if they want to utilise a PGD for an OHS.
Therefore, using a written instruction should be considered before using a PGD. PGD use is appropriate if it offers a benefit to service delivery, such as provision by healthcare practitioners other than nurses (or occupational health vaccinators for influenza/coronavirus vaccinations) who may legally operate under a PGD.
PGDs in NHS OHS
Under the HMR 2012, NHS bodies and local authorities are exempt from the restrictions that apply to the supply of prescription only medicines, where they are supplied or administered in accordance with a PGD.
There are slight differences depending on whether the OHS is in-house or contracted to an external provider.
In-house OHS
If an organisation’s OHS for their own staff is being provided by a doctor or registered nurse acting in accordance with the written instructions of a doctor, written instructions can be used and should be considered in preference to PGDs.
NHS in-house OHS services can use PGDs to provide OHS services, including peer-to-peer-vaccinations, to their own staff, including staff who are contracted to work for the organisation, where it has been locally determined that a written instruction cannot adequately meet the needs of the service.
Externally provided OHS
For seasonal influenza vaccination only, it is acceptable for an NHS organisation which does not operate an in-house OHS to offer staff the vaccination under a PGD (including peer-to-peer vaccination) where it has been locally determined that a written instruction cannot adequately meet the needs of the service.
All other OHS provided medicines/vaccines must be provided via the organisation’s OHS provider.
PGDs in independent provider OHS
Private services include those provided by independent healthcare providers. NHS and non-NHS publicly funded OHS who provide OHS to external organisations are also acting in a private capacity. These services can only use PGDs when they are registered with the CQC to provide one or more regulated activities, in compliance with section 10 of the Health and Social Care Act 2008. OHS are not a regulated activity and as such are not registered with the CQC. This means that PGDs cannot be used for private provision of OHS. This is also the case when an NHS or other publicly funded body provides OHS to another organisation, be it private or publicly funded, as the OHS is being provided as a private service.
Therefore, such OHS can only be provided by a doctor, independent prescriber or registered nurse working in line with the legal exemptions afforded to OHS in the HMR 2012 (i.e. a written instruction). The OHS exemptions cannot be used by professions other than registered nurses and the written instruction must be signed by an OHS doctor.