The attached Q&A has been written in response to enquiries we have received concerning the use of Patient Group Directions (PGDs) and written instructions in Occupational Health Services (OHS) in England and follows discussions with the SPS PGD Advisory Board, the Care Quality Commission (CQC), Public Health England (PHE), the Royal College of Nursing (RCN), BMA Occupational Medicines Committee, an independent healthcare provider and the Medicines and Healthcare Regulatory Agency (MHRA). It was updated in June 2019 to provide further clarification on the use of PGDs in NHS organisations for staff seasonal ‘flu vaccinations.
An Occupational Health Service (OHS) is a multidisciplinary service that aims to protect and promote workers’ physical, mental and social health and well-being through actions related both to the work environment and to the workers themselves. For the purposes of this Q&A the terms Occupational Health Scheme and Occupational Health Service are deemed interchangeable.
Under the Human Medicines Regulations 2012 OHS are exempt from the restrictions that apply to prescription only medicines. Medicinal products can be supplied or administered in the course of the OHS by a registered nurse acting in accordance with the written and signed instruction of a doctor; this instruction is commonly documented as a written instruction. The written instruction is different to a PGD and is an arrangement between the named registered nurse(s) and the authorising doctor and isn’t subject to the legislated framework of a PGD – PGDs and written instructions are not interchangeable. A written instruction template is available from the BMA.
Under the Human Medicines Regulations 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; however they can only use PGDs to provide OHS to their own staff where they have an in-house OHS.
Independent providers can only use PGDs when they are registered with CQC to provide one or more regulated activity, 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; as a result PGDs cannot be used by independent providers 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.
Given the complexities of this area of practice the PGD Advisory Board have concluded that the best way to advise on the use of PGDs and written instructions in OHS is to outline common scenarios that occur in practice and advise on each in the document below.