The attached Q&A has been written in response to enquiries the SPS PGD Service has received concerning the use of Patient Group Directions (PGDs) in Occupational Health Schemes in England. It has been written in 2018 in collaboration with the SPS PGD Board which includes representatives from the Care Quality Commission (CQC), Public Health England (PHE) and the Medicines and Healthcare Regulatory Agency (MHRA).
For the purposes of this Q&A the terms Occupational Health Scheme and Occupational Health Service are deemed interchangeable.
An Occupational Health Scheme (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.
Under the Human Medicines Regulations 2012 OHS are exempt from the restrictions that apply to prescription only medicines, where medicinal products are supplied or administered in the course of the OHS by a doctor, or by a registered nurse acting in accordance with the written (and signed) directions of a doctor; this instruction is commonly documented in a written operating protocol. NICE guidance on Patient Group Directions (MPG2 2017) recommendation 2.1.3 states ‘Do not use PGDs for medicines when exemptions in legislation allow their supply and/or administration without the need for a PGD.’ – in the OHS service described a PGD is not required in addition to the written instruction.
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 occupational health services.
Under the Human Medicines Regulations 2012, National Health Service 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 written direction or a PGD.
Given the complexities of this area of practice the PGD Board have concluded that the best way to advise on the use of PGDs in OHS is to outline common scenarios that occur in practice and advise on each one in the attached Q&A.
Specialist Pharmacist (Patient Group Directions) SPS Medicines Use and Safety Division