Patient Group Directions

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What are the legal requirements for labelling a Prescription Only Medicine (POM) issued via a PGD before supply to the patient?

9 September 2020The MHRA have advised that medicines supplied under a PGD would usually be considered to be “dispensed medicines” but that the definition in the legislation…

The supply of unlicensed medicinal products (“specials”) MHRA Guidance Note 14

9 September 2020The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices work, are safe and of appropriate quality. The…

Quality PGDs – 7 steps to success

9 September 2020Following the many and varied enquiries which we receive about PGDs, we have developed this step by step guide in consultation with the PGD Board…

Can a medicine with Risk Minimisation Measures (RMM) be included in a PGD?

9 September 2020This Q&A has been developed with the MHRA in 2017 and it reflects MHRA guidance on the use of PGDs for medications which have risk…

Is it acceptable to have a dose range specified in a Patient Group Direction (PGD) rather than a specified dose?

9 September 2020Yes this is acceptable. The legislation requires that the applicable dose or maximum dose is specified. The PGD may therefore specify a single dose or…

Can two licenced medicinal products be mixed together prior to administration under a PGD?

9 September 2020The MHRA states that the mixing of two separate medicinal products will result in a new, unlicensed product if one product cannot be described as…

Safe and Secure Administration of Medication in Police Custody

9 September 2020These guidelines published by the Faculty of Forensic and Legal Medicine (FFLM) help clarify, roles, responsibilities and legalities in this area of practice. The guidelines…

What is the advice on the use of PGDs for supply of repeat contraception or repeat supply/administration of any other medication?

9 September 2020The preferred way for patients to receive medicines is for trained health professionals to prescribe for individual patients on a one-to-one basis. Patient Group Directions…

Managing PGDs when healthcare organisations merge, cease to exist or services are transferred to a new provider

9 September 2020When healthcare organisations cease to exist, boundaries change, mergers occur or when services are transferred from one provider to another consideration needs to be given…

Can a PGD be used to adjust doses of a patient’s medication?

9 September 2020No – a PGD does not give a legal framework for healthcare professionals to adjust a dose of medicine already in a patient’s possession and…