Frequently Asked Questions on Patient Group Directions and Patient Specific Directions
18 August 2010 - Update
What is a Patient Group Direction (PGD)?
Patient Group Directions (PGD) are written instructions for the supply or administration of medicines by nurses to groups of patients who may not be individually identified before presentation for treatment. The supply and administration of medicines under PGDs should be reserved for those few situations where this offers an advantage for patient care without compromising patient safety [1].
Who can write and sign off a PGD?
The law relating to who writes and signs off PGDs for use in the NHS is described by the Medicines and Healthcare products Regulatory Agency (MHRA) [1-3]. The PGD must be signed by a senior doctor and a senior pharmacist, both of whom should have been involved in developing the PGD. Additionally the patient group direction must be authorised locally by the relevant appropriate body as set out in the legislation [3]. Therefore, a service provider e.g. GP cannot independently authorise a PGD [4]. See also NaTHNaC Clinical Update: Patient Group Directions.
Can Primary Care Organisations withdraw PGDs for certain medicines?
Legislation does not state that Primary Care Organisations (PCO) have to develop PGDs, they merely have to authorise them. Providing a PGD has been developed and is in accordance with legislation [3], practices should consult with the PCO justifying why a PGD is required (see guidance provided by the BMA) [4].
Can a PGD be used for the administration of all travel vaccines by those working in a private travel clinic, operating within a GP practice?
No. The legal position relating to vaccines for travel that are administered as a private service in an NHS setting, has been reviewed by the MHRA [6].
A PGD cannot be used for certain travel related vaccines (e.g. yellow fever, tick-borne encephalitis, meningococcal meningitis ACWY, and rabies pre-exposure (for travel)) [4, 6].
For those working in a NHS setting, a Patient Specific Direction (PSD) should be written for any vaccines provided for travel that are not available on the NHS (see below).
A PGD can be used to administer vaccines given according to the General Medical Services Contract e.g. hepatitis A, typhoid and polio [5].
Can a PGD be used for the administration of all travel vaccines by those working in the private sector?
For those working in the private sector a PGD can be used for all travel vaccines [6]
What is a Patient Specific Direction (PSD)?
A PSD is a written instruction from an independent prescriber, e.g. GP, to another healthcare professional, e.g. nurse, and can be written by a doctor or nurse prescriber, for a named patient or group of named patients [7]. Providing each patient has been considered individually by the prescriber, a list of patients to be treated with a medicine, signed by the prescriber, would constitute a PSD in general practice [4].
Who can use a PSD?
A registered nurse with current Nursing & Midwifery Council (NMC) registration
A registered pharmacist with current Royal Pharmaceutical Society of Great Britain (RPSGB) registration.
Is there an example PSD I can use?
There is no set format for a PSD. It may be a written or electronic instruction for the nurse in the patient’s clinical record. It should include the patients name, the name and dose of medicine to be administered and indicate that the patient has been considered individually. An example PSD for yellow fever vaccine is available on the NaTHNaC website. UKYFVC login is required.
What is NaTHNaC doing to resolve the PGD issues for those operating in the NHS providing travel vaccines not available on the NHS?
Since December 2008, NaTHNaC has been working with other national organisations for the necessary Amendment to the Medicines Act 1968. There is unlikely to be a rapid resolution of this problem for non-NHS travel medicines provided in NHS settings. In the meantime, for those working in a NHS setting, a PSD should be written for those vaccines provided for travel purposes that are not available on the NHS.
References
1. Patient Group Directions in the NHS. Medicines and Healthcare products Regulatory Agency (MHRA). [Accessed 18 August 2010]. Available at http://www.mhra.gov.uk/Howweregulate/Medicines/Availability
prescribingsellingandsupplyingofmedicines/Exemptionsfrom
MedicinesActrestrictions/PatientGroupDirectionsintheNHS/
2. Medicines Act 1968 (c.67) [Accessed 18 August 2010]. Available at: http://www.opsi.gov.uk/acts/acts1968/pdf/ukpga_19680067
3. Medicines Act Statutory Instrument 2000 No. 1917. The Prescription Only Medicines (Human Use) Amendment Order 2000. [Accessed 18 August 2010]. Available at: http://www.opsi.gov.uk/si/si2000/20001917.htm
4. Patient Group Directions and Patient Specific Directions in general practice. BMA August 2010. [Accessed 18 August 2010]. Available at http://www.bma.org.uk/health_promotion_ethics/drugs_
5. General Medical Services Contract, Department of Health. [Accessed 18 August 2010 ]. Available at http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalas
sets/@dh/@en/@ps/documents/digitalasset/dh_116303.pdf
6. Patient Group Directions in the Private Sector. Medicines and Healthcare products Regulatory Agency (MHRA). [Accessed 18 August 2010]. Available at: http://www.mhra.gov.uk/Howweregulate/Medicines/
Availabilityprescribingsellingandsupplyingofmedicines/
ExemptionsfromMedicinesActrestrictions/PatientGroup
Directionsintheprivatesector/index.htm
7. Salisbury D, Ramsay M, Noakes K. Immunisation by nurses and other healthcare professionals. In: Salisbury D, Ramsay M, Noakes (Eds.) Immunisation against infectious disease. 3rd Edition. London. TSO. 2006.35-39
Links
National Prescribing Centre Patient Group Directions guide and competency framework (2MB PDF)
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