21 April 2009

Patient Group Directions: Travel vaccines provided as a private service in an NHS setting

The law relating to who writes and signs off Patient Group Directions (PGDs) for use in the NHS is described by the Medicines and Healthcare products Regulatory Agency (MHRA) [1-3]. 

The legal position relating to vaccines for travel that are administered as a private service in an NHS setting, has recently been reviewed by the MHRA [4]. As a result, it has been confirmed that currently, PGDs 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]. Therefore, 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. A PSD is a written instruction from an independent prescriber to another healthcare professional and can be written by a doctor or nurse prescriber, for a named patient or group of named patients [5]. Guidance for those using a PSD for the administration of yellow fever vaccine is available on the NaTHNaC website.

A model PGD for yellow fever vaccine was posted on the NaTHNaC website in 2008. This followed consultation with both the Department of Health and the MHRA. This PGD should not now be used by those administering yellow fever vaccines in an NHS setting.

This situation does not affect those providing travel vaccines in the private sector who may continue to access the model PGD available on the NaTHNaC website. Information relating to the use of PGDs in the private sector is available from the MHRA.

NaTHNaC is working with other organisations to resolve this issue and further information will be posted as it becomes available.

References

1. Medicines Act 1968 (c.67) Accessed 15th April 2009. Available at http://www.opsi.gov.uk/acts/acts1968a

2. Medicines Act Statutory Instrument 2000 No. 1917. The Prescription Only Medicines (Human Use) Amendment Order 2000. Accessed 15th April 2009. Available at http://www.opsi.gov.uk/si/si2000/20001917.htm

3. Patient Group Directions in the NHS. Medicines and Healthcare products Regulatory Agency (MHRA). Accessed 20 April 2009. Available at http://www.mhra.gov.uk/Howweregulate/Medicines/

Availabilityprescribingsellingandsupplyingofmedicines/

ExemptionsfromMedicinesActrestrictions/PatientGroup

DirectionsintheNHS/index.htm

4. PGDs and GP private travel clinics posted 2.12.08. National electronic Library for Medicines. Accessed 15th April 2009. Available at http://www.portal.nelm.nhs.uk/PGD

5. 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