Travel health update

New guidance from the BMA says practices can develop patient group directions for the administration of private travel vaccines in an NHS setting

PGDs for private travel vaccines in England – breaking news!

Legislation passed in 2000 brought patient group directions (PGDs) and patient specific directions (PSDs) into operation, and at that time we were administering most travel vaccines under PGDs. However, in 2007-2008, it emerged that the only travel vaccines that could be administered under a PGD in an NHS setting were the NHS vaccines. (These were and still are hepatitis A, typhoid, polio, cholera and ANY vaccine that has one of these components within it e.g. Revaxis is combined tetanus, polio and diphtheria, so is NHS for travel in an NHS setting).

The Human Medicines Regulations 2012 came into force on 14 August 2012 and it would appear that within the statutory document, an exemption was made for the provision of prescribing within private practice. In its GP Mythbuster 19: Patient Group Directions (PGDs)/Patient Specific Directions (PSDs) (December 2014) the Care Quality Commission states: ‘A GP practice can, in law, develop their own PGDs for use in their private practice (non NHS work), for example for the administration of travel vaccines (such as yellow fever, rabies and Japanese B Encephalitis). When doing this they will need to make sure that they involve the appropriate people in the development of the PGD, and follow the information in the sections also included in the mythbuster about writing, operating, information contained and labelling’.

This provision in the 2012 legislation does not appear to have been known to the travel medicine community, and the legislation from the Human Medicines Regulations 2012 only applies to England. However, it would have significant impact on the administration of private travel vaccines in an NHS GP surgery. Currently, we operate under a patient specific direction or a prescription if a private travel vaccine is needed (e.g. yellow fever, rabies, Japanese encephalitis and tick borne encephalitis). If, following risk assessment, it is decided the traveller needs such vaccines they need to be prescribed before they can be administered. This has made the smooth running of the consultation challenging, with some travel nurses getting the prescription signed after the event, which is both incorrect and illegal.

Public Health England has produced immunisation PGD templates to support national immunisation programmes, which were developed, ratified and signed by Public Health England’s national immunisation team – see https://www.gov.uk/government/collections/immunisation-patient-group-direction-pgd . PGDs for the NHS travel vaccines are usually provided by the Medicines Management Team within a CCG at the current time.

In July 2015 the BMA published updated guidance on PGDs and PSDs, which can be found at http://bma.org.uk/practical-support-at-work/gp-practices/service-provision/prescribing . This document includes the important information that the MHRA has taken the view that English GP surgeries registered with the Care Quality Commission for relevant regulated activities (for example, treatment of disease, disorder or injury) can develop and sign off their own PGDs for any wholly private services they offer. GPs can sign off a PGD for a private service or private travel clinic. Of course the GP would need to follow legislation governing authorisation of PGDs in a private setting. A pharmacist would need to be involved in the development of the PGD and it would seem sensible to have a healthcare professional who is highly experienced and qualified in the practice of travel medicine to be involved in the development of such a document. In the resources section of the information regarding PGDs on the NICE website, a Patient Group Direction template has been provided and it would again seem sensible to me to follow this format when developing a private vaccine PGD. https://www.nice.org.uk/guidance/mpg2/resources

This news will – I hope – change the practice of travel medicine in a GP setting for the provision of private vaccines, not only making it far safer, but also improving standards for the many practice nurses who provide excellent travel health care.

For further links see http://www.janechiodini.co.uk/news/faqs/faq-no-1/

My thanks go to Elaine Biscoe (National Practice Nursing Advisor) and Brian Brown (National Medicines Manager) at the CQC for informing me of these changes.