Jane Chiodini, an immunisation nurse specialist, explains why practices need to have PGDs for influenza vaccines in place, and how to set them up

The aim of the influenza campaign is to provide immunisation to those most at risk of serious illness or death should they develop influenza. The DoH recommends immunisation for the following groups:

  • Patients of any age with:
    • chronic respiratory disease, including asthma
    • chronic heart disease
    • chronic renal failure
    • diabetes mellitus
    • immunosuppression due to disease or treatment, including asplenia or splenic dysfunction
  • All those aged 65 years and over
  • All those living in long-stay residential accommodation where influenza may spread rapidly once it has been introduced.

In addition, from 2000, NHS employers were recommended to offer influenza immunisation to employees who are directly involved in patient care, and social care employers were advised to consider similar action.1

Patient group directions (PGDs) have been a legal requirement for the administration of prescription-only medicines (POMs) by nurses throughout the UK since August 2000. To date, however, national guidance has only been available in England2 and Wales.3

This is the second influenza vaccination season since it became a legal requirement to have PGDs in place for the administration of POMs, to groups of patients who may not be individually identified before presentation at the surgery.

Given the large numbers of patients attending the surgery within an influenza programme, it would be impossible to operate a system that required a prescription to be written up before the vaccine was administered. Indeed, such a requirement would seriously impede the success of the national programme.

Nurses administering influenza vaccines should therefore only administer them within their influenza vaccination sessions if there is an appropriate PGD in place. To do otherwise would be to act illegally and could result in a criminal prosecution under the Medicines Act.2, 3

Unfortunately, while some primary care organisations (PCOs) have developed these documents and cascaded them to surgeries within their areas, others have not – even now, some staff in general practice remain unaware of the need for PGDs.

Surgeries without such PGDs need to find out from their PCO about the development of these necessary and vital documents, as a matter of urgency.

In the absence of any PCO strategy on PGDs, some surgeries have started to create their own. While this is to be applauded, it must be remembered that any such document should have a senior doctor and pharmacist sign and be involved in its development, and it must be authorised by someone from the PCO, e.g. the clinical governance lead.

The writing of the document requires background searching to obtain relevant information on the subject. A letter from the Chief Medical Officer, the Chief Nursing Officer and the Chief Pharmaceutical Officer was issued on 16 July 2001, and a copy should be available in surgeries.1 It can also be downloaded from the DoH website at: www.doh.gov.uk/cmo/cmo0104.htm

Other sites of interest for background information on the influenza campaign can be accessed via links from www.doh.gov.uk/flu/index.htm. Surgeries should be aware of the content of these sites.

The use of the Department of Health 'Green Book' is also of value.4 Extensive information on influenza can be obtained from the World Health Organization on www.who.int/emc/diseases/flu

PGDs can be written generically for the influenza vaccine. However, healthcare professionals must bear in mind that there are some differences between the products. To ensure that all the required information is available collectively for their chosen vaccine(s), they may ultimately find it more time saving to write PGDs for individual products.

It is essential to have access to the Summary of Product Characteristics (SPC) for each vaccine. These are available directly from the drug manufacturer, but can also be found in the Data Sheet Compendium. Advancing technology now means that such information is readily available on the internet and SPCs for the influenza vaccines can be obtained from http://emc.vhn.net/

When all the resource materials have been collected, development of the PGD can commence. This should include:

  • Name of the business to which the direction applies
  • Date the direction comes into force and the date it expires
  • Description of the medicine(s) to which the direction applies
  • Class of health professional who may supply or administer the vaccine
  • Signature of a senior doctor or dentist and a pharmacist
  • Signature of an appropriate health organisation
  • Clinical condition or situation to which the direction applies
  • Description of those patients excluded from treatment under the direction
  • Description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral
  • Details of the appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration and minimum or maximum period over which the medicine should be administered
  • Relevant warnings including potential side-effects
  • Details of any necessary follow-up action and the circumstances
  • A statement of the records to be kept for audit purposes.

A sample of an influenza PGD is shown in Figure 1 (below).

Figure 1: Sample patient group direction for an influenza vaccine
PGD page 1
PGD page 2
PGD page 3

Strains of influenza vaccine are recommended by the World Health Organization following careful surveillance of influenza viruses worldwide. As a result of this monitoring, predictions are made as to which strains are most likely to cause influenza outbreaks, and vaccines are manufactured accordingly. For this reason, influenza PGDs should be reviewed annually.

Because of the increased workload in the surgery at this time, some practices choose to employ bank and agency nurses. To work in accordance with a PGD, the nurse administering the POM must be named within the document and sign it, as must the senior doctor giving his/her authorisation for the nurse to work within the PGD.

However, in order to do this, the senior doctor within the practice must be satisfied that the locum nurse has adequate knowledge and is competent to administer the vaccine in line with the UKCC Professional Code of Conduct58and UKCC Standards for the Administration of Medicines.6 This may present a problem if the doctor is unfamiliar with the locum nurse.

In addition, the temporary nurse must only sign the PGD if he/she feels comfortable in doing so, having read and understood its contents. The nurse must also be certain of his/her personal competence to work within the details of the document. Confirmation of indemnity insurance within this situation should also be considered.

However, while a PGD for influenza vaccine is a legal requirement, guidance on the influenza clinic consultation should also be prepared. This provides evidence of best practice and should address the issues of the process of care for this group of patients.

Within my own surgery, our protocol includes details regarding the following issues:

  • Aim of the influenza vaccination protocol
  • Target groups
  • Staff involvement and role responsibilities
  • Practice administration organisation
  • Management of the influenza clinic sessions
  • Audit.

Last year we exceeded our target of immunising 70% of patients aged 65 years and over, and a total of more than 1000 doses of vaccine were used in the surgery influenza campaign.

Over the years, various methods have been tried to maximise response. Last year, all patients on the 'flu register' were sent a letter at the beginning of the campaign and given a specific date and time for attending the clinic. Those who found this inconvenient were invited to telephone us and rebook. This greatly reduced the number of calls to the surgery.

The main influenza clinics are held on three Saturdays in October, with additional provision within the week for those unable to attend on Saturdays.

The operation runs very smoothly. As the surgery is not paperless, we use a simple index card system. The card is given to the patient to give to the healthcare professional before vaccination for annual recording of the vaccine details.

Patients are generally familiar with the process and the sessions are attended with enthusiasm, friendliness and humour.

A returnable laminated card is given to everyone arriving at the clinic to read. This reminds them to inform the vaccinator of contraindications, side-effects and their management, and asks them to remove outer clothing and roll up sleeves before entering the treatment room to speed up the process.

Patients are seen on average one per minute, with three healthcare professionals available to vaccinate at any one time. We are considering extending the session to allow routine checking of administrative information and general health, and to provide the opportunity for health promotion and education.

Royal College of Nursing. Patient Group Directions Guidance and Information. Available from the RCN Direct tel no. 0845 7726 100 or on www.rcn.org.uk/pgdirections/index.html

Department of Health influenza leaflets Beat flu, use a jab also available in Arabic, Bengali, Cantonese, Hindi, Greek, Gujarati, Polish, Punjabi, Turkish, Urdu and Vietnamese from the Department of Health, PO Box 777, London SE1 6XH or visit www.doh.gov.uk/fluvaccinationleaflet

  1. Department of Health Influenza Immunisation Programme 2001/2002. CMO Letter PL/CMO/ 2001/04.
  2. Patient Group Directions (England Only). HSC 2000/026. Leeds: NHS Executive.
  3. The National Welsh Assembly. Review of Prescribing, Supply and Administration of Medicines - Sale, Supply and Administration of Medicines by Health Professionals Under Patient Group Directions (PGD). CMOCNOCDOCSOCPhA-SALEMED3. 22 December 2000.
  4. Department of Health. Immunisation against Infectious Disease. London: HMSO, 1996.
  5. UKCC. Code of Professional Conduct for the Nurse, Midwife and Health Visitor: 3rd edn. London: UKCC, 1992.
  6. United Kingdom Central Council for Nursing, Midwifery and Health Visiting. Standards for the Administration of Medicines. London: UKCC, 2000.

Guidelines in Practice, October 2001, Volume 4(10)
© 2001 MGP Ltd
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