Jane Chiodini, immunisation nurse specialist, explains how to draw up a patient group direction for the newly introduced DTaP pre-school pertussis booster

In October 2001, the DoH introduced a pre-school acellular pertussis booster immunisation.1 Supplies of the vaccine were distributed that month and the new schedule came into force on 5 November. Diphtheria, tetanus and acellular pertussis (DTaP) vaccination should now be routine practice in primary care.

Pertussis (whooping cough) is a highly infectious bacterial disease caused by Bordetella pertussis. It is spread by droplet infection and has an incubation period ranging from 7 to 10 days.

The disease starts with a catarrhal stage which is the most infectious period. An irritating cough gradually becomes paroxysmal, and can last for 2–3 months even when treated with antibiotics. It can cause choking spells that can lead to difficulty in eating, drinking and breathing.2,3

Pertussis can result in respiratory, central nervous system and nutritional complications, as shown in Table 1 (below).

Affected area

Symptoms Outcome
Respiratory Most cases involve some degree of collapsed lung and/or pneumonia. Babies may stop breathing. Respiratory illness is the most common complication. Around 15% of babies get pneumonia and this may be severe enough to lead to death.
Central nervous system Most commonly altered consciousness or convulsions. This may result from a lack of oxygen or small bleeds into the brain. Death, permanent brain damage or full recovery are each equally likely to result. Around 66% of children under 1 year old with whooping cough may be hospitalised. Up to 2% of babies can suffer convulsions. Just under 1% have encephalopathy. Around 0.5% of babies suffer long-term neurological problems.

Repeated vomiting may cause severe weight loss.


Reproduced from Diphtheria, Tetanus and Acellular Pertussis Pre-school Booster Factsheet3 © Queen's Printer and Controller of Her Majesty's Stationery Office

Today, pertussis rates are very low and vaccine uptake is high (about 95%).1 However, morbidity and mortality in the very young remain significant. The number of pertussis notifications in young infants has not declined over the past decade.

Most hospital admissions for pertussis have occurred in the under-6 months age group, some of whom were seriously ill and required intensive care therapy.3 These babies may have caught pertussis from older siblings or parents.1

Mathematical modelling at the PHLS demonstrated that a booster dose of pertussis would reduce levels of morbidity and mortality, reducing illness in older age groups and lowering the transmission of pertussis to babies too young to be fully protected.1

The DoH advises that babies should receive whole cell pertussis vaccine in the combined diphtheria, tetanus and pertussis (DTwP) vaccine at 2, 3 and 4 months of age. However, this vaccine is considered unsuitable for routine boosters because of increased reactions in older children.

Acellular pertussis vaccine is well tolerated in older children and has been introduced into the pre-school immunisation programme between the ages of 3 and 5 years.1

Patient group directions (PGDs) have been a legal requirement throughout the UK since August 2000. Guidance is now available in England,4 Wales5 and Scotland.6 PGDs should be in place for the administration of these prescription-only medicines (POM) to groups of patients who may not be individually identified before presenting at the surgery.

Nurses administering these vaccines must only do so if there is an appropriate PGD in place. To do otherwise could result in a criminal prosecution under the Medicines Act.4-6

To work in accordance with a PGD, the nurse administering the POM must be named in the document and sign it, as must the senior doctor giving his/her authorisation for the nurse to work within the PGD. This doctor must be satisfied that the named nurse is competent to administer the immunisation in line with the UKCC Professional Code of Conduct7 and UKCC Standards for the Administration of Medicines.8

It is essential to have access to the Summary of Product Characteristics (SPC) for the vaccine, available from the drug manufacturers or at http://emc.vhn.net/.

Drawing up a PGD

A PGD should include the following:

  • The name of the business to which the direction applies
  • The date the direction comes into force and the date it expires
  • A 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
  • The clinical condition or situation to which the direction applies
  • A description of those patients excluded from treatment under the direction
  • A 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
  • Detail of necessary follow-up action and the circumstances
  • A statement of the records to be kept for audit purposes

A PGD is provided for DTaP (see Fig. 1, below). Although the SPC for this vaccine indicates that it can be used for primary immunisation, current DoH guidance recommends that DTaP is used only for the pre-school booster and that DTwP is administered for the primary immunisation course.

Figure 1: Sample PGD for the diphtheria, tetanus and acellular pertussis vaccine, Infanrix
DTaP PGD page 1
DTaP PGD page 2
DTaP PGD page 3


It is important to explain to parents the reasons for the new immunisation schedule. A new patient information leaflet, A guide to pre-school immunisation9 is available from the local health promotion unit or from HPE Customer Services on 01235 465565/6.

An information pack for health professionals can be obtained by registering at www.immunisation.org.uk.


  1. Department of Health. Current Vaccine and Immunisation Issues 2001. CMO Letter PL/CMO/2001/5. http://www.doh.gov.uk/cmo/cmo0105.htm
  2. Department of Health. Immunisation against Infectious Disease. London: HMSO, 1996.
  3. Department of Health and Health Promotion. Diphtheria, Tetanus and Acellular Pertussis Pre-school Booster Factsheet. England: 2001. http://www.immunisation.org.uk/dtap.html
  4. NHS Executive (2000) Patient Group Directions (England Only). HSC 2000/026. Leeds:NHSE, 2000.
  5. 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). COCNO CDOCSOCPhA-SALEMED3. 22 December 2000.
  6. Scottish Executive Health Department. NHS HDL (2001)7. Patient Group Directions. January 2001. http://www.show.scot.nhs.uk/sehd/mels/hdl2001_07.htm
  7. UKCC. Code of Professional Conduct for the Nurse, Midwife and Health Visitor: 3rd edn. London: UKCC, 1992.
  8. UKCC. Standards for the Administration of Medicines. London: UKCC, 2000.
  9. Health Promotion England. A Guide to Pre-school Immunisation for 3 to 5 year olds. London: 2001.


Guidelines in Practice, January 2002, Volume 5(1)
© 2002 MGP Ltd
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