Travellers abroad are among those at risk from infection with hepatitis B. Jane Chiodini explains how to draw up a patient group direction for the vaccine

Hepatitis B (HBV) is an acute viral infection of the liver. Transmission is blood borne, and can occur during sexual intercourse, needle sharing, blood transfusion and injections, and through other invasive procedures (including tattooing, body piercing and acupuncture) when inadequately sterilised equipment is used.1

In developing countries, most infections occur as a result of mother to child and child to child contact in household settings, and almost all children become infected with the virus.2

Many HBV infections are asymptomatic or cause mild and often unrecognised symptoms in adults, but others may cause anorexia, abdominal discomfort, nausea, vomiting, arthralgia and rash, followed by jaundice in some cases. In adults, 1% of cases are fatal. Chronic HBV infection persists in a proportion of adults, some of whom later develop cirrhosis and/or liver cancer.1

The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for individuals who become chronically infected during childhood.2

Since 1991, the World Health Organization has called for all countries to add hepatitis B vaccine to their national immunisation programmes, and by 2000 116 countries had complied with this request. The UK has not yet done so, and hepatitis B vaccine is given routinely only to those in the at-risk categories (see Figure 1, below).3

Hepatitis B is highly endemic in Africa, much of South America, Eastern Europe, the eastern Mediterranean, South East Asia and China, and the Pacific Islands but not in Australia, New Zealand and Japan.

Immunisation is recommended in individuals who are at increased risk of hepatitis B because of their lifestyle, occupation or other factors, such as close contact with a case or carrier. Hepatitis B vaccine has an outstanding record of effectiveness and safety, and since 1982 more than one billion doses have been administered worldwide.2

Drawing up a patient group direction

Patient group directions (PGDs) have been a legal requirement in the NHS throughout the UK since 9 August 2000. National 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 presentation at the surgery.

Nurses administering these vaccines must therefore only do so if an appropriate PGD is in place. To do otherwise would be to act illegally and 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 within the document and must sign it, as must the senior doctor giving his/her authorisation for the nurse to work within the PGD.

To sign the PGD, the senior doctor in the practice must be satisfied that the nurse has adequate knowledge and is competent to administer the immunisation in line with the Nursing and Midwifery Council (NMC) Code of Professional Conduct7 and NMC Standards for the Administration of Medicines.8

It is advisable to gather all the information required before commencing work on a PGD, and it is essential to have access to the Summary of Product Characteristics (SPCs) for the vaccines. These are available directly from the drug manufacturers and also on the internet at

The PGD should include:

  • 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
  • Details of any follow up action necessary and the circumstances
  • A statement of the records to be kept for audit purposes.

Hepatitis B vaccine may be indicated in particular for longer stay travellers and those who may place themselves at risk from their behaviour.9

In addition to prophylaxis by vaccination, travellers should be advised to adopt safe sexual practices, avoid using any potentially contaminated instruments for injections or any other skin piercing activity, and be aware that an accident or medical emergency requiring blood transfusion may result in infection if the blood has not been screened for HBV.

Those who work in humanitarian relief situations may also be exposed to infected blood or other body fluids in health care settings.1

Different schedules for administration are recommended, depending on the hepatitis B vaccine used (see Figure 1).

Figure 1: Sample patient group direction for hepatitis B vaccine, Engerix B



  1. World Health Organization. International Travel and Health – Vaccination Requirements and Health Advice. Geneva: WHO, 2002.
  2. World Health Organization Factsheet WHO/204 – Hepatitis B 204.html. WHO, 2000.
  3. Salisbury DM, Begg NT (eds). Immunisation against Infectious Disease. London: Department of Health, 1996.
  4. NHS Executive. 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). COCNOCDOC SOCPhA-SALEMED3. 22 December 2000.
  6. Scottish Executive Health Department. NHS HDL (2001)7. Patient Group Directions. January 2001.
  7. Nursing and Midwifery Council. Code of Professional Conduct. London: NMC, 2002.
  8. Nursing and Midwifery Council. Standards for the Administration of Medicines. London: NMC, 2002.
  9. Department of Health with the PHLS CDSC. Health Information for Overseas Travel, 2nd edn. London: TSO, 2001.

Guidelines in Practice, June 2002, Volume 5(6)
© 2002 MGP Ltd
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