Jane Chiodini, chair of the RCN Travel Health Forum, explains why those responsible for travel vaccinations in primary care need to devise appropriate PGDs urgently


   

The number of people travelling abroad from the UK has increased dramatically over the past few years.1 This trend will almost certainly continue, given the widening use of the internet and last-minute deals available. Such demand is reflected in the increased number of 'travel consultations' within surgeries, with nurses being the main providers of such care.

Travel vaccination within general practice

More than a decade ago, patients requiring travel vaccines were issued with a prescription which they took to the local pharmacist for dispensing. They then either took these products to the surgery for storage until given, or took them home to keep in their own refrigerator until their next surgery appointment.

This method not only wasted valuable time, but also – and more importantly – compromised maintenance of the cold chain, thereby potentially reducing the potency of the vaccine.

Some time later, surgeries began to purchase stock, which brought them greater financial income, by way of discounts and reimbursement for Prescription Pricing Authority claims. Thereafter, travel vaccines would be given from stock held within the surgery.

The nurse was then administering drugs without a prior prescription order and so was, in effect, prescribing when not permitted to do so.

The Medicines Act 1968 allowed only doctors, dentists and vets to prescribe prescription-only medicines (POMs), but did allow others to administer POMs in accordance with the written or verbal direction of the medical practitioner.

By this means, practices managed to administer travel vaccines under group protocols, although in many situations these documents were never developed. This inevitably meant that many nurses were performing tasks illegally and leaving themselves extremely vulnerable.

In March 1997, a review of prescribing, supply and administration of medicines was commenced, led by Dr June Crown. The first part of the review, known as The Crown Report, was published in 1998, and was entitled A Report on the Supply and Administration of Medicines under Group Protocols.2

This report stated that group protocols could be used as a direction to administer POMs, and provided criteria for their development. However, the legality of group protocols under the existing legislation remained uncertain.

In 2000, the Medicines Control Agency and the DoH held a short consultation that resulted in amendments to section 5(1)(b) of the Medicines Act 1968 and the Prescription Only Medicines Order 1997.3

These changes resulted in the issue of NHS Executive Health Service Circular 2000/026 on 9 August 2000 entitled Patient Group Directions (England Only),4 which specified that the term 'group protocol' was to be replaced by 'patient group direction' (PGD).

PGDs are written instructions to allow a nurse to administer a POM. The legal requirements of a PGD are detailed in Table 1 (below), along with suggestions to help in drawing up a PGD.

Table 1: Legal requirements for Patient Group Directions (PGDs) and implications for your own PGD
Legal requirements for PGDs Suggestions and comments for your own travel vaccine PGD
The name of the business to which the direction applies. Your surgery name.
The date the direction comes into force and the date it expires. Both these dates should be documented, although review must be earlier if there are any changes to the SPC.
A description of the medicine(s) to which the direction applies. This can state POM drugs, but also a description of the vaccine can be given, including whether it is live or inactivated.
Class of health professional who may supply or administer the vaccine. Any registered nurses administering the travel vaccines who are working at the surgery must be named within the document, ideally be involved in its development and sign the PGD. NB. Locum staff would need to be included, but in the situation of agency nurses covering an emergency, they would not be able to administer any vaccines if not known to the practice and therefore not named and included.
Signature of a senior doctor or dentist and a pharmacist. This should be a senior doctor from the practice and a senior pharmacist (possibly from the health authority) who should be involved with the PGD development.

Signature of an appropriate health organisation.

The HSC document suggested a clinical governance lead from a PCT or PCG. The document must be authorised by such a body.
The clinical condition or situation to which the direction applies. The inclusion criteria for use of the specific travel vaccine.
A description of those patients excluded from treatment under the direction. For example, severe febrile illness, previous reaction to any component of the vaccine.
A description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral. If temporary exclusion, rearrangement for further appointment. If permanent exclusion, advice on prevention of the travel vaccine specific disease
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. This may be better broken down into sections for greater clarity, e.g. vaccine schedule, length of protection, dosage, administration route, and administration before travel. Product-specific information could also be included as 'special notes' e.g. shaking the vaccine in the barrel well before use. Always refer to the SPC.
Relevant warnings including potential side-effects. It is useful to detail all adverse side-effects. Details could also be included regarding use in children, pregnancy and lactation.
Detail of any follow-up necessary, follow-up action and the circumstances. Local reaction management. Reporting of serious or unusual reactions or, in the case of black triangle drugs, all reactions to the CSM using the yellow card system.
A statement of the records to be kept for audit purposes. The date of administration, vaccine type, batch number and site of administration on the patient records.

While it is the responsibility of the senior doctor to ensure that the nurses named within the PGD are able to perform the task to a reasonable standard, the nurses undertaking the task must also be sure of their competence to do so and act in accordance with the United Kingdom Central Council for Nursing, Midwifery and Health Visiting (UKCC) Code of Professional Conduct5 and Standards of Administration of Medicines. 6

Generic or product-specific patient group directions

In some cases, generic PGDs have been devised. Although these may reduce paperwork, users are advised to consult other sources for further information, namely specific product leaflets and the DoH 'Green Book' – Immunisation against Infectious Diseases.7 However, it should be noted that while the Green Book is an excellent publication, it is currently out of date in parts, and does not include newer vaccines that have been launched since it was written.

Consequently, PGDs written for individual vaccines ultimately save considerable time within a travel consultation. There can be many small but important differences between similar products.

For example, hepatitis A vaccine is available in five different formulations for the monovalent vaccine and within three additional combined vaccines. Furthermore, among these eight types of hepatitis A vaccine, administration differs for ages 1, 2, 15, 16 and 18 years, depending on the specific product used.

It is also thus preferable to have all information on an individual product within one resource for ease of use and simplicity (see Figure 1, below, for a sample PGD).

Figure 1: Patient group direction for the administration of ORAL POLIO VACCINE*
Patient group direction for the administration of oral polio vaccine, page one
Patient group direction for the administration of oral polio vaccine, page two
* Reproduced from : Chiodini J. The Rose Cottage Surgery Sample Patient Group Directions and Guidelines for a Travel Health Consultation. SmithKline Beecham Vaccines, 01/2001

Writing PGDs for individual vaccines is initially somewhat daunting, but once done the specific PGD need only be updated when the Summary of Product Characteristics (SPC) changes.

Black triangle drugs and drugs used outside a product licence

PGDs may include black triangle drugs, although such drugs must be clearly identified and all suspected reactions, including minor ones that could conceivably be attributable to the drug, reported to the Committee on Safety of Medicines (CSM) using the yellow card system.

Some travel vaccines can be used outside the terms of the SPC in certain circumstances. For example, the Green Book states that rabies vaccine could be given intradermally (unlicensed route) when more than one person is to be immunised.7

Specifics should be included within the PGD when the product is being used outside the terms of the SPC, and documentation of such action should include the reasons why such use is necessary. 4

Use of unlicensed vaccines

Within the field of travel, protection against Japanese B encephalitis and tick-borne encephalitis is given using unlicensed products. In these cases, if the drugs are not licensed for use within the UK, they should not be included within a PGD.

Administration of unlicensed vaccines should be prescribed in advance by a physician who then takes responsibility for their use. Such drugs need to be ordered from suppliers on a named-patient basis.

Recently, a severe shortage of yellow fever vaccine in the UK has meant that an unlicensed product has had to be imported and used. Similar steps need to be taken for administration of this vaccine, although it is hoped that this problem will be resolved later this year.

Where to from here?

Since the publication of Patient Group Directions (England Only) in August 2000, strategies to develop the necessary documentation have been developed in a variety of ways.

Some health authorities have formed teams to devise appropriate PGDs within their area. This may have been undertaken within health authorities, PCTs or PCGs. In other areas, however, such work has not been undertaken, and it has been left to individual practices to evaluate their situations.

Although HSC 2000/026 was cascaded to chief executives of health authorities and NHS trusts (England only) and copied to key personnel within these areas, it did not reach all health professionals at general practice level. As a result, some are still not aware of these important changes and the urgent need to implement them.

The first anniversary of the distribution of this directive document is fast approaching, and it could be hard to defend the failure to enforce such legal requirements a year down the line.

It is therefore imperative that all health professionals responsible for the administration of travel vaccines have appropriate PGDs in place as soon as possible, not only to ensure good standards of care, but also to protect them legally.

It must be emphasised that, while PGDs are a legal requirement, they refer only to the use of vaccines within a travel health consultation.

I firmly believe that, in addition to this requirement, guidelines for the travel health consultation itself are essential, to ensure that a thorough pre-travel risk assessment is performed and appropriate advice given.* Only when this has been done can the adviser decide which vaccines need to be administered, thereby demonstrating evidence of best practice.

References

  1. Office for National Statistics. Travel and Tourism. Numbers of visits abroad by UK residents 1986–1997. London: Office for National Statistics, 2000. http://www.statistics.gov.uk/press_Release/CurrentReleases.asp
  2. Department of Health. Review of Prescribing, Supply and Administration of Medicines: A report on the supply and administration of medicines under group protocols. London: DoH, 1998.
  3. Medicines Control Agency 2000. Sale, Supply and Administration of Medicines by Health Professionals under Patient Group Directions. Consultation letter MLX260. http://www.open.gov.uk/mca/
  4. NHS Executive. Patient Group Directions (England Only). HSC 2000/026. Leeds: NHSE, 2000.
  5. UKCC. Code of Professional Conduct for the Nurse, Midwife and Health Visitor (3rd edn). London: UKCC, 1992.
  6. UKCC. Standards for the Administration of Medicines. London: UKCC, 2000.
  7. DoH. Immunisation Against Infectious Disease. London: HMSO, 1996.

* A folder entitled The Rose Cottage Surgery Sample Patient Group Direction and Guidelines for a Travel Health Consultation is available as a free service from your local SmithKline Beecham representative.

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Guidelines in Practice, May 2001, Volume 4(5)
© 2001 MGP Ltd
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