Guidelines on the use and development of Patient Group Directions for nurses caring for people with a dermatological problem

Developed by the British Dermatological Nursing Group, Nurse-Prescribing Taskforce, Chaired by Karina Jackson.
March 2002

What are patient group directions?
Patient group directions (PGD) are written instructions for the supply and administration of medicines to groups of patients who may not be individually identified before presentation for treatment. They are not the same as patient-specific directions and do not bestow the right to prescribe. They should be reserved for limited situations where they offer an advantage to patient care. In the past PGD's may have been referred to as group protocols or standing orders.

A patient group direction is essentially a written document produced by a multi-disciplinary team (that must include a senior doctor and pharmacist) that authorises the named user/s to administer or supply certain medicines in specific situations. The PGD document must be drawn up according to the framework and criteria as specified in HSC 2000/026 Patient Group Directions available via www.doh.gov.uk/coinh.htm. This is a legal requirement (England only).

PGD's are not a substitute for clinical assessment and nurse accountability. They are tools that enable the nurse to give treatment (i.e. medicinal therapy) following a thorough assessment and care planning. PGD's are NOT nurse prescribing.

When should PGD's be used?
They should be used to benefit patients, not for organisational convenience or to save money. A flow chart designed to assist decision making regarding the appropriateness of PGD is available at www.groupprotocols.org.uk. Each PGD written should detail a defined clinical condition or situation to which the PGD applies.

PGD's are required for licensed medicines only, therefore they may not be necessary for dressings, medical devices or emollients.

Who can use patient group directions to supply or administer drugs?
Qualified nurses, midwives, health visitors, pharmacists, optometrists, orthoptists, chiropodists, radiographers, physiotherapists and ambulance paramedics employed by NHS organisations or other organisations funded by the NHS to provide care for NHS patients can use patient group directions as named individuals. The practitioner must be competent in their area of practice and use PGD's only within their professional boundaries. The seniority of the nurse using the PGD and / or length of experience in a particular area of practice is for each local area to discuss for each respective PGD. The imperative is that the practitioner can demonstrate competence.

Is there any training course for nurses using patient group directions?
There is NO specific course designed to train practitioners in the use of patient group directions or provide the necessary background pharmacy and pharmacology knowledge required to supply and/or administer treatment. Individual NHS Trusts must apply their own minimum training / experience standards. It is the responsibility of the individual practitioner and the employer to ensure that sufficient training has been given to achieve competence in the use of PGD's.

What drugs can be included in a patient group direction?
Any licensed medicines that are deemed safe and appropriate for supply and/or administration via PGD. Black triangle drugs (i.e. those recently licensed and subject to special reporting arrangements for adverse reactions) and 'off label' drugs can be included in PGD's, but only if this is justified by best practice guidance. 'Off label' means use outside of the terms of the summary of product characteristics (as is often the case in children), that is, use in an unlicensed indication. Controlled drugs (CD) cannot currently be included in PGD's.

How do I develop a patient group direction?

1. Assess whether a PGD is the most appropriate means of supplying and/or administering treatment to the group of patients you are considering. Is the patient likely to benefit?
2. Assess whether you have the resources, facilities and manpower to realise the idea. Would the practice be safe? Which staff are competent to use PGD's? What training might they require?
3. Familiarise yourself with the requirements detailed in the government directive HSC 2000/026.
4. Establish whether there is a local policy on development of PGD's within your NHS Trust. In this instance, you will be required to follow the local policy on the development and approval of PGD's .
5. List the professionals that need to be involved in the development of PGD's and start discussions as soon as possible! This may include your nursing manager, lead clinician, business manager and senior pharmacist.
6. Devise an action plan for the development of the PGD and assign roles to named individuals.

What must I include in the patient group direction?

• The name of the business to which it applies (e.g. The Royal Hospital Trust)
• The date the direction comes into force and the date it expires (a maximum period of 2 years before review is required)
• A description of the medicine(s) to which the direction applies (e.g. Amethocaine gel)
• The class of health professional who may supply or administer the medicine (e.g. qualified nurses working in the dermatology laser suite, who have at least 6 months experience working in the department and have been assessed as competent by the unit nursing sister)
• The signature of a doctor and a pharmacist
• The signature by an appropriate health organisation (e.g. Trust chief executive or other delegated nominee).
• The clinical condition or situation to which the direction applies (e.g. skin anaesthesia pre - laser treatment)
• A description of those patients excluded from the treatment under the direction
• A description of the circumstances in which further advice should be sought from a doctor and arrangements for referral
• Details of 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 (NB You will need to indicate if the medicine is for a child or adult - if doses vary according to age group then each dosing schedule must be detailed).
• Relevant warnings, including potential adverse reactions
• Details of any necessary follow-up action and the circumstances
• A statement of the records to be kept for audit purposes

(see 'Templates' for an example of these criteria in a sample context)

What other things should I consider before implementing a PGD?

• Storage
  Remember PGD's are not prescriptions, so a pharmacist might not be involved in the supply of the medicine. Therefore consideration should be given to where the medicine can be safely stored and how drug accountability will be maintained. In the interests of safety, as far as possible we would recommend the pharmacy play a role in the storage and supply of the medicines but this is not always possible.
• Cost
  You will need to discuss the issue of medicine costs with the Trust and whether payment will be collected from patients if a treatment supply is provided.
• Patient information
  If supplying medicines to a patient, who will label the drug and what information will be given to the patient? (Accompanying written information should be available to patients for all licensed medicines).
• Documentation
  How will the medicine administration and/or supply be documented? How will this information reach the patients case notes if the record is not made directly at the time of consultation? Do you need to inform the patient's GP or other primary care practitioners of your action?
• Patient Choice
  Patients should be informed that they are being treated by a nurse (or other health professional) and give their consent to this.
• Clinical Governance
  Ensure each version of PGD is numbered. Always keep old versions of PGD's under which you have worked in the past. Ensure you consider how you will audit the use of PGD's and do it!!
• Continuous learning
  Consider the training requirements for staff that will use the PGD and think about how knowledge and competence can be maintained and measured.
• Roles and responsibilities
  A statement of roles and responsibilities in relation to the PGD is useful. This will assist multi-disciplinary involvement, audit and clinical governance.

Nurse Prescribing

If you are providing a nurse led service treating patients with skin diseases or conditions that may require a number of different treatments, or there are a variety of treatments that you would wish to choose from depending on your assessment (e.g. atopic eczema), it is probably more appropriate for you to train as a nurse prescriber. Click on 'types of nurse prescribing' for more information.

What further reading is recommended?

Department of Health (1998) Review on prescribing, supply and administration of medicines. Report on the supply and administration of medicines under group protocol arrangements, London: DoH (Crown II, part 1)
www.doh.gov.uk

NHS Executive (2000) Patient Group Directions (England only), HSC 2000/026. Leeds, NHSE

Royal College of Nursing (Jan 2001) Patient Group Directions: Guidance and information for nurses London, RCN publication code no. 001 370
www.rcn.org.uk

Nursing and Midwifery Council (April 2002) Code of Professional Conduct, London NMC
www.nmc-uk.org

United Kingdom Central Council for Nursing, Midwifery and Health Visiting (1998) Guidelines for records and record keeping, London UKCC
www.nmc-uk.org

United Kingdom Central Council for Nursing, Midwifery and Health Visiting (2000) Guidelines for the administration of medicines, London UKCC
www.nmc-uk.org

Patient Group Direction: TEMPLATES

How to use the templates
The aims of the templates are to put the guidance notes into context and help shape the development of your own PGD's. The templates to follow are for very specific clinical situations, which makes them simple examples. They adhere to the minimum criteria required according to HSC 2000/026.

The templates are for information only. Clinical practice, policy, patient population and resources will vary in different workplaces therefore it is not advised that these templates are copied and used without consideration of local factors.

Patient Group Direction Templates

1. Cryotherapy - liquid nitrogen
2. Pre laser local anaesthesia and post laser prophylactic treatment (Amethocaine gel, Amethocaine Hydrochloride eyedrops, Fusidic acid 1% eyedrops)

We hope to add further templates in the near future.

CRYOTHERAPY - Liquid Nitrogen

1. Characteristics of staff authorised to take responsibility for the supply and administration of cryotherapy under this Patient Group Direction

Cryotherapy: Registered named nurses who have a minimum of 2 years post registration experience in dermatology nursing and are practising at grade E or above, who have completed a period of supervised practice and achieved cryotherapy administration competence at level 3 or above (according to the scale cited in Dawber et al 1997) as assessed by a consultant or specialist registrar in dermatology.

2. Clinical situations to which this Patient Group Direction applies

Definition of clinical condition / situation
Cryotherapy for viral warts (incl. verrucae), molluscum contagiosum, seborrhoeic warts, actinic keratoses

Inclusion criteria (i.e. more specific details)
Patients aged 5 years and older referred directly by consultant or specialist registrar or new GP referrals. Written consent obtained from parents/guardian of children under the age of 16.

Exclusion criteria
Children under the age of 5 or children that do not understand what the treatment involves. Patients (or parents/guardians) who do not give consent. Genital lesions.

In the case of repeated treatment: Severe inflammation or infection or broken skin or expressed discomfort following last treatment. Dissatisfaction by the patient with treatment.

A description of the circumstances in which further advice should be sought from a doctor
If lesion is not resolved within 6 months of treatment. If lesion grows or worsens during treatment. If patient has an adverse reaction to treatment.

Referral arrangements to the doctor when applicable
Immediate accessibility to consultation with dermatology clinic doctor if required. If non-urgent follow up appointment in dermatology clinic within 1 month.

Routine follow up action (if applicable)
Warts treated by nurse every 2-4 weeks depending on patient tolerance. If lesion(s) resolve, 3 month open appointment with cryotherapy nurse provided with the scope to recommence therapy in that period if required. A GP letter will be sent and copied to notes at the end of therapy or when a progress report is deemed appropriate. Review by doctor every 6 months if lesion(s) unresolved.

For seborrhoeic warts and actinic keratoses discuss with referring doctor within a 12-week period if continuing treatment.

Action for patients excluded from treatment or not wishing to receive care from the nurse
Education on self resolution of warts / molluscum or refer back to the referring doctor or referral to genito-urinary medicine for genital warts. In the case of GP referrals the patient will be booked onto a dermatology clinic list within 4 weeks.

Treatment records (information that should be included)
The following information will be documented in the patient's hospital notes:

• Date of visit
• Verbal informed consent obtained (1st visit only)
• Written consent from parent / guardian if child under 16 (1st visit only)
• Patient advice sheet given (1st visit only)
• Side effects or problems associated with treatment
• Paring of lesion performed
• Body stamp showing location of lesions
• Length of time (seconds) of each cycle (total number of cycles)
• Equipment used (including size of nozzle if cryo gun used)
• Progress report
• Review / follow up date and arrangements
• GP letter sent (as applicable)
• Signature of nurse administering treatment

3. Medicine that may be administered: Liquid Nitrogen

References:
COSHH regulations for liquid nitrogen
Dawber R. Colver G. Jackson A. (1997) Cutaneous Cryosurgery: Principles and Clinical Practice (2nd edition) Martin Dunitz, London
Manufacturers guidelines on use of cryo - gun

PRE LASER LOCAL ANAESTHESIA AND POST LASER PROPHYLACTIC TREATMENT
Amethocaine gel, Amethocaine Hydrochloride eyedrops, Fusidic acid 1% eyedrops

1. Characteristics of staff authorised to take responsibility for the supply and administration of Amethocaine gel, Amethocaine hydrochloride eyedrops and fusidic acid 1% eyedrops under this Patient Group Direction

Registered named laser therapy nurses who have been assessed as competent practitioners in the administration of pulsed dye laser treatment by the department consultant dermatologists.

2. Clinical situations to which this Patient Group Direction applies

Definition of clinical condition / situation
Pre and post pulsed dye laser procedure treatment. Pulsed dye laser is given to patients with the following conditions: proliferative phase haemangioma, port wine stain, rosacea, telangectasia, spider naevi, keloid and scars.

Prior to laser treatment the patient requires topical anaesthesia to the treatment area. If they require the insertion of an eye guard they will also require topical eye anaesthesia and prophylactic antibiotic eye drops. Post insertion of an eye guard the patient will be required to apply antibiotic eye drops.

Inclusion criteria (i.e. more specific details)
Patients from one month old who are referred for laser treatment directly by dermatology consultant or specialist registrar. Written consent for laser treatment obtained from patient (parent or guardian if the child is under the age of 16) by laser therapy nurses.

Exclusion criteria
Premature infants or those under the age of 1 month old. Women who are pregnant or breastfeeding. Patients with known allergies to the medicine/s. Patients dissatisfied with their treatment.

A description of the circumstances in which further advice should be sought from a doctor
If the patient does not consent to the procedure. If patient has a known allergic response to the proposed treatment or an adverse reaction following application of the treatment. If patient requests advice from a doctor.

Referral arrangements to the doctor when applicable
Immediate accessibility to consultation with dermatology surgery / laser SpR, consultant or research fellow. If non-urgent, follow up appointment in laser and surgery clinic after a course of treatments or at the nurse's discretion.

Action for patients excluded from treatment or not wishing to receive care from the nurse
Direct back to a member of the referring medical team.

Treatment records (information that should be included)
The following information will be documented in the hospital notes in relation to the use of the drugs specified in the drug tables (laser treatment details will also be entered into the notes but are not detailed here):

• Date of visit
• In the case of topical anaesthetic: Time applied and time to remove the gel/cream and who applied the treatment
• Treatment supplied to patient to take home and instructions given (if applicable)
• Review / follow up arrangements
• Name and signature of nurse administering treatment

3. Medicines that may be administered: Amethocaine gel, Amethocaine Hydrochloride eyedrops, Fusidic acid 1% eyedrops

Amethocaine (Ametop™ Gel)

References:
Manufacturers guidelines and information sheet distributed by Smith and Nephew Ltd.
British National Formulary; Summaries of Product Characteristics

Amethocaine Hydrochloride (Minims™)

References:
Manufacturers guidelines and information sheet distributed by Chauvin Pharmaceuticals
British National Formulary; Summaries of Product Characteristics


Fusidic acid 1% eye drop (Fucithalmic®)

References:
Manufacturers guidelines and information sheet distributed by Leo Pharmaceuticals
British National Formulary; Summaries of Product Characteristics