Reason - New patient group directions should comply with new legal requirements set out in HSC 2000/026. Failure to comply could result in criminal prosecution under the Medicines Act.

Purpose - These are written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment such as in Primary Ear Care Treatment Clinics in general practice. These directions are for situations where this offers an advantage for patient care without compromising patient safety and are consistent with professional relationships and accountability.

Contents - The contents follow the law as directed in HSC 2000/026

Name of business - Primary Health Care - Rotherham Health Authority

Date direction comes into force - July 2001

Expiry date - July 2003

The medicines to which this direction applies - Ointments and creams used in the treatment and prevention of ear disorders in the primary setting as documented in Appendix 1 together with product information.

Health professionals who may administer the medicines - A first level nurse who has successfully completed The National Primary Ear Care Course or Modules 1, 3 and 4 of the modular version of this course. A nurse who has completed a portfolio of primary ear care learning. The method of learning should include assessment of theoretical knowledge and practical skills and up-date of these once every 3 years.

Signature of senior doctor - _______________________________
Printed Name - _______________________________

Signature of senior pharmacist- _______________________________
Printed Name - _______________________________

Signature of health organisation - _______________________________
Printed Name - _______________________________

The clinical conditions or situation to which each direction applies - Ear trauma through self abuse; itchy, dry flaky ear meatus; acute otitis externa; chronic otitis externa; chronic supporative otitis media; first line management of middle ear disease while waiting for consultation. See Appendix 2.

Patient group to which these directions apply -

• All patients with ear related problems referred by a general practitioner, ENT Consultant or another nurse.
  
  
• Self-referral of patients 16 years and over with ear related problems, or parental referral.
  
  
• No patients requesting treatment will be excluded except if medical advice prohibits this.

Circumstances in which medical advice should be sought -
These are outlined under the directions for each ear condition. See Appendix 2

Arrangements for referral -

To request first available appointment for the patient to talk with a general practitioner.

The ear care trained nurse may request immediate medical advice if there is any uncertainty as to most appropriate treatment.

If the patient requires ENT Consultant/Audiological advice, in the trained nurses' limits of clinical judgement and as agreed by the supporting general practitioner, the patient notes together with a request for further ENT advice may be passed to the doctor for a referral letter to be written.

Dosage of treatments -

Ointments/creams used in topical applications for various ear problems are mainly for the treatment of skin infections, the meatus being a skin (epithelium) lined cul-de-sac. The amount used and repeat administration is dependent on the severity of the problem. This may vary from a one off application of 1mm of anti inflammatory/antiseptic to 3 monthly application of the same for a recurrent skin irritation. The appropriate ointment applied on a 96mm dressing for a normal ear meatus or a dressing up to 450mm for a large mastoid cavity will mean that the dosage for some patients with similar bacterial infection could be much larger dependant on the status of the ear meatus. Using clinical judgement the treatment would be given over the shortest possible time to ensure effective clearance of the infection.

Ointment dressings will remain in situ for no longer than 60 hours and cream/water based dressings for 24 hours only. If aural toilet followed by first line management is unsuccessful (evidence based care) a swab will be taken and treatment changed to second line management until the swab result is known. If ear drop prescriptions are requested for the patient to self care following initial treatment, 10 days use will be advised and return for review if not improved. See Appendix 3 and Data sheets for pharmaceutical information related to form and strength of treatments.

Treatment - Potential adverse reactions and relevant warnings -

Nurses are trained to recognise a sensitivity reaction to ear treatments and also, when treating patients, to always advise them that there could be a sensitivity reaction to the treatment and what to do should this occur. Any allergies or reactions are recorded in patients notes for future reference. All contra-indications and warnings are documented on the enclosed drug data sheets. See Appendix 3.

Patient records -

All ear care treatments will be documented according to the UKCC Guidelines for the administration of medicines (October 2000) and kept for audit purposes. The documents will be signed by the nurse providing treatment who will also name the ointment provided and the reason for the choice.

On going competency of nurses operating within these directions -

The Primary Ear Care Centre will offer clinical supervision to assist in ensuring that only fully competent, qualified and trained professionals operate these directions.

Antimicrobials -

The Primary Ear Care Centre policy to train nurses to prevent infections wherever possible by recognition of potential infections, advising patients about future prevention and using the minimal amount of an antiseptic/anti inflammatory ointment to prevent the later possible long term use of antibiotic treatment. Where a bacterial or fungal infection is present in the ear canal aural toilet and application of first line management together with patient advice on future management of the problem usually resolves the problem. Where the problem is persistent other medical reasons for this are considered and medical advice sought. Regular audit of reductions in prescribing by using these methods shows the effectiveness of treatment.

The signatures of:-

• Each member of the multi-disciplinary group
  
• The Clinical Governance lead on behalf of the authorising NHS organisation.
  
• The individual health professionals working under the directions.
  Should be added to this document.