PATIENT GROUP DIRECTION draft For the supply of Chloramphenicol eye ointment and eye drops for the treatment of conjunctivitis 1. 2. BUSINESS TO WHICH THE DIRECTION APPLIES: 1.1 Community Pharmacies in the former Peterborough Primary Care Trust Area 1.2 Issue date: 1.3 Review date: October 2016 October 2014 CLASS OF HEALTH PROFESSIONAL WHO MAY SUPPLY THE MEDICINE 2.1 Professional qualifications Member of the GPhC Practising community pharmacist 2.2 Specialist qualifications, training, experience and competence that must be achieved relevant to the clinical conditions and medicines used 2.3 Undertaken appropriate training to carry out clinical assessment of patient leading to determination of treatment according to the indications listed in the PGD. Has undertaken appropriate training for working under patient group directions for the supply and administrations of medicines. Has undertaken training appropriate to this PGD. Requirements for continued training or education for staff Attendance on relevant study days and training session Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 1 of 8 3. CLINICAL CONDITION OR SITUATION TO WHICH THE PATIENT GROUP DIRECTION APPLIES 3.1 Definition of the clinical condition/situation Infective conjunctivitis 3.2 Clinical criteria under which a patient will be eligible for inclusion Individuals aged over 6 months old presenting in the pharmacy with two or more of the following symptoms of conjunctivitis Diffuse redness of the conjunctiva Redness of the sclera Presence of discharge that tends to be purulent in bacterial infection and watery in viral infection Discharge may prevent the eye from opening, particularly in the morning (sticky eye) Gritty feeling in the eyes Slight disturbance of vision due to the presence of secretions Mild itching 3.3 Criteria for excluding a patient from Treatment under the Patient Group Direction Infants under 6 months Known allergy to chloramphenicol or any other ingredient Pregnant or breast feeding Pain in the eye Ocular or facial pain Eye movement restricted Photophobia Blurring of vision not caused by secretions Concurrent eye medication being used Systemically unwell Presence of pain 2 hours after removal of a foreign body Treated with chloramphenicol for conjunctivitis on 2 other occasions in the past 3 months Inflammation of the eye associated with a rash on the scalp or face The eye looks cloudy or the pupil appears unusual The eye appears injured or there is suspicion of contact with a foreign body Those who have undergone eye surgery or laser treatment in the past six months Contact lens use Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 2 of 8 3.4 Patients who have experienced myelosupression during previous exposure to chlorampenicol Patients who have a known personal or family history of blood dyscrasias including aplastic anaemia Patients who are concurrently on myelotoxic drugs For children who are not Fraser competent whose parents do not give consent for treatment Description of circumstances in which further advice should be sought from a doctor/dentist and arrangements for referral Any patient who presents for treatment but is not eligible due to the criteria for exclusion should be referred to their own GP for further medical assessment or Accident and Emergency. 3.5 Action for patients who do not wish to receive, or do not adhere to, care under the patient group direction Document all advice given and refer patient to their GP Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 3 of 8 4. DESCRIPTION OF THE MEDICINES TO WHICH THIS PATIENT GROUP DIRECTION APPLIES 4.1 Medicines to be supplied Name Dose Range Route of Administration Frequency of administration Maximum dose Follow Up treatment Advice to Patient/Carer Chloramphenicol 0.5% eye drops 10ml bottle 1.0% eye ointment 4g tube Drops Instil one drop every two hours during waking hours for two days and then reduce frequency as infection is controlled to one drop four times a day and continue for 48 hours after healing. Ointment Apply three to four times a day Apply at night if drops are being used during the day Topical Drops – use every two hours reducing frequency as infection is controlled Ointment – Use 3 – 4 times a day or at night if drops are used during the day Drops - 1 drop two hourly Ointment - four times a day or once at night if in conjunction with drops Advise the patient to consult their GP if they see no sign of improvement in 2 days If condition worsens, advise patient to stop chloramphenicol and visit their GP The patient should be given full advice on how to administer the preparation. Drops Pull down the lower lid of the eye being treated Instil one drop in the centre of the lower lid Close eye for about one or two minutes Compressing the lacrimal sac for a minute during and following instillation of the drops may reduce systemic absorption. This blocks the naso-lacrimal duct. This procedure is especially advisable in children Ointment Pull down the lower lid of the eye being treated. Apply ointment by squeezing a thin line along half the inside margin of the eyelid The ointment will melt and blinking will help spread it over the eye Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 4 of 8 Hygiene The patient should also be advised on certain hygiene procedures. Wash hands thoroughly with soap and water prior to and after touching the eye Use a separate towel to other members of the household If wiping the eye with a tissue, discard it carefully Other Do not wear contact lenses Avoid wearing make-up Keep drops in the fridge Discard any unused medication carefully Adverse outcomes When to refer Transient blurring of vision may occur on instillation The following reactions may be observed Irritation Burning Stinging Itching Dermatitis If a localised reaction occurs, the patient should stop using chloramphenicol and further medical advice should be sought promptly if needed. The pharmacist can recommend the use of antihistamines which may be purchased. Refer patients who present for treatment but are excluded by the patient group direction Advice on concurrent medication Do not use whilst using other eye drops or ointments Legal Status POM (Prescription Only Medicine) Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 5 of 8 4.2 Facilities and supplies that must be available at sites 4.3 Adequate supplies of chloramphenicol drops and ointment Chloramphenicol eye drops should be stored in a fridge Both the ointment and the drops when issued are to be labelled with the date of dispensing and the client’s name Records to be kept for audit purposes 4.4 A record of supply under PGD should be kept. The record can be made in the PMR, Prescription book or a copy of the assessment form completed by the pharmacist can be kept. Prescription charges need to be collected in the usual manner and exempt patients will need to fill in a exemption declaration form Record the details of the patient’s name, address and date of birth and GP practice on the assessment form and return to the Primary Care Trust for payment Obtain patient consent to pass on this information to the GP practice Bibliography Brochlor Product Information Leaflet from www.medicines.org.uk BNF 64 September 2012 Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 6 of 8 5. AUTHORISATION 5.1 Names and signatures of multidisciplinary group which drew up the patient group direction. NAME DESIGNATION/TITLE Dr S Yogasundrum GP Nene Practice Ms R Bali Pharmacist Signed by email 04.10.12 Sofina Taj Pharmacist Signed by email 27.09.12 5.2 Valley Medical SIGNATURE Signed by email 09.10.12 Authorisation of Cambridgeshire and Peterborough Clinical Commissioning Group, name and signature of GP Clinical Lead for Prescribing, Chief Pharmacist and Lead Nurse NAME SIGNATURE Richard Spiers - GP Clinical lead for prescribing Signed by email 07.10.2014 Sati Ubhi - Chief Pharmacist Signed by email 07.10.2014 Jill Houghton - Director of Quality and Nursing Signed by email 06.10.2014 5.3 Individuals working under this patient group direction …………………. …………………. …………………. …………………. …………………. In signing this I accept personal responsibility for working in accordance with this Patient Group Direction Pharmacy name Address Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 7 of 8 6. THIS PGD IS TO BE READ, AGREED AND SIGNED BY ALL HEALTH CARE PROFESSIONALS IT APPLIES TO: The Pharmacist should retain a copy of the document after signing. Pharmacy authorisation for supply of chloramphenicol eye drops and ointment for the treatment of conjunctivitis without a prescription for a named individual I, …………………………….. Pharmacist give authorisation on behalf of the pharmacy for the named pharmacists who have signed this Patient Group Direction, to supply chloramphenicol drops or ointment for the treatment of conjunctivitis without a prescription under patient group direction Signed ………………………… Date ……………………. PHARMACY STAMP Patient Group Direction: Chloramphenicol Date of Policy: November 2002 Reviewed Oct 03, Oct 04,Oct 06, Oct 08, Oct 10, Oct 12, Oct 14 Review Date: Oct 2016 PGD No: 00056 Page 8 of 8