Title: PATIENT GROUP DIRECTION FOR THE SUPPLY OF CHLORAMPHENICOL EYE DROPS 0.5% UNDER THE MINOR AILMENT SERVICE Identifier: Across NHS Boards Organisation Wide Directorate Clinical Service Sub Department Area This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Review date: July 2008 Author: Policy application: Alison Strath Scottish Executive NHS Scotland Caroline Hind NHS Grampian NHS Grampian Purpose: This Patient Group Direction (PGD) authorises appropriately qualified Community Pharmacists registered as members of the Royal Pharmaceutical Society to supply chloramphenicol eye drops 0.5% to individuals without the requirement for a patient specific prescription written by a medical practitioner. Responsibilities for implementation: Organisational: Local Policy statement: Review: NHS Grampian Pharmacy Medicines Unit Community pharmacy contractors It is the responsibility of individual pharmacists and their managers (where applicable) to ensure that they work with the terms laid down in this PGD and that pharmacists using this PGD act within their own level of competence. This policy will be reviewed in two years or sooner if current treatment recommendations change. This policy is also available in large print and on computer disk. Other formats can be supplied on request. Please call the Pharmacy Medicines Unit on 01224 556610 or 556088 for a copy.
PATIENT GROUP DIRECTION FOR THE SUPPLY OF CHLORAMPHENICOL EYE DROPS 0.5% UNDER THE MINOR AILMENT SERVICE A Patient Group Direction is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by Doctors, Pharmacists and other appropriate professionals, approved by the Employer and advised by the relevant professional advisory committees. In most cases, appropriate clinical care is provided on an individual basis by a specific prescriber to a specific individual patient. Patient Group Directions should only be considered where they offer a benefit to patient care without compromising patient safety in any way. Effective from 1 st July 2006 Review date July 2008
PATIENT GROUP DIRECTION FOR THE SUPPLY OF CHLORAMPHENICOL EYE DROPS 0.5% UNDER THE MINOR AILMENT SERVICE 1 Introduction This patient group direction (PGD) is designed to guide pharmacists on the supply of chloramphenicol eye drops 0.5% under the Minor Ailment Service (MAS). This will allow pharmacists to dispense a POM pack of chloramphenicol under PGD. Acute bacterial conjunctivitis will give the patient a sensation of a gritty, uncomfortable eye or eyes, with possibly a purulent or watery discharge, or crusting of the eyelid margins occurs because of the discharge, usually after sleep. It will only have been present for a few days and is not associated with any reduction in vision. The affected eye(s) will often look slightly red / infected, but this is not usually very marked. Severe pain is not a feature of simple conjunctivitis. 2 Clinical Decision Making 2.1 Patients who may be considered for the supply of chloramphenicol eye drops 0.5% Patients presenting in Community Pharmacy with a need for treatment of symptoms of bacterial conjunctivitis, and registered for the Minor Ailment Service (MAS). 2.2 Patients who may receive the supply of chloramphenicol eye drops 0.5% All patients in 2.1 above, who do not want specifically to consult a doctor and are willing to have treatment from the pharmacist. Patients over 1 year of age. 2.3 Consent Prior to the supply of chloramphenicol eye drops 0.5%, consent must be obtained either from the patient, parent or guardian. There is no legal requirement for consent to be in writing but written consent does serve to provide a permanent record that the individual (patient, parent or guardian) has been informed about the process, benefits and risks of chloramphenicol eye drops 0.5%. Individuals (patient, parent or guardian) should also be informed about how data will be stored, who will be able to access that information and how that data may be used. If a patient s fitness and suitability cannot be established, supply should be deferred and the patient referred to their doctor. Written and verbal information should be available in a form that can be easily understood by the person who will be giving the consent. Where English is not easily understood, translations and properly recognised interpreters should be used.
2.4 Consent for supply to children. A patient under 16 years of age may give consent, provided he or she understands fully the benefits and risks involved. The patient should be encouraged to involve a parent/guardian, if possible, in the decision. For young children not competent to give or withhold consent, such consent can be given by a person with parental responsibility. 2.5 Contraindications Patients may not receive a supply of chloramphenicol eye drops 0.5% if they: are under 1 year of age. are pregnant. are breast-feeding. have a known hypersensitivity or a previous adverse reaction to chloramphenicol, benzalkonium chloride or disodium edetate. 2.6 Patient Referral Urgent referral: - if painful, rather than just uncomfortable or gritty - if reduced visual acuity - if eye looks cloudy - if pus level visible in anterior chamber - if any history of trauma to eye, immediately prior to onset of symptoms - if possibility of foreign body on/in eye - if history of welding without eye protection immediately prior to onset of symptoms - if no improvement within 48 hours - if there is marked redness of the eye Routine referral: - pregnancy - breast-feeding 2.7 Action to be taken when a patient is excluded from treatment under this PGD Patients should be referred to their doctor where they are excluded from treatment in 2.5. 2.8 Action to be taken when a patient does not wish to receive treatment under this PGD The patient should be referred to their doctor. 2.9 Concurrent medication Patients should be advised to allow at least 5 minutes between administration of two different eye drop preparations.
3 Designated Staff Authorised to Supply Chloramphenicol Eye Drops 0.5% Community Pharmacists registered as members of the Royal Pharmaceutical Society of Great Britain are authorised to use the PGD for the supply of chloramphenicol eye drops 0.5% under the Minor Ailments Service. It is important to note that the above professionals may only supply or administer medicines under a PGD as named individuals. In addition the following requirements are necessary. Staff must: agree to be professionally accountable for their work (Appendix 1). be aware of current treatment recommendations. have appropriate experience and competence to identify and recommend treatment for bacterial conjunctivitis. have access to the current PGD for chloramphenicol eye drops 0.5% under the Minor Ailments Service. maintain their skills and knowledge in this area according to their individual Code of Professional Conduct. agree to work within the terms of the NHS Grampian PGD. be familiar with the RPSGB Practice Guidance: OTC chloramphenicol eye drops. The Director of Pharmacy and Medicines Management will be responsible for: Ensuring that the current PGD for chloramphenicol eye drops 0.5% is available to community pharmacists providing care under this PGD. Maintaining a current record of all pharmacists authorised to supply chloramphenicol eye drops 0.5% under this PGD. 4 Description of Treatment Available Under this Direction 4.1 Presentation Chloramphenicol eye drops 0.5% 10mL pack. Description and excipients can vary with manufacturer. Chloramphenicol eye drops 0.5% are a Prescription Only Medicine (POM). 4.2 Dose, route and frequency Adults and children 1 year and over Ocular administration: Apply one (1) drop every two (2) hours for the first 48 hours then reduce frequency to 4 hourly as infection is controlled. To be used during waking hours only. The course of treatment is 5 days. Use for at least 48 hours after healing, up to a maximum of 5 days.
4.3 Adverse effects Occasional : Transient stinging on instillation. Rare : Allergic reaction (persistent burning, swelling of lids) Also see current BNF. In the event of a Suspected Adverse Drug Reaction, please complete a Yellow card and submit to the MHRA. A Yellowcard can be found at the rear of the BNF. Record findings, advice and actions in person s record. 4.3.1 Medical advice in cases of anaphylaxis 4.4 Advice to patient Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999. Provide Patient Information Leaflet. Contact lenses to be removed during period of treatment. Contact lens wearers should be advised to follow strict hand hygiene. Hard contact lenses or disposable contact lenses may be replaced after successful treatment. Soft contact lenses should not be replaced until 24 hours after successful treatment. Measures to reduce spread of infection/do not allow the end of the dropper to touch the eye/do not share towels/hand cleanliness etc. Continue for 48 hours after healing. Store in a fridge (2-8º), and keep cap tightly closed between applications. Discard after course of treatment. Warn of possibility of blurred vision which may affect driving/operating machinery. Consult with a doctor if no improvement in 48 hours or if symptoms worsen. Packs are for individual patient use do not share bottles. 4.5 Follow up treatment Not applicable 5 Documentation 5.1 Authorisation of supply under PGD The following staff are authorised to supply chloramphenicol eye drops 0.5% without a medical prescription, under MAS, providing the patient falls into one of the categories listed in 2.2 of this PGD. Staff must be employed either directly by NHS Grampian, or contracted to provide NHS services, or providing services in partnership with NHS Grampian under the direction of this authorised PGD Registered pharmacists as recognised by RPSGB
Appendix 1 HEALTH CARE PROFESSIONAL AGREEMENT TO SUPPLY MEDICINES UNDER PATIENT GROUP DIRECTION I: Based at: agree to supply medicines under the direction contained within the following Patient Group Direction PATIENT GROUP DIRECTION FOR THE SUPPLY OF CHLORAMPHENICOL EYE DROPS 0.5% UNDER THE MINOR AILMENT SERVICE I have completed the appropriate training to my professional standards enabling me to supply medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor outwith the recommendations of the Patient Group Direction. Signed: Print name: Date: RPSGB No
Appendix 2 CERTIFICATE OF COMPETENCE TO SUPPLY MEDICINES UNDER PATIENT GROUP DIRECTION This authorises: Based at: To supply medicines under the following Patient Group Direction PATIENT GROUP DIRECTION FOR THE SUPPLY OF CHLORAMPHENICOL EYE DROPS 0.5% UNDER THE MINOR AILMENT SERVICE The above named person has satisfied the training requirements and is competent to supply medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed: Professor George Downie Director of Pharmacy and Medicines Management Date: