Title: PATIENT GROUP DIRECTION FOR THE SUPPLY OF FLUCONAZOLE 150MG 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 fluconazole 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 FLUCONAZOLE 150MG 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 FLUCONAZOLE 150MG UNDER THE MINOR AILMENT SERVICE 1 Introduction This patient group direction (PGD) is designed to guide pharmacists on the supply of fluconazole under the Minor Ailment Service (MAS). This will allow pharmacists to dispense a POM pack of fluconazole under PGD. Candidiasis is a yeast infection caused by the Candida species of fungus, usually Candida albicans. Many women are affected by vaginal thrush at some point in their lives and in some women it may recur regularly. The condition develops when Candida albicans, which is often present in the vagina, causes itching, irritation, redness, soreness and swelling of the vagina and vulva and a thick, white vaginal discharge. 2 Clinical Decision Making 2.1 Patients who may be considered for the supply of fluconazole Women with previous history of vaginal candidiasis presenting in Community Pharmacy with a need for treatment of symptoms of vaginal candidiasis, and registered for the Minor Ailment Service (MAS). 2.2 Patients who may receive the supply of fluconazole All patients in 2.1 above, who do not want specifically to consult a doctor and are willing to have treatment from the pharmacist. Women over 16 years of age and under 60 years of age. 2.3 Consent Prior to the supply of fluconazole, consent must be obtained from the patient. 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 fluconazole. 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. Not applicable This PGD cannot be used to supply to patients under 16 years of age. 2.5 Contraindications Patients may not receive a supply of fluconazole if they are: Women who are experiencing the symptoms for the first time. Women with a history of liver or kidney disease. At risk of sexually transmitted infection (STI) or other cause for vaginal discharge. Experiencing irregular or abnormal vaginal bleeding. Experiencing genital ulceration. Known to have a hypersensitivity to fluconazole or any of the components of the capsule. Pregnant. Breast-feeding. A known diabetic with recurring candidiasis Presenting for a second request within one month. Presenting with vaginal pain, bleeding or blistering. Are known to have more than two infections of thrush within the last six months. 2.6 Patient Referral Urgent referral: Not applicable Routine referral: If symptoms not clearing within 3 days Pregnant Breast-feeding Renal impairment Known diabetic and recurring candidiasis Second request within one month Vaginal pain, bleeding or blistering 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 but also if symptoms have not cleared within 3 days. 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 Not applicable.
3 Designated Staff Authorised to supply fluconazole Community Pharmacists registered as members of the Royal Pharmaceutical Society of Great Britain are authorised to use the PGD for the supply of fluconazole 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 vaginal candidiasis. have access to the current PGD for fluconazole 150mg 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. The Director of Pharmacy and Medicines Management will be responsible for: Ensuring that the current PGD for fluconazole is available to community pharmacists providing care under this direction. Maintaining a current record of all pharmacists authorised to supply fluconazole under this PGD. 4 Description of Treatment Available Under this Direction 4.1 Presentation Fluconazole 150mg capsule (non-proprietary) single-capsule pack Description and excipients can vary with manufacturer Fluconazole is a Prescription Only Medicine (POM). 4.2 Dose, route and frequency For the treatment of Vaginal candidiasis a single dose of 150mg by mouth. One capsule completes the course.
4.3 Adverse effects Occasional: nausea, abdominal discomfort, diarrhoea, flatulence, headache, rash. Rare: dyspepsia, vomiting, taste disturbance, hepatic disorders, hypersensitivity reactions, anaphylaxis, dizziness, seizures, alopecia, pruritus, toxic epidermal necrolysis, Stevens-Johnston syndrome, hyperlipidaemia, leucopenia, thrombocytopenia, hypokalaemia. Also see current BNF. In the event of a Suspected Adverse Drug Reaction, please complete a Yellowcard and submits 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. Treat at any time of menstrual cycle, including during periods. Discuss any possible side-effects with the patient. Advice regarding re-infection and that partner may need treatment if symptomatic. Washing the vaginal area with water only, avoiding the use of perfumed soaps, vaginal deodorants or douches. Avoiding using latex condoms, spermicidal creams and lubricants if they cause irritation. Wearing cotton underwear and loose-fitting clothes if possible. 4.5 Follow up treatment Not applicable 5 Documentation 5.1 Authorisation of supply under PGD The following staff are authorised to supply fluconazole without a medical prescription 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 FLUCONAZOLE 150MG 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 FLUCONAZOLE 150MG 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: