NHS FIFE COMMUNITY HEALTH PARTNERSHIPS. It is the responsibility of the person using this PGD to ensure that they are using the most recent issue.

Transcription

1 NHS FIFE COMMUNITY HEALTH PARTNERSHIPS Patient Group Direction for Named Community Pharmacists to Supply Fluconazole 150mg Capsule TO WOMEN WHO ARE BETWEEN 16 AND 60 YEARS OF AGE UNDER THE MINOR AILMENT SERVICE (MAS) Number 115 Issued October 2011 Issue Number 3 Date of review October 2013 First Issued July 2006 If this PGD is past its review date then the content will remain valid until such time as the PGD review is complete and the new issue published. It is the responsibility of the person using this PGD to ensure that they are using the most recent issue. Developed by Designation Signature Date Margery Reid PGD Pharmacist Reviewed by Designation Signature Date Andrea Smith Lead Pharmacist Pharmacy Services Dr Drew Smart Medical Director NHS Fife Primary care Emergency Service Antibiotic - Reviewed by Designation Signature Date Dr Susan Smith Consultant Microbiologist Department of Microbiology and Infection Control Fife Area Laboratory THIS PATIENT GROUP DIRECTION HAS BEEN APPROVED BY: NHS FIFE COMMUNITY HEALTH PARTNERSHIPS CLINICAL POLICIES & PGD AUTHORISATION GROUP Name Designation Signature Date Mollie Tevendale Associate Nurse Director NHS Fife Dr Brian Montgomery Medical Director NHS Fife Primary Care Mrs Evelyn McPhail Director of Pharmacy/ Chief Pharmacist Page 1 of 5

2 1. Clinical situation/condition to which the patient group direction applies Define clinical situation/condition 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, discharge, redness, soreness and swelling of the vagina and vulva and a thick, white vaginal discharge. Objectives of care To provide a single dose oral antifungal treatment for the above condition. Criteria for inclusion Women who are aged between 16 and 60 years of age. Woman 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). Informed consent to treatment obtained. Criteria for exclusion Patient not eligible for MAS. Women who are under 16 or over 60 years of age. Women who are experiencing the symptoms for the first time. Women currently taking cisapride or terfenadine Liver disease. Breast feeding. Pregnancy or risk of pregnancy. Risk of sexually transmitted disease (STD) or other cause for vaginal discharge. Irregular or abnormal vaginal bleeding. Genital ulceration. Known hypersensitivity to fluconazole or to related azole compounds or any excipient in the capsule. (Consult Summary of Product Characteristics (SPC) or manufacturer s Patient Information Leaflet (PIL). Second request within one month or more than two infections of thrush within the last six months. Consent to treatment refused. Additional Information Although fluconazole has the potential to interact significantly with a number of drugs the BNF notes that in general fluconazole interactions relate to multiple dose treatments.please check Appendix 1 in the current edition of the BNF for the latest information on Fluconazole interactions and refer to a doctor if necessary. Caution in patients with potentially proarrythmic conditions consult SPC or PIL and refer to a doctor if necessary Referral Criteria Urgent referral: Not applicable Routine referral: If symptoms not clearing within 3 days Pregnant Breast feeding Known diabetic and recurring candidiasis Vaginal pain, unusual bleeding or blistering Page 2 of 5

3 Action if excluded The patient must be referred to GP. The reason for referral should be recorded. Action if treatment declined The patient must be referred to GP. The reason for refusal should be recorded. Ensure awareness of implications of declining treatment. Reference to national/local guidelines British National Formulary (BNF) current edition (61st) NHS Scotland National PGD for Fluconazole 150mg NHS Fife Antibiotic Guidance for Management of Common Infections 2010 Summary of Product Characteristics for Fluconazole 150mg Capsule (Pfizer Ltd) Date of revision of text February available at 2. Characteristics of staff Qualifications required Pharmacist who is currently registered with The General Pharmaceutical Council. Additional experience/training required Registered Pharmacist competent to undertake supply of medicines under Patient Group Directions.. It is the responsibility of the named community pharmacist using this PGD to ensure that treatment with the drug detailed in this direction is appropriate. If in any doubt, advice should be sought and recorded before the preparation is supplied. Continued training requirements Updates on the management of candidiasis when appropriate Maintain own professional level of competence and knowledge in this area. Keep up-to-date with information on contraindications, cautions and interactions for Fluconazole from the BNF, SPC and PIL and refer to a doctor if necessary 3. Description of treatment Name, strength & formulation of drug Fluconazole 150mg Capsule Legal class POM/P/GSL Prescription Only Medicine Storage Store below 30 o C. Ensure within expiry date Dose/Dose Range Vaginal candidiasis a single dose of 150mg by mouth Method/Route Oral Quantity to be supplied One capsule of 150mg Frequency of administration One single dose only Page 3 of 5

4 Maximum dose and number of treatments One single dose of 150mg completes the course. Follow up treatment None Patient advice (verbal and written) Identification and management of adverse reactions Provide Patient Information Leaflet. The capsule should be swallowed whole. Treat at any time of menstrual cycle, including during periods. Discuss any possible side effects with the patient. Advise 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. Advise patient that if condition worsens or if no sign of improvement within 3 days they should seek further medical advice. 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-Johnson syndrome, hyperlipidaemia, leucopenia, thrombocytopenia, hypokalaemia. Consult the current edition of the BNF for the latest information on the side effects of Fluconazole. Reporting procedure of adverse reactions Arrangements for referral to medical advice Additional facilities/supplies required Patient asked to seek medical advice for significant side effects or if concerned All suspected serious reactions should be reported directly to the Commission on Human Medicines through the yellow card scheme, (Yellow Card Centre Scotland ) and recorded in the client s medical records. Yellow cards are available at the back of the BNF. Reports may also be made online at Record findings, advice and actions in person s record. The patient may be referred to a doctor at any stage, if this is necessary, in the professional opinion of the pharmacist. Patients should be referred to a doctor if treatment proves to be ineffective in relieving the symptoms. Current BNF Disposal Not applicable Record required of Supply/Administration Following to be noted in the computerised patient information records and on the CP 2 form: Dose, frequency and the quantity supplied Date of supply to patient Page 4 of 5

5 This Patient Group Direction has been assessed for Equality and Diversity Impact 4. Management and monitoring of Patient Group Direction Pharmacist Agreement Supply of Fluconazole 150mg Capsules by Community Pharmacists I, confirm that I have read and understood the above Patient Group Direction. I confirm that I have the necessary professional registration, competence, and knowledge to apply the Patient Group Direction. I will ensure my competence is updated as necessary. I will have ready access to a copy of the Patient Group Direction in the clinical setting in which the supply of the medicine will take place and agree to provide this medicine only in accordance with this PGD. I understand that it is the responsibility of the pharmacist to act in accordance with the Code of Ethics for Pharmacists and to keep an up to date record of training and competency. Name of Pharmacist GPharm Council Registration Number Normal Pharmacy Location Signature Date Note: A copy of this agreement must be signed by each pharmacy practitioner who wished to be authorised to use the PGD for the supply of Fluconazole 150mg Capsules under MAS. Please fax a copy of this page to Pharmacy services on Each authorised pharmacy practitioner should be provided with an individual copy of the authorised PGD. Page 5 of 5