NHS FIFE PRIMARY CARE Patient Group Direction for Named Nurses in Contraception and Sexual Health Clinics to Supply Clotrim azole lo/o cream TO WOMEN CLIENTS for use in the treatment of vaginal candidiasis where there is extensive vulval irritation or vulvitis Number 136 Issued March 2007 Issue Number I Date of review March 2009 It is the resnonsibilitv of the person usine this PGD to ensure thaf they are using the most recenf issue Developed bv Designation Sisnature Date Joan Butchart Senior Pharmacist NHS Fife Primary Care :f tr,6 B-l-l-t c2 a'3 {7 Reviewed bv Dr Karin Piegsa Desienation Consultant in Reprod. Health Fife Contraception and Sexual Health Service \j,3 0+ Antibiotic - Reviewed bv Dr Cyril Lafong Desisnation Consultant Microbiologist Department of Microbiology and Infection Control Fife Area Laboratory xrfslt THIS PATIENT GROUP DIRECTION HAS BEEN APPROVED BY: NHS FIFE PRIMARY CARE CLINICAL POLICIES & PGD AUTHORISATIOI\ GROUP Name Desisnation Sisnature Date Mr James Slaven Head of Nursing NHS Fife 5,** BL"'/e'rr 24,"/"2 Dr Stella Clark Medical Director NHS Fife Primary Care {6^1 Otc(L!?i:lr+ Mrs Evelyn McPhail Chief Pharmacist NHS Fife Primary Care t"d N^^*^'Q' f.o 't-crt. Clotrimazole cream l% CASH Pase I of5
1. Clinical situation/condition to which the patient group direction applies Define clinical situation/condition Clotrimazole 1% cream should be used along with Clotrimazole 500mg pessary in vaginal candidiasis where there is extensive vulval irritation or vulvitis Candidiasis is a yeast infection caused by the Candida species of fungus, usually Candida albicans. Many women are affected by vaginal candidiasis (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 topical treatment for the above condition Criteria for inclusion Women with proven candida from high vaginal swab (HVS) or visual evidence of candida Woman presenting with symptoms of vaginal candidiasis if previous proven candida infection Agreed consent to treatment obtained Criteria for exclusion Known hypersensitivity to Clotrimazole or any constituents of the cream, or to any other imidazole-type antifungal drugs Genital ulceration Second request within one month Agreed consent refused Please check the current edition of the BNF for the latest information on Clotrimazole and refer to a doctor if necessary. Cautions / Need for further advice Testing for other genital tract infections, incl. sexually transmitted infections (STIs) should be offered to all women. Other, non-infective causes for client s symptoms should be considered and client discussed with/referred to doctor as appropriate. Recurrent candida (more than four symptomatic episodes per year) should be referred to GUM for further assessment and management. Irregular or abnormal vaginal bleeding follow clinic guideline Management of abnormal bleeding. Pelvic or abdominal pain or dysuria follow clinic guideline Management of pelvic pain. It is the responsibility of the designated, authorised staff who are 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 product is supplied Action if excluded The patient must be discussed with/referred to Doctor. The reason for referral should be recorded Action if patient declines treatment The reason for declining treatment should be documented. Ensure patient is aware of the implications of declining treatment. Inform clinic Doctor and (with client s permission) the GP. Reference to national/local guidelines British National Formulary (BNF) current edition (52 nd ) NHS Fife Primary Care Code of Practice Medicines National Walk-in Centre PGD for Clotrimazole Cream September 2003 to September 2005 via Internet Summary of Product Characteristics for Clotrimazole Cream (Bayer plc Date of revision of text September 2004) Page 2 of 5
Reference to national/local guidelines (Continued) Oxford Handbook of Genito-Urinary Medicine, HIV and AIDS, Oxford Medical Publications 2005 NHS Fife Antibiotic Guidance for Management of Common Infections 2006 Genital Tract Infections Management of pelvic pain Management of abnormal discharge Faculty of Family Planning & Reproductive Health Care (FFPRHC) Clinical Effectiveness Unit Guideline - Drug Interactions with Hormonal Contraception, April 2005 Faculty of Family Planning & Reproductive Health Care (FFPRHC) Clinical Effectiveness Unit Guideline The management of women of reproductive age attending nongenitourinary medicine settings complaining of vaginal discharge, January 2006 British Association for Sexual Health and HIV (BASHH) Clinical Effectiveness Group National Guideline Management of Candida (2002) 2. Characteristics of staff Qualifications required RGN with current registration with NMC and current Family Planning Certificate Additional experience/training required Undertaken a minimum of 50 Family Planning sessions in the last 1-2 years Continued training requirements Minimum of half day of update on hormonal contraception annually 3. Description of treatment Name, strength & formulation of drug Clotrimazole 1% Cream Legal class POM/P/GSL P - Pharmacy Medicine Storage Do not store above 25 o C. Ensure within expiry date Dose and frequency of administration Topical application - Apply the cream two or three times a day to the affected area Method/Route As above Quantity to be supplied One 20g tube of cream Maximum dose and number of treatments To be used two or three times a day for up to 7 days Follow up treatment None Page 3 of 5
Patient advice verbal and written (documented in case notes) Identification and management of adverse reactions Reporting procedure of adverse reactions Arrangements for referral to medical advice Additional facilities/supplies required Provide client with patient information leaflet on Candida and vaginal discharge. Discuss administration and any possible side effects with the patient. Washing the vaginal area with water only, avoiding the use of perfumed soaps, vaginal deodorants or douches. Advise patient of possible damage to latex condoms and the need to use alternative contraceptive method for at least five days after using the cream. Wearing cotton underwear and loose-fitting clothes if possible. Advise patient that if condition worsens, or if symptoms not relieved within one week of using the cream they should seek further medical advice. Advise client that partner treatment not required. Occasional local irritation Consult the current edition of the BNF for the latest information on the side effects of Clotrimazole Patient asked to seek medical advice for significant side effects or if concerned All suspected reactions should be reported directly to CSM Scotland (0131 242 2919) through the yellow card scheme. Yellow cards are available at the back of the BNF. The patient may be referred to a doctor at any stage, if this is necessary, in the professional opinion of the Nurse Patients should be referred to the Doctor or GUM if treatment proves to be ineffective in relieving the symptoms. Access to a BNF Disposal Not applicable Records Enter in medical record: Relevant medical history. Check List Genital Infection Treatment. Sign all case note entries and print name & designation. Enter route of administration, batch number, manufacturer, and date of expiry. Record treatment on case notes prescription sheet. Record of supply of medicines through patient group direction should be documented. Inform GP (with permission) by letter about treatment. Page 4 of 5
4. Management and monitoring of Patient Group Direction This Patient Group Direction is to be read, agreed to, and signed by all nurses it applies to. One signed copy is to be given to each nurse with the original being kept on file by the Contraception and Sexual Health Service One signed copy should be forwarded to the appropriate lead nurse. Name of nurse------------------------------------------------------------------ Is authorised to give----------------------------------------------------------under this Patient Group Direction Signature of nurse------------------------------------------------------------- Date----------------------------------- Review date--------------------------- Authorised by: Name of authorising clinician/manager----------------------------------------------- Signature------------------------------------ Date----------------------------------------- Page 5 of 5