PATIENT GROUP DIRECTION FOR AZITHROMYCIN

Transcription

1 Staff Characteristics Pharmacist registered with the RPSGB who has undertaken relevant training as specified by NHS Bristol Has undertaken appropriate training to carry out clinical assessment of patient who requires treatment according to the indications listed in the PGD Has undertaken appropriate training for working under patient group directions for the supply and administration of medicines Has undertaken training appropriate to this PGD in line with current requirements of the BNSSG Contraception & Sexual Health Services Guidelines Group [reference 1] THE PHARMACIST MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORK ING ACCORDING TO IT [references 2-6] Page 1 of 12

2 Clinical Details Indication Male and female clients who have a positive genital Chlamydia result following screening by the Avon Chlamydia screening programme. Sexual contact of a client with positive genital Chlamydia result Inclusion criteria Age adults and young people over the age of 12 years up to and including those aged 24 years Weight 45kg or more Young persons under the age of 16 years should be competent under the Lord Fraser guidelines (or have treatment consent from a carer with parental responsibility) [reference 9] In a female client the risk of pregnancy is nil or negligible 1. Clinical Details Exclusion criteria No valid consent Age less than 12 years Age 25 years or above Weight less than 45kgs Known hypersensitivity to azithromycin or other macrolide antibiotics (erythromycin, clarithromycin or spiramycin) or serious adverse reactions with previous treatment with azithromycin Hepatic disease Renal impairment Acute Porphyria 1 Recent publications form the FFPRHC CEU refer to being Reasonably certain the woman is not pregnant and define this as has not had intercourse since the last normal menses; has been correctly and consistently using a reliable method of contraception; is within 7 days after normal menses; is within 4 weeks postpartum; is within 7 days post-abortion or miscarriage; is fully or nearly fully breastfeeding, amenorrhoeic and <6 months postpartum. Pregnancy testing adds weight to the diagnosis. [reference 10] The authors of this PGD add that the interval from the last unprotected intercourse to the pregnancy test should be at least 3 weeks. Page 2 of 12

3 Pregnancy or breast-feeding. History of cardiac disease Predisposition to QT interval prolongation (including electrolyte disturbances) Male client with scrotal pain Female client with pelvic pain Presence of genital tract symptoms: *Urinary symptoms such as stinging when passing urine *Penile discharge *Unusual vaginal discharge and/or bleeding *Concomitant conjunctivitis and/or joint bleeding Concurrent use of any of the following drugs is an exclusion: Terfenadine Ciclosporin (cyclosporine) The anticoagulants; warfarin, acenocoumarol (nicoumalone) or phenindione. Digoxin Theophylline Nelfinavir Cisapride Rifabutin Reboxetine Mizolastine Antimalarials Quetiapine Sertindole Ritonavir Methysergide Ergot derivatives; ergotamine or proprietary products containing ergotamine Cafergot, Migril. These are all drugs for migraine. Concomitant use of drugs that prolong the QT interval such as; amiodarone, cisapride, amitryptyline or sumatriptan. Check appendix 1 of the latest version of the BNF for a comprehensive list of potential drug interactions and go to (search under azithromycin and view summary of product characteristics (SPC)) for further information. Management of excluded patients Record the reason for exclusion / referral in the case records. Record any advice given. Refer to a doctor or CaSH service such as Bristol Sexual Health Centre, and highlight the need to seek further medical advice. Page 3 of 12

4 Action for patients not wishing to receive care under this PGD Record the refusal in the case records. Refer to a doctor where appropriate. Record any advice given in patient s notes. Drug Details Name, form & strength of medicine Legal classification Route/Method Dosage Frequency Duration of treatment Maximum or minimum treatment period Quantity to supply/administer Cautions Azithromycin capsules 250mg (Tablets may be used if capsules are not available) POM Oral 1g stat dose to be given as a supervised dose Maximum dose: as above As required Single stat dose Single stat dose 4 x 250mg capsules (Tablets may be used if capsules are not available) Drug interactions See exclusion section and current edition of the BNF for full details of interactions. Concurrent use of the following require special advice for the patient Combined oral contraceptive (COC) pill. see Advice to patient section Antacids see Advice to patient section Page 4 of 12

5 Drug Details Side effects Azithromycin is well tolerated with a low incidence of side effects. The most common side effect is nausea. Other occasional side effects include loss of appetite, vomiting and diarrhoea. These usually settle by themselves and the patient should be reassured. Rarely anaphylaxis can occur. For a comprehensive list of possible side effects please see the latest BNF, or go to (search under azithromycin ). Advise to contact the clinic if the patient experiences any adverse effects to the treatment. Any side effects should be recorded in the notes and the client referred to a doctor where necessary. Advice to patient Use the Yellow Card System to report adverse drug reactions directly to the Committee of Safety in Medicines (CSM). Yellow Cards and guidance on their use are available at the back of the BNF as well as on the MHRA website ( The Pharmacist should check that the client understands the reason for treatment and how the treatment should be taken. Swallow capsules whole on an empty stomach; advise no food for 1 hour after taking capsules. Warn of side effects such as gastro-intestinal upset and skin rash The manufacturer s patient information leaflet should be given. Offer verbal and written information on Chlamydia infection and its treatment. The importance of sexual partner(s) being evaluated and treated should be highlighted. The client should be advised to abstain from any sexual intercourse (including protected vaginal, anal and oral sex) whilst taking treatment and until partner(s) have completed treatment and waited 7 days following treatment with Azithromycin. Antacids The client should be advised to take the medication at least one hour before or two hours after food or antacids. Page 5 of 12

6 Combined oral contraceptive pills (or patches) Women on the combined pill should be advised according to the latest guidelines from the Faculty of Family Planning 2 The client should be advised to avoid sexual intercourse during treatment and for the 7 days following treatment. If abstinence from sexual intercourse can not be achieved, the patient should be strongly advised to use protection (condom) during the treatment and for 7 days after the antibiotic has been stopped. If fewer than 7 active pills are left in the pack after the antibiotic has been stopped, she should omit the pill-free interval (or discard any inactive pills). Similar advice applies to contraceptive patch users. 2 The FFPRHC CEU guidance Drug interactions with hormonal contraception April 2005 [reference 12] says that: a COC user taking a short course ( less than 3 weeks) of non-liver enzymeinducing antibiotics should be advised to use additional contraceptive protection, such as condoms, during the treatment and for 7 days after the antibiotic has been stopped. If fewer than seven active pills are left in the pack after antibiotics have stopped, she should omit the pill-free interval (or discard any inactive pills). Equivalent advice applies to contraceptive patch users but the efficacy of progestogen-only methods of contraception is not reduced by non-liver enzyme-inducing antibiotics and additional contraceptive protection is not required Page 6 of 12

7 Records and Follow Up Referral arrangements As per local arrangements / protocol and Avon Chlamydia Screening Programme Protocol Records/audit trail Record the consultation in line with the NMC Guidelines for records and record-keeping [reference 13] and the service protocol. Patient s name, address, date of birth and consent given Ensure that the documentation meets the service s requirements for audit trail. This should include the date of administration as well as the signature of the person supplying the azithromycin. Also record the batch number, expiry date and quantity of azithromycin supplied (see below). Diagnosis and suitability for treatment under PGD confirmed with Avon Chlamydia Screening Programme where not ascertained in full by staff operating under the PGD Azithromycin PGD followed Diagnosis Name of medicine Dose and form administered Date and time given Amount given Batch number if appropriate Expiry date Signature and name of health professional administering medicine Advice or warnings given to patient Details of any exclusion or refusal Referral arrangements (including self care) Details of any adverse drug reactions and actions taken Follow up As per local arrangements / protocol Incident Reporting Incidents need to be reported in accordance with NHS Bristol s incident reporting policy. Page 7 of 12

8 Reference to National/Local policy and guidelines 1. BNSSG Contraception & Sexual Health Services Guidelines Group 2005; Training and experience requirements for BNSSG Contraception & Sexual Health Services nurses prior to use of PGDs October Department of Health (DH), Review of Prescribing, Supply and Administration of Medicines. Final Report Department of Health (DH), Patient Group Directions (England only) (HSC) 2000/ Royal College of Nursing Patient Group Directions Guidance and information for nurses (publication code ) 5. NMC Code of Professional Conduct (2002) 6. NMC Guidelines for the Administration of Medicines (2002) 7. Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases) National Guideline on the Management of Non-gonococcal Urethritis Clinical Effectiveness Group (Association for Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases) National Guideline on the Management of Chlamydia trachomatis Genital Tract Infection Department of Health 2004, Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health. Gateway reference number July Faculty of Family Planning & Reproductive Healthcare 2005 Clinical Effectiveness Unit Guidance; The use of contraception outside the terms of the product licence July British National Formulary (BNF 58 September 2009) and Electronic Medicines Compendium accessed at on 05/01/ Faculty of Family Planning & Reproductive Healthcare 2005 Clinical Effectiveness Unit Guidance; Drug interactions with hormonal contraception April NMC Guidelines for records and record keeping (2002) Family Planning Association Leaflet on Chlamydia Page 8 of 12

9 This patient group direction must be agreed to and signed by all health care professionals involved in its use. The PGD must be easily accessible in the clinical setting Organisation NHS Bristol South Plaza Marlborough Street, Bristol, BS1 3NX Authorisation PCT Head of Medicines Management PCT Clinical Governance Lead Name: Sue Mulvenna Signature: Name: Dr Tony Fielding Signature: Name: Signature: Name: Signature: Date: Date: Date: Date: Page 9 of 12

10 Individual Authorisation I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own code of professional conduct. Note to Authorising Managers: Authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the authorisation sheet showing their authorisation. Name of Pharmacist Signature Authorising Manager Date Page 10 of 12

11 Azithromycin supply Pharmacist Record Sheet (This record should be kept for a minimum of 8 years if the client is believed to be over 16 and if they are believed to be under 16 the record should be kept until their 26 th birthday) Age and Date of Birth: Post code: CSP Number: Time: Day: Today s Date: Where did you hear about this service? : Pharmacy: Pharmacist s Name and registration number: Client s Name (Not essential): Current medication (inc herbal): Known allergies: Any C/I to Azithromycin: Current or past serious illness s are issued before this date.) 11of 12 pages

12 Fraser Guidelines This applies to clients who are believed to be less than 16 years of age. Discussion with the young person should explore the following issues at each consultation. This should be fully documented and should include an assessment of the young persons maturity. Fraser Guidelines Assessment Yes No Understands the advice given Encouraged to involve parents Adverse effect on the physical or mental health of the young person if advice or treatment withheld Action is in the best interests of the young person Is likely to continue with sexual activity without advice or treatment Counselling given Yes No Reason, administration information and side effects discussed Azithromycin taken on premises Importance of sexual partner(s) being evaluated/treated Interaction information if appropriate Advise to attend GP/ CaSH if adverse effects or other worries Information sheet and medication provided Other relevant notes: Action taken Inclusion: Batch number / expiry date of Azithromycin capsules provided: Patient Information Leaflet given (from Azithromycin pack) Yes No Dose supervised: Yes No Exclusion Referral Non Supply Reason Reason Reason The above information is correct to the best of my knowledge. I have been counselled on the use of Azithromycin and understand the advice given to me by the nurse/pharmacist. Client Signature: Date: The action specified was based upon the information given to me by the client, which, to the best of my knowledge, is correct. Pharmacist Signature: Date: Time taken to complete consultation minutes s are issued before this date.) 12of 12 pages