National Chlamydia Screening Programme September 2012 PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS

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1 PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS Below is a template that can be used to produce a local patient group direction (PGD) for the administration of Azithromycin in cases of uncomplicated Chlamydia trachomatis infection. The template can be used by any programme, but needs to be locally developed and endorsed before use. The template also covers the use of Azithromycin in pregnancy. Produced: February 2008 Last updated: September

2 Important note: This template PGD is for guidance only and must be locally developed and endorsed before use CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS Protocol Details Date comes into effect Date of expiry and review Staff characteristics Level One Registered Nurse with current Nursing and Midwifery Council licence to practice Currently working in Sexual Health Services Having undertaken specific training relating to care and management of chlamydia positive clients and their partners, and assessed as competent by the Chlamydia Screening Programme Coordinator, Lead Nurse or Practice Development Nurse (Sexual Health) Having undertaken specific training relating to working to PDG You must be authorised by name under the current version of this PGD before working under it Clinical details Indication Inclusion criteria Exclusion criteria Use in pregnancy or when the client is at risk of pregnancy Management of excluded patients Uncomplicated Chlamydia trachomatis infection Clients with laboratory evidence of Chlamydia trachomatis, including those with an equivocal result Identified contact of an index client who has had a positive Chlamydia test To re-treat clients who vomited within two hours of taking original medication for the treatment of Chlamydia Clients at risk of re-infection as non-compliant with advice given regarding avoidance of all sexual contact (see advice below) Clients under 16 years must be assessed as meeting Fraser criteria Client under 16 years who is felt not to meet Fraser criteria Client aged under 16 years weighing less than 45kg Any known adverse reaction to macrolide/ azalide antibiotics Any medicine known to interact with Azithromycin including drugs known to prolong QT interval (see current British National Formulary (BNF)) Complicated chlamydial infection in males e.g. epididymo-orchitis Complicated chlamydia infection in females e.g. pelvic inflammatory disease Breast feeding Porphyria Hepatic impairment Renal impairment Myasthenia Gravis Previous history of cardiac arrhythmia Azithromycin may be used when the client is at risk of pregnancy or has an established pregnancy, if the available alternative erythromycin 500mg bd for 14 days, is either not acceptable to the client or cannot be tolerated by the client; in line with guidelines from British Association for Sexual Health and HIV and World Health Organisation. Refer to health care professional as locally agreed. Document reason for referral. 2

3 Action for patients not wishing to receive care under this PGD Make client aware of the need for treatment, document refusal and refer to doctor. Description of treatment Name of medicine Azithromycin Formulation Capsule, tablet or oral suspension Route Oral Dosage 1g Duration of Stat (single dose) treatment Quantity of supply 4 x 250mg capsules or equivalent for tablets / suspension Legal status Available in a pharmacy without prescription, under the supervision of a pharmacist Special precautions in clients at risk of pregnancy or known to be pregnant Adverse effects Advice necessary Records to be kept If the client is at risk of pregnancy or known to be pregnant, she should be informed that Erythromycin 500mg twice daily for two weeks is the currently recommended option in the UK However, if the client is unable to tolerate the above, or feels she is unlikely to complete the two week course, the client can opt to take Azithromycin The client must be informed that although the use of Azithromycin in pregnancy is thought to be safe, there is limited research available and therefore it is not the preferred treatment Gain verbal consent for off-label use and document in notes Azithromycin is generally well tolerated However, adverse effects can include gastro-intestinal upset, skin rash, antibiotic associated colitis, candidiasis For infrequent side effects please see current BNF Swallow capsules whole on an empty stomach; advise no food for one hour after taking capsules If taking antacid for indigestion, advise to take Azithromycin capsules one hour before or two hours after the antacid Warn of risk of gastro-intestinal upset and skin rash Emphasise importance and need for client s sexual partner/s to be treated Recommend abstinence (see below) or if unacceptable advise additional contraceptive protection whilst taking the antibiotic and for a further seven days. No sexual intercourse (included protected and oral) whilst taking treatment and until partner(s) have completed treatment (and waited seven days if treated with Azithromycin) Provide leaflets on Chlamydia and Azithromycin for the patient Record in patient notes whether computer or paper based: 1. Drug name 2. Batch number 3. Expiry date 4. Total dose administered 5. Route and site of administration Note if off-label use Any advice or warnings given to patient Date and signature Ensure either the client s name or number and the date of supply is added to the medicine label Audit trail Documentation as per Trust Clinical Records Policy; ensure: Full history recorded Advise re availability of full sexual health check at Dept of GUM Contract tracing undertaken Documentation (manual or computerised) to enable immediate access to the details of individuals receiving this drug must exist. 3

4 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS Protocol owner Details of protocol owner Name: Contact address: Contact Telephone: Protocol Authorisation Lead Doctor Name: Lead Pharmacist Name: Organisational Name: authorisation by Peer reviewed by Name: Date Further Information NCSP Core Requirements: Patient Group Directions website: Medicines and Healthcare Products Regulatory Agency (MHRA): Brook. Consent to Medical Treatment (2006) BASHH Clinical Effectiveness Group (2010). Standards for the management of sexually transmitted infections. World Health Organisation (2005). STI and other reproductive tract infections a guide to essential practice Faculty of Sexual and Reproductive Healthcare - Interactions with hormonal contraceptives: 4

5 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS Individual Authorisation I have read and understood the Patient Group Direction (PGD) and agree to supply this medicine only in accordance with this PGD. Note: 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 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 Professional Signature Authorising Manager Signature Date 5