Approval of Patient Group Direction

Notice to all staff: NHS Hertfordshire, Patient Group Directions (PGDs) may only be used by members of the healthcare professions named on the title page and only if each professional has individually been listed by their manager as an authorised user, meeting the competency and training requirements of that PGD. Each healthcare professional using a PGD must also have signed a copy of that PGD and have one available to refer to. Staff must not download PGDs from the intranet and use them. The PGDs are only on the intranet so that clinical managers can access them when they need to authorise their team members or to check that their team is using the most recent version. Managers should also have signed the appropriate section of the PGD. Page 1 of 14

Patient Group Direction (PGD) Number 21 0113: Supply of Azithromycin tablets or capsules for the treatment of Uncomplicated Chlamydia Trachomatis infection By Registered Nurses Working within the Hertfordshire Chlamydia Screening Programme who are employed by NHS Hertfordshire or GP Practices in either Primary Approval of Patient Group Direction This Patient Group Direction has been approved on behalf of NHS Hertfordshire Ratifying NHS Hertfordshire Board Clinical Standards Committee Sub-committee Authorising Officer for NHS Hertfordshire Signature: Dr Michael Edwards Medical Director Date: 17.12.12. Date of Issue 1 st January 2013 Issue Number PGD 21 0113 Date of Review 1 st January 2015 NHS Hertfordshire is committed to being an organisation within which diversity, equality and human rights are valued. We will not discriminate either directly or indirectly and will not tolerate harassment or victimisation in relation to gender, marital status (including civil partnerships), gender reassignment, disability, race, age, sexual orientation, religion or belief, trade union membership, status as a fixed-term or part-time worker, socio-economic status and pregnancy or maternity leave status. Equality Impact Assessment (Level 1) completed Date: September 2012 This document is available electronically or in a larger font or alternative format on request. Page 2 of 14

Document History: To replace: Patient Group Direction (PGD) Number 21 0111: Supply of Azithromycin 250mg tablets or capsules for the treatment of Uncomplicated Chlamydia Trachomatis infection by Registered Nurses Working as part of the Hertfordshire Chlamydia Screening Service who are employed by NHS or GP Practices and signatories to the PGD Progress Lead Person & Contact Number Date PGD Precedent Dipesh Songara (01727 732283) January 2011 Updated draft Jo Jenkins (01279 827230) September 2012 Circulation List Dr K Uthayakumar, Lead Specialist for Sexual Health HCT September 2012 Carolyn Haselden, Lead Pharmacist HCT Heather Gray, Chief Pharmacist NHS Hertfordshire Elizabeth Fisher, Health Improvement Manager, NHS Hertfordshire Dr Mike Edwards, Medical Approved & Ratified by NHS Hertfordshire CSC Review Date Date of Archiving PGD 21 0111 Director NHS Hertfordshire Jo Wilson Lead Nurse, Hertfordshire Chlamydia Screening Programme Table of Contents Page Front Sheet 4 Clinical Condition or Situation to which the Direction Applies 5 Description of Treatment 6 Audit 9 Characteristics and qualification required of staff 10 References 10 Management/authorisation of Patient Group Direction 12 Page 3 of 14

Patient Group Direction (PGD) Number 21 0113: Supply of Azithromycin tablets or capsules for the treatment of Uncomplicated Chlamydia Trachomatis infection By Registered Nurses Working within the Hertfordshire Chlamydia Screening Programme who are Employed by NHS Hertfordshire or GP practices in the Primary Care Trust and signatories to the PGD Valid from: 1 st January 2013 Expiry (review) date: 1 st January 2015 After this date the direction is no longer valid. (Note: a review will be carried out sooner as a result of a critical incident, new safety or clinical information, changes in legislation or change in best practice.) Supersedes: Patient Group Direction (PGD) Number 21 0111: Supply of Azithromycin 250mg tablets or capsules for the treatment of Uncomplicated Chlamydia Trachomatis infection by Registered Nurses Working as part of the Hertfordshire Chlamydia Screening Service who are employed by NHS Hertfordshire and signatories to the PGD Development of Patient Group Direction This Patient Group Direction has been developed on behalf of NHS Hertfordshire by: Name Signature Date Lead Specialist Dr S Uthayakumar 18 th HCT Pharmacist Jo Jenkins 13 th Health Improvement Service Manager Elizabeth Fisher September 2012 November 2012 13. 11.2012 Page 4 of 14

1. Clinical condition or situation to which the direction applies: Indication Treatment of uncomplicated genital infections due to Chlamydia trachomatis Treatment of identified contact of an index client who has had a positive Chlamydia test Criteria for inclusion Informed client consent is obtained Clients aged 15-24 with laboratory evidence of Chlamydia trachomatis Identified contact of an index client who has had a positive Chlamydia test Clients at risk of re-infection as non-compliant with advice given with regards to avoidance of all sexual contact (see advice below) Clients aged 15 years and over (Clients under 16 years must be over 45kg body weight) Clients under 16 years must be assessed as competent using Frazer Guidelines Clients over the age of 24 if they are the identified sexual partner of the index client. To retreat clients who have vomited within 2 hours of taking original medication for the treatment of Chlamydia. Criteria for exclusion Client consent refused Patients with a known hypersensitivity to azithromycin or any of the macrolide or ketolide antibiotics, erythromycin or to any excipients thereof of tablet or capsule contents Patients with a known hypersensitivity to soya or peanut azithromycin tablets must be avoided. Pregnant or suspected pregnancy Breast-feeding Porphyria Hepatic impairment Renal impairment Patients at increased risk for prolonged cardiac repolarisation (predisposition to QT interval prolongation (including electrolyte disturbances, concomitant use of drugs that prolong QT interval). Client under 15 years of age Client aged under 16 years weighing less than 45 kg Client under 16 years who is felt not to be Fraser competent Clients over the age of 24 unless they are the identified sexual partner of the index patient. Male patient presenting with symptoms associated with complicated Chlamydia infection (acute testicular pain and/or swelling suspected epididymo-orchitis) Female patient presenting with symptoms associated with complicated Chlamydia infection (acute pelvic pain Page 5 of 14

suspected pelvic inflammatory disease) Patients with suspected re-infection Clients who are severely systemically unwell or with any serious illness Immunocompromised clients Patients with known Human Immunodeficiency Virus (HIV) infection Myasthenia Gravis Cautions/Need for further advice from a doctor Past history of cardiac arrhythmias Patients taking any of the following medication: o Ergot derivatives (including ergotamine and methysergide) o Ciclosporin o Digoxin o Nelfinavir o Coumarin-Type Oral Anticoagulants (e.g. warfarin) o Rifabutin o Reboxetine o Mizolastine o Artemether/ Lumefantrine o Ritonavir o Bromocriptine and Cabergoline o Droperidol o Colchicine o Disopyramide o Oral typhoid vaccine All other concurrent medication should be checked for interactions before supply under PGD (see appendix 1 of the British National Formulary (BNF) and the product s current Summary of Product (SPC) Characteristics) None Action if excluded Refer client to clinic doctor (if available), Genito Urinary Medicine (GUM), Sexual and Reproductive Health Service or their own GP Action if patient declines treatment Document reason(s) for exclusion and advice given Provide advice on Chlamydia Trachomatis infection and provide leaflet and make client aware of the importance of treatment Refer client to their own GP Document reason(s) for decline and advice given 2. Description of Treatment: Name, strength and formulation of drug or Azithromycin 500mg film coated tablets (as azithromycin monohydrate hemi-ethanolate) Azithromycin 250mg tablets (azithromycin (as monohydrate hemi-ethanolate) Page 6 of 14

or Azithromycin 250mg capsules (capsules contain azithromycin dehydrate equivalent to 250mg azithromycin) Legal status POM (prescription only medicine) Method / Route Oral Dose / Dose range 1g (2 x 500mg tablets) as a single dose or or 1 g (4 x 250mg tablets) as a single dose 1 g (4 x 250mg capsules) as a single dose (capsules should be swallowed whole at least 1 hour before or 2 hours after food (or on an empty stomach) Frequency of administration Single dose (Once during current episode by nurse prior to seeking medical advice) Quantity to be supplied Single dose (2 x 500mg tablets) or Single dose (4 x 250mg tablets) or Single dose (4 x 250mg capsules) Patient advice / Follow Also see Special considerations/ Additional information up treatment Screening, treatment, advice, follow-up and management of partner notification (contact tracing) should be in accordance with the Bedfordshire and Hertfordshire Chlamydia Screening Service, Standard Operational Procedures & Protocols Advice on Chlamydia Trachomatis infection and provide leaflets and contact cards Advice on treatment including indication, mode of action, efficacy, benefits and risks and how to take the medication Advice on possible adverse effects and drug interactions and when to seek medical advice Capsules should be swallowed whole at least 1 hour before or 2 hours after food and if relevant antacids Patient to be advised of where to obtain alternative treatment if vomiting occurs within 2 hours of taking medication Patient to be advised to abstain from sexual intercourse (no genital, oral or anal sex, even with a condom), until one week after both partners have been treated. If their partner(s) receive a one week course of treatment rather than single dose therapy then sexual intercourse should be avoided until the end of the course or if the partner(s) choose testing only until the partner(s) have a negative test Patient to be given sexual health promotion advice Warn of the risk of re-infection if has sexual contact with an untreated partner Manufacturer s written Patient Information Leaflet (PIL) should be given to the patient at the time of each supply available at www.medicines.org.uk Page 7 of 14

The patient should be advised to return as appropriate or refer client to Genito Urinary Medicine (GUM), Sexual and Reproductive Health Service or their own GP if they develop any symptoms, or they have not fully complied with treatment, or there has been a re-infection risk Advise re availability of full sexual health check and screening for other STIs at Genito Urinary Medicine (GUM) or Sexual and Reproductive Health Service clinics Advise patient on follow up care arrangements if required Emphasise importance and need for client s sexual partner(s) to be treated All patients identified with C. trachomatis should have partner notification discussed at time of treatment by a trained healthcare professional The method of partner notification agreed for each partner/contact identified should be documented, as should partner notification outcomes Attempt to contact other sexual partners within the last six months, or the most recent sexual partner if over six months All sexual partners should be offered, and encouraged to take up a full STI screen, including HIV test and if indicated hepatitis B screening +/- vaccination Initially inform Hertfordshire Chlamydia Screening Programme if the client develops any symptoms, or they have not fully complied with treatment, or there has been a re-infection risk Adverse Reactions and their Management Reporting procedure of Adverse Reactions Drug Interactions Azithromycin is generally well tolerated Very common adverse effects can include nausea, diarrhoea, wind, abdominal pain For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current British National Formulary (BNF) and the current Summary of Product (SPC) Characteristics All adverse reactions to be recorded in the patient s notes Any adverse outcomes should be notified to the clinic doctor. If in a clinic without a doctor, client should be advised on seeing a doctor at another clinic, or their GP, and the degree of urgency A letter detailing the problem should be given to the client to take with them Complete an incident form Appropriate suspected reactions should be reported to the Commission on Human Medicines via the Yellow Card system (copies of the yellow card are available at the back of the BNF or via (www.yellowcard.gov.uk) by the Nurse or the Doctor. State brand and batch number See inclusion/ exclusion criteria and special considerations/ Page 8 of 14

additional information Additional Facilities Following to be available at site where Patient Group Direction is operated: Azithromycin tablets or capsules, pregnancy testing kits, patient information leaflets and demonstration kits, current edition of the British National Formulary (BNF) Special Considerations / Additional Information Arrangements for handling, security, storage and labelling Records 3. Audit: For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current British National Formulary (BNF) and the current Summary of Product (SPC) Characteristics Store in a locked drug cupboard, in a dry place, at room temperature (below 25 C), away from direct sunlight (protect from light) All medicines supplied to a patient under PGD must comply with the EC labelling and leaflet directive, i.e. must be fully labelled and an appropriate Patient Information Leaflet (PIL) supplied In all cases records should be completed immediately, be clear, accurate, legible and include: Signature and printed name of nurse, date and time Patient s name, NHS number, address, date of birth/age and consent given If under 16 years old document Fraser ruling competent Contact details of GP (if registered) Details of assessment, discussions and treatment including name (brand as appropriate), route, dose, quantity supplied, date and time, batch number and expiry date Advice given to patient (including side effects and sexual health promotion advice) Details of any adverse drug reaction and actions taken including documentation in the patient s medical record Complete Appendix 1: Chlamydia Treatment Form for each index patient and partner treated and fax to Hertfordshire Chlamydia Screening Programme or scan and email to: enh-pct.hertschlamydiascreeningprogramme@nhs.net Stock Reconciliation Stock Storage Stock balances should be reconcilable with receipts, administration records and disposals on an individual patient basis. Product should be stored in accordance with the specifications of the PGD and Summary of Product Characteristics relating to the medication 4. Characteristics of Staff: Qualifications required Registered nurse with current Nursing & Midwifery Council (NMC) registration as an appropriate practitioner and employed by NHS Hertfordshire or a Hertfordshire GP Page 9 of 14

Practice Additional requirements Has undertaken appropriate training for working under PGDs for supply and administration of medicines Undertaken specific training relating to the Hertfordshire Chlamydia Screening Programme and the care and management of Chlamydia positive clients and their partners, and assessed as competent Training to ensure that nurses undertaking the Direction have a confident and clear understanding of the limits of the Patient Group Direction and when to refer The nurse should have had training for this Patient Group Direction, and have given written agreement to abide by it Evidenced up to date training in cardiopulmonary resuscitation skills (annually) and management of anaphylaxis (yearly) in line with the NHS Hertfordshire Mandatory Training Needs Framework Continued training Attend training dates as required and keep up to date with requirements changes The nurse is expected to ensure that he/she is up to date with the most current British National Formulary (BNF) and the most current Summary of Product Characteristics (SPC) guidance relating to the medication in the PGD The Registered Nurse must act at all times in accordance with the Nursing and Midwifery Council (NMC) code of professional conduct and Standards for medicines management, and must at all times acknowledge any limitations in their knowledge or competence. 5. References - National / Local Policies or Guidelines: 1. Current edition of the British National Formulary (BNF) Accessed September 2012 2. Most recent version of the Manufacturer s Summary of Product Characteristics (SPC) (www.emc.medicines.org.uk) Accessed September 2012 3. PGD 21 0111: Hertfordshire Chlamydia Screening Service: Azithromycin for the treatment of Uncomplicated Chlamydia Trachomatis infection: NHS Hertfordshire 4. National Chlamydia Screening Programme, Patient Group Direction for the administration of Azithromycin (Feb 2008) 5. The National Chlamydia Screening Programme in England, Core requirements, 5 th Edition (August 2010) 6. The British Association for Sexual Health and HIV (BASHH) Clinical Effectiveness Group Guidelines, National Guideline for the Management of Genital Tract Infection with Chlamydia trachomatis (http://www.bashh.org/documents/61/61.pdf) 7. Health Service Circular HSC 2000/026: Patient Group Directions (England only), 9 August 2000 8. NMC- The Code: Standards of conduct, performance and ethics for nurses and midwives (May 2008) 9. NMC- Standards for medicines management (Feb 2008) 10. Resuscitation Council (UK) Emergency Medical Treatment of Anaphylactic reactions by first medical responders and community nurses (updated January 2008) 11. Department of Health (6th April 2001) Reference Guide to Consent for Examination of Treatment. Crown copyright (ww.dh.gov.uk) Page 10 of 14

12. NHS Hertfordshire Consent Policy 13. National Chlamydia Screening Programme Chlamydia Connects. Issue 3 2012 Page 11 of 14

6. Management of Patient Group Direction number 21 0113: Authorisation of Lead Doctor/Lead Nurse or GP (on behalf of the practice) for the supply of this medication without a prescription by the named nurse(s) below I,., Lead Doctor/Lead Nurse or General Practitioner, give authorisation for the named nurse who has signed this Patient Group Direction to supply the above named medicine as described in this direction and in accordance with current guidelines Signed Date This Patient Group Direction is to be read, agreed to and signed by all registered nurses it applies to. One copy should be given to each nurse with the original signed copy being easily accessible within the practice/clinical setting. A fully signed copy of this page to be kept by the GP Practice/Lead Nurse. By completing the section below I confirm that I have read and understood the content of this Patient Group Direction and that I fulfil the criteria set out in the Characteristics of Staff section and I am willing, competent and authorised to work under it within my professional code of conduct. Name and designation of Authorised Nurse Signature of Authorised Nurse Date Page 12 of 14

Appendix 1 Patient Treatment Form Hertfordshire Chlamydia Screening Programme Apsley 1 Brindley Way Apsley Hemel Hempstead HP3 9BF Tel: 0800 007 5206 Fax: 01442 453070 (safe haven) PATIENT TREATMENT FORM TO BE RETURNED TO HERTS CHLAMYDIA SCREENING PROGRAMME VIA FAX WITHIN 48 HOURS OF TREATMENT THIS INFORMATION IS VITAL TO COMPLETE PATIENT RECORDS AND FOR PAYMENT UNDER THE LES Please Test & Treat Partners Date D.O.B Name Index/Contact (delete) Contact of Lab no/name Pregnancy Risk: Symptomatic Y/N Yes/No Lab No LMP Site Code Name of Prescriber Medication Given Azithromycin 1g stat Doxycycline 100mg BD 7/7 Erythromycin 500mg 14/7 Treatment Site Treatment is free under the programme. Please use the first line treatment of Azithromycin if no contraindications. No prescription is needed. NB Do not use Azithromycin or Doxycycline during pregnancy Medication Batch Number Medication Expiry Date Date Medication Administered If unable to treat under the PGD please contact Chlamydia Screening Health Advisors on 0800 007 5206 Did clients partner attend? (if applicable) Yes/No If yes please fill in a separate treatment form & return to Chlamydia Screening Health Advisors Page 13 of 14

Partner Name Partner D.O.B If no: Has partner been treated? Yes/No (delete as appropriate) Where were they treated With What Medication? Azithromycin/Doxycycline/Erythromycin PLEASE ADVISE NO SEXUAL CONTACT FOR 1 WEEK POST TREATMENT (2 WEEKS FOR ERYTHROMYCIN). THIS MUST ALSO TAKE INTO CONSIDERATION PARTNER TREATMENT. Signature Date Name (printed) If you have any queries please call Jackie Lamb - The Screening Support Officer on 0800 007 5206 Page 14 of 14