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LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS WORKING IN A COMMUNITY PHARMACY CONTRACTED BY [NAME OF LOCAL AUTHORITY] Version Number 2 Change History VERSION 2 New template. Updated SPC/BNF/NICE and other references Amendments in line with BASHH guidelines (2015) Organisations Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD. Community pharmacists Each community pharmacist using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and the governance lead on behalf of the authorising organisation to ensure this document meets legal requirements of a PGD This PGD must only be used by registered community pharmacists who have been named and authorised to do so. This will be a locally agreed arrangement between the commissioner and the provider. The most recent and in date final signed version of the PGD must be used. Pharmacists are responsible and accountable for ensuring that they work under the relevant PGD and correct Service Specification applicable to the area, and commissioner, where they are working. Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 1 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS TABLE OF CONTENTS CONTENTS PGD for the supply of azithromycin PAGE NUMBER 1-15 Staff Characteristics 11-12 Authorisation and Signatures To be added by approving organisation Individual authorisation to supply azithromycin using this PGD To be added by approving organisation Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 2 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS AZITHROMYCIN 250 mg CAPSULES OR TABLETS or AZITHROMYCIN 500 mg CAPSULES OR TABLETS CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES INCLUSION CRITERIA Uncomplicated genital Chlamydia trachomatis infection Individuals with a definite or equivocal diagnosis of Chlamydia trachomatis Sexual contacts of individuals with chlamydia evidenced by contact slip, text message or other written confirmation Re-treatment of individual who has had sexual intercourse within 7 days of receiving treatment for the above condition in the same pharmacy or who has had sex with a partner untreated for the above condition Re-treatment of an individual who has been treated with azithromycin in the same pharmacy for the above indications but has vomited the dose within 3 hours of taking the medication EXCLUSION CRITERIA (I.E. SITUATIONS NOT COVERED BY THE PGD) Personal Characteristics Individuals aged under 15 years of age Individuals aged under 16 years who are assessed as not competent using Fraser Guidelines Individuals aged 16 years of age and over and not competent to consent Individual known to have co-existing untreated gonorrhoea and chlamydia Medical history Males with epididymitis and testicular pain Males with dysuria and urethral discharge Females with pelvic pain or symptoms of Pelvic Inflammatory Disease (PID) Severe hepatic impairment Severe renal impairment Current/past history of cardiac rhythm or conduction disturbance Presence of concomitant conjunctivitis and/or joint pain/swelling Acute porphyria See next page Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 3 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS EXCLUSION CRITERIA (I.E. SITUATIONS NOT COVERED BY THE PGD) Continued from previous page Medical history Myasthenia gravis Known or suspected pregnancy Breastfeeding Medication history CAUTIONS/NEED FOR FURTHER ADVICE/ACTION TO BE TAKEN ACTION IF EXCLUDED Choice of therapy: the treatments in this PGD template are written according to national guidance; however the pharmacist should also refer to the local formulary or other local supporting guidance for selection of the most appropriate preparation. Some brands of azithromycin contain soya or soya lecithin and are therefore contraindicated in individuals with an allergy to soya or peanuts. If individual is allergic, check manufacturer’s information for brand being used and if necessary, exclude from PGD or select an alternative suitable brand if available. If allergic to azithromycin, consider doxycycline as a alternative treatment Refer to sexual health services as soon as possible with information about further options Explain reasons for exclusions with individual and refer to appropriate services For young people, consider if safeguarding action is needed Document all actions taken in the relevant patient record ACTION IF PATIENT DECLINES TREATMENT Interacting medicines – Check Appendix 1 of current British National Formulary (BNF) Known allergy or hypersensitivity to macrolide antibiotics or any constituent of the medication Make individual aware of the need for treatment and refer to relevant sexual health provider/GP/urgent care Record the refusal in the relevant patient record Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 4 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS DRUG DETAILS NAME, FORM & STRENGTH OF MEDICINE ROUTE/METHOD LEGAL CATEGORY Prescription Only Medicine (POM) USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION Best practice advice given by the British Association for Sexual Health and HIV (BASHH) is used for guidance in this PGD template and may vary from the Summary of Product Characteristics (SPC) Azithromycin 250 mg or 500 mg capsules or tablets Oral Children under 16 years or under 45kg weight No brand of azithromycin tablets or capsules is licensed for use in those aged under 16 years and/or weighing under 45 kg. This unlicensed use is supported by the BNF for Children (BNFC) which states that children aged 12 to 18 years of age may receive a single dose of 1g azithromycin. Individuals must be informed that the medicine is being given outside the terms of the SPC and given the option of seeing a doctor/ independent non-medical prescriber. QUANTITY 250 mg capsules or tablets (x4) or 500 mg capsules or tablets (x2) DOSAGE/FREQUENCY 1g as a single dose, ideally taken as directly observed therapy DURATION OF TREATMENT MAXIMUM OR MINIMUM TREATMENT PERIOD Single dose for immediate self administration Single dose for immediate self administration Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 5 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS SIDE EFFECTS Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines. Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for further information. This list may not represent all reported side effects of this medicine. Common Nausea Vomiting Diarrhoea Anorexia, Dyspepsia Less common Dizziness Headache, Drowsiness Abdominal discomfort (pain/cramps) Rare Allergic reactions including angioneurotic oedema Photosensitivity Arthralgia Hepatitis and cholestatic jaundice Interstitial nephritis and renal failure Constipation Paraesthesia Tinnitus Insomnia Syncope Convulsions and taste disturbances In the event of untoward or unexpected adverse reactions: If necessary seek appropriate emergency advice and assistance Document in the individual’s clinical record and inform appropriate doctor/independent nurse prescriber Complete incident procedure if adverse reaction is severe (refer to local organisational policy) Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA). Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at www.yellowcard.mhra.gov.uk. The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so. Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 6 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS ADVICE TO INDIVIDUAL Provide Manufacturer’s Patient Information (PIL) and discuss Verbal and written information on Chlamydia trachomatis Explain mode of action, side effects, and benefits of the medicine Azithromycin tablets can be taken at any time in relation to food but there should be a gap between taking the tablets and antacids Azithromycin capsules should be taken one hour before or two hours after food or antacids If vomiting occurs within 3 hours of taking capsules/tablets offer option of repeat dose of azithromycin (under PGD) or refer to sexual health service provider Abstain completely from sexual contact (even with a condom) for 7 days after treatment and for 7 days after partner(s) treated Warn that if sexual contact takes place after treatment with an un-treated partner there is a risk of re-infection. Discuss implications of incomplete/untreated infection of self or partner Ensure partner notification has taken place and document. Offer condoms and advice on safer sex practices and possible need for testing for sexually transmitted infections (STIs) Ensure the individual has contact details of local contraceptive /sexual health services Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 7 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS FOLLOW UP RECORDS Follow local protocol for chlamydia follow up and partner notification Individuals with chlamydia who have not had a full STI screen (or who did not have chlamydia diagnosed in a sexual health clinic) should be referred to a sexual health clinic for a full STI screen Individuals age under 25 years should be offered a repeat chlamydia test 3 to 6 months after treatment because of the high risk of re-infection The authorised community pharmacist must ensure the following is documented in the individual’s medical record: Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Individual’s name, address and date of birth GP contact details if registered Attendance date Reason for attendance Relevant past and present medical history, including drug history Any known allergy The consent of the individual If individual is under 15 years of age, record action taken If individual is under 16 years of age document competency using Fraser guidelines If individual is aged 16 years of age and older and not competent to consent, record action taken. Relevant symptoms (where appropriate) Inclusion or exclusion from PGD A statement that supply or administration is by using a PGD Advice given about the medication including side effects, benefits, and when and what to do if any concerns Details of any adverse drug reactions and what action taken Any administration outside the terms of the marketing authorisation Record the name/brand, dose of the medication and quantity supplied Record batch number and expiry date according to local policy or national guidelines Any referral arrangements Record follow up and/or signposting arrangements Any other relevant information that was provided to the individual Name and signature (which may be an electronic signature) of the community pharmacist supplying the medicine) Expiry date: 26/11/2018 Reference Number : Page 8 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS REFERENCES Manufacturers’ Summaries of Product Characteristics (SPC) This list may not be comprehensive. This PGD does not restrict which brands can be supplied. See http://www.mhra.gov.uk/spc-pil/ or http://www.medicines.org.uk for further information. Azithromycin film coated tablets 250mg, Sandoz Limited Last updated: 31.05.15 Accessed 27.10.15 https://www.medicines.org.uk/emc/medicine/26131 Azithromycin film coated tablets 500mg, Sandoz Limited Last updated: 06.08.13 Accessed 27.10.15 https://www.medicines.org.uk/emc/medicine/21720 Azithromycin 250mg film-coated tablets. Actavis UK Ltd. Last updated: 25.07.13 Accessed 27.10.15 https://www.medicines.org.uk/emc/medicine/27825 (250mg) Azithromycin 500mg film-coated tablets. Actavis UK Ltd. Last updated: 25.07.13 Accessed 27.10.15 https://www.medicines.org.uk/emc/medicine/27576 Clamelle tablets ® (Azithromycin 500mg). Actavis UK Ltd. Last updated: 21.11.13 Accessed: 27.10.15 https://www.medicines.org.uk/emc/medicine/24273 Zithromax 250 capsules ® (Azithromycin 250mg). Pfizer Limited Last updated: January 2015 Accessed: 27.10.15 https://www.medicines.org.uk/emc/medicine/1477 Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed via <http://www.medicinescomplete.com> on 15/02/15 National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2 http://www.nice.org.uk/guidance/MPG2 See next page Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 9 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS References Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Continued from previous page British Association for Sexual Health and HIV (BASHH) (2015) UK National guideline for the management of infection with Chlamydia trachomatis (2015) http://www.bashh.org/documents/2015_UK_guideline_for_th e_management_of__Chlamydia_trachomatis_final_12....pdf British Association for Sexual Health and HIV (2013) Retesting of young persons diagnosed with chlamydia infection http://www.bashh.org/documents/Retesting%20of%20young %20peoplediagnosed%20with%20chlamydia%20(Sep%202 013).pdf Expiry date: 26/11/2018 Reference Number : Page 10 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS STAFF CHARACTERISTICS The named community pharmacist authorised to supply and/or administer medications under the PGD must meet the following criteria: THE COMMUNITY PHARMACIST MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT Registration The community pharmacist must be registered with the General Pharmaceutical Council (GPhC) or Pharmaceutical Society of Northern Ireland (PSNI) Specialist qualifications and competencies Has successfully completed the CPPE PGD e-learning programme or can provide evidence that they have achieved the competency levels specified in NICE Competency Framework for Health Professionals using Patient Group Directions http://www.nice.uk/mpc/goodpracticeguidance/GPG2.jsp Has had the training which enables them to make a clinical assessment in order to establish the sexual health need and supply the medicine according to this PGD Can satisfy the requirements of self-declaration of qualifications and competence to deliver sexual health services according to the CPPE Programmes for o Sexual health in pharmacies (CPPE 2015) o Safeguarding children and vulnerable adults o Consultation skills for pharmacy practice: taking a patient-centred approach o Chlamydia screening and treatment o Contraception o Emergency contraception (2015) or Can provide evidence of competencies achieved through other local training which delivers the equivalent knowledge. Pharmacists must ensure that the pharmacy where they are providing the service is contracted for this service Have a current contract of employment with (insert name of organisation here) See next page Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 11 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS STAFF CHARACTERISTICS The named community pharmacist authorised to supply and/or administer medications under the PGD must meet the following criteria: Continued from previous page Maintenance of competencies Has demonstrated that they are competent to provide the service The pharmacist should be aware of any changes to the recommendations for this medication Is familiar with current BASHH guidelines on Chlamydia trachomatis An up to date list and signatures of registered community pharmacists who are authorised to practise under this PGD is kept in by Practitioners not listed are not authorised to practise under this PGD. Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 12 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS PGD DEVELOPMENT GROUP Date PGD template comes into effect: Review date 26/11/2015 26/05/2018 or earlier in the light of significant changes in best practice 26/11/2018 Expiry date: This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group: NAME/ROLE Kathy French Chair - Working Group Angela Bussey Advisor - Working Group POSITION DATE Project Lead Independent Nurse Advisor SRHC, Project Lead 25/11/2015 Principal Pharmacist Medicines Information Projects. Guy’s and St Thomas’ NHS Foundation Trust. 26/11/2015 Lead Medical Consultant Dr Nneka Nwokolo 25/11/2015 Consultant Physician GUM/HIV Chelsea and Westminster NHS Hospital Foundation Trust Lead Pharmacist Josie Mansell Community Health Services 25/11/2015 Pharmacist Guy’s and St Thomas’ NHS Foundation Trust. Lead Community Pharmacist Reviewer Community Pharmacist Chair Brent & Harrow LPC. 25/11/2015 Shabbir Panju Specialist reviewers Rosie Jackson Marielle Perraut Head of Nursing - Women’s and Sexual Health, Lewisham and Greenwich NHS Trust Matron, Sexual and Reproductive Health, Guy’s and St Thomas’ NHS Foundation Trust The PGD template is not legally valid until it has had the relevant organisational approval. See next page. Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 13 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS This page may be deleted if replaced with a format agreed according to local PGD policy with relevant approvals and authorisation. The PGD is not legally valid until it has had the relevant organisational authorisations. To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the person signing on behalf of the authorising organisation. You may either complete details below or delete and use a format agreed according to local PGD policy which complies with PGD legislation and NICE MPG2 PGD 2013. Name Job title and organisation Signature Date Senior doctor Senior pharmacist Senior representative of professional group using the PGD e.g. Lead Community pharmacist (Optional but best practice) Lead Specialist Reviewer e.g. microbiology* if relevant Person signing on behalf of authorising body E.g. Director of Public Health on behalf of a local authority or clinical governance lead on behalf of an NHS Trust. Whilst this PGD is written according to national guidance such as BASHH, NICE PGD Guidelines recommend that each organisation ensures that a local antimicrobial specialist or antimicrobial stewardship committee lead is involved in its approval and local adoption It is the responsibility of the authorising organisation to ensure that all legal and governance requirements for authorising the PGD. It is the responsibility of the provider organisation to ensure that all legal and governance requirements for using the PGD are met. To meet legal requirements, authorising organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement. See next page Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 14 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS BY COMMUNITY PHARMACISTS 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 the General Pharmaceutical Council, Standards of Conduct Ethics and Performance. Individual practitioners must declare that they have read and understood the Patient Group Direction and agree to supply/administer medicines listed only in accordance with the PGD. Pharmacists are responsible and accountable for ensuring that they work under the relevant PGD and correct Service Specification applicable to the area, and commissioner, where they are working. (See page one) Version No: 2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 26/11/2018 Reference Number : Page 15 of 15