LONDON CONTRACEPTION AND SEXUAL HEALTH

PATIENT GROUP DIRECTION (PGD) TEMPLATE

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.

CONTENTS / PAGE NUMBER
PGD for the supply of azithromycin / 1-15
Staff Characteristics / 11-12
Authorisation and Signatures / 14
Individual authorisation to supply azithromycin using this PGD / 15
City & Hackney azithromycin PGD assessment pro-forma (appendix 1) / 16
Mental Capacity Act 2005 (appendix 2) / 17
AZITHROMYCIN 250 mg CAPSULES OR TABLETS or
AZITHROMYCIN 500 mg CAPSULES OR TABLETS
CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES /
  • Uncomplicated genital Chlamydia trachomatis infection

INCLUSION CRITERIA /
  • 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 15years 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
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
  • Interacting medicines – Check Appendix 1 of current British National Formulary (BNF)
  • Known allergy or hypersensitivity to macrolide antibiotics or any constituent of the medication

CAUTIONS/NEED FOR FURTHER ADVICE/ACTION TO BE TAKEN / Choice of therapy: the treatments in this PGD templateare written according to national guidance; however the pharmacist should also refer to thelocal 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.

ACTION IF EXCLUDED /
  • If allergic to azithromycin, consider doxycycline as a alternative treatment
  • Refer to sexual health services(including patient’s GP)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 /
  • 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
  • Record refusal by individual and/or by community pharmacist if individual does not meet the inclusion criteria

DRUG DETAILS
NAME, FORM & STRENGTH OF MEDICINE /
  • Azithromycin 250mgor 500 mg capsules or tablets

ROUTE/METHOD / Oral
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)
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 / 250mg capsules or tablets (x4)
or 500mgcapsules or tablets (x2)
DOSAGE/FREQUENCY / 1g as a single dose, ideally taken as directly observed therapy
DURATION OF TREATMENT / Single dose for immediate self administration
MAXIMUM OR MINIMUM TREATMENT PERIOD / Single dose for immediate self administration
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
  • The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so.

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 capsulesshould 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

FOLLOW UP /
  • Follow local protocolfor 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 toa 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

RECORDS / The authorised community pharmacist must ensure the following is documented in the individual’s medical record(see consultation proforma appendix):
  • 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 and the outcome
  • 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)

REFERENCES /
  • Manufacturers’ Summaries of Product Characteristics (SPC)
This list may not be comprehensive. This PGD does not restrict which brands can be supplied.
See or further information.
  • Azithromycin film coated tablets 250mg, Sandoz Limited
Last updated: 31.05.15 Accessed 27.10.15

  • Azithromycin film coated tablets 500mg, Sandoz Limited
Last updated: 06.08.13 Accessed 27.10.15

  • Azithromycin 250mg film-coated tablets. Actavis UK Ltd.
Last updated: 25.07.13 Accessed 27.10.15
(250mg)
  • Azithromycin 500mg film-coated tablets. Actavis UK Ltd.
Last updated: 25.07.13 Accessed 27.10.15

  • Clamelle tablets ® (Azithromycin 500mg). Actavis UK Ltd.
Last updated: 21.11.13 Accessed: 27.10.15

  • Zithromax 250 capsules ® (Azithromycin 250mg). Pfizer Limited
Last updated: January 2015 Accessed: 27.10.15

  • Joint Formulary Committee. British National Formulary (online)
London: BMJ Group and Pharmaceutical Press
Accessed via < on 15/02/15
  • National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2

See next page
References / 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)
  • British Association for Sexual Health and HIV (2013) Re-testing of young persons diagnosed with chlamydia infection

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
  • 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
  • Sexual health in pharmacies (CPPE 2015)
  • Safeguarding children and vulnerable adults
  • Consultation skills for pharmacy practice: taking a patient-centred approach
  • Chlamydia screening and treatment
  • Contraception
  • 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 the pharmacy providing this service
See next page
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
  • Responsibility to keep up to date with CPD and to take part in regular audit of supply of this medication
  • 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 by London Borough of Hackney Public Health Team.

Practitioners not listed are not authorised to practise under this PGD.

PGD DEVELOPMENT GROUP

Date PGD template comes into effect: / 26/11/2015
Review date / 26/05/2018 or earlier in the light of significant changes in best practice
Expiry date: / 26/11/2018

This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group:

NAME/ROLE / POSITION / DATE
Kathy French
Chair - Working Group / Project Lead
Independent Nurse Advisor SRHC, Project Lead / 25/11/2015
Angela Bussey
Advisor - Working Group / Principal Pharmacist Medicines Information Projects.
Guy’s and St Thomas’ NHS Foundation Trust. / 26/11/2015
Lead Medical Consultant
Dr Nneka Nwokolo / Consultant Physician GUM/HIV
Chelsea and Westminster NHS Hospital Foundation Trust / 25/11/2015
Lead Pharmacist
Josie Mansell / Community Health Services Pharmacist
Guy’s and St Thomas’ NHS Foundation Trust. / 25/11/2015
Lead Community Pharmacist
Reviewer
Shabbir Panju / Community Pharmacist
Chair Brent & Harrow LPC. / 25/11/2015
Specialist reviewers
Rosie Jackson / Head of Nursing - Women’s and Sexual Health, Lewisham and Greenwich NHS Trust
Marielle Perraut / 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.

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 / Dr Sarah Creighton, Homerton Sexual Health Services / / 01/09/2016
Senior pharmacist / Mr Viral Doshi MRPharmS, Consultant Pharmacist / / 26/08/2016
Person signing on behalf of authorising body / Dr Penny Bevan, Director of Public Health, London Borough of Hackney and City of London Corporation / / 01/09/2016

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 antimicrobialstewardship committee lead isinvolved 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.

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)

STANDING ORDER PATIENT GROUP DIRECTION FOR THE SUPPLY OF AZITHROMYCIN FOR THE TREATMENT OF UNCOMPLICATED GENITAL CHLAMYDIA TRACHOMATIS, BY AUTHORISED COMMUNITY PHARMACISTS WORKING IN CITY & HACKNEY