Pharmacist Training

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					 Pharmacist Training




 British Association for       College of      National Pharmacy
Sexual Health and HIV      Pharmacy Practice       Association
Contents

 Foreword                                                                             3

 Preface – introduction to the training guide                                         4


 Aims and objectives of training                                                      5

 1. Introduction                                                                      6

 2. About chlamydia                                                                   8

 3. Clamelle chlamydia service pharmacy model                                        10
   Stage 1    Clamelle Chlamydia Test Kit                                            10
   Stage 2    One to one sexual health consultation                                  14
   Stage 3    Eligibility for Clamelle Azithromycin 500mg Tablets                    16
   Stage 4    Supply of Clamelle Tablets                                             17
   Stage 5    Signposting to NHS sexual health service providers                     19
   Stage 6    Record keeping for sale of Clamelle Tablets                            21

 4. Antibiotic resistance                                                            22

 5. Continuing professional development (CPD) elements                               22


 Appendices
 Appendix 1   Testing service registration and set up procedures                     25
 Appendix 2   SmPC                                                                   26
 Appendix 3   Communication and behavioural skills for the sexual health consultation 28
 Appendix 4   NHS services and NHS individuals proforma                              30
 Appendix 5   Clamelle patient questionnaire                                         33
 Appendix 6   Signposting template and local key contacts                            35
 Appendix 7   Resources                                                              37
 Appendix 8   Frequently asked questions (FAQs)                                      38
Foreword


           Simon Barton, Clinical Director of Genitourinary and HIV Medicine,
           Chelsea and Westminster Hospital:

           “Improving sexual health is a public health priority. Alongside specific national efforts to
            increase education, deliver effective prevention strategies and offer better access to
            sexual health clinics, the aim to increase screening and treatment for chlamydial infection
            is a major goal.


           “Pharmacists are well placed to develop their role as part of this sexual health initiative.
            They already provide condoms, contraception and advice and are readily accessible across
            opening hours. This training programme is designed to enable pharmacists to develop their
            role in chlamydia testing and provision of treatment with Clamelle Azithromycin 500mg Tablets
            and to establish strong links with their local sexual health network. We hope that this practical
            project will lead to closer liaison with local GUM clinics and sexual health providers and
            enable further initiatives and projects to develop.”



           Colette McCreedy, Chief Pharmacist and Director of Practice,
           National Pharmacy Association:

           “The reclassification of azithromycin for the treatment of chlamydia is both an exciting and
            challenging opportunity for pharmacists. It is also, in my opinion, a mark of recognition of
            our role as trusted healthcare professionals in the community. The Prescription Only Medicine
            to Pharmacy (POM to P) switch is also unique in that it combines the supply function with
            a public health intervention and a diagnostic test, effectively giving us the opportunity to
            provide a clinical service outside the NHS – a very interesting development for community
            pharmacy.


           “This training programme has been carefully designed to help pharmacists meet their
            CPD needs for this new service, ensuring they have the relevant clinical and sexual health
            knowledge as well as an understanding of where the service fits in relation to NHS sexual
            health services. It will equip pharmacists to provide a first class service which will demonstrate
            further the value of community pharmacists as healthcare providers.”




                                                                                                                 3
    Preface
    introduction to the training guide
    Clamelle Chlamydia Test Kit and Clamelle Azithromycin 500mg Tablets –
    a complete professional service

    The Clamelle chlamydia service is a private service that           up the Clamelle chlamydia testing service. The NPA will also
    is paid for by the customer. It consists of two components:        provide details of how tests and results will be managed by
                                                                       the partner laboratory GLG. Each pharmacy must register
    • Clamelle Chlamydia Test Kit – tests are bought from the          with the NPA and complete the set up requirements in the
      pharmacy, posted off by the customer to the laboratory           NPA resource pack before they can sell Clamelle Chlamydia
      and results available to the pharmacy                            Test Kits and Tablets. Set up details and subscription
                                                                       information for the service are provided in the Appendix 1.
    • Clamelle Azithromycin 500mg Tablets – OTC
      treatment supplied after a confirmed positive test
                                                                       Getting started:
      and if appropriate to the individual (using a customer
                                                                       • Register with NPA and order the NPA Chlamydia
      questionnaire).
                                                                         Resource Pack
                                                                       • Ensure you have Internet access – broadband is the best
    The Clamelle Chlamydia Test Kit and Tablets can only be
                                                                       • Complete set up procedures in NPA Chlamydia Resource
    sold by pharmacies that are registered on the Clamelle
                                                                         Pack
    chlamydia service. The Clamelle chlamydia service is run
                                                                       • Complete Clamelle training
    jointly by Actavis, the National Pharmacy Association (NPA),
                                                                       • Order Clamelle Chlamydia Test Kits and Tablets.
    which manages registrations, and Gordon Laboratory
    Group (GLG), an accredited private laboratory which
    carries out the testing, manages the test results and the            Important note: The necessary set up procedures
    customer database.                                                   outlined in the NPA Chlamydia Resource Pack
                                                                         must first have been completed by pharmacies,
    The NPA is involved with registration of pharmacies with             before commencing the Clamelle training
    the testing laboratory as well as the provision of a resource        that follows.
    pack and standard operating procedure (SOP) for setting




       Why azithromycin reclassification differs to previous POM to P switches

       The reclassification of azithromycin for the treatment of chlamydial infection is the first of its kind for pharmacy,
       for the following reasons:

       • The drug treats a sexually transmitted infection (STI) – chlamydia is a significant communicable disease and is
          associated with significant complications; the reduction in infection is a major public health target

       • The switch is linked directly to a professional service – the Clamelle chlamydia service involves the
          Clamelle Chlamydia Test Kit and Tablets – and is not just about the treatment. The treatment can only
          be supplied by pharmacies that are enrolled for the Clamelle chlamydia testing service

       • The pharmacist is required to conduct a one to one sexual health consultation with the individual when
          supplying Clamelle treatment, giving important sexual health advice and providing information about local
          specialist sexual health venues

       • It is the first POM to P where an accredited laboratory test is required to confirm diagnosis before treatment is supplied

                                                                              .
       • Azithromycin is the first oral antibiotic to be switched from POM to P




4
Aims and objectives of training
Overall aim of training

To enable the pharmacy to offer a chlamydia treatment service, which involves raising awareness of the infection,
providing testing kits, appropriately managing the supply of Clamelle Azithromycin 500mg Tablets and signposting to NHS
sexual heath venues when appropriate.


                                                              Competencies

   Learning objectives                                        This training guide will help pharmacist to meet the following
                                                              CPD competencies. The College of Pharmacy Practice has
   • Update knowledge of Chlamydia trachomatis,               accredited this training in line with these competencies.
     its diagnosis, and public health significance
                                                               G1a Using expert knowledge and skills to benefit patients
   • Understand the impact of chlamydia (and the
     consequences of not treating individuals and              G1c Giving informed and accurate pharmaceutical advice
     their sexual partners) to the individuals
                                                               G1d Taking a patient-centred approach
     themselves and also to community public health
                                                               G1v      Signposting to other services
   • Understand the importance of the associated
     risk of other STIs and how to access testing and          G1w Taking on new roles or responsibilities
     treatment for other STIs in the local area                G2o Responding to requests for advice or information
   • Gain an overview of the current sexual health             C1a      Assessing the medication needs of patients
     services for managing chlamydia
                                                               C1f      Providing advice and counselling
   • Provide the required sexual health counselling
                                                               C2a Providing information to promote public health and
     and necessary signposting to local NHS sexual
                                                                        prevent disease
     health venues
                                                               C3       Addressing the health and medication needs of
   • Identify ways to develop relationships with local
                                                                        specific client groups
     sexual health providers

   • Understand this reclassified product and                 This training can help meet the CPD requirements as
     associated service provision in the context of           stipulated by the RPSGB. For training to be effective, refer
     existing services for STIs                               to the CPD cycle (reflection on practice, planning, action,
                                                              evaluation) and use your learning to make an entry on
   • Supply Clamelle Azithromycin 500mg Tablets
                                                              your official CPD records (www.uptodate.org).
     appropriately

   • Recognise pharmacy’s contribution to helping             This training has been produced in consultation with:
     patients with chlamydia testing and treatment            • Simon Barton, Clinical Director of Genitourinary and HIV
     and its wider role in sexual health                        Medicine, Chelsea and Westminster Hospital
                                                              • Alan Tang, Consultant in Genitourinary Medicine,
                                                                Royal Berkshire Hospital, Reading.


  The training is accredited by the College of Pharmacy Practice
  (CPP) and the British Association for Sexual Health and HIV (BASHH)
  and has been awarded the National Pharmacy Association (NPA)
  Training Seal.




                                                                                                                               5
    1. Introduction
    Chlamydia is the most common sexually transmitted bacterial infection in the UK1, 2 with more than 123,000
    new infections diagnosed each year through genitourinary medicine (GUM) clinics and the National
    Chlamydia Screening Programme (NCSP) combined.3, 4 However, this is just the tip of the iceberg as most
    people who are infected (up to 70%) are asymptomatic 1,5 and they can remain undiagnosed and untreated.
    Both men and women are at risk of serious long-term complications, including infertility. Moreover, they may
    unwittingly be passing the infection on to their partners. As a result, the annual cost to the NHS of chlamydia
    and its consequences is estimated to be around £100million.6

    The POM to P switch of azithromycin (Clamelle) and its availability with the Clamelle Chlamydia Test Kit, as part of the
    Clamelle chlamydia service through pharmacy, will give people with asymptomatic chlamydial infection, and their partners,
    rapid and more convenient access to a chlamydia test and treatment. This accessibility means pharmacy can contribute
    to helping the Government achieve its sexual health targets and fulfil its wider public health agenda in minimising the
    spread of infection in the community and long-term consequences to individuals.


                                                         Clamelle and existing NHS chlamydia services

                                                         The Clamelle chlamydia service – consisting of Clamelle Chlamydia Test
                                                         Kit and Clamelle Tablets – is a private service that will sit alongside
                                                         existing NHS services. These include:

                                                         • GUM clinics

                                                         • NCSP in England – for under 25-year-olds (and their partners
                                                           of any age)

                                                         • Community sexual health clinics (e.g. community contraceptive
                                                           clinics, young people’s clinics)

      Who is likely to access the                        • GP surgeries
      private Clamelle chlamydia
                                                         • Terence Higgins Trust (THT) and Brook are commissioned by some
      service from the pharmacy?
                                                           Primary Care Organisations (PCOs) to provide STI services.

      • Anyone who is sexually active, particularly
                                                         See Appendix 4 for further details on NHS chlamydia services.
         if they have had unprotected sex (of any
         kind) and are worried they may have a
         chlamydial infection

      • Those considering starting a family                 Barriers to accessing NHS service
         and want to ensure they have no
         chlamydial infection that could affect             • Not necessarily conveniently sited
         their fertility
                                                            • Opening times do not always fit in with individuals’ commitments
      • Couples who perceive there has been
                                                            • Public perceptions of sexual health services may be misleading.
         failure or delay in conception (see
         Section 5 CPD elements)                            For people wanting to access tests and treatment for chlamydia,
                                                            the pharmacy will therefore offer an alternative choice of access
      • Men and women 16 years and over
                                                            to treatment.
         who want advice on maintaining
         health, sexual enjoyment and fertility.




6
Why get involved?                                                  3. Developing new commissioned services
                                                                      from your PCO
The availability of the Clamelle chlamydia service provides
                                                                   • Strengthens pharmacists’ position in getting involved in
new professional and business opportunities for pharmacy:
                                                                     commissioned services in the PCO

1. Providing an alternative choice for chlamydia                   • Helps pharmacists to develop into a Pharmacist with a
   services                                                          Special Interest – organisations such as the British
                                                                     Association for Sexual Health and HIV (www.BASHH.org),
• Accessible and discreet environment with fast and
                                                                     as well as local GU clinicians can help pharmacists in
  easy access to the service without the need for
                                                                     developing these skills.
  an appointment

• The pharmacy venue may also encourage more partners              4. Increased profile in the community
  to access chlamydia testing and treatment
                                                                   • Increases range of OTC medicines for sale
• Encourages asymptomatic people to test for the infection
                                                                   • Link sales of products from the pharmacy’s other
• Making azithromycin available OTC means pharmacists                sexual health categories and services, e.g. emergency
  can recommend a clinically proven treatment that is                hormonal contraception, supply of condoms, pregnancy
  prescribed routinely for chlamydial infection through the NHS.     testing, fertility aids such as ovulation kits

                                                                   • Increased customer access.
2. Fulfilling the pharmacy contract

• Helps fulfil a number of obligations under the pharmacy
  contract

• Reinforces the pharmacy’s health promotion role in
  sexual health and gives the pharmacy a practical tool in
  managing an STI in the community

• Adds to the pharmacy’s existing diagnostic range
  of screening services.




   Role of support staff

   Since pharmacy support staff will not be involved in the         • Direct the individual to the consultation area
   consultation process or in supplying treatment, their role         for privacy and give them the Clamelle patient
   in the management of chlamydia could be to:                        questionnaire to complete, while waiting for
                                                                      pharmacist
   • Help raise awareness of the infection through
     pharmacy campaigns, displays and leaflets                      • Reinforce the message that the pharmacy is a place
                                                                      to visit for sexual health advice
   • Raise awareness to the availability of the Clamelle
     Chlamydia Test Kit (you may wish to place test kits next       • Advise customers in other areas related to sexual
     to family planning products)                                     health, e.g. contraception, pregnancy, prevention
                                                                      of STIs.
   • Provide Clamelle Chlamydia Test Kits for purchase in
     conjunction with the pharmacist
                                                                    It is up to the pharmacist of each pharmacy to determine
   • Raise awareness of the availability of OTC treatment           the roles and responsibilities of staff and the extent of
     (Clamelle) if there is a positive test result                  their involvement in the service, depending on their level
   • Pass enquiries and potential customers to the                  of competence. For more information see the Clamelle
     pharmacist                                                     Support Staff Training pack.




                                                                                                                                 7
    2. About chlamydia
    Genital chlamydial infection, caused by the bacterium Chlamydia trachomatis, affects both men and women
    and is the most common curable STI in the UK.1 The bacteria are found in the semen and vaginal fluids of
    infected individuals and can infect the cervix, the urethra and the rectum.

    The most significant feature of chlamydia is that most infections are asymptomatic, which means individuals may be
    inadvertently passing on the infection to partners without their knowledge.



    Transmission                                                    Symptoms

    Chlamydia may be transmitted through unprotected                Chlamydia is a “silent
    vaginal, anal and oral sex or genital contact with an           infection” because it is
    infected sexual partner or sex toy. Chlamydia can also be       largely asymptomatic;
    passed from a mother to her baby during pregnancy and           around 70% of women
    childbirth and this can result in complications for the baby    and 50% of men
    (see Complications).                                            do not experience any
                                                                    symptoms of infection.1 Only asymptomatic individuals are
                                                                    suitable for Clamelle Azithromycin 500mg Tablets; those with
    Risk factors                                                    symptoms (see below) are not suitable for OTC treatment
                                                                    and should be referred to a local NHS sexual health venue
    Anyone who is sexually active is at risk of infection,                    .
                                                                    or their GP Symptomatic individuals are at a greater risk of
    but in particular:                                              serious complications.

    • People under 25 years of age1

    • People 25 years or more who have a new sexual partner
      or with two or more sexual partners in the past year.1            Chlamydia symptoms

    The lack of barrier protection and having multiple partners
                                                                        Women
    increases the risk of getting chlamydia.
                                                                        May include:
                                                                        • Pain when passing urine
    Prevalence                                                          • Bleeding between periods
                                                                        • Unusual vaginal discharge
    The overall prevalence in the UK is unclear, since a large
                                                                        • Bleeding after sex
    number of infected people are asymptomatic and therefore
    undiagnosed. However, chlamydia diagnosis has risen by more         • Pain when having sex
                                     7,8
    than 300% since the mid-1990s , partly because of greater           • Any unexpected pain below the belly button
    awareness among the public and healthcare professionals.             (indicating lower abdominal pain and pelvic pain).
    Now more than 123,000 new infections are diagnosed
    each year through GUM clinics and the NCSP combined.3,4             Men
                                                                        May include:
    The infection rate is highest in men and women under
                                                                        • Discharge from penis
    25 years of age; 1 in 10 people who are tested have a
                                                                        • Pain when passing urine
    positive result.9 Although there is no up to date published
    literature on existing infection rates in 25-40 year olds,          • Pain or swelling in the testicles (indicating
    it is estimated to be between 5-10%.                                 epididymo-orchitis – see Complications).




8
Complications                                                      Statistics

People with chlamydial infection, who remain undiagnosed           • Between 10 – 40% of women with chlamydia
                                                                                   1, 11
and untreated, are at risk of developing serious long-term           develop PID
complications which become more difficult to treat.
                                                                   • Chlamydial infection accounts for an estimated 50%
Complications can have significant impact on individuals
                                                                     of PID cases and 40% of ectopic pregnancies10
and on NHS resources. These provide a strong case for early
detection and treatment. Complications include:                    • Ectopic pregnancy accounts for 9% of maternal
                                                                     deaths in the UK.10
Women
• Pelvic inflammatory disease (PID)
                                                                Diagnosis
• Infertility
                                                                Diagnosis of chlamydia is confirmed by a laboratory Nucleic
• Chronic pelvic pain                                           Acid Amplification Technique (NAAT) test, a simple urine test
                                                                which detects the nucleic acid of the C. trachomatis
• Ectopic pregnancy.
                                                                bacterium. A NAAT test is the required gold standard test for
Chlamydia passed from mother to baby can cause                  detecting chlamydial infection in men and women. Both the
conjunctivitis and pneumonia; there is also evidence that it    Clamelle Chlamydia Test Kit and NHS postal testing service
may contribute to miscarriage, preterm birth, stillbirth and    use urine samples. Some NHS postal kits use self-taken vulval
low birth weight.10                                             swabs for women. Other sexual health services may use urine
                                                                samples, vaginal or urethral swabs depending on their local
                                                                laboratory recommendations.
Men
• Urethritis

• Epididymo-orchitis (infection of the epididymis causing
                                                                Treating chlamydia
  swollen testicles)
                                                                Uncomplicated (asymptomatic) genital chlamydial
• Infertility                                                   infection is treated with antibiotics: a single 1g dose of
                                                                azithromycin (now available OTC as Clamelle Tablets) or
• Sperm damage
                                                                doxycycline 100mg twice daily for 7 days.
• Sexually acquired reactive arthritis (SARA) and Reiter’s
  syndrome (affects both sexes but is more common in men)       Although treatment can be accessed through existing
                                                                NHS sexual health services (see Section 1, page 6 and
  can cause inflammation to the joints, the urethra and eyes,
                                                                Appendix 4 for further details) the availability of Clamelle
  and is the most common cause of arthritis in young men.
                                                                Tablets means people with asymptomatic chlamydial
                                                                infection can now access treatment through pharmacy,
                                                                so providing them with an alternative choice of access.
    Infertility
    One of the most likely concerns for women will be
                                                                Treating partners
    the risk of infertility as a result of chlamydial
    infection. Chlamydia is the most common                     Preventing reinfection of an individual and spread of
    preventable cause of infertility in women. The risk         infection to others is a key goal in managing chlamydia.
    of PID and reproductive complications, including            The risk of infection of sexual partners is very high (studies
    infertility, increases with each repeated chlamydial        show that two-thirds will test positive for the infection10) so it
    infection.1, 12, 13 It is important for pharmacists to be   is essential that all sexual partners are notified and treated.
    aware of this and to offer the correct advice and           This is known as ‘epidemiological partner treatment’ and is
    reassurance. Women aged 25-40, in particular, who           an essential component of clinical guidelines for
    may be considering starting a family can be given           management of chlamydia.1,2,10 Partner Notification (PN)
                                                                slips are often used, so that chlamydia-positive individuals
    advice on maintaining their fertility e.g. practising
                                                                can give or send these to their sexual partner(s). In NHS
    safe sex, testing for chlamydia (and other STIs)
                                                                sexual health services, partners are offered a test as well as
    regularly and seeking early treatment.
                                                                epidemiological treatment; however, treatment is always
                                                                supplied if the partner refuses a test.




                                                                                                                                     9
     3. Clamelle chlamydia service pharmacy model
     There are two main components of the Clamelle chlamydia service: Clamelle Chlamydia Test Kit and
     Clamelle Tablets. The test kit can be available for self selection, however the pharmacist should be
     directly involved in verifying the test result and the subsequent stages of the pharmacy model. The model
     (journey) from test sale through to the supply of treatment involves 6 chronological stages:

      Stage 1    Clamelle Chlamydia Test Kit and verifying test result

      Stage 2    One to one sexual health consultation – ensures appropriate sexual health advice and partner notification

      Stage 3    Eligibility for Clamelle Azithromycin 500mg Tablets – checks for the suitability of OTC treatment (Clamelle questionnaire)

      Stage 4    Supply of Clamelle Tablets and product information

      Stage 5    Signposting to NHS sexual health service providers

      Stage 6    Record keeping for sale of Clamelle Tablets


       Stage 1      Clamelle Chlamydia Test Kit

       This involves the sale of the Clamelle Chlamydia Test Kit and the verification of the test result.
       Remember, a pharmacy wishing to sell the Clamelle Chlamydia Test Kit and Clamelle Tablets must first
       register for the service through the NPA. Details for registering are in Appendix 1. Clamelle Chlamydia
       Test Kits and Clamelle Tablets can be ordered from the wholesaler. However, to run the Clamelle
       chlamydia service (i.e. sell the test kits and tablets) pharmacists need to have completed set up
       procedures in the NPA Chlamydia Resource Pack (including validating registration with the private
       testing laboratory) and training.

     Details of the test

     The test is a simple kit which allows the individual to collect        Importance of verification slip
     a urine sample in the privacy of their own home and post
     the sample directly back to the laboratory for analysis by             It is important individuals keep their verification tear off
     Nucleic Acid Amplification Technique (NAAT).                           slip safe:
                                                                            • If they requested to receive their test result by letter
     Each test kit contains:                                                   and they tested positive, they need to bring their
     • A patient instruction and information leaflet                           results letter or verification slip to the pharmacy to
                                                                               be able to purchase Clamelle treatment. If they
     • A test request form, with a patient tear off slip
                                                                               have lost both their verification slip and their results
       (verification slip)
                                                                               letter, they will not be able to purchase treatment.
     • A urine sample bottle                                                   They will need to purchase another Clamelle
                                                                               Chlamydia Test Kit
     • A transport container for the sample bottle and a
       sealable plastic bag                                                 • If they requested to receive their test result by returning
                                                                               to the pharmacy, and they have lost their verification
     • A pre-paid padded envelope.
                                                                               slip, they will not be able to get their result. They will
                                                                               need to purchase another Clamelle Chlamydia Test Kit.
     Each test kit carries a Unique Reference Number (URN) on
     the test request form and the verification tear off slip, which        This is highlighted on the test kit carton and
     ensures the individual receives the correct result – either            instruction leafllet.
     directly by post or via the pharmacy if they prefer.




10
                                                                  The test is suitable to use in pregnancy. However, if the test
  Note: A number of patient ‘self-tests’ for chlamydia            result is positive, the woman will need to be referred to her
  which do not involve NAAT laboratory analysis are               GP or GUM clinic for treatment, since Clamelle Tablets are
  available for sale on the Internet and in some                  contraindicated in pregnancy (see Stage 3 Eligibility protocol).
  pharmacies. These type of tests cannot be accepted
  as eligibility for the supply of Clamelle. The Department       Verifying the test result
  of Health (DoH) and the British Association for Sexual
  Health and HIV (BASHH) advise that the gold standard            Pharmacists should be directly involved in the patient
  of care is NAAT test. NAATs are more sensitive and              consultation from this point onwards.
  specific than Enzyme Immunoassay (EIAs); use of
                                                                  To be able to purchase Clamelle Azithromycin 500mg
  suboptimal tests (e.g. EIAs) is not appropriate.
                                                                  Tablets, the individual who has completed a Clamelle test
                                                                  must bring into the pharmacy either their:

                                                                  • Test result letter, or
Obtaining a test
                                                                  • Their verification tear off slip which contains their
Individuals can purchase tests from pharmacies participating        specific URN.
in the Clamelle chlamydia service. It is advisable to encourage   In either case the pharmacist must verify the result. This is
individuals to return to the same pharmacy to obtain results      carried out online. The pharmacist will need the individual’s:
(if they choose) and if appropriate, treatment. The majority
                                                                  • Unique reference number (URN) – original copy
of people will prefer to do this. However, if this is not
                                                                    (URN found on results letter or verification slip)
possible, they are able to visit another pharmacy
participating in the Clamelle chlamydia service. Details of       • First part of postcode (district digits e.g. NE32)
other participating pharmacies can be found by visiting
                                                                  • Year of birth.
the Clamelle consumer website www.clamelle.co.uk and
the pharmacist can direct individuals accordingly.                This will then enable them to verify the result on the GLG
                                                                  lab pharmacy database (access is via a secure web-portal).
                                                                  Results are usually available within 7 days of testing.
Who is the Clamelle test appropriate for?
                                                                  Informing individuals of their test result
The sale of a Clamelle Chlamydia Test Kit is appropriate in       All discussions regarding the test result need to be handled
the following circumstances:                                      sensitively and discreetly, especially for those who choose
                                                                  to obtain their test result by returning to the pharmacy. The
• Sexually active individuals aged 16 years or over
                                                                  pharmacist needs to be empathetic to how individuals
  experiencing no symptoms (asymptomatic) but who
                                                                  may react; some individuals may be upset. See Appendix 3
  have had unprotected sex and are worried they may
  have a chlamydial infection, or when there is a change          for appropriate communication and behaviour skills.
  of sexual partner
                                                                  Negative test results
• Partners who do not have a Partner Notification (PN) slip.      An individual who has used a Clamelle
  A PN slip confirms that they are a sexual partner of someone    Chlamydia Test Kit correctly and then
  who has tested positive for chlamydia (see page 9 Treating
                                                                  chosen to return to the pharmacy for
  partners and page 13 Partner notification). A test is not
                                                                  their test result and receives a negative
  necessary for partners with a PN slip (although some
                                                                  result, should first be advised that they
  people may still choose to perform one). Individuals who
  don’t have their PN slip will have to perform a test first.     do not have chlamydia. They should
                                                                  then be counselled on safe sex and
If the patient has symptoms suggestive of chlamydia or            the use of protection, and advised to
other STIs, or is under 16 years of age, they need to be          attend a GUM clinic if they are
referred to a local NHS sexual health venue for testing (refer    concerned about other STIs. The same
to your Signposting template of local contacts – see              applies to an individual who has chosen
Appendix 6a). Symptoms suggestive of other STIs include:
                                                                  to receive their result by letter and
• Lumps, bumps, blisters or sores around the genital or           returns to the pharmacy for further
  anal area.                                                      advice.




                                                                                                                                     11
                                                                          Positive test results
                                                                          A patient who receives a positive test result for
     Counselling for test kit at the point of sale                        chlamydia is known as the index patient. They should be
                                                                          advised to treat the infection as soon as possible, either
     The Clamelle Chlamydia Test Kit is available for                     through the pharmacy with Clamelle Tablets or
     customers to self-select from the open display shelves in            alternatively they can go through NHS services. They
     the pharmacy. At point of sale, offer the customer the               should be given Partner Notification slip(s) to give to their
     opportunity for a consultation. The customer might                   partner(s) so their partner(s) can get treatment (e.g. with
     decline this. If so, it is important to remind them:                 Clamelle Tablets [without the need for testing] or through
                                                                          local NHS venues) – see Partner Notification (Stage 2).
     • It is essential to keep their verification tear off slip with
       their URN safe – they will need this to: i) obtain their
                                                                          Equivocal test results
       test result from the pharmacy ii) if appropriate receive
                                                                          Sometimes the test result is equivocal, in other words the
       treatment and iii) obtain a free repeat test kit if their
                                                                          test was unable to confirm the presence of the bacteria
       result is equivocal (see Verifying test result)
                                                                          C. trachomatis.
     • If they lose their verification slip or test result letter, they
       will not be able to get their result/purchase treatment.           In such cases, the test should be repeated and
       They will need to buy another Clamelle test kit                    individuals advised to return to the pharmacy from which
     • To follow the instructions on the leaflet inside the test          they bought the test kit and ask for another test kit. The
       kit – explains how to use the test kit correctly.                  pharmacy should supply a replacement Clamelle test kit
                                                                          free of charge. Refer to the NPA Chlamydia Resource
     If more advice is requested, the following counselling               Pack for full details on supplying a free test kit for
     points are useful:                                                   equivocal results and claiming a replacement test kit
                                                                          from GLG (the testing lab).
     • Explanation about how to use the test

     • Explanation that it may take up to two weeks for                   Individuals who have a second equivocal result upon
       chlamydial infection to show up after unprotected                  repeat test should be referred to a local sexual health
                  14
       exposure. It is advisable to take this into consideration          venue.
       when deciding when to actually use the test kit. This
       means that if the episode of unprotected intercourse
       was recent, they may need to wait to use their test kit
       until two weeks after this exposure, otherwise they may                General sexual health advice
       get a false negative result
                                                                              If the customer would like general advice about
     • Advise them to abstain from sex (vaginal, oral and anal,
                                                                              safe sex and reducing risk of STIs, the following
       including use of sex toys) even with a condom until
                                                                              points are important:
       they have their result and, if this is positive, until both
       (all) of them have been treated and they have waited                   • Using condoms every time you have sex
       for seven days after the last person of the partnership                  reduces your risk of getting or passing on STIs
       has been treated. This is to avoid re-infection                        • Use a condom each time you have a new
                                                                                sexual partner
     • Emphasise the confidentiality of the service and
       explain that they have a choice of receiving the                       • Each time you have a new sexual partner, it is
       results at home or by returning to the pharmacy                          advisable that you both get a chlamydia test.

     • Even if they choose to have their results sent to their                You can give the customer sexual health leaflets
       home by letter, remind them to return to the                           (see Appendix 7 Resources for sources of various
       pharmacy once they have the results, regardless of                     leaflets). Your PCO may also its their own sexual
       whether they test positive or negative, to get important               health leaflet that you can use.
       sexual health advice.




12
                                                                   Follow-up tests
  Handling customers who have lost their
  verification slip:                                               Clinical guidelines do not recommend follow-up testing for
  This situation should not arise very often, since:               chlamydia after treatment with azithromycin (or other
                                                                   treatment) unless re-infection is suspected.1,2,10 The customer
  i) The test kit carton and leaflet highlight that it is
     important they keep their verification slip (and test         may still choose to undertake a follow-up chlamydia test
     result letter) safe and also that they will not be able       to confirm they are clear of infection but this is a personal
     to obtain their test result or purchase Clamelle              choice and is not a clinical requirement. If a follow-up test is
     treatment if they do not bring at least one of these          performed, it should not be repeated within 6 weeks of
     items with them to the pharmacy                               treatment. In this timeframe the NAAT test may still remain
  ii) Pharmacy staff will be reminding the customer of this        positive – although this does not necessarily mean active
      at the point of sale of the test kit (see Counselling for    infection, it may be detecting the presence of nucleic acid
      test kit at point of sale section).                          of non-viable chlamydia organisms that have been
  If the customer has lost their verification slip, you can        successfully treated.
  do the following:
  • Take customer to a quieter area of pharmacy, or                A repeat chlamydia test is advised whenever there is a
    consultation area                                              change of sexual partner (but not within six weeks of
  • Advise customer that unfortunately they cannot                 treatment, as explained above).
    obtain their result or purchase treatment without
    their verification slip (or result letter)
  • If necessary, you can show the customer that this              Individuals with a positive NHS test result and
    important point is highlighted on the test kit carton,         their partners
    instruction leaflet, test request form and the
    verification tear off slip.                                    Individuals who are NHS test-positives are also able to
  • Advise the customer of options:                                purchase Clamelle Tablets if they choose to, provided:
     - They can purchase another Clamelle test kit
                                                                   i) the proforma for NHS individuals is completed
     - If they do not want to purchase another test,
                                                                     (see Appendix 4c)
       advise them they can obtain an NHS chlamydia
       test free of charge and signpost them to the local          ii) they are eligible (as determined by Clamelle questionnaire).
       GUM clinic.
  Should the customer still not be satisfied and should they       NHS test-positives are most likely to seek free treatment on
  request a contact address for follow up, provide them            the NHS; they have already accessed NHS sexual health
  with the GLG address (see Appendix 1).                           services. However, Clamelle Tablets may be an attractive
                                                                   option for partners of NHS test-positives, if they do not wish
                                                                   to access treatment from NHS services.
Procedure for partners
                                                                   See Appendix 4 for full details on how to manage supply of
Partners of test-positives (index patients) must bring their PN
                                                                   Clamelle Tablets to individuals who are NHS test-positives
slip into the pharmacy, which would have been given/ sent
                                                                   and their partners.
to them by the index patient. The slip will contain the index
patient’s URN (see Stage 2 - information on partner
notification). The pharmacist should use the URN to access
                                                                   Pharmacist helpline numbers
the GLG pharmacy database and confirm the positive test
                                                                   (NOT for general public use)
result of the index patient. In this case, only the URN is
required, no additional information (e.g. post code, date of
                                                                   See Appendix 1
birth) is needed. Once confirmed, the partner may be offered
                                                                   NPA Information Helpline: 01727 891800
Clamelle treatment (if Clamelle questionnaire indicates this is
                                                                   General queries relating to the testing service.
appropriate) without the need to take a Clamelle test. Some
partners may choose to also carry out a test; this is a personal   Gordon Laboratory Group: 0800 011 2857
choice, it is not a requirement.                                   Technical/clinical queries relating to test results.




                                                                                                                                      13
         Stage 2       One to one sexual health consultation

         This needs to be carried out for all chlamydia-positive individuals, regardless of whether they are eligible
         for Clamelle. This is an important aspect of the chlamydia service as chlamydia is a communicable
         disease with public health implications for individuals and their sexual partner(s). One to one intervention
         is in line with NICE Public Health Intervention Guidelines8 and BASHH Guidelines.1



     Conducting the consultation                                        2   Safe sexual practice

     This consultation needs to be carried out discreetly,                  Key points to convey to customer:
     using the pharmacy’s consultation area and should
                                                                           Individuals who have tested positive must abstain from
     involve assessment of risk, reassurance of the individual
                                                                            sex (oral, vaginal, anal or use of sex toys) – even with a
     and provision of detailed information pitched at the level
                                                                            condom – until 7 days after both they and their
     of the individual. Appropriate communication and
                                                                            partner(s) have been treated for chlamydia

                                                                        
     behavioural skills are important for the sexual health
     consultation. These are covered in the Appendix 3.                     Individuals who take the single dose Clamelle Tablets
                                                                            must not have sex for 7 days after both they and also
     There are four key elements to cover in the one to                     their partner(s) have been treated, to ensure the
     one consultation.                                                      infection has cleared and they are not re-infected by
                                                                            their partner(s)
     1     Information about chlamydia                                     To reduce the risk of re-infection, individuals should use
                                                                            barrier methods with new partners and consider STI
           Key points to convey to customer:

     
                                                                            testing before having unprotected sex
           Chlamydia is a bacterial infection which can remain             Although safer sexual practices will reduce the risk of
           asymptomatic in individuals who have been infected

     
                                                                            transmission of chlamydia, condoms do not prevent
           People remain unaware they have the infection and                the transmission of chlamydia 100%; chlamydia can
           can pass the infection on to partners                            also be transmitted through other types of intercourse

     
                                                                            such as oral or anal sex and use of sex toys.
           Both men and women can experience asymptomatic
           infection with chlamydia

     
                                                                        3   Partner notification
           Chlamydia can damage internal organs, even in those
           individuals who are asymptomatic, and cause                      Key points to convey to customer:
           subsequent infertility, pain and bleeding if left
                                                                           Partner notification is important because the infection
           untreated in those who are unaware they are infected

     
                                                                            will have been transmitted to them by a sexual partner
           OTC treatment with Clamelle Azithromycin 500mg                   and/or they may be transmitting the infection to a
           Tablets is for asymptomatic chlamydia – if symptoms              sexual partner. Studies show that two thirds of sexual
           develop they need to go to their local sexual health             partners will also be positive for chlamydia1
           venue or GP
                                                                        
     
                                                                            It is essential that they are treated to avoid re-infection
           If they express a wish to obtain treatment elsewhere             and further spread of the infection. Re-infection
           (e.g. from a GUM clinic or via a GP prescription), they          increases the risk of serious complications; each
           should be reminded that rapid treatment is essential.            recurrence of infection increases the risk of Pelvic
           They must be reminded to take their verification                 Inflammatory Disease (PID) and reproductive
           tear off slip or letter with the positive result with them       complications 1,12,13
           as proof.




14
   All partners within the last six months (or until the last
    previous sexual partner if this was longer than six              Handling partner notification sensitively
    months) should be notified and advised to seek
    treatment1                                                       Explain to the individual that the questions you need


                                                                     to ask them are standard ones to establish if others
    Partners can be treated without the need for a test              may be at risk of chlamydial infection.
    (epidemiological treatment). Some partners may still
                                                                     It is important to reassure the individual that
    choose to take a test first – this is a personal choice
                                                                     confidentiality of their results and / or treatment as
    and not a requirement


                                                                     well as their partner’s will be paramount and that
    Individuals wanting expert help with partner                     they will not be able to find out from the pharmacist
    notification can be signposted to NHS sexual                     who tests positive, who tests negative or who
    healthcare professionals e.g. at local GUM clinic or             has been treated. Emphasise that results will only
    NCSP treatment venue.                                            be given to the individual and not shared with
                                                                     others/sexual partners.
                                                                     If there are difficult or contentious issues, or if the
                                                                     individual would like help with partner notification,
    How to use Clamelle                                              from an NHS specialist sexual healthcare expert,
                                                                     signpost them to a local sexual health venue where
    Partner Notification slips
                                                                     they can receive assistance e.g. health advisors at
                                                                     the local GUM clinic or the local chlamydia
    • The individual can give or send a PN slip to a
                                                                     screening co-ordinator (see Stage 5 Signposting).
      partner, so that their partner can bring it in
      to the pharmacy to purchase treatment
      N.B. Only issue PN slips to test-positive individuals
      (index patients)

    • From your consultation with the index patient,
      provide the appropriate number of PN slips
      (either the number of sexual partners they have
      had within the last six months, or if their last sexual
      partner was longer than six months ago, one slip
      for this last partner)

    • Write on all PN slips the URN of the index patient’s       4   Risk of other STIs and need for testing
      positive test result
                                                                     Key points to convey to customers:

                                                                 
    • Stamp (with pharmacy stamp) and date the
      PN slip                                                        Individuals who have tested positive for chlamydia may
    • Ensure you store your stock of PN slips safely in the          also be at risk of having other STIs. These include
                                                                     gonorrhoea, syphilis, HIV, genital warts and genital herpes

                                                                 
      pharmacy – they should be under the personal
      control of the pharmacist                                      They should be advised to visit their local GUM clinic for
                                                                     further STI testing and treatment

                                                                 
    • If supplying Clamelle to a partner, provide partner
      notification counselling but DO NOT issue any PN               Individuals should be reminded that Clamelle Tablets
      slips – their partners will need to be tested. If the          only treat asymptomatic chlamydia, not other STIs

                                                                 
      partner needs help with notifying their partner(s),
                                                                     Some of these other STIs can also be asymptomatic,
      signpost them to a local NHS sexual health venue
                                                                     so they will not know they are infected unless they
    • Clamelle Tablets can only be supplied to                       are tested

                                                                 
      confirmed chlamydia-positive individuals or
                                                                     Individuals should be signposted to local sexual
      partners of confirmed chlamydia-positives.
                                                                     health services for tests for other potential STIs
                                                                     (see Stage 5 Signposting).




                                                                                                                                   15
       Stage 3       Eligibility for Clamelle Azithromycin 500mg Tablets

       The Clamelle patient questionnaire is designed to help pharmacists identify people who are
       suitable for OTC azithromycin treatment (see Appendix 5)



     Clamelle patient questionnaire
                                                                          Five key elements to the questionnaire:
     Individuals presenting in the pharmacy for chlamydia                 • About your chlamydia test – confirms that the
     treatment will be one or the other:                                    customer has a positive test or is a partner of
     i) Someone who has positive test result (private or NHS test)          someone who has tested positive
                                                                          • About you and your health – confirms the customer
     ii) Sexual partner of the above.
                                                                            is aged 16 years and over and is asymptomatic
     If the individual is either an NHS test-positive or a partner of
                                                                          • About your medicines – eliminates medicines that
     an NHS test-positive and is choosing to purchase Clamelle
                                                                            are contraindicated for Clamelle Tablets. Also lists
     Tablets, they will need to first complete the NHS proforma
                                                                            medicines that are not contraindicated but where
     (See Appendix 4c) before the pharmacist proceeds to check
                                                                            the pharmacist needs to give specific advice to
     for eligibility for Clamelle Tablets.
                                                                            the individual (oral contraceptives, antacids) – see
     Anyone who has received a positive test result for                     Stage 4 – Supply of Clamelle Tablets and product
     chlamydia and anyone who is a sexual partner of                        information
     someone who has tested positive, should be asked to fill in          • Pharmacist intervention details – the pharmacist
     the questionnaire. They should be reassured that it is                 completes this section. Includes a record of supply
     anonymous and confidential. Use the questionnaire as a                 or referral plus checklist of essential counselling
     tool to aid discussion during the consultation. The individual         points to be covered in the pharmacy
     can complete the questionnaire while waiting for their                 consultation. Although not an obligatory
     private consultation with the pharmacist – the Medicines               requirement to retain the questionnaire for
     Counter Assistant (MCA) can provide the individual with a              pharmacy records, it may be considered good
     questionnaire and direct them to the consultation area for             practice for Clinical Governance, especially as this
     privacy (see Section 1, page 7 Role of support staff).                 medicine is for treatment of a significant
     If any of the responses suggest that OTC supply is                     communicable disease i.e. STI
     unsuitable (see Stage 4 and SmPC), the individual should             • Patient treatment/advice slip – a tear off slip at the
     be referred to an appropriate local sexual health venue                bottom of Clamelle patient questionnaire. Used as
     (see Stage 5 Signposting and Appendix 6a – Signposting                 a record of supply of Clamelle Tablets or a referral
     template). It is still important to conduct the one to one             slip (to take to GUM clinic or other NHS venue) and
     sexual health consultation (see Stage 2), even if Clamelle             includes reminder of counselling points – see Stage
     treatment is unsuitable.                                               6 Record keeping.



      Explanation of symptoms listed in questionnaire
      Question 5 – Females:                                             Question 6
      • Pain when passing urine; unusual vaginal discharge;             • Unusual lumps, bumps, blisters or sores around genital area
        pain when having sex; bleeding between periods;                   or back passage – symptoms suggestive of other STIs.
        bleeding after sex – all chlamydia symptoms                     Question 7 and 8
      • Unexpected pain below your belly button – symptom               • Unexpected or worsening joint pain; unexpected or
        suggests complications e.g. chronic pelvic pain, PID.             worsening conjunctivitis (itchy, sore eyes) – both are
      Question 5 – Males:                                                 symptoms suggestive of the complications Sexually
      • Discharge from penis; pain when passing urine –                   Acquired Reactive Arthritis (SARA) or Reiter’s syndrome
        chlamydia symptoms                                                (more common in men).

      • Pain or swelling in testicles – symptom suggestive of the       Clamelle (OTC azithromycin) cannot be sold if any
        complication epididymo-orchitis.                                of the above symptoms are present.




16
  Stage 4      Supply of Clamelle Tablets and product information

  Azithromycin is recommended as therapy for the treatment of uncomplicated chlamydial infection,1,10
  available since 1991 and used in tens of millions of people worldwide. Azithromycin is a broad spectrum
  azalide, a subclass of the macrolide antibiotics, and works by inhibiting protein synthesis in susceptible
  organisms.



Indication                                                       Safety

Clamelle Azithromycin 500mg Tablets is a new Pharmacy-           Azithromycin is generally
only antibiotic indicated for confirmed asymptomatic             well tolerated with a low
genital Chlamydia trachomatis infection and                      incidence of side effects.
epidemiological treatment of their sexual partners.              As with other macrolide
It may be given to men and women aged 16 years and               antibiotics, the most
over who have tested positive for chlamydia and can              commonly reported
also be given to their sexual partners, without them             adverse events are
needing to take a test.                                          gastrointestinal in nature
                                                                 (e.g. abdominal pain and cramps, nausea, vomiting,
Although the licensed indication is for 16 years and over,       diarrhoea), although they are usually mild and less
most customers are expected to be those aged 25-40               frequent than found with erythromycin. 17,18,19
years since under 25-year-olds can receive free treatment
                               .
at community venues through NCSP                                 Azithromycin may cause dizziness and drowsiness so
                                                                 affected individuals should not drive or operate machinery.


Dose                                                             As with other macrolides, rare serious allergic reactions
                                                                 including angioneurotic oedema and anaphylaxis (rarely
Clamelle Tablets is available as packs of 2x500mg                fatal) have been reported with azithromycin. See Section
azithromycin tablets. The treatment is a single 1g dose.         4.8 of SmPC for further details and for list of uncommon
It should be taken as soon as possible after confirmed           (1/100 to more than 1/1000) and rare (1/1000 to more than
diagnosis. For sexual partners of these individuals, it should   1/10000) side effects associated with azithromycin.
be taken as soon as possible after they have been notified.


                                                                 Interactions
Efficacy
                                                                 If taking an antacid, Clamelle Tablets should be taken at
Azithromycin given as a 1g single dose is recommended            least one hour before, or two hours after, taking the antacid.
as a first line therapy for the treatment of uncomplicated
Chlamydia trachomatis infection, and studies show it is as       Drugs that are contraindicated due to interactions are:
effective as doxycycline 100mg twice a day for seven             • Ciclosporin
days.16
                                                                 • Digoxin

Studies have shown cure rates of 97% for azithromycin and        • Ergotamine and ergot derivatives

98% for doxycycline (no significant difference). There is        • Terfenadine
considerably less evidence available for efficacy of other       • Theophylline
antibiotics in treating chlamydia.1,10
                                                                 • Disopyramide
                                                                 • Rifabutin
                                                                 • Coumarin anticoagulant therapy, e.g. warfarin




                                                                                                                                  17
     Who CANNOT take Clamelle Tablets                                 Patient counselling
     (OTC azithromycin)
                                                                      • Take both tablets together as a single dose with a glass
     • Anyone with symptoms of chlamydia or its complications           of water
       (see symptoms listed on questionnaire and in Section 2,        • To reduce the risk of vomiting individuals should be
       page 8)                                                          advised to take the dose before bed and at least two
     • Anyone with symptoms suggestive of other STIs (any               hours after food or any other drink besides water
       unusual lumps, bumps, blisters, sores around genital or        • Where possible avoid antacids. If using antacids, take
       anal area [see questionnaire])                                   Clamelle Tablets at least one hour before or two hours
     • Children under the age of 16 years                               after the antacid
     • Renal or hepatic impairment                                    • In females taking oral contraceptives, if they do experience
     • History of cardiac disease                                       vomiting or diarrhoea after taking Clamelle Tablets,
                                                                        this may lead to contraceptive failure. They should
     • Pregnancy and breast feeding
                                                                        refer to the instruction leaflet that comes with their
     • Known hypersensitivity to azithromycin, any macrolide            oral contraceptive pill, to minimise the risk of
       antibiotic or any excipient                                      contraceptive failure
     • Individuals taking azithromycin for any other infection          – there is no interaction between azithromycin and
     • Individuals taking any of the medicines listed as                  oral contraceptives;20 the warning is related to risk of
       contraindications in interaction section, page 17                  vomiting/diarrhoea after taking azithromycin
     • Individuals who have already taken azithromycin or             • They and their partner(s) should refrain from sex
       another treatment for chlamydia in the last six months           (including vaginal, oral, anal sex and using sex toys) until
       (this is because the risk of serious complications increases     both (all) of them have been treated and they have
       each time you are infected).                                     waited for seven days after the last person of the
                                                                        partnership has been treated
                                                                      • Remind individuals to take both tablets – partner(s)
                                                                        will need their own treatment.



                                                                      Repeat treatment

                                                                      Repeat treatment may be necessary if tested positive
                                                                      following a change in sexual partner. If this occurs within
                                                                      six months of having been previously treated for chlamydia,
                                                                      then the individual should instead be referred to a GUM
                                                                      clinic (because of increased risk of complications with
                                                                      each infection of chlamydia).


                                                                      See Clamelle Tablets SmPC (Appendix 2) and PIL for further
                                                                      details.




18
  Stage 5      Signposting to NHS sexual health service providers

Establishing links with local sexual health
network and completing signposting template
                                                                    Key local contacts to develop
It is important to establish strong communication links with
                                                                    communication links with
local NHS sexual health service providers, so that each
                                                                    • GUM clinic (some will be called sexual health
pharmacist:
                                                                      clinic): GU Consultants, GU Health Advisors
• Has an understanding of how the local sexual health               • NCSP: Chlamydia Screening Co-ordinator
  network operates
                                                                    • PCO Sexual Health Lead
• Can signpost individuals to the most appropriate
                                                                    • Family Planning Clinic
  specialist care for their specific circumstances
                                                                    • Local GPs with a Special Interest (GPwSI)
• Can contact local NHS specialist sexual healthcare
                                                                      in sexual health.
  workers for advice and support when needed
                                                                    The Local Key Contacts template in Appendix 6b
• Can inform local NHS sexual health service providers that
                                                                    needs to be completed by each pharmacy.
  the pharmacy is providing a private chlamydia testing
  and treatment service
• Is familiar with the style of NHS Partner Notification (PN)
                                                                 NCSP (under 25 year olds):
  slips used in the local area (GUM and NCSP).
                                                                 Contact should be made with the local chlamydia
                                                                 screening coordinator and chlamydia screening office
The NPA Chlamydia Resource Pack contains template                              ,
                                                                 (CSO) for NCSP to find out which sites are offering testing
letters that should have been completed and sent off to
                                                                 and/or treatment for chlamydia and whether the PCO is
local NHS sexual health service providers, as part of the set
                                                                 offering dual screening (chlamydia and gonorrhoea) for
up procedure for the testing service. It is important that the
                                                                 under 25-year-olds. The NCSP website
pharmacy continues to develop strong links with these
                                                                 www.chlamydiascreening.nhs.uk
local service providers.
                                                                 has more information on activities in the local area.


                                                                 Clamelle Tablets may be sold to asymptomatic individuals
Key contacts
                                                                 who test positive through NCSP or to their partners.

GUM clinic:                                                      However, it cannot be sold to those who have had a dual

Some localities operate a fast track referral system to GUM      test and are also gonorrhoea positive – they should be

clinics for symptomatic patients and other urgent cases.         referred back to the testing site for appropriate treatment

A common mechanism is a dedicated phone line for                 of both gonorrhoea and chlamydia at the same time (see

healthcare professionals (not general public) to contact         Appendix 4c NHS proforma).

the Health Advisor at the local GUM clinic. Some clinics
offer a ‘walk-in’ service with patients triaged and              PCO:
straightforward cases seen more quickly. Pharmacists should      Find out if the local PCO has a specific leaflet for its sexual

check services in their area and advise any symptomatic          health services which can be ordered and provided to

individuals about accessing services through fast track.         individuals coming to the pharmacy. The PCO may hold

Some individuals will want the pharmacist to arrange a fast      locally-run chlamydia or STI management training events

track appointment for them, others will choose to refer          that are open to pharmacists to attend (there may be a

themselves (self-referral).                                      cost to this). Ask who the PCO Sexual Health Lead is.


BASHH runs STI training workshops (STIF) in local regions.
See BASHH website
www.bashh.org/education/stif_course/index.asp
and Appendix 7 on Resources).




                                                                                                                                   19
         NHS Partner Notification (PN) slips

         The local GUM clinic and NCSP chlamydia screening coordinator will be able to provide examples of NHS PN
         slips, so they can be easily recognised if individuals bring them in and ask to purchase Clamelle Azithromycin
         500mg Tablets. See Appendix 4, for procedure for NHS individuals and their partners.




     Signposting                                                       Signposting template

     Within NHS sexual health services, the majority of                The template in Appendix 6a needs to be completed
     attendance is ‘self-referral’ by an individual. Individuals       by each pharmacy and used as a reference source
     will still need to self-refer to NHS services if the pharmacist   of all local NHS sexual health service providers. This can
     feels the private Clamelle chlamydia service is not suitable      be used when signposting individuals to local NHS
     for them.                                                         services and the list may be photocopied and handed
                                                                       out to individuals.
     When signposting, pharmacists must ensure
     the individual knows:
     • What they need to do
     • Why it is important to self-refer
     • Where to go to locally and how to access
       local services.




         Examples where pharmacists will
         signpost individuals to local NHS sexual
         health venues:

         • Symptoms present

         • Not eligible for Clamelle Tablets for other reasons
           (confirmed by questionnaire)

         • Need for other STI testing

         • Individual requests NHS help with partner
           notification

         • Individual wants free testing and treatment

         • Partners of NHS index patients who do not have
           a PN slip.




20
  Stage 6      Record keeping for sale of Clamelle Tablets

The following applies to all sales of Clamelle Tablets, after     4. Partners – PN slips
a positive result has been verified against the URN on the
                                                                     • Once treatment has been issued and partner sale
GLG pharmacy database:
                                                                        recorded on the database, you can destroy the
                                                                        Clamelle PN in-store. This will stop any attempt for it to
1. Proof of positive test result – index patient
                                                                        be re-used.
   • Either stamp and date the customer’s test result letter
      and return letter to customer

   • Or, if customer brought in tear off portion of their test
                                                                  NHS test-positives and their partners
      request form, destroy the slip in-store in an appropriate
                                                                  Follow the procedure outlined in Appendix 4b.The
      way, that prevents unauthorised persons accessing
                                                                  individual must complete the NHS proforma, before
      the individual’s test result i.e. to ensure the URN
                                                                  commencing a consultation for sale for Clamelle (see
      cannot be read. This is in line with RPSGB Professional
                                                                  Stage 1: Verifying test result, and Appendix 4b & 4c).
      Standards and Guidance for Patient Confidentiality.

                                                                  After supplying Clamelle Tablets, if an NHS letter/test
2. Patient advice slip on bottom of Clamelle
                                                                  report/partner notification (PN) slip was brought in as proof,
   questionnaire
                                                                  the pharmacist must stamp and date it and indicate on it
   • Fill in advice slip for customer                             that Clamelle has been sold. The letter/test report/PN slip

   • Stamp (with pharmacy stamp) and date the slip                should then be returned to the NHS individual.

   • Tear off advice slip, give to customer, advise them to       The completed NHS proforma should then be sent to the
      keep it safe and take with them if they go to a local       originating NHS testing site as soon as possible (and no
      sexual health venue or their GP                             later than within five working days). As these completed
   • Explain why it is important: acts as a referral slip and     proformas contain confidential patient information, they
      informs healthcare professional if individual has           need to be stored securely out of sight of patients,
      received treatment with Clamelle.                           members of the public or any person who should not have
                                                                  access to them. This is in line with other types of confidential
3. Record the Clamelle Tablets sale on the GLG                    patient information that pharmacists have to store securely
   Clamelle database, through the web portal                      and is covered in the RPSGB Professional Standards and
                                                                  Guidance for Patient Confidentiality.
   • This is important as it closes the loops between a URN
      chlamydia positive test result and treatment issue

   • It is also important as the Health Protection Agency            Health Protection Agency (HPA) and
      (HPA) count the number of cases of chlamydia                   anonymised data provision
      and treatment in the UK (routine STI surveillance).
      Anonymised data on test results and numbers of                 The HPA counts how many people in the UK have
      Clamelle treatments issued, are provided to the HPA            chlamydia, as part of routine STI communicable
      as part of this routine STI surveillance (see Box: HPA         disease surveillance and protecting public health.
      and anonymised data provision)                                 Anonymised details of test results and treatment
   • The database has separate sections to record index              supplies, but NOT name or contact details, are
      patient sale and partner sale/sales against a URN              provided by the private laboratory to the HPA. This is
      positive test result. The date of sale is automatically        the same as with NHS chlamydia testing. Patient
      logged when sale is recorded.                                  consent is not required for this. This is covered under the
                                                                     Control of Patient Information Regulations 2002. The test
                                                                     kit patient information leaflet explains this to customers.




                                                                                                                                     21
     4. Antibiotic resistance
     Chlamydia

     Current evidence and expert opinions suggest that                             suboptimal azithromycin dose. This may potentially
     resistance to azithromycin (and other macrolide antibiotics)                  encourage selection of azithromycin resistance in
     when treating Chlamydia trachomatis is rare21 and unlikely                    gonorrhoea.
     to be a significant public health issue. Long-term resistance
     has not been established. There is currently no resistance                    There is national surveillance for gonorrhoea resistance.22
     surveillance for chlamydia, as resistance is rare. Use of 1g                  Some NHS individuals may have been tested for both
     azithromycin to treat chlamydia is targeted appropriate                       chlamydia and gonorrhoea. If these individuals are also
     treatment of a confirmed infection by a diagnostic NAAT                       gonorrhoea positive, they cannot be sold Clamelle Tablets
     test or of a partner of a confirmed case of infection.                        and should be referred to the local GUM clinic for
                                                                                   appropriate specific treatment of their gonorrhoea at the
                                                                                   same time as their chlamydia (see section on Clamelle
     Gonorrhoea                                                                    chlamydia service pharmacy model – Stage 1, page 10
                                                                                   and Stage 5, page 19).

     Although a higher 2g dose of azithromycin is effective for
                                                                                   Remember, Clamelle Tablets are only indicated for treatment
     treating gonorrhoea, it is not a recommended treatment
                                                                                   of asymptomatic chlamydia. Individuals may also be at risk
     and is not included in national treatment guidelines.
                                                                                   of other STIs e.g. gonorrhoea and should be advised to visit
     Co-infection with chlamydia and gonorrhoea can occur.
                                                                                   their local GUM clinic for further STI testing (see section on
     In these cases treating chlamydia with 1g azithromycin
                                                                                   Clamelle chlamydia service pharmacy model – Stage 2,
     exposes the Neisseria gonorrhoea organisms to a
                                                                                   page 14).




     5. CPD elements
     Self test questions
                                                                                                                                      True    False

     1   OTC azithromycin may be given to men and women over the age of 16 years who have asymptomatic chlamydia

     2   The most commonly reported adverse events associated with azithromycin include nausea and stomach pain

     3   Studies show that one-third of sexual partners will also test positive for chlamydial infection

     4   Pregnancy, symptomatic cases of chlamydia and history of cardiac disease are contraindications to treatment with Clamelle

     5   Patients and partners should abstain from sexual intercourse until they have both been treated and for 7 days after
         both have completed their treatment with Clamelle

     6   Partners of chlamydia infected individuals must also test positive for chlamydia before receiving treatment with Clamelle

     7   Clamelle Tablets may be safely given to patients taking disopyramide

     8   The National Chlamydia Screening Programme is available only to women

     9   Follow-up testing for chlamydia after OTC treatment with azithromycin is usually required

     10 The customer questionnaire will help you determine whether a customer is suitable for OTC treatment with azithromycin




22
Case studies

Case study 1
An 18-year-old girl presents to the                              • If the customer is unwilling to visit a local NCSP venue for
pharmacy requesting emergency                                      testing but is interested in buying a Clamelle Chlamydia
hormonal contraception (EHC).                                      Test Kit, you should explain that it may take up to two
                                                                   weeks after exposure for chlamydial infection to show up
Considerations                                                     with the test, so she should wait until two weeks have
• Since this customer wants to buy EHC, it is likely that she      passed since the episode of unprotected sex before using
  has had unprotected sex and may be at risk of chlamydia          the test kit, unless she wishes to test anyway (due to
  and other STIs                                                   concern over a previous exposure). You should also
                                                                   explain how the test kit is used and that she can choose
• Whether or not you decide to provide EHC, it is essential to
                                                                   to receive her test result either by letter or by returning to
  counsel the customer on the importance of barrier
                                                                   the pharmacy
  methods of protection and ‘safe sex’ practices to reduce
  the risk of STIs. You should also explain the long-term        • Explain that she should keep the verification tear off slip
  complications that may occur if STIs such as chlamydia           safe and bring it into the pharmacy with her if she chooses
  are left untreated (e.g. infertility)                            to return to the pharmacy to obtain her test result. Explain
                                                                   that if she does test positive, she will need either her test
• It may be appropriate for this customer to undergo testing
                                                                   result letter, or her verification tear off slip to purchase
  for chlamydia and other STIs, and since she is under 25
                                                                   Clamelle Azithromycin 500mg Tablets
  years of age, she should be referred for free chlamydia
  screening and treatment under the NCSP                         • Provide the customer with pharmacy leaflets related to
                                                                   sexual health.




Case study 2
A 27-year-old man presents to the pharmacy                       • If the customer is not experiencing any symptoms, explain
requesting to buy a chlamydia test kit.                            that it may take up to two weeks for chlamydia to show
                                                                   up after infection, so he should delay testing till at least
Considerations                                                     two weeks have passed since the episode of unprotected
• The man may be buying the test kit for himself or on             sex. Briefly explain how the kit works and that he needs to
  behalf of someone else                                           keep his test verification tear off slip safe and bring it with
                                                                   him if he chooses to return to the pharmacy for his test
• If this customer is experiencing any unusual symptoms
                                                                   result
  (e.g. discharge, dysuria) he should be advised to visit the
  local GUM clinic or his GP for diagnosis and possible          • Explain if he does test positive he will need to bring either
  treatment. Provide signposting information for GUM clinic.       his test result letter or his verification tear off slip into the
  If the man does have symptoms and if the local GUM               pharmacy to purchase Clamelle Tablets
  clinic operates a fast-track phoneline, you can ask him if     • Recommend he returns to the pharmacy anyway to get
  he would like you to phone and arrange a fast-track              follow-up advice; this should include safe sex and testing
  appointment for him                                              for other STIs

                                                                 • Provide the man with pharmacy leaflets related to sexual
                                                                   health.




                                                                                                                                       23
     Case study 3
     A 39-year-old woman presents to the pharmacy                        • Explain importance of testing for other STIs. Provide necessary
     with a PN slip that she received in the post,                          contact details for local NHS sexual health venues (signposting)
     informing her that a sexual partner of hers has
                                                                         • If the woman is interested in receiving pharmacy
     tested positive for chlamydia. She wants
                                                                            treatment, provide her with the questionnaire to assess
     some advice about what to do next.
                                                                            whether it is safe to supply Clamelle Tablets

     Considerations                                                      • If Clamelle treatment is appropriate, explain that both

     • This woman may be suitable for pharmacy treatment with               tablets should be taken as a single dose and she should

       Clamelle provided she is asymptomatic and there are no               avoid all sexual intercourse for seven days until the

       contraindications to treatment with azithromycin                     treatment is complete. To avoid the risk of nausea and
                                                                            vomiting, she can take the tablets at bedtime at least two
     • Explain to the woman that a single dose treatment for
                                                                            hours after food or drink. Clamelle Tablets should not be
       chlamydia is now available from the pharmacy and she
                                                                            taken at the same time as antacids . Advise she should
       does not need to take a chlamydia test in order to receive
                                                                            refrain from sex for 7 days after both herself and her
       treatment. This is because a sexual partner of hers has
                                                                            partner(s) have been treated
       already tested positive. She may, however, choose to take
       a test and confirm a positive result before buying a treatment    • If the woman has had more than one sexual partner in the
                                                                            recent past, explain that her other sexual partner(s) are
     • Explain the importance of early diagnosis and treatment
                                                                            also likely to be infected and will need treating. Explain
       of chlamydia to prevent long-term effects on fertility
                                                                            importance of partner notification. As this woman is a
       should she wish to start a family, and to prevent onward
                                                                            partner, not an index (test-positive) patient, you cannot
       transmission to partners. Provide advice on safe sex, testing
                                                                            issue PN slips. Instead you should signpost her to a local
       for other STIs and signposting information to local NHS
                                                                            NHS sexual health venue for help and advice with partner
       sexual health venues
                                                                            notification
     • Provide her with pharmacy leaflets on sexual health
                                                                         • There is no need for follow-up testing unless she suspects
     • Explain options:                                                     reinfection. Explain that Clamelle Tablets is only effective
       i. May want to perform a test. Can do this by purchasing a           against chlamydia and that she may need to be tested
                                                                 .
         test kit or through local NHS services – GUM clinic or GP          for other STIs at a GUM clinic.
       ii. Testing is not essential. May opt for treatment. May be
         eligible for Clamelle Tablets. Alternatively can access
         treatment through NHS (e.g. GUM clinic or GP)




     Case study 4
     A 30-year-old woman presents to the                                   explain that it may take up to two weeks for chlamydia to
     pharmacy requesting information about                                 show up after infection, so she should delay testing until at
     infertility. She has heard that chlamydia may                         least two weeks have passed since the last episode of
     be associated with infertility.                                       unprotected sex. You should also explain how the test kit is
                                                                           used and advise that she can choose to receive the result
     Considerations                                                        by post or return to the pharmacy to collect her result
     • The customer may have problems conceiving. If so, they            • Explain she should keep the tear off slip (from her test
       may need investigation and she should be advised to                 request form) safe and bring it in to the pharmacy if she
       discuss them with her GP                                            chooses to return there to obtain her test result. Explain
     • The customer may be worried that she has chlamydia.                 that if she does test positive she will need either a test
       Chlamydial infections can cause infertility. If the customer is     result letter or the verification tear off slip to purchase
       symptomatic she should be referred to her local GUM clinic          Clamelle Tablets

     • If the customer is asymptomatic, she may wish to                  • Advise customer on safe sex, testing for other STIs and
       purchase a Clamelle Chlamydia Test Kit. You should                  provide any pharmacy leaflets related to sexual health.




24
Appendices
 Appendix 1 – Testing service registration and set up procedures
Registration and set up procedures for the testing             Getting started
service is through the National Pharmacy                       • Chlamydia testing service set up procedures
Association (NPA) and Gordon Laboratory Group
                                                               • Checklist
(GLG), the testing laboratory.
                                                               • Process reminder chart.

Register for the chlamydia testing service by calling the      Implementation
NPA sales department (01727 800401). Once you have
                                                               • NPA guidance on starting chlamydia testing service
registered, the NPA:
                                                               • SOP
• Issues the pharmacy with the NPA Chlamydia Resource
                                                               • Chlamydia testing – a guide for support staff.
  Pack for the testing service (see details below)
                                                               Resources
• Sends pharmacy membership details to GLG laboratory
                                                               • Template letters to local NHS sexual health services
  who will then contact the pharmacy directly with the
  secure weblink details for accessing the test results        • Posters
  database.                                                    • Window sticker.


Once you receive this you will need to:
                                                                 Pharmacist helpline numbers for testing service
• Complete the set up procedures, guidance and                   (NOT for general public use)
  Standard Operating Procedure (SOP) in NPA
                                                                 NPA Information Helpline: 01727 891800
  Chlamydia Resource Pack
                                                                 General queries relating to the testing service:
• Go to the GLG secure weblink to validate your registration     • Registration to the testing service
  details and activate your access to the secure web portal      • Set up procedures
  of the GLG Clamelle pharmacy database                          • NPA Chlamydia Resource Pack
                                                                 • General chlamydia testing queries.
• Order test kits from wholesaler.
                                                                 Gordon Laboratory Group (GLG): 0800 011 2857
                                                                 Technical/clinical queries relating to test results and
  Important: In order for you to sell the test kits and          the NAAT testing process. Helpline open
  run a live service, you need to have first completed           Mon-Sat 10am-10pm; Sun and BH 10am-8pm.
  the registration and set up procedures outlined in
  the NPA Chlamydia Resource Pack, as described
  above. If you have not done this, you will not be            Procedure for customer complaints
  able to access the GLG database to verify test               Customer queries and complaints (e.g. lost verification
  results and sell Clamelle Tablets.                           slip or result letter) should be resolved in the pharmacy
                                                               (see Section 3, Stage 1, page 10 – The Clamelle
                                                               Chlamydia Test Kit). If the situation cannot be resolved
NPA Chlamydia Resource Pack                                    satisfactorily in the pharmacy and the customer requests
You must complete the NPA Chlamydia Resource Pack              a contact address for follow up, provide them with the
before you commence the Clamelle (azithromycin) POM            GLG private testing lab address:
to P training materials. The Resource Pack contains the
following elements:                                            Gordon Laboratory Group
                                                               Clamelle Queries
                                                               Sedgefield (Head Office)
                                                               Salter's Lane, Sedgefield
                                                               Stockton-on-Tees TS21 3EE



                                                                                                                           25
      Appendix 2 – Summary of product characteristics (SmPC)
     1.   NAME OF THE MEDICINAL PRODUCT                                                  and coumarin-type oral anticaoagulants. Although a causal
          Azithromycin 500mg Tablets                                                     relationship has not been established, Clamelle Azithromycin
          Clamelle ® Azithromycin 500mg Tablets                                          500mg Tablets are contraindicated.
     2.   QUALITATIVE AND QUANTITATIVE COMPOSITION                                       Digoxin:
          Each film-coated tablet contains 500 mg azithromycin as                        Some of the macrolide antibiotics have been reported to impair
          dihydrate.                                                                     the metabolism of digoxin (in the gut) in some individuals. Since
          For excipients, see 6.1                                                        there is the possibility of raised digoxin levels, Clamelle Azithromycin
                                                                                         500mg Tablets are contraindicated.
     3.   PHARMACEUTICAL FORM
          Film-coated tablets.                                                           Disopyramide:
          Light blue, oval, biconvex tablets imprinted with PLIVA on one side            Some of the related macrolide antibiotics have been reported to
          and 500 on the other side.                                                     increase serum disopyramide levels, which can result in ventricular
                                                                                         fibrillation
     4.   CLINICAL PARTICULARS
                                                                                         Ergot derivatives:
     4.1. Therapeutic indications
                                                                                         Because of the theoretical possibility of ergotism, azithromycin and
          Treatment of confirmed asymptomatic Chlamydia trachomatis                      ergot derivatives should not be co-administered.
          genital infection in individuals aged 16 years and over and the
          epidemiological treatment of their sexual partners.                            Rifabutin:
          Consideration should be given to official guidance on the                      Co-administration of azithromycin and rifabutin did not affect the
          appropriate use of antibacterial agents.                                       serum concentrations of either drug. Neutropoenia was observed
                                                                                         in subjects receiving concomitant treatment of azithromycin and
     4.2. Posology and method of administration                                          rifabutin. Although neutropoenia has been associated with the use
          A single 1g (2 x 500mg tablets) dose.                                          of rifabutin, a causal relationship to combination with azithromycin
          It is not necessary to alter the dose in elderly.                              has not been established.
     4.3. Contraindications                                                              Terfenadine:
          Known hypersensitivity to azithromycin or any macrolide antibiotic             There is a theoretical risk of serious dysrhythmias due to
          or any of the excipients.                                                      prolongation of QTc interval.
          Relative for Azithromycin sold as a Pharmacy Medicine:-                        Theophylline:
          Symptomatic infection.                                                         Theophylline levels may be increased in individuals taking
          Symptoms suggestive of other STIs e.g. any unusal genital or anal              azithromycin.
          swellings or lesions.
                                                                                    4.6. Use during pregnancy and lactation
          Children aged under 16 years.
                                                                                         Clamelle Azithromycin 500mg Tablets are contraindicated during
          Renal or hepatic impairment.                                                   pregnancy and lactation.
          History of cardiac disease.
                                                                                    4.7. Effects on ability to drive and use machines
          Individuals receiving ciclosporin, digoxin, ergotamine, terfenadine,
                                                                                         Azithromycin has the potential to cause dizziness and somnolence.
          theophylline, disopyramide, rifabutin and coumarin anticoagulant
                                                                                         If affected, the individual should not drive or operate machinery.
          therapy, such as warfarin.
          Individuals receiving azithromycin for treatment of other infections.     4.8. Undesirable effects
          Pregnancy and breast feeding.                                                  Azithromycin is well tolerated with a low incidence of side effects.
                                                                                         The most commonly reported adverse events are gastrointestinal in
     4.4. Special warnings and precautions for use                                       nature.
          As with erythromycin and other macrolides, rare serious allergic
                                                                                         Infections and infestations
          reactions including angioneurotic oedema and anaphylaxis (rarely
                                                                                         - Rare (≥1/10,000, ≤1/1000) candidiasis
          fatal), have been reported with azithromycin (see Section 4.8
          Undesirable Effects).                                                          Blood and lymphatic system disorders
          Vomiting: To reduce the risk of vomiting, advise the individual to take        - Rare) (≥1/10,000, ≤1/1000) neutropenia
          the dose before bed and at least 2hrs after food or drink. If vomiting         - transient mild reductions in neutrophil counts have occasionally
          occurs after taking the dose pharmacist advice should be sought.                 been observed in clinical trials, however a causal relationship has
          Oral contraception: if vomiting or diarrhoea occurs whilst taking                not been confirmed thrombocytopenia
          Clamelle Azithromycin 500mg tablets refer to the oral                          Psychiatric system disorders
          contraceptive’s instructions for measures to minimise the risk of              - Rare (≥1/10,000, ≤1/1000) aggressiveness, restlessness, anxiety and
          contraception failure.                                                           nervousness
     4.5. Interactions with other medicinal products and other forms                     Nervous system disorders
          of interaction                                                                 - Uncommon (≥1/1,000, ≤1/100) dizziness, vertigo, convulsions (as
          Antacids:                                                                        seen with other macrolides), headache, somnolence, taste
          In individuals receiving azithromycin and antacids, azithromycin                 perversions, syncope
          should be taken at least 1 hour before or 2 hours after the antacid.           - Rare (≥1/10,000, ≤1/1000) paraesthesia, hyperactivity, asthenia,
          Due to interaction, Clamelle Azithromycin 500mg tablets are                      insomnia
          contraindicated if individual is concomitantly taking any of the               Ear and labyrinth disorders
          following medications (see also Section 4.3 contraindications):                - Rare (≥1/10,000, ≤1/1000) hearing impairment has been reported
          Ciclosporin:                                                                     with macrolide antibiotics. There have been rare reports of
                                                                                           hearing impairment, including hearing loss, deafness and tinnitus
          Some of the related macrolide antibiotics interfere with the
                                                                                           in some patients receiving azithromycin. Many of these have
          metabolism of ciclosporin. In the absence of conclusive
                                                                                           been associated with prolonged use of high doses in
          pharmacokinetic studies or data investigating the potential for an
                                                                                           investigational studies. In those cases where follow-up information
          interaction between azithromycin and ciclosporin, Clamelle
                                                                                           was available, the majority of these events were reversible.
          Azithromycin 500mg tablets are contraindicated.
                                                                                         Cardiac Disorders
          Coumarin-Type Oral Anticoagulants:
                                                                                         - Rare (≥1/10,000, ≤1/1000) palpitations and arrhythmias including
          In a pharmacodynamic interaction study, azithromycin did not alter               ventricular tachycardia (as seen with macrolides) have been
          the anticoagulant effect of a single 15mg dose of warfarin                       reported. There have been rare reports of QT prolongation and
          administered to healthy volunteers. There have been reports                      torsades de pointes, especially in patients at risk for prolonged
          received in the post-marketing period of potentiated                             cardiac repolaristaion (see Section 4.3 Contraindications).
          anticoagulation subsequent to coadministration of azithromycin



26
     Vascular disorders                                                           5.2. Pharmacokinetic properties
     - Rare (≥1/10,000, ≤1/1000) hypotension                                           Absorption
     Gastrointestinal disorders                                                        Azithromycin is well absorbed following oral administration and
     - Common (≥1/100, ≤1/10) nausea, vomiting, diarrhoea (rarely                      rapidly passes from serum to tissues and various organs. After a
       resulting in dehydration), abdominal discomfort (pain, cramps)                  single 500 mg oral dose of azithromycin, 37% of the drug is
     - Uncommon (≥1/1,000, ≤1/100) loose stools, flatulence, digestive                 absorbed, and a peak plasma concentration (0.41ug/ml) is
       disorders, anorexia, dyspepsia                                                  achieved in 2-3 hours.
     - Rare (≥1/10,000, ≤1/1000) constipation, tongue discoloration,                   Distribution
       pseudomembraneous colitis, pancreatitis                                         Azithromycin is widely distributed throughout the body, achieving
                                                                                       high tissue concentration (up to 50 times higher than observed
     Hepatobiliary disorders                                                           concentration in plasma). Volume of distribution is approximately
     - Rare (≥1/10,000, ≤1/1000) abnormal liver function, including                    31 l/kg.
       hepatitis and cholestatic jaundice, as well as rare cases of
                                                                                       Azithromycin is rapidly distributed to a wide range of tissues and
       hepatic necrosis and hepatic failure
                                                                                       achieves high tissue concentrations ranging between 1 and 9
     Skin and subcutaneous tissue disorders                                            ug/ml, depending on the tissue. Therapeutic concentrations of
     - Uncommon (≥1/1,000, ≤1/100) allergic reactions including pruritus               azithromycin are maintained in tissues for five to seven days after
       and rash                                                                        the ingestion of last oral dose.
     - Rare (≥1/10,000, ≤1/1000) serious allergic reactions including                  Azithromycin is taken up and achieves very high concentrations in
       photosensitivity, oedema, urticaria, angioneurotic oedema, serious              phagocytic cells, which migrate to infected sites.
       skin reactions including erythema multiforme, Stevens Johnson                   Excretion
       Syndrome and toxic epidermal necrolysis.
                                                                                       Plasma terminal elimination half-life closely reflects the tissue
     Musculoskeletal, connective tissue and bone disorders                             depletion half-life of 2-4 days. Biliary excretion of azithromycin is a
     - Uncommon (≥1/1,000, ≤1/100) arthralgia                                          major route of elimination. Approximately 50% biliary excretion is in
     Renal and urinary disorders                                                       the form of unchanged compound. The other half are 10
     - Rare (≥1/10,000, ≤1/1000) interstitial nephritis and acute renal                metabolites formed by N-and O-demethylation, by hydroxylation of
       failure have been reported                                                      desosamine and aglycone rings, and by cleavage of the cladinose
                                                                                       conjugate. Comparison of HPLC and microbiological assay
     Reproductive and breast disorders                                                 suggests that metabolites play no part in the microbiological
     - Uncommon (≥1/1,000, ≤1/100) vaginitis                                           activity of azithromycin. Approximately 6% of administered dose is
     General disorders                                                                 excreted in urine.
     - Rare (≥1/10,000, ≤1/1000) anaphylaxis (see Section 4.4 Warnings                 In elderly volunteers (> 65 years), slightly higher (30%) AUC values
       and Special Precautions for Use), fatigue, malaise                              were seen than in younger volunteers (< 45 years), but this is not
4.9. Overdose, symptoms, emergency procedures, antidotes                               considered clinically significant and hence no dose adjustment is
     Adverse events experienced in higher than recommended doses                       recommended.
     were similar to those seen at normal doses. In the event of an               5.3. Preclinical safety data
     overdosage, general symptomatic and supportive measures are                       In higher-dose animal studies azithromycin has been noted to
     indicated as required.                                                            cause reversible phospholipidosis, generally without discernible
5.   PHARMACOLOGICAL PROPERTIES                                                        toxicological consequences.
                                                                                  6.    PHARMACEUTICAL PARTICULARS
5.1. Pharmacodynamic properties
     ATC code: J01FA10                                                            6.1. List of excipients
     Mode of Action:                                                                   Core:
     Azithromycin is an azalide, a subclass of the macrolide antibiotics.              Calcium hydrogen phosphate, anhydrous; Hypromellose;
     The mode of action of azithromycin is based upon suppression of                   Maize starch; Pregelatinised starch; Microcrystalline cellulose;
     bacterial RNA-dependent protein synthesis, by reversibly binding to               Sodium laurylsulfate; Magnesium stearate
     the 23S ribosomal RNA in the 50S subunit of the ribosomes.                        Film-coating:
     Mechanism of resistance:                                                          Hypromellose; Colour Indigotin (E132); Titanium dioxide (E171)
     Stable resistance to azithromycin has not been described for                      Polysorbate 80; Talc
     Chlamydia trachomatis.                                                       6.2. Major Incompatibilities
     In vitro evidence to date indicates that whilst certain point                     Not applicable.
     mutations in the 23S rRNA gene may lead to decreased sensitivity
     to macrolides, including azithromycin, such strains seem to carry a          6.3. Shelf life
     prohibitive physiological cost which may make their maintenance                   36 months.
     in the wild (i.e. dissemination in clinical cases) presently unlikely.       6.4. Special precautions for storage
     Breakpoints:                                                                      Store below 25 °C in a dry place, in original packaging.
     Chlamydiae are obligate intra-cellular pathogens. Determination
                                                                                  6.5. Nature and contents of container
     of sensitivity/ resistance to antibiotics in vitro requires a cell culture
     technique which is inappropriate for routine monitoring of                        Blisters (PVC/Al foil) packed in a carton box containing 2 tablets.
     resistance. The complexity of the chlamydial life cycle is such that         6.6. Special orecautions for disposal
     a universally agreed method for determining mininmal inhibitory                   There are no special instructions for disposal.
     concentratons and breakpoints of anibiotics is not available.
                                                                                  7.    MARKETING AUTHORISATION HOLDER
     Comparative activity of antibiotics on chlamydia can be
     compared within a laboratory using the same method. Qualitative                    PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield,
     results can be compared between laboratories, but cauton is                        Hampshire, GU32 3QB
     required when applying numerical values to comparative data in               8.    MARKETING AUTHORISATION NUMBER
     this setting.                                                                      PL 10622/0164
     The prevalence of acquired resistance may vary geographically                9.    DATE OF FIRST AUTHORISATION OR RENEWAL OF THE AUTHORISATION
     and with time for selected species and local information on
     resistance is desirable, particularly when treating severe infections.             17th May 2004
     As necessary expert advice should be sought when the local                   10.   DATE OF REVISION OF THE TEXT
     prevalence of resistance is such that the utility of the agent in at               July 2008
     least some type of infectons is questionable.
                                                                                        LEGAL CLASSIFICATION
     Stable resistance to azithromycin has not been described for                       P
     Chlamydia trachomatis.




                                                                                                                                                                 27
      Appendix 3 – Communication and behavioural skills for the sexual health consultation

                                                                       Stopping, listening and asking open questions is the best
       Pharmacist attitudes and embarrassment                          way to cope with such situations that occur quite often in

       Before taking part in a sexual health consultation, it is       sexual history taking. For instance, if people want to have

       important to consider your personal feelings about sex,         tests for other infections including gonorrhoea, HIV, syphilis or

       different sexual cultures, orientations and preferences.        to seek hepatitis tests and vaccination, then they should be

       Men and women come from all walks of life, but                  given information about their local GUM clinic (see section

       disapproving attitudes by healthcare professionals is a         on Signposting).

       well recognised problem. Also, to help you avoid any
       embarrassment yourself when discussing sexual health            Language / words:
       issues, it is a good idea for you to explore the language       It is important to use words that individuals will understand.
       that you feel comfortable using.                                Clearly, this depends on the level of education, culture and
                                                                       ethnic background of the individual ,and it is most likely
                                                                       that pharmacists will be very experienced in choosing the
       Customer embarrassment                                          most appropriate word. However, it can become difficult for
                                                                       healthcare professionals when individuals either clearly do
       The questionnaire which is filled in by the patient goes
                                                                       not understand (and it is important that the healthcare
       a long way towards putting customers at ease and
                                                                       professional recognises this early), or reply in the vernacular
       more comfortable with a follow-on in-depth
                                                                       or using slang. Should the healthcare worker then use the
       consultation with the pharmacist about sexual health.
                                                                       words that the patient has chosen to describe sexual acts
       But remember that it often takes time for a person to
                                                                       or parts of the genitalia or return to their more comfortable
       summon the courage to discuss a sexual problem. You
       should always ensure you have sufficient time to                medical use?

       devote to a sexual health consultation and schedule             The answer lies in the healthcare worker and the individual
       additional appointments if necessary. Watch for signs           should try to be as comfortable as possible with the
       of unease in body language and encourage people                 phraseology being used by the individual, but also to
       to feel relaxed when relating their problems to you.            ensure that they do not make themselves uncomfortable,
       Signs of unease might include a ‘bolt upright’ position,        or to be lured into trying to compete with evermore loose
       flushing on the chest and neck and nervous hands.               or offensive language by the individual client.


     The key facts need to be conveyed to the individual in a          Managing the consultation:
     non-judgmental manner and one which makes no
                                                                       It is important for any healthcare professional to be able to
     assumptions about their previous sexual experience,
                                                                       manage the consultation and not to be led by it. It is
     orientation or desire. It is very important that the pharmacist
                                                                       important that individuals are encouraged to learn about
     observes carefully and is empathetic to the individual’s
                                                                       their bodies, about STIs, and also about how to enjoy and
     reaction. If someone is becoming upset it is very important to,
                                                                       express themselves sexually in the safest way possible. This
     at any point, stop and ask the individual why they are
                                                                       is something which some healthcare workers feel more
     becoming upset and whether they wish to continue.
                                                                       comfortable with than others, but only by practice and
     Sometimes this will be just because people are shocked at the
                                                                       attending appropriate courses and development can
     nature of the discussion they are having, or because of some
                                                                       individuals develop these skills. Organisations such as the
     intimate, personal issue or secret that they then need to
                                                                       British Association for Sexual Health and HIV (BASHH), as well
     choose whether to share, or not, with the healthcare
     professional.                                                     as your local GUM clinician should be able to assist you in
                                                                       developing these skills.




28
Communication skills considerations

Counselling customers on sexual health issues is not new
in pharmacy. However, there may be particular areas
                                                               How do you overcome your own embarrassment?
                                                                Are there questions you can build into a routine to
that need consideration when dealing with an STI. The

                                                            
                                                                help you overcome this?
following checklist gives pointers and helps you identify
                                                                What is the ideal language to use for different


areas where further training may be needed.
                                                                types of people, different age groups and
      How would you opportunistically raise the subject

                                                            
                                                                different cultural and backgrounds?



      for discussion without offending customers?
                                                                Which words/type of language should you avoid?
      How would you tackle the issue of partner

                                                            
                                                                Which common colloquialisms would people use?



      notification?
                                                                Read up on case studies/scenarios to give you an



      What is the appropriate body language to use?

                                                            
                                                                idea of a typical conversation



      How would you use open and closed questions?
                                                                Anticipate common misunderstandings and how


                                                            
      What are the barriers to overcome when dealing            you could deal with them



      with the opposite sex?
                                                                Think about the appropriate level of privacy
      How do you deal with embarrassed customers                needed in the pharmacy environment for


                                                            
      and what would you do to help alleviate                   carrying out a consultation
      embarrassment?
                                                                Produce a check list of 'do's' and 'don'ts'




Notes




                                                                                                                      29
      Appendix 4 – NHS services and NHS individuals’ proforma
     4a NHS chlamydia services                                      • GP surgeries

     • Genitourinary medicine clinics                                  Some individuals are happy to discuss sexual health
                                                                                           .
                                                                       matters with their GP Testing is free but individuals will
       These clinics are often located within a hospital
                                                                       need to pay for a prescription (if issued) unless they are
       and offer a full range of services including testing,
                                                                       exempt from NHS charges. Some patients prefer to refer
       counselling, treatment for all STIs and partner
                                                                       themselves to sexual health clinics confidentially, without
       notification. Testing and treatment are free.
                                                                       needing to involve their GP and without information
     • National Chlamydia Screening Programme (NCSP)                   being passed back to their GP    .
       The NCSP (introduced in 2003) offers opportunistic
       community-based screening for genital chlamydial
       infection for men and women aged under 25 years              4b NHS individuals choosing to purchase
       through the NHS in England. Anyone testing positive for      Clamelle
       chlamydia is offered free treatment (first line treatment    Clamelle can only be sold to NHS test-positives and
       with azithromycin 1g single dose), advice and partner        partners of NHS test-positives if the customer first agrees to
       notification (to encourage the treatment of sexual           complete the proforma for NHS individuals. This should be
       partners and avoid re-infection). All partners (regardless   done before the individual completes the Clamelle
       of their age) are offered free treatment.                    questionnaire. The pharmacist should explain to the
       Most venues only offer a chlamydia service. A small          individual that as they (or their sexual partner) were tested
       minority also offer a gonorrhoea testing service but this    within the NHS, their details will need to be sent back to the
       is funded separately through the Primary Care                NHS venue where they (or their sexual partner) were tested,
       Organisation (PCT).                                          to inform the venue that treatment has been supplied and
                                                                    matched against the NHS positive test record.
       NCSP venues are more community based to try to
       improve access. The most common screening venues             All individuals should be made aware of their options for
       are community contraceptive services (CCS), young            treatment and that they can receive free treatment
       people’s clinics, general practice and educational           through NHS sexual health services (there is a prescription
       establishments.                                              charge if they visit their GP and they have to pay for their
                                                                    prescriptions).
       Some community pharmacies are involved in the NCSP
       but the numbers are small (2006/7 figures – accounting
       for only 2% of NCSP venues). They provide access to free
                                                                    NHS test-positive index patients
       NCSP test kits. Some also supply antibiotic treatment to
       test positives under an NHS Patient Group Direction          These are patients who have had a positive test result from
       (following appropriate training).                            a test they had carried out at an NHS venue. Some
                                                                    individuals from GUM and NCSP may have been notified of
       Some, but not all of the NCSP testing sites also offer
                                                                    their positive test result by letter/test report. The majority
       treatment – this varies locally. The Chlamydia Screening
                                                                    receive results by SMS text – the message does not state
       Office (CSO) provides treatment. GUM clinics can also
                                                                    that the result is positive, it will usually just request that the
                                           .
       act as treatment venues for NCSP Over the last couple
                                                                    recipient phones a specific number (the testing site).
       of years, the number of individuals accessing treatment
                                                                    Individuals then receive their result over the phone.
       through the community based sites has increased.23
                                                                    Patients accessing sexual health services through their GP  ,
       Individuals aged 25 years and over are not eligible for
                                                                    are most likely to be informed of their result in a face to
       the NCSP but can obtain free supply from a GUM clinic
                                                                    face consultation or by phone.
       or obtain a prescription from their GP (see below).
                                                                    Ask the individual how they were informed of their positive
     • Community sexual health clinics                              test result:
       These include community contraceptive services and           • If they were provided with a letter/test report ask if they
       young people’s clinics. These may or may not be part of        have this on them. Transfer the details from the letter/
                .
       the NCSP They offer free testing and treatment.                test report (including URN) onto the NHS proforma and
                                                                      ask the customer to complete the rest of the proforma




30
• If they were informed by phone, text, by their GP surgery         If longer than six months, the individual needs to be re-
  or do not have their letter/test report on them, ask them         tested. They can be offered a test kit or if they prefer,
  to complete the NHS proforma.                                     signposted to an NHS venue.
Only individuals with chlamydia and no other STI can be
                                                                 In all cases:
considered for Clamelle supply.
                                                                 • The individual must sign the consent on the proforma,
The individual must complete the “NHS test-positive” part of
                                                                   confirming they have been sold Clamelle and giving
the proforma. The following information is needed:
                                                                   permission to the pharmacist to send their form back to
• Name                                                             the testing venue
• URN (if available)
                                                                 • The pharmacist must stamp and date the NHS proforma
• Postcode                                                         and post it to the address provided of the NHS sexual
• Date of birth                                                    health venue as soon as possible within five working days
• Address of NHS testing venue where they were tested            • As these completed proformas contain confidential patient
  for chlamydia                                                    information, they need to be stored securely out of sight of
• Date of test (Clamelle can be sold within a two week             patients, members of the public or any person who should
  window of the date of the NHS test. If longer than two           not have access to them. This is in line with other types of
  weeks, the individual should be referred back to their           confidential patient information that pharmacists have to
  NHS testing venue)                                                store securely and is covered in the RPSGB Professional
• Has the individual also tested positive for gonorrhoea?           Standards and Guidance for Patient Confidentiality.
  If they have, they cannot be sold Clamelle and should be
  signposted/fast tracked to their original testing site or if
  this is not local, signpost to a local GUM clinic (see the
  adjacent box on NHS individuals and gonorrhoea positives).        NHS individuals – gonorrhoea positives

                                                                    Some NHS individuals may also have been tested
Partners of NHS test-positives                                      for gonorrhoea at the same time they were tested
These are partners of patients who have been tested at an           for chlamydia. It is important that the pharmacist
NHS venue. The individual must bring in their NHS Partner           checks if this was the case when they fill in the
Notification slip as proof.                                         proforma, and what the result was. If they also
                                                                    tested positive for gonorrhoea, Clamelle cannot be
Format and content of PN slips vary locally, however all
                                                                    sold and the individual should be signposted/ fast
usually contain a URN number and the address of the
                                                                    tracked to their original testing site or if this is not
issuing NHS venue.
                                                                    local, then to a local GUM clinic.
They also contain index patient diagnosis in coded format.
                                                                    If an individual presents with an NHS PN slip, they
Only C4A or C4C codes with no other letters or digits can
                                                                    can only be considered for Clamelle supply if the
be considered for Clamelle supply. Any other code
                                                                    disease code on the PN slip is C4A or C4C. If any
(including those containing C4A or C4C in combination
                                                                    other code (including those with C4A or C4C in
with other letters or digits) means that the index patient
                                                                    combination with other letters or digits) is on the PN
also tested positive for another STI. In these cases, the
                                                                    slip, Clamelle cannot be sold and the individual
partner cannot be sold Clamelle and must be signposted
                                                                    must be signposted to a GUM clinic.
to a local GUM clinic.

Important: This coding is for healthcare professional use           It is important these individuals are referred for
only. Do not share the coding with customers.                       appropriate specific treatment of their gonorrhoea
                                                                    at the same time their chlamydia is treated. This is in
The individual must fill in the “partner” section of the NHS
                                                                    line with HPA guidance24 and is to minimise risk of
proforma. The following information is needed:
                                                                    azithromycin resistance in gonorrhoea. Azithromycin
• URN number
                                                                    is not recommended in national guidelines for
• Address of NHS testing venue on the PN slip                       management of gonorrhoea.
• Date on PN slip (or date PN slip received by customer if
  no date on slip)                                               Find out if your PCO is offering dual screening for chlamydia
   • Clamelle can be sold to partners with NHS PN slips within   and gonorrhoea for under 25-year-olds – see Establishing
     a six month time window of the date on the PN slip.         links with local sexual health network, within Stage 5
                                                                 Signposting, page 19.



                                                                                                                                  31
     4c Clamelle NHS proforma




       NHS Proforma
       Information which should be requested from NHS positive index patients or partners of positive patients
       1. NHS positive index patient

          URN:
          Name:


          Postcode:
          Date of birth:                  D    D   /   M    M    /   Y   Y    Y    Y

          Name and address of NHS test site e.g. local GUM clinic, NCSP venue, community contraception
          clinic, GP surgery:


                                                                             Postcode


          Date of test:                   D    D   /   M    M    /   Y   Y    Y    Y

          Were you tested
          for gonorrhoea?                Yes           No       If ‘yes’ please discuss this with the pharmacist

       2. Partner of NHS positive index patient

          URN of index patient:
          Name and address of NHS test site where index patient was tested e.g.
          local GUM clinic, NCSP venue, community contraception clinic, GP surgery:



                                                                             Postcode

          Date notification slip           D    D   /   M    M    /   Y   Y    Y    Y
          was issued:
           Pharmacist to complete:
           Partner notification slip denotes chlamydia only. Can be considered for Clamelle              Yes        No

       3. Declaration and consent
        I declare the information I have given is correct and to the best of my knowledge               Yes

        I declare I have given the pharmacist permission to send this form back to the NHS test site
        stated above and that I have been supplied with Clamelle azithromycin 500mg tablets             Yes


       Customer Signature:                                                    Date:

           4. Pharmacist to complete:
           Clamelle azithromycin 500mg tablets supplied
                                                                                                       Pharmacy Stamp
           Date:

32
       2008 OTC 0658
Appendix 5 – Clamelle patient questionnaire (double sided) page 1




        Azithromycin 500mg Tablets

   Patient Questionnaire
   Please answer the questions below by ticking the boxes that apply to you.
   Please complete both sides of this questionnaire.
   If you are unsure about any of the questions, leave them blank and the pharmacist will help you.

    About your chlamydia test:                                                 About you and your health:
    1. I confirm that:                                                          4. I am          under 16 years old              16 years of age or over
       I have had a chlamydia test and my result was
                                                                               5. Tick if you have any of the following symptoms:
               positive (go to question 3)
                                                                                  Females
               negative (speak with pharmacist)                                          pain when passing urine
               I have not had a chlamydia test (go to question 2)                         unusual vaginal discharge
                                                                                          pain when having sex
    2. I confirm that I have been given/sent a partner notification
                                                                                          bleeding between periods
       slip from one of my sexual partners, informing me that they
       have tested positive for chlamydia, and I have the partner                         bleeding after sex
       notification slip with me.                                                          any unexpected pain below your belly button
               Yes (go to question 4)                                              Males
               No (speak with pharmacist)                                              discharge from penis
                                                                                          pain when passing urine
    3. I had my test carried out through:                                                 any pain or swelling in your testicles
               Pharmacy/Chemist
               Genito-Urinary Medicine (GUM) Clinic                            6. Do you have any unusual lumps, bumps, blisters or sores
                                                                                  around your genital area or back passage?
               Family Planning Clinic
                                                                                       Yes                No
               GP
                                                                               7. Do you have any unexpected or worsening joint pain?
                                                                                       Yes              No
              Other venue (please state where)
                                                                               8. Do you have any unexpected or worsening conjunctivitis
        .................................................................         (itchy/sore eyes)?
                                                                                        Yes             No
        .................................................................
                                                                               9. Tick here if you have none of the symptons listed
        .................................................................
                                                                                   in sections 5-8

                                                                                              Now please turn over for questions 10 to 15


                                                                            Pharmacy Stamp and Date:
                                                                            See reverse side of slip – pharmacist to complete

       Azithromycin 500mg Tablets
                                                                             Advice
   Patient Advice Slip
   Keep this slip safe. If your pharmacist has referred you to              • Don’t have sex, even with a condom, until seven days after you and your
                                      ,
   a sexual health venue or your GP or you choose to go for                   partner have been treated, otherwise you can become reinfected.
   tests for other sexually transmitted infections (STIs), take this        • Using a condom can help reduce your risk of getting or passing
   Clamelle patient advice slip with you when you attend.                     on chlamydia and other sexually transmitted infections (STIs),
                                                                              such as gonorrhoea, syphilis, HIV.
                                                                            • If you have tested positive for chlamydia, your current sexual partner and
                                                                              recent partners will also need to be treated.They should also receive
                                                                              advice from a healthcare professional.There are a number of ways that
                                                                              partners can be contacted confidentially, for example, partner notification
                                                                              slips.Your pharmacist can tell you how to go about this.
                                                                            • If you have tested positive for chlamydia, you are also at higher risk of
                                                                              other STIs like gonorrhoea. It is important that you visit a local sexual health
                                                                              venue to be checked for this.Your pharmacist can advise you on this.
                                                                                                                                                                 33
     Appendix 5 – Clamelle patient questionnaire (double sided) page 2




            Azithromycin 500mg Tablets

         About you and your health (continued):                            Pharmacist to complete this section:
         10. Have you ever had liver or kidney problems, now or
                                                                           Outcome of consultation:
             in the past?
                                                                               Clamelle supplied
                   Yes              No
                                                                                   Not supplied & individual referred to:
         11. Have you ever had heart problems, now or in the past?
                                                                           ..........................................................................
                  Yes                 No

         12. Are you allergic to azithromycin or macrolide antibiotics?    ..........................................................................
                  Yes                  No
                                                                           Reason for referral:
         13. Females only
             Are you, or might you be pregnant?             Yes       No   ..........................................................................

            Are you breastfeeding?                          Yes       No   ..........................................................................

         About your medicines:                                             Advice given on:
         14. Have you taken Clamelle tablets or been treated for
                                                                                   chlamydia infection
             chlamydia within the last six months?     Yes       No
                                                                                   abstaining from sex for 7 days after treatment
         15. Tick if you are taking any of the following medicines:                safe sexual practice
                  ciclosporin (to help prevent rejection of transplant             partner notification & treatment
                  organs or for use in arthritis or skin problems)
                                                                                   other STIs - importance of full STI check & signpost
                  digoxin (for heart disorders)
                                                                                   to local venues
                  ergotamine (for migraine or poor blood flow)
                  terfenadine (to treat allergy and hayfever)              Date:
                  theophylline (for asthma)
                                                                           ..........................................................................
                  disopyramide (for irregular heart rate)
                  rifabutin (for tuberculosis)                             Pharmacist name:
                  anticoagulants such as warfarin (to thin the blood)
                                                                           ..........................................................................
                  azithromycin (for other infections e.g. respiratory,
                  sinuses, ear, skin)
                  oral contraceptives (the pill)                           Pharmacist signature:

                  antacids (indigestion remedies)                          ..........................................................................




                                                                           Pharmacist to complete this section:
            Azithromycin 500mg Tablets
                                                                           Outcome of pharmacy consultation:
        Patient Advice Slip                                                   Clamelle supplied
                                                                                   Not supplied & individual referred to: . . . . . . . . . . . . . . . .

         Pharmacy Stamp & Date:                                            .....................................................................
                                                                           .....................................................................

                                                                           Reason for referral: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
                                                                           .....................................................................

                                                                           Pharmacist Initials:

                                                                           .....................................................................
34
                                                                                                                                                                             2008-OTC-0442
 Appendix 6 – Signposting template and local key contacts
6a: Signposting template –
                                                              Local sexual health services and useful contacts in the
local sexual health venues
                                                                                                                  area
Complete this template for your local area and keep a
master copy safe. It can be photocopied and used to provide
to customers, when you are signposting them.
                                                              Genitourinary medicine (GUM) clinics:
                                                              1:
 PHARMACY STAMP
                                                              Address:
                                                              Opening hours:

                                                              2:
                                                              Address:
                                                              Opening hours:

 GP surgeries:
 1:                                                           Family planning clinics:
 Address:                                                     1:
 Opening hours:                                               Address:
                                                              Opening hours:
 2:
 Address:                                                     2:
 Opening hours:                                               Address:
                                                              Opening hours:
 3:
 Address:
                                                              Other community sexual health clinics:
 Opening hours:
                                                              1:
 4:                                                           Address:
 Address:                                                     Opening hours:
 Opening hours:
                                                              2:
                                                              Address:
 Services for young people
                                                              Opening hours:
 National Chlamydia Screening Programme (NCSP)
 venues (England only):
                                                              Other services (e.g. Brook clinics):
 1:
                                                              1:
 Address:
                                                              Address:
 Opening hours:
                                                              Opening hours:
 2:
                                                              2:
 Address:
                                                              Address:
 Opening hours:
                                                              Opening hours:
 3:
 Address:
                                                               Useful numbers/websites
 Opening hours:
                                                               • Sexual Health helpline 0800 567 123
 4:                                                            • NCSP website www.chlamydiascreening.nhs.uk/
 Address:                                                      • NHS Direct (England and Wales) 0845 46 47
 Opening hours:                                                  www.nhsdirect.nhs.uk/
                                                               • NHS24 (Scotland) 08454 24 24 24 www.nhs24.com/
                                                               • (FPA) helpline: England and Wales 0845 122 8690
                                                                 9am to 6pm Monday to Friday; N Ireland 028 90 325 488
                                                                 9am to 5pm Monday to Thursday; 9am to 4pm Friday
                                                                 www.fpa.org.uk/
                                                                                                                         35
     6b: Local key contacts list – sexual health network
     (For pharmacy use only)

     Complete this list for your local area. This sheet can be photocopied and kept in the pharmacy for pharmacist
     ready reference.



      GUM clinics                                                    NCSP

      1:                                                             Chlamydia Screening Coordinator



      GUM Consultant                                                 CSO phone number



      Health Advisor/GUM nurse



      Phone Number                                                   Family planning clinic

                                                                     Contact name

      Fast track number (healthcare professional use only)

                                                                     Phone number




      2:



                                                                     PCO
      GUM Consultant
                                                                     PCO Sexual Health Lead


      Health Advisor/GUM nurse
                                                                     Phone number


      Phone Number



      Fast track number (healthcare professional use only)




36
 Appendix 7 – Resources
Further reading/sources of training                          • Sexual health line. Free confidential advice on STIs,
• Centre for Pharmacy Postgraduate Education (CPPE)            sexual health and local services.

  Sexual Health, Testing and Treating – open learning pack     Tel: 0800 567 123 (24 hours).

  and workshop. Dealing with difficult discussions – open    • Sexwise advice line. Free confidential advice on sex,
  learning pack. Emergency Hormonal Contraception –            relationships and contraception for anyone under 18.
  open learning pack. www.cppe.manchester.ac.uk                Tel: 0800 28 29 30 (7am–midnight).

• NHS Education for Scotland                                 • NCSP website. Information about screening in England
  (NES) distance learning pack.                                for under 25-year-olds. Patient site and a healthcare
  www.nes.scot.nhs.uk/pharmacy/                                professional site. Contact details for your local region.
  courses/distance/course/default.asp?id=56                    www.chlamydiascreening.nhs.uk

• British Association for Sexual Health and                  • Condom Essential Wear website. Information about
  HIV (BASHH)                                                  STIs, safe sex, where to get help, sexual health clinic
  Sexually transmitted infection foundation (STIF) course.     locator www.condomessentialwear.co.uk
  Provides training in attitudes, skills and knowledge for
                                                             • Royal Pharmaceutical Society of Great Britain
  managing STIs. Run at regional level.
                                                               leaflet: Ask about Sexual Health. A Customer Leaflet
  www.bashh.org/education_training_and_careers/stif
                                                               providing information can sexual health advice people
  BASHH website also has a GUM clinic locator
                                                               can get from pharmacy.
• Chlamydiae.com
                                                             • Marie Stopes International. Range of sexual and
  Information for health professionals and patients.
                                                               reproductive healthcare services (information, advice
  www.chlamydiae.com
                                                               support). Includes resources and leaflets.
                                                               Tel: 0800 300 8090. www.mariestopes.org.uk

                                                             • Terence Higgins Trust. A range of services (information,
Organisations, websites, phone numbers
                                                               advice, support) on STIs, HIV, sexual health matters.
Additional sources of information for pharmacists and to
                                                               www.tht.org.uk
pass on to customers:
                                                             • Men’s Health Forum. All aspects of mens’ health –
• FPA. Confidential information and advice, booklets on
                                                               includes chlamydia. Tel: 0207 922 7908.
  individual methods of contraception, common STIs,
                                                               www.menshealthforum.org.uk
  planning a pregnancy, details of contraception clinics,
  sexual health clinics and GUM clinics.
  Helpline: 0845 122 8690. (Monday to Friday 9am–6pm).       • Fertility UK. National fertility awareness and natural
  Information on chlamydia                                     family planning service. Information, advice, support. Also
  www.fpa.org.uk/information/leaflets/documents_               education for healthcare professionals. www.fertilityuk.org
  and_pdfs/detail.cfm?contentid=128                          • Department of Health. Information on chlamydia.
                                                               www.dh.gov.uk/en/Publichealth/Healthimprovement/
• Brook. Services and advice for young people on               Sexualhealth/Chlamydia/index.htm
  contraception, STIs and unwanted pregnancy.                • Health Protection Agency. Information and statistics
  Tel: 0800 0185 023 (Monday to Friday 9am to 5pm)             about STIs. www.hpa.org.uk/web/home
  www.brook.org.uk/content/

• NHS Direct.                                                Where to order or download leaflets on sexual health and
  Tel: 0845 46 47                                            chlamydia and point of sale materials:
  www.nhsdirect.nhs.uk/
                                                             FPA: www.fpa.org.uk/shopping/detail.cfm?contentid=295
• NHS 24.                                                    NPA: www.npa.co.uk
  Tel: 08454 24 24 24 (Scotland)
                                                             THT: www.tht.org.uk/
  www.nhs24.com




                                                                                                                             37
      Appendix 8 – Frequently asked questions (FAQs)
     1 What advice should I give a customer with chlamydia who              - They may be concerned because they used their test kit
       has vomited after taking Clamelle treatment?                           less than two weeks after they had unprotected sex. In this
        If the customer has vomited within 3 hours of taking                  case, it is advisable to carry out another test two weeks after
        Clamelle, it may not be effective in clearing up the                  their last exposure. They can purchase another test kit, or if
        chlamydial infection. The individual should be referred to a          they prefer, can be signposted into NHS services for a retest.
        local sexual health venue or their GP .                             If the first test was equivocal?
     2 What advice should I give a customer with chlamydia who has          - All individuals with an equivocal test result are advised to
       mistakenly taken Clamelle at the same time as an antacid?              retest and they are not charged for the repeat test kit.
        Antacids reduce the absorption of azithromycin. This may            - Check how soon individual carried out their test kit after
        reduce the effectiveness of Clamelle.                                 unprotected sex
        The individual should be referred to a local sexual health            o If it was less than two weeks, there is a possibility that
        venue or their GP.                                                      they may be infected, but it can take up to two weeks
     3 What should I do if a customer returns to the pharmacy for               for the chlamydial infection to be detected by the
       Clamelle treatment after they have already received treatment?           NAAT test. Advise they use their free retest kit two weeks
                                                                                after their last exposure
        Enquire as to why they have returned:
                                                                              o If the test was carried out correctly (at least two weeks
        • If they are symptomatic they need to be referred to a
                                                                                after unprotected sex) and they have not had further
          local GUM clinic
                                                                                exposure since the first test, then they can use their free
        • If they think they have been reinfected, and have been
                                                                                re-test kit immediately.
          treated for chlamydia within the last 6 months, refer to a
          local sexual health venue                                         If the first test was positive?
        • It is not recommended that asymptomatic individuals who           They may be asking for another test for one of three reasons:
          have been treated should be retested just to confirm that         - To check to see if they are clear from infection after
          infection has cleared.                                              having been treated. If this is the case, advise there is no
                                                                              clinical need to do this (guidelines do not recommend it).
     4 What should I do if I suspect a customer requesting
                                                                              However, if they still choose to do so, then advise them to
       Clamelle is under the age of 16 years?
                                                                              allow six weeks to elapse after having finished their
        Refer individual to a local NHS sexual health venue.
                                                                              treatment before carrying out another test.
     5 How do I know if a woman has uncomplicated cystitis or               - They believe they may still be infected because they have
       if she has symptoms of chlamydial infection?                           developed symptoms of chlamydia. If this is the case, refer
        Clamelle is only indicated for treatment of asymptomatic              them to a GUM clinic.
        chlamydia. If her symptom picture is unclear or she has             - They have had unprotected sex again within a short
        symptoms and thinks she may have chlamydia, she should                period since they took Clamelle treatment (e.g. within six
        be referred to a local sexual health venue.                           weeks). In this case refer them to a GUM clinic – they need
     6 How do I know if a woman with symptoms of discharge has                GU specialist consultation.
       candidiasis or a reaction to an irritant (e.g. perfumed soap),    10 What should a pharmacist recommend if a patient has two
       or if she has symptoms of chlamydial infection?                      consecutive equivocal results?
        Clamelle is only indicated for treatment of asymptomatic            Refer them to a specialist GUM clinic.
        chlamydia. If her symptom picture is unclear or she has
                                                                         11 Individuals with one equivocal test result are advised to
        symptoms and thinks she may have chlamydia, she should
                                                                            retest and they are not charged for the repeat test kit.
        be referred to a local sexual health venue.
                                                                            How does the pharmacist get reimbursed?
     7 Can the test be supplied if there is not an accredited
                                                                            Record on GLG pharmacy database (against the equivocal
       pharmacist on site?
                                                                            test result URN) that you have issued a free repeat test kit to
        Yes.
                                                                            the individual. GLG lab will then post you out a free
     8 Can Clamelle Tablets be supplied if there is not an                  replacement test kit. See NPA Chlamydia Resource Pack for
       accredited pharmacist on site?                                       full details on managing equivocal results.
        No.                                                                 How does this re-test result link with the first equivocal
     9 How soon can a retest be performed:                                  test result?
        If the first test was negative?                                     Before you issue free re-test kit to individual, on the test
        Try to establish the reason for the individual asking to carry      request form, tick the box “For Pharmacy Use Only –
        out a retest.                                                                          .
                                                                            equivocal re-test” Replace the form into the test kit. When
        - They may have had unprotected sex again since their test          the sample and test request form are received by GLG lab,
          and are concerned. In this case they will need to retest;         it is logged on the database that it is an equivocal re-test.
          they can either purchase another test kit or if they prefer,      You verify the re-test result by the usual procedure. If this re-
          can be signposted into NHS services for a retest. Advise          test is also equivocal, the database records result as SECOND
          them that it can take two weeks after unprotected sex for         EQUIVOCAL. All individuals with SECOND EQUIVOCAL need
          the infection to be detected by testing, so they should           to be referred to a local NHS sexual health venue.
          take this into consideration when they use the test kit.




38
Notes




        39
This training material has been approved by the National Pharmacy
Association (NPA). The NPA in no way endorses any product(s),
product range(s) or treatment regimen(s) mentioned in this material.




                                                                                                                                        www.clamelle.co.uk




References
1   BASHH: 2006 UK National Guideline for the Management of              13 Hillis SD, Joesoef R, Marchbanks PA, Wasserheit JN, Cates W, Jr.,
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                                                                         14 Testing for chlamydia – the “window period”. Clinical                   1               T
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                                                                         18 Hopkins et al. Clinical Toleration and Safety of Azithromycin.
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                                                                         19 Periti etal. Adverse effects of Macrolide antibacterials.
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                                                                                                                                                    10              T
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                                                                         21 www.chlamydiae.com/restricted/docs/labtests/treat_
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10 PRODIGY Clinical Knowledge Summary: Chlamydia –
   uncomplicated genital                                                 23. New Frontiers: Annual Report of the National Chlamydia
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   Epidemiology: What Do We Know and What Do We Need to                  24. Resistance Alert – High level azithromycin resistance in
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12 Westrom LV. Sexually Transmitted Diseases and Infertility.
   [Review] [30 refs]. Sexually Transmitted Diseases 1994
   March;21(2 Suppl):S32-S37




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