Local Authority Service Specification (LASS)
SEXUAL HEALTH SERVICES FOR UNDER 25s, 2014-15
Content
1. Background
2. Service Aims and Outcomes
3. Service Specification
4. Clinical Governance Arrangements
5. Criteria for Eligibility and Accreditation
6. Reporting and Monitoring
7. Contacts for further information
Appendix 1
a. Issuing of condoms protocol
b. c – card monitoring and claim form
Appendix 2 - Fraser Guidelines
Appendix 3 - Patient Group Directives (PGDs)
Appendix 4 -Young People Friendly Criteria
1. BACKGROUND
1.1. Context
The Service Specification incorporates work that supports the modernisation agenda for
both sexual health services and pharmacies and will contribute to the achievement of
targets for Chlamydia Screening, reducing Teenage Pregnancy and improving Genito
Urinary Medicine (GUM) Access.
This service specification should be read in conjunction with Council policies and
professional guidance, including appropriate and relevant guidelines on the British
Association of Sexual Health and HIV website - www.bashh.org/BASHH/home ).
1.2. Essential Services
All community pharmacy services, whether offering the Service Specification or not, will
continue to provide essential services including:
1.2.1. Participating in all North Somerset Public Health-organised annual health
promotion campaigns per annum, of which sexual health is usually one.
1.2.2. Providing opportunistic sexual health advice, including the supply of Chlamydia
screening kits to young people under 25 years old, in postal boxes which are
returned to the Avon Chlamydia Screening Programme laboratory.
1.2.3. Signposting people to other services (incl. The WISH Clinic, “No Worries!”
service and their local general practitioner or specialist SH GP practice) –
including display of relevant leaflets.
1.2.4. Services who do not offer this service specification are still encouraged to meet
the young people friendly criteria (see Appendix 4) so that they can brand
themselves as offering a good sexual health service for young people.
2. SERVICE AIMS AND OUTCOMES
2.1. Aims and intended service outcomes
2.1.1. To increase the knowledge, especially among young people, of the availability of
emergency hormonal contraception1 and Chlamydia screening.
2.1.2.
To improve access to emergency hormonal contraception, treatment for
Chlamydia, pregnancy testing and sexual health advice.
2.1.3.
To increase the use of emergency hormonal contraception by women who have
had unprotected sex and help contribute to a reduction in the number of
unplanned pregnancies in the client group.
2.1.4.
To increase opportunities for young people to talk in, a confidential environment,
about their sexual health
2.1.5.
To refer clients, especially those from hard to reach groups, into mainstream
sexual health services
2.1.6.
To promote free condoms in order to reduce unwanted pregnancy and
transmission of STI’s
2.1.7.
To increase the knowledge of risks associated with Sexually Transmitted
Infections (STIs).
3. SERVICE SPECIFICATION
Community pharmacies offering the Sexual Health Service Specification will offer a clientcentred and confidential service in line with the quality criteria of our local sexual health
services for young people.
This service will include
3.1. Condom distribution
Pharmacies can issue free condoms (in bags of 10) to young people against either:
 The North Somerset 17 – 24 year old condom card (c-card)
or
 The “No Worries!” c-card
This should be used as an opportunity to offer young people an chance to talk about
their sexual health in a confidential environment.
The c-card number should be recorded on PharmOutcomes for audit and monitoring
purposes.
3.2. Condom Registration
1
Emergency contraception methods are not limited to EHC and include the use of Intra-uterine devices
(IUDs). Though this service would only supply EHC, it would raise awareness of other methods of
emergency contraception that are available and facilitate access to these.
The provider can opt to have pharmacists, dispensers or counter staff trained to register
17 – 24 year olds to receive a 17-24 c-card, through a confidential one to one
consultation (which will take around 15mins). If trained staff are not available, staff
should be able to refer young people to another pharmacy with trained staff, or to a
specialist Sexual Health GP Practice or to another local service that will be able to assist
them as soon as possible.
If the young person is under 17 they should be referred to the “No Worries!” Service for a
condom card (c-card)
Pharmacists will ensure all staff are familiar with the scheme and have up to date
information concerning referral if this is deemed appropriate
3.3. Emergency Hormonal Contraception (EHC)
Pharmacists will supply emergency hormonal contraception (EHC) to women where there
is a clinical need, in line with the requirements of the Patient Group Direction for
Levonorgestrel 1500microgram tabs (Appendix 3). The supply will be free to women
under 25 years old at North Somerset Council expense.
All women should be informed about the possibility of use of an Intra-uterine device (IUD)
as a more effective form of emergency contraception, and should be referred to a local
service as soon as possible as required.
Pharmacists will ensure all staff are familiar with emergency contraception, and have up
to date information concerning referral if no qualified pharmacist is available.
People should only be invited to buy the Pharmacy medicine product if the young person
is 25 or over
3.4. Pregnancy Testing
Appropriately trained pharmacists and other staff located in pharmacies where there is
access to toilet and hand wash facilities, can choose to provide a pregnancy test to girls
under the age of 25
A service will be provided that provides a safe environment to carry out a free pregnancy
test with a girl who has had unprotected sex and is concerned she may be pregnant. The
test will be carried out in a consultation room and appropriate counselling, advice and
referral will be made as part of the consultation according to the guidelines provided by
North Somerset
During the consultation the pharmacist/staff member will promote safer sex and the use
of effective contraceptive use.
3.5. Chlamydia
Pharmacists will participate in the Avon Chlamydia Screening Programme by offering
free treatment to people testing positive for Chlamydia, under a Patient Group Directive
for Azithromycin (Appendix 3), decreasing any delay before treatment.
Treatment will be provided according to the guidelines laid out in the PGD, on referral
from the Chlamydia Screening Programme, following a positive result.
Inclusion and exclusion criteria, detailed in the Patient Group Directive will be applied
during provision of the service. Clients excluded from the criteria will be referred to
another local service that will be able to assist them as soon as possible.eg their GP,
WISH Clinic
All pharmacy staff will be proactive in routinely promoting and offering Chlamydia test
kits to young people, as appropriate.
4. CLINICAL GOVERNANCE ARRANGEMENTS
4.1. The service will be provided in compliance with Fraser guidance and Department of Health
guidance on confidential sexual health advice and treatment for young people aged under
16 in line with the sexual health policy for North Somerset and the
4.2. The service is delivered according to the guidelines laid out in the PGDs
4.3. The pharmacy reviews its standard operating procedures and the referral pathways for the
service on an annual basis.
4.4. The pharmacy participates in regular North Somerset Public Health organised audit of
service provision.
4.5. The pharmacy co-operates with North Somerset Public Health led assessment of service
user experience e.g. through periodic ‘mystery shopping’ exercises to monitor quality.
4.6. Pharmacists will ensure all staff are familiar with the service and have up to date
information concerning referral if this is deemed appropriate.
5. Criteria for Eligibility & Accreditation
Training requirements
(details should be reported to Pubic Health and certificates shown)
5.1. Pharmacist should attend a local or complete a CPPE “Safeguarding Children” child
protection course (Every 3 years).


Emergency Hormonal Contraception training complete CPPE EHC course;
Attend Levonelle Patient Group Directive training in North Somerset, : (every 2
years or whenever PGD is substantially updated)
5.2. Chlamydia Screening
 attend Azithromycin Patient Group Directive training in North Somerset.(every 2
years or whenever the PGD is substantially updated)
5.3. A majority of staff should attend the Basic Sexual Health training provided by North
Somerset Public Health
5.4. All staff registering young people for a 17 -24 c-card should attend the condom registration
training provided by North Somerset Public Health
5.5. All staff carrying out pregnancy testing consultations should have attended the training
provided by the “No Worries!” service
5.6. All trained pharmacists and sexual health lead member of staff should attend annual
Networking and Update session with N Somerset Public Health Team
other recommended courses include:


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CPPE Sexual Health: testing and treating Open Learning Programme (8 hrs)
CPPE Dealing with difficult discussions Open Learning Programme (8 hrs)
CPPE Patient group direction (PGD) – developing and implementing them safely
6. REPORTING AND MONITORING
6.1
Invoices will be submitted automatically through PharmOutcomes for monthly
payment
6.2
Payments will not be made unless the consultation is recorded on PharmOutcomes
6.3
The remuneration is outlined in Appendix E
7 CONTACTS FOR FURTHER INFORMATION
Chris Burton
Health Improvement Co-ordinator,
Public Health Directorate, North Somerset Council
PO Box 238, Castlewood, Tickenham Road, Clevedon BS21 6FW
Tel: 01275 885525 Email: chris.burton@n-somerset.gov.uk
Avon Chlamydia Screening Programme
Karl Pye
Co-ordinator, Avon Chlamydia Screening Programme
Tel: 0117 922 2265 (General Info)
Email: csp.avon@bristol.gov.uk (Treatment record returns)
APPENDIX 1
Guidelines and checklist for condom distribution
These guidelines should be adhered to when distributing free condoms. Condoms can be
distributed against the No Worries! c-card and the 17-24 c-card.
Pasante supply the condoms, from a budget provided by North Somerset Public Health;
the condoms will carry the British Standard Kite/CE quality standard logo. (Contact Public
Health on 01275 885138 if further supplies or range of sizes are needed)
(Be aware that “No Worries!” use durex condoms and young people may need to be
reassured that the different brand should be used in exactly the same way)
A named Sexual Health Lead in the practice/pharmacy will be responsible for the
safety and storage of the condoms ordered.
Distribution Checklist
 Check the young person has a valid (in last 12 months) No Worries! c-card or the 1724 c-card.

Give 10 condoms with 2-3 tubes of lube in a bag and sealed. (Include condom
instruction leaflet, credit card and consent card).

ASK “Is there anything you would like to talk about?” If yes refer to a pharmacist or GP
or Nurse or take to consultation room if possible.

Record the condom distribution, with the c-card number, on the condom monitoring
form or in PharmOutcomes for payment and to allow stock control.

Please note
1. A new c-card and teach will need to be given annually for younger people with a
No Worries! c-card – if the young person is under 16, they should be referred to
a No Worries! Clinic. For 17 – 24 year old’s the trained professional in the
pharmacy can issue a new card.
2. Fraser Competence should have been assessed when the c-card was issued
but it is advisable to be aware of the young person’s competence.
3. Where a valid c-card is presented questions can be asked to determine the best
size and type of condom. (Any problems with condoms slipping off or breaking?)
Condom Distribution Monitoring Form – submit quarterly
Venue:
Bag issued
Card Number
Date
Name
of
person
issuing the condoms
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Please send transfer this data to PharmOutcomes for payment, audit and monitoring
purposes.
APPENDIX 2
Confidentiality
Fraser Guidelines
A doctor or other professional would be justified in giving advice and treatment
without parental knowledge or consent, provided they are satisfied:

That the young person could understand the advice given and had sufficient
maturity to understand what was involved in terms of the moral, social and
emotional implications.

That the young person cannot be persuaded to inform their parents or to allow
the professional to inform them that contraception advice was being sought.

That the young person would be very likely to begin, or continue having,
sexual intercourse with or without contraception treatment.

That, without contraception advice or treatment, the young person’s physical
or mental health would be likely to suffer.

That the young person’s best interests require the professional to give
contraceptive advice, treatment or both without parental consent.
The Fraser guidelines were issued following a House of Lords Judgment in 1985
Patient Group Direction
for the supply of
AZITHROMYCIN
by Community Pharmacists
Valid from: 1st June 2014
Expiry date: 31st May 2016
PGD Reference Number: NS/63/14
Version 1.0
January 2010, Updated January & May 2011, January 2012, December 2013
January 2010, Updated January & May 2011, January 2012, December 2013
Patient Group Direction (PGD) for the supply of Azithromycin
This patient group direction (PGD) is a specific written instruction for the supply of azithromycin to
groups of patients within the areas covered by Bristol City Council, North Somerset Council and
South Gloucestershire Council.
The majority of clinical care should be provided on an individual basis. The supply of medicines
under Patient Group Directions should be reserved for those limited situations where this offers an
advantage for patient care (without compromising patient safety) and where it is consistent with
appropriate professional relationships and accountability.
Staff Characteristics

Pharmacist registered with the GPhC who has
undertaken relevant training as specified by NHS Bristol

Has undertaken appropriate training to carry out clinical
assessment of client who requires treatment according
to the indications listed in the PGD, including use of the
Fraser guidelines.

Has undertaken appropriate training for working under
patient group directions for the supply and administration
of medicines

Has undertaken training appropriate to this PGD in line
with current requirements of the BNSSG Contraception
& Sexual Health Services Guidelines Group

Pharmacist should be familiar with the information on
azithromycin in the current BNF

All registered Pharmacists are professionally
accountable for their practice in accordance with the
GPhC. In the exercise of professional accountability
there is a requirement to maintain and improve their
professional knowledge and competence.
THE PHARMACIST MUST BE AUTHORISED BY NAME,
UNDER THE CURRENT VERSION OF THIS PGD
BEFORE WORKING ACCORDING TO IT
January 2010, Updated January & May 2011, January 2012, December 2013
Clinical Details
Indication
Male and female clients who have a positive genital
Chlamydia result following screening by the Avon
Chlamydia screening programme.
Inclusion criteria
Sexual contact of a client with a positive genital
Chlamydia result diagnosed through the Chlamydia
screening programme.
Male or female client with a diagnosis of uncomplicated
Chlamydia or a sexual contact requiring treatment.
(The pharmacy will receive confirmation from the local Chlamydia
screening office that the client tested positive for Chlamydia.)
Age – adults and young people aged 13 years and over, up
to and including those aged 24 years*
(*In exceptional circumstances, the pharmacist may use their
professional judgement to supply to a patient aged 25 years or above
provided the patient meets the PGD requirements and has been
referred by the Avon Chlamydia Screening Programme)
Young persons under the age of 16 years should be
competent under the Lord Fraser guidelines (or have
treatment consent from a carer with parental responsibility)
In a female client the risk of pregnancy is nil or negligible 2.
To re-treat client who has vomited within 2 hours of taking
the azithromycin for the treatment of Chlamydia.
Clinical Details
Exclusion criteria
Exclusion
continued
criteria
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The pharmacy has not received confirmation from the
local chlamydia screening that the presenting client has
tested positive for chlamydia trachomatis
No valid consent
Age less than 13 years
Clients aged 13 -16years who are not Fraser
competent
Age 25 years or above
2
Recent publications from the FFPRHC CEU refer to being
“Reasonably certain the woman is not pregnant” and define this as
“has not had intercourse since the last normal menses;
has been correctly and consistently using a reliable method of contraception;
is within the first 7 days of the onset of a normal menstrual period;
is within 4 weeks postpartum for non-lactating women;
is within the first 7 days post-abortion or miscarriage;
is fully or nearly fully breastfeeding, amenorrhoeic and <6 months postpartum.
Pregnancy testing if available adds weight to the exclusion of pregnancy but only if ≥
3 weeks since the last episode of unprotected sexual intercourse”.
January 2010, Updated January & May 2011, January 2012, December 2013

Exclusion
continued
criteria

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Known hypersensitivity to azithromycin or other
macrolide antibiotics (erythromycin, clarithromycin or
spiramycin) or their excipients or serious adverse
reactions with previous treatment with azithromycin
Hepatic disease
Renal impairment
Patients with myasthenia gravis or systemic lupus
erythematous
Pregnancy or breast-feeding (For women using the
contraceptive pill, compliance and effectiveness in the
current and previous cycle should be checked.)
History of cardiac disease or predisposition to QT
interval prolongation (including electrolyte
disturbances)
Known HIV infection
Known or suspected alcohol dependence
Male client presenting with ANY symptoms associated
with complicated chlamydia infection (acute testicular
pain and/ or swelling, penile discharge, urinary
symptoms such as stinging when passing urine,
concomitant conjunctivitis)
Female client presenting with ANY symptoms
associated with complicated chlamydia infection (acute
lower abdominal/ pelvic pain, interrmenstrual or postcoital bleeding, unusual vaginal discharge, urinary
symptoms such as stinging when passing urine,
concomitant conjunctivitis)
Concurrent use of any potentially interacting drugs
which includes the following medications, is an
exclusion criteria:
Ciclosporin
Coumarin type oral anticoagulants; warfarin,
acenocoumarol (nicoumalone) or phenindione.
Digoxin
Theophylline
Nelfinavir
Rifabutin
Reboxetine
Mizolastine
Colchicine
Cabergoline
Bromocriptine
Artemether with Lumefastrine
Quetiapine
Ritonavir
Oral typhoid vaccine
Ergot derivatives; ergotamine or proprietary products
containing ergotamine “Cafergot”, “Migril”.
January 2010, Updated January & May 2011, January 2012, December 2013
Also concomitant use of drugs that prolong the QT
interval such as; amiodarone, cisapride, amitryptyline
or sumatriptan.
Appendix 1 of the latest version of the BNF www.bnf.org
should be checked for a full, comprehensive list of all potential
drug interactions and go to www.medicines.org.uk (search
under ‘azithromycin’) and view Summary of Product
Characteristics (SPC) for further information.
Management
of Record the reason for exclusion / referral in the case records.
excluded patients
Record any advice given.
Inform the Avon Chlamydia screening office that
treatment has not been supplied.
Refer to a doctor, independent prescriber or the local sexual
health services, and highlight the need to seek further medical
advice.
For male clients with scrotal pain or women with acute pelvic
pain, emphasise the importance of seeking prompt advice
from another healthcare professional.
Action for patients Emphasise the importance of treatment and potential risks if
not
wishing
to not treated, for example; infertility, risks to sexual partners.
receive care under Record the refusal in the case records.
this PGD
Encourage the client to contact the Avon Chlamydia screening
office or refer to a doctor or independent prescriber where
appropriate, for example; GP or the local sexual health
service.
Record any advice given in patient’s notes.
Drug Details
Name,
form
&
strength
of
medicine
Legal classification
Azithromycin tablets (250mg or 500mg)
(Azithromycin capsules 250mg may be used if tablets are not
available)
POM
Route/Method
Oral
Dosage
1g single dose to be given preferably as a supervised dose
Maximum dose: as above
* See cautions section
A single dose as needed
of Single stat dose
Frequency
Duration
treatment
Maximum
or Single stat dose
minimum treatment
period
Quantity
to 2 x 500mg tablets or 4 x 250mg tablets
supply/administer
(4 x 250mg capsules may be used if tablets are not available)
January 2010, Updated January & May 2011, January 2012, December 2013
Cautions
Drug interactions
See exclusion section and the current edition of the BNF or
product SPC for full details of interactions.
Concurrent use of the following require special advice for the
patient
 Antacids
see “Advice to patient” section
 Combined hormonal contraception
The Faculty of Sexual Health and Reproductive Healthcare
issued guidance in January 2011 on drug interactions and
hormonal contraception15 and this no longer advises that
additional precautions are required when using combined
hormonal contraception with antibiotics that are not enzyme
inducers. The only proviso would be if the antibiotic (and/or
illness) caused vomiting or diarrhoea, then the usual
additional precautions should be observed. Condoms should
be considered for STI prevention. Also recommending that the
client avoids sexual intercourse for 7 days after both client and
partner(s) complete treatment is important.
Weight less than 45kg
The BNF for children 2011/12 states that the dose of
azithromycin for children aged 12-18 years is 1gram as a
single dose for uncomplicated genital chlamydia infections
and non-gonococcal urethritis. The SPC for azithromycin
capsules/tablets, suggests that those children under 45kg may
require a different formulation, other than a tablet or capsule.
If the client is happy to take a capsule or tablet then this can
be provided under the PGD, otherwise refer to a prescriber.
Soya or peanut allergy
If tablets are used note that they contain soya lecithin which
may be a source of soya protein and therefore, should not be
taken by clients allergic to soya or peanuts due to the risk of
hypersensitivity reactions.
January 2010, Updated January & May 2011, January 2012, December 2013
Drug Details
Side effects
Azithromycin is well tolerated with a low incidence of side
effects. The most common side effect is nausea. Other
occasional side effects include loss of appetite, vomiting
and diarrhoea. These usually settle by themselves and the
client should be reassured. Also other effects include;
convulsions, headaches, taste perversions, dizziness,
drowsiness or rarely anaphylaxis can occur.
For a comprehensive list of possible side effects please
see the latest BNF, or go to www.medicines.org.uk
(search under ‘azithromycin’).
Advise the client to contact their GP or a sexual health
clinic if the client experiences any adverse effects to the
treatment.
Any side effects should be recorded in the notes and the
client referred to a doctor where necessary.
Use the Yellow Card System to report adverse drug
reactions directly to the Committee of Safety in Medicines
(CSM). Yellow Cards and guidance on their use are
available at the back of the BNF as well as on the MHRA
website (www.yellowcard.gov.uk).
Anaphylaxis
Before administering any medication, the possibility of
anaphylaxis must be considered and appropriate medical
treatment should be available for immediate use in case of
anaphylactic reactions.
For further information, please see the resuscitation council
guidelines.
http://www.resus.org.uk/pages/glalgos.htm
http://www.resus.org.uk/pages/reaction.pdf
Advice to patient
The Pharmacist should check that the client understands
the reason for treatment and how the treatment should be
taken. The manufacturer’s patient information leaflet should
be given.
The client should be advised that the tablets may be taken
with food if the client wishes. If capsules are used these
should be swallowed whole on an empty stomach taking
the medication at least 1 hour before food or 2 hours after
food.
Advice
to
continued
Warn of side effects such as gastro-intestinal upset and
skin rash.
patient Offer verbal and written information on Chlamydia infection
and its treatment. (Information on Chlamydia and other
January 2010, Updated January & May 2011, January 2012, December 2013
sexually transmitted diseases is available from:
http://www.fpa.org.uk/helpandadvice/sexuallytransmittedinf
ectionsstis/chlamydia )
The importance of sexual partner(s) being evaluated and
treated should be highlighted.
The client should be advised to abstain from any sexual
intercourse (including protected vaginal, anal and oral sex)
whilst taking treatment and until partner(s) have completed
treatment and waited 7 days following treatment with
Azithromycin.
Discuss interactions where appropriate and if taking
antacids highlight that the client should be advised to take
the medication at least one hour before or two hours after
the antacid and may find it easier to take just before bed.
In females taking oral contraceptives, if they do experience
vomiting or diarrhoea after taking azithromycin, this may
lead to contraceptive failure. They should refer to the
instruction leaflet that comes with their oral contraceptive
pill, to minimise the risk of contraceptive failure. There is no
interaction between azithromycin and oral contraceptives;
the warning is related to risk of vomiting/diarrhoea after
taking azithromycin.
Advise the client that if they vomit within two hours of
taking the medication, it is likely they will need re-treating
and so should return to the pharmacy or to visit their GP or
the local Sexual Health Service to discuss re-treatment.
January 2010, Updated January & May 2011, January 2012, December 2013
Records and Follow Up
Referral arrangements
Records/audit trail
As per local arrangements / protocol and Avon
Chlamydia Screening Programme Protocol
Record the consultation in the patient’s medication
records, in line with the service protocol.
Ensure that the documentation meets the service’s
requirements for audit trail.
Records should include;
 Client’s name
 Address
 Date of birth (where possible)
 Consent given
 Up to date drug/medication history (prescribed,
non prescribed & complementary)
 Date and time of administration
 Batch number, expiry date and quantity of
azithromycin supplied
 Dose advised
 Name and signature of health professional
administering medicine
 Referral arrangements (including self care) and
any advice given
 Any exclusions or client refusals.
 Information or leaflets supplied to the client
 Document details of any adverse drug reactions
and actions taken
 Date and time of administration of azithromycin
Fraser guidelines followed and additional information
record sheet completed for all clients under 16 or where
competence is in doubt.
Diagnosis and suitability for treatment under PGD
confirmed with Avon Chlamydia Screening Programme
where not ascertained in full by staff operating under the
PGD.
Follow up
As per local arrangements / protocol
Re-treatment may be needed in clients who have not
completed the course of treatment or have had
unprotected sex with an untreated partner, including
within one week of starting treatment if both treated
simultaneously. If re-treatment is required refer to the
Avon Chlamydia Screening Programme, the client’s GP,
or local Sexual Health Services.
Incident Reporting
Incidents need to be reported in accordance with the local incident reporting policy.
January 2010, Updated January & May 2011, January 2012, December 2013
Reference to National/Local policy and guidelines
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Department of Health (DH), Review of Prescribing, Supply and Administration of
Medicines. Final Report 1999 www.dh.gov.uk
Department of Health (DH), Patient Group Directions (England only) (HSC) 2000/026
www.dh.gov.uk
Royal College of Nursing Patient Group Directions Guidance and information for
nurses (publication code 001370)
NMC Code of Professional Conduct (2008) www.nmc-uk.org
NMC Guidelines for Standards for Medicines Management (April 2010)
www.nmc-uk.org
British Association for Sexual Health and HIV, Clinical Effectiveness Group, 2007 UK
National Guideline on the management of Non-Gonococcal Urethritis, Updated 2008,
www.bashh.org
British Association for Sexual Health and HIV, Clinical Effectiveness Group, 2006 UK
National Guideline for Management of genital tract infection with Chlamydia
trachomatis, Guidelines – BASHH
Department of Health 2004, Best practice guidance for doctors and other health
professionals on the provision of advice and treatment to young people under 16 on
contraception, sexual and reproductive health. Gateway reference number 3382 29
July 2004
Faculty of Family Planning & Reproductive Healthcare 2005 Clinical Effectiveness Unit
Guidance; The use of contraception outside the terms of the product licence July 2005
www.ffprhc.org.uk
BMA & RPS, British National Formulary (BNF 64 March 2013)
BMA, RPS & RCPCH, BNF for Children 2011-12
Electronic Medicines Compendium accessed at www.emc.medicines.org.uk
NMC Guidelines for record keeping - guidance for nurses and midwives (2010)
www.nmc-uk.org
Family Planning Association Leaflet on Chlamydia
http://www.fpa.org.uk/Information/Readourinformationbooklets/chlamydia
Faculty of Sexual and Reproductive Healthcare Clinical Guidance, Drug Interactions
with Hormonal Contraception, January2011
http://www.ffprhc.org.uk/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
Centers for Disease Control and Prevention (CDC), Sexually transmitted diseases
treatment guidelines, 2010
http://www.cdc.gov/std/treatment/2010/chlamydial-infections.htm
Clinical Knowledge Summaries – Chlamydia – uncomplicated genital – management,
accessed 09/01/2012
http://www.cks.nhs.uk/chlamydia_uncomplicated_genital/management/scenario_chlam
ydia_uncomplicated_genital#367716006
This patient group direction must be agreed to and signed by all health care professionals involved
in its use. The PGD must be easily accessible in the clinical setting
Organisations
Bristol City Council
North Somerset Council
South Gloucestershire Council
January 2010, Updated January & May 2011, January 2012, December 2013
Contact
details for
chlamydia
screening
service
Contact
details for
Sexual Health services
Avon Chlamydia Screening Office
Tel: 0117 900 2634
Email: csp.avon.nhs.net
Bristol
Young People’s Clinic, Bristol Sexual Health service
Tel: 0117 342 6900
Brook Advisory Service
Tel: 0117 929 0090
Also see: www.4ypbristol.co.uk
North Somerset
No Worries Service (under 21)
Tel: 01934 425718
Weston Integrated Sexual Health (WISH)
Tel: 01934 881234
Also see: www.shnsomerset.co.uk
South Gloucestershire
Contraceptive and Sexual Health Service (CASH)
Tel: 0117 342 6900
No Worries
Tel: 0117 342 6900
Worth Talking About
0800 28 29 30
Also see: http://no-worries.youthunltd.com
Safeguarding
issues
(including clients not
deemed
Fraser
competent)
•
Any patient under 16 must be deemed to be
Fraser competent, and Child Protection procedures
must be followed.
•
Should a client accessing this service be
identified as having potential safeguarding issues, the
pharmacist should discuss their concerns with a
safeguarding lead to be advised on any appropriate
actions. (see contact details below)
Bristol
Designated nurse for safeguarding children
Tel: 0117 9002670
Email: Jackie.mathers@bristol.nhs.uk
Named Doctor for safeguarding children
Tel: 0117 9002670
Email: wanda.owen@nhs.net
North Somerset
Designated nurse for safeguarding and looked after
children
Tel: 01275 546758
January 2010, Updated January & May 2011, January 2012, December 2013
Mob: 07795403153
Named Doctor for child protection
Tel: 01934 515878
Mob: 07595361522
Email: mike.pimm@gp-L81643.nhs.uk
South Gloucestershire
Safeguarding Lead Designated Nurse
Tel: 07824608656
Email: sgccgsafeguarding.children@nhs.net
OR Telephone NBT switchboard (Mon-Fri, 9am-5pm):
0117 970 1212 and ask for the Child Protection Doctor
on call
(Out of Hours, telephone UHB switchboard: 0117 923
0000, and ask for the Consultant Community
Paediatrician on call)
January 2010, Updated January & May 2011, January 2012, December 2013
Individual Authorisation – Azithromycin PGD
I have read and understood the Patient Group Direction and agree to supply
this medicine only in accordance with this PGD.
PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR
ACCOUNTABILITY.
It is the responsibility of each professional to practice only within the bounds
of their own competence and in accordance with their own code of
professional conduct.
Name of Pharmacist
Signature
Date
January 2010, Updated January & May 2011, January 2012, December 2013
Azithromycin supply Pharmacist Record Sheet
(This record should be kept in the pharmacy for a minimum of 8 years if the
client is believed to be over 16 and if they are believed to be under 16 the
record should be kept until the child is 25 years old, or for eight years after a
child’s death)
OR the record may be taken and saved on PharmOutcomes and a paper
copy is then not necessary.
Pharmacy:
Pharmacist
Number:
Name
and
Registration
Client name:
(not essential)
Post code:
Chlamydia Screening Programme Number:
Date of Birth:
Age:
(if under 16 assess
Fraser Competence)
Date seen:
Time seen:
Where did you hear about this service?
Yes
Client has a Chlamydia diagnosis from the
Avon Chlamydia Screening Service
Client is a sexual contact of a client with a
positive genital Chlamydia result
Client requires re-treatment due to vomiting
within 2 hours of azithromycin administration
for Chlamydia treatment
Comments
Client is under 16 and Fraser
assessment (see overleaf) has
been completed
Any known medication or food
Allergies or hypersensitivities
Medication history assessed for
interactions
(including
non
prescribed
&
herbal/
complementary)
Current or past medical history of
relevance e.g. pregnancy, renal or
hepatic impairment, porphyria
Any symptoms of Chlamydia
complications
or
symptoms
suggestive of other STIs
January 2010, Updated January & May 2011, January 2012, December 2013
No
Fraser Guidelines
This applies to clients who are believed to be less than 16 years of age. Discussion with the
young person should explore the following issues at each consultation. This should be fully
documented and should include an assessment of the young person’s maturity. These details
can be recorded on PharmOutcomes – no paper record then necessary
Fraser Guidelines Assessment
Yes
No
Yes
No
Understands the advice given
Encouraged to involve parents
Adverse effect on the physical or mental health of the young person
if advice or treatment withheld
Action is in the best interests of the young person
Is likely to continue with sexual activity without advice or treatment
Have you covered the following:
Reason for treatment, administration information and side effects
discussed?
Azithromycin taken on premises?
Importance of sexual partner(s) being evaluated/treated?
Interaction information if appropriate?
Advise to attend GP/ CaSH if adverse effects or other concerns?
Importance of abstaining from any sexual intercourse whilst taking
treatment and until partner(s) have completed treatment and waited
7 days following treatment?
Information sheet and medication provided?
Other relevant notes:
Time taken to complete consultation ____________________________minutes
Action taken
Inclusion
Date
Client
consent
Yes
No
Exclusion
Reason:
Patient
refusal
Referral
&
any advice
Reason:


Rx
Azithromycin 1g
(4 x 250mg or 2 x
500mg)
Capsules

Tablets

Batch
number
and
expiry
date
Supervised
administration
Yes
No


Patient
Information
leaflet given
(from
Azithromycin
pack)
Yes 
No 
Reason:
The above information is correct to the best of my
knowledge. I have been counselled on the use of
Azithromycin and understand the advice given to
me by the pharmacist.
The action specified was based upon the
information given to me by the client, which, to
the best of my knowledge, is correct.
Client
Pharmacist
2012, December 2013
Signature: January 2010, Updated January & May 2011, January
Signature:
Date:
Date:
Client’s signature not essential
Patient Group Direction
for the supply of
LEVONORGESTREL
1500 microgram tablets
by Community Pharmacists
Valid from: 1st June 2014
Expiry date: 31st May 2016
PGD Reference Number: NS/62/14
Version 1.0
Patient Group Direction (PGD) for the supply of Levonorgestrel
This patient group direction (PGD) is a specific written instruction for the supply of levonorgestrel
to groups of patients within the areas covered by Bristol City Council, North Somerset Council and
South Gloucestershire Council.
The majority of clinical care should be provided on an individual basis. The supply of medicines
under Patient Group Directions should be reserved for those limited situations where this offers an
advantage for patient care (without compromising patient safety) and where it is consistent with
appropriate professional relationships and accountability.
Staff Characteristics

Pharmacist registered with the GPhC who has
undertaken relevant training as specified by the
commissioner of the service.

Has undertaken appropriate training to carry out clinical
assessment of client who requires treatment according
to the indications listed in the PGD, including use of the
Fraser guidelines.

Has undertaken appropriate training for working under
patient group directions for the supply and administration
of medicines

Has undertaken training appropriate to this PGD with
one of the three local authorities that this PGD covers.

Pharmacist should be familiar with the information on
levonorgestrel in the current BNF

All registered Pharmacists are professionally
accountable for their practice in accordance with the
GPhC. In the exercise of professional accountability
there is a requirement to maintain and improve their
professional knowledge and competence.
THE PHARMACIST MUST BE AUTHORISED BY NAME,
UNDER THE CURRENT VERSION OF THIS PGD
BEFORE WORKING ACCORDING TO IT
Clinical Details
Indication
Inclusion criteria
Emergency contraception in females presenting within 72
hours of unprotected or inadequately protected sexual
intercourse. (UPSI)
Any female aged up to and including 24 years who
presents within 72 hours of UPSI and is at risk of
pregnancy (refer to further information section for reasons
why UPSI may have occurred)
Any female aged up to and including 24 years who
presents within 72 hours of UPSI and is at risk of
pregnancy who has received treatment with progestogen
only emergency contraception (POEC) for this episode of
UPSI and vomiting has occurred within 3 hours of taking
the tablet (SPC recommendation)
Young persons under age 16 should be competent under
Lord Fraser guidelines (or have treatment consent from a
carer with parental responsibility)
Clinical Details
Exclusion criteria
 Aged 25 years or over
 This episode of UPSI occurred more than 72 hours ago
 Known hypersensitivity to levonorgestrel or any ingredient
contained in the product.
 Galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption. This product contains
lactose.
 Pregnancy or suspected pregnancy e.g. menstrual
bleeding overdue or UPSI in the same cycle >72 hours
previously and no emergency contraception used. If the
menstrual cycle is late but a full sexual history and/or
negative pregnancy test has been performed at the correct
interval (3 weeks post penultimate episode of UPSI) and
pregnancy has been excluded, then EHC may be given
under this PGD.
 Less than 21 days post partum
 Non-active or active acute porphyria (see current BNF for
more detail)
 Unexplained or unusual menstrual bleeding
 Acute severe liver disease
 Acute episode of Inflammatory Bowel Disease or Crohns
Disease. These conditions may affect the absorption of
POEC. Women whose disease is active should be advised
that insertion of an IUD would be the most effective
emergency contraception for them and referred
accordingly
 Two known previous episodes of supply of emergency
contraception within this menstrual cycle
 No informed consent for treatment provided
 The patient wishes to see a doctor.Taking selegiline,
ciclosporin, tizanidine or ulipristal (see section on
interacting drugs)
 Current breast cancer
 If UPSI occurred in the 12 hours following a treatment
dose of levonorgestrel progesterone only emergency
contraception(POEC). (The FSRH advises that if further
UPSI occurs within 12 hours of a dose of POEC, further
POEC treatment is not required.)
Cautions
and
further information
Management
excluded patients
 Emergency post-coital intrauterine device (IUD) should
always be considered as a more effective alternative when
emergency contraception is required
 If under 13 years of age, follow local safeguarding policy
 If individual vomits within 3hours from ingestion, a repeat
dose may be given
 UPSI may have occurred as a result of any of the
following. The Additional notes on page 13 contains
further information to assist pharmacists assessing the
clinical need for POEC treatment
- No contraception used
- Barrier method failure e.g. slipped or split condoms,
diaphragm or cap inserted incorrectly or dislodged during
intercourse or found to be torn/damaged or removed too
early.
- Prolonged oral contraceptive pill or patch or ring free
interval including vomiting or diarrhoea due to medication
and/or illness leading to a prolonged contraceptive pill or
patch or ring free interval
- Complete or partial expulsion of an intrauterine
contraceptive device (IUCD) including mid-cycle IUCD
removals
- Late or missed Depo-Provera contraceptive injection. i.e.
last injection administered more than 14 weeks ago.
of Discuss reasons for exclusion
Refer patient to a GP or the sexual health clinic as appropriate
(see page 15) for further discussion and treatment
If more than 72 hours but less than 120 hours (5 days) since
the latest episode of UPSI alternative methods that should be
discussed with the woman include:
1. Intrauterine contraceptive device (IUCD) can be inserted up
to 120 hours after the first episode of unprotected sexual
intercourse or within 5 days of the earliest expected date of
ovulation. Refer to the local sexual health clinic or a GP with
emergency coil fitting services
2. Efficacy of levonorgestrel 1500 micrograms has been
demonstrated up to 96 hours after UPSI and may be supplied
by a GP or local sexual health service.
3. Ulipristal acetate (ellaOne®) is licensed for use up to 120
hours following UPSI. This is not available on PGD and
therefore will require referral to the local sexual health service
or a GP.
Document reason for exclusion in client’s record including any
advice given, and suggested referral destination
Action for patients Refer to local sexual health service or their usual GP
not
wishing
to
receive care under Document treatment declined in client’s record including the
this PGD
reason for declining treatment if known, any advice given
included suggested referral destination
Drug Details
Name,
form
& Levonorgestrel 1500 microgram tablets
strength
of
medicine
Legal classification POM-Prescription Only Medication
Route/Method
Oral
Dosage
One tablet to be taken as a single dose as soon as possible
and no later than 72 hours after UPSI. (dose can be repeated
if vomiting occurs within 2 hours of first dose – see inclusion
criteria.)
Two tablets to be taken as a single dose as soon as possible,
and not later than 72 hours after UPSI for women taking liver
enzyme inducing drugs or taking liver inducing enzymes in the
last 28 days if they are ineligible or do not wish to have an
intrauterine emergency method (dose can be repeated if
vomiting occurs within 2 hours of first dose – see inclusion
criteria). See page 8 for further information on enzyme
inducing drugs.
Maximum treatment Treatment for two separate episodes of UPSI may be supplied
period
in each menstrual cycle and repeated use of POEC in one
menstrual cycle is supported by FSRH.
Duration
of Stat dose to be consumed on the premises at the time of
treatment
consultation and supervised by the pharmacist
Quantity
to 1 x 1500 microgram tablet
supply/administer
Or
Obtaining supplies
Side effects
2 x 1500 microgram tablet for women taking liver enzyme
inducing drugs or taking liver inducing enzymes in the last 28
days
Community pharmacists operating this PGD use their
pharmacy supplies and are reimbursed at Drug Tariff price
The patient should be provided with advice about side effects.
In particular both written and verbal advice should be given
about vomited tablets
Levonorgestrel is generally well tolerated, but the patient may
experience the following:
 Very Common (>1/10)
Bleeding not related to menses, headache, nausea, low
abdominal pain, fatigue
 Common (>1/100, <1/10)
Vomiting, delay of bleeding >7 days, irregular bleeding and
spotting, dizziness, diarrhoea, breast tenderness
 Very rare (<1/10,000)
Rash, urticarial, pruritus, face oedema
Bleeding patterns may be temporarily disturbed, but most
women will have their next menstrual period within 7 days of
the expected time.
See current BNF and Summary of Product Characteristics for
full list of potential side effects.
Any adverse event that may be attributable to the POEC
should be documented in the patients clinical notes
Any adverse event that may be attributable to the POEC
should be reported following local incident reporting
procedures.
Any serious adverse event that may be attributable to the
POEC should be reported to the Medicines and Healthcare
products Regulatory Agency (MHRA) using the yellow card
scheme www.yellowcard.gov.uk
If vomiting occurs within two hours of taking the tablets, a
second dose will be required as soon as possible, see PGD
inclusion criteria.
Drug Details
Interactions
Enzyme-inducing drugs reduce efficacy of POEC
Enzyme-inducing drugs reduce efficacy of POEC, so an
emergency copper-IUD would be preferable as it is the only
contraceptive method not affected by enzyme inducing
drugs. If copper-IUD is declined or while awaiting copperIUD fitting, a double dose of POEC should be given where
the woman is currently taking or has used enzyme inducing
drugs in the last 28 days. (Note: this double dose is an
unlicensed dose, but recommended by the FSRH in these
situations)
The following list of enzyme inducing drugs is derived from
the FSRH guideline ‘Drug Interactions with Hormonal
Contraception’ Jan 2012
Anticonvulsants
Carbamazepine,
Eslicarbazepine,
Oxcarbazepine, Phenobarbital, Phenytoin, Primidone,
Rufinamide, Topiramate
Anti-infectives Rifabutin, Rifampicin
Anti-viral
treatments
Ritonavir,
Ritonavir-boosted
atazanavir, Ritonavir-boosted tipranavir, Ritonavir-boosted
saquinavir, all other ritonavir boosted protease inhibitors
(darunavir, nelfinavir, fosamprenavir, lopinavir) Efavirenz,
Nevirapine.
Others St Johns Wort (Hypericum perforatum), Bosentan,
Modafinil, Aprepitant, Sugammadex
Potential Drug Interactions
Cyclosporin – metabolism may be inhibited leading to
potential toxicity. Discuss with patients GP.
Anticoagulants – Warfarin and phenindiones effect may be
unpredictably altered. Advise INR check witin 7 days and
inform patients GP.
Selegiline – Selegiline levels may increase.
concomitant use. Discuss with patients GP.
Avoid
Tizanidine – progestogens possibly increase plasma
concentration of tizanidine potentially leading to toxicity.
Avoid concomitant use. Discuss with patients GP.
Ulipristal – Contraceptive effect of progestogens possibly
reduced by ulipristal thus POEC may be ineffective. Seek
local sexual health service advice regarding suitable
treatment options for the client.
Sugammadex – Administration of a bolus dose of
sugammadex is considered to be equivalent to one missed
daily dose of oral contraceptive steroids (either combined
or progestogen-only).
Disease interactions
Severe malabsorption syndromes – such as Crohn’s
disease, or removal of sections of intestines might impair
the absorption and the efficacy of levonorgestrel –advise
patient to seek advice regarding treatment with IUCD from
the local sexual health service or a GP with emergency coil
fitting service.
Current breast cancer – Advise patients of possible
disease interaction and the availability of alternative
treatment with emergency IUCD fitting.
The above list of drug interactions is not exhaustive. For
full interaction information please refer to a current version
of the BNF or Summary of Product Characteristics.
Information and advice
to be given to the
patient
before
treatment is provided
 Inform clients that the IUCD is the preferred first line
treatment for all suitable individuals due to its low
documented failure rates. (This is a recommendation
from the FSRH).
 The pregnancy risk from a single act of intercourse is
highest (between 20-30%) in the days just before and
just after ovulation. Counting the first day of menstrual
bleeding as day 1, the pregnancy risk is low before day
7 and after day 17 inclusive in a 28-day cycle.
 Failure rates – data suggests that levonorgestrel POEC
is effective up to 96 hours and that delay in treatment
up to this time did not appear to affect efficacy
 Give client a copy of the manufacturers patient
information leaflet and the FPA leaflet on emergency
contraception – discuss as required especially any
difference in missed pill advice between the
manufacturer’s PIL and the FPA leaflets (developed
in conjunction with FSRH)
 Explain treatment and administration including advice
if vomiting occurs within two hours of taking the tablets
 Explain levonorgestrel mode of action – not known:
Probably prevents ovulation or affects tubal motility and
uterine lining
 The patient should be provided with advice about side
effects. In particular both written and verbal advice
should be given about what to do if vomiting occurs
within 2 hours of treatment
 Use of levonorgestrel 1500 micrograms beyond 72







hours and up to 96 hours (4 days) – if referring clients
for this then the client should be aware that an IUCD is
more effective than levonorgestrel 1500 micrograms in
preventing pregnancy, particularly after 96 hours
Advise client that she could still become pregnant. Her
period may arrive earlier or heavier than normal and
stress that this supply only treats this episode of UPSI.
If menstrual periods are delayed by more than 7 days or
is lighter than usual or she is concerned about changes
to her period, the client should be advised to have a
pregnancy test and seek medical advice from her GP or
local sexual health service.
There is no guarantee of a normal outcome to any
pregnancy. However there is no evidence of EHC
causing birth defects if it fails.
The possibility of an ectopic pregnancy should be
considered particularly in women with a previous
ectopic pregnancy, fallopian tube surgery or pelvic
inflammatory disease. Inform women to seek medical
advice if there is any moderate to severe lower
abdominal pain after taking levonorgestrel.
Advise the practice of abstinence or careful use of
barrier method until onset of the next period or the
OCP/contraceptive patches are effective again, discuss
future contraceptive need and give information pack
that contains free condoms.
Patient should be advised to make a follow up
appointment with her GP or local sexual health service
as soon as is practical to ensure that the method has
worked and to discuss on-going contraception.
The client should be advised on continuation of regular
contraceptives.
As part of raising awareness around sexually
transmitted infections and to increase Chlamydia
screening uptake, all clients presenting for
levonorgestrel 1500 micrograms should be informed
that POEC does not protect against sexually transmitted
infections and should be offered a Chlamydia screening
kit and advised how to submit it for testing.
Records and Follow Up
Records/audit trail
Record the following in clients electronic pharmacy
record:
 Client name
 Client date of birth
 Medical history
 Drug history
 Manufacturer, brand, batch number, expiry date
 Dose supplied
 Date supplied
 Time(s) of supply
 Name of staff member who made supply
 Informed consent received/ given (and if not given by
client by whom and relationship to client)
 Details of any adverse reactions reported and actions
taken
 Fraser rules assessment if under 16
Note: It is strongly recommended that the client
takes the dose of levonorgestrel at the time of the
consultation. If this is not the case, the reason why
should be recorded in the clients record.
Follow up
Advise a follow up appointment with their GP or local
sexual health service in 3 to 4 weeks to ensure that the
method has worked.
If the patient does not have a period within 3 to 4 weeks
of taking emergency contraception, or their period is
unusually light, short or painful, or they have abdominal
pain, they should take an early morning sample of urine
with them to that appointment.
Patient should be advised to contact their GP or local
sexual health service at any time to discuss on-going
contraception.
In addition to offering a Chlamydia screening kit to each
client, if a sexually transmitted infection is suspected,
investigate or refer to the patients GP or local sexual
health service.
References used for this PGD














Levonelle-1500 microgram tablet, Bayer plc, SPC – accessed via the eMC
www.medicines.org.uk SPC last revised 27.11.12
Evra SPC – accessed via the eMC www.medicines.org.uk SPC last revised 22.1.14
British National Formulary – accessed online www.bnf.org/bnf/index/htm
Guillebaud, J. 2009. Contraception your questions answered Fifth edition. Churchill
Livingstone: Edinburgh
FFPRHC Members Enquiry Response 985 9/3/2005 Are there any CI to using
levonelle twice within 1 cycle for women under 16?
Family Planning Association website –
www.fpa.org.uk/helpandadvice/contraception/combinedpill#forgetting-the-pill
Faculty of Sexual and Reproductive Healthcare (2009) UK Medical Eligibility Criteria
for Contraceptive Use: www.fsrh.org.uk/pdfs/UKMEC2009.pdf
Faculty of Sexual and Reproductive Healthcare (2009) Guidance on Progesterone
only Pills: www.ffprhc.org.uk/pdfs/CEUGuidanceProgesteroneOnlyPill09.pdf
Faculty of Sexual and Reproductive Healthcare (2009) Guidance on progestogen only
injectable contraception
www.ffprhc.org.uk/pdfs/CEUGuidanceProgestogenOnlyInjectables09.pdf
Faculty of Sexual and Reproductive Healthcare (2011) Drug Interactions with
hormonal contraception
www.ffprhc.org.uk/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
Faculty of Sexual and Reproductive Healthcare (2010) Antiepileptic drugs and
contraception: CEU statement January 2010
www.fsrh.org/pdfs/CEUStatementADC0110.pdf
Faculty of Sexual and Reproductive Healthcare (2011) Missed Pill recommendations
CEU Statement www.ffprhc.org.uk/pdfs/CEUStatementMissedPills.pdf
Faculty of Sexual and Reproductive Healthcare (2012) Emergency Contraception CEU
Statement www.fsrh.org/pdfs/CEUGuidanceEmergencyContraception11.pdf
Faculty of Sexual and Reproductive Healthcare (2010) Quick starting contraception.
Clinical Effectiveness Unit
www.fsrh.org/pdfs/CEUGuidanceQuickStartingContraception.pdf
Additional notes
The licensed indication for Levonelle – 1500 is as emergency contraception within 72
hours of unprotected sexual intercourse or failure of a contraceptive method.
1. According to the SPC:
 Levonelle-1500 is not recommended in children and very limited data are
available in women under 16 years of age
 Repeated administration within a menstrual cycle is not advisable because of
the possibility of disturbance of the cycle.
 If vomiting occurs within three hours of taking the tablet, another tablet should
be taken immediately
2. According to the SPC for depot medroxyprogesterone acetate injection, EHC may
still be required if the depot is delayed and the interval between injections exceeds 12
weeks and 5 days (89 days in total). However, based on current best practice
recommendations from the FSRH this PGD supports the view that EHC will not be
required unless the interval between depot injections is more than 14 weeks (98
days)
3. The licenses for combined oral contraceptives (COCs) state that additional
measures should be taken if the COC is taken more than 12 hours late, for
progestogen only pills (POPs) this is an additional 7 days of contraceptive cover if the
pills are late, the latest guidance (May 2011) from the FSRH on missed pills give
different guidance based on the number and when the tablets were missed. This PGD
operates the FSRH guidance.
http://www.ffprhc.org.uk/pdfs/archive/ContraceptionProductLicence.pdf
(July 2005)
http://www.ffprhc.org.uk/pdfs/CEUStatementMissedPills.pdf
(May 2011)
Safeguarding/ Child Protection considerations
 Any patient under 16 must be deemed to be Fraser competent, and Child
Protection procedures must be followed.
 Should a client accessing this service be identified as having potential
safeguarding issues, the pharmacist should discuss their concerns with a
safeguarding lead to be advised on any appropriate actions. (see contact details
below)
Bristol
See the following website for contact details:
North Somerset
www.4ypbristol.co.uk/for-professionals/wpcontent/uploads/sites/3/2013/09/E_Safeguarding-ContactDetails_Jan2014.pdf
Designated nurse for safeguarding and looked after
children
Tel: 01275 546758
Mob: 07795403153
Named Doctor for child protection
Tel: 01934 515878
Mob: 07595361522
Email: mike.pimm@gp-L81643.nhs.uk
Consultation and referral Children and Young People Referral and Assessment Team
Tel: 01275 888266
Out of Hours emergency duty team (after 5pm and w/e)
Tel: 01454 615165
South Gloucestershire
Safeguarding Lead Designated Nurse
Tel: 07824608656
Email: sgccgsafeguarding.children@nhs.net
OR Telephone NBT switchboard (Mon-Fri, 9am-5pm):
0117 970 1212 and ask for the Child Protection Doctor on
call
(Out of Hours, telephone UHB switchboard: 0117 923
0000, and ask for the Consultant Community Paediatrician
on call)
Contact Details for Sexual Health Services
Bristol
Bristol Sexual Health Service
Tel: 0117 342 6900
Brook Young People’s Clinic
Tel: 0117 929 0090
Also visit www.4ypbristol.co.uk for the most up to date list
of sexual heath services in Bristol, including GP practices,
sexual health clinics and school based services.
North Somerset
No Worries Service (under 21)
Tel: 01934 425718
Weston Integrated Sexual Health (WISH)
Tel: 01934 881234
Also see: www.shnsomerset.co.uk
South Gloucestershire
Contraceptive and Sexual Health Service (CASH)
Tel: 0117 342 6900
No Worries
Tel: 0117 342 6900
Worth Talking About
0800 28 29 30
Also see: http://no-worries.youthunltd.com
Individual Authorisation - Levenogestrel PGD
I have read and understood the Patient Group Direction and agree to supply
this medicine only in accordance with this PGD.
PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR
ACCOUNTABILITY.
It is the responsibility of each professional to practice only within the bounds
of their own competence and in accordance with their own code of
professional conduct
Name of Pharmacist
Signature
Date
APPENDIX 4
Becoming Young People Friendly – a guide for pharmacies
(criteria will be monitored through mystery shopping and the pharmacy audit)
Taking the following criteria into consideration and working towards adopting them,
will ensure that the pharmacy not only offers a good sexual health service for young
people but one which they will want and be easily able to use.
The first group of criteria are essential if the pharmacy is to deliver the service
specification, the second group are quality criteria. The pharmacy could complete a
Young People Friendly questionnaire to demonstrate they meet all the criteria and
could then become accredited to display the ‘Young people friendly’ logo. To arrange
accreditation contact Chris Burton at NHS North Somerset (chris.burton@nsomerset.gov.uk)
Part A - Essential Young People Friendly Criteria
1. Clients feel that the service they receive is appropriate to them and their needs
2. The part of the pharmacy used for provision of the service provides a sufficient level of
privacy (ideally at the level required for the provision of the Medicines Use Review
service)
3. Client confidentiality is made explicit to the client and is maintained
4. The client is asked permission if there is a need to refer information about the client to
another health or social services professional
5. The service complies with Fraser guidance and Department of Health guidance on
confidential sexual health advice and treatment for young people aged under 16 3
Part B - Young People Friendly Criteria
1. Access and Environment
a) The service is accessible to young people by public transport and at times convenient
to them
b) When making appointments and attending consultations, young people can express a
preference about how they wish to be seen
c) Where appropriate, there are opportunities for self-referral and clear lines of referral to
specialist services as required
d) The service is provided in accordance with the Disability Discrimination Act 2005
e) Services are provided to marginalised and socially excluded young people
f) Care is delivered in a safe, suitable and young people friendly environment
g) The reception, waiting and treatment areas are young people friendly
2. Staff Training, Attitudes, Confidentiality and Consent
a) All staff who are likely to come into contact with young people receive appropriate
training on understanding, engaging and communicating with young people
b) Appropriate staff members receive training, supervision and relevant appraisal to
ensure they are competent to work with young people
c) There is a written policy on confidentiality and consent to treatment and this is made
explicit to young people, parents and carers
d) Where required, arrangements are in place to enable young women with unplanned
pregnancies to be seen immediately by a practitioner, to enable impartial discussion of
options
3
Guidance available at www.swcpp.org.uk
e) All staff routinely explain who they are and what services they can/cannot provide to
help young people
3. Involvement of young people
a) Young people are routinely consulted in relation to current services, relevant new
developments and included in patient satisfaction surveys
b) The service invites all clients to give their opinions of the services offered and these
are reviewed, acted upon and reported back to clients
4. Publicity and joined up working
a) The service provides information in a variety of languages and formats including
leaflets for young people, which are kept up to date
b) In accordance with the Disability Discrimination Act 2005, service publicity material is
available in forms that can be easily understood by young people with learning
disabilities, physical disabilities and sensory impairment
c) Service materials make clear young people’s entitlement to a confidential service and
opportunities to attend a consultation on their own, with or without the involvement of a
parent or carer
d) Where possible, other relevant services for young people are co-located within the
service. If not, information is provided about other local service provision
e) Information about the service is provided to other relevant organisations and to key
professionals working with young people
5. Health Issues for Young People
a) As appropriate, consultations routinely promote healthy lifestyles
b) Staff/the service ensures that the emotional, psychological and spiritual needs of
young people are met. A clear referral pathway is identified for young people with
identified emotional and mental health concerns
c) The service prepares young people for the transition from health services designed for
children and young people to adult health services, consistent with current Department of
Health guidance
d) The care and support of young people with complex needs are considered in the
context of their cognitive ability and chronological age
e) In order for parent/carers to discuss health issues with young people, they are
provided with relevant information and support, in ways that are sensitive to different
cultures and religions
6. Sexual and Reproductive Health Services
a) A range of sexual health services is offered, including sexually transmitted infection
(STI) testing treatment. Where STI services are not available on-site, there are clear,
integrated care pathways for seamless referral to other services or clinicians
b) Young people are offered appropriate information and advice to help them develop
their ability to make safe, informed choices. This includes advice to help them develop
the confidence and skills to delay early sex and resist peer pressure
c) Appropriate, easy-to-understand information is available on a range of sexual health
issues, including contraception, STIs, relationships, use of condoms and sexuality
d) Appropriate staff receive training, supervision and appraisal to ensure that they are
able to talk to young people about sexual health issues
e) The service will see young people who are not ordinarily registered with them in order
to provide sexual health advice and contraception, including emergency contraception