LONDON CONTRACEPTION AND SEXUAL HEALTH

PATIENT GROUP DIRECTION (PGD) TEMPLATE

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PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND INSERTION OF LEVONORGESTREL 52 mg PROGESTOGEN ONLY INTRAUTERINE DELIVERY SYSTEM (IUS) (LEVOSERT®) BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES.

PATIENT GROUP DIRECTION (PGD)

FOR THE SUPPLY AND INSERTION OF LEVONORGESTREL 52 mg PROGESTOGEN ONLY INTRAUTERINE DELIVERY SYSTEM (IUS) (LEVOSERT®)

BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES

Version Number 1.1

Change History
Version and Date / Change details
N/A
Version 1
Version 1.1
November 2016 / Amendments in light of UKMEC 2016 guidance and minor changes in blue
Updated Summary of Product Characteristics (SPC) references and to include registered midwives
Statement that references correct at time of publication

Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD.

This Patient Group Direction (PGD) must only be used by registered nurses/midwives who have been named and authorised by their organisation to practise under it. The most recent and in date final signed version of the PGD must be used.

TABLE OF CONTENTS
CONTENTS / PAGE NUMBER
PGD for the supply and insertion of Levonorgestrel 52 mg (Levosert®) progestogen-only intrauterine system (IUS) / 1 -14
Staff Characteristics / 11
Authorisation and Signatures / To be added by approving organisation
Individual authorisation to supply and insert Levonorgestrel 52 mg (Levosert®) progestogen-only intrauterine system / To be added by approving organisation


DRUG NAME /STRENGTH/FORM
Levonorgestrel 52mg Intrautrauterine System (Levosert®)
CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES / ·  Contraception
INCLUSION CRITERIA / ·  Any individual (age from menarche) presenting for contraception
EXCLUSION CRITERIA
EXCLUSION CRITERIA / Personal Characteristics & Reproductive History
·  Known or suspected pregnancy
·  Individual under 16 years of age and assessed as not competent using Fraser guidelines
·  Individual 16 years of age and over and assessed as not competent to consent using local safeguarding guidelines
·  Known hypersensitivity to any constituent of the IUS
·  48 hours to less than 4 weeks post–partum
·  Postpartum sepsis
·  Post-abortion sepsis
·  Gestational trophoblastic disease with decreasing or persistently elevated β-hCG levels or malignancy
Cardiovascular Disease
·  Development of ischaemic heart disease, transient ischaemic attack or stroke whilst using the IUS
·  Known long QT syndrome
Cancers
·  Current or past history of breast cancer
·  Cervical cancer (awaiting treatment)
·  Radical trachelectomy
·  Endometrial cancer
·  Malignant liver tumour (hepatocellular carcinoma)
Gastro – Intestinal Conditions
·  Severe decompensated cirrhosis
·  Benign liver tumour (hepatocellular adenoma)
See next page
Continued from previous page
Infections
·  Current pelvic inflammatory disease (PID)
·  Chlamydial infection either symptomatic or asymptomatic
·  Current purulent cervicitis or gonorrhoea
·  Known pelvic tuberculosis
·  HIV infection with CD4200cells/mm3
Anatomical Abnormalities
·  Fibroids with distortion of the uterine cavity
·  Anatomical abnormalities distorting the uterine cavity
Other Conditions
·  Organ transplant with complications
·  Undiagnosed abnormal vaginal bleeding
·  Individual wishes to see a doctor
CAUTIONS
(INCLUDING ANY ACTION TO BE TAKEN) / ·  If individual is under 13 years of age follow local safeguarding policy
·  Ensure emergency drugs and equipment, including adrenaline, atropine and oxygen are available for the treatment of anaphylaxis and emergencies according to local policy
·  Discuss with appropriate doctor/independent non-medical prescriber any medical condition or medication of which the nurse/midwife is unsure/uncertain
·  Interacting medicines – see current BNF on interactions
ACTION IF EXCLUDED / ·  Refer to appropriate doctor/independent non-medical prescriber
·  Discuss/offer alternative contraceptive method
·  Document all actions taken
ACTION IF PATIENT DECLINES TREATMENT / ·  Record refusal in the clinical record
·  Refer to appropriate doctor/ independent non-medical prescriber
·  Discuss /offer alternative contraceptive method
·  Document all actions taken
DRUG DETAILS
NAME, FORM & STRENGTH OF MEDICINE / Levonorgestrel 52mg intrauterine delivery system
ROUTE/METHOD / Intrauterine
LEGAL CATEGORY / Prescription Only Medicine (POM)
USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION / Best practice advice given by the Faculty of Sexual and Reproductive Healthcare (FSRH) is used for guidance in this PGD and may vary from the Summary of Product Characteristics (SPC)
This PGD includes unlicensed use as follows:
·  Postpartum insertion under 6 weeks
·  Initial insertion after day 7 of the menstrual cycle
·  Use under 16 years of age
QUANTITY / ·  One intrauterine delivery system
DOSAGE/FREQUENCY / ·  Levosert® releases 20 micrograms levonorgestrel in 24 hours
·  Insert on day 1-7 of the menstrual cycle with no need for additional protection
·  The IUS can be inserted at any time after day 7 of the menstrual cycle if it is reasonably certain that the individual is not pregnant. Additional contraception is then required for 7 days after the insertion of the IUS
·  For guidance on changing from one contraceptive method to another, and when to start after an abortion and postpartum refer to FSRH guidelines
DURATION OF TREATMENT / ·  For as long as the individual requires the IUS and has no contraindications
MAXIMUM OR MINIMUM TREATMENT PERIOD / ·  Maximum - Three years
SIDE EFFECTS / Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for full list and further information.
This list may not represent all reported side effects of this medicine.
The IUS is well tolerated. Some of the common side effects are;
·  Acne
·  Breast tenderness
·  Headache
·  Disturbance of bleeding patterns
·  Changes in mood
·  Weight change
·  Loss of libido
Insertion complications may include infection, expulsion or perforation.
In the event of untoward or unexpected adverse reactions:
·  If necessary seek appropriate emergency advice and assistance
·  Document in the individual’s clinical record and inform appropriate doctor/independent non-medical prescriber
·  Complete incident procedure if adverse reaction is severe (refer to local organisational policy)
·  Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA). Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at www.yellowcard.mhra.gov.uk.
The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so.
ADVICE TO INDIVIDUAL / ·  Provide Manufacturer’s Patient Information Leaflet (PIL) and discuss
·  Explain mode of action, side effects, and benefits of the system
·  Advise about the risks of the system including failure rates and serious side effects and the actions to be taken
·  Advise about the possible symptoms or serious sequelae e.g. infection, ectopic pregnancy, expulsion and perforation and when to seek clinical advice
·  Teach individual how to check threads and to seek clinical advice if threads not felt
·  Provide a copy of the FPA leaflet on the IUS http://www.fpa.org.uk/sites/default/files/ius-your-guide.pdf
·  Offer condoms and advise on safer sex practices
·  Ensure individual knows what to do if her medical condition changes in the future
·  Ensure individual has the contact details of the service
FOLLOW UP / ·  Individual to return to clinic if she has any concerns
·  Review in three to six weeks after insertion
RECORDS / The authorised registered nurse /midwife must ensure the following is documented in the clinical record:
·  Individual’s name, address and date of birth
·  GP contact details where appropriate
·  Attendance date
·  Reason for attendance
·  Relevant past and present medical and family history, including drug history
·  Any known allergy
·  Relevant examination findings
·  Inclusion or exclusion from PGD
·  A statement that supply and insertion is by using a PGD
·  Advice given about the system including side effects, benefits, and what to do if any concerns
·  Details of any adverse drug reactions and what action taken
·  Any referral arrangements
·  Any supply and administration outside the terms of the product marketing authorisation
·  The consent of the individual
·  If individual is under 13 years of age, record action taken
·  If individual is under 16 years of age document competency using Fraser guidelines
·  If individual is 16 years of age and over and not competent, record action taken
·  Record the name/brand of the IUS
·  Record batch number and expiry date according to local policy or national guidelines
·  Record follow up and/or signposting arrangements
·  Any other relevant information that was provided to the individual
·  Name and signature (which may be an electronic signature) of the nurse /midwife inserting the IUS
REFERENCES
Note- all links were correct at the time of publication of the final template. (November 2016) / ·  Manufacturer’s Summary of Product Characteristics
Levosert Allergan Ltd Accessed via https://www.medicines.org.uk/emc/medicine/30120
on 25/09/2016 Date of revision of the text 03/2016
·  Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press http://www.medicinescomplete.com accessed 03/11/2016
·  National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2
http://www.nice.org.uk/guidance/MPG2
·  Faculty of Sexual and Reproductive Healthcare (2015) Intrauterine Contraception Clinical Effectiveness Unit
https://www.fsrh.org/standards-and-guidance/documents/ceuguidanceintrauterinecontraception/
·  Faculty of Sexual and Reproductive Healthcare (2016) UK Medical Eligibility Criteria for Contraceptive Use https://www.fsrh.org/standards-and-guidance/uk-medical-eligibility-criteria-for-contraceptive-use/
·  Faculty of Sexual and Reproductive Healthcare (2012) Drug interactions with hormonal contraception https://www.fsrh.org/standards-and-guidance/documents/ceu-guidance-drug-interactions-with-hormonal-contraception-jan/
·  Faculty of Sexual and Reproductive Healthcare (2010) Antiepileptic drugs and contraception https://www.fsrh.org/standards-and-guidance/documents/ceustatementadc0110/
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REFERENCES / Continued from previous page
·  Faculty of Sexual and Reproductive Healthcare (2013) Update on newer antiepileptic and antiretroviral drugs and interactions with hormonal contraceptives (CEU statement) https://www.fsrh.org/standards-and-guidance/documents/cec-ceu-statement-new-art-antiepileptic-interactions-2013/
·  Faculty of Sexual and Reproductive Healthcare (2016) Service Standard for Resuscitation in Sexual Health Services https://www.fsrh.org/news/updated-service-standards-for-resuscitation/
·  Faculty of Sexual and Reproductive Healthcare (2014) Contraception choices for women with cardiac disease https://www.fsrh.org/standards-and-guidance/documents/ceu-guidance-contraceptive-choices-for-women-with-cardiac/
·  Faculty of Sexual and Reproductive Healthcare (2015) Problematic bleeding with hormonal contraception https://www.fsrh.org/standards-and-guidance/documents/ceuguidanceproblematicbleedinghormonalcontraception/
STAFF CHARACTERISTICS
The named nurse/ midwife authorised to supply and/or administer medications under the PGD must meet the following criteria: / THE NURSE/MIDWIFE MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT
Registration
The nurse/midwife must be registered with the Nursing and Midwifery Council (NMC)
Education/training, qualifications and competencies
The nurse/midwife must satisfy the following criteria:
·  Qualification in contraception/sexual health (university modules/FSRH: Note: an introduction to contraception/ sexual health is not sufficient
·  Qualification/training in the insertion technique of the IUS Note: The FSRH Letter of Competence (LoC) in Intrauterine techniques (IUT) is the gold standard
·  Has had training in the use of PGDs
·  Has had training which enables the nurse/midwife to make a clinical assessment in order to insert the system according to this PGD.
·  Has undertaken the competency training appropriate to this PGD.
·  Is competent in the assessment of individuals using Fraser guidelines
·  Has undergone regular training and updating in safeguarding children and vulnerable adults
·  Has undergone regular updating in basic life support and anaphylaxis
Maintenance of competencies
·  The nurse/midwife must ensure she/he is aware of any changes to the recommendations for these medicines
·  It is the responsibility of the nurse/midwife to keep up to date with continuing professional development and take part in audit of clinical records on a regular basis
·  The nurse/midwife must be familiar with current FSRH clinical guidelines on intrauterine contraception

An up to date list and signatures of registered practitioners who are authorised to practise under this PGD is kept in by

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

PGD DEVELOPMENT GROUP

Date PGD template comes into effect: / 15.11.2016
Review date / 30.4.2019 or earlier in the light of significant changes in best practice
Expiry date: / 15.11.2019

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

NAME/ROLE / POSITION / DATE
Kathy French
Chair - Working Group / Independent Nurse Advisor Project Lead / 15.11.2016
Angela Bussey
Advisor - Working Group / Principal Pharmacist Medicines Information Projects.
Guy’s and St Thomas’ NHS Foundation Trust. / 15.11.2016
Lead Doctor
Sarah Pillai / Lead Associate Specialist, Contraception and Sexual Health Service, Central London Community Healthcare NHS Trust / 15.11.2016
Lead Pharmacist
Sandra Wolper / Associate Director for Specialist Pharmacy Service Hounslow and Richmond NHS Trust / 15.11.2016
Lead Nurse
Sandra Bennett / Lead Nurse
Integrated Sexual Health
Barts Health NHS Trust / 15.11.2016

The PGD template is not legally valid until it has had the relevant organisational approval.

See next page

ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS

This page may be deleted if replaced with a format agreed according to local PGD policy with relevant approvals and authorisation.

The PGD is not legally valid until it has had the relevant organisational authorisations.

To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the person signing on behalf of the authorising organisation.

You may either complete details below or delete and use a format agreed according to local PGD policy which complies with PGD legislation and NICE MPG2 PGD 2013.

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Name / Job title and organisation / Signature / Date
Senior doctor
Senior pharmacist
Senior representative of professional group using the PGD e.g. Lead Contraception /Sexual Health Nurse
Person signing on behalf of authorising body / e.g. Director of Public Health on behalf of a local authority or a clinical governance lead on behalf of an NHS Trust.

It is the responsibility of the authorising organisation to ensure that all legal and governance requirements for authorising the PGD are met.

It is the responsibility of the provider organisation to ensure that all legal and governance requirements for using the PGD are met.

To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement.