Download Progestogen only pills `POP` (Micronor and Cerelle)

This Patient Group Direction (PGD) must only be used by registered nurses who have
been named and authorised by their organisation to practice under it. The most recent
and in date final signed version of the PGD should be used.
Patient Group Direction
for the supply of
Progestogen only pills ‘POP’ (Micronor and
Cerelle)
by registered nurses for
oral contraception
in Coalfields sexual health clinic
Version number: 1.1
Change history
Version
number
Change details
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
Date
1
PGD development
Name
Medicines Optimisation
Pharmacist
Sunderland CCG
Medicines Optimisation
Pharmacist
Sunderland CCG
Practice Nurse
Representative to the
Executive Committee
Sunderland CCG
Job title and organisation
Signature
Hannah Willoughby
(Interface Pharmacist)
Date
Dec 15
Dec 15
Paula Russell
(Senior Pharmacist)
Dec 15
Florence Gunn
(Senior Nurse)
Dr Claire Bradford
(Senior Doctor)
Medical Director
Sunderland CCG
Other members of the
PGD working group
Dec 15
Not applicable
PGD authorisation
Name
Job title and organisation
Medicines Optimisation
Pharmacist
Signature
Date
Dec 15
Paula Russell
(Senior Pharmacist)
Sunderland CCG
Dec 15
Practice Nurse
Representative to the
Executive Committee
Florence Gunn
(Senior Nurse)
Sunderland CCG
This PGD has been
approved for use in
Sunderland CCG by
Medical Director,
Dec 15
Dr Claire Bradford
(Senior Doctor)
Sunderland CCG
Person signing on behalf
of authorising body
PGD adoption by the provider1
Name
Job title and
organisation
Signature
Signatures to be
determined locally, if
relevant
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
2
Date
Training and competency of registered nurses
Qualifications and
professional registration
Requirements of registered nurses working under the
PGD
Professionals using this PGD must be currently
registered with their relevant professional body;
Initial training
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For nurses: - Nursing & Midwifery Council (NMC)
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Have a current contract of employment with a GP
practice within Sunderland CCG
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Has had training in the use of PGDs
Has had training which enables the healthcare
professional to make a clinical assessment in order
to establish the contraceptive need and supply the
POP according to this PGD.
Has undertaken the competency training appropriate
to this PGD
Has been assessed and achieved the required
standard deemed necessary by the senior medical
representative who deems the healthcare
professional competent to practice under the PGD.
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Competency
assessment
Ongoing training and
competency
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Is competent in the assessment of the individuals
using Fraser guidelines
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Has undergone regular training and updating in
safeguarding children and vulnerable adults
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Has undergone regular updating in basic life support
and anaphylaxis
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Must have demonstrated an appropriate level of
competence to their clinical manager in
contraceptive services.
 The registered nurse should ensure she/he is aware
of any changes to the recommendations for this
medication. It is the responsibility of the healthcare
professional to keep up-to-date with continuing
professional development and take part in audit of
clinical records on a regular basis.
 Continuous professional development completed as
per governing body
Reaccreditation of nursing qualification as dictated by
governing body
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
3
Clinical condition
Clinical condition or
situation to which this PGD
applies
Contraception using progestogen only pills (POP). To
supply combined oral contraception to female patients
aged from menarche to 55 years of age.
Inclusion criteria
Only use those criteria that are specific to your
authorised role & competence. Ensure appropriate
consent has been obtained before proceeding.
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Exclusion criteria
Any female (age menarche to 55 years of age)
presenting for contraception
Understands the risks, benefits and side effects
Valid informed consent.
Refer to current SPC for additional details
Personal Characteristics & Reproductive History
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Known or suspected pregnancy
Known hypersensitivity to any constituent of the
POP
Under 16 years of age and assessed as not
competent using Fraser guidelines
Any rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
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Cardiovascular Disease
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Active venous thromboembolic disorder. venous
thromboembolism (VTE, deep venous thrombosis
and pulmonary embolism)
History of thrombo-embolic disorders
Known thrombogenic mutations e.g. Factor V
Leiden, prothrombin mutation, protein S. protein
C, and antithrombin deficiencies
Severe arterial disease
Development of ischaemic heart disease,
transient ischaemic attack or stroke
History of cerebrovascular disease, including
transient ischaemic attack occurring whilst taking
POP
Hyperlipidaemias
Multiple risk factors for arterial cardiovascular
disease (such as age, smoking, diabetes,
hypertension and obesity)
History of DVT or PE, current VTE on
anticoagulants.
Major surgery with prolonged immobilisation
Chronic illness with prolonged immobilization
Cancers
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Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
Known or suspected sex-steroid sensitive
4
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malignancies.
Current or past history of breast cancer
Benign liver tumour
Malignant liver tumour (hepatocellular adenoma
and malignant hepatoma)
Progesterone dependent tumours
Gastro-intestinal Conditions
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Severe decompensated cirrhosis
Other conditions
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Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
Interacting medicines –see current British National
Formulary (BNF) on interactions (This includes the
use of potent enzyme inducers in the past 4 weeks)
Liver enzyme inducing drugs including: Rifampicin,
and rifabutin, anti-epileptics (carbamazepine,
eslicarbazepine, barbiturates, oxcarbazepine,
phenytoin, rufinamide primidone, topiramate), St
John’s Wort, griseofulvin . This list is not
exhaustive. Refer to most recent edition of BNF
Presence or history of severe hepatic disease as
long as liver function values have not returned to
normal.
Ritonavir-boosted protease inhibitors
Systemic Lupus Erythematosus (SLE) with positive
or unknown anti-phospholipid antibodies
Acute Porphyria
Porphyria
Individual wishes to see a doctor
Undiagnosed abnormal vaginal bleeding
Heavy, prolonged bleeding (includes regular and
irregular) or irregular bleeding without heavy
bleeding.
Undiagnosed breast mass or carrier of known gene
mutations associated with breast cancer eg.BRCA1
HIV – infected and not using antiretroviral therapy
AIDS
Diabetes
Past or current gallbladder disease
History of cholestasis
Choleostatic jaundice and/or pruritis
Hepatic focal nodular hyperplasia
Dubin-Johnson Syndrome and Rotor Syndrome
Inflammatory bowel disease (includes Crohn’s
disease, ulcerative colitis)
Raynauds disease with lupus anticoagulant.
SLE without antiphospholipid antibodies
Past ectopic pregnancy
Non-nucleoside reverse transcriptase inhibitors
5
Cautions (including any
relevant action to be taken)
Arrangements for referral
for medical advice
Action to be taken if
patient excluded
Action to be taken if
patient declines treatment
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
If the patient is receiving any concomitant medication or
treatment, it is the responsibility of the healthcare
professional conducting the consultation and supply to
ensure that treatment with the medicines detailed in
this PGD is appropriate. In case of any doubt, further
advice must be sought from an appropriate healthcare
professional and this must be recorded as having been
sought before the medicine is given.Check drug history
and refer to current BNF for more details and potential
drug interactions and ask for advice on management if
necessary. All patients taking a medication that
interacts significantly (indicated with a black dot in the
paper version, or shaded red in the online version) with
the contraceptive being given, should be excluded.
 If under 13 years of age, follow local safeguarding
policy
 Discuss with appropriate doctor/independent nonmedical prescriber any medical condition or
medication of which the nurse is unsure/uncertain
Doctor/specialist appointment as and when appropriate
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Refer to appropriate doctor/independent nonmedical prescriber
 Discuss /offer alternative contraceptive method
 Document all actions taken
 Record refusal in the clinical record
 Refer to appropriate doctor/independent nonmedical prescriber
 Discuss /offer alternative contraceptive method. For
example condoms
 Document all actions taken
Consider the supply of an alternative hormonal
contraceptive under PGD or another method of
contraception.
6
Details of the medicine
Name, form and
strength of medicine
Include ▼for black
triangle medicines
Brand
Name
Form
Pack
size
Content
Description
Cerelle
Tablet
84
Desogestrel
75micrograms
Micronor
Tablet
84
Norethisterone
350micrograms
Progestogen
only pill 28
day pack
administration
is continuous
Progestogen
only pill 28
day pack
administration
is continuous
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Legal category
Indicate any off-label
use (if relevant)
Route/method of
administration
Dose and frequency
Progestogen only oral contraceptives specified in
this PGD will be available overlabelled.
 Stock which is not overlabelled must not be used
 In the event that no overlabelled stock is available,
the patients current stock of medication should be
ascertained.
 If the patient has no medication left, or is newly
starting on this medication, the patient should be
given an FP10 prescription for dispensing at a
community chemist.
 The FP10 must be signed by a GP or other
appropriate prescriber.
 The practice manager will be responsible for
maintaining appropriate levels of stock.
Prescription only medications
Not applicable
Tablets are for oral administration only
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Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
One tablet is taken daily at the same time without
interruption for 28 days
Once one pack has been completed, the next pack
should be started immediately without a break.
Tablets must be taken every day at about the same
time so that the interval between two tablets always
is 24 hours.
The first tablet should be taken on the first day of
menstrual bleeding.
Cerelle can be started on days 2-5 of the menstrual
cycle, but extra precautions should be taken for an
additional 7 days
Micronor 350mcg can be started on days 1-5 of
menstrual cycle without need for additional
precautions
Micronor can be started at any other time, if
pregnancy can reasonably be excluded. In this case,
additional contraceptive precautions must be taken
for the first 48 hours of tablet taking
Thereafter, follow manufacturer’s instructions for
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individual product use. If the patient is
amenorrhoeic, pregnancy should be excluded prior
to starting Micronor and there is no risk of
conception.
For guidance on changing from one contraceptive method
to another, and when to start after an abortion and post
partum, refer to Table 2 FSRH guidelines Progestogen-only Pills
(March 2015)
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
8
Quantity to be
administered and/or
supplied
Maximum or minimum
treatment period
Adverse effects
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Initial supply is three (3) months unless clinical
reason for lesser supply.
 Maximum treatment period for repeat supplies is 6
months.
 Less of a supply may be made if there is concern for
the individual.
Duration of treatment is for as long as the individual
requires the POP and for as long as the individual has no
contraindications to use of the POP.
As this PGD covers different oral contraceptives, please
refer to the manufacturers guide (SPC or patient information
leaflet) and the BNF for full information. The information
listed below is a guide only.
This list may not represent all reported side effects of this
medicine
Most POPs are well tolerated. Some of the common side
effects are;
 Breast tenderness
 Headache
 Disturbance of bleeding patterns
 Changes in mood
 Weight change
In the event of untoward or unexpected adverse reactions:
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If necessary seek appropriate emergency advice
and assistance
 Document in the individual’s clinical record and
inform appropriate doctor/independent nurse
prescriber
 Complete incident procedure if adverse reaction is
severe ( refer to local organisational policy)
All serious adverse reactions should be reported using the
Yellow Card system, which can be done online at
http://yellowcard.mhra.gov.uk/ or obtained via Freephone
0808 100 3352.
Records to be kept
The registered nurse must ensure the following is
documented in the clinical record:
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Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
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 (where appropriate)
Initial examination to include body mass index (BMI)
9
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and blood pressure recording and thereafter according
to local policy
Inclusion or exclusion from PGD
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A statement that supply is by using a PGD
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Advice given about the medication including side
effects, benefits, and when and what to do if any
concerns
Details of any adverse drug reactions and what action
taken
Any supply 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, dose of the medication and
quantity supplied
Record batch number and expiry date according to local
policy or national guidelines
Any referral arrangements
Record follow up and/or signposting arrangements
Any other relevant information that was provided to the
individual
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Name and signature (which may be an electronic signature)
of the nurse supplying the medicine
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
10
Patient information
Written information to be
given to patient or carer
Follow-up advice to be
given to patient or carer
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Provide manufacturer’s Patient Information Leaflet
(PIL) and discuss content including but not limited
to missed pills advice and steps taken in the event
of diarrhea or vomiting.
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Provide a copy of the FPA leaflet on the POP
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Explain mode of action, side effects, and benefits of
the medicine
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Advise about the risks of the medication including
failure rates and serious side effects and the
actions to be taken
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Offer condoms and advice on safer sex practices
and possible need for screening for sexually
transmitted infections (STIs)
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Ensure the individual has contact details of the
service /sexual health services.
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Reiterate to patient that oral contraceptives do not
provide protection against STIs.
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Advise on what to do if vomits within two (2) hours
of taking the pill or in cases of prolonged vomiting
or severe diarrhoea. See FPA leaflet/FSRH
guidance
Advise on what to do if she forgets to take it
(missed pills; three hours for all POPs except
Cerazette and Cerelle which is 12 hours). See FPA
leaflet/FSRH guidance
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.
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Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
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If the woman gets abdominal pain they should seek
medical advice.
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Women with a tendency to chloasma should avoid
exposure to the sun or ultraviolet radiation whilst
taking Cerelle.
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Appendices
Appendix A Key references
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Please note; best practice advice given by Faculty of Sexual and Reproductive
Healthcare (FSRH) is used for guidance in this PGD and may vary from the
Summary of Product Characteristics (SPC).
Faculty of Sexual and Reproductive Healthcare (FSRH) response to new data
on quickstarting hormonal contraception after use of ulipristal acetate 30mg
(ellaOne®) for emergency contraception, September 2015.
SPCs for Cerelle and Micronor via http://www.medicines.org.uk
BNF online
Patient Group Direction for the supply of progestogen only oral contraceptive
(POP) pills by registered nurses in sexual and reproductive health services,
London contraception and sexual health patient group direction, Version 1.1,
Expiry 31.08.2016.
Repeat issue of progestogen only oral contraceptives, NHS North Lancashire,
NHS Cumbria and North Cumbria University Hospital Trust, Version: Repeat
issue POP – 2010.1, Expired 31st October 2012.
Patient Group Direction For The Initial And Repeat Supply Of The
Contraceptive Progestogen-Only Pill By Nurses Within Sexual Health Services
And Midwives Working Within NHS Grampian, NHS Grampian, Version 3,
Expires October 2015.
CEU Guidance - Quick Starting Contraception September 2010 (review: September 2015)
Appendix B Registered nurses agreement to practise
Insert statement to be signed by individual nurses agreeing to practice under
the PGD.
For example:
I have read and understood the Patient Group Direction and agree to supply
and/or administer this medicine only in accordance with this PGD.
Name of nurse
Signature
Senior
representative
authorising nurse
Other appendices may be added as agreed locally.
Valid from: December 2015
Review date: September 2017
Expiry date: December 2017
12
Date