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LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD)
FOR THE SUPPLY OF
COMBINED ORAL CONTRACEPTIVE (COC) PILLS BY
REGISTERED NURSES/MIDWIVES IN SEXUAL AND
REPRODUCTIVE HEALTH SERVICES
(See under Drug Details section for list of preparations)
Version Number 2
Change History
Version and
Date
Version 1.2
Version 1.3
Version 2
July 2016
Change details
New template
Spelling and minor changes in blue
Independent nurse prescriber changed to non-medical prescriber
Changes in light of Faculty of Sexual and Reproductive Health
(FSRH) 2015 guidance on quick starting hormonal contraception
Minor amendments, change to dosage/frequency section to clarify
additional precautions
Correction to strength of tablet.
Amendments to exclusions in light of UKMEC 2016 guidance
Updated Summary of Product Characteristics (SPC) references and
to include registered midwives
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.
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 1 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
TABLE OF CONTENTS
CONTENTS
PAGE NUMBER
PGD for the supply of COC pills
1-21
Drug details section (list of preparations)
7
Staff Characteristics
15
Appendix 1
Equivalent brands that may be supplied against the
PGD
16 -19
Authorisation and Signatures
To be added by approving
organisation
Individual authorisation to supply COC (see drug
section for individual preparation) using this PGD
To be added by approving
organisation
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 2 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
DRUG NAME
Combined Oral Contraceptives (COC) tablets
(See under Drug Details section for list of preparations)
CLINICAL CONDITION
TO WHICH THIS
DIRECTION APPLIES
INCLUSION CRITERIA
EXCLUSION CRITERIA
(I.E. SITUATIONS NOT
COVERED BY THE
PGD)

Contraception

Any individual (age from menarche to 50 years) presenting for
contraception and who has no contraindications
Personal Characteristics & Reproductive History
 Known or suspected pregnancy

Individuals under 16 years of age and assessed as not
competent using Fraser Guidelines

Individuals 16 years of age and over and not competent to
consent

Known hypersensitivity to any constituent of the combined
oral contraceptive pill

Less than 21 days postpartum

Breastfeeding and less than six weeks postpartum

Not breastfeeding and 3-6 weeks post partum with other
risk factors for venus thromboembolism (VTE)
Cardiovascular disease
 Individuals aged 35 years or more and a smoker or
stopped smoking less than one year ago
 Body Mass Index (BMI) equal to or greater than 35kg/m2

Blood pressure greater than 140/90mmHg or controlled
hypertension

Multiple risk factors for Cardio Vascular Disease (CVD)
(such as smoking, diabetes, hypertension, obesity and
dyslipidaemias)

Current or past history of ischaemic heart disease, stroke
or transient ischaemic attack
See next page
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 3 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
EXCLUSION CRITERIA
(I.E. SITUATIONS NOT
COVERED BY THE
PGD)
Continued from previous page
 Current or past history of venous thromboembolism
 Complicated valvular or congenital heart disease e.g.
pulmonary hypertension, history of subacute bacterial
endocarditis
 First degree relative with venous thromboembolism under
45 years of age
 Known thrombogenic mutations e.g. factor V Leiden,
prothrombin mutation, protein S, protein C and
antithrombin deficiencies
 Cardiomyopathy with impaired cardiac function
 Atrial fibrillation
 Significant or prolonged immobility, including planned
major surgery
Neurological Conditions
 Current or past history of migraine with neurological
symptoms including aura at any age
 Migraine without aura, first attack when on oestrogenic
method of contraception
Cancers
 Past or current history of breast cancer

Undiagnosed breast mass (for initiation of method only)

Carrier of known gene mutations associated with breast
cancer e.g. BRCA1or 2

Malignant liver tumour (hepatocellular carcinoma)
See next page
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 4 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
EXCLUSION CRITERIA
(I.E. SITUATIONS NOT
COVERED BY THE
PGD)
Continued from previous page
Gastro-intestinal Conditions
 Viral hepatitis, acute or flare (for initiation only)

Severe decompensated cirrhosis

Gall bladder disease, symptomatic, medically treated

Gall bladder disease, currently symptomatic

Bariatric (or other) surgery resulting in malabsorption e.g.
Roux-en-Y, biliopancreatic diversion

Cholestasis (past combined hormonal contraceptive
related)

Benign liver tumour
Other conditions
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:

Diabetes with end organ disease

Positive anti-phospholipid antibodies (with or without
systemic lupus erythematosus)

Organ transplant, with complications

Undiagnosed abnormal vaginal bleeding

Individuals using enzyme-inducing drugs/herbal products
or within 4 weeks of stopping them

Individual wishes to see a doctor
Expiry date: 15.07.2019
Reference Number :
Page 5 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
CAUTIONS
(INCLUDING ANY
ACTION TO BE TAKEN)




ACTION IF EXCLUDED
ACTION IF PATIENT
DECLINES
TREATMENT







Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
If under 13 years of age, follow local safeguarding policy
Discuss with appropriate doctor/independent non-medical
prescriber any medical condition or medication of which the
nurse/midwife is unsure/uncertain
Offer Long Acting Reversible Contraception (LARC) to women
with medical conditions for whom pregnancy presents an
unacceptable risk
Interacting medicines (not enzyme inducers –see current
British National Formulary (BNF)
Refer to appropriate doctor/independent non-medical
prescriber
Discuss /offer alternative contraceptive method
Document all actions taken
Record refusal in the clinical record
Refer to appropriate doctor/independent non-medical
prescriber
Discuss /offer alternative contraceptive method
Document all actions taken
Expiry date: 15.07.2019
Reference Number :
Page 6 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
DRUG DETAILS
NAME, FORM &
STRENGTH OF
MEDICINE
This is a generic list of combined oral contraceptive pills.
For branded products available at time of writing please refer to
Appendix 1 (pages 14-17).
This list may not be comprehensive. This PGD does not restrict
which brands can be supplied. See http://www.mhra.gov.uk/spcpil/ or http://www.medicines.org.uk for further information.
Monophasic
Ethinylestradiol 20 micrograms and desogestrel 150
micrograms
Ethinylestradiol 20 micrograms and gestodene 75 micrograms
Ethinylestradiol 20 micrograms and norethisterone 1mg
Ethinylestradiol 30 micrograms and desogestrel 150
micrograms
Ethinylestradiol 30 micrograms and drospirenone 3mg
Ethinylestradiol 30 micrograms and gestodene 75 micrograms
Ethinylestradiol 30 micrograms and levonorgestrel 150
micrograms
Ethinylestradiol 30 micrograms and norethisterone 1.5mg
Ethinylestradiol 35 micrograms and norgestimate 250
micrograms
Ethinylestradiol 35 micrograms and norethisterone
500micrograms
Ethinylestradiol 35 micrograms and norethisterone 1mg
Monophasic every day
Ethinylestradiol 30 micrograms and gestodene 75 micrograms
+ 7 inactive
Ethinylestradiol 30 micrograms and levonorgestrel 150
micrograms + 7 inactive
Estradiol (as hemihydrate) 1.5mg and nomegestrol acetate
2.5mg + 4 inactive ▼
Phasic
Ethinylestradiol 30/40/30 micrograms and gestodene
50/70/100 micrograms
Ethinylestradiol 30/40/30micrograms and levonorgestrel
50/75/125micrograms
Ethinylestradiol 35micrograms and norethisterone 0.5/1mg
Ethinylestradiol 35micrograms and norethisterone 0.5/1/0.5mg
Ethinylestradiol 35micrograms and norethisterone
0.5/0.75/1mg
Phasic every day
Ethinylestradiol 30/40/30 micrograms and levonorgestrel
50/75/125micrograms + 7 inactive
Estradiol valerate 3/2/2/1mg + dienogest 0/2/3/0mg + 2 inactive
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 7 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
ROUTE/METHOD
Oral
LEGAL CATEGORY
Prescription Only Medicine
Black triangle ▼
Estradiol ( as hemihydrate) 1.5mg and Nomegestrol acetate
2.5mg+4 inactive is a black triangle▼
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 (0ff label) use(s) for many
different types and brands of COC listed within Appendix 1
The London SH PGD group have agreed it is not practical to list
these individually within this template.
QUANTITY
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
(See FSRH 2010 guidance on combined hormonal
contraception in References section)
 Initial supply of one original pack (3 months)
 Subsequent supply up to twelve months, four original packs,
according to local agreement
Expiry date: 15.07.2019
Reference Number :
Page 8 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.

A single tablet taken at the same time each day starting on
day 1-5 of the menstrual cycle with no need for additional
precautions.( The exception to this is Qlaira®, which should
be started on day 1, or if not, additional precautions should
be used for 9 days after starting)

Thereafter follow manufacturer’s instructions for individual
product use

COC can be started at any time after day 5 if it is reasonably
certain that the individual is not pregnant. Additional
precautions are then required for 7 days after starting (9
days for Qlaira®)

Starting the COC as quick start after levonorgestrel
emergency contraception, additional contraception is
required for 7 days.

After the use of ulipristal acetate, it is recommended that
hormonal contraception should not be used for five days,
then started/restarted. A barrier contraceptive should then
be used for a further 7 days (9 days for Qlaira®)

A pregnancy test is advised three weeks after any oral
emergency contraception- See FSRH guidance Oct 2015.

For guidance on changing from one contraceptive method to
another, and when to start after an abortion and postpartum,
refer to the Faculty of Sexual and Reproductive Healthcare
(FSRH) guidelines
DURATION OF
TREATMENT

For as long as individual requires COC and has no
contraindications to the use of COC
MAXIMUM OR MINIMUM
TREATMENT PERIOD

Minimum three months supply

Maximum twelve months supply (by local agreement)
DOSAGE/FREQUENCY
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 9 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
SIDE EFFECTS
Any drug may produce
unwanted or unexpected
adverse reactions.
Detection and recording of
these is of vital
importance. Patients
should be actively
encouraged to report any
suspected adverse
reaction, particularly to
black triangle medicines.
Refer to current Summary of Product Characteristics (SPC) of
relevant product and current British National Formulary (BNF)
for full list and further information.
This list may not represent all reported side effects of this
medicine.
Side effects may include:
 Nausea

Breast tenderness

Headache

Temporary disturbances of bleeding patterns

Change in mood

Fluid retention
Serious adverse effects
These are less common but the risks should be discussed with
the individual
 Venous thromboembolic disorders

Arterial thromboembolic disorders

Strokes (e.g. transient ischaemic attack, ischaemic stroke,
haemorrhagic stroke)

Hypertension

Liver tumours (benign and malignant)
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.
See next page
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 10 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
SIDE EFFECTS
Continued from previous page
The public can report adverse effects directly to the MHRA via
the yellow card scheme and should be encouraged to do so.
For black triangle medicines: report ALL suspected adverse
reactions, however minor to Medicines and Healthcare Products
Regulatory Agency (MHRA) via the Yellow Card Scheme.
ADVICE TO INDIVIDUAL







Provide Manufacturer’s Patient Information Leaflet (PIL) and
discuss
Explain mode of action, side effects, and benefits of the
medicine
Advise about the risks of the medication including failure
rates and serious side effects and the actions to be taken
Advise on what to do if diarrhoea or vomiting occurs, or if the
individual misses any pills-see FPA leaflet/FSRH guidance
Provide a copy of the FPA leaflet on the COC
http://www.fpa.org.uk/sites/default/files/the-combined-pillyour-guide.pdf
Offer condoms and advice on safer sex practices and
possible need for screening for sexually transmitted
infections (STIs)
Ensure the individual has contact details of the
service/sexual health services
Serious symptoms
 The individual should stop taking the COC and see a doctor
urgently if she experiences calf swelling, heat or pain in the
calf, shortness of breath, chest pain or haemoptysis
 The individual should seek advice if she experiences her
first ever migraine or develops aura with existing migraine
FOLLOW UP
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:


Individual to return to clinic if she has any concerns
Review in 3 months after initial supply, then annually as
appropriate or according to local agreement
Expiry date: 15.07.2019
Reference Number :
Page 11 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
RECORDS
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
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 (where appropriate)
 Initial examination to include Body Mass Index (BMI) and
blood pressure recording and thereafter according to local
policy
 Inclusion or exclusion from PGD
 A statement that supply is by using a PGD
 Advice given about the medication including side effects,
benefits, and when and what to do if any concerns
 Details of any adverse drug reactions and what action taken
 Any 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
 Name and signature (which may be an electronic signature)
of the nurse/midwife supplying or administering the medicine
Expiry date: 15.07.2019
Reference Number :
Page 12 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
REFERENCES

Manufacturer’s Summary of Product Characteristics
(See Appendix 1)

Joint Formulary Committee. British National Formulary June
2016. (Accessed online 04.07.2016 London. BMJ Group and
Pharmaceutical Press <http://www.medicinescomplete.com>

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 (2011)
Combined Hormonal Contraception
https://www.fsrh.org/documents/combinedhormonalcontraception/

Faculty of Sexual and Reproductive Healthcare (2016) UK
Medical Eligibility Criteria for Contraceptive Use.
https://www.fsrh.org/documents/ukmec-2016/

Faculty of Sexual and Reproductive Healthcare (2011) Drug
interactions with hormonal contraception
http://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormon
al.pdf

Faculty of Sexual and Reproductive Healthcare (2010)
Antiepileptic drugs and contraception: CEU statement January
2010 http://www.fsrh.org/pdfs/CEUStatementADC0110.pdf

Faculty of Sexual and Reproductive Healthcare (2013) Update
on newer antiepileptic and antiretroviral drugs and interactions
with hormonal contraceptives (CEU statement)
http://www.fsrh.org/pdfs/CEUstatementUpdateNewerAntiepilept
icAntiretroviralDrugs.pdf
See next page
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 13 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
REFERENCES
Continued from previous page


Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Faculty of Sexual and Reproductive Healthcare (2010): CEUQuick starting contraception
https://www.fsrh.org/documents/ceuquickstartinghormonalcontr
aception/

Faculty of Sexual and Reproductive Healthcare (2015)
Statement from Clinical Effectiveness Unit (CEU) on quickstarting hormonal contraception after use of Ulipristal Acetate
30mg (ellaOne®) for emergency contraception
https://www.fsrh.org/documents/ceuguidancequickstartingcontr
aception/

Faculty of Sexual and Reproductive Healthcare (2010): CEUQuick starting contraception
https://www.fsrh.org/documents/ceuquickstartinghormonalcontr
aception/

Faculty of Sexual and Reproductive Healthcare (2015)
Guidance problematic bleeding with hormonal contraception
https://www.fsrh.org/documents/ceuguidanceproblematicbleedi
nghormonalcontraception/

Faculty of Sexual and Reproductive Healthcare (2014) Venous
Thomboembolism (VTE) and Hormonal Contraception
http://www.fsrh.org/pdfs/FSRHStatementVTEandHormonalCon
traception.pdf

Faculty of Sexual and Reproductive Healthcare (2011) Missed
pills recommendations
http://www.fsrh.org/pdfs/CEUStatementMissedPills.pdf
Expiry date: 15.07.2019
Reference Number :
Page 14 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
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
Qualifications
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


Has had training in the use of PGDs
Has had training which enables the nurse/midwife to make a
clinical assessment in order to supply the medication
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 combined hormonal 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.
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 15 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
APPENDIX 1 Equivalent brands that may be supplied against the PGD (from the British
National Formulary June 2016 accessed on line 04.07 2016). This list may not be
comprehensive. This PGD does not restrict which brands can be supplied.
Name of
contraceptive
Manufacturer
Date SPC
updated
Date accessed
Link
COC with ethinylestradiol 20 micrograms (low strength)
Gedarel®
20/150
Consilient Health
Ltd
17.09.2014
4.07 2016
http://www.medicines.org.uk/
emc/medicine/26770/SPC
Mercilon®
Merck Sharp &
Dohme Limited
15.02.2016
4.07 2016
http://www.medicines.org.uk/
EMC/medicine/5384/SPC/M
ercilon/
Lestramyl ®
20/150
Generics [UK]
Limited t/a Mylan,
21.03.2014
4.07 2016
http://www.mhra.gov.uk/hom
e/groups/spcpil/documents/s
pcpil/con1456466159437.pdf
Loestrin 20®
Galen Limited
28.09.2015
4.07 2016
http://www.medicines.org.uk/
EMC/medicine/1425/SPC/Lo
estrin+20/
Femodette®
Bayer plc
17.06. 2015
4.07 2016
http://www.medicines.org.uk/
EMC/medicine/2542/SPC/Fe
modette/
Millinette®
20/75
Consilient Health
Ltd
17.09.2014
4.07 2016
http://www.medicines.org.uk/
emc/medicine/26767/SPC/Mi
llinette+20+75+microgram+c
oated+tablets
Sunya 20/75®
Stragen UK Ltd
07.08.2014
4.07.2016
http://www.mhra.gov.uk/hom
e/groups/spcpil/documents/s
pcpil/con1447997333043.pdf
APPENDIX 1 (continued) Equivalent brands that may be supplied against the PGD (from the
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 16 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
British National Formulary June 2016 accessed on line 04.07 2016). This list may not be
comprehensive. This PGD does not restrict which brands can be supplied.
Name of
contraceptive
Manufacturer
Date SPC
updated
Date accessed
COC with ethinylestradiol 30 or 35 micrograms (standard strength)
Cilest®
Janssen-Cilag Ltd
114.09.2015
4.07 2016
Link
http://www.medicines.org.uk/e
mc/medicine/30493
Lizinna®
Morningside
Healthcare
21.07.2014
4.07 2016
Gedarel®
30/150
Marvelon®
Consilient Health Ltd
17.09.2014
4.07 2016
Merck Sharp &
Dohme Ltd
10.06.2016
4.07 2016
Cimizt®
Morningside
Healthcare
07.08.2014
4.07 2016
Lestramyl
30/150 ®
Generics [UK]
Limited t/a Mylan,
21.03.2014
4.07 2016
Microgynon 30®
Bayer plc
17.06.2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/1827/SPC/Micro
gynon+30/
Ovranette®
Pfizer
15.04.2016
4.07 2016
Elevin®
Leandra®
Medrix Healthcare
LLP
16.05.2016
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/7518/SPC/Ovran
ette+150+30+micrograms+Co
ated+Tablets/
http://www.mhra.gov.uk/home/
groups/spcpil/documents/spcpi
l/con1463719001774.pdf
Rigevidon®
Consilient Health Ltd
04.03.2016
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/26765/SPC/Rige
vidon+coated+tablets/
Microgynon 30
ED®
Bayer plc
17.06..2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/1828/SPC/Micro
gynon+30+ED/
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
http://www.mhra.gov.uk/spcpil/?IdcService=SS_GET_PAG
E&nodeId=%3C%25%3D+nod
eId+%25%3E&searchFiled=lizi
nna
https://www.medicines.org.uk/
emc/medicine/26769
http://www.medicines.org.uk/E
MC/medicine/5383/SPC/Marve
lon/
http://www.mhra.gov.uk/spcpil/?prodName=CIMIZT%2015
0%20MICROGRAM/30%20MI
CROGRAM%20TABLETS&su
bsName=DESOGESTREL&pa
geID=SecondLevel
http://www.mhra.gov.uk/home/
groups/spcpil/documents/spcpi
l/con1456466263906.pdf
Expiry date: 15.07.2019
Reference Number :
Page 17 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
APPENDIX 1 (continued) Equivalent brands that may be supplied against the PGD (from the
British National Formulary June 2016 accessed on line 04.07 2016). This list may not be
comprehensive. This PGD does not restrict which brands can be supplied.
Name of
contraceptive
Manufacturer
Date SPC
updated
Date accessed
COC with ethinylestradiol 30 or 35 micrograms (standard strength)
Levest®
Morningside
11.06.2013
4.07 2016
Link
http://www.mhra.gov.uk/spcpil/?prodName=LEVEST%201
50/30%20MICROGRAM%20C
OATED%20TABLETS&subsN
ame=LEVONORGESTREL&p
ageID=SecondLevel
Femodene® ED
Bayer plc
17.06.2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/1818/SPC/Femo
dene+ED/
Yasmin®
Bayer plc
31.07.2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/8777/SPC/Yasmi
n+filmcoated+tablets+0.03mg+3mg/
Lucette®
Consilient Health
Ltd
18.07.2014
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/28559
Femodene®
Bayer plc
17.06.2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/1817/SPC/Femo
dene/
Katya 30/75®
Stragen UK Ltd
08.08.2014
4.07 2016
Millinette® 30/75
Consilient Health
Ltd
17.09.2014
4.07 2016
http://www.mhra.gov.uk/spcpil/?prodName=KATYA%2030/
75%20COATED%20TABLETS
&subsName=GESTODENE&p
ageID=SecondLevel
http://www.medicines.org.uk/e
mc/medicine/26766/SPC/Millin
ette+30+75+microgram+coate
d+tablets/f
COC with ethinylestradiol 30 or 35 micrograms (standard strength)
Norimin®
Pfizer Limited
01.08.2014
4.07 2016
Ovysmen®
Janssen-Cilag Ltd
15.12.2015
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/1919/SPC/Norimi
n+Tablets/
http://www.medicines.org.uk/E
MC/medicine/2999/SPC/Ovys
men+Oral+Contraceptive+Tabl
ets/
APPENDIX 1 (continued) Equivalent brands that may be supplied against the PGD (from the
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 18 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
British National Formulary June 2016 accessed on line 04.07 2016). This list may not be
comprehensive. This PGD does not restrict which brands can be supplied.
Name of
contraceptive
Manufacturer
Date SPC
updated
Date accessed
COC with ethinylestradiol 30 or 35 micrograms (standard strength)
Brevinor®
Pfizer Limited
27.10.2014
4.07 2016
Loestrin 30®
Galen Limited
28.09.2015
4.07 2016
Link
http://www.medicines.org.uk/E
MC/medicine/1899/SPC/Brevin
or+Tablets/
http://www.medicines.org.uk/E
MC/medicine/19893/SPC/Loes
trin+30/
COC with nomegestrol acetate 2.5 mg and estradiol (as hemihydrate) 1.5 mg
Zoely▼
Merck Sharp &
Dohme Ltd
21.04.2016
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/27581/SPC/Zoely
+2.5+mg+1.5+mg+filmcoated+tablets/
Bayer plc
17.06.2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/1823/SPC/Logyn
on/
TriRegol®
Consilient Health
Ltd
13.07.2015
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/26768/SPC/TriRe
gol+coated+tablets/
Logynon ED®
Bayer plc
13.01.2014
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/1824/SPC/Logyn
on+ED/
Triadene®
Bayer plc
07.07.2015
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/1847
Synphase
Pfizer Limited
30.06.2014
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/8406
Binovum
Janssen-Cilag Ltd
15.12.2015
4.07 2016
http://www.medicines.org.uk/e
mc/medicine/879
Qlaira®
Bayer plc
15.11.2015
4.07 2016
http://www.medicines.org.uk/E
MC/medicine/21700/SPC/Qlair
a/
Phasic COC
Logynon®
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 19 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
PGD DEVELOPMENT GROUP
Date PGD template comes into effect:
Review date
Expiry date:
15.07.2016
15.01.2019 or earlier in the light of
significant changes in best practice
15.07.2019
This template was peer reviewed and ratified by London Contraception and Sexual Health
PGD Working Group:
NAME/ROLE
Kathy French
Chair - Working Group
Angela Bussey
Advisor - Working Group
POSITION
DATE
Independent Nurse Advisor
Project Lead
15.07.2016
Principal Pharmacist
Medicines Information
Projects.
Guy’s and St Thomas’ NHS
Foundation Trust.
15.07.2016
Lead Doctor
Dr Sarah Pillai
Associate
Specialist, 15.07.2016
Contraception and Sexual
Health
Service,
Central
London
Community
Healthcare NHS Trust
Lead Pharmacist
Sandra Wolper
Associate Director for
Specialist Pharmacy
Service, Hounslow and
Richmond NHS Trust
Lead Nurse, Integrated
Sexual Health Services,
Barts Health NHS Trust
Lead Nurse
Sandra Bennett
15.07.2016
15.07.2016
Specialist reviewers
Lead Specialist Reviewer, Community
Pharmacist
Community Pharmacist, Chair of Brent and Harrow
LPC
Shabbir Panju
The PGD template is not legally valid until it has had the relevant organisational
approval.
See next page
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 20 of 21
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY OF COMBINED ORAL CONTRACEPTIVE
PILLS BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH
SERVICES.
ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS
This page may be deleted if replaced with a format agreed according to local PGD
policy with relevant approvals and authorisation.
The PGD is not legally valid until it has had the relevant organisational authorisations.
To ensure compliance with the law, organisations must add local authorisation details i.e.
clinical authorisations and the person signing on behalf of the authorising organisation.
You may either complete details below or delete and use a format agreed according to local
PGD policy which complies with PGD legislation and NICE MPG2 PGD 2013.
.
Name
Job title and
organisation
Signature
Date
Senior doctor
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.
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. Individual
practitioners must declare that they have read and understood the Patient Group Direction
and agree to supply/administer medicines listed only in accordance with the PGD.
ORGANISATIONS MAY ALSO ADD:
 Local training and competency assessment documentation.
 Other supporting local guidance or information.
 Links to local PGD Policy and other supporting guidance.
Version No: 2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 15.07.2019
Reference Number :
Page 21 of 21