Download Hormonal Emergency Contraception G16

Trust Guideline for the use of Emergency Contraception.
A clinical guideline recommended for use:
In:
Contraception and Sexual Health, GU Medicine, Obstetrics &
Gynaecology and Emergency Medicine
By:
Medical and Nursing staff
For:
Prevention of unplanned pregnancy
Key words:
Emergency Contraception, Levonelle, Levonorgestrel, Ulipristal
Acetate, ellaOne, Intrauterine Device
Written by:
Dr Megan Griffiths, Specialist Registrar Community Sexual and
Reproductive Health.
Supported by:
Dr Catherine Schunmann, Consultant, Sexual and Reproductive
Health.
Approved by:
Gynaecology Guidelines Committee
Reported as approved Clinical Effectiveness Committee
to the:
Date of approval
23rd January 2015
To be reviewed before: 23rd January 2018
To be reviewed by:
Dr Schunmann
Guideline supersedes: Previous Emergency Hormonal contraception guideline (G16)
Guideline Reg. No:
G16(v2)
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
1
Trust Guideline for the use of Emergency Contraception.
1) Quick reference guideline
•
•
•
•
Key Messages
Insertion of a copper intrauterine device (Cu IUD) is the gold standard form of
Emergency Contraception (EC) – Patients must be advised of this and given
the option to access it. (Further information on Page 8)
If last menstrual period (LMP) was not normal in timing, duration or severity or
> 4 weeks ago – consider a pregnancy test prior to EC as they may already be
pregnant.
There is no time in the cycle when there is no risk of pregnancy
Unprotected sexual intercourse (UPSI) means potential exposure to Sexually
Transmitted Infection (STI) – Provide GU clinic times for review
Assess timing and number of episodes of UPSI since LMP
Single or multiple
UPSI <120 hours
ago
<72
hours
ago?
More than 120 hours ago? Assess
regularity of menstruation e.g. 1st
day approx every 28 days or
every 31 days?
72 – 120
hours?
Cu IUD or
Levonelle
1.5mg single
dose stat po
Cu IUD or
Ulipristal
Acetate 30mg
po stat
Regular cycle – allows
prediction of date of
ovulation (See table 2 for
help)
If <5 days after date of
predicted ovulation e.g.
day 19 of 28 day cycle, a
Cu IUD may still be fitted
as EC – Contact CASH
clinic asap.
Vomits <3 hours
after pill - see
special
considerations
chart for further
advice.
Advise to perform pregnancy test if abnormal or no period 3 weeks after UPSI.
Advise on
future contraception.
Emergency
Hormonal contraception
Jan 2015
Offer Chlamydia
G16 (v2) screening in under 25s & provide
Review GU
Jan clinic
2018 times for review.
Cycle irregular – i.e. no
definable pattern of
menstruation. Emergency
contraception is not
appropriate. Advise PT 3
– 4 weeks after UPSI
Please note special
considerations such as
drug interactions, lactation,
age <16 and effect on
hormonal contraception are
considered on Page 3,
Table 1.
2
Trust Guideline for the use of Emergency Contraception.
Special Considerations – Table 1
Scenario
Breast feeding
Levonorgestrel (Levonelle)
Safe to use while breast
feeding.
Multiple doses in a single
cycle
If further UPSI <12 hours
after dose no additional
dose needed. Multiple
doses in the same cycle
are acceptable but patient
should be warned that
may already be pregnant.
If using as their regular
method, they should use
additional precautions for
7 days.
Oral hormonal
contraception (as regular
method but missed pill
scenario)
Age 13 - 16
Age under 13
Vomiting after EC.
Enzyme inducing drugs
(See page 6 for full list)
Ulipristal Acetate (ellaOne)
Unknown safety – advise
to avoid breast feeding for
36 hours and dispose of
expressed milk.
Repeated use in same
cycle not recommended
as effect on early
pregnancy unknown
If current method, to use
barrier methods for 14
days for Combined Oral
Contraception, 9 days for
Progesterone Only Pills &
16/7 for Qlaira.
An assessment of their ability to consent to this should
be performed and documented. See “Fraser Guidance”
section on pages 7. AND
Child safeguarding should be considered and action
taken as appropriate.
A child safeguarding issue IS present. Social Services
must be informed as a minimum. Seek senior advice
urgently.
Vomits within 2 hours –
Vomits within 3 hours –
offer repeat dose or IUD & offer repeat dose or IUD &
consider antiemetic.
consider antiemetic.
IUD is best option re risk
IUD is best option.
of failure. If declined,
Ulipristal not
Levonelle dose should be
recommended in this
doubled to 3mg.
group. If IUD is declined,
3mg of Levonelle should
be used.
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
3
Trust Guideline for the use of Emergency Contraception.
Table 2 – Assessment of whether insertion of Copper IUD for emergency
contraception may be appropriate in this cycle.
Note must have a regular cycle length. Assess cycle length over preceding 3
months. Day 1 of menstruation is day 1 of cycle.
No of days in cycle (n)
Day of ovulation (n-14)
Last possible day of IUD
insertion for EC (n-14+5)
21
Day 7
Day 12
22
Day 8
Day 13
23
Day 9
Day 14
24
Day 10
Day 15
25
Day 11
Day 16
26
Day 12
Day 17
27
Day 13
Day 18
28
Day 14
Day 19
29
Day 15
Day 20
30
Day 16
Day 21
31
Day 17
Day 22
32
Day 18
Day 23
33
Day 19
Day 24
34
Day 21
Day 25
35
Day 22
Day 26
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
4
Trust Guideline for the use of Emergency Contraception.
2) Objective
Emergency contraception given within 120 hours of unprotected sexual intercourse
(UPSI) or failed contraception will reduce the chance of pregnancy occurring. It is
more effective when given earlier in that time period. The fitting of an emergency IUD
is always more effective than oral EC. Oral EC includes 2 possible drug therapies,
and this guideline will advise on the most appropriate agent according to the clinical
scenario.
3) Rationale
The copper IUD as emergency contraception works via its toxic effect on sperm and
prevention of implantation. Working independently of ovulation, the insertion of a CuIUD can prevent implantation up to 5 days after unprotected intercourse, acting
between fertilisation and earliest possible implantation. Ulipristal is a selective
progesterone receptor modulator and its primary method of action is to delay or
inhibit ovulation. Levonorgestrel has similar actions, but is also thought to act on
endometrium to prevent implantation. The action of Levonorgestrel declines with
increasing time following UPSI, whereas Ulipristal effects are maintained. The
introduction of Ulipristal allows a pharmacological and licensed method of EC to be
prescribed between 72 and 120 hours. It therefore replaces the unlicensed use of
Levonelle at >72 hours and has a higher efficacy rate at preventing pregnancy during
that time frame. Efficacy rates are given below for comparison between methods.
Method of Emergency Contraception
IUD
Levonorgestrel <72 hours
Levonorgestrel >72 hours
Ulipristal <72 hours
Ulipristal >72 hours
Efficacy (%)
99%
84%
63%
Unlicensed
85%
Likely to be ≥ Levonorgestrel
Licensed
4) Broad recommendations
i.
Women who present for emergency contraception should be seen and
assessed as soon as possible. If oral emergency contraception is appropriate,
tablets should be taken immediately.
ii.
Screening for STIs should be considered if risk factors are present (e.g. age
<25, new partner, unprotected intercourse, or condom failure).
iii.
Excluding pregnancy predating current events
a. History establishing timing of and number of episodes of Unprotected Sexual
Intercourse (UPSI) elicit previous pregnancy risk.
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
5
Trust Guideline for the use of Emergency Contraception.
b. Last menstrual period (LMP) - normal in timing and nature within the last 5
weeks. If not a pregnancy test (PT) should be done prior to giving Emergency
contraception (EC).
c. If UPSI 6 or more days ago within the same cycle as well as within 120 hours
check PT is negative.
d. If UPSI earlier in the same menstrual cycle as well as within 72 hours
Levonelle may be given but the patient should be advised even with a
negative PT she may already be pregnant. Ulipristal must not be given in this
scenario as the effects on the fetus are not known.
iv.
Vomiting after taking oral emergency contraception is unusual but may affect
absorption. Patients should return for a further dose if vomiting occurs within 2
hours of Levonelle or 3 hours of Ulipristal. An antiemetic may be given with
the subsequent dose.
v.
Advice about future contraception should be given and, if possible, provided.
vi.
A pregnancy test should be performed if the patient has not had a normal
period within 3 weeks.
5) Special groups
i. Special groups - Interacting Medications
Enzyme inducing medication (taken within the previous 4 weeks) may reduce
the efficacy of emergency hormonal contraception. Examples of enzyme
inducers are included in Table 3. The IUD is the only method unaffected by
these but an increased dose of Levonelle (3 mg) can be given if the woman
understands reduced efficacy is present. These drugs may also affect the
action of Ulipristal and the current advice is that Ulipristal should not be used
in women who are on or have used enzyme inducing drugs in the last 28 days.
Antacids, Proton pump inhibitors and H2 receptor antagonists – Concomitant
use may reduce the absorption of Ulipristal and therefore is not advised.
Table 3 – Enzyme Inducing Drugs
Drug Group
Examples of Enzyme inducers
Antiepileptics
Antibiotics
Carbamazepine,
Eslicarbazepine,
Oxcarbazepine,
Phenobarbital, Phenytoin, Primidone, Rifinamide, Topiramate
Ritonavir All other ritonavir boosted protease inhibitors
(atazanavir, darunavir, nelfinavir, fosamprenavir, lopinavir,
tipranivir, saquinavir), Efavirenz and Nevaripine.
Rifampicin, Rifabutin,
Herbal
St Johns Wort
Others
Aprepitant (Nausea and vomiting esp chemotherapy),
Bosentan (Pulmonary hypertension or systemic sclerosis),
Sugammadex (Neuromuscular blockade reversal agent)
Antiretrovirals
ii. Special Groups – Postnatal and Breast feeding
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
6
Trust Guideline for the use of Emergency Contraception.
Contraception not necessary until 21 days post partum.
Lactating. If exclusively breastfeeding (ie no bottle top ups), amenorrhoea and within
6 months of delivery, risk of pregnancy is already low, but Levonelle can be used
without restriction. Ulipristal is a newer drug and it is not known whether it is excreted
in breast milk. Lactating women are advised to avoid breastfeeding, and discard
expressed milk for 36 hours after using Ulipristal.
iii. Special groups - age under 16
Child safeguarding should be considered and action taken as appropriate.
An assessment of Fraser competence should be made and documented.
Health professionals are able to give contraceptive advice and treatment to a young
person under 16 without parental knowledge provided they are satisfied that:
•
•
•
•
•
The young person understands the advice being given
The young person cannot be persuaded to tell their parents or allow the
doctor to tell them, that they are seeking contraceptive advice
The young person is likely to begin or continue to have sex without
contraception
The young person’s physical or mental health are likely to suffer unless
they receive contraceptive advice or treatment
It is in the young person’s best interests to receive contraceptive advice
or treatment.
6) Contraindications
There are not considered to be any absolute medical contraindications to Levonelle.
Conditions for careful consideration include severe hepatic dysfunction,
hypersensitivity to levonorgestrel and trophoblastic disease with an abnormal hCG.
Use of Ulipristal is not recommended in the presence of severe hepatic impairment,
galactose intolerance or malabsorption or in those with severe asthma not controlled
by the use of oral glucocorticoid therapy. The most common drug interaction is with
acid reducing medication eg proton pump inhibitors or H2 receptor antagonists and
concomitant use is not advised.
7) Accessing Emergency Intrauterine Contraception
The fitting of an IUD is more effective than either form of oral emergency
contraception. It should be considered in all cases, particularly when there is a high
risk of pregnancy (days 9-16 of 28 day cycle), when UPSI occurred more than 72
hours previously and when there are interacting medications which may affect the
efficacy of oral EC. CASH clinic can be contacted on (01603) 287347 Monday,
Tuesday, Thursday, Friday & Saturday morning to arrange this. Outside these hours
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
7
Trust Guideline for the use of Emergency Contraception.
the patient should be given oral EC as an interim measure and the clinic contacted
as soon as possible thereafter to arrange IUD insertion.
Possible exposure to STI is not a contraindication to IUD insertion, as it can be
inserted with antibiotic cover.
8) Clinical audit standards
Pregnancy test performed appropriately pre-prescription of hormonal emergency
contraception?
Offered Intrauterine device (unless contraindicated) or reason for not offering?
If IUD chosen but unable to fit at first presentation, were they given hormonal
emergency contraception in the interim period? Target 100%
Documentation of other drug history to exclude interactions.
STI screening opportunity given? Target 100%
Future contraception discussion documented? Target 100%
9) References
1. Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit.
FFPRHC Guidance (April 2006) Emergency Contraception. J Fam Plann Reprod Health
Care 2006; 32(2): 121-128.
2. Faculty of Sexual and Reproductive Health Care Clinical Effectiveness Unit. (January
2011) “Drug interactions with hormonal contraception.” Available on the Faculty Website
http://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
3. Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit.
FFPRHC Guidance (July 2004) Contraceptive choices for breastfeeding women. J Fam
Plann Reprod Health Care 2004; 30(3): 181-189.
4. Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness unit Statement,
December 2009, “Frequently asked questions on Ulipristal Acetate (ellaOne) Emergency
Contraception” – available on Faculty Website
http://www.fsrh.org/pdfs/UlipristalFAQsCEU.pdf
5. Faculty of Sexual and Reproductive Health Care Clinical Effectiveness Unit. “Ulipristal
Acetate(ellaOne) – new product review” October 2009– available on Faculty Website
http://www.fsrh.org/pdfs/ellaOneNewProductReview1009.pdf
Emergency Hormonal contraception
Jan 2015
G16 (v2)
Review Jan 2018
8