Transcript GP Spring meeting An update on Contraception 17 March 2004

An update on Contraception
to
the Hillingdon Independent GP Group
18 August 2004
Dr Bela Reed
Family Planning & Reproductive
Health Service for Harrow/Hillingdon
The main contraceptive methods in the UK
•Male condom
•Female condom
•Diaphragm, caps, spermicides
•Natural methods
• Combined Pills
• Transdermal Patch
• Vaginal ring
• Progestogen only pills
•Contraceptive injection(s)
•Sub-dermal implant
•Hormonal Emergency Contraception
Levonelle-2 (Levonelle)
•Intra-uterine devices
Intrauterine systems (Mirena)
Intrauterine implant (GyneFix)
•Male and Female sterilisation
Balancing clinical risks and benefits
4 categories of
risk (WHO):
1.No restriction for use
2.Advantages outweigh risks
3. Risks outweigh advantages
4. Unacceptable health risk
Barrier methods and spermicides
Nonoxynol-9
• No evidence that condoms
lubricated with N-9 are more
effective in preventing a
pregnancy than … silicone. Such
condoms should no longer be
promoted
• N-9 offers no protection against
STI
• N-9 increases the risk of HIV
infection when used by women
at high risk
• It is better to use a N-9
lubricated condom than no
condom at all
WHO 2001
Lactational Amenorrhoea Method (LAM)
The risk of pregnancy is
1% providing …
• Fully or almost fully
breastfeeding
• Amenorrhoeic
• Baby < 6 months
COC and Arterial Disease
ie Myocardial infarction, Ischaemic stroke (incl TIA),Haemorrhagic stroke
• Age (>35) is a risk factor
• Of the women who had MI
<45 years, 88% had one or
more risk factors
Estimated excess risk of death per
million women on COC
with no CVS risk factors x Age
30
25
• No difference on risk of MI
between 2nd and 3rd
generation COCs
• Young women who wish to
preserve their health
should be advised to stop
smoking above all else
20
15
25
10
5
0
20-24yrs
0
2
5
30-34yrs
40-45 yrs
COC and Cardiovascular disease
• Avoid COC if 2 or
more risks apply or if
>35 years + 1 risk
factor
• Discontinue COC if
smoker age >35 years
• Discontinue COC at
age 50 years
COC and Migraine
Risk of ischaemic stroke
20-25 years – increased 5x
COC contraindicated when
• Migraine with with aura/focal
neurological symptoms
• Migraine lasting >72 hours
• Migraine treated with ergot
derivatives
• Common migraine but other
risk factors for stroke
COC and Migraine
Use COC with caution
when
• Migraine or headaches
worsening
• First onset of migraine
after starting COC
• A history of focal
migraine but no recent
attacks
COC and VTE
• High profile court case
in 2002
• Risk of VTE is 25 per
100,000 women per
year (cf to 15 with 2nd
generation COCs)
• Risk higher in first
year of use
COC and VTE
Good practice for
prescribing 3rd gen
COC
• Screen for risk markers for
VTE
• Arrange a thrombophilia
screen if first degree relatives
had VTE age <45
• Ensure informed consent –
that patient aware of this
increased risk of VTE
Risk markers for VTE:
• Family history of VTE
age <45 years
• BMI > 30 kg/m2
•
•
•
Severe varicose veins
Trauma, major surgery,
abdominal or leg surgery, leg in
plaster
Acquired thrombophilia –
chronic disease -anti-
phospholipids and lupus factor
•
•
?long distance travel
Congenital or valvular heart
disease
COC and VTE
COC and smoking
•
Smoking in women <35 years, on COC,
increases the risk of CVD from 3.56 to
42.7 per million user years
•
Smoking in women >35 years, on COC,
increases the risk of CVD from 40.4 to
484.6 per million user years
Dunn et al BJFP 1997:23:88-91
•
The pill taker who smoked was more
likely to suffer a heart attack and more
likely to die from it
RCGP studies 1983
COC and obesity
• Weight gain on COC due to
– water retention
– Increase in appetite
– Metabolic disturbance
• BMI >30 associated with
increase in risk of venous
thrombo-embolism and
cardio-vascular disease
Avoid COC if other risk
markers present
• BMI >39 COC
contraindicated
COC and Breast cancer
• Age is most significant risk factor
Breast cancer is rare in women < 40
whether on COCs or not
background risk increases with age
– significant after age 35.
The excess risk with users of COC
gradually disappear after 10 years
• Duration of use is less important
• The possible increase in risk of
breast cancer should be discussed
with the user and weighed against
the benefits
From the meta-analysis of the collaborative group
on hormonal contraceptives in breast cancer.
Lancet 1996
• Good practice –
discuss breast cancer risks
routinely at age 35
The risk of familial breast cancer
• Most women with breast cancer
have no positive family history
• Increased risk with a family
history
– 2 first degree relatives, 13.3%
– 1 first degree relative 5.5%
– Risk grater the younger the
affected relative
If women with positive family
history do develop breast cancer
- unlikely to get it at a younger age
- does not affect tumour spread nor
mortality
COC and Cervical cancer
• “a causal link between the pill and cervical cancer
was likely…increasing risk of cervical cancer and
increasing duration of use of OCs”.
• Risk disappears when pill stopped.
• taking OCs for up to 5 years – no increase in risk
use OC 5-10 years or more – 3 fold increase
use OC >10 years – 4 fold increase of cervical
cancer”
The Lancet. March 2002
• “Evidence not sufficiently robust … based on small number
of cases
DH March 2002 CEM/CMO/2002/5
Further information on www.doh.gov.uk or www.cancerscreening.nhs.uk
Reminder!
– Ca Cx is an STI – HPV
– Risk is higher in smokers
– No need to stop COC
because of an abnormal
smear
– Be scrupulous about
cervical cancer screening
if used OC >5 years
– Pills are safe and highly
effective in preventing
pregnancy
What is new/news?
• COCs containing cyproterone acetate (Dianette)
have 3.9 times increased relative risk of VTE than
on an LNG pill (Microgynon)
(Vasilaakis-Scaramozza C, Jick H. Lancet 2001; 358: 1427-1429)
• Dianette is not licensed as a contraceptive. It is to be
used for acne or hirsutism and discontinued 3-4
months after condition has resolved
(CSM/MCA Oct 2002)
Is COC effective for acne?
• COC usually improves acne.
• Third generation COCs and
oestrogen dominant COCs
are particularly helpful
• POP and progestogen
dominant pills should be
avoided
• Dianette is useful but remains
a second choice for long term
treatment
• ? Yasmin
New COC “Yasmin”
30mcg ethinyl oestradiol + 3mg drospirenone
drospirenone –
• “a progestogen resembling natural progesterone”
• Anti-mineralocorticoid - prevents sodium retention
– Mean weight below baseline value (2 year data)
– BP both systolic and diastolic less compared to
Marvelon
– Improvement in PMT and PMDD symptoms
• Anti-androgenic
– Improvement in skin – acne and sebum formation less
– No data on effect on PCO or hirsutism
The contraceptive transdermal patch –
Evra®
• Contains ethinyl oestradiol
and norelgestromin
• Constant levels of
hormones
• Each patch for 7 days
effective up to 9 days
• Applied to clean dry skin
on buttocks, front/back
(not breasts), abdomen,
upper arm
• Similar to COC in
efficacy, side effects etc
The contraceptive transdermal patch –
ADVANTAGES
Evra®
•
•
•
•
•
Better compliance = less failures
? teenagers
Women who are unable to swallow pills
Gastrointestinal problems
??? Less VTE (as in HRT studies)
DISADVANTAGES
• Local reaction
• Patch gets unstuck
• ?effectiveness if weight over 90kg
• Cost (£23.23 for 3 months)
compared to Microgynon 30 at £2.82, Cilest at £6.42
Progestogen only pills
• Use in women over 70 Kg (11 stone)?
Possible increase in failure especially in younger women
More effective in older women (>40 effective as COC), breastfeeding women
and meticulous pill takers.
Use of double dose?? Unlicensed use but consider in women who bleed
“regularly” or with nuisance bleeding
• Use in women with PCO?
Functional ovarian cysts common (50%)
Risk/benefit assessment required in individual cases.
• Increased risk of ectopic pregnancy
• Emergency Contraception indicated if
pill taking late by >3 hours and UPSI has taken place
from time of missed pill to 48 hours of restarting POP
What is new?
Cerazette - Each tablet
contains 75 mcg
desogestrel (metabolised
to etonogestrel)
• Inhibits ovulation
Efficacy: Pearl index for
Cerazette was 0.14
compared to 1.17 for LNG
30 microgram
• Low androgenic activity
• Some ovarian follicular
activity present
• Bleeding pattern – early
treatment phase (first
month) variable bleeding
pattern
late phase (9-12 months) –
bleeding less frequent
• Less dysmenorrhoea
• Acne not worse
• No weight change
• Effective taken up to 12
hours late
“Insufficient evidence that it is more effective than other POPs. Irregular vaginal
bleeding similar. ..No compelling reason to use Cerazette instead of a standard
POP” DTB Sep 2003
Depo-Provera
Long term DMPA use and effect on bone mass
- Review by Olav Meirik IPPF Medical Bulletin 5 Oct 2000
• women in the ‘middle years’ of reproductive life effects small and transient. Changes negligible with
rapid return to normal
Use DMPAwith caution in
• adolescents (<20) - process of building up bone mass
• perimenopausal years (>45) - about to lose bone
mass rapidly
• women with risk factors for osteoporosis
Risk factors for osteoporosis
• genetic - causasians and
asians
• Amenorrhoea – athletes,
anorexia
• diet - low in calcium or
vitamin D
• physical inactivity
• smoking
• excessive alcohol intake
• excess of hormones eg
steroids, thyroid,
parathyroid
• lack of oestrogen
• BMI <18
IMPLANON
A biodegradable single
flexible rod 4cm long x
2mm diameter
Contains 68mg
ETONOGESTREL, an
active metabolite of
desogestrel
Licensed for 3 years –
what about women weighing
>70 Kg
Implanon
Release of etonogestrel
60-70ug/day in first 5-6
weeks
35-45ug/day end of year 1
30-40ug/day end of year 2
25-30ug/day end of year 3
Implanon
Benefits
• reliable long term
contraception
• Improvement in
menorrhagia and
dysmenorrhoea
• Beneficial effect on acne
in 59%
• No adverse effects on
bone mass
• No significant effect on
lipids, haemostasis or
liver function
Adverse side effects
• Bleeding pattern altered:
Amenorrhoea 20%
Infrequent B-S 26%
Frequent B-S 6%
Prolonged BS 12%
• Weight gain of >10% in 21%
- no change from reference group
• Hormonal ‘nuisance’ effects eg
breast pain, headache, libido
decrease, dizziness, nausea
• Other (<2.5%)
alopecia,depression,change in
libido
How effective is Levonelle-2?
• Overall effectiveness is
85% ie prevents 7 out of
8 pregnancies
• Taken within 24hours, it
prevents 95% of
pregnancies
• Taken 25-48 hours after
UPSI, it is 85%
• Taken 49-72 hours, it is
58%
What are the contraindications?
• Pregnancy
• previous adverse
reactions
• severe liver disease
• active pophyria
• Current breast cancer
• Certain medical
conditions
Special precautions
• Enzyme inducing medications
Pharmacy
• Under 16
• Gastro-intestinal disease
Levonelle-2
Does it affect menstruation?
• Temporary disturbance of menstrual pattern
• menstrual pattern after treatment:
at expected time (57%), a week early (15%)
or a week late (15%)
• Any bleeding outside this range should be
checked
Levonelle-2
Whats new?
*Change in license – 2 tablets to be taken together asap
within 12 hours and no later than 72 hours after UPSI
*Other - FFPRHC Guidance on Emergency
Contraception April 2003 – unlicensed use
• Increase dosage in women taking enzyme inducing
drugs – double the first dose
• Interval between tablets can be up to 16 hours
• Repeat use in same cycle is safe
• Offer L-2 if within 72 hours of UPSI even if referred
for emergency IUD fitted
• May be effective up to 5 days after UPSI – small study, IUD better
Levonelle-2
Advice from the Chief Medical Officer (2002)
12 cases of ectopic pregnancies have been reported to the CSM
out of a total of 201 unintended pregnancies
The Committee on Safety of Medicines (CSM) advises
• Women should be encouraged to seek treatment as soon as
possible and advised that treatment failure may occur
• Women who do not experience a normal period after using
Levonelle-2 should be followed up to exclude pregnancy
• The possibility of an ectopic pregnancy should be considered
especially if history of previous ectopic, tubal surgery or PID
NB. High
index of suspicion for ectopic
pregnancy
Other advice …
• Importance of follow
up after 3-4 weeks
• contraception
- interim
- longer term
(starter pack COC)
• Risk assessment for
STI
Emergency Contraception -IUD
Indications
• UPSI >72 hours but
<120 hours
• UPSI before day 19 of a
28 day cycle
• Multiple episodes UPSI
• Choice as ongoing
contraception
• LEI drugs, L-2
contraindicated
Advice
• Offer L-2 if <72
hours since UPSI
even if IUD to be
fitted
• Remove IUD with
onset of next menses
INTRA UTERINE
CONTRACEPTION
Types of devices:
Cu IUD
T safe Cu 380A
Multiload 375
Nova T 380
Flexi-T 300
Multiload Cu 250
multiload Cu 250 short
Other
Gynefix (IUI)
Mirena
Intra-uterine Contraception
Gyne T 380S
UK gold standard for long
term use in younger
women
• Low intra and extra uterine
pregnancy rates - Tcu-380A failure rate 2.2 after 12 years
• Licensed for 8 years use –
effective to 10 years
• Discontinued after June 2001
T-Safe CU 380A
• ‘The replacement for
Gyne T 380’
• Stem Cu surface area
200sq mm + copper
sleeves = total Cu surface
area of 380sq mm
• problems with inserting
the device into introducer
• Cost 165 euros
Intra-uterine Contraception
Multiload
• 375 mm2 surface area of
Cu
• Useful post-partum and
for repeated expulsion
• Low failure rate (2.9)
• High rate of removal for
pain and bleeding
• Also 250 versions short
and standard
Intra-uterine Contraception
Nova T 380
• Increased surface area of
Cu of 380mm2 with silver
core
•
•
Effective for 5 years
Cost £13.50
Intra-uterine Contraception
GyneFix IUI - (Belgium 1985)
“frameless and flexible”= less
pain and bleeding
Non-biodegradable suture thread 6 Cu
tubes (5mmx2.2mm) surface area
330mm2
Special inserting device to anchor knot
into fundal myometrium
Suitable for nullips
Expulsion after ToP less than other IUDs
Cost +/- £30
Intra-uterine Contraception
Flexi-T 300
Size: 2cm wide x 3cmlong
Inserter device 3mm
Surface area of Cu 300mm2
Push in technique
Unplanned pregnancy at end
of year three: 2.5
(Pearl index 1.0)
Cost £7.35
Intra-uterine Contraception
SUMMARY
• Devices with surface area
>300mm2 Cu are more
effective and reduce ectopic
pregnancy rates
• Gyne T 380 is effective for
10 years
• Flexi-T 300 for emergency
use only
• After age 40, any IUD may
be left in situ till the
menopause
CHOICES
• T-Safe Cu 380A
• Nova T 380
• Multiload 375
SPECIAL INDICATIONS
• GyneFix IUI
• Mirena IUS
• Flexi T 300
Intra-uterine Contraception
Reminder
• Infection
• Missed pregnancy
• Ectopic pregnancy!!
• Expulsion
• perforation
Intra-uterine Contraception
Local Clinical Guidelines
Sexual history
RISK MARKERS for
Chlamydia
• Age <25 years
• New sexual partner in the last 3
months
• 2 or more partners in the last 12
months
• History of Chlamydia/BV/PID or
NSU in partner
• Symptoms and/or signs of
cervicitis/PID
Intra-uterine Contraception
Local Clinical Guidelines
Chlamydia Screening (contd)
At high risk
• Refer for sexual health
screen prior to IUD
• In an emergency,
i. Take an endocervical swab
ii. prophylactic treatment
Azithromycin or Doxycycline
iii. Sexual health screen
(7-10 days after insertion)
iv.advise barrier/spermicide
At low risk
• Routine endocervical swab
for Chlamydia screening
Procedure
–
–
–
–
Pre-test written information
Inform patient of the result
Treatment and STI screen
Contact tracing
What next?
NEW CHALLENGES
The Male implant
The latest trend in contraception?
Dr Jonathan Healey, West Sussex GP