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CHECKLIST FOR PRESCRIBERS – COMBINED HORMONAL
Please use this checklist in conjunction with the Summary of Product
Characteristics during combined hormonal contraceptive (CHC)
Thromboembolism (e.g. deep vein thrombosis, pulmonary embolism, heart
attack and stroke) is a rare but important risk with use of a CHC.
A woman’s risk will also depend on her baseline risk of thromboembolism. The
decision to use a CHC should therefore take into consideration the contraindications and a woman’s risk factors, particularly those for thromboembolism – see boxes below and the Summary of Product Characteristics.
The risk of a thromboembolism with a CHC is higher:
when re-starting use after an intake break of 4 or more weeks.
CHCs that contain ethinylestradiol in combination with levonorgestrel,
norgestimate or norethisterone are considered to have the lowest risk of venous thromboembolism (VTE).
The decision to use any CHC should be taken only after a discussion with the
o the effect of any intrinsic risk factors on her risk of thrombosis o the risk of thromboembolism with her CHC o that she must be alert for signs and symptoms of a thrombosis
Do not prescribe a CHC if you tick any of the boxes in this section. Does
the woman have:
Current or personal history of a thromboembolic event e.g. deep vein thrombosis, pulmonary embolism, heart attack, stroke, transient ischaemic attack, angina pectoris?
Knowledge of predisposition for a blood clotting disorder?
Diabetes mellitus with vascular complications?
Very high blood pressure eg systolic ≥160 or diastolic ≥100mm Hg?
Major surgery or a period of prolonged immobilisation coming up? If so, advise to use a non-hormonal method of contraception for at least 4 weeks beforehand and two weeks after full ambulation.
Discuss the suitability of a CHC with the woman if you tick any of the
boxes in this section:
Is she a smoker? If yes and also over the age of 35 she should be strongly advised to stop smoking or use a non-hormonal method of contraception.
Does she have high blood pressure eg systolic 140-159 or diastolic 90-99mm Hg?
Does she have a close relative (eg parent or sibling) who has had a thromboembolic event (see above list) at a young age (eg before 50)?
Does she or someone in her immediate family have high blood lipids?
Does she have a cardiovascular condition such as atrial fibrillation, arrhythmia, coronary heart disease, cardiac valve disease?
Has she given birth in the last six weeks?
Does she travel for more than 4 hours per day?
Does she have any other medical conditions that might increase the risk of thrombosis (eg. cancer, systemic lupus erythematosus, sickle cell disease, Crohn’s disease, ulcerative colitis, haemolytic uraemic syndrome)?
Is she taking any other medicines that can increase the risk of thrombosis (eg. corticosteroids, neuroleptics, antipsychotics, antidepressants, chemotherapy etc)?
More than one of the above risk factors may mean a CHC should not be
Don’t forget, a woman’s risk factors may change over time and should be
revisited at regular intervals.
Please make sure your patient understands that she should tell a
healthcare professional she is taking a combined hormonal contraceptive
Needs to have a period of prolonged immobilisation (eg because of an
injury or illness, or if her leg is in a cast)
In these situations it would be best to discuss whether a non-hormonal
contraceptive should be used until the risk of VTE returns to normal.
Please also tell your patient that the risk of a blood clot is increased if
Travels for extended periods (eg during long-haul flights)
Develops one or more of the above risk factors for VTE
Has given birth within the last few weeks
In these situations your patients should be particularly alert for any signs
Please advise your patient to tell you
if any of the above situations change or
get much worse.
Please strongly encourage women
to read the Patient Information Leaflet that
accompanies each pack of CHC. This includes the symptoms of blood clots that
she must watch out for.
Please report any adverse events suspected to be caused by a combined
contraceptive to the company or the MHRA
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