Whether to stop prescribing off-label drugs

A GP was concerned about the risks of stopping a patient's prescription for sodium valproate, and called the MDU for advice.

The scene

A GP member contacted the MDU advice line about a patient of childbearing years who was on sodium valproate for epilepsy.

The patient had been advised about the risks of sodium valproate and had agreed to take contraception in the form of the combined oral contraceptive as part of the primary pregnancy prevention programme (PPP). However, she had failed to order her progesterone-only pill and to come in for her annual check. Given MHRA guidance, the GP wanted to know if they should stop prescribing the sodium valproate.

The member explained that they were concerned as sodium valproate is associated with a significant risk of birth defects (1 in 10) and developmental problems (4 in 10) in children whose mothers took the drug during pregnancy.

MDU advice

Sodium valproate is used to treat epilepsy (where other drugs have not worked) or bipolar disorder. In March 2018 the Medicines and Healthcare products Regulatory Agency (MHRA) announced that sodium valproate should not be used by women or girls of childbearing age unless they have a pregnancy prevention programme in place.

Sodium valproate is not licenced for woman of childbearing age who are not enrolled in a PPP, but when making prescribing decisions, particularly in patients who are not adhering to monitoring or treatment plans, GPs are left with the task of balancing competing risks when working out the safest course of action. To stop prescribing sodium valproate would expose the patient to risk of sudden unexpected death in epilepsy (SUDEP), loss of seizure control and other impacts on quality of life.

A competent patient has the right to decline any treatment as long as they are properly informed of the consequences of their refusal. However, the acceptance of this risk does not remove the responsibility from the GP of working out whether it is right to continue the prescription.

While it is not the case that a competent patient can demand a treatment the doctor considers inappropriate or unsafe, in finely balanced circumstances such as these, it may be appropriate for the doctor to continue the treatment - provided the patient understands the risks of remaining on valproate without a PPP, and the doctor thinks it remains the most appropriate treatment for the patient, even in this context.

The adviser suggested the GP contact the patient to discuss why she had not attended for review or picked up her prescription. The GP should discuss the risks to the foetus if the patient became pregnant while taking sodium valproate.

The GP could give the patient information about patient support groups for families affected by in utero exposure to valproate, as well as discussing other forms of contraception, such as copper intrauterine device, levonorgestrel intrauterine system or progesterone-only implant.

The adviser suggested an urgent referral to the neurologist looking after the patient to review her need for sodium valproate, and that the GP should continue prescribing the sodium valproate until they had discussed the issues with the patient and the patient had seen the specialist.

The adviser suggested that the discussion and decision should be carefully documented and revisited at least annually. These would be essential to the doctor being able to evidence the efforts they had taken to properly counsel and support the patient and to look for alternative treatment before making a decision about the prescription should any concern be raised at a later date.

The outcome

The GP had a long and detailed discussion with the patient, who said she did not like the inconvenience of having to remember to take the tablets. After a negative pregnancy test, the patient was given a progesterone only implant and stayed on valproate.

This page was correct at publication on 02/07/2020. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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