In 2018, new guidelines were issued on the prescribing of valproate, introducing strict criteria for female patients who are either pregnant or of child-bearing age. As a GP, what should you do when a patient already taking a valproate medicine attends for another prescription without meeting these criteria?
On 21 March 2018, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) authorised new measures to avoid babies being exposed to valproate medicines in the womb, due to the high risk of malformations and developmental problems.1
While medicines containing valproate have been approved nationally and within the EU to treat conditions such as epilepsy and bipolar disorder – and in some countries, migraines – these new measures include a ban on the use of valproate during pregnancy.
For women or girls who are not pregnant, but are of child-bearing age, valproate must not be prescribed unless all the Valproate Pregnancy Prevention Programme conditions – outlined by the Health Products Regulatory Agency (HPRA)2 – are met.
The strict rules, set out by the Valproate Pregnancy Prevention Programme, include ensuring that
female patients taking valproate medicines:
• have been told and understand the risks of use in pregnancy and have signed a Risk Acknowledgement Form
• are on highly effective contraception if necessary
• see their specialist at least every year.
But what happens if a patient already taking a valproate medicine comes for another prescription and doesn’t meet one of the above criteria?
Making a judgement call
If a patient’s medication is stopped abruptly, it can present a health risk. But if a doctor were to prescribe outside the Pregnancy Prevention Programme it can present a medicolegal risk, and if the patient becomes pregnant, a potential risk to an unborn child.
There is no explicit guidance on how GPs should proceed in the event that an Annual Risk Acknowledgement Form has not been completed, so you should exercise your own clinical judgment and consider available professional guidance, such as the Medical Council’s ethical guide.3
The Medical Council advises doctors to ensure that prescriptions are “safe, evidence-based and in the patient’s best interests.” Doctors should “weigh up the potential benefits with the risks of adverse effects and interactions when deciding what to prescribe.”
Where an annual review with a specialist has not been carried out in time, in accordance with the Pregnancy Prevention Programme, a GP would need to consider whether it is justifiable to continue to prescribe valproate medication, for example, if the risk to health of stopping the medication abruptly is deemed to be greater than the risk of temporarily continuing the medication. Once the decision has been made it should be documented in the patient’s medical record, along with the rationale for it.
However, any such prescription should function only as a stopgap between the last annual review and the next available opportunity for the annual specialist review to be conducted. The prescription should be approached with due caution, both for the safety of the patient primarily, and to ensure that you are in a position to explain and justify a decision to continue prescribing valproate medicines.
The benefits and risks of the medication should be carefully reconsidered at regular treatment reviews. It may be a decade or more before harm emerges, and accurate, detailed and contemporaneous medical records are crucial. The HPRA has a comprehensive patient information booklet4 that should be shared with the patient, with this clearly documented in the medical record.
A thorough discussion should be had with the patient, where you detail the risks as noted in the Risk Acknowledgement Form.5 You should explain that while a specialist would normally complete the form, in the current circumstances it is good practice for you – as the prescribing GP – to be assured of the patient’s awareness of the associated risks before any repeat prescription.
This discussion should be accurately documented in the patient’s notes. In this way, the purpose of the Annual Risk Acknowledgement Form may still be fulfilled in lieu of the form being completed in due course.
It is also advisable for you to enquire as to why the specialist annual review has not taken place. You should liaise with the patient and secondary care to ensure this required review is conducted as a matter of urgency where the review date has passed.
If you are concerned that an issue has been caused by secondary care not reviewing the patient when required, this should be raised via the appropriate channels – in the first instance, with the secondary care provider itself. Any efforts made to liaise with secondary care and local services should be well documented in the patient’s notes.
Alternatively, if the patient concerned has not attended their annual review, this should be urgently addressed directly with the patient, stressing the importance of attendance to their continued treatment and care.
Medical Protection has a three-hour Medication Errors and Safer Prescribing workshop, which has been developed for, and is delivered by, GPs and is free as a benefit of membership.
1 New measures to avoid valproate exposure in pregnancy endorsed | European Medicines Agency. 2019. https://www.ema.europa.eu/en/news/new-measures-avoid-valproate-exposure-pregnancy-endorsed
2 Valproate (Epilim). HPRA. http://www.hpra.ie/homepage/medicines/special-topics/valproate-(epilim)
3 Guide to Professional Conduct and Ethics for Registered Medical Practitioners. 8th edition. 2016. Medical Council. https://www.medicalcouncil.ie/News-and-Publications/Reports/Guide-to-Professional-Conduct-Ethics-8th-Edition.html
4 Valproate Pregnancy Prevention Programme: Patient Guide for Women and Girls. HPRA. http://www.hpra.ie/docs/default-source/Valproate/epilim-patient-guide_updated-june-2018.pdf?sfvrsn=0
5HPRA. Valproate Risk Acknowledgment Form. http://www.hpra.ie/docs/default-source/Valproate/risk-acknowledgment-form-2018.pdf?sfvrsn=0