New Service Available Fetal Exposure to Medicine Service (FEMS) pilot

What is the Fetal Exposure to Medicine Service (FEMS) pilot?

The Fetal Exposure to Medicines Service (FEMS) is a pilot that provides a specialised diagnostic and care management advice service to those who have been exposed to certain antiseizure medicines (also known as anticonvulsant medicines or antiepileptic drugs) before birth in the North of England (North West, North East, Yorkshire and Humber).

Why is there a FEMS pilot?

The FEMS pilot has been established in response to the First Do No Harm report which highlighted the need for a specialist service to provide an expert assessment and care advice for those affected by medicines during pregnancy. The pilot aims to establish a service model; to enable assessment of the impact of FEMS, and the commissioning requirements should there be decision for FEMS clinics to be established across England.

Where is the FEMS pilot located?

The pilot is located at the Manchester University NHS Foundation Trust and Newcastle Upon Tyne Hospitals NHS Foundation Trust. The teams will work together to deliver an equivalent service at each site.

Who is eligible for this pilot?

Patients (child or adult) living in the North of England with health (physical or neurodevelopmental) concerns and who were exposed in utero to specific antiseizure medicines (see table A) This will include: • Patients not diagnosed with a Fetal Valproate Spectrum Disorder (FVSD) or another Fetal Anticonvulsant Syndrome (FACS) but with a concern about one or more aspects of physical health and development or neurodevelopment in relation to the in-utero exposure. • Patients with an FVSD diagnosis or FACS diagnosis who require an updated clinical management plan. The exposure eligibility is not limited to an indication for maternal epilepsy or seizures. As this is a pilot service, there are limitations to the scope of the service.

What is the referral process?

Patients meeting the eligibility criteria listed above can be referred to the service through their GP or other health care professional. Please complete the referral proforma. The referral must include: Tuesday 14th January 2025 2 1. Type and dosage of medication taken during pregnancy. 2. Patient symptoms and reasons for concerns / requesting referral. The referral, whether it is for the Manchester or Newcastle team, must be sent to the following central email address:Fem.Service@mft.nhs.uk Referrals will be accepted until January 2026. If multiple children, from one family, have been exposed then they can be referred together however one referral pr forma must be completed for each person referred. Note that only patients living in the North of England can be referred into this service. Table A. Table of Antiseizure Medicine exposures meeting eligibility criteria for referral to FEMS pilot. Exposure can have been as a monotherapy, duo-therapy or polytherapy.

Initial pilot referral criteria based on exposure to the following medications: Sodium valproate Topiramate From April 2025, the pilot will extend to cover the additional medications: Acetazolamide, Levetiracetam, Brivaracetam, Oxcarbazepine, Buccal midazolam, Perampanel, Cannabidiol, Phenobarbital, Carbamazepine, Phenytoin, Cenobamate, Piracetam, Clobazam, Pregabalin, Clonazepam, Primidone, Eslicarbazepine acetate, Rufinamide, Ethosuximide, Stiripentol, Everolimus, Tiagabine, Fenfluramine, Valproic acid, Gabapentin, Vigabatrin, Lacosamide, Zonisamide and Lamotrigine.