new prescription conditions and delivery in January 2025

L’National Agency for the Safety of Medicines and Health Products (ANSM) is changing the prescription and dispensing conditions for the following medicines [1] :

• valproate and derivatives (DEPAKINE, MICROPAKINE, DEPAKOTE, DEPAMIDE, DIVALCOTE and generics) [2] :
  • in men and adolescents: initial prescription reserved for a pediatrician, neurologist or psychiatrist, and set up an annual certificate of shared information co-signed by the patient and the prescriber to be presented at the pharmacy to authorize the delivery of the treatment,
  • in girls, adolescents and women of childbearing age : the annual certificate of shared information replaces the care agreement form;
• topiramate (EPITOMAX and generics) [3] :
  • in the prophylactic treatment of migraine in adult women: the initial annual prescription is extended to competent “pain” doctors, in addition to neurologists,
  • the annual shared information certificate replaces the care agreement form;
• carbamazepine (TEGRETOL and generics) [4] : the presentation of an annual certificate of shared information becomes mandatory to authorize the delivery of treatment in pharmacies.

The application of these new provisions are planned, to count:

• from January 6, 2025 for any initiation of treatment;
• of June 30, 2025 for patients already undergoing treatment, when compliance with prescriptions is necessary.

All of these new provisions are summarized in the table below (cf. Boxed).

Valproate: a more regulated prescription in the male population

As of January 6, 2025 (or June 30, 2025 for patients already under treatment), the initial prescription of valproate and its derivatives in men and adolescents will be reserved for doctors specializing in neurology, psychiatry and pediatrics. Renewal can be carried out by any doctor.

The prescription must be accompanied by an annual certificate of information shared by the prescriber and the patient (or their legal representative) must co-sign. This certificate replaces the information sheet put in place in August 2023 (cf. our article of August 8, 2023).

The revision of the conditions for prescribing and dispensing valproate in the male population is justified by the risk potential of neurodevelopmental disorders in children whose father was treated with valproate in the 3 months before conception (cf. our article of August 8, 2023).

About the annual shared information certificate

This certificate presents:

• information on the potential risk of neurodevelopmental disorders associated with valproate if used within 3 months before conception of a child;
• the need for a effective contraceptionincluding for the female partner, during treatment and at least 3 months after stopping treatment (cf. our article of November 23, 2023);
• various additional instructions:
  • do not donate sperm during treatment and at least 3 months after stopping,
  • the possibility of freezing the sperm before starting treatment,
  • consult a specialist doctor as soon as the patient plans to conceive a child,
  • consult a doctor quickly if the partner is pregnant,
  • do not stop valproate and derivatives without talking to the doctor, whether for the indication of epilepsy or bipolar disorders.

This certificate is valid for 1 year. It must be re-signed each year.

A conditional dispensation

Presentation of this co-signed and valid certificate conditions the delivery of treatment in pharmacies. It must be presented to the pharmacist, in addition to the prescription drawn up by the specialist doctor (initiation) or by another doctor (renewal) [5].

When dispensing, the pharmacist must give the patient the patient card contained in the medication box.

Valproate, topiramate and carbamazepine: what changes in the female population

The care agreement form replaced by the annual shared information certificate

As of January 6, 2025 (or June 30, 2025 for patients already under treatment), the care agreement form which has been used until now will be replaced by the annual shared information certificate for any prescription of valproate and derivatives and topiramate in girls, adolescents and women of childbearing age:

For patients currently undergoing treatment for whom a care agreement form was established less than 1 year ago, this form remains valid until the end of its year of validity.

Carbamazepine: the shared information certificate becomes mandatory

In addition, the shared information certificate becomes mandatory in the event of prescribing carbamazepine, in order to inform patients (girls, adolescents, women of childbearing age) about the teratogenic risk of this medication (malformations and neurodevelopmental disorders in the event of exhibition in utero).

From January 6, 2025 (or June 30, 2025 for patients already under treatment), the delivery of treatment will be conditional on the presentation of this certificate co-signed by the patient and the prescriber and dated less than 1 year [6].

The initial prescription of cabamazepine remains open to any doctor.

Topiramate and migraine: competent doctors « pain » can prescribe

As of January 6, 2025, the initial annual prescription of topiramate for prophylactic treatment of migraine in adult women of childbearing age is extended to competent “pain” doctorsin addition to neurologists.

The renewal of this prescription can be carried out by any doctor during the year [7].

This decision aims to strengthen access to care for patients suffering from migraine. Competent “pain” doctors are doctors holding a diploma of additional specialized studies, specific transversal training or validation of acquired experience.

As a reminder, for migraine prophylaxis, topiramate is only indicated in adults. In this indication, it is contraindicated during pregnancy and in patients likely to have children who are not using highly effective contraception.

On the other hand, in the treatment of epilepsy, topiramate is indicated in adults and children. The initial prescription and annual renewal of this medication are reserved for neurologists, pediatricians or competent “pain” doctors. DEvery year, the treatment can be repeated by any doctor.

Box – Valproate and derivatives, topiramate and carbamazepine : summary of prescription and delivery conditions added by the ANSM coming into force on January 6, 2025