Box 1 Norwegian Pharmaceutical Compendium's guidelines for healthcare personnel (12)
Women with epilepsy: valproate is contraindicated in pregnancy unless there are no other suitable alternatives. Valproate is contraindicated in women of reproductive age unless the conditions of the pregnancy prevention programme have been met.
Women with bipolar disorder: valproate is contraindicated during pregnancy. Valproate is contraindicated in women of reproductive age unless the conditions of the pregnancy prevention programme have been met.
Use of valproate in pregnancy prevention programme
Specialists in neurology/psychiatry with experience in epilepsy treatment/bipolar disorder must only initiate the use of valproate in girls and women of reproductive age if other treatment has no effect or causes adverse reactions.
Prior to start-up, pregnancy must be ruled out through a blood pregnancy test. The result must be confirmed by medical personnel.
The specialist must review the indication for treatment at least once a year.
The specialist must complete the form on the risk of fetal damage together with the patient at the start of treatment, at the annual check-up, at pre-pregnancy planning appointments and upon confirmation of the pregnancy. Doctors who meet female users of valproate must inform the patient/parents/guardians/carers about the risk of fetal damage when using valproate, the need for reliable contraception, and tell them to consult a doctor in the event of pregnancy. The information must be provided at all appointments with doctors as well as health visitors and midwives. Pharmacists in chemists must also provide information.
The doctor must provide patient guidelines to all female patients/parents/guardians/carers treated with valproate.
Women who are trying to conceive must switch to another suitable treatment. For patients with epilepsy, the specialist must 'do everything possible to switch to an appropriate alternative treatment' before discontinuing contraception.
The lowest effective dose must be used, and total and free serum concentrations must be measured before, during and after pregnancy.
Women exposed to valproate during pregnancy and their partners must be referred to a specialist with experience in assessing fetal damage from medicines so that they can be given information on the significance of the exposure.
In the case of unplanned pregnancies, the woman must see a doctor without delay, and following the consultation must switch to another suitable treatment, if possible.
The above conditions also apply to sexually inactive patients if future pregnancy cannot be completely ruled out.