A review by two specialists is required for initiating valproate but not for male patients already taking valproate, the Commission on Human Medicine (CHM) has advised.

The Medicines and Healthcare products Regulatory Agency (MHRA) previously advised that men taking valproate and their partners should use effective contraception, as a precaution against potential teratogenic risks.

And it has now released three infographics outlining risk minimisation measures required for valproate prescribing, which clarify in which situations a review by two specialists may be required.

Male patients under 55 should be informed about the potential reproductive risks of infertility and neurodevelopmental disorders in children born to men treated with valproate in the three months before conception.

If reproductive risks apply, as a precaution men, and their female partners, should be advised to use effective contraception during valproate treatment, the MHRA said.

But if a male patient is already taking valproate, this can can continue to be prescribed in accordance with standard clinical practice by a single prescriber, and a second specialist review is not required.

In this case, the Male Risk Acknowledgement form does not need to be completed.

However, where a patient has not yet been initiated on valproate, two specialists must independently consider and document that there is no other effective or tolerated treatment, the MHRA said.

In this case, the Male Risk Acknowledgement form does need to be completed, but does not need to be repeated annually.

However, for women aged under 55, two specialists must review the treatment unless there is a permanent reason the reproductive risks do not apply.

And in men and women aged over 55, valproate can be prescribed in accordance with standard clinical practice by a single prescriber. Although men aged over 55 should still be informed about the reproductive risks and they and their female partners, should be advised to use effective contraception during valproate treatment as needed, the MHRA said.

The CHM has advised that specialists could include:

  • Consultant adult or paediatric neurologists
  • Consultant psychiatrists
  • Speciality and associate specialist doctors in psychiatry and neurology
  • Speciality doctors in psychiatry
  • Paediatrician with special interest in epilepsy
  • Paediatrician who regularly manages complex epilepsy or bipolar disorder
  • Epilepsy nurse consultant
  • Specialist nurses in relevant disciplines
  • Specialist pharmacists

The General Pharmaceutical Council (GPhC) has gathered information relating to sodium valproate in one place on its website, including advice to pharmacy teams on dispensing and supplying valproate safely.