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    Monday, 30 April 2018 12:08
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    Thursday, 26 April 2018 11:48
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Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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A pregnant lady imageApril 26 2018

Women and girls of childbearing potential must no longer take valproate medicines unless the conditions of the Pregnancy Prevention Programme are being met.

In addition, “use of valproate in pregnancy is contraindicated for bipolar disorder and must only be considered for epilepsy if there is no suitable alternative treatment.”

The medicines regulator, the MHRA, has confirmed the contraindication and is calling on health professionals to ensure that “all women and girls (and their parent, caregiver, or responsible person, if necessary) are fully informed of the risks and the need to avoid exposure to valproate medicines in pregnancy.”

In a Drug Safety Update published on April 24, the MHRA says that valproate should only be considered in such circumstances if other treatments are ineffective or not tolerated, as judged by an experienced specialist.

Pharmacists are being asked to: 

  • ensure valproate medicines are dispensed in whole packs whenever possible, and to make sure the packs have a warning label either on the carton or via a sticker when dispensing for women and girls of childbearing potential;
  • discuss the risks in pregnancy with female patients each time valproate medicines are dispensed;
  • ensure female patients have the Patient Guide and have seen their GP or specialist to discuss their treatment and the need for contraception.

GPs are being asked to contact all female patients who may be of childbearing potential to provide the Patient Guide and check they have been reviewed by a specialist in the last year and are on highly effective contraception. 

In addition to male and/or female sterilisation, methods of contraception considered ‘highly effective’ are long-acting reversible contraceptives (LARC) with a less than 1% failure rate: 

  • copper intrauterine device (Cu-IUD);
  • levonorgestrel intrauterine system (LNG-IUS);
  • progestogen-only implant (IMP).

“If a user-independent form is not used, two complementary forms of contraception including a barrier method should be used and regular pregnancy testing considered,” says the MHRA.

It will be sending information to health professionals regarding the Valproate Pregnancy Prevention Programme, and is revising online materials to reflect the updated status around valproates. 

Computer systems suppliers have updated pharmacy IT systems to include an alert when valproates are dispensed, and GP systems are being upgraded with a search and audit function to allow GPs to identify women on valproates.

Simon Wigglesworth, deputy chief executive of the charity Epilepsy Action, said: “We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy. It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines.”

The Royal Pharmaceutical Society has endorsed the measures being taken by the MHRA and will update its guidance for members once the MHRA publishes its updated resources for health professionals in May.

RPS President Ash Soni said: “The RPS fully supports these new measures implemented today by the MHRA to ensure women understand the risks of taking sodium valproate during pregnancy. They must get the right information from health professionals in order to make informed choices about their health and parenting options. 

“Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional. Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.”

Links:
MHRA DSU on valproate           
Epilepsy Action statement        
RPS statement 

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