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  • General practice pharmacist scheme evaluation indicates ‘improved capacity’ as the main benefit

    General practice pharmacist scheme evaluation indicates ‘improved capacity’ as the main benefit

    Tuesday, 31 July 2018 15:31
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    Asthma deaths levels increase by a quarter in a decade

    Thursday, 26 July 2018 15:08
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    NPA and Age UK ask for help on building polypharmacy dossier

    Wednesday, 25 July 2018 13:46
  • Pharmacy bodies welcome Health Secretary’s pledge to invest in community pharmacy

    Pharmacy bodies welcome Health Secretary’s pledge to invest in community pharmacy

    Tuesday, 24 July 2018 12:53
  • NHS Digital seeks views on SCR with Additional Information

    NHS Digital seeks views on SCR with Additional Information

    Tuesday, 24 July 2018 12:41

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
More inWhite Papers  

pregnancy blood pressure testFebruary 22 2016

The medicines regulator, the MHRA, has issue new communication materials to raise awareness of the risks to the developing foetus of mothers taking valproate. It is calling on health professionals to use the material to actively discuss the risks with women of child-bearing potential and girls taking valproate, and to also encourage them to acknowledge the information.

New resources include a booklet for healthcare professionals, a consultation checklist, a guide to give to patients, and an information card to give to patients. In addition, outer packaging for medicines containing valproate will be introduced this year which will include a warning for women on the risk of adverse pregnancy outcomes.

The MHRA advice specifically for pharmacists is:

  • whenever dispensing a medicine related to valproate for a woman of childbearing potential or girl, give her a patient card, unless she confirms that she already has one;
  • encourage the woman to read the card (as shown) and enter her name and date to reinforce her own accountability to consider the information it contains;
  • ensure that processes are in place to allow these requirements to be met;
  • continue to report any suspected side effects to valproate or any other medicine on a Yellow Card.

“Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases),” says the MHRA. “Valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated.”

In addition, valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder, and risks and benefits must be carefully considered at regular intervals.

The MHRA points out that valproate is only licensed for treating epilepsy or bipolar disorder. It is advising prescribers: “We are aware that these medicines are sometimes used ‘off-label’ (eg for migraine or chronic pain). If you are considering initiating or continuing such treatment, the same risks and advice in this article apply.”

Valproate

Valproate1

Valproate2

Links:

MHRA announcement 

Practice News

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