New valproate dispensing rules: RPS help for pharmacists

New valproate licencing rules came into effect earlier this year, following links to developmental disorders and birth defects. As a result, the Royal Pharmaceutical Society has produced a guide to help pharmacists meet the new valproate dispesing guidelines.

RPS QRG valproate cr RPS 18

The Royal Pharmaceutical Society (RPS) has produced a quick reference guide (QRG) to help pharmacists adhere to new guidance on dispensing valproate.

Valproate use during pregnancy has been linked to developmental disorders and birth defects and in April 2018 the Medicines and Healthcare products Regulatory Agency (MHRA) announced that, under new licensing rules, valproate must no longer be prescribed to women or girls of childbearing potential unless they are on a pregnancy prevention programme.

The QRG signposts to MHRA materials that can help female patients meet the requirements of the pregnancy prevention programme, including guides for patients and healthcare professionals and a risk acknowledgement form.

The QRG also features a downloadable resource, “Safe supply of valproate medication”, which has been jointly developed by the RPS and other pharmacy organisations represented on the MHRA’s Valproate Stakeholder Network. The resource includes a pathway to help pharmacists counsel female patients taking valproate, and a checklist to ensure all appropriate steps are taken when dispensing the medicine.

The pathway emphasises that a valproate prescription must always be dispensed where clinically appropriate.

“Every pharmacist advising patients on valproate should use this toolkit”, said Sandra Gidley, chair of the RPS English Pharmacy Board. “We are proud to have worked with so many pharmacy organisations to help protect women, girls and babies from the dangers of using valproate medicines in pregnancy.

“Pharmacists and pharmacy teams have a very important role to play in talking to women about the risks of valproate, but also to ensure they never suddenly stop taking their medicines without a review from the prescriber first.”

Last updated
The Pharmaceutical Journal, New valproate dispensing rules: RPS help for pharmacists;Online:DOI:10.1211/PJ.2018.20205062

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