Other safety alerts

United Kingdom : Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

Medicines and Healthcare products Regulatory Agency (MHRA) announces that valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place; and it reminds the healthcare professionals, such as general practitioners (GPs), specialists and dispensers to start action for the programme.

The healthcare professionals are reminded for the following :
General Practitioners
- Identify and recall all women and girls on valproate who may be of childbearing potential.
- Provide the Patient Guide to the patients (or her parents or responsible person as necessary); and check that they have been reviewed by a specialist in the last year (i.e.: they have an in-date Risk Acknowledgement Form) and are on highly effective contraception

Specialists
- Book in review appointments at least annually with women and girls under the Pregnancy Prevention Programme and re-evaluate treatment as necessary.
- Explain clearly the conditions as outlined in the supporting materials.
- Complete and sign with the patient or their responsible person the Risk Acknowledgement Form—copies of the form must be given to the patient or responsible person and sent to their GP.

Dispensers
- Valproate medicines must always be dispensed with the accompanying patient information leaflet.
- Dispense whole packs whenever possible, and ensure there is a warning label either on the carton or added via a sticker.
- Discuss risks in pregnancy with female patients each time you dispense valproate medicines and ensure they have the Patient Guide and have seen their GP or specialist to discuss their treatment and the need for contraception
- Ensure new packs of valproate information materials are placed in a designated place accessible to all dispensing staff and dispose of any old materials related to valproate medicines

The MHRA states that packs of information materials to support informing women on valproate of the risks in pregnancy and the need to be enrolled in the Pregnancy Prevention Programme have already been sent to prescribers, dispensers, and healthcare professionals. As stated in the risk minimisation materials, the requirement for a Pregnancy Prevention Programme is applicable to all premenopausal female patients unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.

Please refer to the following website in MHRA for details: http://www.gov.uk/drug-safety-update/valproate-pregnancy-prevention-programme-actions-required-now-from-gps-specialists-and-dispensers

In Hong Kong, there are 11 registered pharmaceutical products containing valproic acid and/or valproate, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 9 cases of adverse drug reaction related to valproic acid or valproate, but these cases are not related to adverse effects on new-born babies whose mothers took valproate for their medical conditions.

Related news on the review of valproate was previously issued by MHRA and various other overseas drug regulatory authorities, and was posted on the Drug Office website since 13 Mar 2017, with the latest update posted on 19 Sep 2018. Letters to local healthcare professionals to draw their attention for a European Medicines Agency (EMA) recent review were also issued on 12 Feb 2018.

In Dec 2014, the Registration Committee of the Pharmacy and Poisons Board (Registration Committee) of Hong Kong discussed the findings of an EMA previous review on the risk of valproate products in pregnancy and had decided that warnings and precautions on the risk of pregnancy should be included in valporate products. In light of the new reviews from overseas authorities and the above MHRA announcement, the matter will be discussed by the Registration Committee and the DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.

Ends/ Wednesday, September 26, 2018
Issued at HKT 17:45

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