All valproate containing products reclassified as special containers from October 2023

Following the recommendations made by the Independent Medicines and Medical Devices Safety Review and the outcome of a recent public consultation on Original pack dispensing and supply of medicines containing sodium valproate, changes to Human Medicines Regulations 2023 come into effect on the 11th October that mandate full pack dispensing of all licensed medicines containing valproate (see exemption in note below).

To align with this, from 1 October 2023, all licensed medicines containing sodium valproate, valproic acid and semisodium valproate were reclassified as special containers so where the quantity on a prescription is not for a quantity in an original pack size or multiple  of pack sizes, the nearest number of full packs will be reimbursed (either rounded up or down; rounded down when the quantity prescribed is exactly half way between rounding up or down). Contractors do not need to endorse the prescription, they will automatically be paid for the relevant number of complete packs.  The special container criteria outlined in Part II Clause 10B of the October 2023 Drug Tariff was updated accordingly.

The manufacturer’s original packs include specific warnings and pictograms on the labelling, including a patient card, along with the statutory patient information leaflet (PIL) and an additional patient booklet, which highlight the risks of taking valproate while pregnant. Supplying complete packs of medicines containing valproate ensures patients, and particularly women and girls of childbearing potential, always receive the PIL with warnings about taking the medicine while pregnant.

Please note: pharmacists will be able to make an exception to supply complete packs of medicines containing valproate, based on an individual risk assessment to assess the need for a patient to be supplied the medicine in different packaging (for example in a monitored dosage system) and provided processes are in place to ensure a PIL is supplied.

Community Pharmacy England welcomes this change particularly as we have been seeking complete pack special container status for several valproate containing medicines (based on existing special container criteria), since 2020. For a list of all the monthly changes to the special container status of products please see the following page Notice of changes to special container status of products.

For more information on the Original Pack Dispensing (OPD) and Valproate regulation changes, please refer to our briefing: Briefing 025/23: Regulations for Original Pack Dispensing

FAQs

Q. Why have all sodium valproate containing products been reclassified as complete pack special containers?

A. Whole-pack dispensing of medicines containing valproate has been introduced to support the Pregnancy Prevention Programme (PPP) and further decrease the number of babies who are born with serious complications. Sodium valproate a commonly used anti-epileptic (and in some cases the only effective treatment for some patients) is known to be associated with birth defects and neurodevelopmental disorders in children where sodium valproate is taken during pregnancy. To minimise the risk of unborn babies being exposed to the effects of this medication the PPP was introduced in 2018. This further measure of whole pack dispensing has been introduced to ensure that those taking sodium valproate have access to information setting out the risks and need for a woman or girl of child-bearing potential to have a PPP in place before taking sodium valproate. This is because the manufacturer’s original packs include specific warnings and pictograms on the labelling, including a patient card, along with the statutory patient information leaflet (PIL), which highlight the risks of taking the medicine while pregnant.

Q. Can I dispense the exact prescribed quantity if this is different to the special container pack size? 

A. Where the quantity ordered does not coincide with that of the special container pack size you are required to supply the nearest complete pack size. For example, where a prescription requests Sodium valproate 300mg modified-release tablets x 28 tablets, you should dispense the nearest complete pack size of 30 tablets.  The pharmacy would be reimbursed accordingly as the complete pack of 30 will be treated as a special container by the NHSBSA.

A. Only one pack of 30 capsules should be supplied. This is in-line with the special container ‘half-way’ rule for special containers which states that, ‘where the quantity ordered falls exactly between two containers, pharmacy teams should round down, and supply the nearest complete container’.

Q.I have received a prescription for Sodium valproate 500mg gastro-resistant tablets x 50 tablets, there are two pack sizes in the Drug Tariff 30 and 100, can I round up to supply 100 tablets?

A.  No. For a prescription ordering Sodium valproate 500mg gastro-resistant tablets x 50 tablets pharmacy teams would supply and be reimbursed for the nearest number of complete packs which is 2 x 30 tablets.

Q. Can I supply sodium valproate in a Monitored Dosage System (MDS)?

A. Medicines containing sodium valproate, valproic acid or valproate semisodium must be sold or
supplied in their original outer packaging. However, pharmacists will be able to make an exception to complete-pack dispensing of medicines containing valproate, provided an individual risk assessment is in place that refers to the need for a patient to be supplied the medicine in different packaging (for example in a monitored dosage system) and where processes are in place to ensure the supply of a patient information leaflet (PIL).

Pharmacists will also need to consider the impact on the stability of certain valproate medicines once moved outside their original packaging. For example, Epilim tablets are hygroscopic in nature and therefore sensitive to the effects of moisture. The  ‘Special precautions for storage section’ in the SPC states that ‘the tablets should not be removed from their foil until immediately before they are taken’. Any water ingress may result in the chemical and/or physical stability of the drug being compromised.

For further guidance on stability of drugs in Monitored Dosage Systems (MDS) please refer to the Specialist Pharmacy Service tool on Usage of Medicines in Compliance Aids.

Q. Do the changes apply to all formulations including injectable preparations?

A. Yes. The changes to mandate complete pack dispensing of products containing valproate extend to all licensed formulations of sodium valproate, valproic acid or valproate semisodium. For a prescription ordering Episenta 300mg/3ml solution for injection ampoules x 3 ampoules, pharmacy teams should supply the complete pack of 5 ampoules. The pharmacy would be reimbursed accordingly as the complete pack will be treated as a special container by the NHSBSA.