Valproate and Valproic Acid Dispensing
From 11th October 2023, in England, Wales and Scotland amendments to the Human Medicine Regulations 2012 (as amended by The Human Medicines (Amendment Relating to Original pack Dispensing) (England and Wales and Scotland) Regulations 2023) will make it mandatory for pharmacists to supply sodium valproate, valproic acid and valproate semisodium in complete original packs, except where the pharmacist is satisfied that:
‘a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system)’
In rare cases / exceptional circumstances, the legislation permits pharmacists to make an exception on an individual patient basis when:
- The medicine is unlicensed; or
- A risk assessment is in place that refers to the need for the patient to be supplied the valproate/valproic acid containing medicine in different packaging (e.g. the patient needs their medicines in a monitored dosage system)
This applies to all patients, not just females of childbearing potential.
In all these exceptional cases, the pharmacist must ensure that the patient is given the associated Patient Information Leaflet (PIL). Pharmacists should explain to the patient/representative why the medicine has not been supplied in the manufacturer’s original full pack.
Download Risk Assessment Template
The risk assessment template is intended to assist the pharmacist in assessing the risks involved in supplying valproate/valproic acid containing medicines in different packaging and allow them to make the right decision for the individual patient. It is advisable to review and update the risk assessment periodically (e.g when there are changes in the patient’s circumstances). Advise patients to proactively inform the pharmacy if their circumstances change.
When valproate/valproic acid products are dispensed in Monitored Dosage Systems (MDS) pharmacy teams 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.
Further guidance on the stability of drugs in Monitored Dosage Systems (MDS) can be found on the Specialist Pharmacy Service website’s Medicines in Compliance Aids Stability Tool.
Reclassification to Special Containers
To align with the legislation, 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.
Some examples:
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A prescription for Sodium valproate 300mg modified-release tablets x 28 tablets
Dispense the nearest complete pack size of 30 tablets |
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A prescription for Sodium valproate 300mg modified release tablets x 45 tablets Dispense one pack of 30 capsules as 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’ |
More information about Special Containers
Pregnancy Prevention Programme
The existing requirements when supplying valproate/valproic acid containing medicines to women and girls as per GPhC and MHRA guidance still applies.
Dispensing Valproate and Valproic Acid containing medicines SOP