Valproate must now be dispensed in original packaging
Changes to dispensing regulations so safety warnings are not missed
IMPORTANT: You should never stop taking your medication without first consulting your doctor. To do so, could leave you at risk of seizures.
A new change in regulations means that all valproate containing medications must now be dispensed in the manufacturer’s original full packaging.
This follows a change to the Human Medicines Regulation 2012 designed to ensure that patients always receive specific safety warnings and pictograms, including patient cards and patient information.
These are critical in informing patients of the risks linked to valproate for an unborn baby exposed to the medication during pregnancy. Up to 40 per cent of babies exposed to valproate are at risk of being born with a birth defect or neurodevelopmental disorder.
This means that women and girls of child bearing age can only be prescribed valproate if they are part of the Valproate Pregnancy Prevention Programme.
Complete packs only
The new legislation allows dispensers such as pharmacists to round the prescribed amount of valproate-containing medicines either up or down so that the patient receives only complete packs. The medicine must not be re-packaged into plain dispensing packaging.
In rare cases, pharmacists can make an exception on an individual patient basis. This can only happen where a risk assessment is in place that refers to the need for different packaging. For example, the patient may need a monitored dosage system. In all these exceptional cases, the pharmacist must ensure that the patient is given the Patient Information Leaflet about valproate-containing medicine, and the pharmacist can explain why the patient is not receiving the manufacturer’s original full pack.
June Raine, Chief Executive of the MHRA, said: “It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed. The changes in the law announced today ensure this happens. People’s situation may change, especially with regard to the possibility of pregnancy, so it is vital that the warnings about the harms of valproate are always brought to mind.
“We are pleased to provide guidance to support the further strengthening of safety warnings around dispensing and we ask all dispensers of medicines containing valproate to consult the new guidance carefully.”
Minister for Public Health, Maria Caulfield, said: “This safety information will help patients stay informed about risks of valproate, and I encourage all dispensers of valproate to consult the new guidance carefully.
“This continues our commitment to listening and learning from the experiences of people impacted by valproate and their families and using what we hear to improve patient safety.”
Nicola Swanborough, Head of External Affairs at the Epilepsy Society welcomed the change in regulations as a positive step in ensuring that women would be aware of the safety warnings every time they opened their medication.