Safety warnings to be provided to all patients with every valproate-containing medicine they receive under new law
Patients to receive the latest valproate safety information with every pack, following changes to the Human Medicines Regulations, 2012
Valproate-containing medicines will be dispensed in the manufacturer’s original full pack, following changes in regulations coming into effect on Wednesday, 11 October 2023. The Medicines and Healthcare products Regulatory Agency (MHRA) has today published new guidance for dispensers to support this change.
Following a government consultation, this change to legislation has been made to ensure that patients always receive specific safety warnings and pictograms, including a patient card and the Patient Information Leaflet, which are contained in the manufacturer’s original full pack. These materials form a key part of the safety messaging and alert patients to the risks to the unborn baby if valproate-containing medicines are used in pregnancy.
The changes follow a consultation on original pack dispensing and supply of medicines containing sodium valproate led by the Department of Health and Social Care (DHSC), in which there was overwhelming support for the introduction of the new measures, to further support safety of valproate-containing medicines.
A large majority of respondents to the consultation – 85% – agreed or strongly agreed with the requirement that the full-pack dispensing of medicines containing valproate in the manufacturer’s original pack will ensure patients always receive the safety information supplied on the label and in the Patient Information Leaflet.
MHRA Chief Executive, Dr June Raine, 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.
“It is very important that patients do not stop taking valproate-containing medicines without advice from a healthcare professional. If you are concerned about the risks, talk to your doctor, pharmacist or another healthcare professional.”
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.”
There is a significant risk of birth defects for unborn babies and developmental disorders in children born to women who take valproate-containing medicines during pregnancy. Because of these risks, prescribing to women and girls of childbearing potential must fulfil the conditions of the Valproate Pregnancy Prevention Programme which is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.
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.
Further information
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For more information about the risks of valproate-containing medicines in pregnancy see the MHRA’s Valproate use in women and girls page.
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Guidance has been published and is available here
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Original Pack Dispensing legislation relates to all medicines. This MHRA guidance relates to valproate-containing medicines only. Further guidance on wider amendments for dispensing of original packs is being brought in after discussion between DHSC and appropriate community pharmacy representative bodies on how the arrangements will apply.
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Anyone experiencing any side effects from their medicine can report these to the MHRA, using the Yellow Card scheme.