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
dispensersto 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, , 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
-
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.
