Sodium Valproate guidance – The Sunday Times published in Aril that there are investigations into the prescribing of sodium valporate to pregnant woman. Sodium valproate has been linked to causing serious birth defects and also learning and behavioural issues further down the line.
In 2018, MHRA tightened their guidelines which meant that females of child bearing age should not be prescribed it unless there was a pregnancy prevention programme being followed.
The patient information leaflet for this drug has since then been updated with a clear warning box of the risks associated with taking this drug and falling pregnant. Furthermore, since the MHRA guidance came out, manufacturers have also supplied this drug with warning pictures on the packaging. It has been reported that there are cases where the patient is given this drug without any warnings of the risks associated and/or the drug has been given in plain white boxes which have no warning labels and, in some cases, no patient information leaflet is supplied nor any counselling to the patient.
I believe the grounds of negligence do not solely lie with the pharmacist in every case, nor with the prescriber alone. The responsibility to safeguard and counsel the patient lies with all parties involved in the patient’s care. The prescriber needs to have a clear conversation addressing the risks. The pharmacist needs to ensure the medicine is supplied with all the appropriate warnings clearly visible and in the original packaging where possible and a patient information leaflet should always be supplied every time. This also posses the question of responsibility that lies with the manufacturer and even the wholesalers. They too have a degree of responsibility of patient care and should ensure the guidelines are followed on how the drug is packaged and signed off ready for supply. The guidance is very simple to follow so why doesn’t it get done every time? I believe a huge part of it is because someone always assumes that another person has done the job. The prescriber would have counselled on the risks surely? The patient would surely read the patient information leaflet inside so it doesn’t need any warning labels on the outside? The patients had this before, so I don’t need to counsel or even give them a patient information leaflet, right? It’s aways better to do or say something again rather than assume its already understood or done when there is a chance it hasn’t. The risks associated with sodium valporate use in females who are of child bearing age are significant and well advised in the healthcare industry so there simply isn’t any excuses for not giving these patients the care that is required.