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Fewer than half of pharmacists issue warning cards for patients using valproate

It is a requirement that patient cards detailing information on the risks are issued every time valproate is dispensed, under Medicines and Healthcare products Regulatory Agency guidance.

Valproate packet

Source: Alamy Stock Photo

Valproate can affect the development of babies in the womb.

Only 40% of pharmacists are meeting a patient safety requirement when dispensing valproate to women, an audit carried out by the Company Chemists’ Association (CCA) has found.

The drug can cause birth defects in women who take it when pregnant.

In April 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) stated that valproate must not be used by women and girls of childbearing age unless a pregnancy prevention programme (PPP) is in place.

Under the PPP, patients must be told the risks of taking valproate during pregnancy and have signed a risk acknowledgement form. MHRA guidance on the role of pharmacists in the safe supply of valproate medicines also says that a patient card giving information on the risks should be issued every time valproate is dispensed.

The two-part CCA audit found that just 40.1% of the 6,480 audited pharmacy teams issued the cards when dispensing valproate, between February and March 2019. The first part of the audit, taken between July and October 2018, found that only 21.4% of 6,761 pharmacy teams had provided the warning cards.

During the first part of the audit, the pharmacy teams also reported that only 26.4% (4,532) of prescriptions they received had an indication that a PPP was in place. In the second part of the aduit, 36.6% (2,848) of prescriptions were reported to include information on whether the patient had a PPP in place.

Duncan Rudkin, chief executive of the General Pharmaceutical Council (GPhC), said pharmacies must do more to ensure the safe dispensing of valproate.

“The CCA’s findings provide evidence of some improvement between 2018 and 2019 in terms of pharmacy teams’ awareness of the need to follow the PPP for valproate, but it is clear there is still more to be done.”

Rudkin added that valproate dispensing was now included as part of the GPhC inspection regime of pharmacies.

“Our inspectors are looking for evidence that the pharmacy team are complying with the PPP for valproate in every inspection, and record their findings in inspection reports, which are now published online,” he said.

“Any pharmacy found not to be complying would have to take immediate action to resolve this.”

Janice Perkins, chair of the Community Pharmacy Patient Safety Group, acknowledged that “there are still improvements to be made”.

”The CCA, through its work with the Community Pharmacy Patient Safety Group as well as the MHRA’s Valproate Stakeholder Network, will continue working to raise awareness and understanding among the profession to help eliminate avoidable harm caused by valproate,” she said.

Among a series of recommendations made following the audit, the CCA called on drug manufacturers to ensure that the patient card is supplied with every order placed for valproate.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207410

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