I was dismayed to read in the Sunday Times this April an investigation into the continued prescribing of sodium valproate to pregnant women. Sodium valproate has been likened to Thalidomide because of evidence that it can cause serious birth defects as well as problems with a baby’s learning and behaviour.

The requirements for prescribing sodium valproate were significantly tightened by the Medicines and Healthcare products Regulatory Agency in 2018 and it must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme in place.

The patient information leaflet (PIL) for sodium valproate contains a large, boxed warning that the product can seriously harm an unborn child when taken during pregnancy. The warning gives specific advice to females able to have a baby. In addition, since 2018, sodium valproate has been supplied by manufacturers in packaging that includes a pictographic warning about use in pregnancy.

However, The Sunday Times found that sodium valproate was still being prescribed to women who were pregnant or who might become pregnant. The report revealed that on some occasions, sodium valproate had been supplied by pharmacies in plain boxes without a PIL and without a warning on the external packaging. In other cases, dispensing labels had been stuck over the pregnancy warnings, concealing them.

 

Advice from manufacturers on split packs

 

The Human Medicines Regulations require original packs to be supplied with a PIL, but there is no legal requirement to supply a PIL with a repackaged medicine, for example because a split pack is used.

Since April 2018, the MHRA has advised pharmacies supplying sodium valproate to:

• provide a patient card;
• remind patients of the risks in pregnancy;
• to dispense in manufacturers’ packs. If repackaging cannot be avoided, a copy of the PIL should be supplied and a warning sticker should be attached to the outer box.

In June 2018, the manufacturers of sodium valproate wrote to pharmacists, with the agreement of the MHRA, saying that original packs should always be provided to patients, but that if this could not be done, pharmacists should “always provide a copy of the package leaflet, patient card, and add a warning sticker to the outer box”. 

This advice has been reinforced by the General Pharmaceutical Council (GPhC), which has warned pharmacies that its inspectors are checking that supplies are being made safely.

 

Possible grounds for negligence claims

 

A patient who has suffered harm as a result of a pharmacist’s negligence will normally be entitled to recover damages from the pharmacist or pharmacy owner. Negligence involves a breach of the duty of care owed to the patient. The standard of care depends on whether the pharmacist has acted in accordance with a responsible body of opinion within the profession.

In view of the guidance given by the MHRA, the GPhC, the manufacturers and others, it is likely that a pharmacist who supplies sodium valproate in a package that does not contain a PIL, or who covers the warning on the packaging with a dispensing label, will be held to be negligent. It is not sufficient to assume that the prescriber has discussed the risks with a patient and has not made a mistake. The failure to remind a female patient of childbearing age of the risks in pregnancy would also be negligent. It would be prudent to make a contemporaneous written record of the advice given in case of a later dispute.

It does not automatically follow that a patient will be awarded damages against a negligent pharmacist, because the patient must show that any loss was probably caused by the pharmacist’s negligence. Causation is often the most difficult issue in clinical negligence cases.

A patient may not succeed in recovering damages from a negligent pharmacist if she had been informed by the prescriber or by the pharmacist of the risks involved and she made a conscious decision to take the medication anyway and a covered-up warning or the absence of a PIL would not have made any difference.

In the case of a covered-up warning, a patient would have to satisfy a court that she would probably have taken steps to avoid becoming pregnant or would not have continued with a pregnancy if she had seen a warning that was covered up. In the case of a missing PIL, she would also have to persuade the court that she would have read and acted on the warning in a PIL if one had been supplied.

A patient who decides on a termination after subsequently learning of the risks to a foetus may be awarded damages for having to undergo the procedure. A far larger claim may be brought on behalf of a child who is born with birth defects or developmental disorders for all the additional, lifelong costs attributable to its mother having taken sodium valproate.

 

Assessing the prescriber and pharmacist’s degree of responsibility

 

If a patient brings a claim, the prescriber will probably be a defendant. If both the prescriber and the pharmacist have been negligent, it is likely that the court will be asked to assess their respective degrees of responsibility. For example, in a well-known case where a GP prescribed an overdose of Migril, which a pharmacist failed to spot, causing serious injuries to the patient, the court ordered the GP to pay 60% of the damages and the pharmacy owner 40%.

Well-known law firms are already investigating claims on behalf of women who took sodium valproate during pregnancy. These are called “wrongful birth” claims. Most of these are likely to be focussed on whether the manufacturers negligently failed to advise regulators and prescribers of the risks associated with sodium valproate before regulatory action was taken in 2018. Claims against doctors who have prescribed since 2018 are also on the cards. However, claims against pharmacists cannot be ruled out.

David Reissner is chair of the Pharmacy Law & Ethics Association