‘Horrifying’ failure to provide safety warnings for high-risk medicine

Concerns have been raised that patients may not be receiving “vital” safety information after HSJ discovered a high-risk medication was frequently not being dispensed as originally packaged. 

In 2018, the Medicines and Healthcare Products Regulatory Agency asked pharmacies to dispense valproate-containing medications in their original pack where possible, to ensure packages include safety warnings. 

It also asked manufacturers to produce smaller pack sizes and add pictorial warnings, while pharmacists were additionally asked to add stickered warnings to the outer box of any valproate-containing medication not dispensed in its original packaging.

Yet, data obtained via freedom of information requests to the NHS Business Services Authority revealed that while the proportion and number of valproate-containing items dispensed as split packs – as opposed to whole packs – had decreased over the last five years, split packs still accounted for more than half of items dispensed in 2022-23. 

Emma Murphy, of campaign group In-Fact, said the figures on split pack dispensing were “quite horrifying” and showed “the system is not working”.

She added: “Attitudes have got to change – prescribers, GPs etc need to be proactive and warn women of the risks because this isn’t just a side effect, this is harming real babies. As a mum of five affected children, the consequences of valproate in pregnancy on that baby is devastating.”

Alison Fuller, of Epilepsy Action, said the high proportion of split packs being dispensed made it “clear why the change in guidance introduced in October 2023 was necessary”, adding: “The manufacturer’s original full pack always contains all the relevant information, which is why it’s the best option for patient awareness.”

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Source: HSJ,