Heart :: Wide UK variation in use of adult heart drug given to children

The amount and formulation of an adult heart drug given to children with congenital heart failure varies widely across the UK, reveals a survey published ahead of print in the Archives of Disease in Childhood.

The discrepancies suggest that children might not be getting the most effective dose for their condition, and that they may also be being put at risk, say the authors.

The findings are based on survey returns from pharmacies linked to, or located in, 13 children?s specialist heart centres and 13 large referring hospitals about their use of captopril in children with congenital heart failure.

Around 1000 children are prescribed the drug. But it?s licensed only for use in adults and manufactured as a tablet, which many children are either unable or unwilling to swallow, say the authors.

The drug must therefore either be crushed and water added, or obtained from a “specials” manufacturer in liquid form.

The survey results showed that only four organisations dispensed captopril tablets for crushing and dissolving in water first. The other 22 used nine different liquid formulations of the drug, which came from a variety of sources.

Three of the liquid formulations came from specials manufacturers; one came from an NHS manufacturing unit. Four were prepared “in-house” and one was imported from Australia.

Three hospitals recommended different formulations for use after discharge from those that had been used while the child was an inpatient.

Worryingly, only three specialist centres and their referring hospitals used the same liquid formulations. Ten specialist centres and their referring hospitals used completely different formulations.

The stated shelf life of the formulations from specials manufacturers and those made up on site varied from a couple of weeks to several months. But with one exception, there were no hard data to confirm the stated time frame.

Where “like for like” (bioequivalence) data are available, it is common practice to use different licensed formulations of a drug interchangeably, say the authors. But there are no such data available for captopril in children.

“The present lack of consistency in liquid captopril formulations dispensed to children with heart disease raises the issues about efficacy and toxicity,” conclude the authors.

“Moreover, failure to optimise captopril treatment in children with heart failure has potential repercussions for both immediate and long term surgical outcomes as many children require further and often multiple surgical interventions,” they add.

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