Asthma death girl 'was let down'

Emma Frame died in 2001, aged five

A sheriff has hit out at the "complacency" of health professionals and a drugs manufacturer over the safety of an asthma inhaler steroid.

A fatal accident inquiry found that the death in 2001 of Emma Frame, from Strathaven, Lanarkshire, might have been avoided if precautions were taken.

Emma, five, had been given five times the licensed dose of fluticasone.

Her parents, Stewart and Karen, said they and their daughter had been let down in a "devastating way".

In her report, Sheriff Carol Kelly concluded that the cause of Emma's death was "adrenal insufficiency".

We hope that the people and organisations involved will carefully consider their part in Emma's death and in this inquiry Stewart and Karen Frame

She added that the case had led to warnings over dosage which had "shattered" the "complacency" about the safety of these drugs.

However, she also warned that an "outbreak of steroid phobia" should be avoided and said inhaled steroids had transformed the lives of asthma sufferers.

In a statement, Mr and Mrs Frame said they never believed the doctors in charge of their daughter's care ever wished her harm.

It added: "However, it became clear during the inquiry that the medical profession had become complacent about the off licence use of inhaled steroids in the treatment of asthma."

They said Emma was a "bright, lively and loving girl" who would never be forgotten.

Emma's tragic death highlighted the link between adrenal suppression and high doses of inhaled corticosteroids Yorkhill Hospital statement

"We hope that the people and organisations involved will carefully consider their part in Emma's death and in this inquiry," they said.

"We relied on their knowledge, professionalism, governance and care. They let Emma, Calum and us down in the most devastating way possible."

Drugs firm GlaxoSmithKline said Emma's death was "a tragic case" and that its sympathies lay with her family.

Fluticasone propionate was licensed for children aged between four and 16, initially up to a dosage of 200 micrograms and, since 2001, up to 400 micrograms.

Doctors are able to exercise clinical judgement to prescribe drugs in larger doses and to those beyond the licence categories.

'Proactive role'

Emma had been receiving the drug in excess of the licensed dosage for more than four years when she died.

One month after her death, Emma's seven-year-old brother Calum, who had also been on a high dose of inhaled steroids, was admitted to hospital with an unexplained illness.

Sheriff Kelly said that Emma's death might have been avoided if the consultant paediatrician at Yorkhill Hospital in Glasgow and her GP or pharmacist had acted differently.

She was heavily critical of the paediatrician for not urging Emma's GP to reduce the extremely high dosage and said Emma's parents should have been issued a steroid card to alert other health care practitioners to the fact that she was receiving such a high dosage.

Flixotide is a steroid-based inhaler for treating asthma

Sheriff Kelly said: "I have come to the belief that it would have been a reasonable precaution for the consultant involved in Emma's care to have taken a more proactive role in reducing the dosage of fluticasone prescribed for her and that if such a precaution had been taken, Emma's death might have been avoided."

Health chiefs at Yorkhill Hospital welcomed the sheriff's findings and said they were reviewing the drugs prescription procedures for respiratory doctors.

A spokesman for the hospital said: "Emma's tragic death highlighted the link between adrenal suppression and high doses of inhaled corticosteroids, particularly fluticasone, used in the treatment of asthma.

"Accordingly, at the beginning of 2002, Yorkhill NHS Trust decided all other children under the hospital's care who were receiving high-dose inhaled fluticasone should be identified and their adrenal function tested."

Most widely used

GlaxoSmithKline, the manufacturer of fluticasone, was also criticised for stressing the safety of the drug.

This led many medical professionals to be "complacent" about its safety and that in turn contributed to the practice of prescribing high doses, said the sheriff.

Sheriff Kelly ruled: "The emphasis placed by the manufacturer of fluticasone propionate upon its safety in the promotion and marketing of the drug contributed to the complacency by many within the medical profession about its safety, which in turn contributed to the practice of prescribing high doses of the drug."

The drugs company stressed that fluticasone was the most widely used inhaled steroid and had been used to treat more than 250,000 children in the UK.

The sheriff also criticised the Medicines Control Agency, whose guidelines did not highlight the potential danger of prescribing high doses.

Government guidelines issued on asthma management were said to lack clarity.