Tragic death of 5 year old asthma patient was avoidable and due to complacency of health professionals

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

Emma Frame from Strathaven, Lanarkshire, died in 2001, aged five and the inquiry found that her death might have been avoided if precautions were taken. Emma had been given five times the licensed dose of fluticasone, an asthma inhaler steroid.

Sheriff Carol Kelly in her report, concluded that the cause of Emma's death was "adrenal insufficiency", and said the case had led to warnings over dosage and had shattered the complacency about the safety of the drugs.

She did however warn against an "outbreak of steroid phobia" and said inhaled steroids had transformed the lives of many asthma sufferers.

Mr and Mrs Frame said they never believed the doctors in charge of their daughter's care ever wished her harm, but they had relied on their knowledge, professionalism, governance and care, and they and their daughter had been let down in a "devastating way". They hope that the people and organisations involved will carefully consider their part in Emma's death and in the inquiry. They said Emma was a "bright, lively and loving girl" who would never be forgotten.

Emma's tragic death has highlighted the link between adrenal suppression and high doses of inhaled corticosteroids and it became clear during the inquiry that the medical profession has become complacent about the off licence use of inhaled steroids in the treatment of asthma.

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.

At the time of her death Emma had been receiving the drug in excess of the licensed dosage for more than four years.

A 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 was extremely critical of the consultant paediatrician at Yorkhill Hospital in Glasgow, and said Emma's death might have been avoided if the health experts involved had acted differently.

Kelly said she believes 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 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 says that Emma's tragic death highlights the link between adrenal suppression and high doses of inhaled corticosteroids, particularly fluticasone, used in the treatment of asthma.

Yorkhill NHS Trust decided as a result of the tragic death of Emma that all other children under the hospital's care who were receiving high-dose inhaled fluticasone should be identified and their adrenal function tested.

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

The company said Emma's death was "a tragic case" and that its sympathies lay with her family.

In conclusion 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.

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