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MHRA warn of medico-legal risk of inhaled steroid scripts

By Christian Duffin

The MHRA has warned that GPs are placing themselves at medico-legal risk by prescribing inhaled steroids as a monotherapy in COPD, with new figures suggesting almost 200,000 patients remain on steroids alone.

The UK drug regulator issued a fresh alert in response to the statistics, warning that steroids were only licensed for COPD as a combination treatment – meaning use of monotherapy was legally risky.

Statistics for England collected by Pulse from Cegedim Strategic Data suggest many GPs are ignoring NICE guidelines advising against use of steroids as monotherapy, because of the risk of pneumonia.

Between June 2008 and June 2009, the proportion of patients on steroids as a monotherapy, as a proportion of those receiving the drugs, dropped only slightly from 43% to 40%.

The MHRA expressed concern that in June 2009, 184,485 COPD patients were still on inhaled steroids alone, urgings GPs to move patients to fixed-dose combinations of inhaled steroids and long-acting beta-agonists.

An MHRA spokesperson said: ‘Monotherapy inhaled steroids for COPD has not been shown to be effective and exposes patients to the risks including pneumonia. Monotherapy inhaled steroids for COPD is an unlicensed indication.'

Dr Rupert Jones, clinical research fellow at Peninsula Medical School and a GP in Plymouth, said: ‘COPD patients on inhaled steroids should be on a long-acting bronchodilator. They should not be on monotherapy because COPD is largely unresponsive to inhaled steroids.'

Dr Jones argues that some patients may be misdiagnosed or misrecorded as COPD patients when in fact they have asthma.

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