The peak body for sleep physicians is calling for Continuous Positive Airway Pressure machines to be made prescription-only.
The Australasian Sleep Association is calling on the TGA to regulate the sale of Continuous Positive Airway Pressure (CPAP) machines, used to treat obstructive sleep apnea (OSA), arguing the move is needed to stop the needless sales of expensive devices to patients who do not need them.
The ASA raised the alarm in 2015 after the Department of Health noted 75 % of patients who had Medicare-funded home-based sleep studies had not seen a respiratory or sleep physician within 12 months either side of having the test.
The ASA said it was also concerned about the “duality of interest” of commercial enterprises who offer sleep studies and sell CPAP machines, which can cost around $2000.
ASA president Dr Maree Barnes said it was not uncommon for sleep specialists to see patients who were using CPAP devices but still had symptoms.
“They come in for a second or third opinion and say, ‘I am using CPAP but still have this problem and why is that?’
“They are not being looked after by someone trained in the area (of sleep medicine).”
One mooted solution is to mandate that patients who undertake Medicare-funded sleep studies are seen by a sleep or respiratory specialist.
But Dr Barnes said the move won’t cover sleep studies by commercial enterprises that do not attract a Medicare rebate.
“It is of great concern to us which is why we have been pushing for years to have CPAP regulated as a prescription only item, so that only people who benefit from CPAP actually get it, and people aren’t paying for a machine that’s not appropriate for what’s wrong with them.”
“We have been talking to the TGA about this because CPAP is a medical device but have been told at least twice (in the past 4 years) that the TGA will not be regulating it,” Dr Barnes said.
And last month the ASA again wrote to the TGA making the prescription-only call.
In its submission it stated “we would endorse accepting the USA policy of prescription only, in order to protect the patient from purchasing expensive devices that are unnecessary, or are in excess of the patients’ requirements”.
A TGA spokesperson told the limbic that unlike medicines, medical devices are generally not subject to scheduling classifications such as “prescription-only”, with the exception of a few types of Class III medical devices that administer medicines or poisons.
The spokesperson noted that the MBS Review Taskforce had made recommendations to improve the clinical value of Medicare-funded sleep studies used to investigate patients for OSA.
“The recommendations are directed to improving GP referral so that patients who are likely to have sleep apnea can get tested without the need to be seen by a sleep specialist beforehand and those patients who have a positive test are seen by well qualified doctors who can advise them about the right treatment.”