Leading respiratory specialist attacks push to legalise OTC budesonide sales


By Geir O'Rourke

20 Jun 2022

Professor John Upham

A leading respiratory physician has criticised a bid to allow OTC pharmacy sales of budesonide, warning it could fragment care and lead to misdiagnosis.

The medicines watchdog has not revealed which organisation is behind the application to the TGA to down-schedule the inhaled corticosteroid, which is currently before the regulator’s advisory committee on medicines scheduling.

Published in late April, the application says the drug carries low risk of misuse and is “substantially safe with pharmacist intervention” to monitor its use.

“In regional, rural and remote areas that are underserviced by other healthcare professionals, pharmacists are highly trained healthcare professionals that could provide a greater contribution to the management of asthma for all patients,” it says.

But respiratory physician Professor John Upham says there are grave concerns, given pharmacists’ lack of training in asthma diagnosis and management.

“There are a number of concerns about the problems of pharmacists giving out the medication to patients who don’t necessarily need it and without really understanding the diagnosis,” he told the limbic.

“When a patient comes in, the pharmacist needs to be asking questions like whether their asthma has been confirmed by a doctor and how it is being managed.

Professor of Respiratory Medicine at the Princess Alexandra Hospital in Brisbane, he added: “You can imagine in a high throughput chain pharmacy, where it is all about high volume and keeping costs down that some of those critical questions won’t be asked.”

“They are just going to sell the person the inhaler.”

The president of TSANZ stressed he was speaking in a personal capacity given the society had not made a formal submission to the TGA.

He added there was also some merit to the argument that improving access to budesonide could encourage patients to move away from medications like salbutamol.

Nevertheless, it was still vital to ensure that only “the right people” were accessing budesonide, Professor Upham said.

“If you open up access but you don’t target it very well then at the very worst you are not going to make things any better and there is a potential that you might do some harm,” he said.

It comes after the RACGP voiced its opposition to the move earlier this month, in a submission labelling it “harmful for patients”.

“Due to their central care coordination role, skills and knowledge, GPs are best placed to manage asthma and prescribe patients with the medication/s they require,” the college said.

“GPs will prepare asthma management plans in the context of the patient’s medical history. Patient care becomes fragmented when similar services are offered by multiple health professionals.”

The Advisory Committee on Medicines Scheduling is to meet on 21-23 June to consider the application.

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