The TGA has rejected a submission to down-schedule inhaled budesonide from prescription-only to OTC status, saying that retail pharmacists could not safely diagnose and manage asthma in their shops.
An application from an un-named sponsor sought the creation of a Schedule 3 entry (over the counter pharmacist sale) for inhaled budesonide dry powder inhaler available to people over the age of 12 in three doses at 100mcg, 200mcg and 400 mcg each.
The applicant claimed that OTC availability would improve access to preventer therapy for people with asthma, especially in rural areas, and help achieve the aim of reducing overuse of short-acting beta agonist inhalers.
However in an interim decision handed down by the Advisory Committee on Medicines Scheduling, the application was turned down on the grounds that the risks of inhaled steroids being sold without medical supervision would outweigh any benefits.
The Committee concluded that there were risks for overuse or inappropriate use of inhaled steroids when made available through pharmacy sales, especially with the availability of multiple strengths, which could lead to confusion and potential harm for patients. The Committee also advised that OTC sales of preventers could result in decreased health professional oversight, with a risk of increased non-compliance for asthma treatment and high risk of worsening of disease.
“I remain of the view that the oversight of medical professionals is essential in the diagnosis and ongoing treatment of the conditions which budesonide is used to treat and prevent,” stated the decision summary of the delegate of Department of Health Secretary from the ACMS.
The Committee’s advice was that retail pharmacists did not have the proper time and tools to assess a patient’s symptoms and history, and asthma could easily be misdiagnosed.
“The potential misdiagnosis of asthma in place of another respiratory condition such as croup, chronic obstructive pulmonary disease (COPD) or pneumonia increases the risk of a delay in seeking appropriate and timely medical assistance,” the Delegate noted.
“I am concerned that self-managed treatment of asthma, which requires medical assessment and discussion of patient history, may lead to undesirable and potentially harmful patient outcomes.
The rejection was also based on advice received in submissions from Asthma Australia, the AMA and the RACGP.
“All expressed their concerns in relation to the Proposal, citing the importance of appropriate diagnostic tools, monitoring of any disease progression and the ability to check patient history to properly diagnose asthma,” the Committee noted.
The TGA also found that down-scheduling would contravene Quality Use of Medicines (QUM) principles and would be at odds with international practices, with countries such as the USA, Canada, Ireland and New Zealand all regulating inhaled budesonide products as prescription-only medicines.
“Having considered the need for medical practitioner oversight and the risks to consumers due to the lack of patient review and follow up, and the increased risk of inappropriate use, I have decided that the current scheduling of budesonide is appropriate,” the decision statement concluded.