The proposed down-scheduling of budesonide and topical hydroxypinacolone retinoate poses a danger to patients, the college says.

Pharmacist holding asthma puffer
The RACGP believes making budesonide available over the counter would be dangerous for patients.

The RACGP has voiced its opposition to proposed amendments that would allow pharmacists to sell budesonide and hydroxypinacolone retinoate over the counter, in a recent submission to the Therapeutic Goods Administration (TGA).


Earlier this year, the regulatory body requested feedback on proposed amendments to the Poisons Standard that would see the down-scheduling of budesonide from Schedule 4 to Schedule 3, as well as changes to the Schedule 4 entry for hydroxypinacolone retinoate.


In response, the college outlined why it would be inappropriate and potentially harmful for pharmacists to be allowed prescribe these medicines, while emphasising GPs’ central care-coordination role.


According to the college, the proposed change to scheduling for budesonide poses a danger to patients because pharmacists are not clinically trained to diagnose and treat asthma, and misdiagnosis could risk patient health and safety.


‘Asthma is a chronic condition that requires a clinical diagnosis,’ the submission states.


‘This includes taking a medical history, examination of the respiratory system, performing and interpretating spirometry, and undertaking shared decision-making with the patient.’


The college’s submission asserts that GPs’ skills and knowledge mean they are best placed to effectively and safely manage the condition and prescribe appropriate medication/s, as part of preparing a comprehensive asthma-management plan with the patient.


Budesonide remains a prescription-only medication in Canada and New Zealand, while the US only permits over the counter sales when used in nasal sprays.


The proposal to down-schedule the asthma medication – which was made by a ‘private applicant’ – appears to be the latest in a string of attempts to expand pharmacy scope of practice, including failed efforts to allow over the counter sales of oral contraceptives, and the ongoing North Queensland UTI pilot.


The RACGP has long advocated against what it views as pharmacy overreach that puts patient safety as risk, including recent protests against a potential North Queensland Pharmacy Scope of Practice Trial.


Aside from opposing over the counter sales of budesonide, the RACGP also warned against down-scheduling the topical form of hydroxypinacolone retinoate.


The medication listing for hydroxypinacolone retinoate warns that it may cause birth defects, so prescribers should ensure that there is no possibility the patient is pregnant. The must also be certain that patients understand that pregnancy should be avoided while the medication is being used, and for one month afterwards.


‘As some patients given the topical preparation may be of child-bearing age, prescribing of this medication is best managed in general practice,’ the submission states.


Along with safety concerns related to the use of the medications, the RACGP warned that patient care becomes fragmented when similar services are offered by multiple health professionals, especially when they do not have equivalent levels of training.


The college contends that the care-coordination role played by GPs is essential to maintaining patient safety, and that pharmacists are not appropriately qualified to diagnose and treat chronic illnesses and may lack the benefit of knowing a patient’s medical history.


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asthma budesonide hydroxypinacolone retinoate Poisons Standard TGA

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