No change to Symbicort scheduling, TGA confirms, however an antihistamine will move to Schedule 3
The TGA has confirmed a previous interim decision to reject the downscheduling of the asthma treatment budesonisde-formoterol (Symbicort).
This proposal was to move budesonide and formoterol from Schedule 4 to Schedule 3 when combined in an inhaler, for “use as an anti-inflammatory reliever in the treatment of medically diagnosed asthma”.
The TGA delegate had rejected the move saying “increased availability could compromise medical management of asthma.”
“I am concerned that… the provision of patient review and follow-up, would not be adequately in place under the care of a pharmacist. I find that the potential for harm in the absence of medical practitioner oversight carries more weight than the benefit of increased patient access”.
This has been confirmed: “I have made a final decision to confirm my interim decision to not amend the current Poisons Standard with respect to budesonide and formoterol,” the delegate said.
However, the delegates noted two written submissions opposing the interim decision.
“These argued that the product would deliver better patient outcomes compared to over the counter
use of short acting beta agonists. The submissions also noted that pharmacists are already familiar with the medicine, and can ensure patient safety in conjunction with Appendix M criteria”.
However, the delegate said while these two written post-meeting submissions opposed the interim decision, the majority of pre-meeting public submissions did not support the proposed rescheduling – including responses from several asthma peak representative bodies.
Meanwhile, the delegate confirmed the interim decision to amend the current Poisons Standard with respect to the antihistamine, bilastine.
The applicant proposed an amendment to include bilastine in Schedule 2 in preparations for oral
use, and Schedule 4 for all other uses.
This was rejected, instead the delegate decided to add bilastine to Schedule 3 (Pharmacist Only) “in divided oral preparations containing 20 mg or less in adults and adolescents 12 years of age and older”.
“I find that there is sufficient information to support the safety and lower toxicity of bilastine in these preparations,” the delegate decided.
“Bilastine has a well-defined safety and tolerability profile, with a wide therapeutic index”.
The delegate also rejected a proposal to unschedule the acne treatment azelaic acid down to general sales level.
It will remain available in Schedule 2 (Pharmacy Only) in dermal preparations, and in Schedule 4 (prescription only) for all other preparations.