Division over scheduling decisions


Schedule changes confirmed for a number of commonly dispensed medicines, despite pharmacy opposition to some proposals

The TGA has confirmed previous interim decisions to amend (or not amend) the current Poisons Standard, from the June meeting of the Advisory Committee on Medicines Scheduling (ACMS).

The changes now confirmed have all been subject to a public consultancy periods, and some were opposed in submissions form pharmacy groups.    

One change opposed by pharmacy groups was the decision to amend the scheduling of ibuprofen, broadening access to the medicine by adding a clause to its S2 entry to include ibuprofen “in divided immediate release preparations, each containing 400mg or less of ibuprofen in a primary pack containing not more than 12 dosage units”.

This proposal had been opposed by the Pharmacy Guild of Australia who said it did “not warrant the increased risk associated with the potential for confusion and misuse created by an additional strength of ibuprofen being more readily available”.

“The Guild believes that there is neither a public need for the increased access to oral preparations
containing 400mg of ibuprofen or that greater access to such products is in the public interest. Of
particular concern are the many possible interactions with commonly used medicines and precautions for
use in people with commonly occurring conditions.” 

The Society of Hospital Pharmacists of Australia also opposed the change, saying in its submission: “Unrestricted access to larger doses of these medicines is not appropriate for the treatment of acute pain and fever. The provision of larger strength doses in schedule 3 will ensure patients better manage their pain by seeking advice from a pharmacist if continued supply of these medicines is required.”

The TGA delegate also confirmed the previous decision to down-schedule eletriptan from Schedule 4 to Schedule 3, with a new Appendix H listing.

“I have decided to include a pack size limit in the new Schedule 3 entry to mitigate the risks of medication overuse headache, unintentional and intentional overdose,” the delegate said.

“I have made the Schedule 3 entry indication specific on the grounds that eletriptan is not effective for other types of headache,” they said, noting that this was consistent with the recent decisions to down-schedule sumatriptan, zolmitriptan and rizatriptan.

Medicines where proposals to alter scheduling were rejected, include sildenafil, oxymetazoline nasal sprays and clotrimazole.

Submissions from pharmacy groups were divided on whether sildenafil should be down-scheduled. The proposal called for an S3 listing for Sildenafil “in divided preparations for oral use containing 50 mg of
sildenafil per dosage unit in packs of not more than 4 dosage units”.

SHPA was opposed saying it did “not believe that pharmacies in the community setting have the adequate resources to screen for these risks, irrespective of any Appendix M entry that would mandate the pharmacist to undertake accredited CPD and confirm that a PDES inhibitor has previously been prescribed by a medical practitioner for the treatment of erectile disfunction”.

The Guild was “supportive of a staged approach to consumer marketing of sildenafil, following a period of
implementation and review. This would enable pharmacists to undertake training, develop, embed and
review professional practice and workflow processes associated with the supply of sildenafil, and ensure
safe, effective and quality use of medicines.”

However, it opposed an Appendix H listing allowing advertising, saying this was not warranted.

In a detailed submission, PSA said it “supports the rescheduling of sildenafil to Schedule 3 with Appendix M controls, and an entry in Appendix H, as proposed.

“This view is based on relevant Appendix M criteria being addressed to fulfil risk reduction to an acceptable level, and an assessment that there is likely to be public health benefits”.

In the final decision, the TGA delegate noted “the public submission on the interim decision from the Pharmaceutical Society of Australia, which reiterates their earlier submission, supporting the applicant’s down-scheduling proposal.

However, no new information has been provided to mitigate my concern that the down-scheduling of sildenafil may lead to risk for consumers accessing sildenafil without medical intervention and lack of follow up.

I remain of the firm view that the medical practitioner oversight is required and the current scheduling of sildenafil under Schedule 4 is appropriate”.

Final decisions on the scheduling of nicotine and cannabidiol were not published and are “expected in mid December and late December 2020, respectively”, the TGA said.

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