M for Empty

From February, an empty appendix has appeared in the Poisons Standard. Appendix M initially promised much, but today, all it contains is a heading that says, “Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist”. Other than that, it is empty.

The idea of appendix M was to facilitate the easier down-scheduling of certain medicines from Schedule 4 (S4) prescription only, to Schedule 3 (S3) pharmacist only. It seemed simple enough when it was discussed in early 2108, but even though it now appears in the Poisons Standard, to date no explicit guidance on what additional controls might be applied under appendix M has been issued.

With an appendix in place and no guidelines for its use, the TGA has begun seeking comments from interested parties in the hope of moving appendix M forward.

Specifically, the TGA says it is “seeking comments from interested parties on the proposed criteria, accompanying guidance and plans for monitoring of the supply of Schedule 3 (S3) pharmacist only – appendix M substances”.

The TGA’s public consultation paper outlines a proposed framework for the use of appendix M of the Poisons Standard. Appendix M is intended to include substances that have formerly been S4, but, if rescheduled to S3, could be dispensed by a pharmacist with specific controls in place that help to ensure appropriate use.

It is not intended that appendix M controls would be routinely required for medicines that are rescheduled from S4 to S3. However, the addition of appendix M controls might facilitate down-scheduling of S4 substances in circumstances where doubt might otherwise exist as to the public health benefit of doing so.

According to the document, pharmacists will be expected to use questionnaires, checklists or certain guidelines to identify if a medicine is suitable for a patient.  There may be limits on quantities and repeat prescriptions before patients are required to see a doctor. In some cases, dispensing would be allowed only when there has been a formal diagnosis by a doctor.

Now, advice is being sought from a wide range of stakeholders regarding the feasibility, practicality and reasonableness of this framework .

In January 2018, a revised Scheduling Policy Framework was published and came into force, including provision for appendix M. Since then, consideration of these and other issues has been part of the brief of an ad hoc working party formed at the request of Australian Health Ministers Advisory Council to continue work on outstanding scheduling issues.

This diverse group of experts, industry groups and professionals from the medicine, pharmacy and chemicals sectors, as well as consumer representatives met three times in 2018 – in February, March and December. While discussion on the structure and use of appendix M progressed during that time, at the December 11 meeting it was agreed that further public consultation on appendix M was warranted.

The working party did, however, identify an initial group of seven medicines to be considered for down-scheduling, also indicating what training would be needed to dispense them.

These medicines are:

  • Adapalene.
  • Melatonin.
  • Ondansetron.
  • Oral contraceptives.
  • Sildenafil.
  • Trimethoprim.
  • Triptans.

It is believed that after consideration of feedback on the consultation paper is completed, the final criteria for appendix M will be established by the middle of 2019.

If not, an appendectomy might be prudent.

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