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Scheduling delegate's final decisions: ACCS/ACMS, April 2014

Scheduling medicines and poisons

14 April 2014

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Part A - Final decisions on matters referred to an expert advisory committee (ACMS)

3. Scheduling proposals referred to the November 2013 meeting of the Advisory Committee on Medicines Scheduling (ACMS) - ACMS # 10

3.1 Esomeprazole

Scheduling proposal

The medicines scheduling delegate considered a proposal for a new Schedule 3 entry for esomeprazole in oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of symptoms for gastro-oesophageal reflux (heartburn) and symptoms of gastro-oesophageal reflux disease in packs containing not more than 14 days supply.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Substance details

Esomeprazole is the S-isomer of the proton pump inhibitor omeprazole and is used similarly in the treatment of peptic ulcer disease and nonsteroidal anti-inflammatory drug (NSAID)-associated ulceration, in gastro-oesophageal reflux disease and the Zollinger-Ellison syndrome. It is given as the magnesium or sodium salt but doses are calculated in terms of esomeprazole. Esomeprazole magnesium 22.2 mg and esomeprazole sodium 21.3 mg are each equivalent to about 20 mg of esomeprazole.

In the United Kingdom, the dose for treatment of severe (erosive) gastro-oesphageal reflux disease is 40 mg once daily for 4 weeks, extended for a further 4 weeks if necessary; in the USA, where doses of 20 to 40 mg daily are permitted for initial treatment, a further 4 to 8 weeks of treatment may be considered for patients who do not heal after 4 to 8 weeks. For maintenance, or for symptomatic disease without erosive oesophagitis, doses equivalent to 20 mg of esomeprazole daily may be used in both countries.

Scheduling status

Esomeprazole is currently listed in Schedule 4 of the Poisons Standard.

Scheduling history
Esomeprazole

In November 2000, at the request of the New Zealand Ministry of Health, the National Drugs and Poison Scheduling Committee (NDPSC) considered scheduling esomeprazole to harmonise with New Zealand's inclusion of the substance in Schedule 1, Part 1 (equivalent to Schedule 4 of the SUSMP). Noting the benefit to public health, the committee supported harmonisation and made the decision to include esomeprazole in Schedule 4.

Omeprazole

Omeprazole was first considered by the Drugs and Poisons Scheduling Committee (DPSC) in May 1989 as the first in a new class of drug that was useful for the treatment of duodenal ulcers, reflux and Zollinger-Ellison syndrome. The committee recommended it be entered in Schedule 4.

It was then reconsidered in November 2001 for veterinary use, which was captured by its Schedule 4 entry.

Omeprazole and other Proton Pump Inhibitors (PPIs) (pantoprazole and lansoprazole) were considered for a Schedule 3 entry in February 2010. Members supported a limit of 20 mg per dosage unit and limited pack size to no more than 14 days supply after considering the mode of action, safety profile and intended use. The committee decided to create a new Schedule 3 entry for omeprazole in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.

In the same meeting in February 2010, the committee discussed including esomeprazole in their consideration, however felt that consideration should only be given to the substance mentioned in the proposal.

Public pre-meeting submissions

Three public submissions were received. All 3 submissions supported the proposal due to esomeprazole having similar benefit/risk profile to other Schedule 3 PPIs and for the consistency in PPI scheduling.

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ACMS advice to the delegate

The ACMS recommended inclusion of a new Schedule 3 entry for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply and amending the current Schedule 4 entry.

The ACMS recommended an implementation date of 1 June 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee included: a) risks and benefits of the use of a substance, b) the purpose for which a substance is to be used and the extent of use of a substance, and c) the toxicity of a substance.

The reasons for the recommendation comprised the following:

  • Safety profile is consistent with other PPIs and appropriate for a Schedule 3 entry.
  • Consistent with other PPIs for short-term use for symptomatic relief on the advice of a pharmacist.
Delegate's interim decision

The interim decision is to amend the SUSMP by including a new Schedule 3 entry for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply and to amend current Schedule 4 entry to reflect the new Schedule 3 entry.

The delegate agrees with the implementation date being 1 June 2014.

The delegate decided that the relevant matters under subsection 52E (1) of the Therapeutic Goods Act 1989 include: a) risks and benefits of the use of a substance, b) the purpose for which a substance is to be used and the extent of use of a substance, and c) the toxicity of a substance.

The reasons for the interim decisions are:

  • The well-established safety profile of the substance was supported by good clinical trial evidence and is appropriate for a Schedule 3 entry.
  • The first-line use of PPIs in general, and esomeprazole in particular, for typical symptoms of gastro-oesophageal reflux disease (GORD) is recognised and supported by good clinical trial evidence and meta-analyses (Cochrane reviews).
  • That esomeprazole was the only Protein Pump Inhibitor (PPI) not listed in Schedule 3 and that the safety profile of esomeprazole is comparable to those PPIs listed in Schedule 3.
  • As supported by the evidence, there should be consistency of scheduling with the other PPIs for short-term use for symptomatic relief on the advice of a pharmacist

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Delegate's consideration

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • The evaluation report (no publically available);
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors37;
  • Other relevant information.
Submissions on interim decision

Two submissions were received, both supporting the delegate's interim decision.

Edited versions of these submissions are available at Public submissions on scheduling matters.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Scheduling entry
Schedule 3 - New entry

ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply.

Schedule 4 -Amendment

ESOMEPRAZOLE except when included in Schedule 3.

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3.2 Macrogols

Scheduling proposal

The medicines scheduling delegate considered a proposal to either amend the current Schedule 3 entry or create a new Schedule 2 entry for macrogols when in liquid concentrate preparations for oral use in adults and children over 12 years of age for laxative use, with a potential inclusion of a concentration cut-off and/or limited pack size.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Substance details

Macrogol 3350 (macrogols) is the Australian approved name for polyethylene glycol (PEG). It is typically inert and a non-immunogenic chemical that confers greater water solubility to proteins. Macrogol is used as a laxative medicine and to treat constipation. It works by increasing the stool volume, which triggers colon motility via neuromuscular pathways. The consequence is an improved propulsive colonic transportation of the softened stools through the bowel to be emptied.

Scheduling status

Macrogols, in both liquid concentrate form (the product currently undergoing product review) and in powder form (product currently on the market), is unscheduled for laxative use.

Scheduling history

At the May 2000 National Drugs and Poisons Scheduling Committee (NDPSC) meeting, Macrogol 3350 in preparations for bowel cleansing was first scheduled in Schedule 3.The decision was based on the available toxicity profile of Macrogol 3350 comparable to sodium phosphate, which was in Schedule 3.

In August 2000, the NDPSC declined a proposal to include Macrogol 3350 in Appendix H, for the reasons that there was no clear benefit from advertisement. At this meeting the NDPSC also noted that Macrogol 3350 was indicated for bowel cleansing prior to surgery or investigative procedures.

In October 2002, the NDPSC noted that the Schedule 3 entry for sodium picosulphate oral preparations for bowel cleansing prior to diagnostic, medical and surgical procedures was harmonised with New Zealand. The NDPSC was of the view that it would be appropriate to amend the entries for sodium phosphate and Macrogol 3350 to be consistent with the entry for sodium picosulphate. The scheduling entry for Macrogol 3350 was amended from 'in preparations for bowel cleansing' to 'in oral preparations for bowel cleansing prior to diagnostic, medical and surgical procedures'.

In October 2006, as a result of the Trans-Tasman Harmonisation Working Party recommendations, the NDPSC decided to adopt the New Zealand class entry 'macrogols' and delete the Australian entry Macrogol 3350.

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Public pre-meeting submissions

Two public submissions were received.

One submission seemed in favour of the proposal provided that the scheduling proposal was based on a recommended daily dosage, with a pack size consistent with short-term use. Access to a health care professional was advisable.

The other submission did not support the proposed scheduling and believed that the current status of being unscheduled is appropriate as the presentation of the product makes it clear that the substance contained in the product requires dilution prior to use. They also commented that the risk/benefit of macrogol in liquid form has been shown to be no different to that of macrogol powder for solution.

ACMS advice to the delegate

The ACMS recommended creating a new Schedule 2 entry for macrogols in preparations for oral use as a liquid concentrate for laxative use.

The ACCS recommended an implementation date of 1 June 2014.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the committee included: a) the risks and benefits of the use of a substance and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendation comprised the following:

  • The need for diluted form justifies a Schedule 2 entry.
  • Supply to the consumer needs to be in an environment where professional advice is available.
Delegate's interim decision

The delegate accepts the advice of the ACMS and the interim decision is to include a new Schedule 2 entry in the SUSMP being:

MACROGOLS in preparations for oral use as a liquid concentrate for laxative use.

The delegate agrees with the implementation date being 1 June 2014.

The delegate decided that the relevant matters under subsection 52E (1) of the Therapeutic Goods Act 1989 include: a) the risks and benefits of the use of a substance and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for this decision are:

  • The need for dilution of the concentrated liquid justifies a Schedule 2 entry.
  • Due to concerns regarding the potential for misuse of the liquid concentrate, supply to the consumer needs to be in an environment where professional advice is available.
Delegate's consideration
  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors38;
  • Other relevant information.

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Submissions on interim decision

A submission was provided, informing the delegate that the reasons for decision was being considered and that further comment may be provided at a later date. The submission did mention that liquid macrogols was currently in the supply chain to Australia and that the delegate's final decision may impact on product artwork and shipping.

Edited versions of these submissions are available at Public submissions on scheduling matters.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

Scheduling entry
Schedule 2 - New entry

MACROGOLS in preparations for oral use as a liquid concentrate for laxative use.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (2010)
  2. Scheduling Policy Framework for Medicines and Chemicals (2010)

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