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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, February 2016

Scheduling medicines and poisons

3 February 2016

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2.5 Proton pump inhibitors

Part A - Interim decisions on matters referred to an expert advisory committee

2. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#16)

2.5 Proton pump inhibitors

Scheduling proposal

The medicines scheduling delegate has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • to amend the scheduling of lansoprazole to include oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.
    • consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.
  • to amend the scheduling of omeprazole to include 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 7 days' supply in Schedule 2.
    • consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.
  • to amend the scheduling of rabeprazole to include oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.
    • Consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.
Substance summary

Esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole are proton pump inhibitor (PPI) medicines. PPIs reversibly reduce gastric acid secretion by specifically inhibiting the gastric enzyme H+, K+-ATPase proton pump in gastric parietal cells.

PPIs are used in conditions where inhibition of gastric acid secretion may be beneficial, such as the management of peptic ulcer disease, relief of acid-related dyspepsia, treatment of gastro-oesophageal reflux disease (GORD), treatment of NSAID-associated ulceration and treatment of pathological hypersecretory states such as Zollinger-Ellison syndrome.

Over-the-counter (OTC - i.e. Schedule 2 or 3) PPIs are indicated for the relief of heartburn and other symptoms of GORD, when given once daily for at least seven days, and up to 14 days. OTC PPIs appear to have consistent safety and efficacy profiles when used short-term for the relief of symptoms of GORD (OTC use is limited to 14 days except on medical advice, and OTC PPIs are not approved for use in children or adolescents under 18 years of age).

Scheduling status

LANSOPRAZOLE is currently listed in Schedules 3 and 4.

Schedule 3

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole 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

LANSOPRAZOLE except when included in Schedule 3.

RABEPRAZOLE is currently listed in Schedules 3 and 4.

Schedule 3

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole 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

RABEPRAZOLE except when included in Schedule 3.

PANTOPRAZOLE is currently listed in Schedules 2, 3 and 4.

Schedule 2

PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3

PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole 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 except when included in Schedule 2.

Schedule 4

PANTOPRAZOLE except when included in Schedule 2 or 3.

ESOMEPRAZOLE is currently listed in Schedules 3 and 4. However, the delegate has proposed, in an October 2015 interim decision, to reschedule esomeprazole, so that it will be listed in Schedules 2, 3 and 4, as follows (with a proposed implementation date of 1 February 2016).

Schedule 2

ESOMEPRAZOLE in oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3

ESOMEPRAZOLE in oral preparations containing 20 mg or less of esomeprazole 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 except when included in Schedule 2.

Schedule 4

ESOMEPRAZOLE except when included in Schedule 2 or 3.

Scheduling history
National Drugs and Poisons Schedule Committee: June 2005

The NDPSC included the PPI, pantoprazole, in Schedule 3, in oral preparations containing 20 mg or less of pantoprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply (the NDPSC subsequently amended the implementation date until 1 May 2008).

National Drugs and Poisons Schedule Committee: June 2009M

The NDPSC agreed to down-schedule rabeprazole to Schedule 3 in oral preparations containing 10 mg or less of rabeprazole 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 (i.e. with pack size and indication restrictions similar to those for pantoprazole).

National Drugs and Poisons Schedule Committee: February 2010

The NDPSC decided to schedule lansoprazole and omeprazole similarly to pantoprazole and rabeprazole, to harmonise with New Zealand.

Advisory Committee on Medicines Scheduling: November 2013

Delegate's decision: March 2014

ACMS considered an application to down-schedule from Schedule 4 to Schedule 3 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. ACMS recommended, and the delegate confirmed, that esomeprazole should be down-scheduled to Schedule 3, as requested.

Advisory Committee on Medicines Scheduling: November 2014

Delegate's decision: March 2015

The ACMS recommended, and the delegate confirmed, a new entry in Schedule 2 for pantoprazole when supplied in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days of supply. The implementation date for this decision was 1 June 2015.

Advisory Committee on Medicines Scheduling: July (August) 2015

Delegate's interim decision: October 2015

The ACMS recommended a new entry in Schedule 2 for esomeprazole when supplied in oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days of supply.

The ACMS also proposed that the medicines delegate consider initiating a proposal to create new Schedule 2 entries for lansoprazole, omeprazole and rabeprazole in packs containing not more than 7 days' supply (consistent with the current Schedule 2 entry for pantoprazole, and the proposed Schedule 2 entry for esomeprazole).

The delegate's interim decision supported these ACMS recommendations. The proposed implementation date for the inclusion of esomeprazole in Schedule 2 is 1 February 2016.

Pre-meeting public submissions

One public submission was received which made the following main points:

  • Objected to the schedule 2 entries. However, noted because other entries exist, that other entries should be included as well.
  • Under these circumstances, the following recommendations were offered:
    • The Schedule 2 entries for PPIs should be consistent. The maximum strength allowable as a Schedule 2 entry should reflect the lowest effective dose.
    • Given that consumers will be able to purchase these products without mandatory health professional oversight, a new advisory statement should be mandated that instructs a consumer to seek the advice of a health professional if they are pregnant or breastfeeding.

The public submission is available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that lansoprazole, omeprazole and rabeprazole be down-scheduled from Schedule 3 to Schedule 2 as follows:

  • Lansoprazole in oral preparations containing 15 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 7 days' supply, be down-scheduled from Schedule 3 to Schedule 2.
  • Omeprazole 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 7 days' supply, be down-scheduled from Schedule 3 to Schedule 2.
  • Rabeprazole in oral preparations containing 10 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 7 days' supply, be down-scheduled from Schedule 3 to Schedule 2.

The ACMS recommended an implementation date of 1 June 2016.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendation comprised the following:

  • The PPIs are safe and effective first line treatment for consumers with frequent symptoms of GORD.
  • Esomeprazole and pantoprazole are already recommended for Schedule 2. The other Schedule 3 PPIs have similar safety and efficacy profiles. Limiting the 7 day availability pack size and lowest effective dose minimises the opportunity for long term adverse effects.
  • Very low toxicity with short-term use.
  • The proposed Schedule 2 seven (7)-day supply, labelling (including RASML warning statements) and provision of Consumer Medicines Information will promote appropriate use and health education as Schedule 2.
Delegates' considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors20;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is to include lansoprazole, omeprazole, rabeprazole in Schedule 2 as proposed below - see "Schedule Entry".

The proposed implementation date is 1 June 2016.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendation comprised the following:

  • The PPIs are safe and effective first line treatment for consumers with frequent symptoms of GORD.
  • Esomeprazole and pantoprazole are already recommended for Schedule 2. The other Schedule 3 PPIs have similar safety and efficacy profiles. Limiting the 7 day availability pack size and lowest effective dose minimises the opportunity for long term adverse effects.
  • Very low toxicity with short-term use.
  • The proposed Schedule 2 7-day supply, labelling (including RASML warning statements) and provision of Consumer Medicines Information will promote appropriate use and health education as Schedule 2.
Schedule entry
LANSOPRAZOLE

Schedule 2 - New entry

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3 - Amendment

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole 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 except when included in Schedule 2.

Schedule 4 - Amendment

LANSOPRAZOLE except when included in Schedule 2 or 3.

OMEPRAZOLE

Schedule 2 - New entry

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 7 days' supply.

Schedule 3 - Amendment

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' supply except when included in Schedule 2.

Schedule 4 - Amendment

OMEPRAZOLE except when included in Schedule 2 or 3.

RABEPRAZOLE

Schedule 2 - New entry

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3 - Amendment

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole 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 except when included in Schedule 2.

Schedule 4 - Amendment

RABEPRAZOLE except when included in Schedule 2 or 3.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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