Scheduling delegate's final decisions: March 2013

Scheduling medicines and poisons

6 March 2013

Notice under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)

A delegate of the Secretary to the Department of Health and Ageing hereby gives notice of the delegates’ final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision.

Matters not referred to an advisory committee

The delegates' final decisions and reasons relate to scheduling proposals considered as delegate-only matters, i.e. not referred to an expert advisory committee.

A delegate may decide not to refer a scheduling proposal to an expert advisory committee for advice and instead may make a delegate-only decision. When deciding not to refer a matter to a committee, the delegate considers the scheduling guidelines as set out in the Scheduling Policy Framework (SPF).

Publishing of the amendments to the Poisons Standard

The amendments to the Schedules, Appendices or other parts of the Poisons Standard are published electronically on ComLaw and in a hardcopy Amendment to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on ComLaw, is available at The Poisons Standard (the SUSMP).

Final decisions on matters not referred to an expert advisory committee

1. New chemical entities - medicines for human therapeutic use

1.1 Besifloxacin hydrochloride

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of besifloxacin hydrochloride, a new chemical entity for a human therapeutic medicine.

Besifloxacin is a fourth-generation fluoroquinolone antibiotic. Besifloxacin hydrochloride 0.6 per cent ophthalmic drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

  • CDC coryneform group G
  • Corynebacterium pseudodiphtheriticum*
  • Corynebacterium striatum
  • Haemophilus influenzae
  • Moraxella lacunata
  • Staphylococcus aureus
  • Staphylococcus epidermidis
  • Staphylococcus hominis
  • Staphylococcus lugdunensis
  • Streptococcus mitis group
  • Streptococcus oralis
  • Streptococcus pneumoniae
  • Streptococcus salivarius
Scheduling status

Besifloxacin is not specifically scheduled, but is captured by the Schedule 4 entry 'antibiotic substances'.

Besifloxacin is not specifically classified in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
  • Scheduling policy for antibiotics to be specifically included in Schedule 4.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to include besifloxacin in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons, with an implementation date of 1 May 2013.

The delegate considers that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use, and (c) toxicity.

The delegate considers that the reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical/marketing experience in Australia.
  • It is for topical use as an eye drop to treat conjunctivitis caused by sensitive bacteria.
  • Adverse events include conjunctival redness, blurred vision, eye pain, eye irritation, eye pruritus, headache and potential hypersensitivity reactions.
  • Prolonged use may result in overgrowth of non-susceptible organisms, including fungi.

Schedule 4 - New Entry

BESIFLOXACIN HYDROCHLORIDE.

1.2 Prucalopride

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of prucalopride, a new chemical entity for a human therapeutic medicine.

Prucalopride, a first class dihydroenzofurancarboxamide, is a selective high affinity serotonin receptor (5-HT4) agonist with enterokinetic activities.

Prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

  • Before prucalopride is considered, patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.
  • If treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.
Scheduling status

Prucalopride is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Prucalopride is classified as a prescription medicine in New Zealand.

Delegate's consideration

The delegate considered the following in regards to this application for scheduling.

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines (not publicly available).
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Delegate's final decision

The delegate has made a final decision to include prucalopride in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons, with an implementation date of 1 May 2013.

The delegate considers that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (a) risks and benefits; (b) purpose and the extent of use and (c) toxicity.

The delegate considers that the reasons for the final decision comprise of the following.

  • It is a new chemical entity with no clinical/marketing experience in Australia.
  • The product is intended to be used by patients requiring medical management for constipation that has been non-responsive to alternative treatments. Ongoing medical management will be required while patients remain on this treatment.
  • The product affects peripheral serotonin receptors. CNS effects are not anticipated to be clinically significant.

Schedule 4 - New Entry

PRUCALOPRIDE.

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2. Editorials and errata

2.1 Diclofenac

The delegate considered an editorial amendment to the Schedule 2 entry for diclofenac.

Delegate's consideration
  • In February 2013, the delegate made a decision to amend the Schedule 2 entry for diclofenac to include transdermal preparations for topical use containing 140 mg or less of diclofenac, with an implementation date of 1 May 2013.
  • The delegate has noted that there had been a transcribing error during the drafting of the amended Schedule 2 entry in that the wording "containing 4 per cent of diclofenac" in paragraph (b) should have read "containing 4 per cent or less of diclofenac".
Delegate's final decision

The delegate has decided to editorially amend the Schedule 2 entry for diclofenac to correct the wording of paragraph (b) to read "in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 1 per cent or less of diclofenac or for the treatment of solar keratosis".

Schedule 2 - Amendment

DICLOFENAC - Amend entry to read:

DICLOFENAC when:

  1. in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac;
  2. in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 1 per cent or less of diclofenac or for the treatment of solar keratosis; or
  3. in transdermal preparations for topical use containing 140 mg or less of diclofenac.

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