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Scheduling delegate's final decisions: ACCS/ACMS, November 2013

Scheduling medicines and poisons

8 November 2013

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

2. Scheduling proposals referred to the July 2013 meeting of the Advisory Committee on Medicines Scheduling (ACMS#9)

2.1 loratadine

Scheduling proposal

The medicines scheduling delegate considered a proposal to reschedule loratadine from Schedule 2 to unscheduled in oral preparations containing 10 mg or less in packs containing not more than 5 daily doses for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over, with a warning labels recommending a daily dose not exceeding 10 mg loratadine for adults and children with body weight over 30 kg, or recommended daily dose not exceeding 5 mg loratadine for children with body weight 30 kg and under.

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

Substance details

Loratadine is a non-sedating, long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. Once daily administration of loratadine provides effective treatment of allergic conditions including seasonal allergic rhinitis (SAR).

Scheduling status

Loratadine is currently listed in Schedules 2 and 4 and included under the entry Antihistamines in Appendix F.

Scheduling history

At the May 1992 National Drugs and Poisons Scheduling Committee (NDPSC) meeting, loratadine was first included in Schedule 4.

In November 1992, the NDPSC declined a proposal to reschedule loratadine from Schedule 4 to Schedule 3, on the grounds of an ADEC (now the Advisory Committee on Prescription Medicines - ACPM) recommendation and concerns about cardiac side effects.

In April 1994, the NDPSC rescheduled loratadine tablets to Schedule 3, and loratadine syrup to Schedule 3 in November 1995.

In May 1997, the NDPSC deferred a down-scheduling application for loratadine from Schedule 3 to Schedule 2, due to an article that was published in the Lancet, raising concerns about cardiovascular safety. At the August 1997 meeting, the NDPSC confirmed the Schedule 3 entry.

In February 1999, the NDPSC considered the rescheduling of loratadine from Schedule 3 to Schedule 2. The NDPSC also considered recommendations from the Trans-Tasman Harmonisation Working Party (TTHWP) in regard to non-sedating antihistamines. The NDPSC agreed that loratadine in preparations for oral use should be rescheduled, and that the restriction to 'only therapeutically active ingredient' should no longer apply. In November 1999, the NDPSC confirmed the down-scheduling of loratadine to Schedule 2.

After discussions in February 2012, the Schedule 2 and Schedule 4 entries were amended to exempt solid dose oral preparations containing 10 mg or less of loratadine in packs containing no more than 5 dosage units for the treatment of seasonal allergic rhinitis (SAR). The exemption was for treatment of adults and children over the age of 12 years.

Public pre-meeting submissions

Three public pre-meeting submissions were received. One supported the proposal, citing that the benefit to older children and adults would be justified.

The other 2 submissions did not support the proposal, recommending that no further changes be made to the current scheduling as the suggested amendment could adversely impact on the health of the age group. The redacted public submissions are available at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).

The redacted public submissions are available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that current loratadine entries remain appropriate.

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 (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Risk of inappropriate use and delay in correct diagnosis.
  • Lack of data on adverse effects/experiences/Poisoning in Australia.
  • No substantial public health benefit in exempting from schedules.
  • Complicated dosage regimen with risk of inappropriate dosing.
Delegate's interim decision

The delegate has made an interim decision that the current scheduling of loratadine remains appropriate.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of the use of a Substance; (b) the purposes for which the substance is to be used and the extent of use of the substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance and (f) any other matters that the Secretary considers necessary to protect public health.

The decision that the entry for loratadine remains appropriate included the following reasons:

  • there is a risk of inappropriate use and delay in correct diagnosis;
  • lack of data on adverse effects/experiences/Poisoning in Australia;
  • the proposed scheduling would have led to an unnecessarily complex requirement including reference to both age and right which differs from some overseas dosing. This would have led to a complicated dosage regimen with a risk of inappropriate dosing; and
  • no substantial public health benefit in changing the scheduling and no evidence of any access issues for the current scheduling.
Submissions on interim decision

No submissions were received.

Delegates Consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors17;
  • other relevant information.
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.

2.2 Lurasidone

Scheduling proposal

The medicines scheduling delegate considered a proposal for a new Appendix K entry for lurasidone.

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

Substance details

Lurasidone hydrochloride is an atypical antipsychotic reported to be an antagonist at dopamine D2, serotonin 5-HT2A and 5-HT7, and adrenergic α2A and α2C receptors, and a partial agonist at serotonin 5-HT1A receptors. It may be given orally for the treatment of schizophrenia in an initial dose of 40 mg once daily with food; the maximum recommended daily dose is 80 mg. The dose should not exceed 40 mg daily in patients with moderate or severe hepatic or renal impairment.

Lurasidone hydrochloride is metabolised mainly by the cytochrome P450 isoenzyme CYP3A4, and a daily dose of 40 mg should not be exceeded in those who are also taking moderate CYP3A4 inhibitors (such as diltiazem); use with potent CYP3A4 inhibitors (such as ketoconazole) or inducers (such as rifampicin) is not recommended.

Scheduling status

Lurasidone is not currently scheduled, but the delegate intends to include lurasidone in Schedule 4 (See Final Decisions on Matters not referred to an Expert Advisory Committee).

Scheduling history

As lurasidone is not currently scheduled, there is no scheduling history to report. However, lurasidone belongs to a class of Substances considered as atypical antipsychotic agents. Other atypical antipsychotic agents, such as quetiapine and risperidone (among others) are included in Appendix K.

Public pre-meeting submissions

No public submissions were received for lurasidone.

ACMS advice to the delegate

The ACMS recommended that lurasidone be included in Appendix K of the Poisons Standard with an implementation date of 1 February 2014.

The matter under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the ACMS included (a) the risks and benefits of the use of the Substance.

The recommendation comprised of the following:

  • The risk of sedation warrants inclusion in Appendix K
Delegate's interim decision

The delegate has made an interim decision to list lurasidone in Appendix K.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of the use of a substance.

The decision to include lurasidone in Appendix K includes the following reasons:

  • the risk of sedation is an issue with this group of drugs; and
  • the risk of sedation warrants inclusion in Appendix K.
Submissions on interim decision

No submissions were received.

Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors18;
  • other relevant information.
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.

Schedule entry
Appendix K - new entry

Lurasidone.

2.3 Vortioxetine Hydrobromide

Scheduling proposal

The medicines scheduling delegate considered a proposal for a new Appendix L entry for vortioxetine hydrobromide.

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

Substance details

Substance details are not available.

Scheduling status

Vortioxetine hydrobromide is not currently scheduled, but the delegate intends to include vortioxetine in Schedule 4 (See Final Decisions on Matters not referred to an Expert Advisory Committee).

Scheduling history

At the May 1992 National Drugs and Poisons Scheduling Committee (NDPSC) meeting, loratadine was first included in Schedule 4.

As vortioxetine hydrobromide is not currently scheduled, there is no scheduling history to report. However, vortioxetine hydrobromide belongs to a class of Substances considered as Selective Serotonin Reuptake Inhibitors (SSRIs). Other substances in this class, such as fluoxetine (among others) are already included in the SUSMP, but do not have Appendix L listings.

Public pre-meeting submissions

The ACMS noted that one public submission was received regarding the proposal; however no comment was given citing lack of information.

The redacted public submissions are available at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).

The redacted public submissions are available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended to not list vortioxetine hydrobromide under Appendix L of the Poisons Standard.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the ACMS include (c) the toxicity of a substance.

The reason for the recommendation comprised of the following:

  • Toxicity is not well established to warrant inclusion in Appendix L.
Delegate's interim decision

The delegate has made an interim decision that vortioxetine hydrobromine should not be listed in Appendix L.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (c) the toxicity of a substance.

The decision not to list vortioxetine hydrobromide in Appendix L included the following reasons:

  • Lack of sufficient information to warrant inclusion in Appendix L. If vortioxetine hydrobromine was to be placed in Appendix L, then all SSRIs and SNRIs would need inclusion which would negatively affect pregnant women accessing antidepressant medication during pregnancy.
  • Appendix L is reserved for highly teratogenic Substances that women should not take during pregnancy and until such evidence is provided for these Substances, vortioxetine and other SSRIs should not be listed in Appendix L.
Submissions on interim decision

No submissions were received.

Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors19;
  • other relevant information.
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.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals
  2. Scheduling Policy Framework for Medicines and Chemicals
  3. Scheduling Policy Framework for Medicines and Chemicals

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