Scheduling delegate's final decisions: December 2013

Scheduling medicines and poisons

19 December 2013

Notice under subsections 42ZXZS 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.

The delegates' final decisions and reasons relate to:

  • scheduling proposals considered as delegate-only matters, i.e. not referred to an expert advisory committee.

Matters not referred to an 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).

Glossary

Scheduling medicines and poisons

Abbreviation Name
AAN Australian Approved Name
AC Active constituent
ACCC Australian Competition and Consumer Commission
ACCM Advisory Committee on Complementary Medicines (formerly Complementary Medicine Evaluation Committee [CMEC])
ACNM Advisory Committee on Non-prescription Medicines (formerly Medicines Evaluation Committee [MEC])
ACPM Advisory Committee on Prescription Medicines (formerly Australian Drug Evaluation Committee [ADEC])
ACSOM Advisory Committee on the Safety of Medicines (formerly Adverse Drug Reactions Advisory Committee [ADRAC])
ADEC Australian Drug Evaluation Committee (now Advisory Committee on Prescription Medicines [ACPM])
ADI Acceptable daily intake
ADRAC Adverse Drug Reactions Advisory Committee (now Advisory Committee on the Safety of Medicines [ACSOM])
AHMAC Australian Health Ministers' Advisory Council
APVMA Australian Pesticides and Veterinary Medicines Authority
AQIS Australian Quarantine and Inspection Service
ARfD Acute reference dose
ASCC Australian Safety and Compensation Council
ASMI Australian Self-Medication Industry
ARTG Australian Register of Therapeutic Goods
CAS Chemical Abstract Service
CHC Complementary Healthcare Council of Australia
CMEC Complementary Medicine Evaluation Committee (now Advisory Committee on Complementary Medicines [ACCM])
CMI Consumer Medicine Information
COAG Councils of Australian Governments
CRC Child-resistant closure
CTFAA Cosmetic, Toiletry & Fragrance Association of Australia
CWP Codeine Working Party
DAP Drafting Advisory Panel
ECRP Existing Chemicals Review Program
EPA Environmental Protection Authority
ERMA Environmental Risk Management Authority (New Zealand)
FAISD First Aid Instructions and Safety Directions
FDA Food and Drug Administration (United States)
FOI Freedom of Information Act 1982
FSANZ Food Standards Australia New Zealand
GHS Globally Harmonised System for Classification and Labelling of Chemicals
GIT Gastro-intestinal tract
GP General practitioner
HCN Health Communication Network
INN International Non-proprietary Name
ISO International Standards Organization
LC50 The concentration of a substance that produces death in 50% of a population of experimental organisms. Usually expressed as mg per litre (mg/L) as a concentration in air.
LD50 The concentration of a substance that produces death in 50% of a population of experimental organisms. Usually expressed as milligrams per kilogram (mg/kg) of body weight.
LOAEL Lowest observed adverse effect level
LOEL Lowest observed effect level
MCC Medicines Classification Committee (New Zealand)
MEC Medicines Evaluation Committee (now Advisory Committee on Non-prescription Medicines [ACNM])
MOH Ministry of Health (New Zealand)
NCCTG National Coordinating Committee on Therapeutic Goods
NDPSC National Drugs and Poisons Schedule Committee
NHMRC National Health and Medical Research Council
NICNAS National Industrial Chemicals Notification & Assessment Scheme
NOAEL No observed adverse effect level
NOEL No observable effect level
NOHSC National Occupational Health & Safety Commission
OCM Office of Complementary Medicines
OCSEH Office of Chemical Safety and Environmental Health (now Office of Chemical Safety [OCS])
OCS Office of Chemical Safety (formerly Office of Chemical Safety and Environmental Health [OCSEH])
ODA Office of Devices Authorisation
OMA Office of Medicines Authorisation (formerly Office of Prescription and Non-prescription Medicines)
OOS Out of session
OTC Over-the-counter
PACIA Plastics and Chemicals Industries Association
PAR Prescription animal remedy
PBAC Pharmaceutical Benefits Advisory Committee
PEC Priority existing chemical
PGA Pharmaceutical Guild of Australia
PHARM Pharmaceutical Health and Rational Use of Medicines
PI Product Information
PIC Poisons Information Centre
PSA Pharmaceutical Society of Australia
QCPP Quality Care Pharmacy Program
QUM Quality Use of Medicines
RFI Restricted flow insert
SCCNFP Scientific Committee on Cosmetic and Non-Food Products
SCCP Scientific Committee on Consumer Products
STANZHA States and Territories and New Zealand Health Authorities
SUSDP Standard for the Uniform Scheduling of Drugs and Poisons
SUSMP Standard for the Uniform Scheduling of Medicines and Poisons
SVT First aid for the solvent prevails
TCM Traditional Chinese medicine
TGA Therapeutic Goods Administration
TGC Therapeutic Goods Committee
TGO Therapeutic Goods Order
TTHWP Trans-Tasman Harmonisation Working Party
TTMRA Trans-Tasman Mutual Recognition Agreement
WHO World Health Organization
WP Working party
WS Warning statement

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Final decisions on matters not referred to an expert advisory committee

Scheduling medicines and poisons

1. New chemical entities - medicines for human therapeutic use

1.1 Lurasidone

Scheduling proposal

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

Lurasidone is an atypical antipsychotic agent.

Lurasidone is indicated for treatment of schizophrenia.

The delegate decided to make a delegate-only decision for the substance. The Advisory Committee on Medicines Scheduling (ACMS) was consulted on the requirement for a sedation warning. The delegate has considered the committee's recommendation and lurasidone is to be included in Appendix K (see Final Decisions on Matters referred to the ACMS #9 http://www.tga.gov.au/industry/scheduling-decision...).

Scheduling status

Lurasidone is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Lurasidone is not classified 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.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
Delegates' final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include lurasidone in Schedule 4, with an implementation date of 1 Feb 2014.

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

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

  • Lurasidone is a new chemical entity with no clinical/marketing experience in Australia.
  • It is a treatment for schizophrenia, a condition requiring medical diagnosis and management.
  • This substance has similar side-effects to other atypical antipsychotic agents and should have similar scheduling requirements.
Schedule 4 - New entry

LURASIDONE.

1.2 Vedolizumab

Scheduling proposal

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

Vedolizumab is immunoglobulin G1-kappa, anti-[Homo sapiens alpha4beta7 integrin (lymphocyte Peyer's patch adhesion molecule 1, LPAM-1), humanized monoclonal antibody.

Vedolizumab is indicated for treatment of

  • adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
  • adult patients with moderate to severe Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

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

Scheduling status

Vedolizumab is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons but may be captured by a group/class entry for monoclonal antibodies:

SCHEDULE 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.

Vedolizumab is not 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.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate's final decision

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include vedolizumab in Schedule 4, with an implementation date of 1 Feb 2014.

The delegate decided 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, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of vedolizumab.

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

  • Vedolizumab is a new chemical entity with no clinical and marketing experience in Australia.
  • Vedolizumab is intended for the treatment of life-threatening conditions.
  • Vedolizumab has side effects that also require close monitoring.
Schedule 4 - New entry

VEDOLIZUMAB.

1.3 Vortioxetine

Scheduling proposal

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

Vortioxetine is an antidepressant with a novel mechanism of action that belongs to a group of selective serotonine reuptake inhibitors (SSRIs).

Vortioxetine is indicated for the treatment of major depressive disorder including prevention of relapse.

The delegate decided to make a delegate-only decision on the scheduling of the substance. The Advisory Committee on Medicines Scheduling (ACMS) were consulted on recommendation of inclusion in Appendix L. The ACMS recommendation was not to include vortioxetine in Appendix L (see Final Decisions on Matters referred to the ACMS #9 http://www.tga.gov.au/industry/scheduling-decision...).

Scheduling status

Vortioxetine is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Vortioxetine is not classified 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.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegates' final decision.

The delegate has made a final decision to amend the Standard for the Uniform Scheduling of Medicines and Poisons to include VORTIOXETINE in Schedule 4, with an implementation date of 1 Feb 2014.

The delegate decided 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, d) dosage, formulation, labelling, packaging and presentation, and (e) the potential for abuse of vortioxetine.

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

  • Vortioxetine is a new chemical entity with no clinical/marketing experience in Australia.
  • Vortioxetine affects multiple CNS receptors, particularly serotonin receptors. Other antidepressants acting at serotonin receptors (e.g. SSRIs) have been associated with pulmonary hypertension and with withdrawal syndrome in newborns.
  • Vortioxetine is an antidepressant with a novel mechanism of action, inhibiting serotonin transport and direct agonist action on serotonin receptors. It also has effects on many other CNS receptors.
  • The toxicity of vortioxetine is similar to that of other already scheduled SSRIs.
  • 5, 10, 15 and 20 mg film coated tablets.
  • The potential for abuse of this substance is limited.
Schedule 4 - New entry

VORTIOXETINE.

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