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Scheduling delegate's final decisions, January 2017
Scheduling medicines and poisons
Final decisions on matters not referred to an expert advisory committee
2. New Chemical Entities – medicines for human therapeutic use
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of fomepizole, a NCE for a human therapeutic medicine.
Fomepizole is an alcohol dehydrogenase inhibitor for the treatment of methanol and ethylene glycol poisoning and acts to inhibit the breakdown of these toxins into their active toxic metabolites.
Fomepizole is indicated for the treatment of methanol or ethylene glycol poisoning.
|Molecular weight||82.11 g/mol|
|Chemical name/s||4-methyl-1H-pyrazole; 4-methylpyrazole|
Fomepizole is not specifically scheduled and is not captured by any entry in the current Poisons Standard.
Fomepizole is on the World Health Organization (WHO) Model List of Essential Medicines as an essential medicine for priority diseases.
Fomepizole is available as a prescription only drug in the USA, Canada and New Zealand.
The delegate made a delegate-only decision; hence the Advisory Committee on Medicines Scheduling was not consulted.
The delegate considered the following in regards to this application for scheduling:
- Subsection 52E(1) of the Therapeutic Goods Act 1989;
- The Scheduling Policy Framework (2015) scheduling factors;
- The TGA evaluation report;
- The advice of the Advisory Committee on Prescription Medicines (ACPM); and
- The new drug application.
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 Poisons Standard to include fomepizole in Schedule 4, with an implementation date of 1 February 2017.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 – New Entry
The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse.
The delegate decided that the reasons for the final decision comprise the following:
- It is a new chemical entity with no clinical experience in Australia;
- The risks and benefits of the medicine have been considered and are outlined in the Product Information, Delegate's Request for ACPM advice and the TGA evaluation reports;
- Fomepizole is indicated as an antidote for the treatment of ethylene glycol or methanol poisoning;
- It has no previous experience of use in Australia but has been approved for many years overseas;
- It is proposed for use in hospitals;
- Fomepizole is a competitive inhibitor of alcohol dehydrogenase;
- The medicine has risks that may require medical intervention, evaluation and monitoring by a medical practitioner;
- Labelling needs to comply with the requirements for a prescription only medicine; and
- It does not appear to produce dependency and the abuse potential appears to be low.