Consultation: Proposed amendments to the Poisons Standard - ACMS and ACCS, November 2019

This consultation closed on 26 September 2019.

Note: In addition to the substances listed below, there will be up to five (5) additional substances referred to the November 2019 scheduling meetings. It is anticipated that invitation for public comment on these five substances will be published on the TGA website on 12 September 2019.

On this page: Scheduling amendments referred to expert advisory committee | 1. Proposed amendments referred for scheduling advice to ACMS #28 | 2.Proposed amendments referred for scheduling advice to ACCS #26 | How to respond | What will happen | Privacy and your personal information | Enquiries

Scheduling amendments referred to expert advisory committee

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the November 2019 meetings of the Advisory Committee on Medicines Scheduling (ACMS #28) and the Advisory Committee on Chemicals Scheduling (ACCS #26).

Submissions must be received by close of business 26 September 2019. See How to respond.

1. Proposed amendments referred for scheduling advice to ACMS #28

In this section: 1.1. Paracetamol | 1.2. Hyoscine butylbromide | 1.3. Calcifediol monohydrate | 1.4. Lidocaine | 1.5. Paracetamol and ibuprofen

1.1. Paracetamol

CAS Number

103-90-2

Alternative names

Chemical/IUPAC Name: Acetamide, N-(4-hydroxyphenyl)ethanamide or N-(4-hydroxyphenyl) acetamide

INCI Name: Acetaminophen

Applicant

Delegate of the Secretary of the Commonwealth Department of Health

Current scheduling

Paracetamol is currently listed in Schedules 2, 3 and 4 and Appendix F and H of the Poisons Standard.

Proposed scheduling

It has been proposed to amend the Schedule 4 and Schedule 2 entries for paracetamol in the Poisons Standard as follows:

Key uses/expected use

Human therapeutic use (analgesic and antipyretic)

Reasons for proposal

• The paracetamol entries in Schedules 2, 3 and 4 of the Poisons Standard aim to minimise the risk of accidental poisoning by limiting the total dose in a pack. However, there is no limit on the amount of paracetamol that can be supplied in the liquid form in Schedule 2.
• A product containing large quantities of paracetamol, particularly in liquid form, carries a potential for significant human toxicity (including delayed irreversible hepatotoxicity) if the product is accidently ingested or deliberately misused.
• In view of the known risks of paracetamol toxicity to humans (the acute toxic effects include hepatic and renal tubular necrosis) and in the interests of public health, it is appropriate to limit the volume or maximum paracetamol mass in Schedule  2 paracetamol liquid preparations.
• Liquid paracetamol products are marketed in formulations containing:
  • 24 mg/mL paracetamol in 50, 100, 200 and 500 mL pack sizes;
  • 48 mg/mL paracetamol in 50, 100, 200 and 500 mL pack sizes;
  • 50 mg/mL paracetamol in 60, 100, 200 and 1000 mL pack sizes;
  • 100 mg/mL paracetamol in 5 and 20 mL pack sizes; and
  • 32.5 mg/mL paracetamol + 1 mg/mL dextromethorphan in 120, 240 and 360 mL pack sizes (intended primarily for use in children, are currently available as a Pharmacy Medicine (Schedule 2)).

International restrictions

Paracetamol is on the World Health Organisation's List of Essential Medicines,^[1] which lists the most effective and safe medicines needed in a health system.

1.2. Hyoscine butylbromide

CAS Number

149-64-4

Alternative names

N-butylhyoscinium bromide; Scopolamine-N-butylbromide; N-Butyl scopolammonium bromide; and scopolamine butylbromide

Applicant

Private Applicant

Current scheduling

Hyoscine butylbromide is currently listed in Schedule 2 of the Poisons Standard as follows:

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Medicine indicated for the treatment of spasms of the gastrointestinal tract, biliary spasm and renal spasm and as a diagnostic aid in radiology.

Reasons for proposal

• The oral tablet dose form of this medicine containing either 10 mg or 20 mg of hyoscine butylbromide per tablet in preparations containing 200 mg or less is currently scheduled as a Schedule 2 (Pharmacy Only) medicine in Australia. This application seeks to amend the Poisons Standard to classify the (undivided) oral liquid dose form for preparations containing 20 mg or less per dose unit in a pack containing 200 mg or less hyoscine butylbromide from a 'Prescription Only' (Schedule 4) to a 'Pharmacy Only' (Schedule 2) medicine. This will result in the harmonisation of the scheduling of the oral tablet and liquid dose forms when supplied in packs containing equivalent amounts of hyoscine butylbromide per dose unit and in the entire pack.
• Abdominal cramping and pain is not life-threatening, but it has a significant impact on the patient's quality of life and subsequent socioeconomic consequences.^[2] Abdominal pain is one of most common reasons for people seeking medical care and hyoscine butylbromide has been proven to be safe and effective when used for relief from pain and discomfort of stomach cramps and spasm. The down-scheduling of the oral liquid dose will provide a significant benefit for paediatric and elderly patients, or other patient groups with dysphagia and difficulty swallowing the tablets (the currently available oral dose form, and classified under Schedule 2).
• The rescheduling of the oral liquid dose form of hyoscine butylbromide at the suggested strength in the respective pack size will not impose any safety risks to the Australian population as the total amount of active pharmaceutical ingredient being sold per pack is the same as in the oral tablet packs; and, control over the medicine is maintained as the pharmacist can refer the individual to their doctor to establish clinical need if they present symptoms that are potentially due to another underlying disorder or illness.

International restrictions

• Hyoscine butylbromide is currently registered as an over-the-counter (OTC) product in Belgium, Germany, Italy, Luxembourg, the Netherlands, Spain, Switzerland, the United Kingdom (UK), Argentina, Colombia, Mexico, Venezuela, Japan and South Korea.
• Hyoscine buytlbromide is on the World Health Organisation's (WHO) List of Essential Medicines, the most effective and safe medicines needed in a health care system.
• The European Chemicals Agency (ECHA) hazard classification and labelling for hyoscine butylbromide is as follows: 'Danger...this substance is harmful if swallowed, is harmful if inhaled and causes serious eye damage.'

1.3. Calcifediol monohydrate

CAS Number

63283-36-3

Alternative names

IUPAC: (3β,5Z,7E)-9,10-secocholesta-5,7-10(19)-triene-3,25-diol monohydrate

ANN: Calcifediol monohydrate

Applicant

The Therapeutic Goods Administration

Current scheduling

Calcifediol monohydrate is not specifically scheduled in the current Poisons Standard. However, it is considered a derivative of vitamin D and is therefore covered by the existing schedule entries for vitamin D.

Vitamin D is currently listed in Schedules 3 and 4 and Appendix H of the Poisons Standard as follows:

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Source of vitamin D in human dietary supplements.

Reasons for proposal

• Vitamin D (in both the colecalciferol and ergocalciferol forms) has a well-established profile and history of use. Calcifediol is the immediate metabolite of colecalciferol and is the circulating form of Vitamin D in the human body.
• The TGA has identified that calcifediol provides the same health benefits as colecalciferol, however the potency appears to be approximately three times greater. The safe daily dosage recommended by the TGA after evaluation is <10 micrograms/day in comparison to the Vitamin D scheduling limit of <25 micrograms/day.
• Calcifediol, as a direct metabolite of colecalciferol, would fall within the current scheduling entry for Vitamin D; i.e. it would be unscheduled at a daily dose of less than 25 micrograms per day. However, a safety evaluation performed by the TGA showed that the safe dosage for calcifediol is less than 10 micrograms per day. As such, it is proposed that a separate schedule entry be created for calcifediol to restrict the daily dosage to less than 10 micrograms per day unless medically prescribed.

1.4. Lidocaine

CAS Number

137-58-6

Alternative names

2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide (IUPAC), lignocaine, xylocaine

Applicant

Private Applicant

Current scheduling

Lidocaine is currently listed in Schedules 2, 4 and 5 of the Poisons Standard as follows:

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Medicines

Reasons for proposal

• Lidocaine 0.6% throat sprays can appropriately be classified as 'exempted from scheduling' as set out in the Scheduling Handbook.
• Lidocaine 0.6% throat sprays can be supplied with reasonable safety and without any access to health professional advice on the same basis that lidocaine throat lozenges are currently available at higher doses without access to health professional advice.
• The proposed amendment meets and exceeds all of the factors for Schedule 2.
• There are legitimate reasons for people to prefer the use of a low-dose spray in preference to a lozenge in relieving the pain of a sore throat.
• Changing the classification of lidocaine 0.6% throat sprays to unscheduled will allow people to choose between those dose forms without having to visit a pharmacy.

1.5. Paracetamol and ibuprofen

CAS Number:

Paracetamol: 103-90-2

Ibuprofen: 15687-27-1

Alternative names

Paracetamol: N-(4-hydroxyphenyl)acetamide (IUPAC); 4′-Hydroxyacetanilide; 4-Acetamidophenol, N-Acetyl-4-aminophenol; N-acetyl-p-aminophenol (APAP); Acetaminophen

Ibuprofen: (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid (IUPAC); α-Methyl-4-(isobutyl)phenylacetic acid, (±)-2-(4-Isobutylphenyl)propanoic acid; isobutylphenylpropionic acid

Applicant

Private Applicant

Current scheduling

Paracetamol is currently listed in Schedules 2, 3 and 4 and Appendix F and H of the Poisons Standard.

Ibuprofen is currently listed in Schedules 2, 3 and 4 and Appendix F and H of the Poisons Standard.

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Medicines

Reasons for proposal

• This application proposes a logical sequence of controls on paracetamol/ibuprofen combinations based on pack size with 12 dosage units or less as 'exempted from scheduling', 13 to 30 dosage units or less as 'Pharmacy Medicine' (Schedule 2), 31 to 50 dosage units or less as 'Pharmacist Only Medicine' (Schedule 3) and larger pack sizes as 'Prescription Only Medicine' (Schedule 4).
• Paracetamol and ibuprofen used separately have long been recognised as safe and effective for the treatment of simple self-limiting pain. The risks that do exist are addressed by label warning statements with small packs being available for general sale and larger packs being available in Schedules 2 or 3.
• The proposed pack sizes for the combination in terms of days' treatment per pack are broadly consistent with pack sizes currently available without prescription for paracetamol or ibuprofen used separately. Quantities of up to 17 days' supply may legitimately be required for short term treatment of intermittent pain over a period of time or where more than one person in a household uses the same medicine. This is currently the case for ibuprofen in Schedule 2 and is now being proposed for the combination in Schedule 3 where pharmacist advice represents a further level of safety.
• The two 'originator' products approved by TGA (XXXX and XXXX) have now been available in Australia since 2013/2014 and in New Zealand since 2011. During that time there have been no 'serious' adverse events reported to TGA or to Medsafe and the number of adverse reactions relative to sales has been small.
• In New Zealand XXXX and XXXX have been available since 2011 as 'general sales' items in packs of 20 and as 'pharmacy medicine' items in packs of 100. In addition, the maximum daily dose of XXXX in Australia is less than half the maximum daily dose of XXXX and exactly half the maximum daily dose of XXXX in New Zealand.
• It has been accepted that the risk of consumers confusing their temporary pain condition with more serious diseases or conditions is very small.
• In recognition of the differences in approved dose between the two major brands of paracetamol/ ibuprofen (XXXX and XXXX) and between these products and paracetamol and ibuprofen used separately XXXX proposes to draw attention to the '1 tablet dose' of XXXX on the front of pack.
• Combinations of paracetamol and ibuprofen are able to be supplied in pack sizes of up to 12 dosage units, with reasonable safety, without access to health professional advice and this small pack size falls outside the factors for Schedules 2, 3, 4 or 8 in the same way that small packs of paracetamol or ibuprofen used separately fall outside these factors.
• Ongoing long-term treatment with any analgesic requires medical intervention. The proposed Schedule 4 pack of more than 50 dosage units will achieve this while enabling medical practitioners to prescribe larger quantities when appropriate.

2.Proposed amendments referred for scheduling advice to ACCS #26

In this section: 2.1. Carbon monoxide | 2.2 Momfluorothrin | 2.3 Methiozolin | 2.4 Lambda cyhalothrin | 2.5 Tetraniliprole

2.1. Carbon monoxide

CAS Number

630-08-0

Alternative names

Carbon monooxide, carbonous oxide, carbon (II) oxide, carbonyl, flue gas, monoxide

Applicant

Delegate of the Secretary of the Commonwealth Department of Health

Current scheduling

Carbon monoxide is not specifically scheduled in the current Poisons Standard.

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Industrial use.

Reasons for proposal

To mitigate public health risks of deliberate inhalation.

2.2 Momfluorothrin

CAS Number

609346-29-4

Alternative names

CAS Name: 2,3,5,6-tetrafluoro-4-(methoxymethyl)phenyl)methyl 3-(2-cyano-1-propen-1-yl)-2,2-dimethylcyclopropanecarboxylate

IUPAC Name: 2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1RS,3SR)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate

Applicant

The Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Momfluorothrin is currently listed in Schedule 6 of the Poisons Standard as follows:

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Insecticide for indoor and outdoor use

Reasons for proposal

• The proposal is to amend the Schedule 6 entry for momfluorothrin to include a concentration cut-off for preparations containing 0.2 per cent or less of momfluorothrin. This proposal is consistent with the original consideration for scheduling, when momfluorothrin was included in Schedule 6 without a cut-off. The Scheduling delegate's final decision on momfluorothrin, published on the TGA website on 19 November 2015, noted that it may be possible to consider a lower schedule for products with a low percentage content of momfluorothrin at a later time.
• The data provided with this application supports a lower schedule for products containing momfluorothrin at 0.2 per cent or less, through the evaluation of acute toxicity tests conducted using a product containing 0.17% momfluorothrin and 0.33% d-phenothrin. The acute oral toxicity tests on the product were conducted using modern protocols that were tested up to 2000 mg/kg bw, with no adverse clinical signs.
• In acute toxicity studies in rats, momfluorothrin was of low acute oral toxicity, low acute dermal toxicity and low acute inhalation toxicity. Momfluorothrin was a slight eye irritant in rabbits, but was not a skin irritant in rabbits or a skin sensitiser in guinea pigs (maximization test).
• The cut off of 0.2 per cent or less is considered to be supported by the data evaluated by the APVMA, based on the toxicity study results from formulations containing 0.17 per cent momfluorothrin in either a hydrocarbon or water based formulation.

2.3 Methiozolin

CAS Number

403640-27-7

Alternative names

IUPAC name: 5RS)-5-[(2,6-difluorobenzyloxy)methyl]-4,5-dihydro-5- methyl-3-(3-methyl-2-thienyl)-1,2-oxazole

Applicant

The Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Methiozolin has not been previously considered for scheduling.

Proposed scheduling

The Applicant's proposed amendments to the Poisons Standard are:

Key uses/expected use

Agricultural herbicide

Reasons for proposal

• It is proposed that methiozolin be included in Schedule 5 of the Poisons Standard, based on sufficient toxicological data being available to recommend a scheduling decision.
• The data supports that methiozolin has very low toxicity across the toxicological database and does not appear to present any substantial toxicological hazard. Methiozolin has very low acute toxicity by oral, dermal and inhalational routes.
• Methiozolin is not a skin irritant or sensitiser but causes a slight eye irritation in rabbits. The active was not genotoxic in a battery of in vivo and in vitro assays. There were no adverse effects on reproduction or development observed. Methiozolin was not neurotoxic in an acute study.
• The product, (containing 250 g/L of methiozolin), has low acute toxicity by the oral, dermal and inhalational routes, is moderately irritating for the skin and eye, but is not a skin sensitiser in guinea pigs by the Buehler method. There are no other concerns in relation to the potential health hazard when used according to the proposed draft label.
• The management of methiozolin toxicological risks would be adequately achieved through a listing in Schedule 5 of the SUSMP with no cut-off or exemptions.

2.4 Lambda cyhalothrin

CAS Number

91465-08-6

Alternative names

(R)-cyano(3-phenoxyphenyl)methyl (1S,3S)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propen-1-yl]-2,2-dimethylcyclopropanecarboxylate; 3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethyl-cyano(3-phenoxyphenyl)methyl cyclopropanecarboxylate

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Lambda-cyhalothrin is currently listed in Schedules 5, 6 and 7 of the Poisons Standard as follows:

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Key uses/expected use

Insecticide

Reasons for proposal

Based on the product acute toxicity, and providing that adequate warnings and safety directions are displayed on the product label, the product formulation containing lambda-cyhalothrin meets the Scheduling Policy Framework (2018) criteria for Schedule 5 of the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). There are no other concerns in relation to the potential health hazard when used according to the proposed draft label. The product is presented in a similar manner to a range of other commonly available insecticidal sprays. No specialised equipment, apart from standard agricultural personal protective equipment (PPE), is required for safe use.

2.5 Tetraniliprole

CAS Number

1229654-66-3

Alternative names: 1H-pyrazole-5-carboxamide, 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino) carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-; 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)- 2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Tetraniliprole has not previously been considered for scheduling.

Proposed scheduling

To exclude tretraniliprole from scheduling

Key uses/expected use

Insecticide

Reasons for proposal

The data supports that tetraniliprole has low toxicity across the toxicological database and does not appear to present any substantial toxicological hazard.

How to respond

Submissions must:

• be relevant to the proposed amendment;
• address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
• submitted by the closing date of 26 September 2019 to medicines.scheduling@health.gov.au or chemicals.scheduling@health.gov.au. (Please include 'Proposed Amendments to the Poisons Standard (Medicines/Chemicals)' in the subject line of the email);
• include whether or not you support the amendment/s; and
• be accompanied by a completed TGA Consultation submission coversheet;.

Submissions might also include:

• Suggested improvements; and/or
• An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment on 6 February 2020.

Privacy and your personal information

• The TGA collects your personal information in this submission in order to:
  • Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
  • Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
• The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet, see How to respond above).
• Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.
• Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
• Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au or chemicals.scheduling@health.gov.au.