Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS

Budesonide is currently in Schedules 2 and 4 of the Poisons Standard as follows:

A request has been made to:

• Amend the Schedule 2 entry for budesonide to increase the dose per actuation from 50 to 64 micrograms; and
• Remove the limit of 200 actuations.

• Allergic rhinitis (AR) it is of substantial public health significance and is widely considered as the most common chronic respiratory disorder.
• Symptoms of AR can have a significant impact on the quality of life.
• AR is a condition that has been well established as suitable for both self-diagnosis and self-treatment.
• People who need to continue with the maximum dose of budesonide to maintain symptom control will benefit from the proposed Schedule 2 64 ?g strength, which requires only 4 sprays per day compared to the current 8 sprays per day.
• The proposed amendment to the Schedule 2 entry for budesonide is likely to have a potentially broad positive healthcare impact by improving AR compliance and treatment outcomes.

Paracetamol is currently in Schedules 2, 3 and 4 of the Poisons Standard.

Ibuprofen is currently in Schedules 2, 3 and 4 of the Poisons Standard.

A request has been made to:

• Amend the Schedule 3 entry for paracetamol to allow the Schedule 3 primary pack size, when combined with ibuprofen, to be increased from 30 to 50 dosage units; and
• Amend the Schedule 4 entry to reflect this change.

• Paracetamol and ibuprofen have been available for many years without a prescription in Australia.
• Fixed dose combinations of paracetamol and ibuprofen offer greater analgesic efficacy at a lower dose while maintaining the acceptable safety profile of each active alone.
• The availability of larger pack sizes of ibuprofen/paracetamol combinations will allow pharmacists to exercise greater discretion in assisting clients with acute intermittent strong pain.
• The proposed amendment will allow pharmacists to offer a safer, more economical and convenient alternative to the stronger analgesics available through medical practitioners.
• The total amount of paracetamol and ibuprofen in the proposed 50 pack is less than half the amounts present in the existing Schedule 2 packs of the separate ingredients.

A request has been made to amend the Schedule 4 and 8 entries for codeine to:

• Up-schedule codeine from Schedule 4 to Schedule 8 when in divided preparations containing more than 12 mg of codeine per dosage unit;
• Up-schedule codeine from Schedule 4 to Schedule 8 when in undivided preparations containing more than 0.25 per cent of codeine; and
• Amend both Schedule 4 and 8 entries for codeine to reflect these changes.

• The proposal seeks to address scheduling inconsistencies highlighted in the Regulation Impact Statement (RIS). This will be achieved by moving high dose codeine-containing medicines and single ingredient 30 mg codeine into Schedule 8 where, as suggested by the RIS, these products belong.
• By up-scheduling high dose codeine-containing medicines to Schedule 8, they will be monitored by State and Territory Real Time Monitoring systems.

Sildenafil is currently in Schedule 4 of the Poisons Standard as follows:

A request has been made to:

• Create a new Schedule 3 entry for sildenafil in oral preparations containing 50 mg of sildenafil per dosage unit in packs containing not more than 8 dosage units;
• To include sildenafil in Appendix H to permit advertising; and
• To include sildenafil in Appendix M to provide additional controls or supply requirements to allow sildenafil to be supplied by a pharmacist.

• Non-prescription availability of sildenafil 50 mg with appropriate informative consumer and pharmacist educational programmes, and advertising of Schedule 3 sildenafil 50 mg, will help to reach many men with erectile dysfunction (ED) who currently do not seek help from their doctor about their condition. It will also direct men away from the unregulated supply of purported ED medications.
• The proposed re-scheduling will help destigmatise ED, raise awareness of the causes of ED and its association with more chronic conditions such as cardiovascular disease (CVD) and diabetes, encourage treatment seeking behaviour, and will offer the potential for earlier and more frequent interaction with the primary healthcare system.
• The important risks for non-prescription sildenafil 50 mg are consistent with those that have been established for sildenafil in the prescription setting. These risks can be effectively managed in the pharmacy setting through routine risk minimisation measures that have been specifically tailored for non-prescription use. Benefits outweigh the risks, and all risks can be appropriately managed through Schedule 3 availability. Any incremental risks associated with non-prescription availability and advertising of sildenafil 50 mg can be effectively managed in the pharmacy setting through key measures such as pharmacist intervention at the point of sale, pharmacist training and consumer education.

Cannabidiol is in Schedules 4 and 8 of the Poisons Standard.

THC is in Schedules 8 and 9 and Appendices D and K of the Poisons Standard.

A request has been made to amend the wording of the Schedule 4 entry for cannabidiol to reflect absolute weight per volume of no more than 1% w/v of the product rather than relative to the cannabidiol content.

According to Therapeutic Goods Order No. 93 (TGO 93), Standard for Medicinal Cannabis) 4 (2):

"...are taken to be active ingredients for the purposes of this order (whether or not those ingredients are specified, disclosed, purported or notified to the Secretary to be active ingredients):

1. any tetrahydrocannabinol present in a medicinal cannabis product, the quantity or proportion of which (together with any corresponding acid) is greater than or equal to 1.0% w/w or w/v of the product"

N/A (group entry).

Examples of volatile alkyl nitrites not listed in the Poisons Standard include:

• 110-46-3, isopentyl nitrite (nitrous acid, 3-methylbutyl ester, isoamyl nitrite);
• 541-42-4, 2-propyl nitrite (IUPAC) synonyms: isopropyl nitrite, isopropyl alcohol nitrite, nitrous acid, isopropyl ester, 1-methylethyl nitrite, 2-propyl nitrite;
• 543-67-9, N-propyl nitrite, Propyl nitrite; Propanol nitrite; Nitrous acid, propyl ester; N-Propyl-nitrite; and
• 5156-40-1, cyclohexyl nitrite (IUPAC) (nitrous acid, cyclohexyl ester; N-cyclohexyl nitrite; cyclohexyl alcohol nitrite; C-hexyl nitrite; O-nitrosocyclohexanol).

The proposed scheduling is aimed to reduce the misuse and abuse of alkyl nitrites in lubricants and inhalants/'poppers' for recreational use by:

• Amending the Appendix A entry for lubricants to clarify use for 'preparations that provide a lubricating action between machinery parts'; and
• Including a group entry for volatile alkyl nitrites in Schedule 4.

• There are increasing reports of misuse and abuse of 'poppers' containing short chain volatile alkyl nitrites for purposes of recreational use alongside narcotics in the clubbing/dance scene in Australia and globally.
• Some suppliers of products containing alkyl nitrites for illicit use are claiming that these substances are used for their lubricant properties and are therefore exempt from scheduling.
• Ophthalmologists in Australia are reporting an increase in the number of cases of maculopathies (retinal damage) caused by recreational use of poppers/'lubricants' containing alkyl nitrites. These reports have also been observed internationally.

2-Butoxyethanol is in Schedule 6 of the Poisons Standard as follows:

To amend the exemption concentration for 2-butoxyethanol and its acetates in Schedule 6 from 10 per cent to 20 per cent or less of such substances as follows:

• Acute toxicity studies indicate the same degree of eye irritation at either 10 or 20 per cent.

DMSO is in Schedules 4 and 6 of the Poisons Standard as follows:

To establish a concentration cut-off for dimethyl sulfoxide in Schedule 6, at 10 per cent or less as follows:

• Acute toxicity of DMSO supports a concentration cut-off.

1797-74-6
allyl phenylacetate; benzeneacetic acid, 2-propenyl ester (CAS); 2-propenyl benzeneacetate.

2835-39-4
allyl isovalerate; butanoic acid, 3-methyl-, 2-propenyl ester (CAS); 2-propenyl isovalerate.

4728-82-9
allyl cyclohexaneacetate; cyclohexaneacetic acid, 2-propenyl ester (CAS); acetic acid, cyclohexyl-, allyl ester.

2705-87-5
allyl cyclohexanepropionate; cyclohexanepropanoic acid, 2-propenyl ester (CAS).

123-68-2
allyl hexanoate; hexanoic acid, 2-propenyl ester (CAS); allyl caproate.

142-19-8
allyl heptanoate; heptanoic acid, 2-propenyl ester (CAS).

4230-97-1
allyl octanoate; octanoic acid, 2-propenyl ester (CAS).

68132-80-9
allyl trimethylhexanoate; hexanoic acid, trimethyl-, 2-propenyl ester (CAS).

7493-72-3
allyl nonanoate; nonanoic acid, 2-propenyl ester (CAS).

Aliphatic allyl esters are captured by the Schedule 7 and Appendix J entries for allyl alcohol in the Poisons Standard as follows:

To amend the current Schedule 7 entry for allyl alcohol to exclude allyl esters as its derivatives and to allow low levels of allyl alcohol as a impurity in preparations containing allyl esters at 5 per cent or less as follows:

AND

To create a new entry in Schedule 6 for allyl esters for use in consumer products, with a purity criterion and a concentration cut-off at 5 per cent, below which the requirements of the standard do not apply as follows:

• Identified uses in domestic products in the Australian marketplace:
  • Two chemicals (CAS No. 123-68-2 and 2705-87-5) have reported domestic uses in automobile products.
• Identified therapeutic uses in medicines and other therapeutic goods:
  • Three chemicals (CAS No. 2705-87-5, 123-68-2 and 142-19-8) are used in products listed on the ARTG.
• International alignment:
  • The chemicals in this group are known to be used as fragrance ingredients in cosmetic and domestic products up to 5 %.
  • European Union, New Zealand (NZ) and the International Fragrance Association (IFRA) Standard have restrictions for allyl esters when used in cosmetic products: the level of free allyl alcohol in the ester shall be less than 0.1 %.

To create a new Schedule 4 entry, as follows:

• The substance is a topical microbicide that is used in a class 2A medical device for the treatment of bacterial vaginosis, and for prevention of sexually transmitted diseases as a condom lubricant.
• Bacterial vaginosis requires medical diagnosis, management and monitoring before the substance is used in alignment with Schedule 4 scheduling factors of the Scheduling Policy Framework (2018).