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Outcomes of the consultation to add substances to Appendix H of the Poisons Standard

26 October 2018

The Poisons Standard contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation.

The Medicines Scheduling Delegate (the Delegate) will shortly consider each of the substances that have been proposed for inclusion in Appendix H. It is expected that the Delegate will be able to make a delegate-only decision in most instances, which may allow those substances to be included in Appendix H of the February 2019 Poisons Standard. Those substances that need to be referred to an expert advisory committee may appear in Appendix H in a later Poisons Standard.

The following proposals for Delegate consideration were developed following consideration of the submissions in response to the public consultation conducted from 4 June 2018 to 9 July 2018 and feedback from stakeholder workshops.

The revised Guidelines For Advertisements For Medicines Containing Schedule 3 Substances are included with this notice and take effect from date of publication.

Proposed additions to Appendix H

The following substances will be considered by the delegate for inclusion in Appendix H.

  • ADRENALINE†
  • CICLOPIROX*
  • CLOBETASONE
  • CYPROHEPTADINE
  • DEXCHLORPHENAMINE (DEXCHLORPHENIRAMINE)
  • DIPHENHYDRAMINE
  • DOXYLAMINE
  • FAMCICLOVIR
  • FLUORIDES*
  • GLUCAGON†
  • ISOCONAZOLE*
  • KETOPROFEN
  • LEVONORGESTREL
  • NALOXONE
  • OXICONAZOLE*
  • PARACETAMOL*
  • PHENIRAMINE
  • PODOPHYLLOTOXIN*
  • PODOPHYLLUM EMODI (podophyllin)*
  • PROMETHAZINE
  • PODOPHYLLUM PELTATUM (podophyllin)*
  • SALICYLIC ACID
  • TIOCONAZOLE*
  • TRIAMCINOLONE*

*also included in Schedule 2;

†further discussion below;

consultation paper proposed not including in Appendix H, following consideration of feedback Delegate will consider inclusion in Appendix H.

ADRENALINE - it was proposed to include adrenaline in Appendix H. Most of the submissions that commented on adrenaline were supportive of it being added to Appendix H. There was concern from one submission that advertising would lead to purchase without training, and that misuse can have significant side effects.

On balance, from the comments in the submission, plus workshop feedback and additional requirements for restricted representation in the Advertising Code, the benefit of allowing direct to consumers (DTC) advertising of this substance outweighs the risks.

GLUCAGON - it was proposed to include glucagon in Appendix H. Most of the submissions received were in favour of including glucagon in Appendix H.

Arguments for adding glucagon to Appendix H included that DTC advertising would increase awareness of the availability of this substance in an emergency / rescue situation. It was also suggested that the use of restricted representation approval would strengthen the suitability of advertisements for glucagon.

Opposition to the inclusion of glucagon in Appendix H suggested that patients who need to use this substance are already under the care of their medical practitioner and would be aware of it, and if used incorrectly there is the potential for significant harm.

Substances not to be referred to delegate for inclusion in Appendix H

Justification
Reference Description
1a Negative impact on public health due to potential misuse, abuse or diversion
1b Negative impact on public health due to potential interactions (drug-drug, drug-food)
1c Negative impact on public health due to additional risks associated with dosage form
1d Negative impact on public health due to other specified factors
2 No longer a relevant ARTG entry / out dated substance
Substances not to be referred to delegate for inclusion in Appendix H
Substance Justification
ALCLOMETASONE 2
ALIMEMAZINE

1d - sedating

2

AMINOPHYLLINE

1c

1d - safer alternatives

2

AZATADINE

1d - sedating

2

BROMPHENIRAMINE

1d - sedating

2

BUCLIZINE 2
CHLORBUTANOL

1a

2

CHLORPHENAMINE (CHLORPHENIRAMINE)

1d - sedating

2

CLEMASTINE

1d - sedating

2

CYCLIZINE

1a

1b

2

DIHYDROCODEINE 1a
DIIODOHYDROXYQUINOLINE (iodoquinol) 2
DIMETHINDENE 2
DITHRANOL 1d - safer alternatives
ERYTHRITYL TETRANITRATE 2
FLAVOXATE 2
GLYCOPYRRONIUM 2
INOSITOL NICOTINATE 2
MACROGOLS 1a
MAGNESIUM SULFATE 1a
MALATHION 1d - safer alternatives
MANNITYL HEXANITRATE 2
MEPYRAMINE

1d - sedating

2

METHDILAZINE

1d - sedating

2

NICOTINIC ACID 2
NICOTINYL ALCOHOL 2
PROCHLORPERAZINE 1a
PSEUDOEPHEDRINE 1a
SANTONIN

1d - safer alternatives

2

SODIUM PHOSPHATE 1a
SODIUM PICOSULFATE 1a
SULFACETAMIDE 2
THEOPHYLLINE

1d - safer alternatives

2

TRIPROLIDINE

1d - safer alternatives

2

In addition to the substances listed above, the Delegate will be asked to consider not including the following substances in Appendix H based on the feedback from the public consultation.

CHLORAMPHENICOL - it was proposed to include chloramphenicol in Appendix H. Most of the submissions received were against the inclusion of chloramphenicol in Appendix H.

Arguments against including in Appendix H included:

  • Advertising this substance (or any antibiotic) is inconsistent with the National Medicines Policy to reduce the misuse of antibiotics;
  • Overuse may result in increased antibiotic resistance;
  • There is difficulty in differentiating viral and bacterial conjunctivitis and advertising could lead to increased pressure on pharmacists to supply.

The counter argument in support of including chloramphenicol in Appendix H is that early treatment is important and DTC advertising would inform consumers they can see a pharmacist for early treatment.

CIMETIDINE - It was proposed to excluded cimetidine on the grounds of 1b (negative impact on public health due to potential interactions) 1d (negative impact on public health due to other specified factors - sedating) and 2 (no longer a relevant ARTG entry / out dated substance).

A consultation submission argued that:

  • Related substances are included in Schedule 2, which can be advertised.
  • The proposed potential interaction is a theoretical interaction.
  • The issue of sedation could be managed through appropriate warnings.

Further they argued more generally that a lack of ARTG product should not be grounds for exclusion.

Feedback during the stakeholder workshops in February and March 2018 did not support this substance being advertised.

Regarding the arguments put forward about excluding substances where there are no relevant ARTG entries or the substance is out-dated, this approach was strongly supported in the stakeholder workshops, and was not raised in any other submission. If a medicine containing any of these substances is to be registered as a Schedule 3 product, inclusion in Appendix H can be considered at that time.

METOCLOPRAMIDE - it was proposed to include metoclopramide in Appendix H. Most of the submissions received were against including metoclopramide in Appendix H.

The submission received in favour of including metoclopramide in Appendix H argued that it is appropriate for consumers to know that a pharmacist can provide advice on migraine through DTC advertising.

The three submissions against inclusion in Appendix H all argued that it was not in the public interest to allow this substance to be advertised for the following reasons:

  • It has a similar profile to other substances excluded on the grounds of sedation;
  • DTC advertising could lead to increased pressure on pharmacists to supply off label;
  • There are numerous precautions and contraindications that could result in misuse associated with this substance.

ORLISTAT - it was proposed to exclude orlistat from Appendix H. Submissions received that addressed orlistat were in support of including orlistat in Appendix H. Feedback from stakeholder workshops was divided on whether it should be included in Appendix H.

Arguments for including orlistat in Appendix H were:

  • DTC advertising could increase awareness of a product that has been proven to be effective in weight loss. The new Code provides greater controls on advertising as well as the engagement with pharmacist to assess suitability.
  • The potential for misuse is based on theoretical misuse when previously included in Appendix H. When considered with the new Code, there is a benefit to the public to allow advertising of this substance.

SALBUTAMOL - it was proposed to include salbutamol in Appendix H. Submissions received were divided as to whether salbutamol should be included in Appendix H.

Submissions in favour argued that DTC advertising would allow more targeted education and awareness of availability of salbutamol in emergency situations.

Those against inclusion in Appendix H argued that DTC advertising could add to the current misuse of salbutamol and the mis-management of asthma, could impact on non-adherence to longer-term medication plans and is contrary to growing global concern of the over use of this class of substances.

TERBUTALINE - it was proposed to include terbutaline in Appendix H. Submissions received were divided as to whether terbutaline should be included in Appendix H.

Submissions in favour argued that DTC advertising would allow more targeted education and awareness of availability of terbutaline in emergency situations.

Those against inclusion in Appendix H argued that DTC advertising could add to the current misuse of terbutaline and the mis-management of asthma, could impact on non-adherence to longer-term medication plans and is contrary to growing global concern of the over use of this class of substances.

Substances proposed to be referred to ACMS for further advice

Following consideration of the submissions, the Delegate is asked to consider referring the following substances to the ACMS for further advice before making a final decision.

GLYCERYL TRINITRATE - it was proposed to include glyceryl trinitrate in Appendix H. Most of the submissions received were in favour of including glyceryl trinitrate in Appendix H.

Arguments for adding this substance to Appendix H included:

  • DTC advertising of this substance would increase awareness of the availability of this substance in an emergency / rescue situation.
  • The use of restricted representation approval would strengthen the suitability of advertisements for glyceryl trinitrate.

Arguments against the inclusion of this substance in Appendix H claimed patients who need to use this substance are already under the care of their medical practitioner and would be aware of it. It was also argued that glyceryl trinitrate can have serious side effects and has numerous contraindications.

ISOSORBIDE DINITRATE - it was proposed to include isosorbide dinitrate in Appendix H. Submissions received were divided as to whether isosorbide dinitrate should be included in Appendix H.

The argument for inclusion was on the basis that it would enable information on availability to be provided to patients who had initially been diagnosed by a doctor.

The submission against inclusion in Appendix H argued that pharmacists would require evidence of angina which they are not trained to diagnose. It could also be abused as a sex aid similar to volatile alkyl nitrites and should be excluded on the grounds of potential for misuse.