$27 million for new medicines

Source: Australian Ministers for Health

Media event date: 

1 September 2019

Date published: 

2 September 2019

Media type: 

Media release

Audience: 

General public

The Morrison Government will invest $27 million to provide affordable access to three new medicine listings through the Pharmaceutical Benefits Scheme (PBS), helping Australians who are living with complications following stroke, those fighting cancer, and to support the enhanced response to the outbreak of syphilis in northern, central and southern Australia.

Three extended or amended PBS listings from 1 September will include:

Amending the current listing for the medicine Opdivo® (nivolumab) for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma and squamous cell carcinoma of the head and neck to allow patients to receive treatment every four weeks instead of every two weeks;

  • Amending the current PBS listing for this medicine is expected to shorten patient waiting times, reduce costs and fit more easily into patients’ schedules away from the clinic, which can help reduce the burden on the lives of cancer patients
  • Opdivo belongs to a new class of immunotherapy medicines which supercharge the body’s immune system, to fight and kill cancer
  • without subsidy, patients would pay up to $254,200 per course of treatment for Opdivo®
  • patients will be able to access these medicines for $40.30 per script and $6.50 per script for a patients with a concession card.

Botox® (botulinum toxin type A) will have its current PBS listing extended to include adults with lower limb focal spasticity following a stroke;

  • This medicine temporarily relaxes muscles that are overactive or contracting
  • more than 2,800 patients per year are expected to benefit from this listing
  • without PBS subsidy, patients would pay more than $5,400 per year for this treatment.

As part of the Morrison Government’s contribution to the enhanced response to the outbreak of syphilis in Aboriginal and Torres Strait Islander populations in northern, central and southern Australia, the current PBS listing of Bicillin L-A® (benzatheine benzylpenicillin) will be extended to now be available through the Emergency Drug Supply Schedule (Prescriber Bag);

  • The listing of this medicine as part of the Emergency Drug Supply Schedule means that eligible patients will receive this treatment free of charge
  • listing Bicillin L-A® is an important measure to address this outbreak by supporting the timely treatment of syphilis in non-remote settings for Aboriginal communities, creating a mechanism for these health services to have stock on site, and/or obtain supply for patients in advance of a consultation
  • there is an ongoing outbreak of infectious syphilis in Aboriginal and Torres Strait Islander populations in northern, central and southern Australia. Since the start of the outbreak in 2011 to 31 May 2019, there have been 2,786 cases of infectious syphilis and 16 congenital syphilis cases linked to the outbreak regions of northern and central Australia
  • this listing improves the ability to provide syphilis treatment to any patients who the prescriber may consider are at risk of loss to follow up, and potentially reducing time to treatment
  • this is especially important where urgent treatment is required, such as for pregnant women diagnosed with infectious syphilis and to address the subsequent risk of transmitting the infection to the unborn child, which can cause miscarriage, stillbirth, birth complications, and congenital syphilis.

All of these PBS listings were recommended by the independent expert Pharmaceutical Benefits Advisory Committee.

Since 2013, the Australian Government has listed over 2,100 new or amended items on the PBS. This represents an average of around 30 listings per month – or one each day – at an overall cost of around $10.6 billion.

Unlike Labor we are listing all medicines recommended by the medical experts on the PBAC. In 2011 Labor stopped listing medicines on the PBS because they could not manage the economy.

Our commitment to ensuring that Australians can access affordable medicines, when they need them, remains rock solid.

Ministers: 

Australian regulatory guidelines for sunscreens (ARGS)

Source: Australian Department of Health

The Australian regulatory guidelines for sunscreens (ARGS) have been developed to provide guidance to sponsors and manufacturers, and to assist in the understanding of the regulatory requirements for sunscreens in Australia.

The Australian Regulatory Guidelines for Sunscreens include information about:

  • the different types of sunscreens
  • which regulatory organisation regulates which type of sunscreen:
    • TGA
    • National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Australian Competition and Consumer Commission (ACCC)
  • the differences between the 2012 sunscreen Standard AS/NZS 2604:2012 and the 1998 Standard
  • when therapeutic sunscreens are allowed to comply with the 1998 Standard, and when they need to comply with the 2012 Standard
  • other regulatory requirements for sunscreens regulated by the TGA.

The TGA developed these guidelines in consultation with NICNAS, Accord Australasia, Australian Self-Medication Industry Inc (ASMI) and the Advisory Committee on Non-prescription Medicines (ACNM). A public consultation was also conducted.

The ARGS replaces Chapter 10 ‘Sunscreens’ in the Australian regulatory guidelines for OTC medicines (ARGOM).

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 10/10/2012
V1.1

Updated to reflect the changes to the Therapeutic Goods Regulations 1990 by removing references to sunscreens with a claimed SPF of <4 that contain certain human or animal derived ingredients.

Updated the relevant sections by including reference to the recently made Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015.

Updated the table listing the permitted active ingredients by adding the newly approved sunscreen active Tris-biphenyl triazine.

Complementary and Over the counter Medicines Branch
OTC Medicines Evaluation
22/01/2016
V1.2 Updated to remove Table 3 – Permitted active ingredients for therapeutic sunscreens and replace with links to the Therapeutic Goods (Permissible Ingredients) Determination Complementary and Over the Counter Medicines Branch 30/08/2019

Consultation: Changes to permissible ingredients – Low-negligible risk

Source: Australian Department of Health

This consultation closes on 11 October 2019.

Proposed changes to the Permissible Ingredients Determination – low-negligible risk

The Therapeutic Goods (Permissible Ingredients) Determination (‘the Determination’) is a legislative instrument under section 26BB of the Therapeutic Goods Act 1989. This instrument specifies all of the ingredients that are available for use in listed and assessed listed medicines and their associated requirements. The Determination is continually reviewed by the TGA to ensure that all ingredients and their requirements are appropriate for use in low-risk medicines.

The proposed ingredient changes in this consultation have been reviewed and categorised as being of low-negligible risk. The purpose of this consultation is to provide an opportunity for consumers, health professionals, industry and other interested parties to comment on these proposed changes which are due to commence on 2 March 2020 (see schedule for low-negligible risk changes for 2019-2020). Interested parties may provide submissions (see How to respond) which address any, or all, of the proposed changes in the consultation document or other identified issues.

Interested parties should respond by close of business 11 October 2019 (see How to respond).

The TGA will publish notification of the final determinations from these considerations by 2 December 2019 (see What will happen).

Proposed low-negligible risk changes

Boron containing compounds are found in a number of pharmaceutical products and used in listed medicines mainly in oral and topical medicines. Boron containing compounds are used as antimicrobial preservatives, buffering agents to control the pH and as tonicity-adjusting agents. They are also used as active ingredients, mostly for mineral supplementation.

Commonly used boron-containing compounds include boric acid, salts of boric acid such as borax (also known as sodium borate), and other borates (i.e. boron-containing oxyanions). Sponsors who include boron in listed medicines from these ingredients must declare the content of boron used within their listed medicine applications.

Recently, the European Medicines Agency[1] (‘EMA’) have found evidence linking boron exposure to the increased risk of infertility and established safe limits of boron exposure, dependant on age group. The EMA also considered it necessary to include appropriate information on boron-containing medicines so that consumers can be well-informed of the potential impacts these medications may have on sensitive populations i.e. pregnant women and children. The TGA proposes that listed medicines that contain boron exceeding the EMA limits should require warning statements to ensure safer and appropriate use of listed medicines.

Background

The EMA has identified that boron exposure can cause infertility later in life. EMA’s review found that animal toxicity studies showed reduced fertility or complete sterility in rats, as well as teratogenic and fetotoxic effects. Human data is limited. Based on these studies, the EMA have established the following amounts of boron per age group in humans which may impair fertility if exceeded:

  • <2 years - 1 mg boron/day
  • <12 years - 3 mg boron/day
  • <18 years - 7 mg boron/day
  • ≥18 years – 10 mg boron/day

In addition, the maximum recommended daily dose of a listed medicine must not provide more than 6 mg of boron due to scheduling within the Poisons Standard. The schedule 5 entry for boron-related substances such as boric acid aims to align with European Union (‘EU’) concentrations for cosmetics and to also ensure that persons using boron-containing products have adequate information to determine legitimate safe use of boric acid and related products.[2]

During the 20th meeting of the Advisory Committee on Complementary Medicines (‘ACCM’), the committee discussed and advised the TGA that warning statements in line with the EMA review were appropriate for listed medicines containing boron. The committee acknowledged the potential of systemic absorption associated with the use of topical preparations on broken, inflamed or irritated skin and therefore considers a warning statement for topical preparations is warranted. This was similarly considered within joint meetings of the Advisory Committee on Chemicals and Medicines Scheduling regarding labelling of cosmetic products containing boric acid with “NOT TO BE USED ON PEELING OR IRRITATED SKIN”. The ACCM also advised the TGA that warning statements are warranted to appropriately inform consumers to minimize the risk of systemic boron absorption in children depending on the amount of boron provided in the medicine.

Please note the current requirements for boron were a reflection of the Poisons Standard prior to a recent interim decision to amend the Poisons Standard (to be implemented on 1 February 2020). These requirements will be reviewed for accuracy separate to this consultation.

Proposal

The TGA proposes to update the current requirements for boron containing medicines in line with the EMA requirements. Sponsors of boron-containing medicines will need to label listed medicines containing boron to caution use in children under the age of 2 or 12 (depending on the dose of boron). In line with ACCM advice and recent proposal to change the Poisons Standard for cosmetic products, the TGA proposes that a label statement is required on boron-containing medicines to warn consumers not to use these products on broken skin. Sponsors of existing boron-containing medicines will have until the end of the transition period to amend the specific ingredient requirements as shown below.

Change to the Therapeutic Goods (Permissible Ingredients) Determination

Permissible ingredients and requirements
Ingredient name Purpose Existing specific requirements Proposed specific requirements
BORAX A, E, H

Boron is a mandatory component of Borax.

The percentage of Boron from Borax should be calculated based on the molecular weight of Borax.

The maximum recommended daily dose must provide no more than 6mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of Boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%.

Boron is a mandatory component of Borax.

The percentage of Boron from Borax should be calculated based on the molecular weight of Borax.

The maximum recommended daily dose must provide no more than 6mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of Boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%.

When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON12) ‘Do not give to a child less than 12 years old as this medicine contains boron and may impair fertility in the future.’.

When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON2) ‘Do not give to a child less than 2 years old as this medicine contains boron and may impair fertility in the future.’.

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

  • (EXTRNL) ‘For external use on unbroken skin only.” (label warning or directions for use).
BORAX PENTAHYDRATE A, E

Boron is a mandatory component of Borax Pentahydrate.

The percentage of Boron from Borax pentahydrate should be calculated based on the molecular weight of Borax Pentahydrate.

The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 g/L or 0.35%.

Boron is a mandatory component of Borax Pentahydrate.

The percentage of Boron from Borax pentahydrate should be calculated based on the molecular weight of Borax Pentahydrate.

The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 g/L or 0.35%.

When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON12) ‘Do not give to a child less than 12 years old as this medicine contains boron and may impair fertility in the future.’.

When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON2) ‘Do not give to a child less than 2 years old as this medicine contains boron and may impair fertility in the future.’.

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

  • (EXTRNL) ‘For external use on unbroken skin only.’ (label warning or directions for use).
BORIC ACID A, H

Boron is a mandatory component of Boric acid.

The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid.

The maximum recommended daily dose must provide no more than 6mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%.

Boron is a mandatory component of Boric acid.

The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid.

The maximum recommended daily dose must provide no more than 6mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%.

When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON12) ‘Do not give to a child less than 12 years old as this medicine contains boron and may impair fertility in the future.’.

When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON2) ‘Do not give to a child less than 2 years old as this medicine contains boron and may impair fertility in the future.’.

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

  • (EXTRNL) ‘For external use on unbroken skin only.’ (label warning or directions for use).
SODIUM PERBORATE A, H

Boron is a mandatory component of sodium perborate.

When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron.

When used preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

  • (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

Boron is a mandatory component of sodium perborate.

When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron.

When used preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

  • (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON12) ‘Do not give to a child less than 12 years old as this medicine contains boron and may impair fertility in the future.’.

When the maximum recommended daily dose of the medicine provides more than 1 mg of boron but less than 3 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

  • (BORON2) ‘Do not give to a child less than 2 years old as this medicine contains boron and may impair fertility in the future.’.

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

  • (EXTRNL) ‘For external use on unbroken skin only.’ (label warning or directions for use).

Impact on existing listed medicines

A search of the ARTG on 17 June 2019 indicates there were 196 listed medicines that contain the ingredients specified in the proposed change. Of these medicines, 184 are for internal use and/or oral application and 12 are for a topical route of administration.

References

Withania somnifera, known in Ayurveda as ‘Ashwaghanda’, is a plant that has been used in traditional medicines and is currently permitted for use in listed medicines as an active, excipient or homeopathic ingredient without specific requirements. Traditional and anecdotal evidence indicates that Withania somnifera has been used to benefit pregnancy and, in alternative paradigms, to induce abortion. As a result of this, World Health Organization (‘WHO’) and Health Canada include safety concerns regarding pregnancy and the use of Withania somnifera. The TGA proposes that a similar warning label statement is appropriate for listed medicines containing Withania somnifera.

Background

There is conflicting anecdotal evidence in some traditional medicine paradigms that report Withania somnifera is used to support pregnancy and lactation or used as an emmenagogue (stimulates or increases menstrual flow) and/or as an abortifacient. The Health Canada monograph for Ashwagandha and WHO monographs on selected medicinal plants[1] caution against use of the herb during pregnancy and breastfeeding.

The TGA identified seven publications[2-8] relating to traditional use of Withania somnifera. Two (2) of these publications report abortifacient properties for Withania somnifera. Al-Qura’n[2] interviewed 80 informants from southern Jordan and reports 17 informants’ specified abortion and sterility as toxic effects of Withania somnifera. Sahu[7] published the results of their survey in Madhya Pradesh, India which reports the ‘root is very efficacious for toning up the ulcerus [sic] of women who habitually miscarry and is used for easy abortion’, but does not specify the number of informants for these claims.

The remaining 5 publications suggest Withania somnifera can be used to aid conception, pregnancy or lactation, to treat gynaecological problems such as infertility[3], [6], sexual illness[4] and to reduce menstrual cycle irregularities[5], [8].

The publications did not provide detail which would allow assessment of whether the preparation method of the plant was a factor in the differing effects reported.

The contradictory uses of Withania somnifera were presented at the 21st meeting of the Advisory Committee on Complementary Medicines (‘ACCM’) and the committee advised that the available anecdotal and clinical evidence is insufficient to establish that Withania somnifera is safe in pregnancy or as an abortifacient. The committee also noted that the Health Canada monograph requires label warning statements advising consultation with a health care professional during pregnancy or when breastfeeding and advised that similar warning statements are appropriate for listed medicines containing Withania somnifera.

Proposal

In line with ACCM advice, the TGA proposes to introduce warning statements for medicines containing Withania somnifera advising consumers to consult a health care professional if they are pregnant or breastfeeding. Sponsors of existing medicines containing Withania somnifera will have until the end of the transition period to amend the specific ingredient requirements as shown below.

Change to the Therapeutic Goods (Permissible Ingredients) Determination

Permissible ingredients and requirements
Ingredient name Purpose Existing specific requirements Proposed specific requirements
WITHANIA SOMNIFERA A, E, H

The medicine requires the following warning statement on the label:

  • ‘Consult a health care professional prior to use if you are pregnant or breastfeeding.’

Impact on existing listed medicines

A search of the ARTG on 17 June 2019 indicates there were 172 listed medicines which contain Withania somnifera as an active ingredient intended for oral use.

References

Vitex agnus-castus is also known as Chaste Tree, Chasteberry and Monk’s Pepper. The plant has a traditional use as a tonic for both male and female reproductive systems and is marketed for menstrual disorders, including symptoms of premenstrual syndrome and/or menopause, as well as for acne. It is currently permitted for use in listed medicines as an active, excipient or homeopathic ingredient without specific requirements. The TGA has considered evidence that indicates is an interaction between Vitex agnus-castus in combination with medications affecting hormones such as oral contraceptives. Several international health authorities have also released publications which highlight safety concerns of Vitex agnus-castus in combination with hormone-related medication.

Background

The TGA recently published a safety advisory on the potential for a Vitex agnus-castus interaction with oral contraceptives following a report of unintended pregnancy. The Health Canada monograph for Vitex agnus-castus[1] advises warning statements to consult a health care professional prior to using Vitex agnus-castus if taking hormone-containing medications. A similar warning for Vitex agnus-castus containing medicines is also stated by the European Medicines Agency[2]. Additionally, WHO[3]and the United States Food and Drug Agency[4] identified possible interactions between hormone-related medications and conditions with Vitex agnus-castus. The WHO monograph for Fructus Agni Casti (dried Vitex agnus-castus fruit) highlights the interaction of Vitex agnus-castus with medications such as dopaminergic-receptor antagonists.

Vitex agnus-castus has been known to effect menstrual cycle irregularities as well as infertility and premenstrual syndrome[5]. The impact of Vitex agnus-castus on estrogen and progesterone metabolism is also scientifically recognised[6].

Since Vitex agnus-castus is presented as a premenstrual syndrome remedy, there is a strong likelihood that it will be taken in combination with hormone-related medications. Before concurrent consumption of such medicines with Vitex agnus-castus, the advice of a health care professional would be necessary to consider the impacts of this interaction.

Proposal

The TGA proposed to require a label warning statement which identifies potential interactions between formulations containing Vitex agnus-castus and other medicines, particularly the oral contraceptive pill. Sponsors of existing medicines containing Vitex agnus-castus will have until the end of the transition period to amend the specific ingredient requirements as shown below.

Change to the Therapeutic Goods (Permissible Ingredients) Determination

Permissible ingredients and requirements
Ingredient name Purpose Existing specific requirements Proposed specific requirements
VITEX AGNUS-CASTUS A, E, H

When for internal use, the medicine requires the following warning statement on the label:

  • (VAC) ‘Vitex agnus-castus can affect hormones in the body and may interact with prescription medicines such as oral contraceptives. Consult your health care professional before use.’

Impact on existing listed medicines

A search of the ARTG on the 17 June 2019 indicates there were 77 listed medicines which contain Vitex agnus-castus that are intended for internal administration. All of these medicines are for an oral route of administration and contain Vitex agnus-castus as the active ingredient.

References

Hydroxyisohexyl-3-cyclohexene carboxaldehyde, (‘HICC’), is a synthetic fragrance chemical that contains a mixture of isomers. HICC is currently used within a number of listed medicines in proprietary fragrance formulations, including sunscreens. The National Industrial Chemicals Notification and Assessment Scheme[1] and the Scientific Committee on Consumer Safety (‘SCCS’)[2] of the European Commission have considered that the ingredient is an established skin sensitiser and common contact allergen, and is unsuitable for cosmetic goods. Under European Union Regulations, the ingredient should be removed from cosmetic products by 23 August 2021. The TGA suggest that existing availability of HICC as an ingredient within fragrance formulations is inappropriate, and the ingredient should be removed from the Determination.

Background

HICC is a synthetic 70:30 mixture of two chemicals, 4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde (CAS No. 31906-04-4) and 4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde (CAS No. 51414-25-6) and is used as an ingredient used within fragrance proprietary ingredients of listed medicines. A review of the scientific literature shows that HICC has been reported as a contact allergen[2].

The European Union[3] has mandated the exclusion of HICC in cosmetic products of any form from 23 August 2021. The removal of HICC from cosmetics was based on a report[2] by the SCCS which details documented cases related to HICC induced allergy since 1999. To prevent contact allergy and limit consequences to individuals who have already become sensitised, the SCCS have advised that HICC should not be used in consumer products.

Proposal

The TGA proposes that HICC will be removed from the Determination as it is not suitable as an ingredient for use in listed medicines. New products which contain HICC will not be available for listing in the Register. Sponsors of existing listed medicines will have until the end of the transition period to remove the ingredient from their medicines.

Change to the Therapeutic Goods (Permissible Ingredients) Determination

Note

Deleted text is shown as red, smaller font, with a strikethrough.

Permissible ingredients and requirements
Ingredient name Purpose Existing specific requirements Proposed specific requirements
4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

Impact on existing listed medicines

A search of the ARTG on 12 June 2019 indicates there were 58 listed medicines that contain ‘4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde’ as an ingredient of a proprietary fragrance formulation.

References

The following proposed changes are of a minor nature and clarify the existing requirements for use in listed medicines. Amended text is highlighted in red.

Change to the Therapeutic Goods (Permissible Ingredients) Determination

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

Permissible ingredients and requirements
Ingredient name Proposed change Justification
ISPAGHULA HUSK DRY

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
ISPAGHULA HUSK POWDER

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO AFRA

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO ARENARIA

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO ASIATICA

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO LANCEOLATA

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO MAJOR

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO OVATA

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PLANTAGO SEED DRY

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PSYLLIUM HUSK DRY

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PSYLLIUM HUSK POWDER

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
PSYLLIUM SEED DRY

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

  • (PSYLL) ‘Should only be used for children on medical advice’ (or words to that effect).
Clarify wording of the warning statement. Alignment with Required Advisory Statements for Medicine Labels No. 5 for psyllium.
CYMBOPOGON FLEXUOSUS

Aldehydes calculated as citral is a mandatory component of Cymbopogon flexuosus.

The concentration or of Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

Alignment with the Poisons Standard June 2019
CYMBOPOGON MARTINI

Aldehydes calculated as citral is a mandatory component of Cymbopogon Martini.

The concentration or of Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

Alignment with the Poisons Standard June 2019
CYMBOPOGON NARDUS

Aldehydes calculated as citral is a mandatory component of Cymbopogon Nardus.

The concentration or of Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

Alignment with the Poisons Standard June 2019
CYMBOPOGON SCHOENANTHUS

Aldehydes calculated as citral is a mandatory component of Cymbopogon schoenanthus.

The concentration or of Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

Alignment with the Poisons Standard June 2019
MALUS PUMILA Ingredient to be removed from the Determination Synonym for MALUS DOMESTICA. Sponsors may request TGA to amend existing listed medicines within the transition period.

How to respond

Submissions must be submitted by 11 October 2019 to complementary.medicines@health.gov.au and be accompanied by a completed TGA Consultation submission cover sheet. Please note, late submissions after this date are not able to be considered.

How to access a Word document

Submissions can include any further data or information that may assist the Delegate to make an informed decision. Submissions might also include, for example, suggested improvements or an assessment of how the proposed change will impact on you.

What will happen

Public submissions may be published on the TGA website at Changes to the Permissible Ingredients Determination, unless marked confidential or indicated otherwise in the submission cover sheet.

Following consideration of public submissions received before the closing date and advice from relevant expert advisory committees, decisions on the proposed change will be published as interim decisions on the TGA website Changes to the Permissible Ingredients Determination by 2 December 2019.

Privacy and your personal information

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.

  • 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.
  • 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.

Enquiries

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

TGA actions following 2018 stakeholder surveys

Source: Australian Department of Health

The TGA conducts regular stakeholder surveys to hear from you about where we are doing well and where we can improve. The table below describes some of our actions following the stakeholder surveys of June 2018.

What you said What we have done
Build more awareness of the TGA and its role

We continue to share updates and information with you through our Facebook, Twitter, TGA Topics blog and email newsletters, and are currently looking at ways to expand our social media presence.

Earlier in 2019, we conducted a campaign to raise awareness of the importance of reporting side effects and problems related to medicines and medical devices. Information appeared in waiting rooms and pharmacies around Australia.

But we’re not just about digital communication. Our events team has been busy meeting you in our exhibition spaces at various health and wellbeing events throughout 2019.

Provide more support and training for businesses

Our Small and Medium Enterprise Assist (SME Assist) team held workshops around the country, including in Sydney, Brisbane, Perth and Adelaide.

Meanwhile our advertising team was also on the road presenting a series of seminars on the new Therapeutic Goods Advertising Code.

Following the success of our first Industry Forum on Good Manufacturing Practice, we are holding a second forum in November 2019.

We recognise that not everyone can get to a face to face event or workshop. That’s why we have held webinars on wide-ranging topics, including medicine shortages reforms, permitted indications for listed medicines, and the role of the TGA in digital health.

Head to our events and training page for a full list of forthcoming webinars and workshops.

Provide faster and more helpful responses to my enquiries We have been looking closely at the ways we manage enquiries and updating our internal processes. New technology is now in place that helps us to track our performance more effectively and help make sure we are meeting our customer service standards.
Communicate safety information more effectively

We continue to publish alerts on our website and share these alerts through Facebook, Twitter and email notifications.

We have improved the responsiveness of our Medicines Safety Updates (MSUs) for health professionals by publishing updates as issues arise rather than publishing on a fixed schedule.

We have also developed a range of resources to encourage all Australians to return their unused prescription opioid medicines.

Do more to ensure compliance with the regulations

We continue to take action in response to non-compliance. For example, in July of 2019, the Federal Court ordered an Australian company to pay $10 million for illegally advertising prescription medicines to the public and other breaches of therapeutic goods legislation.

We have also reviewed our processes to help make sure we are effectively prioritising and responding to cases of non-compliance.

Make it easier to find information on the TGA website

We are always looking at ways to enhance the experience on our website.

We continue to publish information hubs to make it easier to find information on key themes, including a new hub to help consumers and health professionals find information and support related to breast implants.

We have also updated a number of pages to provide you with clearer information about how we regulate medicines and medical devices.

Southport Medicinal Cannabis manufacturing facility opens

Source: Australian Ministers for Health

Date published: 

29 August 2019

Media type: 

Media release

Audience: 

General public

The Morrison Government continues to boost the nation’s medicinal cannabis sector, following the opening of a medicinal cannabis manufacturing facility in Southport, Queensland.

The THC Global facility will have the capacity to produce the equivalent of 120 tonnes of medicinal cannabis in oil or capsule form, to meet growing demand in Australia, and secure export opportunities.

Federal Member for Moncrieff, Angie Bell, said the facility brought with it “tremendous opportunities for the local community and medicinal cannabis sector in Australia”.

“This facility will build our local industry, meet domestic and international demand, and create economic growth and jobs,” Ms Bell said.

Minister for Health, Greg Hunt said the opening of the THC facility showcased the Morrison Government’s “commitment to boosting local industry and helping those living with chronic or terminal illnesses”.

“We want a robust Australian medical cannabis industry to ensure a safe, quality supply of medicinal cannabis is accessible to Australian patients, when prescribed by a medical professional.”

The Morrison Government continues to make it easier for doctors to access medicinal cannabis products more rapidly, while maintaining strict safeguards for individual and community safety.

Doctors can apply under the Therapeutic Goods Administration’s Special Access Scheme Category B, or via an Authorised Prescriber (AP) Scheme to legally prescribe medicinal cannabis products.

The Special Access Scheme (SAS) online system allows prescribers in Queensland to submit their applications on behalf of patients in a single online application, which are processed within 2 working days.

As of 31 July 2019, over 11,000 approvals now been given under SAS in Australia for medicinal cannabis products. Over 8,500 patients have been authorised to access a medicinal cannabis product through the Special Access and Authorised Prescriber Schemes. Approximately one-third of these approvals have been granted for patients in Queensland.

The Morrison Government’s strong economic management ensures the continued investment of record funding into vital health initiatives including medical research, mental health, life-saving medicines, Medicare and hospitals.

Ministers: 

Good Manufacturing Practice: the recipe for quality medicine

Source: Australian Department of Health

When you bake a cake you need to have the right ingredients, and use them in the right order. You can’t add an extra egg to the mix after the cake comes out of the oven.

You also need to keep a clean kitchen.  Nobody wants to find a fingernail or strand of hair in their sponge cake.

When you’re making a cake, quality is something you plan for.

Medicine manufacture is the same, but the stakes are much higher.  That’s why the quality and safety requirements for manufacturing medicines are higher and regulated more tightly than they are for a home-baked cake.

If you mess up making a cake, it could just taste bad or be a weird shape.  If a manufacturer doesn’t make a medicine properly, it could make someone sick.

For this reason, in Australia you need a Good Manufacturing Practice (GMP) licence to manufacture a medicine.

What is Good Manufacturing Practice?

GMP is the set of principles and procedures that medicine manufacturers must follow to manufacture a product that meets quality standards.  These requirements cover all aspects of manufacture.

The GMP requirements cover things like premises, equipment, personnel, documentation, procedures and systems that control all stages of manufacture…  Everything someone needs to plan for and follow when they make a medicine.  Australian medicine manufacturers must meet these types of requirements to obtain and maintain a manufacturing license.

For you as a consumer, the benefit is obvious.  GMP means you have confidence that the medicine you buy will be what it says it is.  GMP ensures that the medicine is of an appropriate quality because it contains the right ingredients, at the right strengths, is sealed correctly and is free of any contaminants.

This is an example of what a GMP-licensed facility looks like:

Under GMP we require that:

  • the environment is suitable for the manufacture of medicines
  • ingredients used for the manufacture of the medicines have been tested, are of acceptable quality and from a known source
  • continual checks are performed and controls are in place to ensure that all stages of manufacture meet manufacturing requirements, that the right materials and equipment are used and that there are no mistakes made in the steps of manufacturing, from start to end
  • the facility and the equipment that are used are clean before use and that the equipment performs as expected.

The list goes on…  You can learn more at our Good Manufacturing Practice overview.

What does unlicensed manufacture look like?

Medicines being manufactured in unlicensed facilities is not manufacture under GMP.  This is what it can look like:

Here are some of the risks of this unlicensed operation:

  • The medicine is being mixed in a bathroom.  There is often mould and bacteria in a bathroom, and these could contaminate the medicine.
  • Kitchen bowls, utensils and mugs are being used to make the medicine.  If these came from the kitchen, they could be dirty and be a source of contamination.
  • Many of the containers are open.  The person making the medicine could breathe, spit or dribble in these containers.  Exposure to the air can also change or inactivate some ingredients.
  • The space is disorganised.  It would be easy to forget a step in the process, do things out of order or use the wrong materials.
  • There are few labels here.  The ingredients could be mixed up, or used in the wrong amounts.
  • You don’t know if the ingredients are suitable or what they are composed of.

And that’s without even getting started on the toothbrush…

You and your family’s health depend on quality medicines.  GMP keeps the “kitchen” of medicine manufacture in order.

Consultation: Increased online access to ingredient information

Source: Australian Department of Health

Invitation to comment

We are seeking feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG).

We are responding to consumer frustrations that they cannot easily access this information through existing mechanisms. By making this information available in the public ARTG view, which is available on the TGA website, we hope to help consumers make more informed and safer choices about their medicines.

Consultation documents

Document released for consultation on Thursday, 29 August 2019.

Interested parties should respond by close of business Thursday, 10 October 2019.

Feedback will be released following consideration of submissions. (See ‘What will happen‘).

About the consultation

To make safe and informed choices, people need access to information about the ingredients in their therapeutic goods. It is also important to have this information to identify when specific ingredients may have contributed to an adverse reaction.

Some information about the ingredients in therapeutic goods is available to consumers in public documents. Alternatively, consumers must contact the company responsible for the goods or make a request for specific ingredient information from the TGA. Consumers have expressed frustrations that these mechanisms do not provide easy access to information about excipient (or ‘inactive’) ingredients in all medicines.

In response, we are consulting on options for making this information available online in the public summaries of goods on the ARTG.

Content of submissions

Submissions may address any, or all, of the questions posed in the consultation paper.

We are specifically interested in what impact (health, safety or commercial) displaying the names of excipient ingredients would have on you. If the proposals in the paper are implemented, we are also interested to know if any organisations are willing to collaborate with us to help raise consumer awareness about the availability of this information.

How to submit

Complete the online consultation submission form to upload your submission in either pdf or word format.

Consultation submission form

Alternatively, hardcopy submissions with a printed cover sheet may be mailed to:

ARTG excipients project
Scientific Operations Management Section
Scientific Evaluation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed to ARTG.excipients@tga.gov.au.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Privacy 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).
    • seek feedback about how the consultation was undertaken.
  • 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.
  • More information on consultations and privacy is included in the submission form and on our website.

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

Source: Australian Department of Health

This consultation closes 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.

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

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:

Schedule 4 – Amend Entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in Schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection;
  9. in liquid preparations for oral use except when in Schedule 2.

Schedule 2 – Amend Entry

PARACETAMOL for therapeutic use:

  1. liquid preparations for oral use containing no greater than 50 mg per mL of paracetamol in 100 mL with a maximum of 50 g paracetamol per container;
  2. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  3. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  4. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  6. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
  7. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

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:

Schedule 2

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

Index

HYOSCINE BUTYLBROMIDE

Schedule 2

HYOSCINE
cross reference: HYOSCINE BUTYLBROMIDE

Proposed scheduling

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

Schedule 2 – Amend Entry

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance:

  1. in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide; or
  2. in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide.

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:

Schedule 4

VITAMIN D for human internal therapeutic use except:

  1. in preparations containing 25 micrograms or less of vitamin D per recommended daily dose; or
  2. when included in Schedule 3.

Schedule 3

VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.

Appendix H

VITAMIN D

Index

VITAMIN D
cross reference: COLECALCIFEROL, ERGOCALCIFEROL

Schedule 4
Schedule 3
Appendix H

Proposed scheduling

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

Schedule 4 – New Entry

CALCIFEDIOL MONOHYDRATE for human internal therapeutic use except in preparations containing 10 micrograms or less of calcifediol monohydrate per recommended daily dose.

Index – New Entry

CALCIFEDIOL MONOHYDRATE

Schedule 4

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:

Schedule 5

LIDOCAINE in aqueous gel preparations containing 4.5 per cent or less of lidocaine, for the dermal spray-on administration to post-surgical wounds associated with ‘mulesing’ of sheep; tail docking and castration of lambs; or castration and disbudding/dehorning in calves.

Schedule 4

LIDOCAINE except:

  1. when included in Schedules 2 or 5;
  2. in dermal preparations containing 2 per cent or less of total local anaesthetic substances per dosage unit; or
  3. in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit.

Schedule 2

LIDOCAINE in preparations for topical use other than eye drops:

  1. containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
  2. in divided preparations containing 200 mg or less of total local anaesthetic substances, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

LIDOCAINE

Schedule 5
Schedule 4
Schedule 2

Proposed scheduling

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

Schedule 2 – Amend Entry

LIDOCAINE in preparations for topical use other than eye drops:

  1. containing 10 per cent or less of total local anaesthetic substances, except:
    1. in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
    2. in aqueous sprays for oromucosal use containing 0.6 per cent or less of total local anaesthetic substances; or
  2. in divided preparations containing 200 mg or less of total local anaesthetic substances, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

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:

Schedule 4 – Amend Entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 3050 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection.

Schedule 3 – Amend Entry

PARACETAMOL when combined with ibuprofen in a primary pack containing 3050 dosage units or less except when included in or expressly excluded from Schedule 2.

Schedule 2 – Amend Entry

PARACETAMOL for therapeutic use:

  1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 1230 dosage units per pack except in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  2. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  3. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
  4. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
  6. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

Appendix F, Part 3

PARACETAMOL

Warning Statements: 97 (Adults: Keep to the recommended dose. Don’t take this medicine for longer than a few days at a time unless advised to by a doctor); AND/OR 98 (Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor); 99 (If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage); 100 (Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist).

Appendix H

PARACETAMOL.

Index

PARACETAMOL
cross reference: ASPIRIN, IBUPROFEN, METOCLOPRAMIDE, SALICYLAMIDE, CAFFEINE

Schedule 4
Schedule 3
Schedule 2
Appendix F, Part 3
Appendix H

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

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:

Schedule 7 – New Entry

CARBON MONOXIDE except when included in Schedule 6.

Schedule 6 – New Entry

CARBON MONOXIDE in pressurised gas canisters or cylinders

Appendix E – New entry

CARBON MONOXIDE

Appendix F – New entry

CARBON MONOXIDE

Part 1 – Warning Statements

Part 2 – Safety Directions – General

Appendix J, Part 2 – New Entry

CARBON MONOXIDE

Index – New Entry

CARBON MONOXIDE

Schedule 7
Schedule 6
Appendix E
Appendix F
Appendix J, Part 2

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:

Schedule 6

MOMFLUOROTHRIN.

Index

MOMFLUOROTHRIN

Schedule 6

Proposed scheduling

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

Schedule 6 – Amend Entry

MOMFLUOROTHRIN except in preparations containing 0.2 per cent or less of momfluorothrin.

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:

Schedule 5 – New Entry

METHIOZOLIN.

Index – New Entry

METHIOZOLIN

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 metcamifen has very low toxicity across the toxicological database and does not appear to present any substantial toxicological hazard. Metcamifen 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:

Schedule 7

LAMBDA-CYHALOTHRIN except when included in Schedule 5 or 6.

Schedule 6

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or
  2. in emulsifiable granule formulations containing 25 per cent or less lambda-cyhalothrin; or
  3. in other preparations containing 1.6 per cent or less of lambda-cyhalothrin

    except when included in Schedule 5.

Schedule 5

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 1 per cent or less of lambda-cyhalothrin; or
  2. in aqueous preparations containing 2.5 per cent or less of microencapsulated lambda-cyhalothrin.

Index

LAMBDA-CYHALOTHRIN

Schedule 7
Schedule 6
Schedule 5

Proposed scheduling

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

Schedule 5 – Amend Entry

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 1 per cent or less of lambda-cyhalothrin; or
  2. in aqueous preparations containing 2.510 per cent or less of microencapsulated lambda-cyhalothrin.

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:

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.

First national report shows 1 in 9 Australian women aged 40–44 have endometriosis 

Source: Australian Institute of Health and Welfare

UNDER EMBARGO—until 1.00am, Thursday, 29 August 2019

Almost 7% of women aged 25–29 and 11% of women aged 40–44 have endometriosis, according to a new report from the Australian Institute of Health and Welfare.

The report, Endometriosis in Australia: prevalence and hospitalisations, provides new insights into the painful and historically under-recognised condition which can affect fertility and lead to reduced participation in work and school.

‘Endometriosis is a chronic condition which occurs when tissue similar to that normally found lining the uterus occurs in other parts of the body,’ said AIHW spokesperson Ms Claire Sparke. 

‘The tissue responds to hormones released by the ovaries, which can lead to bleeding, inflammation and scarring,’

‘Women may experience pain, heavy menstrual bleeding, bleeding between periods, lethargy and reduced fertility, among other symptoms.’

Today’s report includes the most recent estimates of endometriosis prevalence in Australia, which are based on data from a large, nationally representative survey.

Researchers at the University of Queensland used data from the Australian Longitudinal Study on Women’s Health, along with health service data, to estimate the prevalence of endometriosis in 2 groups of women—those born in 1973–78 (with data available up until age 40–44) and those born in 1989–95 (data available up until age 25–29).

Around 1 in 15 (6.6%) women born in 1989–95 were diagnosed with endometriosis by age 25–29—a figure that is 1.7 times as high as that for women born in 1973–78 at the same age (4.0%).

This increase may reflect increased awareness of endometriosis among the general public and health professionals, leading to increased diagnosis and/or reporting of diagnosis among women born more recently.

Diagnosis and management of endometriosis is complex. There is an average of 7 years between onset of symptoms and diagnosis and no known cure.

In 2016–17, there were around 34,000 endometriosis-related hospitalisations, 95% of which involved at least 1 procedure.

‘The most common procedures included diagnostic hysteroscopy (to examine inside the uterus) and dilation and curettage of the uterus (where the lining of the uterus is scraped away),’ Ms Sparke said.

Endometriosis-related hospitalisations were more likely to be partly or fully funded by private health insurance than all hospitalisations for females (57% compared with 43%), and around twice as likely to be self-funded as all hospitalisations for females (7.9% compared with 3.6%).

‘Data on hospitalisations in this report are likely to reflect the more severe cases, and does not account for all incidences of endometriosis. Future information is needed on primary care, specialist care, pharmaceutical treatment, and emergency department care,’ said Ms Sparke. 

           Media enquiries: Peter Jean, AIHW: Tel. 02 6244 1148, mob. 0401 312 261

For embargoed media copies of the report: [email protected]

Mandatory information required in advertising for therapeutic goods

Source: Australian Department of Health

This decision tree has been designed to help you identify what information you must include when advertising therapeutic goods to the public in order for the advertising to comply with the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).

This information only applies to advertising more broadly. It does not capture labels or packaging, consumer medicine information leaflets, or patient information leaflets, the content of which is specified in other legislation. It also does not apply to ‘picture/price/point-of-sale’ advertisements – i.e. advertisements with a packshot, price and where the product can be purchased with no therapeutic claims visible or implied.

The decision tree will provide you with the minimum set of information required in your advertisement under the Code, based on the type of therapeutic good and the type of advertisement. You can include additional information in the advertisement if you wish, provided the minimum requirements are met.

Note that compliance with the minimum information requirements does not guarantee that your advertisement will fully comply with the Code and the advertising legislation more broadly. You will still need to review your advertising for compliance with all other relevant requirements in the Therapeutic Goods Act 1989 (the Act) and the Code.

Also note that under the Act and Code requirements:

  • representations that refer to serious forms of a disease, condition, ailment or defect are restricted representations and prior approval from the TGA will be required before you advertise the goods
  • advertisements for medicines intended to appear in ‘specified media‘ (e.g. free-to-air television, radio, newspapers, magazines, billboards) require pre-approval.