Information updates

A study on hereditary angioedema (HAE) prevalence and satisfaction with prophylaxis in South Australia has been published in the World Allergy Organization Journal (2024) 17:100918 http://doi.org/10.1016/j.waojou.2024.100918 by Alexander Troelnikov, Karen Milburn, Pravin Hissaria, Thanh Thao (Adriana) Le, and William Smith. 

This study was funded by an AIFA (Allergy and Immunology Foundation of Australasia) Primary Immunodeficiency Research Grant that was awarded in 2020.

Results from the published study include:

• Identification of 35 people with HAE in South Australia, yielding a population prevalence of 1 in 52,400, in line with average established international prevalence.
• HAE was identified in 4 patients of Indigenous Australian heritage.
• Seventeen of 31 adult patients completed an additional multi-questionnaire survey, revealing overall satisfactory disease control.
• Most common prophylactic therapies were danazol, lanadelumab, and subcutaneous C1 inhibitor.
• Many patients (mostly male) with milder disease had responded well to low-dose danazol with good tolerance and have continued to use it, whereas patients with higher disease burden are now using newer therapies, and overall satisfaction with current prophylaxis is high.

To support AIFA allergy and immunology research grants go to https://www.allergyimmunology.org.au/donate

Research projects funded by AIFA grants are listed at https://www.allergyimmunology.org.au/projects/projects#latest

The Therapeutic Goods Administration (TGA) is seeking public comment on proposed reforms to Part 5 of the Therapeutic Goods Regulations 1990. The proposed reforms are aimed at strengthening and modernising the legislative framework for the examination, testing and analysis of therapeutic goods.

The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing conducted by the TGA assesses compliance with quality and performance standards for the therapeutic goods. This testing provides the TGA, as the regulator, with scientific data to inform and support regulatory decisions and actions, ensuring the safety of therapeutic goods for Australian consumers.

The proposed reforms will impact the procedures for examination, testing and analysis of goods that we conduct within the regulatory framework.

The TGA is seeking consideration of proposed reforms to Part 5 to ensure this improvement activity strikes the right balance of safety for consumers and patients without imposing unnecessary regulatory burden on industry. The TGA understands that changes to legislation can impact how businesses make decisions. Your engagement is critical to ensuring that these reforms are fit for purpose.

The complete consultation, including your opportunity to provide feedback, can be found at https://consultations.tga.gov.au/medical-devices-and-product-quality-division/reforming-australias-therapeutic-goods-testing-reg

The consultation closes on 18 August 2024.

Nestlé Health Science has informed ASCIA that only the updated recipe of Alfamino® amino acid formula for infants will be available on the Pharmaceutical Benefits Scheme (PBS) from 1 August 2024. Since 1 September 2023, both the newer and older recipe Alfamino® products have been available on the PBS. 

The new recipe Alfamino® will also be listed on Pharmac as of 1 August 2024. Both formulations will be listed on Pharmac for a few months to assist with availability while supply changes from Alfamino® to Alfamino® with the inclusion of HMOs. This will also allow time for infants to transition to the new formulation.

The recipe of Alfamino® was updated in 2023 with the addition of two Human Milk Oligosaccharides (HMOs) 2’-FL and LNnT, which are structurally identical to those HMOs found in breastmilk.  From 1 August 2024, the older formulation of Alfamino® infant formula will be deleted, which means that prescribers should only use the item codes (listed below) for the updated Alfamino® product.

PBS item codes for Alfamino®400g with HMOs

The updated Alfamino® recipe (with HMOs) introduced in 2023 will continue to be available on the PBS, using the item codes below:

• 13615N - Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides with 2-fucosyllactose and lacto-N-neotetraose powder for oral liquid, Alfamino 400 g
• 13627F - Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides with 2-fucosyllactose and lacto-N-neotetraose powder for oral liquid, Alfamino 400 g

The older formulation of Alfamino® infant formula will be deleted from the PBS on 1 August 2024. There will be a supply only period, which will enable dispensing the product for existing prescriptions but no new prescriptions can be written for the below item numbers as of 1 August 2024.

Further information is available here: 

ASCIA Notification Alfamino and PBS update254.23 KB

Health professionals can also contact Nestlé Health Science for further information.

Nestlé Health Science has informed ASCIA that supply of Alfaré^® extensively hydrolysed infant formula (400g) is being discontinued in Australia and will be deleted from the Pharmaceutical Benefits Scheme (PBS) on 1 August 2024. 

There will be a supply only period, which will enable health professionals to dispense the product for existing prescriptions, but no new prescriptions can be written for Alfaré® as of 1 August 2024. 

Nestlé Health Science amino acid formula products for infants (Alfamino^® and Alfamino^® Junior) continue to be available in Australia. For the latest details go to https://www.allergy.org.au/about-ascia/info-updates/update-on-alfamino-r-infant-formula-pbs-listings-1-august-2024 

There is an alternative extensively hydrolysed infant formula product available on the PBS to which parents can transition their infants, and this is included in the ASCIA Guide for Milk Substitutes in Cow’s Milk Allergy, which is on the ASCIA website https://www.allergy.org.au/hp/papers/guide-for-milk-substitutes-cows-milk-allergy

Further information is available here: 

ASCIA Notification Alfare Discontinuation159.48 KB

Health professionals can also contact Nestlé Health Science for further information.

Alfaré^® is not sold in New Zealand, so this update is not applicable to New Zealand.

ASCIA recommends the use of adrenaline (epinephrine) as the first line emergency/first aid treatment for severe allergic reactions (anaphylaxis) using either of the following two brands of adrenaline injector devices, EpiPen^® or Anapen^®, which are both available in Australia on the Pharmaceutical Benefits Scheme (PBS).  EpiPen^®  is also available in New Zealand (Pharmac listed since 2023).

ASCIA has updated the form "Request for initial EpiPen Jr or EpiPen or Anapen 500 to be provided on PBS Authority prescription by clinical immunology/allergy specialist" to include Anapen 500, and to make the form easier to find on the ASCIA website.

The form is available open access on the ASCIA website: www.allergy.org.au/hp/anaphylaxis/adrenaline-authority-form

When completing the form please refer to ASCIA Guidelines - Adrenaline (Epinephrine) Injector Prescription - www.allergy.org.au/hp/anaphylaxis/adrenaline-injector-prescription 

The current PBS Authority requirement for the initial PBS authority prescription is for up to two adrenaline devices to be provided to patients:

1. Assessed to be at significant risk of anaphylaxis by a clinical immunology/allergy specialist, respiratory physician, paediatrician, or by a general practitioner (GP) in consultation with one of these specialists. Clinical immunology/allergy specialists often take calls from GPs wanting to provide an initial prescription, which needs to be done within a context that ensures appropriate follow up is in place. Since the PBS listing of adrenaline devices was first introduced in 2003, ASCIA has facilitated this consultation with a template form that can be used for initial prescriptions by GPs if the patient has not yet had treatment with adrenaline in a hospital. The form has recently been updated is now easier to access online at www.allergy.org.au/hp/anaphylaxis/adrenaline-authority-form  

or

2. After treatment with adrenaline for anaphylaxis when they are discharged from a hospital or emergency department (ED).  This allows ED physicians to prescribe adrenaline devices without consultation with other specialists mentioned above, and may include GPs, particularly those in rural and remote locations.

Information about recent changes to Anapen is on the ASCIA website www.allergy.org.au/about-ascia/info-updates/product-update-anapen-r-adrenaline-injector-devices

Registration is still open for the ASCIA 2024 Conference at https://ascia2024.com/registration

To date there are 455 registered delegates (80% in person), a sold out exhibition and more than 150 abstracts have been received for posters and clinical grand rounds. Authors will be advised about their abstracts in early August.

To view the ASCIA 2024 Conference Program Book go tohttps://ascia2024.com/program-overview

The ASCIA 2024 Conference will be held from Tuesday 3rd to Friday 6th September 2024 at the Adelaide Convention Centre, chaired by Dr Jovanka King. This event is being is organised by ASCIA in conjunction with ICMSA.

The ASCIA 2024 Conference is the leading annual event for continuing professional development (CPD) for for ASCIA members and other health professionals working in allergy and clinical immunology in Australia and New Zealand, which will provide:

• An international standard of CPD. 
• An opportunity for important in-person interactions. 
• On-demand viewing of sessions for all registered delegates after the conference.
• The option of virtual registration for delegates who cannot attend in-person, as it is a hybrid conference.

Presentations will feature the latest updates on food, drug, insect and respiratory allergy, immunodeficiency and autoimmunity. There are also dedicated allergy updates for nurses, dietitians and medical practitioners on Friday. We also look forward to celebrating with in-person delegates at the Black and White Gala Dinner at Adelaide Zoo.

We hope to seeing you in September at the ASCIA 2024 Conference.

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The Therapeutic Goods Administration (TGA) public consultation is now open on Updates to Australian medicine labelling rules to support medicine safety to seek feedback to make sure proposed changes to labelling rules support the safe use of medicines.

The TGA is proposing changes to labelling rules to help make sure that certain information important to health professionals is displayed clearly on labels or is available in the appropriate format. The TGA also wants to improve information about large oral dosage forms on listed medicines because the TGA continues to receive reports of serious choking related adverse events.

Medicine labelling rules

Medicines entered in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia must comply with the requirements for labels set out in:

• Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), or
• Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

This consultation is about proposed changes to TGO 91 and TGO 92 to address 3 medicine safety matters identified as needing action before we review labelling rules more broadly. We will conduct further public consultation about more improvements to labelling rules in the future.

Have your say

The TGA wants to know your views on the rules we are proposing and if you think they support the safe use of medicines. The aim of the proposals is to:

1. Make sure that quantities of active ingredients in injectable medicines intended for electrolyte replacement are clearly expressed in units important to health professionals.
2. Make sure that clear instructions on how to prepare and store certain injectable medicines administered by healthcare professionals is available in the appropriate format. This is to support recent changes to the Product Information (PI) as a package insert for injectable products.
3. Improve information on listed medicine labels about large solid oral dosage forms intended to be swallowed whole.

The TGA is particularly seeking feedback from health professionals on a proposal to allow a QR code to link to electronic instructions for preparation instead of a separate package insert, for certain medicines.

How you can give feedback

You can view the public consultation at Updates to Australian medicine labelling rules to support medicine safety on the TGA Consultation Hub. You are invited to give feedback by reading the consultation paper and completing our online survey. You are welcome to give us feedback on all 3 parts of this consultation, or only the parts that are important to you.

The public consultation will remain open until the extended deadline of 18 July 2024.

Please email This email address is being protected from spambots. You need JavaScript enabled to view it. if you have any questions regarding this consultation.

The ASCIA FAQ for patients and carers on Adverse Reactions to Complementary and Alternative Medicine has been updated to include information about Andrographis paniculata. This herb is commonly used in Indian and Chinese medicine and is known as the 'king of bitters'.

Since 2019, the Therapeutic Goods Administration (TGA) has received more than 200 reports of severe allergic reactions (anaphylaxis) and/or hypersensitivity reactions to medicines containing andrographis, including a report of fatal anaphylaxis in June 2024. More information is available on the TGA website.  

Andrographis may be present in multi-ingredient herbal medicine products that are often used for relief of cold and flu symptoms, and is commonly marketed to boost immunity. Around 100 medicines listed in the Australian Register of Therapeutic Goods (ARTG) contain andrographis.

More than 80% of the adverse events reported to the TGA for andrographis are for multi-ingredient medicines that contain both andrographis and Echinacea species (echinacea) together with other ingredients. Echinacea is another herbal ingredient often used in medicines for relief of cold and flu symptoms and immune support. Echinacea has also been reported to cause allergic reactions, including anaphylaxis.