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Information updates

Updates to Australian medicine labelling rules to support medicine safety

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:

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 TGA.Scientific@health.gov.au if you have any questions regarding this consultation.

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Allergic reactions to Andrographis paniculata

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. 

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Saphnelo (anifrolumab) listed on the PBS for patients with severe SLE - 1 July 2024

Saphnelo® (anifrolumab) has been listed on the Pharmaceutical Benefits Scheme (PBS) for patients with severe Systemic Lupus Erythematosus (SLE) with high disease activity despite standard of care from Monday 1 July 2024. ​

The listing details have been published on the PBS website on 1 July 2024 with the following initial clinical criteria:

  • Patient must have a confirmed and documented diagnosis of SLE according to the ACR/ EULAR SLE Classification Criteria 2019, AND​
  • Patient must have persistent disease activity as supported by a SLEDAI-2K score of at least 10 points, AND​
  • Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal, AND​
  • Patient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal, AND​
  • Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal, AND​
  • Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus.​

​Treatment criteria:​

  • Must be treated by a specialist physician experienced in the management of this condition.​

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ASI Clinical Translation School 2024

The second ASI Clinical Translation School will be held at Q Station in Manly, Sydney from Wednesday 18th to Friday 20th September 2024. This in-person intensive 2-day School will host an expert line-up of clinical translation speakers, and an engaged network of up-and-coming researcher students. 

The course is designed for clinical trainees in disciplines related to immunology, including autoimmunity, allergy, infectious disease, oncology, and primary immunodeficiency, as well as higher-degree students and clinical fellows with a passion for translational research that will advance human disease diagnosis and therapy.

The program will consist of presentations by scientists and clinicians, as well as roundtable discussions to give in-depth understanding of recent advances and emerging themes in immunology, and immunological technologies.

Information is available at https://www.immunology.org.au/events/2024-ASI-Clinical-Translation-School-EOI/

pdfASI CTS2024 flyer1.44 MB

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Arexvy® RSV Vaccine

ASCIA has submitted a letter of support for the Arexvy® Respiratory Syncytial Virus (RSV) Vaccine application for new National Immunisation Program (NIP) listing (lodged 29 May 2024) which is available at www.allergy.org.au/ascia-submissions 

Respiratory Syncytial Virus (RSV) recombinant subunit vaccine  

Arexvy® - GlaxoSmithKline Australia Pty Ltd

Powder and suspension for injection (0.5 mL)

Clinical indication: Prevention of lower respiratory tract disease caused by RSV

Application: To request a listing on the NIP for prevention of RSV in patients aged 60 years and over

ASCIA supports the application for the following reasons:

  • Arexvy® is the first RSV vaccine which has been approved in Australia by the TGA for people 60 years and older for the prevention of lower respiratory tract disease caused by RSV. Arexvy® is a recombinant subunit vaccine, which does not contain live virus, and is therefore recommended for immunocompromised patients, which includes many people aged 60 years and older.
  • RSV is a common and contagious respiratory virus that can cause cold and flu like symptoms in children and adults. Whilst in some cases RSV may be a mild infection, RSV can also cause serious illness and in rare cases, even death, in older adults.
  • Older adults who are immunocompromised and/or have chronic medical conditions such as asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure have a greater risk of being hospitalised from RSV compared with those without these conditions.

Symptoms of RSV in adults are often similar to other acute respiratory infections, like colds or influenza, and can include a blocked nose, cough, fatigue, fever, sore throat, runny nose, body aches and headache. Cases of RSV were only officially counted in Australia from 2021, so there are still gaps in fully understanding how common the disease is and what impact it has on the Australian population.

Here is a link to the GSK media release (regarding the TGA approval) for further information.

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Food Allergy Week 2024 - When eating out, always ask, always tell

Food Allergy Week 2024 runs from 26 May to 1 June, and is an initiative of Allergy & Anaphylaxis Australia, the national patient/carer support organisation. The theme for Food Allergy Week 2024 is 'When eating out, always ask, always tell'.

The risk of an allergic reaction increases significantly when eating out or eating anywhere away from home, so everyone living with food allergy, and those around them, need to become more ‘allergy aware’. Not talking about it and presuming food is safe increases the risk of a severe allergic reaction.

At Allergy & Anaphylaxis Australia, trained allergy educators are available to talk on their free helpline about food allergy management questions and point you in the right direction for the best medical care.  

For more information go to https://allergyfacts.org.au/faw

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ASCIA Anaphylaxis e-training for Schools and Childcare Reports

For the first time since ASCIA e-training courses for Schools and Children’s Education/Care (CEC) were introduced in 2010, reports have been developed based on mandatory feedback surveys in the Australasian versions of the courses. The surveys were completed by 43,945 course participants and the reports are available at https://www.allergy.org.au/ascia-reports#nacscec

Highlights from the Schools, CEC and Refresher course reports include:

  • Relevant to current role - 81% to 86% indicated that the courses were entirely relevant to their current roles.
  • Course content - 94% to 99% indicated there was nothing missing and 89% to 98% thought that the course did not need to be improved.

This work has been completed as part of the National Allergy Council Schools and Childcare project, and results will guide course updates.

To access the courses go to https://www.allergy.org.au/about-ascia/about-ascia-e-training

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ASCIA Anaphylaxis e-training for Health Professionals Reports

For the first time since ASCIA e-training for health professionals was introduced in 2011, reports have been developed based on mandatory feedback surveys. These surveys were completed by 1,730 health professionals and the reports are available here

Highlights from the health professional course reports include:

  • Learning needs met – More than 90% indicated that the full and refresher courses had entirely met their learning needs.
  • Relevant to current practice - 71% indicated that the full course, and 83% indicated that the refresher course was entirely relevant to their current practice.
  • Full course content - 96% indicated nothing was missing and 94% indicated that the course did not need to be improved.
  • Refresher course content - 96% indicated nothing was missing and 95% indicated that the course did not need to be improved.

This work has been completed as part of the National Allergy Council Shared Care for Allergy project, and results will guide course updates.

To access the courses go to https://www.allergy.org.au/about-ascia/about-ascia-e-training

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