Information updates

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. 

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.​

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/

ASI CTS2024 flyer1.44 MB

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 https://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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