National medical laboratory workforce certification scheme 

The medical laboratory science profession in Australia now has its own national professional certification scheme. 

The Australian Council for Certification of Medical Laboratory Scientific Workforce (CMLS) has worked with representatives from AIMS, AACB, ASM, HGSA, ASC, ANZSBT, ASCIA, FSA, THANZ, ACS, and AAHH to design a model of medical laboratory science certification for professionals, no matter their chosen discipline.  

The initial scheme launched in 2020 and a revised operating model, aimed at reducing costs to certificants came into operation in mid 2023. New applications for certification and renewals are processed by the professional bodies providing CPD.  Please contact your relevant association for details.

More information is available at https://www.cmls.org.au/ 

Certification and inclusion on a public register demonstrates a commitment to superior professionalism, support of industry standards and is aligned with competency development and assessment processes. Certified medical laboratory scientists and technicians can expect an advantage in career progression, and other benefits, including:

• Public recognition of scientific qualifications.
• Acknowledgement of participation in continuing professional development (CPD) and education.
• Increased professional credibility and prestige of scientists and technicians in the industry.
• Potential to provide further educational and CPD opportunities for scientists and technicians. 

Content updated February 2024

The Therapeutic Goods Administration (TGA) publishes information about medical product shortages on its website https://www.tga.gov.au/safety/shortages 

A medicine shortage occurs when there is unlikely to be enough of a medicine in Australia for the people who need to take it. Suppliers must report shortages of prescription medicines and a small number of over-the-counter medicines to the TGA. Each shortage listed on the TGA medicine shortages reports page refers to a single product. There are usually alternative brands, strengths or dose forms of the same medicine available. 

Product Availability – Recent Updates 2023-2024

Respiratory Syncytial Virus (RSV) vaccine approved by TGA

Monovalent COVID-19 Omicron XBB.1.5 vaccines

Shingrix® varicella zoster virus recombinant vaccine

Jorveza® for the treatment of eosinophilic oesophagitis (EoE)

Dymista® Allergy nasal spray for treatment of allergic rhinitis – now OTC

Content updated January 2024

This webpage has been developed in response to the COVID-19 pandemic caused by the spread of coronavirus (SARS-CoV-2) infections. Content last updated February 2022.

This webpage includes links to the following information:

COVID-19 vaccine information | Govt COVID-19 information | Information from other organisations | COVID-19 and Telehealth | Medical product supply updates | IUIS  COVID-19 Primary Immunodeficiency Survey | COVID–19 Global Rheumatology Alliance Registry | ASCIA COVID-19 Working Party | Healthdirect COVID-19 Symptom Checker | Healthdirect COVID-19 Restriction Checker | COVID-19 Dashboard | Australia-COVID-19-current-situation-and-case-numbers | SBS Translations of Coronavirus Information 

COVID-19 vaccine information 

ASCIA COVID-19 vaccine information  

• Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination FAQ for patients, consumers and carers Updated February 2022
• COVID-19 and Immunodeficiency FAQ for patients, consumers and carers Updated October 2021
• Checklist - Actions to Reduce the Spread of COVID-19 Updated October 2021
• COVID-19 Vaccination Guidelines for Clinical Immunology/Allergy Specialists Updated September 2021
• Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination - Position Statement for health professionals Updated September 2021
• Allergy and COVID-19 Vaccination - Guide for health professionals Updated September 2021
• Immunodeficiency, Autoimmunity and COVID-19 Vaccination - Guide for health professionals Updated September 2021

Other COVID-19 vaccine information

https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/about-covid-19-vaccines/australias-vaccine-agreements

https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-safety-and-approval

Other Information

http://www.abc.net.au/news/2021-01-27/your-top-coronavirus-vaccine-questions-answered/13094594

https://ipopi.org/latest-news-on-covid-19-and-pid/

https://college.acaai.org/covid-19-vaccine-frequently-asked-questions/

https://acaai.org/covid-19-asthma-and-allergies

https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm

https://www.nps.org.au/vaccines-and-covid-19

ASCIA telehealth resources webpage https://allergy.org.au/ascia-telehealth

This webpage allows ASCIA members to have ready access to online ASCIA resources for use in telehealth and face to face consultations. 

Information from governments (AU, NZ) 

AUSTRALIAN GOVERNMENT

Australia-COVID-19-current-situation-and-case-numbers

www.health.gov.au/resources/videos/coronavirus-video-good-hygiene-starts-here

Call the Coronavirus Health Information Line 1800 020 080 (24 hours a day, 7 days a week) or call Healthdirect Hotline 1800 022 22ll the new COVID-19 Health Professionals National Disability Advisory Service on 1800 131 330 (7am – 11pm AEST, 7 days a week). Calls to the Advisory Service will be answered by health professionals with disability service qualifications and experience working with people with disability. 

Information from other organisations 

AUSTRALASIAN MEDICAL/HEALTH ORGANISATIONS

Royal College of Pathologists of Australasia (RCPA) Position Statement about COVID-19 testing https://www.rcpa.edu.au/Library/COVID-19-Updates/COVID-19-Useful-Resources

Guidelines for the management of rheumatic diseases during the COVID-19 pandemic are being developed by the Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network, the Australian Rheumatology Association (ARA) and the Australian Living Evidence Consortium. ASCIA members are invited to complete a survey about what topics are of most importance for inclusion in these guidelines. The link to the survey is https://www.surveymonkey.com/r/ASCIA_COVID and it should take less than 15 minutes to complete.

Australian & New Zealand Childrens Haematology/Oncology Group (ANZCHOG) https://anzchog.org/updated-advice-for-paediatric-oncology-and-bmt-patients-during-the-covid-19-pandemic/

Australasian Society for Infectious Diseases (ASID) www.asid.net.au/resources/resources including a statement about Paediatric Inflammatory Multisystem Syndrome Temporally associated with SARS-COV-2 (PIMS-TS) https://www.asid.net.au/documents/item/1911

Australian and New Zealand Intensive Care Society (ANZICS) https://www.anzics.com.au/coronavirus-guidelines/

Australasian College for Emergency Medicine (ACEM) https://acem.org.au/COVID-19

National Asthma Council (NAC) https://www.nationalasthma.org.au/news/2020/covid-19-and-your-asthma-patients 

Asthma Australia https://asthma.org.au/about-asthma/triggers/coronavirus-and-covid19/

Allergy & Anaphylaxis Australia (A&AA) https://allergyfacts.org.au/news-alerts/latest-news/covid-19

WORLD HEALTH ORGANISATION (WHO)

Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected  
2020 WHO Clinical management suspected COVID-19855.57 KB23/03/2020, 04:17

COVID-19 and telehealth

The most up-to-date information regarding telehealth enabled items can be found at www.mbsonline.gov.au and further information regarding the COVID-19 National Health Plan can be found at www.health.gov.au

ASCIA Telehealth Resources www.allergy.org.au/ascia-telehealth  allow ASCIA members to have ready access to the latest versions of online ASCIA plans, checklists, forms and information for patients, for use in telehealth, as well as face to face consultations.  

Medical product supply updates

In response to the COVID-19 outbreak many suppliers of medical products are working to ensure the continuity of supply to patients in Australia and New Zealand, whilst also protecting the health of their employees. ASCIA is monitoring the situation and will post notices on this page from medical product suppliers and authorities, including the National Blood Authority (NBA) and the Theraputic Goods Administration (TGA).

NBA response to novel coronavirus https://www.blood.gov.au/response-novel-coronavirus-4 

TGA amendment to restrict hydroxychloroquine prescribing https://www.tga.gov.au/scheduling-decision-final/notice-amendment-current-poisons-standard-under-paragraph-52d2a-therapeutic-goods-act-1989

ARRC letter to patients regarding hydroxychloroquine (Plaquenil) https://www.autoimmune.org.au/2020/03/25/hydroxychloroquine-plaquenil-update/ 

TGA critical medicine shortages in Australia https://apps.tga.gov.au/prod/MSI/search

Adrenaline (epinephrine) autoinjector supply www.allergy.org.au/members/adrenaline-autoinjector-availability

Venom allergen supply www.allergy.org.au/members/insect-allergy

IUIS primary immunodeficiency and COVID-19 survey

There is an urgent need to understand the impact of COVID-19 on immunodeficient and immunosuppressed patients. Whilst co-morbidities such as diabetes, cancer, arterial hypertension and heart disease have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for people with primary immunodeficiencies (PID).

ASCIA members are invited to complete the following surveys, that have been sent to ASCIA and other clinical immunology organisations by Professor Stuart Tangye, on behalf of the International Union of Immunological Societies (IUIS) Expert Committee of Inborn Errors of Immunity.

The link to the 2nd phase of the survey is https://dsp.institutimagine.org/copid/connexion.php

The link to the 1st phase of the survey is https://www.surveymonkey.com/r/67RBPNZ

The focus of the 1st phase of the survey is on obtaining top level of information, to get an idea of the number of affected PID patients and the impact of SARS CoV2.

The 2nd phase of the survey requires a greater level of information, for clinicians with affected/infected PID patients to complete.

The IUIS is conscious of the demands on time and resources due to COVID-19 on top of regular busy schedules and is grateful to all participating societies and organizations, which will all be acknowledged for their help and input into this initiative.

The surveys have been prepared by Professors Isabelle Meyts, Nizar Mahlaoui and Kate Sullivan, in conjunction with the European Society for Immunodeficiencies (ESID), the French national reference center for PID (CEREDIH - Centre de Référence Déficits Immunitaires Héréditaires) and the International Patient Organisation for PID (IPOPI). The survey has been approved for global distribution.

COVID–19 Global Rheumatology Alliance registry

ASCIA is part of the COVID–19 Global Rheumatology Alliance. The mission of this alliance is to create a secure, de-identified, international case reporting registry and curate and disseminate the outputs from that registry. The COVID–19 Global Rheumatology Alliance physician-entered data registry is now available at https://rheum-covid.org 

This registry will facilitate the Alliance's primary goals, which are to:

• Understand the outcomes of patients with rheumatologic conditions who develop COVID–19 infection and the influence of their comorbidities and medications on their outcomes.
• Understand the influence of rheumatologic medications, such as hydroxychloroquine, on the outcomes of patients who develop COVID–19 infection.

The COVID–19 Global Rheumatology Alliance is interested in all cases, from asymptomatic to severely affected.

The Alliance aims to provide information back to doctors, patients, and researchers about how rheumatic disease patients and those treated with rheumatology drugs fare when they get infected. Data collected will potentially provide valuable information going forward to help make decisions about how to direct further studies and treat our patients.

ASCIA COVID-19 Working Party 

Since early March 2020, ASCIA  has been extremely acitive developing and updating ASCIA COVID-19 resources. The ASCIA COVID-19 working party comprises the members listed below, and is coordinated by the ASCIA CEO, Jill Smith. 

Chair: Dr Theresa Cole (VIC) - ASCIA Immunodeficiency committee Chair and ASCIA President Elect

Deputy Chair: Dr Paul Gray (NSW)

Members:

Prof Michaela Lucas (WA) - ASCIA President 

Dr Brynn Wainstein (NSW) - Immediate past ASCIA President 

Dr Michael O’Sullivan (WA) - ASCIA Director

A/Prof Jane Peake (QLD) - ASCIA Director

Dr Patrick Quinn (SA) - ASCIA Immunodeficiency committee Deputy Chair

Dr Dean Tey (VIC) - ASCIA 2021 Conference Chair

A/Prof Mike Gold (SA)

Dr Pravin Hissaria (SA)

Dr Kuang Hsiao (NZ)

Dr Miriam Hurst (NZ)

Prof Connie Katelaris AM (NSW)

Dr Karuna Keat (NSW)

Dr Daman Langguth (QLD)

Dr Andrew McLean-Tooke (WA) - Chair, ASCIA COVID-19 vaccine Working Group

Dr Ray Mullins (ACT)

A/Prof Kirsten Perrett (VIC)

Dr William Smith (SA)

Dr Melanie Wong (NSW)

Content updated February 2022

This webpage includes links to: 

Supply updates | PBS listings | FDA report about EpiPen® | Process to follow during shortages | Adrenaline Injector dose guide

Supply updates  

January 2024

Adrenaline (Epinephrine) Injector Training Devices

ASCIA anaphylaxis e-training courses should always be completed in conjunction with practice using adrenaline (epinephrine) injector training devices (EpiPen® and Anapen®), which do not have a needle and do not contain adrenaline.  

To order Anapen trainers email This email address is being protected from spambots. You need JavaScript enabled to view it.

To order EpiPen trainers email This email address is being protected from spambots. You need JavaScript enabled to view it.

The patient support organisation, Allergy & Anaphylaxis Australia (www.allergyfacts.org.au), supply adrenaline injector trainer devices as an alternative source to the supplier, particularly if the supplier is low on stock. This organisation charges a small fee for these devices. These funds help support the charity that gives information and support to many people on a daily basis at no charge. For an order form go to https://allergyfacts.org.au/shop/training-accessories

Some pharmacies also supply adrenaline trainer devices at retail price.

6th January 2023

Pharmac to fund EpiPen^® for severe allergies from 1 February 2023

Pharmac has confirmed on 15 December 2022 that it will be fully funding the EpiPen^® brand of adrenaline autoinjectors from 1 February 2023, which will benefit thousands of New Zealanders. To read more go to https://www.allergy.org.au/about-ascia/info-updates/pharmac-to-fund-epipen-for-severe-allergies-from-1-february-2023

1st September 2021

31st August 2021

There is a good supply of long dated EpiPen^® and EpiPen^® Jr in Australia currently and in the foreseeable future.  Viatris has worked hard to secure good quantities of EpiPen^® in wholesalers and pharmacies with stock dating into late 2022 and early 2023.

16th June 2021

With long-dated EpiPen^® Junior autoinjectors now available in Australia, Viatris has seen an unprecedented demand for the product at pharmacy level in the last two months. Demand has been up to three-fold the normal levels, and as a result Viatris has taken the responsible position and action to temporarily limit supply of bulk orders into the market. This will help to ensure longevity of supply.

Viatris has been working hard to ensure supply of additional EpiPen^® Junior autoinjectors, and these have been shipped to the various wholesalers and pharmacies nationally throughout Australia. We are continuing to transport additional quantities to the market and will continue to do so into the near future.

As with all medications, supply will vary by suburb and pharmacy. If a pharmacy is out of stock, they should contact the EpiPen^® Hotline 1800 931 625 to place a back order.. 

9th June 2021

EpiPen Jr had a 3 day limited supply due to an unprecedented increase in demand over the past month. However, new long dated stock (exp July 2022) is being shipped to wholesalers from Thursday 3^rd June. Stock should be available at pharmacies now, but depending on the state and pharmacy wholesaler, it may be a few more days.

Pharmacists are advised to place a backorder with their preferred wholesaler in line with their usual demand.

4th February 2021

There are NO shortages of EpiPen® or EpiPen® Jr adrenaline autoinjector devices in Australia or New Zealand.  EpiPen® Jr expiry dates may be shorter than in previous years, due to COVID-19 related supply issues. Two new replacement devices can be prescribed on the PBS by a GP or specialist in Australia within 12 months if the devices are due to expire or have been used.  

4th September 2020

The adrenaline shortage reported on the TGA website is for adrenaline ampoules, NOT adrenaline autoinjectors. https://apps.tga.gov.au/Prod/msi/Search/Details/adrenaline-epinephrine

9th March 2020

Mylan Australia has advised that despite there being sufficient supply of EpiPen®. unprecedented, disproportionate demand has meant that some pharmacies are experiencing supply delays and are seeing stock outages at some wholesalers,  

To ensure equitable distribution of EpiPen® nationally, Mylan has commenced controlled supply to pharmacies. Pharmacies now need to call the Mylan EpiPen Customer Service hotline on 1800 931 625 to place an order for EpiPen®.  Only orders placed by pharmacies via Mylan will be processed and stock will still be delivered to pharmacies via wholesalers. 

25th February 2020

Mylan Australia has advised that there has been sufficient supply of EpiPen® Jr 150 microgram adrenaline autoinjectors since early February 2020 at wholesalers and at Mylan’s warehouse to meet current patient needs in Australia.

Orders from wholesalers and pharmacies are being filled as they are received. As a result, EpiPen® Jr has been removed from the Therapeutic Goods Administration (TGA) Medicines Shortage Information Initiative website. https://apps.tga.gov.au/prod/MSI/search#search-msis 

There are currently no supply shortages of EpiPen® 300 microgram adrenaline autoinjectors in Australia or New Zealand.

Mylan Australia’s dedicated, toll-free EpiPen Customer Service hotline 1800 931 625 remains up and running for any enquiries.

To ensure that supply channels are aware of this news, Mylan has emailed the attached notice to pharmacists. The notice is also being distributed by the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia.

EpiPen supply update 24 Feb 2020

PBS Listings

PBS listings for EpiPen^® or Anapen^® adrenaline injectors in Australia allow a maximum quantity of two auto-injectors, and both of these require an authority approval. When accessing the PBS website http://www.pbs.gov.au/medicine/item/8698T it is important that prescribers are aware that they have to click on “Note” on the top left hand side of the webpage, to access the following information:

For more information go to https://www.allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-prescription

FDA report about EpiPen^® 

27 March 2020

EpiPen US HCP letter statement194.89 KB30/03/2020, 12:14

Mylan has issued this letter in response to the recent announcement by the Food and Drug Administration (FDA) about safety issues for some EpiPen®, EpiPen® Jr, and generic products on the the FDA website  This announcement relates to device malfunctions and user administration that may cause product safety issues with some EpiPen® and EpiPen® Jr, as well as their generic products. 

On 24^th March 2020 Pfizer and Mylan published a notification in the US about a very limited number of cases in which the administration of EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg autoinjectors, and their authorised generic versions of these strengths, may potentially be delayed or prevented.  This notification resulted from routine studies and evaluation of real-world data that Mylan and its manufacturing partner Meridian Medical Technologies, a Pfizer company, undertake about how healthcare professionals, patients and carers administer EpiPen®, which is a critical life-saving device. 

The information in this notification serves as an important opportunity to provide precautionary handling instructions and remind people with severe allergy and their carers about the correct administration of EpiPen^®, and recommendation to carry two EpiPen^® or EpiPen^® Jr autoinjectors or the authorised generic version at all times. Potential issues and user errors are listed below.

1. Device failure from activation caused by sideways force to remove blue safety release

In Australia and New Zealand there have been no reports of problems with the removal of the blue safety release. The advice in Australia and New Zealand is to hold the device in one hand (fist around the device) and remove the blue safety release with the other hand. Removing the blue safety release using sideways forces may activate the EpiPen prematurely. To prevent this premature activation, patients and their carers should to follow the clear instructions on how to use EpiPen^® on the ASCIA website. https://www.allergy.org.au/hp/anaphylaxis

2. Device failure from inadvertent or spontaneous activation due to raised blue safety release

In a very limited number of cases, EpiPen^® devices may have a blue safety release that is slightly raised. The function of the blue safety release is to ensure the device does not activate prior to its intended use. It should not be removed until the time of use. If the blue safety release is raised the device may activate prematurely, which could potentially delay or prevent emergency treatment when needed.

If the blue safety release is raised, the autoinjector should NOT be dispensed or used, since premature activation may occur. Internal testing has shown that the probability of a raised blue safety release at 4.6 mm (height of the raised safety pin in the image below) resulting in spontaneous activation rate is 4 units in 1 billion. If the blue safety release is raised, contact Mylan (In Australia: 1800 274 276; In New Zealand: 0800 579 811), to obtain a replacement device at no additional cost. Return the device to the tube and close the lid. Do not attempt to force the blue safety release back down.

3. Difficulty removing the device from the carrier tube

EpiPen® marketed in Australia and New Zealand is labelled and packaged in Australia using a different packaging process, so this issue is not relevant in Australia or New Zealand.

4. Certain identified use errors

The issues identified in the US are not relevant in Australia or New Zealand because administration guidelines in Australia and New Zealand do not recommend the swing and jab technique, that is used in the US.

Note: If you think you may be experiencing a side effect to a medicine or a problem with a medical device, seek advice from a health professional as soon as possible. Mylan and the TGA collect adverse event reports to monitor the safety of medicines and medical devices, but cannot provide you with healthcare or health advice. If you would like to report a side effect or a product complaint, please email or telephone Mylan at:  This email address is being protected from spambots. You need JavaScript enabled to view it. or 1800 274 276 . 

You may also report a side effect to a medicine directly to the TGA. For more information on how to report side effects to the TGA go to: https://www.tga.gov.au/reporting-problems

Process to follow during shortages  

There are now two suppliers of adrenaline injectors:

• Viatris - supplier of EpiPen^® and EpiPen^®Jr in Australia and New Zealand.
• Allergy Concepts - supplier of Anapen^®500, Anapen^®300 and Anapen^®150 in Australia.

Have two brands should prevent shortages and therefore ensure that people at risk of a potentially life-threatening allergic reaction (anaphylaxis) have access to the emergency treatment.

To ensure people at risk of anaphylaxis have access to the treatment they may need if there are future shortages of both brands:

• Only one injector per patient is usually dispensed and supply may be restricted to patients with an injector prescription for a new diagnosis, or because their injector has expired or has recently been used. 
• Schools and children's education/care (CEC) centres should not request additional injectors to be brought to the school or CEC centre for each child at risk of anaphylaxis, and should limit the replacement of general use injectors. 

Whilst the use of an expired adrenaline injector is not ideal, research suggests that recently expired devices retain potency. Therefore, if no other autoinjector is available, use of a recently expired injector to treat anaphylaxis is advised, as stated on the ASCIA website allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-storage-expiry-and-disposal

Adrenaline injector dose guide

• Anapen^® 500 (500 micrograms) are usually prescribed for adults and children over 50 kg.
• EpiPen^® (300 micrograms) or Anapen^® 300 are usually prescribed for adults and children over 20 kg.
• EpiPen^®Jr (150 micrograms) or Anapen^® 150 are usually prescribed for children 7.5-20 kg. Children under 7.5kg are not usually prescribed an adrenaline autoinjector.  

Content updated January 2024