Safety and quality update: Feb 2021

16 February 2021

Pharmac fund empagliflozin; TGA personalised medical devices; latest Australasian Clinical Indicator Report; PBS/RBS mandatory active ingredient listings; and webAIRS update.

Your monthly digest of developments in safety and quality.

Pharmac fund empagliflozin

Surgery was postponed recently in a metropolitan hospital in New Zealand as it was discovered the patient was taking empagliflozin, a newly funded treatment for type 2 diabetes. Up until now this medicine hasn’t been subsidised by New Zealand’s drug buying agency, Pharmac.

Pharmac made the decision to fund SGLT2 inhibitor empagliflozin (Jardiance) and empagliflozin with metformin (Jardiamet) from 1 February 2021 after a broad consultation.
SGLT2 inhibitors were the subject of an ANZCA co-badged alert and media release with Diabetes Australia last year but at that time it was aimed at Australian anaesthetists and patients as the drug was not subsidised in New Zealand..
ANZCA alerted Pharmac to the fact that the funding of this drug, without an alert to the appropriate clinicians, has meant delays in surgery. Pharmac has taken this feedback on board and has updated the information on its website to note the risk of diabetic ketoacidosis (DKA) associated with SGLT-2 inhibitors, and directing prescribers to the relevant information on the Medsafe website. If you want to subscribe to receive notifications from Pharmac directly you can do so here.
SGLT2i carry a small but definite risk of severe DKA. Sometimes this DKA is associated with near normal or only mildly elevated blood glucose levels (i.e. euglycaemic ketoacidosis [euDKA]). The risk is increased if the patient has been fasting or has very restricted dietary intake, has undergone bowel preparation and/or a surgical procedure, is dehydrated or has an intercurrent illness such as active infection.

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TGA personalised medical devices 

The Therapeutic Goods Administration (TGA) has updated regulatory requirements for personalised medical devices. From 25 February 2021, personalised medical devices will be regulated differently depending on which of the TGA definitions they meet.

Most devices currently supplied using the “custom-made medical device” exemption will now be classified as “patient-matched medical devices”, meaning they will need to be included in the ARTG before they can be legally manufactured, imported or supplied in Australia.

There will be a transition period until 1 November 2024 for currently supplied in Australia under the custom-made medical device exemption. You can find further details about the changes on the TGA website.

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Latest Australasian Clinical Indicator Report released

The Australian Council on Healthcare Standards (ACHS) has published the Australasian Clinical Indicator Report 21st Edition 2012-2019 (ACIR). The ACIR summarises clinical indicator data submitted to the ACHS clinical indicator program and highlights significant trends and variations in the data over time. 

Associate Professor Joanna Sutherland, deputy chair of the college’s Safety and Quality Committee, chaired the ACIR Anaesthesia and Perioperative Care Clinical Indicator working party. Her expert commentary appears as an introduction to the chapter on Anaesthesia and Perioperative Care clinical indicators. Further information and a full retrospective report for each clinical indicator set is available on the ACHS website.

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Mandatory active ingredient listings from 1 February

From Monday 1 February 2021 regulatory changes came into effect in Australia meaning PBS (Pharmaceutical Benefits Scheme) and RPBS (Repatriation Schedule of Pharmaceutical Benefits) prescriptions now need to include information about the active ingredients in each medicine. 

The NPS MedicineWise active ingredient prescribing information hub contains further information and resources, including a fact sheet for prescribers.  

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WebAIRS update

Medication is the third most common category of incidents reported to webAIRS and forms 16 per cent of all the incident reports. However, whilst many of these are related to errors of commission, such as look-alike ampoules, syringe swaps and distraction, there are still a number that are errors of omission.

The Australian and New Zealand Tripartite Anaesthetic Data Committee (ANZTADC) Publications Group have recently added a case to the Advisory Notices for Anaesthetists (ANA) - Alerts, on the webAIRS website, and a summary will be included in the Autumn issue of the ANZCA Bulletin.
To view the ANA -Alerts, please login or register webAIRS website or contact

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Last updated 12:27 23.03.2021