Safety and quality update: October 2022

14 October 2022

New this month: safety alerts; ranitidine supply suspension; reminder on serotonin syndrome; MBS telehealth services; WA end of life care; Vic duty of candour; events; and more.

Safety alerts 

• AU recall: AMSORB PLUS Prefilled G-Can 1.0L anaesthesia absorber cartridge, possible gas leakage 

See all Safety alerts 

Ongoing suspension of ranitidine supply 

Background 

Products containing ranitidine were recalled and subsequently removed from sale globally in 2019 to 2020 due to the detection of low levels of an impurity called N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. 

The Therapeutic Goods Administration Australia (TGA) suspended all products containing ranitidine from the Australian Register of Therapeutic Goods (ARTG) in April 2020. Medsafe allowed consent to market in New Zealand to lapse for ranitidine-containing products on a product-by-product basis from 2019 to 2021. 

New developments 

In late September 2022, the TGA’s online list of ARTG medicines suspensions appeared incorrectly to show that many ranitidine products were no longer suspended as of June or July 2022. However, the TGA has advised ANZCA that all such suspensions have been renewed for a further standard term of six months, and remain current until at least December 2022 or January 2023. 

Recommendations 

ANZCA recommends assuming medications containing ranitidine will remain unavailable unless advised otherwise.  

There are few alternative histamine H2-receptor antagonist (H2 blocker) medicines currently available in intravenous (IV) fluid form. Known options include: 

• In Australia, no H2 blockers in IV fluid form appear on the ARTG. However, some jurisdictions have arranged supply of famotidine IV fluid via the TGA Special Access Scheme. 
• In New Zealand, the Pharmac Hospital Medicines List includes famotidine injection fluid 10 mg per ml, 2 ml vial or 4 ml vial. 

For further alternatives to H2 blockers for aspiration risk management during anaesthesia, please refer to the article Aspiration under anaesthesia: risk assessment and decision-making.   

More information 

For more information, refer to: 

• Therapeutic Goods Administration, Australia. Safety Alert: Ranitidine: Update 2 - contamination with N-nitrosodimethylamine. Published: 27 October 2020.  
• Medsafe New Zealand. Alert: Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA). Revised: 26 January 2021. 
• European Medicines Agency, Ranitidine-containing medicinal products: EMA confirms recommendation to suspend all ranitidine medicines in the EU. Last updated: 5 January 2020.  
• Robinson, M, Davidson A. Aspiration under anaesthesia: risk assessment and decision-making, Continuing Education in Anaesthesia Critical Care & Pain, Volume 14, Issue 4, August 2014, Pages 171–175, https://doi.org/10.1093/bjaceaccp/mkt053 

Reminder on serotonin syndrome from combining opioids and serotonergic medicines 

A recent article in Medsafe New Zealand’s Prescriber Update provides a helpful reminder on the risk of serotonin syndrome in patients taking both opioids and serotonergic medicines.  

Pethidine, dextromethorphan and tramadol are the highest risk opioids for serotonin syndrome when used with serotonergic antidepressants. 

Read more 

WebAIRS article on corneal abrasions 

An article titled ‘Perioperative corneal abrasions: A report of 42 cases from the webAIRS database’ Matthew R Bright, Leigh D White, Sandra I Concha Blamey, Yasmin Endlich, and Martin D Culwick, has recently been published in the ASA journal Anaesthesia and Intensive Care. 

Corneal abrasions are an uncommon complication of anaesthesia. The aim of this study was to identify potential risk factors, treatment and outcomes associated with corneal abrasions reported to the web-based anaesthesia incident reporting system (webAIRS), a voluntary de-identified anaesthesia incident reporting system in Australia and New Zealand, from 2009 to 2021.  

Visit the webAIRS website to register to report anaesthetic incidents. 

Read article  

Ongoing MBS specialist telehealth arrangements fact sheet 

Arrangements for Medicare Benefits Schedule Australia specialist telehealth services by video and telephone became permanent on 1 July 2022. 

Read more 

Western Australia end of life and palliative care training framework 

On 23 September 2022, the Western Australian Department of Health launched a campaign to raise awareness and improve understanding of palliative care in the community. 

This follows the creation in April of the WA End-of-Life and Palliative Care Education and Training Framework, a resource for all health professionals, staff and organisations that care for people with end-of-life and palliative care needs.  

View framework 

Victorian Statutory Duty of Candour and protections for adverse event reviews – new resources 

The Health Legislation Amendment (Quality and Safety) Act 2022 introduced reforms that will come into effect in Victoria on 30 November 2022. The reforms create a statutory duty of candour for Victorian health services towards patients and their next of kin/carers when patients suffer a serious adverse patient safety event while receiving health services. 

Safer Care Victoria has published new guidance documents and resources. Recordings from the recent webinars for metro public health services, rural and regional health services, and private health services, are also available to view. 

View resources 

Save the date: HQSC New Zealand Quality Improvement Scientific Symposium | Purihia te rā: Wānanga Pūtaiao hei whakapai kounga 

The Healthcare Quality and Safety Commission New Zealand’s Quality Improvement Scientific Symposium (Purihia te rā: Wānanga Pūtaiao hei whakapai kounga) will take place on 10 May 2023 at the Holiday Inn Auckland Airport. 

Abstract submissions open on 17 October 2022 and close on 10 February 2023. 

More information 

SPANZA ANZAPS 2022 joint conference on paediatric anaesthesia and surgery 

The Society for Paediatric Anaesthesia in New Zealand and Australia (SPANZA) and the Australian and New Zealand Association of Paediatric Surgeons Inc (ANZAPS) would like to invite you to their 4th combined conference on 27 – 30 October 2022 in Sydney. Topics include reconnection following the pandemic, trauma, gender equality, simulation training, intercollegiate co-operation and multidisciplinary teams. 

Register