Balancing act: the next stewardship

Clinical
By
Jennifer Cooke
-

Anticoagulants remain a leading cause of medicine-related harm. As use grows and care becomes more fragmented, anticoagulation stewardship is emerging as the next critical medicines safety focus.

Anticoagulants are used by millions of people around the world to prevent or treat cardiac and vascular disorders, including blood clots that form in patients with atrial fibrillation (AF).1

The use of anticoagulants to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), known collectively as venous thromboembolic (VTE) disease, is expected to at least double by 2050 due to the ageing population, rising rates of obesity and comorbidities, and increased hospitalisations.1

While these beneficial drugs are essential to save lives, they have known risks.2 In Australia, the rate of PE after hip or knee replacement for people aged 15 or older was 556 per 100,000 hospitalisations in 2020, the second highest among the OECD countries
that submitted data.3

Heparins and vitamin K antagonists such as warfarin have been used for decades. Warfarin, once the only oral anticoagulant, is no longer first-line therapy for most indications, partly due to its frequent monitoring requirements and complex dose adjustments.

The advent more than a decade ago of direct-acting oral anticoagulants (DOACs), and their inclusion on the Pharmaceutical Benefits Scheme in 2013, introduced a perceived convenience and safety, but also a complexity into thrombotic reduction and prevention.1

DOACs, such as apixaban, rivaroxaban and dabigatran, now dominate prescribing patterns. They are also a common reason for medicine-related harm, both in and out of hospitals, due to underdosing (inadequate prevention of thromboembolism or stroke), or overdosing, which can cause bleeding.1,4,5

The Australian Commission on Safety and Quality in Health Care (ACSQHC) has identified anticoagulants, all of them high-risk medicines, as a leading contributor to medicine-related harm.6

Much of that harm, anticoagulation stewardship pharmacists agree, can be prevented.

What is anticoagulation stewardship (ACS)?

Dr Adam Livori, Senior Pharmacist at Grampians Health in Victoria and a Research Fellow at the Baker Heart and Diabetes Institute, suggests it might be viewed like this.

Unlike anticoagulation management, which is ‘reactive’ to a situation – ‘something happens, we start a medication, we see what happens’ – anticoagulation stewardship is ‘proactive’ and systems-based.

In 2017, members of the Health Services Medication Expert Advisory Group of ACSQHC and other stakeholders raised concerns that incidents involving anticoagulant medicines were rising. Thereafter, mainly hospital-acquired complications of bleeding were studied from 2017 to 2020, resulting in the 2021 National Anticoagulant Incident Analysis.6

In that report, the ACSQHC reviewed a random 350 of the 3,580 incidents reported nationally relating to anticoagulant management.

The most common adverse events reported in that 4-year period were an omitted or incorrect dose by nursing staff, and duplicate therapy involving inappropriate concomitant DOAC and heparin-based anticoagulants by prescribers.6

Harm can be caused by duplication of therapy, for instance, with patients unintentionally given a therapeutic dose on top of a preventive dose of anticoagulation. Failure to adjust an anticoagulant dose that aligns with patient factors that could change, such as haematology parameters, biochemistry, estimated creatinine clearance and age, can also harm patients.4

Box 1: Definition of anticoagulation stewardship (ACS)

A multidisciplinary, holistic approach to anticoagulation management that spans the continuum of care. It includes coordinated, efficient and sustainable patient- clinician- and system-level initiatives designed to achieve optimal anticoagulant-related health outcomes and minimise avoidable adverse drug events.

Why is ACS necessary?

Work in this growing field has been in motion for decades. However, the term ‘anticoagulation stewardship’, modelled particularly on the successful antimicrobial stewardship, became more common with the introduction of DOACs in the mid–2010s.

Anticoagulant use has risen rapidly, along with the variety of indications for which DOACs are prescribed – most recently in specialised populations with chronic kidney disease and
liver impairment.

Dosing is complex, and significant harm can result from errors in prescribing, dispensing or administration of DOACs, according to Julianne Chong, VTE/Anticoagulation Stewardship and QUM Pharmacist at Concord Repatriation General and Canterbury Hospitals in Sydney.

‘Proactive healthcare facilities have seen the need to address the potential harms from anticoagulants and have developed anticoagulation stewardship programs as a result,’ she says.

Alfred Health in Victoria established Australia’s oldest such program in 2017, followed by the Sydney Local Health District in New South Wales 2 years later. Northern Health and Monash Health began theirs in Victoria in 2020 and 2022 respectively.

‘Facilities can see the financial benefits [of stewardship] through reduced jurisdictional financial penalties for hospital-acquired VTE and reduced health-system costs resulting from in-hospital incidents relating to anticoagulation,’ says Ms Chong.

Case study: Metro South Health, Brisbane

Queensland’s first anticoagulant stewardship (ACS) service started in April 2025 and secured permanent funding in February 2026.

A small team has made demonstrable inroads using an electronic risk stratification dashboard. Conducting thrice weekly virtual multidisciplinary rounds led by advanced pharmacists and senior haematologists, the ACS team comprises one full-time equivalent (FTE) senior pharmacist (job-shared between two) and a 0.8 FTE haematologist (split between three specialists) across Metropolitan South Health hospitals (Princess Alexandra, Queen Elizabeth II Jubilee, Redland, Logan and Beaudesert Hospitals).

Although not operating bedside, and not resourced for on-call cases, of the more than 2,000 patients over the four hospitals per day, the team covers about 1,200 inpatients prescribed anticoagulants and who are then screened for high- or low-risk status.

Working Monday to Friday from 8.00 am to 4.00 pm, they use an electronic dashboard (see above) to enable real-time interventions and collaboration by prioritising high-risk patients requiring proactive ACS review according to criteria including:

  • concurrent use of >2 anticoagulants
  • impaired renal function (eGFR<30 mL/min/1.73m2 while prescribed an anticoagulant
  • platelet count <50 x 109/L with anticoagulant therapy
  • body weight >120 kg or <45 kg
  • warfarin titration (particularly initiation or re-initiation)
  • non-standard anticoagulants (e.g. bivalirudin, fondaparinux, argatroban, danaparoid). 

Results so far:

  1. Emerging reduction in anticoagulant-related bleeding and VTE rates.
  2. Reduction in lower-severity anticoagulant-related incidents – the new ACS program is preventing a lot of near misses or low-harm events, which could potentially then lead to more acute events.
  3. No increase in high-severity events – permanent or irreversible harm from anticoagulation events.

The aim is to reduce hospital-acquired clots as much as possible, ‘but it will never be zero,’ says Vivienne Klyza, Advanced Pharmacist at the Anticoagulation Stewardship Service, Metro South Health. ‘You’ll never get none.’

She is also – with Hadley Bortz, Alfred Health Anticoagulation Stewardship and Haematology Pharmacist – co-chair of the Anticoagulation Stewardship Network, under the Thrombosis and Haemostasis Society of Australia and New Zealand (THANZ).

Strategies for stewardship programs to support safe prescribing and management of anticoagulant medicines were devised during the ACSQHC period of analysis between 2017 and 2020. These included local anticoagulant incident data analysis, electronic medication management, education strategies and alerts, notifications and audits of appropriate use of anticoagulants.6

Moves towards mandating

Momentum has been building for mandatory ACS, Ms Chong and Mr Bortz agree.

In 2021, Victorian pharmacists and clinicians proposed a ‘AAA stewardship’ to manage high-risk medicines with dedicated antimicrobial, anticoagulation and analgesic stewardship programs.7

As roles have evolved in recent years, pharmacists and specialists are not ‘just’ reviewing anticoagulants themselves, says Mr Bortz. They are also reviewing compression stockings and devices such as inferior vena cava filters – blood clot-catching cage-like devices inserted into the large vein in the abdomen – as well as intermittent pneumatic compression devices, which are important in preventing VTE in hospital, particularly in patients with intracranial haemorrhage.

On a day-to-day basis, Mr Bortz says, ACS programs can include reviews of prophylaxis provided for patients in particular high-risk areas – to reduce VTEs in surgical patients, or dosing in obesity, or improving the appropriate management and monitoring of patients who develop a complex reaction to heparin, requiring alternatives.

A recent review of 28 studies on international ACS programs found anticoagulation stewardship programs improved the use of the high-risk medicines. And despite no standard method of implementation as yet, programs were recommended to be ‘embedded’ as an essential component of patient safety within hospitals.8

Biggest system failures?

Transitions of care remain a problem that’s largely unsolved, including inadequate handover, according to Vivienne Klyza, Advanced Pharmacist at the Anticoagulation Stewardship Service, Metro South Health, in Brisbane.

After a patient leaves hospital on a DOAC that was started during hospital admission, ‘in many cases the GP receives a discharge summary that mentions the drug but doesn’t explain the intended duration, what monitoring is needed, or what the plan is if renal function deteriorates’, she says. ‘The GP inherits a prescription without the clinical reasoning behind it.’

The harm is caused, she adds, because the handover was inadequate, not because the inpatient decision was wrong.

In relation to AF, challenges arise because there are so many nuances. Even with good evidence about dosing, there are frequent incidences of underdosing of patients with DOACs that have led to inferior outcomes, Mr Bortz points out.

Last year a major US study found that death, stroke and major bleeding in AF patients were more common outside of cardiology care, which is associated with improved guideline adherence and prognosis.9

‘DOACs are ubiquitous. They are used first line in most indications for anticoagulation, to the point where one of our clinicians says we should “put it in the water”,’ Mr Bortz says.

With DOACs now used in end-stage renal failure, obesity and niche populations where the evidence is grey, he adds that choosing the appropriate dose – and ensuring ‘we’re not under-or overtreating, that we’re using these agents on-label with good documentation’ – are where there may be gaps and areas for improvement in selective prescribing of DOACs.

Nobody owns the whole picture

Up to 2024, there were about 1,300 hospitals in Australia, just over 700 of which were government-run and administered over a total of 127 local hospital networks.10 A few of these networks include the 600-odd private hospitals across the country.

The core problem with anticoagulants appearing prominently in hospital incident reporting systems is ‘complexity meeting a fragmented system’, which can also vary between hospitals and states, says Ms Klyza.

‘A patient might have their anticoagulation initiated by a cardiologist, managed through a GP, adjusted by an emergency physician, and continued by a ward team who inherited the prescription without full context. 

‘Dosing errors, missed renal dose adjustments, inadequate bridging decisions and failure to recognise contraindications are all recurring themes,’ she says. ‘So, you’ll see these transitions of care being impacted – and it being where the risk is – because nobody owns the whole picture’.

Patient education

Multiple medicine specialties can be involved, which creates ‘a complexity around anticoagulation in itself’, says Ms Klyza.

‘DOACs arrived with a perception of simplicity that masked significant nuance around renal function, drug interactions, indication-specific dosing, and reversal.’

In the last decade, ‘more preventable medicine-related harm around anticoagulants’ has been seen as their use increased, she points out. The harm includes thrombosis, stroke, VTE and haematoma requiring intervention, such as internal bleeding into organs requiring hospital admission.

Importantly, monitoring in the community for those who take anticoagulants may be far less frequent than for inpatients.

In fact, says Dr Livori, a common misunderstanding patients have about DOACs when they present in community pharmacy is knowing exactly what their medicine is. ‘In my AF clinic, it is not uncommon for patients to have presented to hospital, been prescribed and dispensed a DOAC, and have not been told they are taking one!’

Another important delineation, he says, is the difference between taking a DOAC due to an active thrombus (clot) versus prevention of a theoretical thrombus (risk), which is more about patient understanding.

In his practice, Dr Livori finds patients are most often at risk of harm post-discharge. This is due to limited access to GPs (especially regionally) for ongoing medicines and long wait times. Additionally, hospital discharge summaries are often not provided to patients at all. Instead, they may be sent days or weeks later to GPs.11

Why, he asks, can’t it be mandated that the same data be sent to primary care pharmacists, giving them ‘the same rights to patient data that I am privileged to access in hospital settings?’

Patient education is vital

John, aged 91, has atrial fibrillation (AF) but forgot to take his cardiologist-prescribed twice-daily apixaban.

He can’t remember how many times this occurred in late 2025.

‘Not a lot, but maybe there were a few days I didn’t remember to take it,’ he told AP.

‘Nobody told me a few missed pills would be a big problem.’

Whatever had been missed was enough to cause a stroke when blood clots were embolised to his brain from a presumed AF event. It happened while John sat in his otolaryngologist’s waiting room. On waking him from apparent slumber, staff noticed he had trouble finding the correct door to the doctor’s office he had been attending for years. Then he did not appear to follow directions and was ‘just not himself’, the specialist recalled.

Later that day, still concerned about John’s abnormal behaviour, the specialist called and urged his patient to see a GP to obtain a referral for a scan.

‘I’ve just driven home,’ John told the shocked specialist. ‘Well, no-one told me not to,’ he said, recalling much later how he had made the journey home on ‘muscle memory’, unsure of which way to turn at each intersection during the 20-minute trip.

An MRI was performed the next day. It was compared to a similar scan 16 months before. Two ‘relatively acute’ infarcts were found in the cortex and right posterior of the hippocampus, which had the potential to affect his memory and vision.

After an eyesight test, a neurologist cleared John to resume driving 8 weeks later. A dose administration aid (DAA) was also introduced.

He cannot recall anyone but family members telling him, even since the stroke, about the importance of not missing his 12-hourly apixaban tablets.

He suggests that if the potentially dire consequences of non-compliance of any medicine were given in writing at the time of prescribing – or dispensing – it would help, as a note could be placed on a wall or near his new DAA.

 

Lagging behind

As a Churchill Fellowship recipient, Ms Chong visited both the US and the UK over 10 weeks in 2024.

In the UK, where ACS services have evolved since the mid-2000s, it is not uncommon to see multiple anticoagulant specialist pharmacists for one health system, she says. Each focuses on a different area of stewardship such as VTE, ward consults, outpatient clinics, research, and cancer-associated thrombosis.

In Australia, ‘we do need to provide the opportunity for community and GP pharmacists to upskill and be confident in anticoagulation management and to allow the continuum of care beyond the hospital, particularly post-discharge’, she says.

When Sydney Local Health District (Concord, Royal Prince Alfred, Canterbury, and Balmain Hospitals) first measured its stewardship in relation to risk-appropriate VTE prophylaxis, it reported significant increases in two key areas.

These were the prescription of risk-appropriate VTE prophylaxis (78–>88%) and VTE risk assessment (71–>93%) which followed ACS implementation of electronic clinical decision support, regular audits and performance feedback, health promotions, gamification, education and consumer awareness campaigns.12

Proactive approaches such as the Monash Health ACS service, which utilises an electronic anticoagulant dashboard, resulted in more than 700 pharmacist interventions on prescribing errors in its first 14 months, 48% of them on high-risk patients such as those with bleeding risk factors.13

At Alfred Health, an audit in the first year following its ACS program implementation in 2017 showed a 33% reduction in hospital-acquired VTE and a 20% reduction in anticoagulant-related bleeding.7,14

Moving ahead

Australia’s only anticoagulation stewardship guidance was released late last year by the Victorian Therapeutics Advisory Group (VicTAG).15 It provides a framework for healthcare facilities to establish new ACS services and recommends quality indicators to monitor success. It is similar to the US-based Anticoagulation Forum’s Advancing Anticoagulation Stewardship: A Playbook.16

Fifteen ACS programs have now been established in Australia, with Royal Melbourne Hospital starting its service this year.

Mr Bortz’s immediate wish list for anticoagulation stewardship consists of broadening scope, more consistent service provision between ACS sites, national surveys (as with antimicrobial prescribing) and a mandated national standard for hospital accreditation.

Of course, says Ms Klyza, ‘we definitely need more of us [ACS pharmacists]’ nationally. In addition, more resourcing and awareness of stewardships as an ‘upfront investment – a funded position, protected time and hospital commitment’ is needed.

‘The returns, while real, often materialise as events that don’t happen, which are notoriously difficult to cost and attribute,’ she says.

On the horizon, ACS services are anticipated to be recognised as best practice in the third edition of the National Safety and Quality Health Service (NSQHS) Standards under the Medication Safety (Standard 4). This is expected to be launched in 2028, with assessments starting in 2030. While not the same as mandating, it is moving forward, pharmacists agree.

VTE prevention, meanwhile, is a current clinical care standard that must be met by hospitals, general practice and other community settings.17

‘Anticoagulants are used nearly every day in every specialty in every hospital’, Ms Klyza points out. ‘Our stewardship is about managing them safely across the patient’s journey and through the health system.’

Or as Mr Bortz likes to quote a colleague: ‘Anticoagulant-related harm should have a similar policy to aviation – zero tolerance.’

References

  1. Burnett A, Rudd KM, Triller D. Advancing anticoagulation stewardship: a call to action for stewardship from the US-based anticoagulation forum. Thromb Update. 2022;9:100125.
  2. Anticoagulation Forum. About anticoagulation stewardship. 2026. At: https://acforum.org/web/stewardship-advancing-model.php
  3. Australian Institute of Health and Welfare. OECD health care quality and outcomes indicators, Australia 2022–23. 2024. At: https://www.aihw.gov.au/reports/international-comparisons/oecd-health-care-indicators-2022-23/contents/patient-safety
  4. NSW Government Clinical Excellence Commission. Anticoagulants. 2024. At: https://www.cec.health.nsw.gov.au/keep-patients-safe/medication-safety/high-risk-medicines/anticoagulants
  5. Osman R, Anderson J, Katelaris A, et al. Navigating the risk of stroke and bleeding in atrial fibrillation. Aust J Gen Pract. 2025;54(5):315-318.
  6. Australian Commission on Safety and Quality in Health Care. National anticoagulant incident analysis. 2021. At: https://www.safetyandquality.gov.au/sites/default/files/2021-10/national_anticoagulant_incident_analysis_report_final_acc.pdf
  7. Bui T, Bortz H, Cairns K, et al. AAA stewardship: managing high-risk medications with dedicated antimicrobial, anticoagulation and analgesic stewardship programs. J Pharm Pract Res. 2021;51:342-347.
  8. Silvari V, Crowley EK, Carey M, et al. Value of hospital anticoagulation stewardship programme: a systematic review. Thromb Update. 2024;14:100158.
  9. Camm CF, Virdone S, Jerjes-Sanchez C, et al. Association of care specialty with anticoagulant prescription and clinical outcomes in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry. Int J Cardiol. 2025;421:132866.
  10. Australian Institute of Health and Welfare. Hospitals. 2026. At: https://www.aihw.gov.au/hospitals/topics/hospital-resources/public-hospital-beds
  11. Livori A, Kuruppumullage R, Simmons M, et al. Evaluating the implementation of a rapid access atrial fibrillation clinic utilising a pharmacist-physician model of care. Res Soc Adm Pharm. 2025;21(7):528-538.
  12. Chong J, Curtain C, Gad F, et al. Development and implementation of venous thromboembolism stewardship across a hospital network. Int J Med Inform. 2021;155:104575.
  13. Raatnayake N, Leitinger E, Taylor S, et al. Dashboard-driven stewardship – a novel business intelligence dashboard complementing an anticoagulation stewardship service. Presented at: AdPHA Medicines Management Conference; 2024; Adelaide. At: https://mm2024.shpa.org.au/wp-content/uploads/2024/11/159-RATNAYAKE-Nadishani.pdf
  14. Ross K, Klyza V, Bird R, et al. Implementation of an anticoagulation stewardship service in Queensland using an electronic risk stratification dashboard. Presented at: AdPHA Medicines Management Conference; 2025; Melbourne.
  15. Victorian Therapeutics Advisory Group. Victorian guidance for anticoagulation stewardship programs. 2025. At: https://www.victag.org.au/Victorian_Guidance_for_Anticoagulation_Stewardship_Programs_FINAL_March_2025.pdf
  16. National Quality Forum. Advancing anticoagulation stewardship: a playbook. Washington (DC): National Quality Forum; 2022. At: https://acforum-excellence.org/Resource-Center/resource_files/1977-2022-08-24-063128.pdf
  17. Australian Commission on Safety and Quality in Health Care. Venous thromboembolism prevention clinical care standard. 2020. At: https://www.safetyandquality.gov.au/publications-and-resources/resource-library/venous-thromboembolism-prevention-clinical-care-standard-2020