By Dr Peter Moodie, College Clinical Advisor
5 July 2022
A recent coroner’s report has highlighted the need for a management plan to ensure that important tests like INRs for patients on warfarin are carried out in a timely manner and that those test results are acted upon. Practice protocols are critical if this is to occur.
The case involves an 83-year-old Tongan woman who sadly died in September 2021, suffering from multiple intracranial haemorrhages and an epidural haematoma. There was also suspicion of an underlying intracranial metastatic disease. She had a past history of atrial fibrillation, biventricular heart failure with pulmonary artery hypertension, tricuspid incompetence and type 2 diabetes. She had been taking warfarin since 2016.
The patient had been admitted acutely some 13 days before her death, with deteriorating consciousness and back pain. Along with the brain haemorrhages she was found to have an INR of over 10.
The patient was admitted to hospital in September 2021; however, her last INR test was carried out some 18 months previously in March 2020. Notwithstanding she had been given five repeat prescriptions for warfarin from three health practitioners at the practice. During this same time four unrelated blood tests were requested without an INR.
The coroner’s formal finding was:
“The cause of death was multiple intracranial haemorrhage and epidural haematoma with suspected underlying intracranial metastatic disease. Her supratherapeutic INR level as a result of her warfarin medication was an antecedent cause”. The coroner identified that the patient should have had her INR tested routinely as part of her prescribing. The expert advice to the coroner identified that monitoring the INR was a fundamental part of patient care.
The practice acknowledged that prescribing without the appropriate testing should not have happened and explained that the failure had occurred as a result of a “breakdown in communications”.
Unfortunately, the coroner did not delve deeper into what and how this “breakdown in communications” had occurred. It is only by exploring these issues that others can learn from the tragedy. The practice and practitioners accepted the coroner’s criticisms of the care provided to the patient and the practice has now put in a number of processes in place to ensure this does not occur again.
It is a shame that a case like this has to occur to highlight that there is a responsibility for practitioners and practices to have clear protocols around the management of important medications such as warfarin.
Communicating effectively to ensure continuity of care, especially in patients with chronic conditions is essential in situations where there are multiple clinicians providing care to the patient.
The tragic, but avoidable outcome was a failure to adhere to basic standards of care when prescribing warfarin. Practices and practitioners can create an environment where the risk of a similar error occurring can be minimised.
Maintaining professional responsibility, ongoing professional scrutiny and professional development ensures there is an awareness and adherence to best practice. Practices must implement processes to ensure critical testing is carried out.
The coroner has stated:
“I do however consider it appropriate to draw the importance of INR monitoring when prescribing warfarin to the attention of all general practitioners” and “further guidance is available on BpacNZ. I direct that these findings be provided to College of General Practitioners for dissemination amongst its members.”
Quality Programmes comment on INR testing and warfarin prescribing.
The Foundation Standard includes several touch points to ensure good practice processes are in place to help support both individual clinicians and practices against cases with fatal outcomes.
Indicator 1: The Code of Health and Disability Services Consumers’ Rights, 1996
The patient is entitled to the right to effective communication and the right to be fully informed.
Indicator 5: Continuity of care
Requires a documented clinical correspondence and investigations policy and procedure be in place. This policy includes how the practice manages and tracks their laboratory results as well as other types of clinical correspondence.
Indicator 9: Prescribing and medicine reconciliation
requires practices to have a documented repeat prescribing policy and procedure. Regular auditing against the policy would have helped identify any adherence discrepancies and possibly caught this earlier.
Indicator 13.3.The practice complies with National Adverse Events reporting policy
Practices should be following The National Adverse Events Reporting Policy 2017 , Once a significant event occurs and is reported, the practice initiates a quality improvement process, identifying, analysing and correcting the risk of reoccurrence.
The scenario presented here demonstrates that if a practice adheres to the requirements of the Foundation Standard and keeps these requirements up to date, the level of care they are delivering should not only be safe and of a high quality but also safeguard against unfortunate events such as this happening.
Practical tips for checking the practice’s anticoagulation therapy management
Review the practice’s current system with the clinical governance team and determine:
- Is there a current documented process on how INR management occurs in the practice?
- Is the process concordant with best practice?
- Is there regular auditing to identify patients who should be having INR testing and those who have been missed?
- Would the practice benefit from having practice nurses trained to manage INR and anticoagulation titration using standing orders?
- Is medicines reconciliation occurring in a timely way from secondary to primary care, especially with anticoagulation treatment?