In this ‘case study’ we would like to take the opportunity to overview ACC’s role in reporting the belief of risk of harm to the public, the events reported in the year to June 2012 and focus on medication-related reports of belief of risk of harm. As always, our intention is to inform as well as promote discussion and debate.
Event: Reporting belief of risk of harm to the public
Injury: Medication Events
ACC has two key legislated roles in relation to treatment injuries, which are:
- to assess, decide cover and then manage accepted claims for individual injuries
- to report a risk of harm to the public.
In 2005 the introduction of the treatment injury provisions and the removal of the medical misadventure criteria meant that ACC no longer considered medical error when determining cover. ACC’s reporting provisions were also changed.
In replacing medical error reporting with a belief of risk of harm to the public, ACC’s reporting obligations moved away from considering the actions of individual clinicians to considering treatment events and their outcomes. This translated adverse event notifications into a positive contribution to the wider adverse medical event reporting system within the health sector.
The majority of reports are issued to the Director General of Health (DGH). However, in some extraordinary cases ACC may also notify an individual health professional to their respective professional council/board. This occurs only where a claim has received peer external clinical advice that identifies that the care provided did not meet professional standards and guidelines, and where ACC can clearly identify the involved health professional.
How many notifications were made in 2011-12?
During the year to 30 June 2012, ACC issued 390 notifications of belief of risk of harm. This was an increase on 2010-11 (302), but is not dissimilar to the number of reports in 2008-09 (381) and 2007-08 (373).
How does this compare with claim numbers?
In 2011-12 ACC made 8,289 treatment injury claim cover decisions, of which 5,366 claims were accepted and 2,923 declined. Less than 1% of the decided claims resulted in a notification of belief of risk of harm.
Who received the reports?
The DGH received the reports with a facility identifier for all reportable events, whilst 160 notifications were sent to Medsafe, four to the Medical Council of New Zealand and two to the Midwifery Council of New Zealand. ACC did not give the DGH the names of any individual clinicians.
Where did the treatment injuries happen?
Overall, most reported events occurred in district health board facilities (250). The remaining 140 reported events occurred in the private sector, with the majority happening in private hospitals, general practice and residential care.
Can report numbers tell me where care is not safe?
No. ACC can only report the number of claims lodged/accepted and claims reported. We know we don’t get all eligible claims, so the data should never be used as an indicator of the quality of health care in New Zealand.
Who is ‘causing’ the injuries?
ACC’s role is to establish cover for an injury and, if accepted, provide assistance where necessary.
The focus of ACC’s reports is on the ‘what’, such as, “are there any patterns, such as types of treatment, particular equipment and specific medications?” Information can then be shared so that the health sector can focus on quality improvement and injury prevention.
OK, so what is being reported?
In the year to June 2012, 63 sentinel and 327 serious events were reported.
The pie graph below shows the six most frequently reported treatment events in the 2011-12 fiscal year.
Delay/failure: the legislative definition of treatment in jury includes “a failure to provide treatment, or to provide treatment in a timely manner”. The most frequently reported injuries in this group are disease progression (21) and pressure injury (48). Other reported injuries include birth-related hypoxic ischemic encephalopathy (6), blindness/visual disturbance (5) and stillbirth (3).
Case studies relating to these types of event were published in July 2009 (failure to follow up report results), June 2010 (delay in diagnosis of lung cancer), July 2010 (delay in treatment), August 2010 (delay in delivery) and April 2012 (delay in diagnosis of metastatic melanoma). All past treatment injury case studies can be found on the ACC website.
Nursing care: the majority of these notifications related to pressure injuries. Case studies relating to this issue were published in June 2009 and April 2011.
Equipment failure/breakage and hip/knee surgery/replacement: reported injuries included prosthetic failure (19) and metallosis (5). Case studies relating to equipment/prosthetic issues were published in November 2008 (gynaecological mesh) and June 2012 (metallosis reaction).
Overall, medication claims were the most frequently notified treatment events and are the focus of this case study. The reported medication claims included adverse reactions (80) and medication omissions (58) relating to prescribing (11), dispensing and formulation (14) and administration (33).
In the following overview the most frequently reported medication types and the associated treatment injuries are given. The information in the blue boxes has detail about medication omissions for each group.
Antibiotics (24 reports)
- The majority of reports concerning antibiotics were for adverse drug reactions, including:
- Augmentin – drug-induced hepatitis, renal failure and anaphylaxis
- Gentamicin – vestibular damage
- Ciprofloxacin – tendonitis/tendon rupture
- Nitrofurantoin – interstitial lung disease (case study September 2012)
- Documented previous cholestasis following flucloxacillin – fatal outcome after client given intravenous flucloxacillin for gout and then discharged with prescription for further 10-day course. Allergy was noted in the GP referral but the page with this detail was not in the hospital notes.
- Client had documented history of anaphylaxis to penicillin, but was prescribed Augmentin.
- Prescribed gentamicin 24-hourly, but was administered 12-hourly (no injury).
Anticoagulants (14 reports)
- Warfarin – cerebral haemorrhage/cerebrovascular accident (CVA), haematoma bruising
- Enoxaparin – haematoma, embolism, CVA and haemorrhage
- Warfarinisation for atrial fibrillation and aortic valve replacement. Therapy changed to dabigatran. Nine days later provider recognised there was no evidence supporting use of dabigatran with artificial valve patients and warfarin was restarted. Client admitted five days later with severe abdominal pain and an INR of 1.3. At laparotomy a portion of bowel was dusky (due to embolus noted on CT) and required excision. Expert advice was that, given the short timeframe for dabigatran effectiveness, the client should have had injectable enoxaparin to cover the period before the warfarin reached therapeutic levels.
- Over-coagulation with Clexane. History of valve surgery, client warfarinised. Admitted with myocardial infarction and International Normalised Ratio (INR) sub-therapeutic so Clexane commenced but was continued when INR therapeutic. Client developed haematomas over abdomen.
- One case relating to the Marevan recall.
- Warfarinised for atrial fibrillation and previous valve replacement. Commenced dabigatran and ceased warfarin. INR 1.3 on admission with severe abdominal pain – 3.5 is recommended with artificial valves. Injury was artery occlusion from an embolus due to inadequate anticoagulation.
- Client was administered five times the intended dose of warfarin. Usual dose 5 x 1mg tablets; however, this had recently been changed to 1 x 5mg tablet. Caregiver at residential facility gave 5 x 5mg tablets (no injury).
- Warfarin withdrawn prior to elective surgery and client was given bridging enoxaparin. warfarin was to be recommenced post surgery and enoxaparin was to continue until INR therapeutic. Despite instructions from surgeon and haematologist, the client was discharged on warfarin only. Client was admitted aphasic. Expert neurology advice confirmed stroke caused by a failure to administer properly the client bridging anticoagulation.
Antipsychotics (10 reports)
Antipsychotic -related omissions
- Given another patient’s medications, which included double the patient’s usual dose of clozapine. Admitted to emergency department (ED), drowsy but no physical injury.
- Given another patient’s clozapine by a visiting community mental health team nurse. Patient vomited, so was taken to ED. No physical injury.
- Patient given 450mg of clozapine, which was not a normal medication. The patient required overnight intubation and ventilation.
- Given another patient’s clozapine. Admitted overnight with sleepiness.
- Dispensed clozapine overdose by the pharmacist, who also delivered to the patient’s residence. Transferred to ED. No injury.
- Patient given another patient’s chlorpromazine rather than usual sodium valproate. Became drowsy and was admitted to ED, where the patient also had a grand mal seizure.
- Patient given 2.5mg of haloperidol rather than intended 0.5mg and developed a dystonic reaction.
- Patient dispensed 5mg of risperidone rather than usual 0.5mg in a blister pack. No injury.
- Nurse gave diluent without risperidone powder added.
- Prescribed prednisolone for dry cough but pharmacist dispensed risperidone 8mg. Child became sleepy and moody. On admission there was sinus tachycardia, oculogyric crisis, cyanosis and bronchospasm.
- Fentanyl – toxicity
- Given 100mg rather than 10mg of morphine. Next day drowsy with myoclonic jerks. Given 2mg of naloxone and admitted for observation.
- Given postoperative morphine with pre-used syringe of patient in next bed.
- Given 60mg of long-acting morphine rather than 10mg.
- Dispensed 300mg gabapentin tablets rather than usual 100mg (three times daily). Felt unwell and admitted for observation overnight.
- Dispensed and given 180mg of methadone rather than usual 30mg. Became dizzy with slurred speech. Admitted and treated with naloxone infusion
- Lung disease – no respiratory assessment prior to commencing treatment
- Idiosyncratic reaction resulting in paraplegia
- Neutropenic sepsis
- Disruption of viable intrauterine pregnancy not ectopic as diagnosed
- Dispensed 10 x 10mg tablets rather than usual 10 x 2.5mg. Client had toxic levels of methotrexate and required activate charcoal and folinic acid treatment. Mislabelling appears to have been the causal issue.
About this case study
This case study is based on information amalgamated from a number of claims. The name given to the patient is therefore not a real one.
The case studies are produced by ACC’s Treatment Injury Centre, to provide health professionals with:
- an overview of the factors leading to treatment injury
- expert commentary on how similar injuries might be avoided in the future.
The case studies are not intended as a guide to treatment injury cover.
Send your feedback to: TI.email@example.com
How ACC can help your patients following treatment injury
Many patients may not require assistance following their treatment injury.
However, for those who need help and have an accepted ACC claim, a range of assistance is available, depending on the specific nature of the injury and the person’s circumstances. Help may include things like:
- contributions towards treatment costs
- weekly compensation for lost income (if there’s an inability to work because of the injury)
- help at home, with things like housekeeping and childcare.
No help can be given until a claim is accepted, so it’s important to lodge a claim for a treatment injury as soon as possible after the incident, with relevant clinical information attached. This will ensure ACC is able to investigate, make a decision and, if covered, help your patient with their recovery.
Published 12/03/2013Share this