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Treatment injury case study
January 2013 – Issue 51
Sharing information to enhance patient safety
Reporting belief of risk
of harm to the public
EVENT: INJURY: Medication Events
Case Study
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.
Introduction
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.
ACC has two key legislated roles in relation to treatment injuries, which are:
Who is ‘causing’ the injuries?
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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?
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.
Top 6 reported adverse treatment events: 2011–2012
Nursing care
Adverse drug reaction
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?
Delay/failure
Medication omissions
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
Equipment mechanical failure
Hip/knee surgery/replacement
Delay/failure: the legislative definition of treatment 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 www.acc.co.nz/for-providers/clinical-bestpractice/case-studies/index.htm.
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.
Case study
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).
Medication Events
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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)
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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)
Antibiotic-related omissions
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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)
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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.
Anticoagulant-related omissions
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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
How ACC can help your patients following treatment injury
Many patients may not require assistance following their treatment injury.
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
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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.
Analgesics (8)
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Fentanyl – toxicity
Analgesic-related omissions
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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.
Antimetabolites (5)
•Methotrexate:
• 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
Antimetabolite-related omissions
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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.
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:
About this case study
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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.
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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.
ACC6580 ©ACC 2013
Printed in New Zealand on paper sourced from well-managed
sustainable forests using oil free, soy-based vegetable inks.
The case studies are produced by ACC’s Treatment
Injury Centre, to provide health professionals with:
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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: [email protected]