How I have used root cause analysis
| In this article, Graham Lavender,
a supplementary prescriber in a Southampton GP practice, describes
three cases in which medication reviews did not result in an intended
outcome and how applying root cause analysis allowed him to learn
from each |
The HOMER study,1 which reported on home-based
medication review by pharmacists, resulted in significant concerns over
the value and, indeed, safety of pharmacist medication review. The study
(a randomised controlled trial involving 872 elderly patients recruited
during an emergency admission) indicated a statistically significant
higher rate of hospital admissions as a result of pharmacist medication
review. Although the study design has been criticised,2 there has been
no detailed look at the individual pharmacist interventions that may
have resulted in the hospital admissions.
In recognition of the increasing clinical role of pharmacists, the Royal
Pharmaceutical Society issued a revised “Clinical governance framework
for pharmacist prescribers” in October 2005 (PDF 170K). One
recommendation of the framework is that pharmacist prescribing should
be considered
in clinical risk management programmes, including root cause analysis
(RCA). An RCA investigation traces the cause and effect trail from a
failure. It is a step-by-step method that leads to the discovery of a
fault’s first (or root) cause.
To date, no attempt has been made to identify the root cause of the increased
hospital admissions in the HOMER study and, until such an analysis is
made, no sound conclusions can be made on the validity of
the individual pharmacist interventions. Although RCA is not the only
clinical governance tool recommended by the Society, it has the advantage
over clinical audit, for
example, because it can analyse a sequence of events.
As a prescribing pharmacist of 30 months’ standing I have followed
the Society guidelines to assess clinical medication reviews that I have
carried out and which have resulted in other than the desired outcome.
The process is similar to a practice encouraged during my supplementary
prescribing course, in which the supplementary prescriber had to write
up and analyse all significant events. I continued with this practice
after the course, entering patient reviews in which a significant event
occurred, onto my online continuing professional development file. Significant
events are any incident where further reflection might be advantageous
in identifying not only the cause of an adverse incident but also any
training requirements and plans needed as a result.
RCA has enabled me to reflect in detail on medication reviews where the
outcomes were not as intended. For each case, a root cause can be identified
from an examination of the sequence of events and subsequent training
can be used to prevent a repeat occurrence. In two of these three cases,
the patients required secondary care and, although my GP practice was
happy with my reviews, it was shown that, in fact, it might have been
possible to avoid the hospital admissions. It should be noted that it
is not necessary to prevent the root cause from occurring — it
is merely necessary to break the chain of events at any point so that
the final “failure” does not occur, for example, with Mrs
KB (case 3), where there was the opportunity to break the sequence when
I later reviewed the patient.
For Mr TM (case 2) incomplete counselling skills were identified as the
root cause of the incident. Assumptions were made that the patient had
a good understanding of diabetes and a need to review the quality of
the information given to patients and to check their understanding was
identified.
RCA allows a detailed breakdown of a sequence of events and the identification
of the actual cause or steps in the sequence of events which might have
caused the adverse outcome. The HOMER study included no such analysis
and without one it is not possible to identify the root causes of the
increased hospital admissions. This reduces the validity of its conclusion
that pharmacist medication review increases hospital admissions. There
will always be adverse outcomes when a significant number of interventions
are made; the challenge is to identify the causes, recognise any training
needs and meet those needs.
Clearly if RCA identifies individuals with unacceptable numbers of adverse
outcomes and training is not addressing the problem, then questions must
be asked about the suitability of the individual for the role. With pharmacists
now taking on increasing roles, the potential for adverse outcomes is
ever present. Only by using tools, such as RCA, can we ensure that patients
have the quality of care they deserve and the profession of pharmacy
can meet the standards of care that its new roles demand. The value of
medication review as an opportunity to break the sequence of events leading
to an adverse outcome must be recognised as well as the inherent advantage
of regular medication review for all patients on regular medication.
References
1. Holland R, Lenaghan E, Harvey I, Smith R, Shepstone
L, Lipp A et al. Does home based medication review keep older people
out of hospital?
The HOMER randomised controlled trial. BMJ 2005;330:293.
2. Hay JW. Pharmacist medication review study design concerns. BMJ
2005;330:347.
Case 1: Stopping a patient's medicine in order to follow guidelines
Mrs JG, a 62-year-old female had had a gastroscopy two years ago,
which was normal aside from some gastric inflammation attributed
to the use of non-steroidal anti-inflammatory drugs. Her appointment
was part of a review of all patients on long-term proton pump inhibitors
(PPIs) using local guidelines similar to the National Institute for
Health and Clinical Excellence dyspepsia guidelines.
When I saw Mrs JG, she was taking omeprazole 20mg od, and co-proxamol
prn for intermittent osteoarthritis. No over-the-counter medicines
were being taken. In her notes, the gastroscopy report suggested
prescribing a PPI for four to six weeks to resolve irritation to
the gastric mucosa after which the drug was to be stopped and only
used if symptoms returned. However, it appeared from the patient’s
notes that she had been taking omeprazole 20mg for the two years
because no medication review had taken place (this in itself is an
example of why it is important to conduct regular medication reviews).
Having confirmed that the patient was asymptomatic it was agreed
that she would stop taking the omeprazole and this would be reviewed
at a later date. I was comfortable with this course of action because
there was no reason to continue a relatively powerful drug when,
in this case (ie, after gastroscopy), there was no indication of
long-term need, and I advised Mrs JG to return if she experienced
any gastrointestinal symptoms.
At a practice meeting some months later I was informed that Mrs JG
had been admitted to hospital with a gastrointestinal bleed but had
made a full recovery. I seemed to be the only one at the meeting
concerned that stopping her omeprazole had been the cause. The comment
by the GP prescribing lead was: “We looked at your intervention.
It followed guidelines. It was in the interest of the patient not
to have unnecessary medication and we have no problems with it. Unfortunately
any intervention you, or any of us, make can have adverse consequences
which, despite best practice, are simply unpredictable and should
not change practices unless evidence suggests otherwise.”
Initially, I was happy to accept the GP’s assessment, but when
I applied RCA a sequence of events that might have prevented Mrs
JG’s gastrointestinal bleed was highlighted. The step that
caused me concern was the sudden stopping of omeprazole after two
years’ continuous therapy. Although the local guidelines and
the gastroscopy report said that therapy should be stopped after
four to six weeks because the patient had been on omeprazole for
two years a slow reduction in the dose of omeprazole would have been
more appropriate. Although the literature is sparse on this point,
it could be assumed that the lower acid levels in the stomach as
a result of long-term omeprazole therapy might have led to some reduction
in gastric protection and a sudden
rebound in acidity may have had adverse
consequences. |
Case 2: Starting a patient on a new medicine for a newly diagnosed condition
Mr TM, a 69-year-old man who had been treated
for prostate cancer in 2004, had an appointment with me following
a raised fasting glucose
level and an HbA1c of 8.4. He had been first seen by a GP in my practice
(my independent prescriber) who agreed a clinical management plan.
I prescribed metformin 500mg tablets, one with breakfast for the
first week, adding one with the evening meal for the second week
and, finally, adding in one with lunch thereafter. The patient’s
BP measurements averaged 150/90 over the past three readings and
his cholesterol was raised but I explained that we were first going
to treat his high blood glucose levels before looking at his blood
pressure and then his cholesterol level. Mr TM had no questions and
I asked him to come back to see me in six weeks, following another
HbA1c test.
At the next appointment, however, his HbA1c was almost
the same (8.6) and before I could ask him any questions he said “I
took the course of tablets, am I now cured of diabetes?”
RCA requires a detailed record of events if the reason for an undesirable
result is to be determined. In this case, although the notes on
examination, therapy and goals were detailed, no record was made
of the counselling
I gave on starting the patient on metformin. Several weeks after
an event it is difficult to remember an individual consultation
but, given the sequence of events and the outcome, I am prepared
to admit
that I had not been clear about the long-term nature of the therapy.
It is relatively easy to make an assumption, based on your own
knowledge, but from a patient’s perspective there is no reason
to assume that a treatment is for life. My RCA for this patient
identified
a failure in my counselling. It indicated the need to be more specific
in future and, if necessary, to provide written instructions and
information.
|
Case 3: Learning to question an independent prescriber's decision
Mrs KB, a 76-year-old woman with a history of chest pain, had been
referred in 1999 to hospital for further investigation for heart
disease and, considering her symptoms and age, was prescribed aspirin,
a statin (simvastatin 40mg od) and an antihypertensive agent (losartan
50mg od). The result of an exercise test was equivocal and a follow-up
stress test showed no indication of cardiac ischaemia. However, the
hospital suggested that Mrs KB continue taking the aspirin, statin
and the antihypertensive as a precaution. The patient was a non-smoker,
with a body mass index of 24.
During the medication review, I found that, at the patient’s
request some months earlier, the GP had stopped prescribing aspirin.
This was because Mrs KB had experienced some bruising (a common side
effect in elderly people taking aspirin). She had no chest pain at
rest, but experienced tightness in the chest on excessive exercise,
which responded to glyceryl trinitrate. However, these episodes were
rare. BP was 148/90 and readings over the past 12 months had all
been in excess of 140/85. Electrolytes and renal function were normal.
I advised Mrs KB that, because of her high BP readings, we should
increase the dose of losartan to 100mg and to repeat electrolytes
and BP measurements after a month. I accepted the reason for stopping
the aspirin and recorded in the patient’s notes that aspirin
was contraindicated due to excess bruising, with a reference to the
date of the consultation where this had been decided with the GP.
Less than a month later, Mrs KB was seen at the surgery having woken
with chest pain that did not resolve with GTN, sweating, nausea and
palpitations. She was admitted to hospital with an acute myocardial
infarction and discharged after having a stent inserted. I saw her
after she was discharged, now taking aspirin and clopidogrel. Again
she was heavily bruised but she had accepted that the risk of a repeat
MI outweighed the concern about bruising. I later discussed the patient
at a practice meeting. The conclusion was that the patient’s
overriding concern about unsightly bruising and the subsequent stopping
of prescribing must be seen as a clear example of patient’s
choice. Clearly, this was most likely to have caused the MI but,
using RCA analysis, there was evidence of opportunities, on a number
of occasions, to break the sequence that led to the MI.
The exercise test is known to have a limited diagnostic value (especially
for elderly patients) and, although followed by a stress test, a
negative result does not completely exclude coronary artery disease — it
is well established that around 30 per cent of atheroma grow into
the artery wall, giving little obstruction of blood flow and hence
not necessarily identified on exercise and stress testing. The aspirin
had been initially prescribed with this possibility in mind and this
was not recognised on at least two occasions: the GP had failed to
balance the risk of stopping aspirin against the patient’s
concern about bruising and I had failed to challenge the GP’s
decision. In this case, RCA not only found the primary event that
led to the adverse outcome but also identified subsequent events
that presented an opportunity to reverse the original error. |
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Prescribing & Medicines
Management
