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Patient safety is an issue that has been at the forefront of practice
for hospital pharmacists for decades. But statistics show that levels
of drug-related adverse events are still high.
The Safer Patients Initiative
(SPI), developed by the Institute of Health Improvement (IHI) in Boston,
Massachusetts, and the Health Foundation in the UK, uses new methods
to tackle old problems, and it seems to be working.
Four acute trusts — Luton and Dunstable NHS Foundation Trust in
England, NHS Tayside in Scotland, Conwy and Denbighshire NHS Trust in
Wales and Down Lisburn Health and Social Services Trust (now South Eastern
Health and Social Care Trust) in Northern Ireland — were chosen
to take part in the SPI, which started towards the end of 2004.
SPI is a four-year programme, the first phase of which has been spent
building effective leadership and expertise in patient safety via a tailored
programme designed by the IHI. Phase 2 will involve developing these
four trusts as exemplars to 20 additional acute trusts that have now
been selected to take part in the initiative (PJ, 25
November 2006, p630).
During this time the exemplars will formulate
their own methods designed to spread their learning and help others to
improve patient safety. Financial
support is provided for trusts to help build capability and capacity
for improving patient safety.
The vision of the SPI is that no patient should experience unnecessary
harm, pain or suffering as a result of an error or planned medical intervention.
It supports leaders at the highest level in the trust so that patient
safety can be made an organisational priority. The SPI uses a “model
for improvement”, which it describes as a simple yet powerful tool
for accelerating improvement (see Panel).
Model for improvement used in the Safer Patients Initiative
The model for improvement — published in 1996 in ‘The
improvement guide: a practical approach to enhancing organisational
performance’ by Gerald Langley and others — is key
to the Safer Patients Initiative and consists of two parts. The
first
part involves asking three fundamental questions:
• What are we trying to accomplish? Answering this first question
involves setting aims. The aims should be time specific and measurable.
They should also define the specific population of patients that
will be affected.
• How will we know if the change is an improvement? Answering the
second question involves establishing measures. Quantitative measures
through monthly audits are used to determine if a specific change
leads to improvement.
• What changes can we make that will result in an improvement?
Answering the third question involves selecting changes. All improvement
requires making changes but not all changes result in improvement.
Organisations must therefore identify the changes that are most
likely to result in improvement.
The second part involves using the plan-do-study-act (PDSA) cycle
to test and implement changes in real work settings. The PDSA cycle
guides the test of change to see if the change is an improvement.
After testing a change on a small scale, learning from each test
and refining the change through several PDSA cycles, the team can
implement the change on a broader scale, for example, a whole ward.
If this is successful, the change can then spread further to the
whole organisation. |
The initiative involves several teams in each trust working simultaneously
on four priority areas: medicines management; intensive care; general
wards; and peri-operative care. Each trust also has a leadership team.
Pharmacists from the trusts play a key part in the multidisciplinary
medicines management teams. Through the initiative, the teams have
focused on three areas of medicines management: medicines reconciliation;
high-risk
medicines, such as anticoagulants; and medication systems, such as
prescribing, ordering, dispensing and administering.
Medicines reconciliation
Medicines reconciliation is defined by the IHI as “the process
of identifying the most accurate list of a patient’s current medicines — including
name, dosage, frequency and route — and comparing it to the current
list in use, recognising any discrepancies and documenting any changes,
thus resulting in a complete list of medicines, accurately communicated”.
The list should be compared with doctors’ prescribing on admission,
transfer and discharge, with reasons for any omissions or dose changes
being documented.
“For many years pharmacy staff in the UK have focused attention on obtaining
accurate drug histories when patients are admitted to hospital, so the
process of identifying the most accurate list of a patient’s medicines
is nothing new to us, whereas this use of staff is relatively rare in
the US. There is a substantial evidence base for this practice, but unfortunately
the ‘reconciliation’ is not always undertaken in a timely
manner due to staffing limitations,” explains Don Hughes, director
of pharmacy at Conwy and Denbighshire NHS Trust.
The target set by the IHI was to reduce the percentage of unreconciled
medicines to less than 10 per cent, and preferably to zero.
Alison Campbell, clinical pharmacy co-ordinator and patient safety pharmacist
at Lagan Valley Hospital, South Eastern Health and Social Care Trust,
explains that the medicines management
team at her trust developed a new multidisciplinary form on which to
record medicines on admission using the plan-do-study-act (PDSA) cycle
(see Panel).
“The IHI taught us to develop a form and to give it to one nurse and one
doctor and test it on one patient,” she explains. Feedback is gathered
and the form is improved and retested. This process is then repeated
on three patients, then on five patients and then extended to a pilot
unit.
“The process of testing and obtaining feedback allows you to get people
on board and willing to work with you because they are involved in developing
the form,” she explains. “Before being involved in the initiative,
we would have launched the new form to the whole unit straight away without
testing.”
The IHI believes that processes should not be person-dependent; they
must be reliable and happen 95 per cent of the time. Because the medicines
on admission form developed in Northern Ireland was a stand alone form
it was often not included in the admission pack, therefore the process
was unreliable. To cut out this person-dependent step the form was printed
on the reverse side of the clinical history sheet so that it appeared
at the right point in the admission procedure.
“The IHI were keen to point out that pharmacists should be what it calls ‘a
redundancy’. They are not there 24/7, 365 days a year. Therefore
there needs to be processes in place that work when pharmacists are not
around,” explains Ms Campbell.
The PDSA cycle sounds time-consuming, but Debbie Corner, senior clinical
pharmacist at NHS Tayside, emphasises that, after the first few, it becomes
easier and quicker. The tool saves time by identifying problems with
a single test before making changes. By using PDSA and a consultant physician
champion, NHS Tayside reduced unreconciled medicines from a baseline
figure of 70 per cent to less than 10 per cent in six months.
At Luton and Dunstable, developing and introducing a new form using the
PDSA cycle has also resulted in improvements: less than 9 per cent of
medicines are now unreconciled, compared with about 30 per cent before
the new form was introduced, explains Mary Evans, chief pharmacist at
the trust.
However, Mr Hughes has not seen positive results in Wales when trying
to improve medicines reconciliation with junior medical staff. He explains
that whatever form the medicines management team produced it did not
appear to make any significant difference to the rate of unreconciled
medicines, which varied between 15 and 20 per cent.
He puts this down
to a number of contributory factors
• the quality of information received
from primary care
• pharmacy-led drug history taking being well established
within the trust
• the medical staff’s primary focus being on
patients’ acute illnesses rather than medicines previously prescribed
for other chronic conditions.
“We measured the rate of unreconciled medicines on admission before the
pharmacy staff undertook their normal duties and again after the pharmacy
contribution, and consistently got the rate down to 1–2 per cent,” he
explains. “Sadly we were unable to achieve the target rate without
pharmacy input, although we recognise the deficiencies that result from
a lack of consistent 24/7 pharmacy input,” he added.
He believes
that the medicines reconciliation process has to be aided by the electronic
transfer of information from primary care. High-risk drugs
 The IHI also wanted the trusts to look at high-risk drugs and all four
decided to start with anticoagulants. The aim was to reduce the percentage
of adverse events due to anticoagulants by 50 per cent using IHI trigger
tool methodology.
The use of “triggers” or clues to identify adverse drug
events is a method for measuring the overall level of harm from medications
in an organisation.
Some of the triggers used for anticoagulants were: low haemoglobin; low
or high INR; antibiotic prescribing; vitamin K administration; fresh
frozen plasma administration; and non-steroidal anti-inflammatory prescribing.
“Whenever we saw a trigger in a patient’s chart, we drilled down
deeper to see if there was an adverse event caused by the anticoagulant.
Sometimes it was quite tricky to confirm this,” Ms Campbell explains.
She admits that the trust did not achieve its target of reducing adverse
events using this method since the problems were not only in secondary
care. The audits did, however, identify a lot of problems associated
with anticoagulants, for example, poor documentation of the indication,
the target INR and the duration of treatment.
“There was also a
lack of evidence of GP referral information and patient counselling in
the notes, and a lack of guidance for junior doctors on the dosing schedule,” she
says.To address these problems, the trust introduced a new warfarin initiation
and GP referral chart using the model for improvement method and PDSA
cycles.
In Wales, the medicines team undertook a similar process. “Our
warfarin chart went through 11 evolutions. We have also put a large amount
of effort into training the doctors in how to use the chart properly,” explains
Mr Hughes. Measures for anticoagulation evolved during the programme
and the rates of high INRs are now being used as an effective measurement
of adverse events.
Thirty months into the initiative, the trust is starting
to see a significant reduction in INRs greater than 6. “We feel
a key message is perseverance with tests of change. It is probably a
combination of factors which affects outcome measures,” he explains.
Lessons learnt
• Not every change leads to an improvement
• Changes must be measured to see if there is an improvement
• There is a lack of awareness of patient safety and of improvement
methodology
• Culture cannot be changed overnight
• It is essential to have senior management working closely with the
teams
• Strong leadership is important
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Medication systems
Another task that the IHI set for the trusts was to do a failure modes
and effects analysis (FMEA) on a core process. FMEA is a technique
that has been adapted from the aerospace industry. It is a systematic,
proactive method for evaluating a process to identify where and how
it might fail, and to assess the relative impact of different failures
in order to identify the parts of the process that are most in need
of change. It allows areas of high risk to be prioritised.
“We feel it is a superb technique in identifying process deficiencies
and fully utilising staff who work within systems to help design new
ways of working,” explains Mr Hughes. “When we looked at
dispensing we identified 12 stages in the process.” A risk score
is assigned to each thing that could go wrong based on likelihood of
occurrence, likelihood of detection and severity of outcome.
The analysis in Wales identified a lack of training for pharmacists on
the clinical check. “We put a training package together for clinical
pharmacy checking and when we risk scored the process independently again
it had come down significantly,” says Mr Hughes.
Luton and Dunstable used the method to improve safety in its anticoagulation
referral process. “We identified two high-risk steps — doses
being written in the yellow book and patients being given an outpatient
appointment,” says Dr Evans. The team came up with a simple discharge
checklist designed to be attached to take home medicine bags. It establishes
whether a dose has been prescribed, whether an outpatient appointment
has been made and whether the patient has been counselled. Each stage
must be signed by the nurse in charge of discharging the patient.
“It sounds ridiculously simple. But it has made a huge difference. The
plan was to reduce the FMEA score of the process by 50 per cent but we
have reduced it by over 60 per cent,” says Dr Evans.
Finding the time
So how do the trusts manage to fit this work into their daily routines? “One
of the benefits of the SPI is that you have to find the time. Audit reports
have to be submitted to SPI on a monthly basis therefore it becomes a
priority,” says Dr Evans. Before Luton and Dunstable joined the
SPI, the pharmacy department appointed a senior technician in charge
of patient safety, who has been heavily involved in the trusts response
and facilitated a lot of the work.
Mr Hughes explains that having the trust’s executive on board helps. “It
is hard to fit everything in, but we had the authority of the project
board behind us and the project was supported at an executive level.”
One of the key parts of the initiative is that all information and learning
is electronically shared between the trusts and the IHI facilitators
via an extranet. The trusts also attend residential teaching sessions
and participate in monthly conference calls as well as going on site
visits to learn from each other.
The future
The four trusts are now in the exemplar phase of the initiative and
have started sharing their experiences with others.
Debbie Corner believes patient safety and the SPI methodology, particularly
the FMEA tool, should be included in the pharmacy undergraduate curriculum.
She explains that within Tayside, the medicines management team is involved
in teaching fifth-year medical students about the SPI tools.
“It
would be good to get patient safety on the agenda within the pharmacy
undergraduate and postgraduate curriculum. Our junior pharmacists have
enjoyed the emphasis on process redesign that SPI has brought. This experience
will be particularly useful as they develop professionally into future
roles, such as independent prescribing,” says Ms Corner. |
The
Pharmaceutical Journal