Memorandum by Professor David Webb (PS
89)
PATIENT SAFETY
Professor Webb trained as a cardiovascular physician
and clinical pharmacologist in London, before moving to Edinburgh
where he was appointed to the Christison Chair of Therapeutics
and Clinical Pharmacology in 1995. He subsequently led Edinburgh's
Department of Medical Sciences (1998-2001), Wellcome Trust Cardiovascular
Research Initiative (1998-2001), and Centre for Cardiovascular
Science (2000-04). He currently runs a Wellcome Trust-funded Scottish
Translational Medicine & Therapeutics Initiative.
He was Clinical Vice-President to the British
Pharmacological Society (BPS: 1996-98), Chair of the Royal College
of Physicians Committee on Clinical Pharmacology (1998-99), Chair
of the BPS Committee of Heads and Professors of Clinical Pharmacology
(2004-07) and Chairman of the Scottish Medicines Consortium (2004-08).
He is currently a member of the Executive Committee of the International
Union for Pharmacology (IUPHAR: 2004-), and Vice-President of
the Royal College of Physicians of Edinburgh (2006-).
FOCUS: PRESCRIBING
OF MEDICINES
1. What are the risks to patient safety in
relation to use of medicines and to what extent are they avoidable?
It is perhaps not surprising that medication
errors occur. Prescribing is a high-level task integrating complex
diagnostic skills, clinical judgement and an understanding of
therapeutics. It is a skill practiced by virtually every doctor
in their routine work, and yet is a task that carries significant
risks as well as benefits. Matters are complicated because, year
on year, there are more medicines available, with an increasing
evidence base for their use. With an ageing population there are
more patients to treat, requiring more complicated drug regimens
that increase the risk of drug interactions, in potentially vulnerable
patients. Standardised protocols now exist for the routine treatment
of many conditions, but many patients either do not meet the criteria
for these protocols, or have a number of conditions that may produce
conflicting requirements. In this situation clinical judgement
is crucial.
Prescribing errors are common in UK hospitals.
One study from a London teaching hospital detected 135 errors
each week, one-quarter of which were potentially serious, with
most made by junior doctors [Dean et al., 2002a]. The National
Patient Safety Agency database receives >50 000 reports annually
of medication incidents from acute and general hospitals [2007]—very
likely a small fraction of all events. An Audit Commission report
[2001] has suggested that adverse medication events were responsible
for the death of 1100 hospital patients in 2001 in the UK, a 5-fold
increase over the previous 10 years. Approximately 6.5% of admissions
to hospital are related to adverse drug reactions, with an associated
mortality of 0.15%; this costs the NHS £466m annually [Pirmohamed
2004]. Most reactions were judged to be "definitely"
or "probably" avoidable.
Some errors are "system" based whereas
others relate to the knowledge or skills of prescribers. System
errors include the risk of receiving the wrong medicine when different
medicines have similar names, the risk of receiving the wrong
medicine when different medicines are presented with similar packaging,
and the risk of giving a medicine by an inappropriate or dangerous
route when they are presented in ways that allow such mistakes
(such as the potentially fatal risk of intra-thecal administration
of anti-cancer drugs designed for intravenous use). These issues
need to be addressed through systems approaches. In particular,
a blame-free approach to reporting of critical incidents, a robust
means of responding to system failures, and electronic support
for prescribing may assist in reducing some of these system-based
errors. The clinical pharmacist has a key role in this area of
work.
In this evidence, I will focus on those errors
related to lack of knowledge or skills. There is evidence that
inadequate training is often a contributory factor in prescribing
errors [Dean 2002b; Leape 1995]. An analysis of 88 serious medication
errors in a UK hospital has suggested that a deficit in "skills
and knowledge" was a factor in 60% of cases [Dean, 2002b].
In 2008, Heaton [Heaton 2008] reported the results
of a web-based survey which sought the opinions of 2,413 students
graduating in 2006-08 from the 25 UK medical schools (mean 96.5
per school) about their undergraduate training to prescribe and
their confidence about meeting the relevant competencies identified
by the GMC. Distinct courses and assessments in "clinical
pharmacology & therapeutics (or equivalent)" were identified
by only 17% and 13%, respectively, with mode of learning described
most commonly as "opportunistic learning during clinical
attachments" (41%). Only 38% felt "confident" about
prescription writing and only a minority (35%) had filled in a
hospital prescription chart more than three times during training.
The majority (74%) felt that the amount of teaching in this area
was "too little" or "far too little", and
most tended to disagree or disagreed that their assessment "thoroughly
tested knowledge and skills" (56%). When asked if they were
confident that they would be able to achieve the prescribing competencies
set out by the GMC, 42% disagreed or tended to disagree, whereas
only 29% agreed or tended to agree.
Subsequently, the GMC Education Committee has
undertaken its own study on preparedness to practice. This involved
three diverse medical schools (Glasgow, Newcastle and Warwick)
with different approaches to undergraduate teaching (problem-based
learning, systems-based integrated curriculum, and graduate entry
respectively). The study was multi-method, cross sectional and
prospective, involving in-depth interviews and questionnaires.
Newcastle and Warwick Foundation year 1 doctors also completed
a safe prescribing assessment. Qualitative triangulating data
were collected from nearly 100 clinicians (undergraduate tutors,
educational supervisors, key managers and members of clinical
teams). Illing and colleagues [GMC website Dec 2008] have now
"published" the report of the study on how prepared
medical graduates are to begin practice. This document clearly
shows that a crucial concern is prescribing ability, as follows:
"There was a consistent thread, from
primary sample data throughout the year, and from triangulation
data, of under-preparedness for prescribing. Weaknesses were identified
both in the pharmacological knowledge underpinning prescribing,
and the practical elements of calculating dosage, writing up scripts,
drug sheets, etc. While there was some feeling from triangulating
data that F1s were prepared for prescribing, pharmacists did identify
severe gaps. Prescribing was also the main area of practice in
which errors were reported by respondents, indicating a significant
potential risk. Risks were reduced, but not removed, by support
from colleagues, with F1s speaking particularly highly about the
help received from pharmacists."
The key significance of this report, part from
confirming the earlier work from Heaton is that it compared the
full range of competencies expected of newly qualified doctors
and identified prescribing as the most significant weakness, and
one that has the potential to put patients at serious risk. Of
10 competencies that were scored under 3 (out of 5), 4 of these
were in the area of prescribing.
The GMC report concludes that the priorities
are to:
"… address particular weaknesses
in prescribing by supporting the development of teaching of prescribing
as a skilled procedure which is subject to the time pressures
and contingencies of all clinical skills. Such teaching should
place greater emphasis on prescribing as an instance of applied
pharmacology, and the need for new doctors to engage with prescribing
and develop their own expertise rather than relying on others."
The report also showed problems in a safe prescribing
assessment administered to Foundation doctors within two of the
schools. Indeed, over 80% of foundation doctors failed the assessment
in the first round. Whilst it may be that this assessment had
problems, it does highlight the need for continuing reinforcement
and reassessment of prescribing skills in the early years after
qualification.
The particular needs for education described
by the GMC—in pharmacokinetics (how the body handles medicines),
interactions between medicines, and common prescribing skills—are
all met by the core curriculum in clinical pharmacology and therapeutics
produced by the British Pharmacological Society [Maxwell 2003].
As a result of Tomorrow's Doctors (1993, 2003), time spent
on undergraduate teaching in this area has reduced substantially
and this now needs to be corrected.
2. What is the effectiveness of current approaches
to patient safety in relation to use of medicines?
It is widely recognised that newly qualified
doctors are at the sharp end of prescribing, and that this work
is largely unsupervised. Although junior doctors are protected
from undertaking many high-risk practical procedures, they are
able to prescribe powerful medicines from their first day of clinical
work. Here, clinical pharmacists are well recognised to play a
very important support and educational role. Nevertheless, there
is a critical need to provide medical students with an undergraduate
education and training in therapeutics and prescribing that prepares
them effectively to fulfil this role, and to be able to develop
as an effective prescriber thereafter. Essential support in prescribing
can be provided, and several studies have suggested that the delivery
of targeted education can improve prescribing performance and
reduce prescription errors [Scobie 2003; Garbutt 2006; Langford
2001; Vollebregt 2006]. However, some of the changes in recent
years have served to reduce the preparedness of doctors for prescribing
(see below).
The GMC's recommendations on undergraduate medical
training published in Tomorrow's Doctors (1993) heralded
a major change in medical training. The focus was on a reduction
in the burden of factual learning, a slimming down of the science
base taught to medical students and the development of an integrated
medical undergraduate curriculum in an organ based structure.
There were many potential benefits to this approach, but one of
non-organ based areas of teaching that lost out was the vertical
theme of pharmacology, clinical pharmacology and therapeutics,
which in most medical schools became a much less visible area
of teaching. Again, in many medical schools, the assessment of
teaching in therapeutics was no longer identifiable and this diminished
the demand on students to focus on this area of learning. Another
important driver for loss of teaching in this area was the national
round of Research Assessment Exercises, which meant that universities
placed a higher value on research than teaching and, as a largely
academic specialists, clinical pharmacologists were encouraged
to focus on this aspect of their work. In some medical schools
therapeutics disappeared as a teaching discipline and it has been
noted that many nursing schools provide more hours of education
in this area than most medical schools [Aronson 2006]. These concerns
about teaching in therapeutics and prescribing within in the UK
[Maxwell 2006], have been mirrored in Europe [Maxwell 2007] and
Australia [Hilmer 2009].
In the past, medical students were encouraged
to prescribe, under supervision, and to have their prescriptions
signed off by a more senior member of staff. This is no longer
considered an acceptable practice but it has not generally been
replaced in medical schools by other means to give students an
understanding of the complexity of prescribing, and to thereby
ensure that they give this area of learning the time and effort
it justifies.
Interestingly, there have been recent moves
by the pharmaceutical industry to fill the void and take on this
role [Coombes 2009]. However, there are well-recognised concerns
about the ability of industry to provide such information in an
unbiased way [House of Commons Health Committee 2005], and in
a recent poll in the British Medical Journal around 80% of respondents
thought that drug companies should not teach therapeutics to medical
undergraduates [This Week 2009]. Indeed, one could argue more
broadly, for the same reasons, that the pharmaceutical industry
should not be involved in the education of doctors but should
focus their efforts on the development of powerful and innovative
new medicines.
Importantly, following a public debate on the
preparedness of newly qualified doctors for prescribing [Aronson
2006, Rubin 2006a], the GMC assisted in creating a Safe Prescribing
Working Group (SPWG) [Rubin 2006b] established by the Medical
Schools Council under the chairmanship of Professor Robert Lechler.
The work of SPWG [Lechler 2007] had two important outcomes: first,
a description of the prescribing competencies required of a newly
qualified doctor; and second, the generation of a major Department
of Health E-Learning project on Prescribing.
The prescribing competencies defined by SPWG,
which now provide a yardstick against which undergraduate education
in this area can be judged, are that all medical graduates should
be able to:
— Establish an accurate drug history.
— Plan appropriate therapy for common indications.
— Write a safe and legal prescription.
— Appraise critically the prescribing of
others.
— Calculate appropriate doses.
— Provide patients with appropriate information
about their medicines.
— Access reliable information about medicines.
— Detect and report adverse drug reactions.
The Department of Health e-Learning for Healthcare
project, led by Dr Simon Maxwell and undertaken in collaboration
with the British Pharmacological Society, will provide funds to
develop a national e-Learning solution in clinical pharmacology
and prescribing for students of medicine and allied professions.
The project will be known as Prescribe and is intended
to provide e-learning materials that will enable students to develop
a firm grounding in the principles of basic and clinical pharmacology,
which underpin safe and effective prescribing in the NHS. Prescribe
will contain both interactive learning sessions and information
covering the pharmacology, clinical pharmacology and therapeutics
that a student might expect to encounter within a standard medical
curriculum. Also in development is an interactive student formulary,
the opportunity to practice skills relevant to prescribing, self-assessment
exercises, a library of important publications, a glossary and
links to other resources. Prescribe will be available free
of charge to students registered with UK universities and NHS-affiliated
organisations. Further details are available at www.cpt-prescribe.org.uk.
3. What should the NHS do next regarding
patient safety in relation to use of medicines?
Together with gathering evidence by taking a
history from the patient, undertaking a medical examination, and
interpreting the results of laboratory investigations, prescribing
of treatments is one of the defining activities of the doctor.
Prescribing is not an exact science, as it requires the weighing
of evidence and the use of clinical judgement about harms and
benefits of intervention, but safe, effective and cost-effective
prescribing requires training in the principles of pharmacology
and its application in therapeutics. In the absence of incontrovertible
evidence (which would be hard to obtain) that poor prescribing
leads to harm to patients, all of the evidence we have to date
would support the risks of poor prescribing skills and the precautionary
principle would justify a greater emphasis on improving prescribing
quality.
Addressing this problem requires collaboration
between the medical schools, GMC and NHS. The following are important
ways in which patient safety in relation to prescribing could
be improved.
1. Undergraduate medical students need to receive
a sound grounding in the principles of pharmacology and therapeutics,
supported by training in the practical skills of prescribing,
and a professional attitude to its performance. The required competencies
in prescribing are defined by the Medical Schools Council Safe
Prescribing Working Group [Lechler 2007]. Research is needed to
define the best way to deliver these competencies.
2. The next iteration of Tomorrow's Doctors
(2009; the last was in 2003), currently in draft form, addresses
many of the previous omissions, and is an important development
in undergraduate medical training. Nevertheless, it should identify
the report from the Medical Schools Council Safe Prescribing Working
Group, and include the full list of prescribing competencies required
of a newly qualified (Foundation) doctor. In addition, it should
identify prescribing as one of the key therapeutic procedures.
The opportunity to make an unequivocal statement on this issue
should not be missed.
3. Teaching and training need to be backed up
by rigorous methods of assessment of knowledge, skills and attitudes
around the time of graduation so that these competencies can be
assured. If necessary, these should be undertaken on a national
basis.
4. It should be anticipated that undergraduate
teaching and training will be very usefully supplemented by the
Department of Health e-Learning for Healthcare package, Prescribe,
currently under construction.
5. In addition, there is a need for continuing
medical education in this area, backed up by assessment of prescribing
in the foundation period of training, and beyond. Benefits would
be gained by having prescribing "champions" in training
environments where foundation doctors are placed. The creation
of a "prescribing skills test" to be undertaken early
in the early postgraduate period might be a helpful step.
6. Additional benefits might well accrue from
introducing a standardised prescribing form across routine UK
hospitals so that there is less risk of error associated with
doctors moving between centres.
7. The creation of effective electronic prescribing
systems would assist in ensuring that patients received the right
medicine at the right dose, would serve to encourage use of the
most effective medicines, and would assist in providing alerts
to potential contraindications and drug interactions. It should
also serve to ensure clarity about current treatment in the movement
of patients between primary care and the hospital setting.
8. Patients need to receive unbiased evidence
about the benefits and harms of licensed medicines. In the US,
direct-to-patient advertising by the pharmaceutical industry can
serve to distort this advice [Berndt 2005], especially in relation
to the relative benefits and harms of medicines. Direct-to-patient
advertising should be resisted within the EU.
9. Clinical pharmacologists, and other clinicians
with skills, knowledge and a focus on teaching of prescribing
skills are required to assist junior clinicians in integrating
prescribing into clinical care. Clinical pharmacists have complementary
roles in education to ensure safe prescribing, and there are substantial
benefits from pharmacists working closely with clinicians in this
important area.
10. The discipline of clinical pharmacology and
therapeutics is the only medical specialty within the NHS that
is declining in numbers, as other specialities grow. Given that
clinical pharmacology is the key medical specialty with a focus
on safe and effective prescribing, and its numbers are at a critically
low state, urgent work is needed within the Department of Health
to increase the numbers of doctors training in clinical pharmacology
and therapeutics in the UK.
Professor David Webb MD DSc FRCP FRSE
January 2009
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