Chat with us, powered by LiveChat Working with the Noncompliant Patient Discussion | All Paper

Alma Faulkenberger is an 85-year-old female outpatient sitting in the waiting room awaiting an invasive pelvic procedure. The health care professional who will assist in her procedure enters the room and calls “Alma.” There is no reply so the professional retreats to the work area. Fifteen minutes later the professional returns and calls “Alma Frankenberg.” Still no reply, so he leaves again. Another 15 minutes pass and the professional approaches Alma and shouts in her ear, “Are you Alma Frankenberg?” She replies, “No I am not, and I am not deaf either, and when you get my name correct I will answer you.” Using the topic 1 materials, develop a plan to help Alma be compliant with the procedure and post-treatment medication. Also, describe the approach you would take to patient education in this case.Must have references


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Should we consider non-compliance a medical error?
N Barber
Qual Saf Health Care 2002;11:81–84
Non-compliance is an extensive intractable problem.
This paper argues that we can gain significant insight
into non-compliance if we apply theories developed to
explain human error in organisations. The resultant
framework encompasses intentional and unintentional
non-compliance, shifts blame from the patient, and
recognises the influence of other factors, including
organisational ones. There are also consequences for
the measurement of compliance and new strategies to
improve it. Terminology will need to be addressed,
particularly whether intentional non-compliance by a
patient should be considered an error. If empirical
research supports the arguments in this paper then, with
some further theory development, the application of
human error theory will offer a useful new approach to
understanding and reducing undesired non-compliance.
Correspondence to:
Professor N Barber, Centre
for Practice and Policy, The
School of Pharmacy,
29–39 Brunswick Square,
London WC1N 1AX, UK;
Accepted for publication
10 January 2002
round one third to one half of patients do not
take their medicines as directed, yet this is
not usually considered to be a medical
error. Should this be the case? This article
explores whether it should, and argues that there
are benefits in applying the literature on errors to
Non-compliance is a substantial and, as yet,
intractable issue; any new insights into it are to be
welcomed. Estimates have remained constant
over the years, that 30–50% of patients on chronic
medication do not take their medicines as
directed.1 2 We do not know the full consequences
of non-compliance on the population as a whole.
The economic studies have been limited, but all of
them suggest substantial consequences. In 1985
Smith estimated cardiovascular non-compliance
alone resulted in 125 000 deaths in the USA
annually and a further $1.5bn in lost earnings
from hospitalisations.3 Another study suggested
non-compliance to just 10 drugs cost the USA
between $396 and $792 million each year,4 and
the overall cost to the USA of all non-compliance
is estimated at $100bn annually.5
The mutual exclusion of non-compliance and
errors is fairly comprehensive. I failed to find any
mention of non-compliance in a quick skim of my
books on error, so I searched Medline over the last
quarter century. Using the terms “patient compliance OR medication errors” there were 24 702
references; searching for “patient compliance
AND medication errors” and restricting the
search to “English” and “journal article” reduced
the number to just 50. Most of these were studies
in which the authors simply regarded noncompliance as an error but did not address it with
reference to any literature on errors. An exception
was the American Society of Hospital Pharmacists which did include non-compliance in its
guidelines on preventing medication errors in
hospitals.6 Considering the development of the
literature on the causes of errors, the growing
application of human error theory in medicine,
and national initiatives to reduce errors in the UK
and USA, it seems a good time to reassess
whether the overlap should be so small.
To understand the reasons for the separation of
these two literatures, we need first to understand
the definitions and causes of non-compliance.
Compliance is usually defined as the extent to
which patients follow medical advice.7 While
often used with respect to medicine taking (as I
will use it in this article), it need not be so, and
could apply to the following of any advice on
health. This commonly used definition is based on
patient behaviour (an outcome based definition
also exists8), and is rather like saying someone
has a “stomach ache”—while it expresses a
condition, it is not clear how serious it is and there
may be many causes, each of which may require
different solutions. Non-compliance to medication is often set at some level—for example,
that less than 80% of doses are taken correctly.
While this definition is precise, if somewhat arbitrary, it is difficult to assess as it is hard to find the
true nature of patients’ behaviour.
The term “compliance” is itself controversial,
and this controversy is informative. In the 1970s it
was felt that doctors told patients the right thing
to do, and that patients should comply with these
directions. However, Stimson,9 in a seminal paper,
argued that it was inappropriate to see patients as
“defaulters” and he put forward the patient’s side
of the argument. More recently the term “adherence” has been suggested as being more suitable
than compliance, as it is seen to lack the implied
one sided value implications of “compliance”.
Adherence became more popular, particularly
with researchers, but it was never that familiar to
practitioners and so has been limited in its use.
More recently, with the growth of interest in
patients participating in decision making, the
objections to “compliance” are weakened (as it is
compliance with, ideally, an agreed regime), and
the term seems to be becoming popular again.
“Concordance” is another term which is sometimes used, inappropriately, as a synonym for
compliance. In a document entitled “From compliance to concordance”10 a specific form of doctorpatient interaction about medicines was suggested, and it was inferred that this would
improve compliance. Perhaps because of the title
of the article, some people incorrectly assume
Figure 1 Non-compliance illustrated
using Reason’s framework.
Intended action
Unintended action
(intentional non-compliance)
(unintentional non-compliance)
Not getting
Taking wrong
Forgetting a
Not getting
Taking ‘drug
holiday’ because
fear addiction
concordance is a modern word for compliance. These
definitional arguments are not just academic semantics, but
have at their core the role of the patient’s free will, and
whether the exercising of free will can be considered an error.
This issue will be discussed later in this paper.
About 200 factors have been attributed to cause noncompliance.11 However, the causes—and hence the patients—
are usually split into two groups: intentional and unintentional non-compliers. Those who intentionally do not comply
have made the decision consciously; the others wish to comply
but cannot do so for some reason. In reality there is some
overlap between these groups. For example, some patients
who forget to take their medicine (which would be classed as
unintentional non-compliance) will do so because their view
of the medicine, its importance and risks, may have made taking the medicine a low priority, and hence more easily driven
out of mind by other matters.
What do we know of patients’ intentions? The trend in
recent times has been for psychologists to focus on the causes
of intentional, rather than unintentional, non-compliance.
They have applied several theoretical models to explain
non-compliance12—for example, social cognition models,
stage models, and Leventhal’s self-regulatory theory. These do
have several limitations and are not particularly good at
predicting actual behaviour. When models allow regression
modelling, in which the extent of compliance is the outcome
variable, they generally account for a relatively small
proportion of the observed variability. One reason for their
limited success may be that they apply a theory to all
non-compliers, whether intentional or unintentional. We
would expect these models to predict intentional noncompliance much more than unintentional. Unless a substantial proportion were intentionally non-compliant, we would
expect the noise from the others to weaken the explanatory
power of the model. Although the division of non-compliance
into intentional and unintentional is of long standing, I have
been unable to find any papers that report the proportion of
non-compliance in each group, so we still do not know how
well we would expect the models to work. This is obviously of
importance if we wish to reduce non-compliance. Different
causes will require different solutions. While these theoretical
approaches have helped our understanding of compliance, as
Horne and Weinman note,12 the capacities of the models to
generate effective interventions have yet to be fully evaluated.
The intractability of non-compliance is another clue that a
new approach may be welcome. A Cochrane review13 found
that there had been few well conducted studies, and that
many interventions failed. Only one study of short term treatment was effective and, of the 17 randomised controlled trials
of long term treatment that were of sufficient quality, only
nine led to improvements in treatment outcome. Nearly all the
successful studies used complex mixtures of interventions.
The current explanatory models of non-compliance are
limited and there is a lack of effective solutions; there is room
for a new approach. Having conducted research into
non-compliance and, separately, into human factors in medical error, I find the stories of non-compliant patients remind
me of the stories of those who have made errors. So far I have
been unable to find any application of human error theory to
non-compliance. In the next sections I describe current thinking on the causes of errors, illustrate how these explanatory
models and techniques could explain non-compliance, suggest how the approaches could inform research, and outline
some difficulties with the approach.
This analysis is based on Reason’s descriptions of the causes of
human error14 15 which are adapted to non-compliance in fig 1.
In Reason’s terms, unsafe human acts follow intended or
unintended actions (equivalent to intentional or unintentional non-compliance). Unintentional actions are made up of
slips and lapses. These occur when people intend to do an
action but do not do it properly; they occur largely in the automatic carrying out of routine tasks. Slips are a result of a lack
of attention—for example, inadvertently taking the wrong
tablet. Lapses result from failure of memory such as forgetting
to take a dose.
Mistakes are intended actions that are wrong, but are
carried out with the intention of doing the right thing, so the
perpetrator is unaware that what they are doing is wrong;
these would be classified as intentional non-compliance. They
occur once a problem has been recognised in the current plan.
There are two types of mistake—rule based and knowledge
based. Rule based mistakes, by far the more common, occur
when the person is operating to a set of rules, but the rule they
use is wrong; knowledge based mistakes are rarer, and occur in
novel situations when the person is faced with a problem and
has to work out what to do from their existing knowledge,
rather than knowing a rule that fits the situation. Rule based
mistakes include misapplication of a good rule and application
of a bad rule. An example from non-compliance would be that
some patients on chronic medication become concerned about
addiction16 and therefore deliberately stop taking a drug for a
period each year (sometimes called a “drug holiday”) even
though the drug is not addictive. Application of a bad rule can
occur in the case of inhaled steroids; I have met patients who,
having heard about the effects of steroid abuse in sport, fear all
steroids so choose not to take their medicine as frequently as
directed. Knowledge based failures would include a patient
who runs out of an important medicine (for some reason that
is not their fault) and is faced with a decision of what to do;
they may err by choosing to wait several days before seeing
their doctor rather than getting an emergency supply from a
The final category of intentional acts/non-compliance is
that of violations; these are deliberate deviations from safe
practice. The boundary between violations and mistakes is
rather blurred, but a guide is obtained by considering whether
the error occurs solely from “internal processing”, in which
the person is trying to do the right thing but does not (a mistake), or whether the issue is more motivational and caused by
their operating in a wider social context (a violation). A deliberate violation would be choosing not to get a prescription
dispensed because the patient felt the doctor hadn’t listened
and so could not have understood the problem. Other
violations include taking “short cuts” that bend the rules to
make life easier, such as taking several medicines together
which should be taken at different times, or taking a
non-steroidal anti-inflammatory drug on an empty stomach.
Violations need not be bad and, indeed, can avoid harm.
Deliberate non-compliance can be the right thing for a patient
to do, such as not taking a diuretic before a long bus journey.
Following the categorisation of errors and violations,
Reason and others have gone on to consider the aetiology of
accidents in an organisation. Organisational processes and
management decisions create an environment that may
encourage errors; these failures are known as latent errors as
they create the background against which errors are more
likely to occur. Partly as a result of the latent failures, there are
also local conditions at the time of the accident which may
increase the likelihood of a worker making an error. While
much of this theory has been derived from studies of accidents
in areas such as nuclear power, aviation and shipping, it also
applies to health care. The patient, even though at home, has
engaged with and is part of—indeed, the end point of—a large
organisation with the goal of improving health. Human error
theory is not the only body of learning to address these areas.
Theories in psychology include attitude and “norms”;
sociology includes organisational and social issues; however,
error theories seem best to pull them all together.
The organisational model presents the people who make the
error as “the inheritors rather than the instigators” of an
accident.15 Consequently, in health care there is a widening
from studying the person who made the error to also seeking
organisational and local factors that caused them to make the
error. There is the need for a similar shift in noncompliance—we should shift the focus from the patient to
their local environment and the organisation of care supporting them. There are differences, of course. Contributing local
factors in a hospital, such as the shift system, being short
staffed that day, poor lighting etc, may have equivalents in the
patient’s home, work or life in general, but may well not be the
responsibility of the healthcare system. However, this approach can direct our attention to the causes of noncompliance and to suggestions of ways in which the patient or
others could resolve them.
Examples of latent failures could be the doctor’s style of
communication with the patient17 or the remuneration system
for pharmacists, which leads to many of them dispensing large
numbers of prescriptions at the cost of helping smaller numbers of patients become compliant (although there are
suggestions which would change this in the current NHS
plans for pharmacy18). Non-compliance resulting from the
system of information transfer on discharge of patients from
secondary to primary care is common.19 Local factors could be
related to where the patient kept their medicines or how they
decided to ask for repeat prescriptions (for example, the
length of time before their medicines ran out that they asked
for them), or the use of a carer to ensure the medicines were
One advantage of the recognition that organisational factors
can produce errors has been a shift away from blaming the
individual who made the error. This is not only fairer (in the
majority of cases), but also has the pragmatic benefit that it
encourages people to be open about errors and, if linked to a
monitoring mechanism, can lead to safer systems. A similar
benefit could accrue if we adopted the same mechanism for
non-compliant patients. I suspect little has changed since
Stimson observed that non-compliant patients were seen as
“deviants” by doctors.9 We need a mechanism to remove this
stigma from patients and to encourage them to speak openly
about how they use their medicines. We need to capture the
information and learn from it.
This is reinforced by another area in which non-compliance
research can benefit from the study of errors—that of deciding
what we should measure and be concerned about. In studies
of non-compliance the term is usually defined as a patient
taking less than 80% of their doses as intended. This
proportion presumably derives from the knowledge that most
drugs follow a log dose response curve, so the reduction in
clinical effect would only be likely to be evident when the total
dose fell below about 80%. This suggests the term “noncompliance” has been used to conflate two terms, one reflecting incidence and the other severity. As with all such
measures, it provides a simple dichotomy but it raises the issue
of whether this dichotomy is helpful. I would suggest that it is
limited as it imposes a threshold before studying errors, and
its link to outcome is tenuous. In contrast, it has been recognised in organisations that, while major errors are rare and
therefore hard to study, they are often unusual concatenations
of commoner minor errors. There is a direct relationship (often
drawn as a pyramid) that, for every case of an error causing
major harm (shown at the tip of the pyramid), there are proportionately larger and larger numbers of incidents producing
less and less harm (shown in layers beneath the tip). One
study showed that, for every case of major harm, there were
seven injuries and 189 non-injury accidents.20 The number of
harmful incidents can therefore be reduced be reducing the
number of minor errors.
What can this teach us about non-compliance? Firstly, that
all cases of non-compliance are of interest, whether one dose
or many, so the use of the 80% cut off is unhelpful. Minor
errors are easier to study and hence to understand their causes
and devise remedial solutions; by reducing their incidence it is
possible to reduce the incidence of major errors. This approach
would seem likely to bear fruit in studying non-compliance. If
all cases of missed and inappropriate doses are studied, we will
be likely to identify common causes including intentional,
unintentional, and latent organisational ones. No theoretical
explanation of non-compliance has been able to do this so far.
We can then devise better solutions that, by reducing the incidence of minor “errors”, will also reduce the harm caused by
Removal of the 80% threshold has another advantage. It
forces us to make explicit the relationship between noncompliance and harm. Instead of just counting the incidence,
we should also be focusing on the effect it has on patient
health. Why do some cases lead to hospitalisation or death and
others do not? More empirical work is needed in this area.
One final implication of the influence of the organisational
model on non-compliance is that it affects the design and
interpretation of research. A study of several hundred patients
of one doctor is less likely to be useful than a study of fewer
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