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Economics ofMedication Safety,
withaFocus onPreventable Harm
RachelA.Elliott
5
Abstract
Adverse drug reactions can be an important
cause of morbidity and mortality and may
have signicant economic consequences,
including the increased use of health services
and wider societal costs. We can refer to this
as ‘economic burden’. This chapter denes
and explores how to quantify the economic
burden of adverse drug reactions. Health
economists are particularly interested in the
avoidable economic burden caused by medication errors. Therefore, this chapter focuses
on the avoidable economic burden caused by
medication errors. There are three types of
evidence required to understand the economic
burden of medication errors: the incidence or
prevalence of medication errors, the consequences (health and wider effects) of those
medication errors, and the resources consumed due to the consequences associated
with those medication errors. The challenges
around quantifying harm from medication
R. A. Elliott (*)
Manchester Centre for Health Economics, Division
of Population Health, Health Services Research and
Primary Care, School of Health Sciences, Faculty of
Biology, Medicine and Health, The University of
Manchester, Manchester, UK
e-mail: Rachel.a.elliott@manchester.ac.uk;
http://research.bmh.manchester.ac.uk/
healtheconomics/
errors are discussed. Strategies which aim to
improve patient safety through interventions
such as those that change prescribing or monitoring behaviour are often costly, so we need
to know if they are effective or cost-effective.
This chapter outlines how different economic
evaluation approaches can be carried out
alongside randomised controlled trials, nonrandomised comparative studies (such as
interrupted time series analysis) or as modelling studies. The published evidence around
the cost-effectiveness of safety interventions
is introduced. The benets of improved
patient safety are not just maximising health,
which affects how they are valued by different stakeholders, so this chapter concludes by
examining the non-health components of
safety intervention outcomes.
Keywords
Economic evaluation · Cost-effectiveness
analysis · Cost-utility analysis · Cost of
illness · Economics of medication safety ·
Economic burden of medication errors ·
Preventable harm · Safety interventions
Learning Objectives
• Understand how the economic burden of sub-
optimal medication safety may be dened and
measured.
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
J. Jose et al. (eds.), Principles and Practice of Pharmacovigilance and Drug Safety,
https://doi.org/10.1007/978-3-031-51089-2_5
105
106
R. A. Elliott
• Discuss challenges in dening and measuring
economic burden.
• Describe and evaluate evidence for economic
burden.
• Understand the methods used to assess the
cost-effectiveness of strategies to improve
medication safety.
• Describe and evaluate evidence for strategies
to improve medication safety.
• Discuss challenges in assessing costeffectiveness of strategies to improve medication safety.
Key Points
• The economic burden of Adverse Drug
Reactions (ADRs) can range from the
harmful effects on health, quality of life
or length of life; the costs incurred by a
healthcare provider of having to deal
with that harm; to broader effects on
society.
• Some medication errors do not cause
any harm or incur any costs and we need
to focus our efforts on reducing clinically important errors.
• If we want to understand the harm
caused by ADRs due to medication
errors, we need to be able to link that
error to harm outcomes and associated
costs.
• Not all harm from medication is pre-
ventable, so we are only focused on
reducing preventable harm and associated costs.
• The harm and cost from a medication
error can extend beyond the initial event,
such as the initial hospitalisation.
• When we design interventions to reduce
medication errors, we need to quantify
the impact on harm and on costs.
• We need to be aware that ADRs can
have an impact on non-health outcomes,
such as trust, and other costs such as litigation and compensation costs.
1 Introduction
In this chapter, the economic burden of Adverse
Drug Reactions (ADRs) is examined. The economic burden of ADRs broadly can be dened as
any effects on the person experiencing the harm
(such as effects on health, quality of life or length
of life); the effects on a healthcare provider of
having to deal with that harm (such as treating a
gastric bleed); and broader effects on society
(such as lost productivity from a person not being
able to work or carry out caring activities).
This chapter will look at:
• how economic burden may be measured;
• challenges in dening and measuring economic burden;
• evidence for economic burden.
The cost-effectiveness of strategies to improve
medication safety is examined, looking at:
• the methods used to assess cost-effectiveness;
• evidence for strategies to improve patient
safety;
• challenges in assessing cost-effectiveness of
these strategies.
In 1955, David Barr dened adverse events as
‘the price to pay for modern diagnosis and
therapy methods’ [1]. ADRs, whether preventable or not, negatively affect health and patient
experience. If these ADRs occur as a result of an
error in the medication use process, this is considered an important cause of avoidable morbidity and mortality [2, 3]. In turn, medication errors
may have signicant economic consequences,
including the increased use of health services
such as avoidable medication- related hospital
admissions. The potential economic impact of
ADRs has been a concern for a long time. In
1965, a Scottish general practitioner estimated
that more than a quarter of night and emergency
calls were due to ‘drug-induced illness’ [4]. It has
been estimated that approximately 6–7% of hos-
5 Economics ofMedication Safety, withaFocus onPreventable Harm
107
pital admissions appear to be medication-related,
with over two- thirds of these considered to be
due to medication errors and therefore avoidable
[5–7]. A recent meta-analysis of burden of error
studies estimated that, globally, around one in 30
patients are exposed to preventable medication
harm in medical care, and more than a quarter of
this harm is considered severe or life threatening
[8]. A recent report suggested that avoidable hospital admissions and increased length of stay due
to medication harm cost Organisation for
Economic Cooperation and Development
(OECD) countries $54 billion annually [9].
The economic impact of medication errors has
motivated most health systems to improve patient
safety [10]. Strategies aim to improve patient
safety through interventions that focus on one or
more aspects of the medicines use process, such
as those that change prescribing, dispensing,
labelling, administration, or monitoring behaviour. These are often costly, with variable evidence of effectiveness or cost-effectiveness
[11–13]. The real impact of these interventions is
often uncertain, as behaviour may not change as
anticipated, or clinical and economic effects of
most errors may be minor [14]. In an increasingly
nancially constrained healthcare environment,
it is essential to be clearer about the true (comprehensive) economic impact of interventions to
improve patient safety.
2 Economic Burden
ofSuboptimal Medication
Safety
The economic burden of ADRs broadly can be
dened as any effects on the person experiencing
the harm (such as effects on health, quality of life, or
length of life); the effects on a healthcare provider
of having to deal with that harm (such as treating a
gastric bleed); and broader effects on society (such
as lost productivity from a person not being able to
work or carry out caring activities).
The ‘perspective’ is important in determining
costs and is discussed in more detail in the subheading ‘Perspective’ in Sect. 2.1.3.
2.1 How Burden May BeDened
andMeasured
Quantifying the economic burden of suboptimal
medication safety requires the following types of
evidence: the nature and incidence or prevalence
of medication errors, the consequences (health
and wider effects) of those medication errors, and
the resources consumed due to the consequences
associated with those medication errors.
2.1.1 Prevalence ofErrors
Estimating the prevalence of medication error
presents challenges due to varying denitions
and classication systems and varying methods
of identication and measurement. This topic is
covered in more detail in Chap. 15. Errors can be
minor, resulting in no patient harm, and range
through to major errors causing serious harm and
death. Therefore, knowing where and how commonly an error occurs is only the beginning of
the story. We need to know how it occurred and
what is the impact of that error.
2.1.2 Health Eects ofaMedication
Error
National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP)
denes patient outcomes from medication error
in the following way (Table5.1) [15]:
This is a helpful taxonomy in that it presents
the range of severity of harm that can occur due
to an error and whether that harm has occurred.
However, further information is needed to understand more fully the level of harm that can occur
and how it is measured. The harm and associated
resource use will be directly related to the specic medication involved in the error, such as
amiodarone causing thyrotoxicity or a
108
R. A. Elliott
Nonsteroidal Anti-inammatory Drug (NSAID)
causing a gastrointestinal (GI) bleed.
Are Medication Errors aPatient Outcome?
Patient outcomes are usually dened as healthrelated events occurring as the result of an illness
or a healthcare intervention. In patient safety,
medication errors are measured more often than
the effect of that error on a patient’s health. The
reasons for this are explored in the section
‘Quantifying Harm from Medication Errors’.
Medication errors are considered to be a ‘bad’
thing that need to be avoided. However, errors are
a process indicator that act as a surrogate for
Table 5.1 NCC MERP denitions of patient outcome
from medication error [15]
NCC
MERP
code Category
31.1 A No error
32.1 B An error occurred but the error did
32.2 C An error occurred that reached the
32.3 D An error occurred that reached the
33.1 E An error occurred that may have
33.2 F An error occurred that may have
33.3 G An error occurred that may have
33.4 H An error occurred that required
34.1 I An error occurred that may have
Patient outcome from medication
error
not reach the patient (an ‘error of
omission’ does reach the patient)
patient, but did not cause patient
harm:
32.2.1 Medication reaches the
patient and is administered
32.2.2 Medication reaches the
patient but not administered
patient and required monitoring to
conrm that it resulted in no harm
to the patient and/or required
intervention to preclude harm
contributed to or resulted in
temporary harm to the patient and
required intervention
contributed to or resulted in
temporary harm to the patient and
required initial or prolonged
hospitalisation
contributed to or resulted in
permanent patient harm
intervention necessary to sustain
life
contributed to or resulted in the
patient’s death
patient outcome, carrying the, not always accurate, assumption that medication errors will have
an impact on patient outcome and costs. For
example, if a study reports prescribing error rates,
an unknown proportion will actually reach the
patient because some of those prescribing errors
may be picked up at the dispensing or administration stage. Some of those prescribing errors may
cause little or no harm if they reach the patient. If
harm does occur, the error may be only one of a
number of factors (such as patient factors or
errors occurring later in the medication use process) leading to a poor outcome.
The value of medication error data is therefore
limited as a measure of harm or patient outcome.
From an economics perspective, there are limited
resources to direct at initiatives to reduce medication errors. Thus, we want to know which medication errors are the ones we should focus on to
derive most benet from nite resources. That
means having evidence about the harm from
those errors, not just the prevalence of those
errors.
The subsequent subsections describe the challenges around quantifying harm from medication
errors and then describe the range of methods
that have been used to quantify harm, patient outcomes, and cost from a medication error.
Quantifying Harm fromMedication Errors
There are some signicant challenges around
directly and robustly estimating patient harm
caused by medication errors. One key ethical
issue is that once an error has been detected at
any point in the medication use process in clinical practice, a research study, or practice audit,
it cannot be left uncorrected to reach the patient.
Following a known error prospectively through
the medication use process to see if it causes
harm is unethical. Similarly, a randomised
controlled trial (RCT) where one arm of the
trial is allocated to receive the error, and the
other arm, no error would not be considered
ethical.
To directly link errors to harm requires a dataset that has both errors and harm collected within
it for an individual patient. This is where routine
data collection in health care can be extremely
5 Economics ofMedication Safety, withaFocus onPreventable Harm
109
useful, especially if datasets from different sectors of the health system are linked. One example
would be a dataset that combines both primary
and secondary care data for a cohort of patients.
This dataset would allow the identication of a
prescribing or monitoring error occurring in primary care and identication of relevant hospitalisations or outpatient visits.
Many types of medication errors cannot currently be detected in routine data records, such as
is commonly the case with medication administration errors. This, therefore, restricts the widespread use of this method to areas where data are
available.
Challenges withCapturing theHealth
Eects ofaMedication Error
There are increasing numbers of studies that
directly link errors to patient harm, primarily
around prescribing errors in settings where routinely collected data are available. However, the
evidence directly linking errors to patient harm
and/or costs is still sparse, with studies using
varying methods and having variable quality
[16]. Very little data are available that directly
measure the link between errors and harm, or
what proportion of errors occurring at different
stages of the medicines use process reach
patients, and what proportion of those errors
reaching patients cause actual harm.
Retrospective Linking ofAdverse Drug
Events toMedication Errors
Researchers have used other methods, in the
absence of direct evidence, to link errors to harm.
The rst, and most commonly used of these, is
via retrospective study, where a known ADR is
linked back to a medication error, requiring some
form of subjective assumption of causality and
preventability. The second of these is to use modelling approaches to link medication errors to
ADRs. These are discussed in more detail in this
section.
One of the most common ways of capturing the
health effects of a medication error is to identify a
medication-related adverse event for a cohort of
patients and then to look backwards in time to
identify a medication error [8, 16, 17]. One of the
earlier studies to attempt to identify patient harm
from medication errors using this method was
Bates et al. (1995) [18]. This US hospital-based
study reported that 5 of 530 medication errors
(0.9%) resulted in ADRs. This study has been followed by many others who used similar methods
that do not directly link medication errors to
patient harm and/or costs, but use some form of
judgement to attribute the harm or ADR to an
error.
A large Dutch study illustrates this approach
very clearly [19]. Damen et al. (2017) took a
sample of 8071 hospital admissions. Nurses and
physicians looked at the notes and decided if a
medication-related ADR had occurred leading to
hospital admission. They then decided if the
ADR was caused by a medication error, and
whether the ADR was avoidable. The overall
study design is summarised in Fig.5.1.
This type of design has been used by many
other researchers [17, 20, 21]. It raises questions
about attributing both causality and preventability to the medication errors and ADRs which are
examined in the next two sections.
Did theError Cause theHarm? (Causality)
Whether the harm, or ADR, has been caused by
a medication error is not always clear. These
outcomes may or may not be associated with
errors in prescribing, dispensing, administration, or monitoring. Not all errors occurring earlier in the medication use process end up
reaching the patient and if they do, they may not
lead to harm. If harm does occur, the medication
error may be only one of many factors leading
to a poor outcome. For older, more frail patients,
it can be difcult to attribute poor outcomes,
such as a hospital admission, directly to the
ADR.These patients have higher resource use,
including polypharmacy, and are already at
greater risk of harm as a result. Furthermore, not
all ADRs are avoidable as ADRs can occur
when the medicine is used correctly. In studies
looking at ADRs retrospectively, causality is
usually assessed retrospectively by a group of
clinicians. There is variability in how this causality is assigned between studies, making comparison difcult.
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