Medication Errors
Medication Errors
Medication Errors
Abstract
Medication error is an important cause of patient morbidity and mortality, yet it can be a confusing and
underappreciated concept. This article provides a review for practicing physicians that focuses on
medication error (1) terminology and definitions, (2) incidence, (3) risk factors, (4) avoidance strategies,
and (5) disclosure and legal consequences. A medication error is any error that occurs at any point in the
medication use process. It has been estimated by the Institute of Medicine that medication errors cause 1
of 131 outpatient and 1 of 854 inpatient deaths. Medication factors (eg, similar sounding names, low
therapeutic index), patient factors (eg, poor renal or hepatic function, impaired cognition, polypharmacy),
and health care professional factors (eg, use of abbreviations in prescriptions and other communications,
cognitive biases) can precipitate medication errors. Consequences faced by physicians after medication
errors can include loss of patient trust, civil actions, criminal charges, and medical board discipline.
Methods to prevent medication errors from occurring (eg, use of information technology, better drug
labeling, and medication reconciliation) have been used with varying success. When an error is discovered,
patients expect disclosure that is timely, given in person, and accompanied with an apology and
communication of efforts to prevent future errors. Learning more about medication errors may enhance
health care professionals’ ability to provide safe care to their patients.
ª 2014 Mayo Foundation for Medical Education and Research n Mayo Clin Proc. 2014;89(8):1116-1125
S
ince the publication of the landmark Insti- errors can be confusing, and the impact on in-
tute of Medicine (IOM) report To Err is dividuals and society can be underappreciated.
For editorial Human,1 there has been an enhanced This article provides an overview of medica-
comment, see focus on improving the safety of health care. tion errors for practicing physicians and fo-
page 1027; for a Medication errors are one remediable portion of cuses on medication error (1) terminology
related article, the safety continuum. and definitions, (2) incidence, (3) risk factors,
see page 1042 Medication use in the United States is highly (4) avoidance strategies, and (5) disclosure
prevalent. In a large national survey, 81% of and legal consequences.
From the Department of In-
ternal Medicine, Division of people took a medication in the preceding
General Internal Medicine week, and 50% took at least 1 prescription MEDICATION ERROR TERMS AND
(C.M.W.) and Department of medication.2 The complexity of modern phar- DEFINITIONS
Anesthesiology (C.M.B.,
W.L.L.), Mayo Clinic, macotherapy lends itself to confusion by pa- Medication error terminology can be confusing
Rochester, MN. tients and errors by health care professionals. because of overlapping definitions.7 In health
In a survey of hospitalized patients, only care, an error has been defined by the IOM
27.9% could list their discharge medications, as “the failure of a planned action to be
and even fewer could state the intended use of completed as intended (error of execution)
their medications.3 Additionally, studies have or the use of a wrong plan to achieve an aim
reported hospital inpatient medication error (error of planning). An error may be an act
rates of 4.8%4 to 5.3%5 and a relationship be- of commission or an act of omission.”8 A medi-
tween medication errors and adverse events.5 cation error has been defined by Bates et al5 as
Importantly, both physicians and patients are re- “any error occurring in the medication use
ported to underestimate the number of deaths process” and focuses on problems with the de-
due to preventable errors of any type,6 including livery of a medication to a patient. Impor-
deaths related to medications. tantly, although some medication errors
Medication errors are an important clinical cause harm to the patient, most do not (eg,
issue. However, even at the most fundamental “near misses”).9 In fact, one study of the fre-
level, the definitions associated with these quency of medication errors discovered that
clinical scenario. For example, error rates are associated with an error, the patients in this series
likely higher for drugs administered intrave- presented to the emergency department to
nously compared with other routes.9 In the receive care for a drug-related insult or harm.
nursing home setting, the medication adminis- The 5 most commonly implicated drug classes,
tration error rateddetermined from direct collectively accounting for 27.7% of the esti-
observation in 58 nursing homesdwas esti- mated adverse drug events, were insulins,
mated to be 12.2%.16 Errors of omission (for opioid-containing analgesics, anticoagulants,
example, not giving aspirin after myocardial amoxicillin-containing agents, and antihista-
infarction) have been studied extensively in pa- mines/cold remedies.22 The events included
tients with acute coronary syndrome. The per- allergic reactions to drugs (33.5%), uninten-
centage of patients that are prescribed aspirin at tional overdoses (32.1%), adverse drug effects
hospital discharge after a myocardial infarction not related to allergy (28.6%), secondary drug
has ranged from 53% to 93.4%,9,17,18 even effects (3.5%), and vaccine reactions (2.3%).
though the current guidelines should yield a Many of these emergency department visits
100% rate if there is not a contraindication to resulted in patient hospitalization. In the adverse
aspirin. Transitions of patient care are particu- drug events that required hospitalization, the in-
larly hazardous for introducing medication er- vestigators reported that the 5 most commonly
rors. Moore et al19 discovered, by comparing implicated drug classes were anticoagulants, in-
inpatient and outpatient records, that 49% of sulins, opioid-containing analgesics, oral hypo-
patients discharged from a hospital had at least glycemic agents, and antineoplastic agents.22
one medication error. The authors discovered that drugs that are
The frequency of harm relative to the fre- usually monitored on an outpatient basis for
quency of medication errors has also been stud- toxicitydie, warfarin, insulin, and digoxind
ied. Bates et al5 studied more than 10,000 accounted for 41.5% of adverse drug event
medication orders and identified 5.3 errors per hospitalizations.
100 orders. However, they concluded that only
0.9% of the errors actually resulted in adverse RISK FACTORS FOR MEDICATION ERRORS
drug events. Barker et al20 studied medication er- There are patient, health care professional, and
rors at 36 institutions. They reported that 19% of medication factors that are associated with the
the doses were in error; yet, only 7% were judged risk of a medication error (Figure). Decline in
to potentially contribute to adverse drug events. patients’ renal or hepatic function is associated
Voluntary reporting systems, including the with higher medication error rates.23 Addition-
US Food and Drug Administration (FDA) ally, patients’ impaired cognition, comorbid-
MedWatch, the Medication Error Reporting ities, dependent living situation, nonadherence
Program, and MEDMARX, are used to track to medications, and polypharmacy may also in-
medication errors. MEDMARX, introduced in crease the risk of medication errors.24
1998, uses a structured taxonomy to report Advanced age is a patient-related risk factor
and classify errors, and to date has received for medication errors. The American Geriatrics
over 1 million entries. The top 10 drugs Society Beers Criteria have been developed
most commonly implicated in drug errors and regularly updated to alert health care
were (in descending order) insulins, albuterol, professionals about potentially inappropriate
morphine, potassium chloride, heparin, cefa- medication use in older adults.25 The most
zolin, furosemide, levofloxacin, and vancomy- problematic medications are anticholinergics,
cin.21 The contributing factors related to these sedatives, and those that may cause orthostatic
inpatient errors included but were not limited hypotension. These factors can predispose
to staffing issues, distractions, workload in- elderly patients to potentially serious effects
creases, patient issues, shift changes, cross such as delirium or falls. However, the use of
coverage, and fatigue.20 these medications in an elderly patient may
Budnitz et al22 studied the National Elec- be appropriate in some cases, and it is not clear
tronic Injury Surveillance System to determine which fraction of adverse effects relate to errors.
which medications are associated with the high- Health care professionaleassociated factors
est rates of emergency department visits due to can lead to medication error. The use of abbrevi-
adverse drug events. Although not always ations in prescribing and other communications
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MEDICATION ERRORS
FIGURE. Examples of causes of medication errors. A, Unapproved abbreviations and illegible handwriting
(for example, the U for units could be confused for a zero; MS is ambiguous and could mean morphine or
magnesium sulfate; trailing zeros after a decimal could be mistaken for 20 rather than 2.0; QD [every day]
could be confused with QOD [every other day] or QID [4 times a day]). B, Look-alike bottles should be
placed in separate locations in a pharmacy. C, Similar sounding medications such as glyburide and glipizide
can be labeled with “tall man lettering” to decrease medication error. D, Patient risk factors such as age,
comorbidities, and polypharmacy can precipitate medication errors.
increases the risk of a medication error. To errors that may lead to medication errors. For
address this issue, the Joint Commission has example, if a medication is usually stored in a
published a list of medical abbreviations that specific compartment in a resuscitation cart,
should not be used.26 Examples include IU (in- those that frequently use the cart may become
ternational units), which could be mistaken for accustomed to this location. If the location is
IV (intravenous), and MS (morphine sulfate), changed, someone could mistake the drug in
which could be mistaken for MSO4 (magnesium this location for the intended drug. The same
sulfate).26 It is recommended that potentially substitution error may occur when frequent
confusing terms be completely written out vendor changes for a given drug or the intro-
rather than abbreviated. duction of a replacement drug (eg, resulting
Cognitive biases by health care profes- from attempts to reduce drug costs or compen-
sionals also may contribute to medication er- sate for drug shortages)28 introduce different
rors. Specifically, confirmation bias, which is label colors and images that, in turn, mimic
the “tendency to look for evidence that sup- labels within the same storage area. In such in-
ports an early working hypothesis,”27 and stances, health care professionalsdparticularly
lack of situational awareness are cognitive when working in a stressful environment in
which quick decisions are requireddmay have patient-days after the intervention.33 Bar codee
confidence that they have accurately confirmed assisted medication administration was reported
the correct medication when in fact they have to reduce the medication error rate in an intensive
not. care unit from 19.7% to 8.7% (a 56% reduc-
Look-alike names and the therapeutic tion).34 This medication error rate improvement
index of the medication can predispose to was mostly due to reductions in errors of wrong
medication errors and subsequent harm. The administration time. Despite success at reducing
Institute for Safe Medication Practices has pub- medication errors, technology such as physician
lished lists of look-alike drug names. Examples order entry and bar codeeassisted adminis-
include dopamine/dobutamine, daunorubicin/ tration systems require considerable financial in-
doxorubicin, vincristine/vinblastine, and pred- vestment, health care professional training, and
nisone/prednisolone. The list was generated system maintenance.32
from medication error reporting programs, Education for both patients and health
errors in the literature, and expert input. Exam- care professionals is an important component
ples of high-alert medications include cardiac of medication error reduction. Programs have
antiarrhythmics, anticoagulants, inotropic med- been deployed to teach patients to maintain
ications, insulin, and opioids. an accurate medication list, know the indica-
tions for each of their medicines, and bring
AVOIDING MEDICATION ERRORS medication bottles to all physician appoint-
Because the root causes of medication errors ments.12 Additionally, promotion of a culture
are diverse, multiple strategies are required of safety is important to improve error report-
to prevent them. The FDA has worked to re- ing. Preparation for medication error discovery
view confusing drug names, improve pack- and disclosure are now being taught to physi-
aging, require identification bar codes, and cians and medical students.35 Real-time educa-
educate patients.29 Campaigns such as the “5 tion by pharmacists may also decrease errors.
Rights of Medication Administration”dright Pharmacist participation as a full member of
drug, right patient, right dose, right route, a health care team on hospital rounds also is
right timedhave been used with limited suc- reported to decrease adverse drug events
cess. The elimination of cognitive bias in med- caused by prescribing errors.36
icine is a difficult problem to overcome.
Systems thinking (ie, using quality improve- Drug Labeling
ment methodologies to discover and correct Drug labeling to help prevent medication er-
root causes of problems rather than blaming rors is not a new idea. In historical apothe-
an individual), error proofing (ie, a lean meth- caries, poisons were kept in colored (often
odology term that means to design an environ- cobalt blue) bottles labeled with sinister warn-
ment in which a mistake cannot happen, such ings (skull and crossbones, “Not to Be Taken,”
as a cable that can only be plugged into an “POISON”). The bottles were also textured so
outlet in one direction), and training have that a pharmacist would have a tactile warning
been suggested methods to remediate drug er- that the contents were toxic. Additionally,
rors or opportunities for drug errors.27 because most apothecary bottles were cylindri-
Information technology has been a mainstay cal, poison bottles were often a unique shape
for reducing medication errors. Computerized such as triangular or even in the shape of a
systems can eliminate illegible handwriting and coffin.
confusing medical abbreviations.30 Drug data- In a similar way, modern techniques to pre-
bases can also help to identify drug-drug interac- vent medication errors have used concepts
tions.31 Computerized physician order entry can from human factors engineering. The goal of hu-
decrease medication errors by more than one- man factors engineering is to consider human na-
half, although not all of these errors would ture and make systems that are “human proof.”27
have resulted in an adverse event.32 In other To help prevent confusion with look-alike drug
research, a computerized physician order entry names, the FDA and Institute for Safe Medical
system helped reduce nonemissed-dose medica- Practices have recommended the use of “tall
tion errors in outpatients from 142 per 1000 man letters.”37 For example, dopamine and
patient-days at baseline to 26.6 per 1000 dobutamine would be labeled as DOPamine
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MEDICATION ERRORS
and DOBUTamine. Tall man lettering has the that, at least in hospitalized patients, there
potential to mitigate medication errors for some currently is no convincing evidence that medica-
of the most hazardous medications including tion review reduces morbidity and mortality.44
pressors and oral hypoglycemic agents (GlyBUR- They elaborated that more clinical trials with
IDE and GliPIZIDE). Tall man lettering has the rigorous methods will need to be completed
potential to avoid confusion of very different before a more definitive conclusion can be
compounds, such as LaMICtal and LamISIL. made. Future trials should cover a multitude
However, studies have yielded mixed results on of different practice venues (eg, hospitals,
whether tall man lettering reduces medication er- nursing homes, outpatient facilities) and types
rors.37,38 For over-the-counter medications, the of patients (eg, pediatric and elderly patients),
FDA has also worked to standardize labels to given that benefits in one location and demo-
make them easier for patients to read.29 graphic may not translate to others.
The FDA has started to review all drug
names and work with drug companies to DISCLOSURE AND LEGAL CONSEQUENCES
select names that avoid confusion.29 The OF MEDICATION ERRORS
FDA has also started requiring that certain
high-risk productsdregardless of the source Disclosure of Errors
of risk for errordbe bar coded so that checks Disclosure of medication errors is import for
can be put into place to ensure that the right the benefit of an individual patient, as well
medication is given to the right patient.29 as to provide data for broader, systemic in-
sights into any recurring patterns of errors.21
Medication Reconciliation Studies have examined patient attitudes to-
An accurate and complete medication list is often ward disclosure of medical and medication er-
highly beneficial when providing medical care to rors. In general, patients and their families want
a patient. Medication reconciliation is defined by transparent communication and full disclosure
the Institute for Healthcare Improvement as “a when an error occurs.45,46 In addition, most pa-
process of identifying the most accurate list of tients want to know about an error even if there
all medications a patient is takingdincluding was no detrimental outcome, and they expect to
name, dosage, frequency, and routedand using be informed as soon as the error is discovered,
this list to provide correct medications for pa- told in person, given an apology, and informed
tients anywhere within the health care system.”39 of efforts to prevent future errors.46-48 Alterna-
Medication reconciliation is a process that in- tively, nondisclosure is reported to diminish pa-
volves (1) verification of the patient’s medication tients’ trust in physicians and increase the
history, (2) clarification that the medications are likelihood they will change physicians.49
appropriate for the patient, and (3) reconciliation From the physician’s perspective, disclosure
of any discrepancies.40 of a medical error can be anxiety-provoking
Medication reconciliation has received because of fear of humiliation, reprimand, or liti-
much attention from health care organiza- gation. Studies of physician disclosure of medi-
tions. The Joint Commission made medication cal errors have found that there is physician
reconciliation one of its National Patient Safety variability about which errors to disclose (eg,
Goals in 2005.41 Reducing errors and harm harm vs near misses) and the use of apology.48
from mislabeling medications and from anti- Additionally, the specialty of the physician
coagulation have remained Joint Commission may affect whether the error is disclosed and
patient safety goals.42 Additionally, Medicare how much detail is included.50 As reviewed by
and Medicaid have developed incentive pay- Gallagher et al,50 both medical and surgical spe-
ment programs for the “meaningful use” of cialists were less likely to disclose an error if it
the electronic health record. Stage 2 of mean- might not be apparent to the patient. However,
ingful use includes medication reconciliation surgeons were more likely to disclose an error
as a core objective.43 but disclosed less information than a medical
Contrary to the logic that medication recon- specialist.50 Additionally, patients and physi-
ciliation must certainly be beneficial, the cians also have divergent definitions of a medical
Cochrane Collaboration has performed a sys- error. In general, patients tend to have more
tematic review of the literature and concluded widely encompassing definitions of medical
errors, whereas physicians tend to have nar- of potassium chloride that pharmacists and
rower definitions that focus primarily on devia- nurses at the hospital should have clarified
tions from standards of care.48 Studies in the proper dosing with him before adminis-
resident physicians indicate that a minority tering it to the patient.55 The civil court jury
had been formally prepared to disclose an awarded the family of the patient $380,000
error.51 for the negligence on the part of the physician.
The effects of full disclosure of medical er- The hospital had previously settled with the
rors on litigation have been studied. The Univer- family for an undisclosed amount representing
sity of Michigan Health System implemented 90% of the blame for the mishap in dosing.55
and studied a program to fully disclose and offer Less commonly, criminal allegations may be
compensation for medical errors and found that filed against physicians when a medication error
there was no increase in total claims or liability results in injury. Since the 1990s in the United
costs.52 Full disclosure of errors also probably Kingdom, there has been an increase in the num-
has a neutral to positive effect on the way a pa- ber of physicians indicted for gross negligence
tient responds to an error and on the patient- manslaughter due to medication errors.56,57
physician relationship.49 This upswing in cases is said to reflect society’s
“intolerance towards ‘accidents’ as being events
Legal Consequences that have an innocent origin.”57 This type of
Common consequences faced by physicians criminal penalty for medication errors is not
after medication errors can include civil ac- limited to the United Kingdom. In August
tions, criminal charges, and medical board 2009, a pharmacist from Ohio, Eric Cropp, was
discipline. According to the Texas Medical sentenced to a prison term for involuntary
Liability Trust, an initiative endorsed by the manslaughter after the death of a 2-year-old child
Texas Medical Association, inappropriate pre- receiving chemotherapy.54 The treatment medi-
scribing of medication, to include medication cation was to be compounded using 0.9% so-
errors, is among the top 10 reasons for physi- dium chloride but instead was mixed using
cians to be sued for medical malpractice.53 hypertonic saline (23.4% sodium chloride). After
For a civil suit of medical malpractice to intravenous administration, the young patient
succeed against a health care professional, complained of a severe headache and fell limp
negligence must have resulted and the negli- in her mother’s arms. She was placed on life sup-
gence must have resulted in injury to the pa- port and diagnosed as brain dead from an over-
tient. The injured party must prove that a dose of sodium chloride. Mr Cropp was
standard of care existed, that the physician sentenced to 6 months of prison time and 6
involved breeched that standard, that an months of home detention and was required to
injury occurred as a result, and that the breech perform 400 hours of community service to
was a cause of the injury.54 include presenting to professional groups on
For example, a nephrologist residing in the topic of medication errors and possible sys-
Texas was assisting in the care of a 72-year- tems to help mitigate the risk to patient safety.54
old patient undergoing kidney dialysis who Statutes and courts require a greater degree
was admitted to the hospital for a toe amputa- of culpability when charging a health care pro-
tion.55 During the patient’s hospital course, the fessional with negligent conduct under a crim-
nephrologist wrote an order for 10 mmol of po- inal act when compared with a civil penalty.
tassium chloride, to be administered by intra- Under criminal negligence, the accused
venous infusion. Feeling that 10 mmol was “should be aware of a substantial and unjustifi-
inadequate, he increased the dose requested able risk that.will result from his conduct.”42
to 20 mmol by writing the number 2 over the Furthermore, “the risk must be of such a nature
number 1, without scratching out the original and degree that the actor’s failure to perceive
number 1. The patient was then given a total it.involves a gross deviation from the stan-
of 120 mmol of potassium chloride instead of dard of care that a reasonable person would
the expected 20 mmol. The patient had cardiac observe in the actor’s situation.”42 Other courts
arrest and subsequently died. At trial, the require gross negligence to be proven. Under
defendant nephrologist argued that the 120 this concept, the health care professional’s ac-
mmol dose was so out of the normal dosing tions must be more than inadvertent but just
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MEDICATION ERRORS
d Adverse drug eventdan adverse outcome that can be attributed to the action of a drug
Incidence
d Medication errors cause 1 of 131 outpatient and 1 of 854 inpatient deaths
d Medications most commonly associated with errors include insulins, opioid-containing analgesics, anticoagulants,
d Medication reconciliation
d Consequences can include civil actions, criminal charges, and medical board discipline
short of intentional behavior.58 Either test used license (K. H. Berge, MD, vice president of the
by the court has limited ability to trigger a Minnesota Board of Medical Practice and Chair
culpable fault accusation (or charge) against a of the Complaint Review Committee, oral
medical professional because most medication communication, May 21, 2013).
errors are more commonly considered “acci-
dents.” Evolving public sentiments may in- CONCLUSION
crease the use of criminal standards (vs civil Medication error is an important cause of
standards) in the future. morbidity and mortality, yet it can be a
A third possible consequence of a medica- confusing and underappreciated concept
tion error is regulatory board action.54 Each (Table). A medication error is any error that oc-
state board of medical practice has unique curs in the medication use process. It has been
administrative characteristics. The “primary re- estimated by the IOM that mediation errors
sponsibility and obligation of the [Minnesota] cause 1 of 131 outpatient and 1 of 854 inpatient
Board of Medical Practice (Board) is to protect deaths. Medication factors (eg, similar sounding
the public.from the unprofessional, improper, names, low therapeutic index), patient factors
incompetent, and unlawful practice of medi- (eg, poor renal or hepatic function, impaired
cine..”59 The Board is complaint-driven, cognition, polypharmacy), and health care pro-
requiring someone (eg, a patient, a family mem- fessional factors (eg, use of abbreviations, cogni-
ber, another health care professional, a pharma- tive biases) can precipitate medication errors.
cist) to file a complaint before an investigation Common consequences faced by physicians af-
can be initiated. The Board is then obligated to ter medication errors can include loss of patient
investigate all complaints. If the Board deter- trust, civil actions, criminal charges, and medical
mines that the minimal standard of care has board discipline. Methods to prevent medica-
not been met and that physician education can tion errors from occurring (eg, use of informa-
remedy the problem, education will be required. tion technology, better drug labeling, and
When a patient has been harmed, remedies are medication reconciliation) have been used with
pursued to ensure that the physician works to varying success. When an error is discovered,
improve his or her practice moving forward. If most patients expect disclosure that is timely,
the event is sufficiently egregious, the Board given in person, and accompanied with an apol-
has the power to suspend or revoke a physician’s ogy and efforts to prevent future errors. Learning
more about medication errors may enhance 16. Barker KN, Mikeal RL, Pearson RE, Illig NA, Morse ML. Medica-
tion errors in nursing homes and small hospitals. Am J Hosp
health care professionals’ ability to provide safe Pharm. 1982;39(6):987-991.
care to their patients. Future research should 17. Krumholz HM, Chen J, Rathore SS, Wang Y, Radford MJ.
focus on identifying the errors that most Regional variation in the treatment and outcomes of myocar-
dial infarction: investigating New England’s advantage. Am Heart
commonly lead to patient harm. Additionally, J. 2003;146(2):242-249.
a better understanding of how information tech- 18. Granger CB, Steg PG, Peterson E, et al; GRACE Investiga-
nology, labeling, medication reconciliation, and tors. Medication performance measures and mortality
following acute coronary syndromes. Am J Med. 2005;
improved care transitions reduce medication er- 118(8):858-865.
rors is needed. A focus on easy-to-use and inex- 19. Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors
pensive techniques for medication error related to discontinuity of care from an inpatient to an outpa-
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Abbreviations and Acronyms: FDA = Food and Drug Med. 2002;162(16):1897-1903.
21. Vecchione A. USP Drug Safety Review: Top 10 drugs involved
Administration; IOM = Institute of Medicine
in medication errors. Drug Topics website. http://drugtopics.
modernmedicine.com/drug-topics/news/usp-drug-safety-review-
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