The Journal of Maternal-Fetal and Neonatal Medicine, 2012; 25(S4): 91–93
© 2012 Informa UK, Ltd.
ISSN 1476-7058 print/ISSN 1476-4954 online
DOI: 10.3109/14767058.2012.714994
Medication errors in the neonate
Elena Sorrentino & Caterina Alegiani
Pediatric, Neonatology and Neonatal Intensive Care Unit, S. Pietro – Fatebenefratelli Hospital, Rome, Italy
Critically ill patients are a high risk population for medication
errors and neonates represent a more vulnerable group. Errors
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can occur in each step of the path from prescription to admini­
stration and their rate varies widely due to the error defini­
tion and identification methods used in the different studies.
Identifying medication errors is a challenge in neonatal care and
should be a priority among care-givers in order to prevent future
incidents and to improve patient safety.
Keywords:  Neonate, medication error, patient safety
Since 1999, when the Institute of Medicine published its report
To Err is Human: Building a Safer Health System [1], in which it
estimated that medication errors annually lead to 44,000–98,000
deaths in the USA, many authors have focused their attention on
For personal use only.
medication errors.
The National Coordinating Council for Medication Error
Reporting and Prevention (NCC-MERP) defines a medica-
tion error as “... any preventable event that may cause or lead to
inappropriate medication use or patient harm while the medica-
tion is in the control of the health care professional, patient, or
consumer…” [2].
Critically-ill patients in the ICU are a high-risk population
for medication errors; within this population, neonatal patients
represent a more vulnerable group where the risk of sustaining
a medication error is three times greater than for an adult. The
main reason is that neonates are a non-homogenous group, where
weight and gestational age change with age. Their metabolism is
different from that of adults and children and changes because of
enzyme system and renal function maturation. Moreover, most of
the medications used to treat neonates are off-label (medication
used for an unapproved indication, dose or form of administra-
tion) or unlicensed for this age group and need dilutions before
being administrated, leading to dosage errors.
Despite the high risk of harm, few studies have been conducted
on evaluating the incidence of medication errors in neonates.
Moreover, the error rate varies widely among studies because of
the differing definitions of an error and the different methods used
to identify medication errors. Some authors report an incidence
in the neonatal intensive care unit (NICU) of 5.5 medication
errors per 100 prescriptions, while others found 15 medication
errors per 100 admissions in NICU. Using the Vermont Oxford
Network’s NICQ.org, some authors have reported that medica-
tion errors account for 47% of medical errors [3].
Identifying medication errors is a challenge in neonatal care.
It allows health care staff to establish error types and frequency,
to perform investigations on the underlying causes and to learn
Correspondence: Elena Sorrentino MD, Pediatric, Neonatology and Neonatal Intensive Care Unit, S. Pietro – Fatebenefratelli Hospital, Rome, Italy.
E-mail: esorrentino@me.com
91
from errors in order to prevent future incidents and to improve
patient safety.
The most effective method of identifying medication errors is
an anonymous, voluntary, non-punitive report. The report can be
prepared using paper forms or online, using a web-based system.
The anonymity and the lack of punishment promote a high level
of reporting, while the voluntary report needs to be supported
by an educational programme involving staff. Nevertheless,
voluntary incident reporting detects mainly harmful events or
incidents that are considered serious and that account for only
8% of all adverse events [4].
Most of the data collected currently come from studies
conducted in the USA and in Canada, a few are European (UK,
Netherlands and Spain) but none are Italian. It would be very
interesting to know the real incidence and types of medication
errors in our country in order to achieve better management of
our neonates.
As shown above, medication errors are not rare in NICUs
but their potential for harm can be very different. According to
Stavroudis, who performed the largest analysis of NICU medica-
tion errors [5], 24% are near misses, errors that do not result in
patient harm due to chance or timely intervention, 55% are errors
that occur but do not reach the patient, while 12% are errors that
reach the patient and require monitoring to confirm that there
is no harm. Fortunately, only 4% of medication errors result in
serious harm and 0.4% in death.
The next step is to analyse when the errors actually occur, what
the different kinds of errors are and what conditions lead to these
errors being committed.
We know that medication error can occur at each step of the
path from prescription to administration (Figure 1): 48.2% of
errors involve the administration phase, 18.4% the transcrip-
tion phase, 14% the prescribing phase, and 12% the dispensing
phase [5]. That means that all health care professionals, such as
doctors, nurses and pharmacists, are concerned and should be
involved in any educational programme established with the aim
of preventing errors.
Avoiding transcription errors is certainly an easy and prompt
way to significantly reduce errors in our NICUs. This can be done
by using a “single therapy sheet”, which can be hand-written or
produced using a computer system: the physician writes the
prescription indicating drug, dosage, time and route of administra-
tion, while the nurse identifies the patient, prepares and administers
the drug and notes the time of administration on the same sheet.
Information technology can be very useful in reducing prescrip-
tion errors, using either a Clinical Decision-support System or a
Computer Physician Order Entry (CPOE) system. The former
 92   E. Sorrentino & C. Alegiani
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Figure 1.  Flow diagram of NICU medication use process. Adapted from Kunac & Reith [10].
For personal use only.
system consists of at least a basic dosage guide for medication,
formulary decision support, and drug allergy, duplicate therapy
and drug-drug interaction checking, while the latter is defined as
a computer-based system that automates the medication-ordering
process to ensure standardized, legible and complete orders [6]. A
recent systematic review on CPOE concludes that “CPOE clearly
reduces medication prescription errors; however, clinical benefit
in paediatric or ICU settings has not yet been demonstrated. The
quality of the implementation process could be a decisive factor
determining overall success or failure” [6].
There are many types of medication errors, and these include
improper dose and quantity of medication, often because of
mistakes in prescribing or in calculating appropriate dilution,
failure to administer a prescribed dose, incorrect time or route
of administration, administration of the wrong medication
or administration to the wrong patient. Obviously, the drugs
involved are those that are more common in the NICU, i.e. anti-
infectious agents (gentamicin, ampicillin), analgesic and sedative
drugs (opiates), electrolytes and fluids (total parenteral nutrition
[TPN], fat emulsions).
In order to prevent most of these errors, the Institute for Safe
Medication Practices (ISMP) has established medication tools
and resources [7], which include Guidelines to improve medica-
tion safety, High-Alert Medications lists indicating medications
that need particular control because of their potential for harm,
LASA (Look Alike – Sound Alike) Medications lists to avoid
confusion, and recommendations about concentrations and types
of infusions of some of the most widely-used medications.
The involvement of a pharmacist in reviewing medication
prescription and preparation can be very helpful in preventing
errors and is recommended by USA and Canadian authors but is
hard to develop in our hospital system. Nevertheless, physicians
The Journal of Maternal-Fetal and Neonatal Medicine
who care for children and neonates must work closely with phar-
macists in order to improve paediatric and neonatal drug formu-
lations and reduce drugs manipulation such as dilutions.
Medication errors can be caused by various causes [8], which
act individually or in association with each other. The most
common causes are human factors, such as inattention, distrac-
tion, inexperience, inadequate training, fatigue or stress. Other
factors include lack of communication, understaffing, poor
equipment and inadequate environment (lack of space, too much
noise, poor lighting).
The usual approach in managing medical errors has been a
punitive approach, identifying and blaming those responsible
for the errors. However, errors are rarely attributable to a single
individual mistake and should rather be considered as a result of
a system failure. Safety experts recommend trying to understand
factors leading to error and suggest that working conditions have
major impact on the risk of errors [9]. Therefore, improving
actions must be performed on organization, education and
environment.
From what we have highlighted in this paper, one could assume
that, over the last 10 years, case reports, observational studies and
reviews that have focussed on adverse events related to medical
errors occurring in the NICU are increasing, and indicate that
medication errors represent a considerable subset of medical
errors, most of which are preventable. Nevertheless, patient safety
intended as freedom from accidental injury is still not a regular
component of medical education.
To address knowledge gaps and to propose a research agenda
on patient safety issues, the National Institute of Child Health and
Human Development (NICHD) held a workshop on “Patient care
in the context of neonatal intensive care: research and educational
opportunities” [9].

With respect to medication errors in the NICU, experts iden-
tified some research opportunities for the scientific community,
such as:
•• define the best processes and develop the safest distribution
models for medications in the NICU
•• develop proper instrumentation and dosage calculation pack-
ages, taking into account changing weight and maturation
•• research medication compatibility with TPN
•• assess optimal space, personnel and other logistics issues at the
pharmacy preparing medication for use in the NICU
•• study the effect of simple alterations in practice on patient
safety, such as colour-coded line tubing or line connectors to
distinguish TPN solutions from human breast milk
Developing a patient safety culture and extending it to neonatal
care is currently a priority, but this effort must be supported both
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by caregivers and by institutions, through the establishment of a
systematic approach to understanding the real extent of this field
through reporting of errors, to understanding the causes leading
to patient harm and the needs for improvement, and to promoting
and encouraging education on patient safety.
Declaration of Interest: The authors declare the absence of any
conflict of interest concerning this publication.
For personal use only.
© 2012 Informa UK, Ltd.
Medication errors in the neonate  93
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