Guidelines peds preventing medication errors

Guidelines for
Preventing Medication Errors
in Pediatrics
J Pediatr Pharmacol Ther 2001;6:426-42
The Pediatric Pharmacy Advocacy Group is a non-profit professional
pharmacy association dedicated to improving the healthcare of all chil-dren.
The sole purpose of PPAG is to advocate for safe and effective
medication use in children through communication, education, and the
promotion of research.
The Institute for Safe Medication Practices is a nonprofit healthcare
agency comprised of pharmacists, nurses, and physicians. Founded in
1994, the organization is dedicated to learning about medication errors,
understanding their system-based causes, and disseminating practical
recommendations that can help healthcare providers, consumers, and
the pharmaceutical industry prevent errors.
Endorsed by:
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The Journal of Pediatric Pharmacology and Therapeutics JPPT
risk of medication error occurrence and
increased potential for morbidity. The pediatric
population is a high-risk group because the
number of potential adverse drug events is
three times that found in hospitalized adult
patients.1 Factors placing pediatric patients at
increased risk for adverse drug reactions can be
found in Table 1.3-9
The special treatment considerations of this
population provided impetus for a collabora-tion
between the ISMP and the PPAG. A sym-posium
was held prior to the 1997 American
Society of Health System Pharmacists Mid-year
Clinical Meeting in Atlanta, Georgia. This meet-ing
included members of the ISMP and PPAG,
as well as a panel of experts in the field. In
hopes of avoiding or decreasing the occurrence
of future medication errors in the pediatric pop-
427
REVIEW
Guidelines for preventing medication errors in pediatrics
Stuart R. Levine, PharmD, Michael R. Cohen, MS, Nicholas R. Blanchard, MEd,
Frank Frederico, MS, Merrell Magelli, PharmD, Chris Lomax, PharmD, Gary Greiner,
PharmD, Robert L. Poole, PharmD, Carlton K. K. Lee, PharmD, MPH,
Anne Lesko, PharmD
From the Institute for Safe Medication Practices, Huntingdon Valley, Pennsylvania and The
Pediatric Pharmacy Advocacy Group, Denver, Colorado
Medication errors commonly occur in healthcare facilities. Most literature has centered on med-ication
errors and prevention of those errors in facilities that care primarily for adults. This article con-centrates
on the medication errors that are common to pediatrics facilities, and recommends strategies
for reducing the potential for medication errors in those settings. Methods reviewed include looking
at system deficiencies vs. the single practitioner, education programs that reduce the risk of error,
strategies for reducing the potential of medication errors, use of automation, and benefits of a comput-erized
prescriber order entry system.
Key words: Medication errors, patient safety, medication safety, pediatrics, computerized prescriber
order entry, automated dispensing devices, prescriptions
(J Pediatr Pharmacol Ther 2001;6:427-43)
In August 1998 the draft guidelines were
published in the Journal of Pediatric Pharmacy
Practice.1 In order to stimulate discussion on the
topic of preventing errors in the pediatric popula-tion
and to refine the draft guidelines this manu-script
was written as a collaborative effort
between the Institute for Safe Medication
Practices (ISMP) and the Pediatric Pharmacy
Advocacy Group (PPAG). The following are the
results of that effort and represent the recommen-dations
of these two organizations.
Medication error prevention is fundamental
in the care of all patients. Although many med-ication
errors go unreported and are often unde-tected
with minimal clinical significance, some
medication errors do result in serious morbidity
or mortality. Certain patient populations are
exposed, by inherent characteristics, to greater
Address correspondence and reprint request to Stuart R. Levine, PharmD, Director of Pharmacy,
Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, Deleware 19803
e-mail address: slevine@nemours.org

JPPT Levine SR, et al
• Different and changing pharmacokinetic parameters between patients at various ages and stages
of maturational development.10
• Need for calculation of individualized doses based on the patient’s age, weight (mg/kg), body
surface area (mg/m2), and clinical condition.
• Lack of available dosage forms and concentrations appropriate for administration to neonates,
infants, and children. Frequently, dosage formulations are extemporaneously compounded and
lack stability, compatibility, or bioavailability data.
• Need for precise dose measurement and appropriate drug delivery systems
• Lack of published information or FDA-approved labeling regarding dosing, pharmacokinetics,
safety, efficacy, and clinical use of drugs in the pediatric population.
FDA=Food and Drug Administration
428
Table 1. Factors placing pediatric patients at increased risk for adverse drug reactions3-9
ulation, this group discussed challenges involved
in medication error prevention in neonates,
infants, and children and addressed methods to
overcome these challenges. The session was
audio taped and later reviewed in order to incor-porate
salient points into this document.
Recommendations for the prevention of med-ication
errors in the general hospitalized popula-tion11
and in patients receiving cancer chemother-apy12
have been published elsewhere. While
many previously published recommendations
apply to the pediatric population, this document
focuses exclusively on this select patient group
and offers specific recommendations for the pre-vention
of medication errors. Some of the recom-mendations
presented in this document may reit-erate
those published in previous documents.
The purpose of this document is to recommenda-tion
medication error prevention strategies for
consideration in the development of: 1) organiza-tional
systems (e.g, computerized order entry sys-tems,
automated dispensing systems, bar coding,
robotics); 2) educational systems; and 3) manu-facturing
and regulatory systems. The paper will
also suggest medication error prevention strate-gies
for individual healthcare professionals.
ORGANIZATIONAL SYSTEM
RECOMMENDATIONS
Medication errors rarely occur from the fail-ure
of a single element or because of mistakes by
single practitioner. Rather, medication errors are
the result of the combined effects of “latent fail-ures”
in the system and “active failures” by indi-viduals.
Latent failures are weaknesses in the
structure of an organization, such as faulty infor-mation
management or ineffective personnel
training, which result from both good- and ill-conceived
decisions. By themselves, latent fail-ures
are often subtle and may cause no problems.
Their consequences are hidden, becoming appar-ent
only when they occur in proper sequence and
are combined with active failures of individuals
to penetrate or bypass the system’s safety nets.
Many of the latent and active failures that were at
the root of medication errors are not apparent
until a root cause analysis is performed.13 For this
reason, providing an optimal level of medication
safety requires both recognition and correction of
latent failures in the system. This document looks
beyond blaming individuals and focuses on the
multiple underlying system enhancements that
can shape individual behavior and create the con-ditions
whereby medication errors may be pre-vented.
It is unrealistic to expect absolute perfec-tion
or error-free performance from any person.
For this reason, it is essential that systems be
established to minimize the risk of medication
errors. In order to increase the number of oppor-tunities
to detect and prevent medication errors,
these systems should be highly redundant and
should be updated as new potential sources of
error are identified. In the post-medication error
evaluation process, system deficiencies should be
identified and corrected before placing all respon-sibility
on human error.

Guidelines for preventing medication errors in pediatrics JPPT
429
Computerized Order Entry System
Recommendations
Every healthcare provider has an occasional
“bad day” or lapse in personal performance that
could result in a medication error. For this rea-son,
available technology should be used, espe-cially
in situations where accuracy is critical. In
healthcare, computers can provide technological
support by providing information, facilitating
clear and accurate communication, alerting the
user to potential errors, and processing data. The
selection and programming of a computer system
should be done with medication error prevention
in mind. The computerized order entry process
will act as a firewall, which can reduce the risk of
medication errors that subsequently occur in
patients. A variety of functions should be incor-porated
into the “ideal” computer order entry
system (Table 2).
Another item that should be considered
involves site-specific programming choices,
which can make a system more helpful in the pre-vention
of medication errors. These systems
should use only metric units and institution-approved
standardized doses and concentrations.
All decimal expressions less than one whole unit
should be preceded by a leading zero (i.e., 0.1 not
.1) and whole numbers should not be followed by
a trailing zero (1 mg not 1.0 mg).14 The use of
abbreviations for drug names should not be per-mitted.
There should be an established link to
data entry requiring input of up-to-date patient
information (e.g., age, weight (in kilograms),
allergies, diagnosis). The software should also
screen for allergies, large or small dosages, and
drug-drug, drug-nutrient, or drug-disease inter-actions
and should sound or flash an alert when a
potential problem is identified. For more serious
warnings, a manual over-ride should be required
and should be accompanied by appropriate doc-umentation.
Caution should be exercised to avoid
manual over-rides for minor problems because
this promotes automatic manual over-riding that
could leads to a failure to appreciate the signifi-cance
of the alert. Finally, there should be a set
and utilize minimum and maximum dose range
based on pediatric age, weight, and height
Table 2. Functions important to the “ideal” computer order entry system
• Prescriber order entry for verification by nurse and pharmacist
• Computer-generated medication administration records from a common data base shared with
the pharmacy and the prescriber
• For each patient, lists of current medications that are readily accessible by caregivers
• Two-way interface between the pharmacy and other institutional systems (e.g., laboratory, admis-sion
and discharge, clinical records)
• Access to historical patient data (i.e., archived information)
• Ability to calculate and verify appropriate height-weight range and dosage for patient
• Access to vital patient and drug information directly from order entry, medication profile, and
medication administration screens
• Ability of system to use patient and drug information to provide unsolicited information during
order entry to reduce potential for adverse drug events (e.g., drug interactions, contraindications,
excessive doses, allergies). This should be part of a comprehensive decision support program.
These programs would include checking for laboratory results and advising the prescriber of the
need for dosing modifications for specified medications. Automatic checking should also include
drug-drug interactions, drug-nutrient interactions, drug duplication, therapeutic duplication,
contraindicated medications, weight-based dosage checking
• Provide a forced function by limiting the route and frequency by which a drug is ordered

430
parameters. Prescriber care sets may also be
linked to patient weight in selecting drug
dosages. Where applicable, the software should
include set dose limits for single doses, 24-hour
doses, course of therapy, and lifetime doses. The
system should also contain a built-in growth
chart to alert the user to obvious patient outly-ers.
15
Because of the potential for selecting the
wrong medication mnemonics should not be
used. If it is determined by an organization to
employ mnemonics, then caution should be used
in selecting mnemonics, ensuring that: 1) no two
mnemonics are so similar as to promote selection
errors by bringing dissimilar items onto the
screen at the same time; 2) separate selections are
available for intravenous products which are
given by a different route. For example, a sepa-rate
computer file should exist for amphotericin B
intranasal administration versus intravenous
administration to prevent IV administration of
the intranasal dosage form; and 3) potentially
misleading abbreviations are not incorporated in
the mnemonics.
The final item important in site-specific pro-gramming
choices involves the selection of labels
and label set-up programs. These systems should
ensure that:
• labels are easy to read
• all vital information is included and extrane-ous
information is excluded
• the most important information is empha-sized
through typeface and placement (e.g.,
patient name, drug name, concentration,
dose, and route)
• appropriate spacing is used between terms
• laser printers are used in order to provide the
greatest clarity
• leading zeros are used (0.1 mg) and trailing
zeros are omitted (1.0 mg)
• dangerous abbreviations are not used.10
Computerized prescriber order entry systems
are one of the many tools that are used as a
method of medication error reduction. No one
device or technology will eliminate all errors. It is
only through the coordinated use of elements of a
medication error reduction strategy that we can
improve the safety of our patients.
Automated Dispensing Systems
Recommendations
In addition to computerized prescriber order
entry, there are several other technologies avail-able
to today’s healthcare system. While there are
some timesaving elements associated with tech-nologies,
it is important to review their potential
for errors in the pediatric population.
Automated dispensing devices (ADD) have
become very common technology. They are
designed to reduce some of the staffing burdens
and allow for reassignment of staff to provide
clinical services. While this may be true in some
hospitals, implementation of this technology may
decrease the use of traditional methods that are
employed to enhance safety and may actually
increase the number of medication errors.
Several issues must be in place before ADDs are
used (Table 3).
Bar code technology is moving to the patient
bedside and can help assure that the right drug,
correct time, precise dosage and right patient are
selected. It can also document the identity of the
person administering the medication. Because a
standardized Universal Product Code (UPC) has
not been created for the dose level, bar code labels
must be prepared for each distinct unit dose.
Robotics for centralized automated dispens-ing
has increased over the last few years. As with
the ADD, care must be taken not to move away
from the unit dosing of medications for the pedi-atric
population. In some cases, standardized
doses can be employed to help implement and
use the robotic technology in the pediatric setting.
Other System Recommendations
While our recommendations apply primarily
to the provision of healthcare in the institutional
setting, some of the general ideas and principles
may be adapted for use in other practice settings.
Institutions dedicated solely to the treatment of
pediatric patients may find it easier to create and
enforce policies and procedures directed toward
the prevention of medication errors in this specif-ic
population, but all facilities involved in the
treatment of pediatric patients should assume the
responsibility for identifying and implementing

• The ADD must interface with the pharmacy computer system and should allow the pharmacist to
review the new order prior to release into the database. The review must also precede release of
any medication from the ADD. This can be accomplished by a profiling interfacing system that
allows the pharmacist to enter all new orders into the pharmacy system before a nurse has access
to the medications in the ADD. Although some ADDs send information to the pharmacy system,
they do not alert the pharmacy that a medication has been released for administration to a patient.
• An override exists in all ADD. The override function must be addressed at the time of implemen-tation
and should be restricted to true “emergencies.” If a liberal approach is used and the func-tion
becomes one of convenience and not one of emergency, many errors will be allowed to occur
prior to pharmacist review. Even during emergencies the pharmacist should be alerted to the inci-dent.
As stated above, some systems will send information to the pharmacy system; however, they
do not alert the pharmacy that a medication has been released for administration to a patient.
Alternatively, during emergencies a second nurse could verify the order before administration to a
patient. All overridden reports should be routinely checked for patterns.
• The use of ADD in the pediatric setting may also decrease the use of patient-specific unit doses.
While these machines may contain commercial unit dose containers, they are not specific to that
patient and act as bulk containers. Nurses are required to calculate doses and draw up medica-tions,
• Stocks in each ADD can be tailored to specific patient care units to assure that medications that are
unfamiliar to a practitioner cannot be removed in error. Careful drug selection based on the needs
of the patient care unit, patient age, diagnosis, and staff expertise should be used to tailor each unit.
• Use of an ADD with specific cells for each that drug are available only when the patient is receiv-ing
that medication at the correct time. Systems that provide open drawer technology increase the
risk of selection of the wrong mediation or provide an opportunity for a medication to inadver-tently
• Asystem should be in place to ensure the pharmacist has verified the placement of medication after
restocking or that there is bar code technology to verify placement.
• With the addition of an ADD there are now an increasing number of locations where medications
can be stored. Multiple locations often result in an increase in the number of missing medications.
Missing medications result in delays for patients and may result in multiple doses being adminis-tered.
• Some additional recommendations include: 1) minimize variety; 2) stock unit dose drugs in the
smallest dose/container size available; 3) supply only a single concentration of medication; 4)
establish maximum dose ranges for high-alert drugs; 5) returns should be made to the pharmacy
and not to the ADD, unless there is a specific return bin within the ADD dedicated to returned
drugs; and 5) use of allergy reminders as needed.
ADD=Automatic dispensing device
431
Table 3. Issues to consider before ADDs are used
and another practitioner must verify the dose before administration.
fall into the wrong container.

432
measures necessary to protect this population
from medication errors.
A strong formulary system that is governed
by the Pharmacy and Therapeutics (P & T)
Committee should be operational and should
consist of physicians, pharmacists, nurses, risk
managers, and other healthcare professionals. If
the facility is not dedicated entirely to the treat-ment
of pediatric patients, the departments
should ensure sufficient representation of all dis-ciplines
within this specialty on the P & T
Committee. Alternatively, a subcommittee of the
P & T Committee could be appointed to consider
and make recommendations regarding pediatric
formulary considerations. The committee should
create and enforce policies regarding evaluation,
selection, prescribing, and use of drugs and
devices for pediatric patients within the organ-ized
health care setting (Table 4). Likewise, the
committee should establish standardized dosing,
medication concentrations, drug administration
schedules, and abbreviations. The committee
should also encourage the use of metric units of
measurement and the rounding of odd doses.
It is also imperative that policies and proce-dures
are developed to ensure adequate person-nel
selection, training, supervision, and evalua-tion.
These policies and procedures should
Table 4. Formulary management
The P&T Committee should:
• ensure that drugs are appropriate for use in the pediatric population (e.g., concentrations, dosage
forms, inactive ingredients).
• guarantee that all devices (e.g., pumps, compounding devices, burette chambers) selected for use
are appropriate for the pediatric population. Procedures for appropriate use of all institutionally
accepted medication administration devices (i.e., enteral and parenteral) should be detailed and
distributed to all patient care areas. These procedures should be delivery system specific and, when
appropriate, drug and/or administration route specific.6,8,16,17 The ability of a device or set to per-mit
free-flow should be evaluated prior to acceptance.
• make certain that special oral syringes used within the institution are not compatible with needles
and needleless IV systems or parenteral catheters.
• ensure that appropriate measuring devices should be available for oral administration and param-eters
should be set to address minimum measurable volumes for these devices (i.e., measuring 0.2
mL in a 10 mL syringe).
• ensure that at the time of formulary review potential medication errors are evaluated. The com-mittee
should determine if the medication: 1) sounds (i.e., verbal order confusion) or looks (i.e.,
written order confusion) like another drug on formulary; 2) uses packaging that appears similar to
other drugs on formulary; 3) requires the performance of certain tests as part of monitoring to
assure safely; 4) is associated with clearly defined dosing information; and 5) allows for standard-ized
dosing that can be used in order to decrease the number of calculations required.
• approve clinical pathways, protocols, preprinted orders, dose calculation forms, etc. via a multi-disciplinary
team or the committee should appoint and oversee a multidisciplinary team for this
purpose.
• be involved in computer software and ADD decisions.
• review methods for ordering total parenteral nutrition and limit choices to mg/kg/day for
younger children and per liter for older children.
P&T = Pharmacy and Therapeutics Committee; ADD = automated dispensing devices

433
include proper interviewing procedures, staff ori-entation
and development programs (including
the discussion of medication errors), and should
consist of regular (annual, biannual) age-related
competency evaluations that include calculation
skills and opportunities for continuing education
specific to pediatrics.18-22 While it is essential that
personnel who regularly serve this patient popu-lation
be well trained and competent, it is very
important that personnel who work with this
population less frequently be competent; there-fore,
these personnel should also be required to
participate in any training and competency eval-uations
required of regular employees in this
area. These policies and procedures should also
establish reasonable workload levels and work-ing
hours and ensure, through adequate staffing,
that these quotas are rarely exceeded.
The work environment where drugs are pre-pared
or administered should be free of potential
factors that contribute to medications errors.
These include high noise or traffic, poor lighting,
temperature extremes, and distractions or inter-ruptions.
A unit dose dispensing system should be in
place and the pharmacy department, should pre-pare
and dispense individual patient doses in
ready-to-administer form to minimize the need
for manipulation of drug products outside of the
pharmacy.3,8,20 In order to facilitate communica-tion
and exchange of information among the
healthcare team, pharmacists should be as acces-sible
as possible, participating in patient rounds
and/or working in or near patient care areas.
A highly redundant system of checks should
be instituted for the entire medication delivery
process from ordering of the medication, to
preparation and dispensing of the drug, to
administration of the medication. This would
provide numerous opportunities for the discov-ery
of potential medication errors before they
reach the patient.23,24 Documentation of any
required change or alteration in medicinal thera-py
is also very important. The system should
provide for review and verification of the pre-scriber’s
original order prior to the dispensing of
the drug (except in emergency situations). To
prevent the occurrence of drug administration
without appropriate review, floor stock should be
eliminated or limited to very low risk medica-tions
or automated dispensing modules should
be available and all orders should be screened by
a pharmacist.14,21
With the increasing use of automated dis-pensing
devices pharmacists have lost some con-trol
over medication dispensing. A feature avail-able
on many automated dispensing systems can,
and should, be used to minimize the potential
error to patients receiving a high-risk drug prior
to appropriate order review and verification. This
feature enables a lock to be placed on selected
drugs so that they cannot be retrieved from the
machine until the order has been screened and
their dispensing has been authorized.14
In children’s hospitals, the standard of care
calls for 24-hour pharmacy operation.3 In other
hospitals with pediatric patients, selected med-ications
should be available in a designated area
when a pharmacist does not provide 24-hour
pharmacy services and automated dispensing
systems are not in use. After-hours when the
pharmacy is closed, pharmacy access by non-pharmacy
personnel is deemed unsafe and unac-ceptable.
In addition, when 24-hour pharmacy
service is not provided, a pharmacist should be
available “on-call” to answer questions and pre-pare
medications as necessary.
Another potential source for error involves
verbal ordering. This practice should be avoided
whenever possible. Policies and procedures
should be established and should specify accept-able
circumstances for this practice and personnel
permitted to accept this type of order. Directive
to repeat back the order for verification and clear
requirements for documentation of these orders,
including the time frame in which the prescriber
must verify and sign the order should be includ-ed
in the policies. The use of computerized pre-scriber
order entry, approved and preprinted
orders, and facsimile transmission of orders
should be used to the maximum extent possible
to eliminate verbal ordering.
Clear and accurate labeling of all drug and
nutrition products is very important. Labels
should clearly express all pertinent information
required for verification of contents by other
healthcare professionals. Auxiliary labels should
also be used in situations where they might

434
emphasize an important aspect of the product.
With respect to the safe use of medications,
there should be an ongoing, multidisciplinary
program of quality improvement and peer review
that includes a formal drug-use evaluation pro-gram,
and a system for monitoring, reporting,
and reviewing medication errors. Policies should
be established that not only eliminate the fear of
reporting errors, but encourage an increased dis-cussion
of errors that have occurred in-house and
elsewhere in the practice of medicine.21Anewslet-ter
or other hospital- or department-wide publi-cation
should be created for the dissemination of
this information.23 One of the most important
methods for preventing adverse drug events is
for institutions to seek and use knowledge from
other institutions that have already solved similar
problems. Staff should regularly monitor publi-cations
such as the ISMP Medication Safety Alert!,
the FDA Medical Bulletin, and other publications
that contain such information. Ultimately, there
should be a mechanism to provide feedback to all
staff members on current and common types of
medication errors within their healthcare system.
In those facilities with medical residents, it is ben-eficial
to establish a relationship with the chief
residents and incorporate medication error reduc-tion
strategies within the resident training cur-riculum.
All healthcare workers involved in patient
care should have ready access to appropriate and
current clinical information about patients (e.g.,
weight, medications, allergies, diagnoses, labora-tory
values) to aid in the appropriate selection of
medications, calculation of doses, and evaluation
of orders. Current references should be easily
accessible when they are need and should be
located through out the facility. These references
should include Internet access to medical infor-mation,
texts and publications, and institution-specific
resources. Information available in the
references should include appropriate uses of the
medication, precautions, drug-drug interactions,
drug-nutrient interactions, adverse effects,
instructions for administration or infusion meth-ods,
usual doses, and patient information and
instructions.10 Expired texts must not be used for
routine drug information because updated infor-mation
or corrections of previous errors will not
be available. Computerized up to date drug
information systems (i.e., CD-ROM), such as
Micromedex® or Facts and Comparisons® should
be available to healthcare providers for ease of
access to current information. Centrally updated
computerized systems have the advantage of lim-iting
the availability of outdated references and
providing timelier updating of information.
Institution-specific references should be created,
incorporating standardized doses accepted by the
institution, standardized concentrations available
within the institution, and osmolality information
for intravenous and oral medications.7,25 Other
institution-specific information, such as restric-tions
on prescribing or administration imposed
by hospital policy may also be included.7,25 These
references should be available in all areas where
medications are prescribed, prepared, monitored,
and administered, and as a pocket-sized version
(hardcopy or electronic) for convenient carrying.23
A critical care drug (emergency medication)
dosage calculation sheet should be completed
and required for each pediatric critical care
patient. Standard sheets for a spectrum of
weights should be available as a reference in the
event that a patient requires emergency treatment
prior to the completion of their individualized
dosage sheet.26,27
Policies should be established that require
documentation of the actual time of medication
administration, rather than simply documenting
administration, which can lead to the assumption
that every dose is administered exactly on sched-ule.
Where appropriate, method of administra-tion
should also be recorded. Newer technologies
will allow for the electronic documentation of
administration. Precise information facilitates
accurate interpretation of laboratory data, phar-macokinetic
calculations, and appropriate dose
and/or interval adjustments.4,28
EDUCATIONAL SYSTEM
RECOMMENDATIONS
An early step toward the prevention of med-ication
errors is the education of healthcare pro-fessionals
involved in medication prescribing,
preparation, labeling, dispensing, monitoring,
and administration. Training programs for all

Training programs for all healthcare professionals should include:
• courses to build and reinforce communication skills among healthcare professionals and improve
communication with patients and their caregivers. It is important for all healthcare professionals
to learn the real potential for human error23 and to recognize the need to function as a team using
each other as resources to achieve optimal patient care. Instruction in medication error prevention
should also be included at the earliest levels of all healthcare training programs and as part of ori-entation
• instruction and practice in performing the mathematical calculations used in patient care. Testing
should be performed to assure that common causes of medication errors are recognized and under-stood.
This includes unit conversions, calculations of dose, calorie and fluid requirements, and dos-ing
intervals, and pharmacokinetic calculations. With more practice comes greater confidence and
fewer errors.18,26,30 Errors involving 10-fold over- or under-doses are common. Other common
errors involve calculating intravenous (IV) infusion rates, using a daily dose as the individual dose
or dividing a daily dose by the time interval instead of the number of times to be administered per
day (i.e., dividing a daily dose by 6 for an every six hour schedule).
• extensive education regarding patient populations such as pediatric patients with special needs
and treatment considerations.3
• instruction and education with regard to patient monitoring. Health care providers should be
skilled in interpretation of laboratory data, physical signs and symptoms, and adverse drug reac-tion
435
Table 5. Suggested components for training programs for all healthcare professionals
programs within each organized healthcare facility.
healthcare professionals should include a variety
of items on errors (Table 5).30
In order for physicians to be prepared to
enter practice their training should include
instruction in the basic requirements of prescrip-tion
writing. They should know that every pre-scription
should be printed legibly and should
contain a variety of information (Table 6). At a
minimum, items to be included on the prescrip-tion
include the patient’s name, date of birth, cur-rent
weight, allergies, and any additional patient-specific
data appropriate to the circumstance. In
addition, generic drug name, drug strength or
concentration, dose volume expressed in metric
units dosage form, quantity to be dispensed
expressed in metric units, complete directions for
use including dose, any calculations used in
determining the dose, route of administration,
and frequency of dosing, purpose of the drug, the
number of authorized refills or intended duration
of therapy, and prescriber’s name should be
included with each prescription. Additionally,
instruction should address what not to incorpo-rate
in a prescription (e.g., certain dangerous
abbreviations, leading and trailing zeros).9-11
These practices would save physicians time, as
well as the time of other healthcare professionals,
and help avoid medication errors.26,30
Writing Discharge Prescriptions
Continuity of care is a method of reducing
potential medication errors. Almost 70% of hos-pital
admissions related to adverse drug events
are associated with patient compliance.33 Clear
directions for the patient or caregiver, as well as
the community pharmacist or nurse will assist in
increasing compliance. Continuity begins with
the prescription. Elements of a prescription are
depicted in Table 6.
MANUFACTURING AND REGULATORY
SYSTEMS
Historically, pharmaceutical manufacturers
have rarely conducted research in the pediatric
population. This lack of research occurs of a vari-ety
of reasons including liability concerns, greater
recognition and reporting.

• Patient’s full name
• Patient’s age (date of birth) and current weight
• Information regarding diagnosis and other patient-specific data appropriate to the circumstance
should be included.
• Any known allergies should be included.
• Drug name, dosage form, and drug strength. If the medication is rarely used, the name should be
print. Concentration should be expressed in metric units.
• Number or amount to be dispensed. If appropriate, quantity to be dispensed should be expressed
in metric units.
• Include calculations, or at least mg/kg/day dosing, so calculation can be independently double-checked
• The prescriber’s name and pager or telephone number should be included.30
• Complete instructions for the patient including indication (i.e., purpose of the drug), directions for
use including dose, frequency of dosing route of administration, intended duration of therapy, and
the number of authorized refills.
• Products to be administered by the patient or caregiver in the outpatient environment should be
labeled expressing the dose in convenient units of measure. Listing equivalent measurements may
be helpful to clarify the intended dose (i.e., 1 teaspoonful (5 mL) by mouth twice daily).
• During discharge counseling, patients and/or caregivers should be asked to demonstrate the meas-urement
demonstrate any manipulation of a commercially available dosage form and the administration of
a dose if special techniques are required (i.e., injection, nebulizer, or inhaler). Appropriate meas-uring
should be demonstrated. Written education materials should provide relevant information in a
clear, easily understood format.31,32 The use of household teaspoons and tablespoons should be dis-couraged
436
Table 6. Recommended elements of a prescription
of a dose if medications are dispensed in liquid form. They should also be asked to
devices should be provided or recommended. Where possible, the actual measuring device
because of their variability and resulting inaccuracies.
(i.e., amoxicillin 40mg po q 8 hrs (40mg/kg/day).
investments of time and money to conduct clini-cal
trials in this population, and (perhaps most
significantly), a limited economic return because
this population comprises only a small portion of
the pharmaceutical market. The lack of pediatric
research by pharmaceutical manufacturers has
resulted in the majority of drugs entering the
market and being used “off-label” in neonates,
infants, or children with little or no dosing, phar-macokinetic,
safety, efficacy, or clinical data.
Pharmaceutical manufacturers and FDA have
become increasingly aware of the challenges fac-ing
pediatric healthcare professionals. Although
this population has long been recognized as
unique and referred to as “therapeutic orphans,”
only recently have changes have occurred that
now require new medications to be evaluated in
pediatric patients.34
In addition to guidelines published previous-ly
for pharmaceutical manufacturers and regula-tory
agencies regarding the naming, labeling, and
packaging of drug products, the following are
recommended:
1. More research should be conducted in pedi-atric
patients to determine safety and efficacy
in neonates, infants, and children. There
should be established pediatric dosage guide-lines,
including the dosing adjustments
required for renal and hepatic dysfunction.
The industry should identify pediatric-specif-

437
ic adverse drug reactions and should include
information in ‘a’ through ‘e’ in the official
product labeling. Formulate standard guide-lines
must be in place for the extemporaneous
compounding of pediatric dosage forms from
commercially available dosage forms when
necessary. These guidelines must include
data regarding product stability, compatibili-ty,
and bioavailability. Companies should
also develop drug delivery devices and infu-sion
systems appropriate for pediatric
patients of all ages.
2. Increase commercially available pediatric
dosage forms, especially for those drug prod-ucts
with pediatric indications. This would
ensure that dosage form and concentration
are appropriate for the pediatric population
and intended route of administration and
would facilitate accurate measurement of
doses.3,8,17 Dose volumes of oral liquids and
intravenous medications should be large
enough to measure accurately, but not too
large to create a medication administration
challenge. Oral products should be available
in palatability of dosage forms. Finally,
appropriateness of all ingredients, including
inactive ingredients (e.g., preservatives such
as benzyl alcohol) should be considered. 3,8,10,17
3. Because look-alike products may lead to
medication errors, similar proprietary
appearances of packaging and labeling
should be avoided for both prescription and
non-prescription drug products.
4. Look-alike or sound-alike trademarked and
generic names, as well as brand name line
extensions, should be avoided for prescrip-tion
and non-prescription drug products,
including store or generic brand over-the
counter products. What is known as “tall-man
lettering” should be utilized to distin-guish
medications with similar looking brand
and generic names (i.e., hydrOXYzine vs.
hydrALAzine).
5. Manufacturers should employ failure mode
and effects analysis or similar techniques that
require practitioners to systematically assess
the potential for error with packaging, label-ing,
and nomenclature prior to market
launch.13
6. Standardization of uniform bar coding that
would be compatible with computer systems
used in organized healthcare settings should
be developed.
7. Standardization of calcium, zinc, and iron
product concentrations should occur.9 This
might include standardizing the ordering of
these products to milliequivalents, millimoles
or milligrams of the elemental product.
8. Healthcare professionals should be informed
about new drugs and their indications using
unbiased information and educational pro-grams.
At a minimum, education should
include indications for use, adverse drug
reactions, and drug-drug and drug-nutrient
interactions.
9. Labeling of non-prescription medications
must clearly differentiate between multiple
concentrations. It should also provide clear
warnings, and usage and dosing information
for patients and caregivers.35 Dosage infor-mation
should be expressed as units of meas-ure
that correspond to the calibration on the
dosing device. Information should be includ-ed
that warns that the measuring device does
not necessarily represent one dose. Ideally,
dosing devices should be calibrated in only
one system of measure, preferably the metric
system, contain no abbreviations, and be
marked in a contrasting color.36
HEALTHCARE PROFESSIONALS
Although errors are most often due to system
deficiencies or failure, individual healthcare pro-fessionals
also play a role in the prevention of
medication errors. Every healthcare professional
should accept responsibility for providing his or
her patients with the best care possible by:37
1. keeping informed of medical knowledge,
especially as it pertains to the treatment of
pediatric patients through review of the med-ical
literature review, continuing education
programs, and communication with other
healthcare professionals.
2. actively participating as a member of the
patient care team, sharing information, wel-coming
the input of colleagues, and being
involved in staff development and education

438
programs.
3. carefully performing and double-checking
calculations to ensure correctness.19,20
4. consulting literature, references, and/or col-leagues
when unsure of appropriate prescrip-tion,
preparation, or administration of a drug
product or pediatric treatment requirements.
5. ascertaining that all pertinent patient infor-mation
is available and current so that a
patient’s total status and appropriateness of
therapy can be evaluated.
6. focusing on a single task, avoiding distrac-tions
and interruptions whenever possible, to
maintain concentration.
7. participating in multidisciplinary committees
to improve system functions.
Recommendations for Prescribers
The first individual who can take steps to pre-vent
the occurrence of a medication error is the
prescriber. Drug orders should be legible. Direct
prescriber computer order entry is preferable and
should be used by all institutions and all pre-scribers.
38 Handwritten prescriptions or orders
increase the occurrence of transcription errors
and fail to utilize the information and safety
checks available via the computer system. When
prescriber computer order entry is not available,
prescribers with poor handwriting should print
or type medication orders. Preprinted orders are
another option for the prescriber with poor hand-writing;
however, a multidisciplinary team of the
P&T Committee must approve these.
Drug orders should be complete and should
include the components described in Table 6.
Likewise, prescribers should also adopt the fol-lowing
measures to ensure that the clear intent of
the order is communicated.
1. Drug name should be either the official
(generic) or trademarked name clearly
spelled. For those medications that contain
multiple ingredients, the use of the trade
name is more appropriate. When the trade
name is used, the generic ingredients should
also be listed on the label. Abbreviations of
the name, acronyms, and chemical or locally
coined names should not be used because
they might be misunderstood.
2. Instructions should be written out, rather
than expressed using abbreviations that are
ambiguous or not approved within the insti-tution.
3. Vague instructions, such as “take as direct-ed,”
should not be used.
4. Because many medications are available in
varying strengths or concentrations, dosage
strengths or concentrations and volumes
should be expressed in exact metric units
(e.g., mg, units), rather than dosage form
units (e.g., # tablets, vials, ampules, capsules,
mL).
5. A leading zero should always precede deci-mal
expressions less than one (i.e., 0.1 mg),
but a trailing zero should never follow a
whole number (i.e., 1.0 mg).
6. To facilitate verification of the appropriate-ness
of the dose by other healthcare profes-sionals,
any calculations used in determining
the dose should be included in the medica-tion
order.
7. For medications other than most topically
administered, both the calculated dose AND
the mg/kg or mg/m2 dose upon which the
dose is based should appear in all medication
orders for pediatric patients. This simple step
helps assure that a nurse and/or pharmacist
do not misread an order. It also promotes
accurate dose calculation by facilitating
redundant checks by nurses and pharmacists.
8. If the order is for a drug product that is not on
formulary or for a new dosage of a formulary
medication, the prescriber should provide
information with the order or in the patient’s
chart for other healthcare professionals. Use
of a non-formulary medication introduces a
new drug into the system that healthcare pro-fessionals
may not recognize; thereby,
increasing the risk of error. A healthcare
provider may assume that it is another drug
that sounds, or looks similar to an agent with
which they are familiar. Use of non-formula-ry
items should be limited for the above rea-sons.
9. If doses are changed for an ambulatory
patient, new prescriptions should be written
and remaining refills of previous doses
should be canceled. This information should

439
be communicated to the pharmacy providing
outpatient services.
In situations where the use of verbal pre-scriptions
or orders is necessary, the prescriber
should dictate the order slowly and clearly,
spelling the drug name and any other words that
may be misheard. Likewise, the prescriber
should restate numbers that may be confused
(i.e., 15 as “one five”). In order to verify accuracy,
the prescriber should have the recipient repeat
the order back to him or her. The prescriber
should also be certain to verify the transcribed
order within a designated time frame.36
When possible, without compromising
patient care, odd dosages should be rounded-off
for more convenient and accurate measurement.
When appropriate, prescribers should write
orders for commercially available drug products,
rather than dosage forms prepared by manipula-tion
of commercially available products. If at all
possible, drugs should be prescribed for oral
administration, rather than by injection.
Prescribers should consider consolidating styles
of managing patients. A variety of ways of man-aging
a patient’s medical condition are possible
and are considered good medicine that is cost
effective. However, diversity in writing medica-tion
orders may lead to confusion and errors.
Consolidating styles in an intensive care unit set-ting
so that all drips are written as either
mcg/kg/minute or mg/kg/hour can avoid cal-culation
errors that occur secondary to moving
back and forth between systems.
The prescriber should also counsel the
patient and his or her caregiver, familiarizing
them with the name, indication, route of adminis-tration,
dose, dose frequency, potential adverse
effects, and how adverse effects might be man-aged
for each medication the patient is receiving.
Recommendations for Pharmacists
Because of their specialized knowledge of
medications and their role in the drug distribu-tion
process, pharmacists are in a unique position
to prevent medication errors and ensure appro-priate
medication use. Pharmacists should inter-act
with other members of the healthcare team to
develop, implement, and monitor a therapeutic
plan to achieve optimal care for each individual
patient, making efforts to detect and resolve
drug-related problems before they reach the
patient. Pharmacists must also pay close attention
to their portion of the drug distribution process,
carefully reviewing prescriptions and preparing
and dispensing medications, while serving as the
drug information specialist. Suggestions that
may assist pharmacists in preventing medication
errors while fulfilling these responsibilities are
found in Table 7.
Prior to patient discharge, the pharmacist
and/or nurse should make certain that patients
and/or their caregivers have all the necessary
drug information and knowledge to correctly
measure and administer doses. It is also impera-tive
that they have appropriate equipment for
correct measurement and administration of the
prescribed dose. The patient and/or caregiver
should also be asked to demonstrate how they
would prepare and administer doses to verify
that they are prepared to perform these tasks. If
problems or difficulties are exposed, further
counseling and teaching are in order.
Recommendations for Nurses
Nurses are in a position too not only identify
prescribing and dispensing errors, but to prevent
these errors from reaching the patient.
Medication administration is an important step in
medicinal therapy. There are no additional oppor-tunities
to detect potential medication errors
beyond this step. Nurses are, in fact, the final
“gatekeeper” for the hospitalized patient.
Therefore, nurses must be especially vigilant to
prevent medication errors. The following are
suggested measures nurses can take to prevent
medication errors.
1. Review the patient’s medication administra-tion
record (MAR) to insure that all orders
have been transcribed correctly, all informa-tion
is complete, and there are no therapeutic
duplications, allergies, or drug-drug, drug-nutrient
or drug-disease interactions. If any
questions arise, the order should be verified
against the original prescriber order, refer-ences
and/or colleagues should be consulted
as necessary, and the prescriber should be

• Be available regularly in patient-care areas to serve as a source of information to other healthcare
professionals regarding current drug therapies and appropriate use of medications.
• Review the original medication order prior to dispensing the medication, unless emergency cir-cumstances
dosage ranges. The prescriber of any questionable medication order should be contacted for clar-ification
above can be performed via computers, bar-coding of patient-specific doses, and scanning prior
to dose administration.
• Research or request information from the prescriber regarding new or unfamiliar medications,
uses, or doses.
• Dispense medications for individual patients in a pre-measured, ready-to-administer form when-ever
preparation instructions prior to administration. Auxiliary labels should also be used in other sit-uations
• Carefully document products used and steps and calculations performed in the preparation or
manufacture of a drug product. This is primarily for high alert drugs, those that have the greatest
consequences of error. For these medications, it is particularly important that an independent
double-check be used for all calculations.
• Carefully document all verbal orders received from prescribers as new orders, renewals, or cor-rections
the order by repeating it back to the prescriber, spelling the drug name and any other word that
might have been misheard and restating numbers that may be confused, such as those in the
teens.38
• Ensure that medications arrive in the patient-care area in a timely fashion following the receipt of
the order. If medication delivery will be delayed for any reason, such as the need to resolve a
problem with the order, the nurse caring for the patient should be notified of the delay and the
reason.
• Counsel patients and their caregivers, verifying that they understand the name, purpose, route of
administration, dose, dose frequency, potential adverse effects, and how adverse effects might be
managed for each medication they are receiving.
440
Table 7. Recommendations to assist pharmacists in preventing medication errors
dictate otherwise—screening for prescribing errors, allergies, drug and disease inter-actions,
correct dose, and indication. Dosage calculations should be checked against acceptable
prior to dispensing the medication.39 Prior to dispensing the pharmacist should com-pare
the original order with the label and the product being dispensed.24,40 Most of the functions
possible.24 When this is not possible, auxiliary labels should be used to clearly communicate
when they will clearly aid in the prevention of errors.
to a new order. This should be done immediately after receiving and carefully verifying
contacted if a change is required.
2. Verify orders, screen for prescribing errors,
allergies, drug-drug, drug-nutrient, and
drug-disease interactions, and appropriate-ness
of dose and indication. Dosage calcula-tions
should be double-checked. Any poten-tial
problems should be resolved prior to
administering the medication.24,41
3. Carefully document all verbal orders received
from prescribers as new orders, renewals, or
corrections to a new order. This should be
done immediately after receiving the order.
The order should be carefully verified by
repeating it back to the prescriber, spelling
the drug name and any other piece of infor-mation
that might have been misheard. The
nurse should also restate numbers that may
be confused, such as those in the teens.38
4. Prior to medication administration, compare
the first dose of medication dispensed with

441
the original prescriber order and the medica-tion
administration record (MAR). The nurse
should confirm that the correct medication,
dose, and dosage form have been provided.
Obviously, any concerns (e.g., the need for
multiple dosage units to obtain a single dose;
inappropriate dosage form or volume for the
individual patient) should be addressed prior
to administration of the drug. Subsequent to
this dose, medications should be verified
against the MAR. Transcribed MARs for
future doses must be verified with the old
MAR to assure accurate transcription.
Medications should not be removed from
packaging until they are ready for adminis-tration.
21
5. Verify patient identity prior to administration
of any medication.21 When appropriate and
reasonable, patients or caregivers should be
told the name and purpose of each medica-tion
when each dose is given. This aids in
patient education and gives the patient an
opportunity to become more involved in his
or her care and prevent possible medication
errors. If the patient questions a medication,
the nurse should listen, answer questions,
and (if appropriate) verify the order and
product before administering the medication.
6. Administer all doses at scheduled times,
unless the patient is unavailable or there are
problems with the order or medication that
need to be resolved. Medication administra-tion
should be documented as soon as it is
completed; thereby, recording the actual time
the dose was administered. An electronic
medical administration record (MAR) with
scannable bar-coded patient-specific doses
will greatly reduce administration errors.
7. Contact a pharmacist regarding missing
doses, rather than “borrowing” from another
patient or stockpiling unused medications.
8. Understand the correct operation of medica-tion-
administration devices and be aware of
the potential for errors that may occur with
the use of these devices (e.g., programmable
pumps).
9. Counsel patients and their caregivers, verify-ing
that they understand the name, purpose,
route of administration, dose, dose frequency,
common adverse effects, and how adverse
effects might be managed for each medica-tion
they are receiving. Provide drug infor-mation
at discharge and assure understand-ing
by the patient/caregiver.
Recommendations for Patients and Caregivers
All caregivers and all but the youngest
patients should be given the opportunity to be
involved in the patient’s drug therapy. To active-ly
participate in their therapy, the patient or care-giver
must be informed about every medication
prescribed and administered and must be encour-aged
to ask questions and raise concerns. A well-informed
patient or caregiver feels less helpless in
a situation that they do not control and also pro-vides
an extra opportunity to prevent the occur-rence
of a medication error. Patient and/or care-giver
education should be considered a standard
of care and policies should be created to increase
the involvement of these individuals in treat-ment.
The following recommendations are
offered to patients and caregivers to assist them in
optimizing their drug therapy and preventing
medication errors (Table 8).10
An important part of patient education is dis-charge
counseling. Continuity of care should be
stressed. Some ways that this may be accom-plished
include:42 1) to ensure availability of simi-lar
products and concentrations that were used
during hospitalized dispense discharge prescrip-tions
through an outpatient pharmacy affiliated
with the institution; and 2) having caregivers fill
discharge prescriptions at the outpatient pharma-cy
they normally patronize so that errors might
be discovered and discharge counseling can be
customized to the products and concentrations
dispensed.
CONCLUSIONS
This document makes recommendations for
the prevention of medication errors in pediatric
patients, incorporating the suggestions of health-care
professionals involved in the daily treatment
of this patient population. By working together
as a patient-care team medication error occur-rence
can be minimized through education,

• Know the name, dose, strength or concentration, dosage schedule, purpose, and appearance of all
medications taken by or administered to the patient.
• Carry an up-to-date list of medications they are taking, including prescription, nonprescription,
and homeopathic medicines; vitamins and minerals; herbal products and home remedies, in
addition to a list of any medications they cannot take and the reasons why these medications can-not
involved in the patient’s care.
• Understand any special storage, preparation, measuring, and administration techniques required
to obtain the maximum benefit from the drug therapy. A healthcare professional involved in the
patient’s care should observe the patient’s technique and make suggestions to improve or correct.
• Understand the importance of taking or giving medications as directed and for the prescribed
length of time.
• If the patient is of sufficient age, or when the caregiver is present at medication administration
time, ask to be shown each medication and told the purpose of each.
• Actively participate in their drug therapy by asking questions and participating in making deci-sions.
• Question anything that seems unusual. A potential error may be prevented by a single question.
442
Table 8. Recommendations to assist patients and caregivers in optimizing drug therapy and
preventing medication errors
be taken. The information on these lists should be given to the healthcare professionals
development of effective systems, individual
efforts, and by healthcare professionals. When
errors do occur, it is important to first minimize
the effect on the patient and then to learn from the
error and improve the system to prevent similar
occurrences in the future.
ACKNOWLEDGEMENTS
We appreciate the participation of Yvonne
D’Antonio, PharmD, Safe Medication
Management Fellow at the Institute for Safe
Medication Practices and the Center for Proper
Medication Use for developing the framework
used to stimulate discussion at the ASHP confer-ence.
We thank Dean Bennett, RPh, and Theresa
Forbes, PharmD, at the Alfred I. duPont Hospital
for Children, Wilmington, Delaware, for their
review and comments of the final guidelines.
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