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19 Safe Prescribing and Monitoring in Pediatrics
Table 19.5 Medication use process and health information technology functionalities
Medication
process stage Pediatric health information technology functionality focused on error prevention
Prescription
and verication
Dispensing – Medication barcoding
Administration – Automated infusion rate calculators
Monitoring – Formatting for lab value reporting with normal ranges
PN Parenteral nutrition, IV Intravenous
– Order sets and order sentences
– Mandatory and pre-populated order entry elds (e.g., frequency, route, dose)
– Automated dosage calculators
– Dose and frequency range alerts
– Automated renal function calculators
– Renal function alerts
– Highlighted antibiotic susceptibility reports and abnormal laboratory values
– Automated dispensing cabinets and medication carousels (it is important to note that some
medications, like opioids, may not be legally allowed to be stored in these dispensing systems)
– Prepopulated medication product selection elds
– IV admixture compounders (e.g., PN compounder, robotic IV preparations)
– Gravimetric scale technology for intravenous medication preparation
– Standardizing concentrations of medications within an institution or within nearby institutions
– IV administration pumps (with or without preset limits on dosages and rates)
– Electronic medication administration record with administration reminders
– Patient and medication barcoding
– Prepopulated administration considerations (e.g., warnings regarding administration of
ciprooxacin via gastric tube labeled on the medication administration record)
– Prepopulated dosage forms or calculators for code situations (may also be considered to be
related to prescribing)
– Prepopulated laboratory value orders within order sets for medications
– Lab monitoring alerts within the electronic health record
451
have been described, although there is variability
between functionalities and institutional customization is usually needed to apply CDS to local
patient care settings [64, 65]. Dosing calculators
and dosing alerts are the most pediatric-focused
CDS functionalities and have led to decreases in
dosing errors independent of CPOE.Use of calculator assistance is highly recommended at
institutions caring for pediatric patients, although
calculation training should still be utilized to
ensure understanding of the system and prevent
inappropriate use.
Table 19.5 provides some examples of HIT
strategies to prevent errors at various phases of
the medication use process. Alert-based CDS has
the risk of causing alert fatigue due to too many
unnecessary alerts, especially if not optimally
designed or implemented [51, 66]. Customization
of CDS systems to meet the unique patient needs
at specic institutions has improved medication
safety. Although improvements have been made,
it’s important for practitioners to know that after
extensive adoption of HIT and CDS, 50% of
errors are still likely not preventable by available
HIT functionalities (e.g., due to HIT rule logic
limitations and difculties integrating HIT within
clinical workow) [38].
5 Summary andConclusions
Medication safety is an essential component of
medication utilization in the pediatric population.
Care providers must be cognizant that the process
of medication for ADR assessment and the type of
ADRs that occur in the pediatric population are
different when compared to other populations.
These differences are largely due to developmental impacts on patient assessment, drug distribution, and possible drug toxicities. Providers
should also be aware that the medication use process from prescription to administration usually
involves more steps and thus is more error-prone
in the pediatric population. Advancements in HIT
452
J. S. Stultz and M. C. Nahata
have improved the safety of medication use in the
pediatric population, although clinicians should
still be aware that no system can fully preventmedication safety incidents.
6 Case Studies
6.1 Case Study 1
A care team is considering use of a betamethasone dipropionate 0.05% ointment (a topical
high-potency corticosteroid) in a 9-month-old
child with moderate severity eczema across 20%
of the body, including some in the diaper area.
The current prescription has two daily administrations to the affected area for 2months.
1. What are the most relevant pharmacokinetic
differences compared to adults that impact the
use of the medication in this patient?
(a) Infants <1 year of age have higher
absorption of medications through their
skin comparatively to adults leading to
higher systemic exposure for topically
administered corticosteroids.
2. If the patient’s team feels the patient requires
this medication to treat their condition, what
are the methods to minimize the possibility of
an ADE in this patient?
(a) Potentially administer only as needed
versus scheduled two times per day.
(b) Do NOT apply this steroid to the diaper or
face area. Consider a lower dose topical
corticosteroid for eczema in those areas.
(c) Avoid wrapping the area, which would
increase absorption.
(d) Ensure it is not the augmented form of
betamethasone dipropionate.
(e) Recommend consideration of other
forms.
3. What are the possible issues with assessing
this patient for an ADE related to this
medication?
(a) Since the patient is 9months old, assess-
ing for adverse events
(e.g.,growthstunting) could take months/
years to assess for and are dependent on
accurate weight and height
measurements.
(b) Subjective issues like headache due to
intracranial hypertension, insomnia, or
neurologic toxicities from corticosteroid
use would be difcult to obtain.
4. What are the possible methods to overcome
the ADE assessment issues?
(a) Ensure weight and height measurements
are done accurately and often to obtain a
trend over time. Importantly, ensure the
patient is weighed in a dry diaper each
time for consistent assessment.
(b) Consider frequent monitoring for hypo-
thalamus pituitary adrenal function via
cortisol stimulation tests.
6.2 Case Study 2
A team utilized morphine in a 2-month-old
(8weeks postnatal) former 27-week GA at birth
during a procedural sedation for pain control/
sedation. The prescriber veried with the team
that patient didn’t have signicant prior opioid
exposure and that the patient’s weight was 5.4.
The dosing guide the prescriber had on hand
said morphine was typically dosed up to 0.6–
0.8 mg/kg for infants <6 months, so the prescriber verbally ordered 3.3mg IV to get faster
onset and since the patient was NPO.Ten minutes later, the nurse entered the order in the
computer system and got an alert that the dosage was too high but overrode the alert with an
override reason that the patient is being
monitored.
Thirty minutes after the dose, just as the procedure was being completed, the patient had
decreased respiratory rate and oxygen saturations
and required naloxone for reversal of opioid
toxicity. When the team discussed what happened, the team realized the dosing weight used
was in pounds versus kilograms. When doublechecking the prescriber’s reference and verifying
with a pharmacist, it was realized that the dosing
range used for calculations was for oral and not
intravenous morphine, and the ranges were also
for a total daily dose versus a single dose.
19 Safe Prescribing and Monitoring in Pediatrics
453
1. What pediatric pharmacokinetic/pharmacodynamic considerations were important in
this scenario?
(a) The patient was an infant based on age,
but because the patient was born preterm
the pharmacokinetics likely would resemble that of a neonate due to a PMA of only
35weeks.
(b) Neonates and preterm infants have
decreased metabolism of morphine which
can increase thechance of toxicities due
to morphine.
(c) Neonates/preterm infants are also more
susceptible to respiratory depression with
opioids compared to infants and
children.
2. Describe the pediatric factors associated with
the error and resulting adverse event?
There were multiple calculation errors in
this case leading to a ~13-fold overdose in
this patient, which typically would receive
up to 0.1 mg/kg/dose or 0.25 mg of IV
morphine. Some of these are not as relevant when prescribing the same medication in adults.
• The patient’s weight in pounds was
used instead of converting to kg, which
is a 2.2-fold dosing error.
• The oral dosage range was used
instead of the intravenous range,
which is at least a twofold higher
dose.
• The total daily dose range was used
instead of the single dose range, which
resulted in a four- to six-fold higher
dose.
3. During what stage(s) of the medication use
process did this error start at?
This was a two-fold error, although the
origin is most likely associated with
the prescription phase. The incorrect
interpretation of dosing recommendations and resulting calculation errors
were clearly associated with decisionmaking during prescription. But there
also was an error during the documentation and communication phase which
led to the use of the incorrect dosing
weight.
4. What other stages of the medication use pro-
cess were involved in the propagation of this
error?
(a) Inappropriate communication/documen-
tation was also involved in the error
related to identifying the appropriate
weight.
(b) The error was continued/propagated by
not being caught in the verication phase
and administration phase(e.g., by nurses
and others in the room).
5. What is a prevention strategy for each stage of
this process?
(a) Prescribing
• Consider utilizing prepopulated dosing
cards based on an accurate weight for
common medications used during
procedures.
• Consider requiring entry of prescriptions in the computer system before
administration unless it is an absolute
emergencysituation.
(b) Verifying
• Require double-checks or read backs
for high-alert medications.
• Consider requiring entry of prescriptions in the computer system with verication before administration unless it
is anabsolute emergencysituation.
• It appears alerts were available but not
utilized at the appropriate time in this
scenario. Education regarding alert
overrides and the possibility for alert
fatigue,especially for high-alert medications, should be done.
(c) Dispensing
• While not discussed in this case in
detail, the correct morphine product
without benzyl alcohol should be
included in the automated dispensing
cabinet for procedures involving preterm infants or neonates.
• Consider nursing double-check when
medications are being pulled from surgical boxes or medication storage
machines outside of the pharmacy.
(d) Administration
• Ensure barcoding of correct product
which may have caught that an incor-
454
J. S. Stultz and M. C. Nahata
rect vial size or number of vials was
utilized.
(e) Documentation
• Ensure consistency between kg and
pounds documentation in charts and
also consider weight-based normal
ranges with alerts as entry of a 5.5kg
35-week PMA child would be on the
higher end of normal or above the 95%
for weight.
(f) Monitoring
• While an error was not made here as
monitoring did occur, patients on highrisk medications should undergo appropriate monitoring (e.g., oxygen
saturation and vitals in this scenario).
This could be a required eld or policy
as part of an order set for some
medications.
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RS, Watson RS, Nguyen TC, et al. Unexpected
increased mortality after implementation of a commercially sold computerized physician order entry
system. Pediatrics. 2005;116(6):1506–12. https://doi.
org/10.1542/peds.2005- 1287.
64. Kazemi A, Ellenius J, Pourasghar F, Toghi S, Salehi
A, Amanati A, Fors UG. The effect of computerized
physician order entry and decision support system
on medication errors in the neonatal ward: experiences from an Iranian teaching hospital. J Med
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s10916- 009- 9338- x.
65. Stultz JS, Nahata MC.Appropriateness of commercially available and partially customized medication dosing alerts among pediatric patients. J Am
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org/10.1136/amiajnl- 2013- 001725.
66. Cash JJ. Alert fatigue. Am J Health Syst Pharm.
2009;66(23):2098–101. https://doi.org/10.2146/
ajhp090181.
Further Reading
Pain Scales for Non-verbal Children
Trottier ED, Ali S, Doré-Bergeron MJ, Chauvin-
Kimoff L. Best practices in pain assessment and
management for children. Paediatr Chiler. Health.
2022;179(4):27(7):429-448. https://doi.org/10.1093/
pch/pxac048.
Ethical Considerations for Children in
Research
Cayouette F, O’Hearn K, Gertsman S, Menon
K.Operationalization of assent for research participation in pre-adolescent children: a scoping review. BMC
Med Ethics. 2022;23(1):106. https://doi.org/10.1186/
s12910- 022- 00844- 2.
Example Recommendations for
Standardized Drug Concentrations
for Use in the Pediatric Population
American Society for Health Systems Pharmacists
Standardize 4 Safety. Pediatric Continuous Infusion
Standards; updated March 2024. Accessed 4/10/2024.
Available at: https://www.ashp.org/-/media/assets/
pharmacy-practice/s4s/docs/Pediatric-InfusionStandards.pdf. Accessed 10 April 2024
Safe Prescribing and Monitoring in
the Older Person
AlpanaRajeshMair, AmilRajeshMair,
SarahN.Hilmer, andLisaKouladjian O’Donnell
20
Abstract
This chapter will consider the main factors
that increase the risk of adverse drug reactions
and events in older people. This will include
changes in physiology that affect the older
person. It will also outline how older people
should be prioritized for medication review
and the monitoring that is needed to minimize
harm, while optimizing patient outcomes from
the use of medications. The chapter will also
discuss the essential factors to be considered
A. R. Mair (*)
Prescribing and Therapeutics Division, Scottish
Government, Edinburgh, UK
Edinburgh Napier University, Edinburgh, UK
e-mail: alpana.mair@gov.scot
A. R. Mair
Emergency Medicine, NHS North East England,
BMJ Best Practice Clinical Champion,
Newcastle-Upon-Tyne, UK
S. N. Hilmer
Kolling Institute, The University of Sydney and
Northern Sydney Local Health District and
Departments of Clinical Pharmacology and Aged
Care, Royal North Shore Hospital,
St Leonards, Australia
L. Kouladjian O’Donnell
School of Pharmacy, Faculty of Medicine and Health,
The University of Sydney, Sydney, Australia
Laboratory of Ageing and Pharmacology, Kolling
Institute, The University of Sydney and Northern
Sydney Local Health District, St Leonards, Australia
while prescribing and the monitoring that is
needed to improve medication use and safety
in this group. Various tools and methods that
could be employed when prescribing and
selecting medications that are considered
appropriate for this population, including
tools to review appropriate prescribing, monitoring of medication use, at the variouslevels
of delivery of patient care and at a systems
level, will be discussed. Medications which
require special consideration among this
group of patients will also be discussed,
including review of existing medication and,
in particular, the importance of patientprioritization due to high-risk medicationuse. Case
studies will be used to illustrate how a personcentered approach can be taken in the reviews,
including shared decision-making.
Keywords
Older person · Person-centered · Medicationrelated harm · Pharmacokinetics and pharmacodynamics · Prescribing safety · Monitoring ·
Medication safety culture · Geriatric
syndrome · Polypharmacy · Deprescribing
Learning Objectives
• Understand the factors that predispose the
older person to medication-related harm
• Understand how medicines can impact healthy
aging and geriatric syndromes
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
J. Jose et al. (eds.), Principles and Practice of Pharmacovigilance and Drug Safety,
https://doi.org/10.1007/978-3-031-51089-2_20
459
460
A. R. Mair et al.
• Apply the principles of structured medication
review and monitoring to improve medication
safety
• Adopt strategies and tools to implement
person- centered medication review
• Understand the importance of multidisciplinary team decision-making and safe prescribing culture
Key Points
• Multimorbidity increases with age and
affects pharmacokinetics and pharmacodynamics. Consequently, older people have a high prevalence of medication
use and medication- related harm.
• Adverse effects of medications fre-
quently present as non-specic geriatric
syndromes, such as falls, delirium,
incontinence, or frailty.
• In clinical practiceinvolving older per-
sons, pharmacovigilance is critical to
prevent, detect, and manage medicationrelated harm.
• Reporting of unexpected or severe
adverse drug events seen clinically in
older patients is important since postmarketing surveillance is a major source
of information on medication effects in
this population.
• Tools to inform pharmacovigilance
include prescribing tools to guide clinical medication reviews and quality indicators at a health service level.
• Medication safety in older people
requires constant review, good communication, and shared decision-making
between all members of the clinical
team in collaboration with the patient.
1 Introduction
Prescribing and safe use of medications in the
older person poses a unique challenge. With an
aging population and the presence of comorbidi-
ties with aging, the number of older people taking multiple medications is increasing. This,
together with the associated age-related changes
in physiology, puts the older person at an
increased risk of medication-related harm.
Regular review of medications is important at initiation of treatment, but also when patients transition across different levels of care.
Therefore, to prevent harm due to medications, clinical management of older people will
require:
• Review of existing medications to consider
whether the presenting problem is the result of
medication-related harm, and before new
medications are added
• Assess if doses may need to be adjusted to
accommodate changes in aging physiology
• Identify the medications most likely to cause
harm in this group
• Use of tools to guide prescribing and
deprescribing
• A person-centered approach
• Involve the older person and their family in
their care to support shared decision-making
and adherence
This chapter introduces readers to how medication use is different in older people, the steps to
be taken at various stages of medication use to
ensure that harm is minimized, and the need for a
multidisciplinary approach in managing this special group of patients.
2 Global Aging
andConsequences
The proportion of the global population over
60years old will increase from 12% in 2015 to
22% in 2050 [1]. During this period, their number
in developing countries is projected to increase
250%, compared to 71% in developed countries
[1], so that in 2050, 80% of older people will be
living in low- and middle-income countries. In
Europe, advances in healthcare, education, and
socioeconomic circumstance mean that in most
countries people can now expect to live beyond
the age of 80 [2]. However, evidence shows that
20 Safe Prescribing and Monitoring in the Older Person
461
the average healthy life years (HLY) for EU citizens is only 61years, meaning that many people
are living for around 20 years in suboptimal
health. One aspect that can affect HLY is medication, which can have an impact on both physical
and cognitive capacity of the older person.
3 Increasing Multimorbidity
withAge
Multimorbidity is dened by the World Health
Organization (WHO)as the co-occurrence of two
or more chronic health conditions in one person
[3]. Patients with multimorbidity may require
medicines to treat each condition, which can lead
to polypharmacy. Currently around 50million EU
citizens are estimated to have multimorbidity.
Most of them are 65years of age and over, and this
number is expected to continue to increase [4].
Epidemiological data indicates that multimorbidity increases markedly with age. In a Scottish
study, multimorbidity was prevalent in 81.5% of
individuals aged 85years and over, with a mean
number of 3.62 morbidities [5]. The most common
morbidities are noncommunicable diseases, which
occur 10–15years earlier in deprived areas than in
more afuent. Ornstein etal. found that the most
prevalent chronic conditions in primary care were
hypertension (33.5%), hyperlipidemia (33.0%),
and depression (18.7%) [6]. The presence of multiple morbidities is associated with multiple symptoms, impairments, and disabilities.
Multimorbidity may result in a combined negative effect on physical and mental health, and
can have a major impact on a person’s quality of
life, limiting daily activities and reducing mobility [7, 8]. The need to take multiple medications
can be just as problematic, resulting in frequent
healthcare contacts and an increase in the likelihood of medication-related harm [9]. The population aged over 60 consumes nearly three times
more medicines as the general population, but
with an adherence to long-term medication ranging onlybetween 25% and 70% [10]. Age and the
number of medications taken are the two major
predictors of the risk of experiencing a
medication- related harm [11].
Furthermore, multimorbidity imposes a large
economic burden to the health service due to
patients’ complexity of healthcare needs and frequent interaction with health services, which may
be fragmented, ineffective, and incomplete [12].
People with multimorbidity utilize twice as many
primary care services and are three times as likely
to be hospitalized than their non-multi-morbid
counterparts [13]. Other factors to consider are
those with underlying illness such as the management of blood-borne viruses (e.g., hepatitis,
HIV), cancer, and vascular disease, as these individuals are living longer due to the improved
treatment and subsequent survival. As a consequence, these older people will be taking medications for multiple chronic diseases. A fourfold
increase in drug interactions is observed in older
people living with HIV [14].
Case study 1 discusses the case of an elderly lady
with multiple morbidities and potential medicationrelated harm to understand the related issues.
4 Impact ofAging
onPharmacokinetics
andPharmacodynamics
The physiological changes of aging affect how
the body handles drugs (pharmacokinetics) and
how drugs affect the body (pharmacodynamics).
Pharmacokinetic changes in aging are better
characterized than pharmacodynamic changes
and are summarized in Fig.20.1. The most signicant pharmacokinetic changes in old age are
reduced drug metabolism and excretion.
Consequently, maintenance dose may need to be
reduced to obtain similar serum concentrations of
drugs to those seen in younger people. Toxicity
can be seen in older people who use usual adult
therapeutic doses of chronic medications.
Age is only one of many variables that impact
on clinical pharmacokinetics. Other factors persist with increasing age, e.g., sex, weight, smoking, alcohol use, and there may be increased
exposure over a long life. Multimorbidity and
polypharmacy increase in old age and are responsible for drug–disease and drug–drug interactions. Many clinical conditions inuence
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