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Paediatric Pharmacy
Practice
1
20 to 25% of total world population
Poorly developed organ functions and highest
risk of toxicity and poor clinical response.
Sulphanilamide elixir- death: Thalidomide
tragedy.
Taste of
Raspberries, Taste
of Death
The 1937 Elixir
Sulfanilamide
Incident 2
Why Do We Need Paediatric
Pharmacists?
Children are at increased risk of adverse
drug events (ADE’s)
Pharmacologic factors
•Age-based variability in absorption,
distribution, metabolism, and excretion of
drugs
Physiologic factors
•Weight and/or body surface area (BSA)
need
to be considered for each drug for each
patient
3
Process factors
•Individualized dilution of stock
medications
and fluids
•Multiple concentrations of same drug
• Dilution errors
Environmental factors
•ICU settingWeight-based dosing
Error dosing rate
Error rates inversely related to size or
weight of patient
4
Paediatric medication orders are more
prone
to errors than adult orders
 Doses are not standard
 Math errors can occur when calculating
the dose
 Suspensions often have to be compounded
 Tablets may have to be cut
 Dilutions need to be made to make
amounts that are measurable
 However, children have less tolerance for
errors
5
Preemie <37 weeks gestation (gestational
age is the time from conception
until
Birth)
Full Term 37-42 weeks gestation
Neonate First 30 days of life
Infant First year of life
Toddler From 1 to 2 years of life
Child Age 3-11
Adolescent Age Age 12 on
Definition of a child is based on age
6
Special Challenges of Practicing in
Pediatrics
 Lack of published information on
therapeutic uses and monitoring of drugs
 Lack of FDA approval for many drugs used
in pediatrics
Lack of appropriate commercially available
dosage forms and concentrations of commonly
used medicationsInability of patients to communicate with
caregivers
Interacting with parents
7
Skills Necessary
Dosage calculations
Dosage-form selection
Specialized drug preparation and
administration techniques
Understanding of PK/PD changes occurring
with age
Understanding of disease-specific
conditions
affecting drug choice or dose
Understanding nature of medication errors
in
pediatric patients 8
Role of the Paediatric Pharmacist
Ensure the patient receives the necessary
drug in a manner that allows the intended
therapeutic effect to be realized.
9
Patient interviews
Medication history
•Inquiring about OTC and herbal
medications
Allergy history
•True allergic reaction?
Immunization history
•Can make recommendations to MD if
patient is not up-to-date on immunizations 10
Discharge counselling
Administration & use of appropriate
measuring device dosage
Preparation of form at home, if
necessary
Attention to taste of liquid medications
Prevention of accidental ingestions
School / day-care issues directed at
patient and/or caregiver
11
Drug Information
Influence selection of drug therapy in initial
phase of patient care
•Consult with physician and patient
Provide current, unbiased and relevant drug
information
Assist with finding literature supporting use of
drugs for unlabeled indications
12
Therapeutic Drug Monitoring
Understanding timing / indication of
monitoring to prevent unnecessary blood draws
on children
Account for age-related differences in
dosage
Documentation in patient chart
Monitor steps of the medication use
process
Reduce drug costs
Avoidance of medication errors resulting
from over- or underdosing
13
Reduce Medication Errors
Report medication errors
Encourage others to report medication
errors or suspected ADE’s
Participation in quality-improvement
committees
Develop and enforce policies and procedures
for safe medication practices 14
Drug Use Evaluation
Low therapeutic index drugs
Those responsible for serious
medication errors
High frequency of preventable adverse
drug reactions
Expensive medications
Education
Patients
 Nursing unit staff
 Physicians
 Pharmacy students and residents
15
Research
 Pediatric patients are “therapeutic
orphans”
Insufficient research in pediatric
patients
Expansion of adult diseases into the
pediatric population (i.e. AIDS)
Use of therapeutic agents in children
without FDA approval
16
Pharmacokinetic
considerations
17
Absorption
– Gastrointestinal
pH- gastric acid output maturity is related to
postnatal age and
approaches adult values by 3 months of age
GI motility- neonates have a delay in gastric
emptying time, adult values are reached at 6-8
months of age
GI contents- develops rapidly within the first
year of life,
underdeveloped flora can increase absorption of
drugs (digoxin)
–
18
19
Percutaneous
Absorption is increased in the newborn
due to immature
epidermal barrier and increased skin
hydration during the first 2
weeks of life
Increased surface area to weight ratio
increases percutaneous
absorption
Distribution
–Body Water
• Neonates are 80% body water compared to 55%
in adults
• Vd is increased for drugs that distribute to
aqueous parts of the body (aminoglycosides)
• Total body fat is 1% in a 29 wk neonate
• Total body fat is 15% in a full term baby
• Total body fat is 20-25% in 2yo toddler
• Fat content tends to increase between 5-10 years
followed by a decrease through age 17
• Vd is increased for drugs that are highly lipid
soluble
20
– Plasma Protein Binding
• Neonates have decreased plasma protein which
increases unbound concentrations (ex: Phenytoin
may only be 70% bound in a neonate compared to
90% in an adult)
– Blood Brain Barrier
• An immature BBB due to incomplete CNS
myelination results in increased CNS drug
penetration
21
Metabolism
– Neonates have decreased activity of many enzyme
pathways, that is why drug dosages are decreased
for neonates
P450 activity is 50% of adult levels
Decreased hydroxylation activity leads to
decreased metabolism of phenobarbital, phenytoin,
lidocaine
Children have increased hepatic enzyme activity
between 2-4 years of age. This may be due to large
liver size compared to total body weight. Doses are
increased during this time for theophylline,
phenytoin, and phenobarbital.
22
At birth, kidney function is decreased, GFR
matures first, then tubular secretion, and lastly
tubular reabsorption
GFR at birth is 2-4 ml/min, which is 0.5% of an
adult level
After the first week of life, a significant
increase in GFR is seen, this explains why
recommended doses change after 7 days of life
At 1 year, GFR reaches 70 ml/min/m2
Around 12-24 month of age, GFR and tubular
secretion are more mature than tubular
reabsorption and cause an increased renal
clearance of drugs (digoxin)
Excretion
23
Administering
Medications to
Children
24
• Safe pediatric dosages calculated by:
– Body weight
• Measured in mg per kg, mcg per kg, etc.
– Body surface area (BSA)
• Measured in m2
Remember
 1 kg = 2.2 lb
– When converting pounds to kilograms, round kilogram
weight to one decimal place
• Tenths
 1 lb = 16 oz
25
Dosage is optimally calculated by using the
child’s body weight or mass and the appropriate
dose in milligrams per kilogram (mg/kg).
A. Fried’s rule for infants
age (in months) X adult dose
............................
= dose for infant
150
26
age (in years)
............................. X adult dose =
age (in years) + 12
dose for child
Young’s rule for children 2 years old or older
weight (lb) X adult dose
........................................ = dose for child
150 lb (avg wt of adult)
Clark’s rule
27
BSA of child (m)2 X adult dose
............................................... =
1.73 m2 (avg adult BSA)
approximate dose for
child
Child’s dosage based on body surface area
(BSA)
In the case of some drugs, such as chemotherapy, doses are
based on body surface area (BSA). This value can be determined
from the patient’s height and
weight, using either a nomogram or the following equation:
height (cm) X weight (kg)
BSA (m)2 = .......................................
3600
28
Although the total body water content of
an adult
accounts for approximately 60% of body
weight, the total body water content of a
healthy newborn is
(A) 40%.
(B) 50%.
(C) 70%.
(D) 80%.
(E) 90%.
29
THANK YOU
30

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Paediatric drugs, its dose and dosage forms

  • 2. 20 to 25% of total world population Poorly developed organ functions and highest risk of toxicity and poor clinical response. Sulphanilamide elixir- death: Thalidomide tragedy. Taste of Raspberries, Taste of Death The 1937 Elixir Sulfanilamide Incident 2
  • 3. Why Do We Need Paediatric Pharmacists? Children are at increased risk of adverse drug events (ADE’s) Pharmacologic factors •Age-based variability in absorption, distribution, metabolism, and excretion of drugs Physiologic factors •Weight and/or body surface area (BSA) need to be considered for each drug for each patient 3
  • 4. Process factors •Individualized dilution of stock medications and fluids •Multiple concentrations of same drug • Dilution errors Environmental factors •ICU settingWeight-based dosing Error dosing rate Error rates inversely related to size or weight of patient 4
  • 5. Paediatric medication orders are more prone to errors than adult orders  Doses are not standard  Math errors can occur when calculating the dose  Suspensions often have to be compounded  Tablets may have to be cut  Dilutions need to be made to make amounts that are measurable  However, children have less tolerance for errors 5
  • 6. Preemie <37 weeks gestation (gestational age is the time from conception until Birth) Full Term 37-42 weeks gestation Neonate First 30 days of life Infant First year of life Toddler From 1 to 2 years of life Child Age 3-11 Adolescent Age Age 12 on Definition of a child is based on age 6
  • 7. Special Challenges of Practicing in Pediatrics  Lack of published information on therapeutic uses and monitoring of drugs  Lack of FDA approval for many drugs used in pediatrics Lack of appropriate commercially available dosage forms and concentrations of commonly used medicationsInability of patients to communicate with caregivers Interacting with parents 7
  • 8. Skills Necessary Dosage calculations Dosage-form selection Specialized drug preparation and administration techniques Understanding of PK/PD changes occurring with age Understanding of disease-specific conditions affecting drug choice or dose Understanding nature of medication errors in pediatric patients 8
  • 9. Role of the Paediatric Pharmacist Ensure the patient receives the necessary drug in a manner that allows the intended therapeutic effect to be realized. 9
  • 10. Patient interviews Medication history •Inquiring about OTC and herbal medications Allergy history •True allergic reaction? Immunization history •Can make recommendations to MD if patient is not up-to-date on immunizations 10
  • 11. Discharge counselling Administration & use of appropriate measuring device dosage Preparation of form at home, if necessary Attention to taste of liquid medications Prevention of accidental ingestions School / day-care issues directed at patient and/or caregiver 11
  • 12. Drug Information Influence selection of drug therapy in initial phase of patient care •Consult with physician and patient Provide current, unbiased and relevant drug information Assist with finding literature supporting use of drugs for unlabeled indications 12
  • 13. Therapeutic Drug Monitoring Understanding timing / indication of monitoring to prevent unnecessary blood draws on children Account for age-related differences in dosage Documentation in patient chart Monitor steps of the medication use process Reduce drug costs Avoidance of medication errors resulting from over- or underdosing 13
  • 14. Reduce Medication Errors Report medication errors Encourage others to report medication errors or suspected ADE’s Participation in quality-improvement committees Develop and enforce policies and procedures for safe medication practices 14
  • 15. Drug Use Evaluation Low therapeutic index drugs Those responsible for serious medication errors High frequency of preventable adverse drug reactions Expensive medications Education Patients  Nursing unit staff  Physicians  Pharmacy students and residents 15
  • 16. Research  Pediatric patients are “therapeutic orphans” Insufficient research in pediatric patients Expansion of adult diseases into the pediatric population (i.e. AIDS) Use of therapeutic agents in children without FDA approval 16
  • 18. Absorption – Gastrointestinal pH- gastric acid output maturity is related to postnatal age and approaches adult values by 3 months of age GI motility- neonates have a delay in gastric emptying time, adult values are reached at 6-8 months of age GI contents- develops rapidly within the first year of life, underdeveloped flora can increase absorption of drugs (digoxin) – 18
  • 19. 19 Percutaneous Absorption is increased in the newborn due to immature epidermal barrier and increased skin hydration during the first 2 weeks of life Increased surface area to weight ratio increases percutaneous absorption
  • 20. Distribution –Body Water • Neonates are 80% body water compared to 55% in adults • Vd is increased for drugs that distribute to aqueous parts of the body (aminoglycosides) • Total body fat is 1% in a 29 wk neonate • Total body fat is 15% in a full term baby • Total body fat is 20-25% in 2yo toddler • Fat content tends to increase between 5-10 years followed by a decrease through age 17 • Vd is increased for drugs that are highly lipid soluble 20
  • 21. – Plasma Protein Binding • Neonates have decreased plasma protein which increases unbound concentrations (ex: Phenytoin may only be 70% bound in a neonate compared to 90% in an adult) – Blood Brain Barrier • An immature BBB due to incomplete CNS myelination results in increased CNS drug penetration 21
  • 22. Metabolism – Neonates have decreased activity of many enzyme pathways, that is why drug dosages are decreased for neonates P450 activity is 50% of adult levels Decreased hydroxylation activity leads to decreased metabolism of phenobarbital, phenytoin, lidocaine Children have increased hepatic enzyme activity between 2-4 years of age. This may be due to large liver size compared to total body weight. Doses are increased during this time for theophylline, phenytoin, and phenobarbital. 22
  • 23. At birth, kidney function is decreased, GFR matures first, then tubular secretion, and lastly tubular reabsorption GFR at birth is 2-4 ml/min, which is 0.5% of an adult level After the first week of life, a significant increase in GFR is seen, this explains why recommended doses change after 7 days of life At 1 year, GFR reaches 70 ml/min/m2 Around 12-24 month of age, GFR and tubular secretion are more mature than tubular reabsorption and cause an increased renal clearance of drugs (digoxin) Excretion 23
  • 25. • Safe pediatric dosages calculated by: – Body weight • Measured in mg per kg, mcg per kg, etc. – Body surface area (BSA) • Measured in m2 Remember  1 kg = 2.2 lb – When converting pounds to kilograms, round kilogram weight to one decimal place • Tenths  1 lb = 16 oz 25
  • 26. Dosage is optimally calculated by using the child’s body weight or mass and the appropriate dose in milligrams per kilogram (mg/kg). A. Fried’s rule for infants age (in months) X adult dose ............................ = dose for infant 150 26
  • 27. age (in years) ............................. X adult dose = age (in years) + 12 dose for child Young’s rule for children 2 years old or older weight (lb) X adult dose ........................................ = dose for child 150 lb (avg wt of adult) Clark’s rule 27
  • 28. BSA of child (m)2 X adult dose ............................................... = 1.73 m2 (avg adult BSA) approximate dose for child Child’s dosage based on body surface area (BSA) In the case of some drugs, such as chemotherapy, doses are based on body surface area (BSA). This value can be determined from the patient’s height and weight, using either a nomogram or the following equation: height (cm) X weight (kg) BSA (m)2 = ....................................... 3600 28
  • 29. Although the total body water content of an adult accounts for approximately 60% of body weight, the total body water content of a healthy newborn is (A) 40%. (B) 50%. (C) 70%. (D) 80%. (E) 90%. 29