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Pharmacotherapy Issues in the Pediatric Population
Continuing Professional Pharmacy Development Dr. Shane Pawluk, PharmD
Dr. Andrea Cartwright, PharmD Dr. Maryam Khaja March 26, 2014
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Outline
• Didactic Session – General Pediatrics – Pharmacy dispensing issues in pediatric patients – Preventing medication errors in pediatric patients
• Small group case work
• Case Discussions
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Learning Objectives • Apply pharmaceutical care principles to solve patient cases specific
to pediatrics (including dosage forms and regimens, and counseling points)
• Recommend an appropriate empiric antibiotic regimen for otitis media and UTI in a pediatric patient
• Calculate an appropriate dose for a pediatric patient based on weight
• Discuss error reduction strategies available to pharmacists to minimize mediation errors in pediatric patients
• Describe 3 clinical pearls relating to pediatric medicine
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Definitions
Pediatrics: • Specialty of medical science concerned with
the physical, mental and social health of children from birth to young adulthood
• Encompasses a broad spectrum of health services ranging from preventative health care to the diagnosis and treatment of acute and chronic diseases
http://www.pedjobs.org/pdf/AAP_Definition_Pediatrician.pdf
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Definitions
• Neonate – Birth to 1 month (28 days)
• Infant – 1 month to 12 months (1 year)
• Child – 1 year to 12 years
• Adolescent – 13 years to <20 years (<18 years)
• Adult – >18 years
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What Makes Pediatrics Unique??
• Physical • Cognitive/Psychological • Behavioural
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Growth & Development
• Growth: – Physical changes in size
• Development: – Changes in function
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http://www.health.gov.bc.ca/pho/pdf/who-pediatric-growth-charts.pdf
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Vitals
Age HR (BPM) SBP (mmHg) RR (Breaths per minute)
Newborn 120-150 60-70 30-60
6 Months 120-140 65-120 25-35
1 Year 120-140 70-120 20-30
5 Years 90-110 80-125 20-25
15 Years 60-90 110-130 15-20
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Pharmacy Dispensing Issues in Pediatrics
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Dosage Forms/Formulations
• Liquid dosage forms preferred to crushing tablets but also have complications – Ensure parents instructed to measure dose – Provide measuring tool – Parents to ensure children swallow medicine
• Beware of crushing certain medications
– Always check reliable reference
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Convenience
• Need to individualize dosing regimens? – Cloxacillin capsules PO QID AC (6 year old child)
• How can the child take when at school? • Can you use your knowledge of
pharmacology/pharmacokinetics/pharmaceutics to suggest a more convenient, effective agent?
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Understanding
• You are dispensing a prescription for salbutamol to an 8 year old child newly diagnosed with asthma. She and her mother are waiting. – Who do you talk to? – What do you say? – How do you counsel?
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Preventing Medication Errors in Pediatric Patients
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Adverse Drug Events
• Medication errors in pediatric patients are approximately 3 times more likely compared to adults
• ¾ of these errors occur in the medication ORDERING phase
Fortescue E, et al. Pediatrics. 2003;111(4 pt 1):722–9. Kaushal R, et al. JAMA. 2001;285:2114–20.
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Reasons for Increased Risk
1. Different and changing pharmacokinetic parameters
2. Lack of pediatric formulations, dosage forms, guidelines, and inconsistent measurement of preparations
3. Calculation errors
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1. Different and changing PK parameters
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Pediatric Pharmacokinetics
• Absorption
• Distribution
• Metabolism
• Excretion
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Absorption Physiological Change PK Consequence
• Stomach pH varies from 6 to 8 at birth
• Gastric acid secretion is lower in premature infants
• Adult values of gastric pH are reached after approximately 3-5 years
• Higher gastric pH in pediatrics
• Reduced dissolution of weak bases
• Enhanced dissolution of weak acids
• Increased bioavailability of acid-labile drugs such as ampicillin and naficillin
• Increased absorption of weak bases and reduced absorption of weak acids
• Variable muscle blood flow, reduced muscle tone and contractions
• Reduced drug absorption from IM injections
• Greater skin hydration and thinner stratum corneum
• Enhanced drug absorption from topical preparations
Nader A. Pediatric Pharmacokinetics. 2014
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NEJM 2003;349:1157-67
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NEJM 2003;349:1157-67
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Distribution Physiological Change PK Consequence
• Proportion of water in premature babies is 85% of body weight, drops to 80% in full-term babies and 50-70% in adults
• Increased body water and reduced body fat in infants and children
• Higher volume of distribution for water-soluble drugs (eg. aminoglycosides) and lower distribution for lipophilic drugs (eg. phenobarbital)
• Albumin and total protein concentrations are lower in newborns
• Adult values reached at 10-12 months
• Reduced plasma protein binding and increased tissue distribution
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NEJM 2003;349:1157-67
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Hepatic Clearance Physiological Change PK Consequence
• Drug conjugation and biliary excretion are immature in newborns
• Increased drug exposure for drugs that are conjugated or excreted in bile
• CYP450 enzyme activities in newborns are 30-50% that of adult values
• Reduced clearance for drugs that are CYP450 metabolized
• Omeprazole (CYP2C19
• CYP1A2 (Caffeine) • Little fetal activity • Adult activity by 4-5 months
• CYP2C9 (warfarin, phenytoin) • Little activity at birth • Adult activity early after birth
• CYP2D6 (dextromethorphan) • Acquired within 2 weeks of birth • Adult activity at 10 years
• CYP3A4 (midazolam) • Exceeds adult levels by 1 year and until puberty
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NEJM 2003;349:1157-67
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Renal Clearance Physiological Change PK Consequence
• The majority of functioning tubular cells is reduced at birth, as are tubule length, blood flow to the peritubular area, and energy supply processes
• Immature glomerular filtration in newborns; reach adult values by 1 month for GFR
• GFR = 2-4mL/min at birth = 8-20mL/min by 3 days = 100mL/min by 1 month
• Reduced drug clearance dependent on glomerular filtration and renal active secretion of elimination (eg. penicillin)
• Ampicillin half-life by age group: One week 4 hours Two weeks 2.8 hours One month 1.7 hours • Inverse correlation of elimination half-
life with age (eg. aminoglycosides)
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NEJM 2003;349:1157-67
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PK Case 1
A premature infant (29 weeks of gestation) developed lethargy, apnea and metabolic acidosis in association with elevated serum concentrations of propylene glycol Thoughts??
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PK Case 1
The infant had received topical therapy with nitrofurazone dissolved in propylene glycol
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PK Case 2
A newborn infant developed difficulty breastfeeding and increasing lethargy at 7 days of age. 4 days later, he was taken to the clinic due to parents concerns about his pale skin color and decreased milk intake. 2 days after the clinic visit, an ambulance team found the baby cyanotic and without vital signs. Resuscitation was necessary Thoughts??
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PK Case 2
The infant has severe morphine toxicity after codeine use to treat mother’s pain
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2. Lack of pediatric formulations, dosage forms, guidelines, and inconsistent measurement of
preparations
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Lack of Pediatric Formulations
• May lead to: – Crushing tablets – Opening capsules and adding to food or beverage – Uses IV formulations for PO – Administering medications rectally – Compounding extemporaneous products
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Lack of Pediatric Formulations
• Pitfalls of altering adult formulations – Insufficient data to fully support practice – Expiry dates??? – Bioavailability – Compounding errors
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Sources of Errors
• Confusion among oral liquid concentrations – Eg. Acetaminophen products
• 100 mg/mL Infant drops • 160 mg/5mL Children’s liquid • 167 mg/5mL Adult extra strength
• “Look-alike” and “sound-alike” packaging and names
• Different dosing styles – Eg. daily dosing versus every __ hours
• Acetaminophen 10-15 mg/kg/dose q6h • Ampicillin 100-200 mg/kg/day divided q6h
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Oral Measuring Devices
• Oral medications are more likely to be dispensed in bulk and not in unit dose
• Many households still use kitchen spoons for measuring
• Pre-packaged dispensing cups or droppers – Often mistaken for whole doses versus measured
doses
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3. Calculation Errors
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Calculation Errors
• There is NO standard dose
• All doses are recommended based on: – Body weight in kilograms – Body Surface Area
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Convert
• Your patient weighs 28 lbs
• How many kilograms are they?
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Calculations
• Patient weight: 45 lbs
• Give 40 mg/kg/day divided q8h How many mg per dose? How much is the 24 hour drug total?
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Calculations and Supply
• MD order is to give 75 mg
• Supply is 160mg/5mL
• Calculate the amount to administer
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Reduction of Calculation Errors
• Establish reliable method of providing current patient weight in kg to the health care team
• Require calculated dose and dose per weight (i.e., mg/kg) on each order – Acetaminophen 100 mg (10 mg/kg) every 6 hours by
mouth – Exceptions
• Vitamins, topicals, other medications not requiring weight-based dosing
• Require independent double check of dosing calculations
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Reduction of Calculation Errors
• Standardize dosing and concentrations – IV drip rates or concentrations – Recipes and strengths for extemporaneous
compounds
• Provide pediatric references in ordering, dispensing, and administration locations
• Encourage rounding to whole numbers when possible
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Reduction of Calculation Errors
• Include warnings for potentially low or high doses in the pharmacy
• Appropriately use decimal points – Utilize leading zeros: 0.1 (right) .1 (wrong) – Do not use trailing zeros: 1 (right) 1.0 (wrong)
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Summary
• Pediatric patients are NOT small adults
• Physiologic differences can affect drug therapy
• Pediatric patients are at a greater risk of medication errors – Variable PK – Lack of dosage availability – Calculations – Measuring devices
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Learning Objectives • Apply pharmaceutical care principles to solve patient cases specific
to pediatrics (including dosage forms and regimens, and counseling points)
• Recommend an appropriate empiric antibiotic regimen for otitis media and UTI in a pediatric patient
• Calculate an appropriate dose for a pediatric patient based on weight and body surface area
• Discuss error reduction strategies available to pharmacists to minimize mediation errors in pediatric patients
• Describe 3 clinical pearls relating to pediatric medicine
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References • http://www.health.gov.bc.ca/pho/pdf/who-pediatric-growth-
charts.pdf • Anatomic and Physiologic Differences Between Children and Adults.
Dr. Elizabeth Farrington • Fortescue EB et al. Prioritizing strategies for preventing medication
errors and adverse drug events in pediatric inpatients. Pediatrics 2003;111(4 Pt 1):722-9.
• Kaushal R et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285(16):2114-20.
• Kearns GL et al. Developmental pharmacology – drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349(12):1157-67.
• http://www.pedjobs.org/pdf/AAP_Definition_Pediatrician.pdf • Pediatric Pharmacokinetics. Dr. Ahmed Nader, College of Pharmacy,
Qatar University