12/23/2015 1 Are Pediatric Patients Small Adults? Maria Paulina Duarte, Pharm.D. PGY-1 Pharmacy Resident Mercy Hospital A Campus of Plantation General Hospital Goals and Objectives Understand the history and evolution of pediatric dosing and labeling Understand the pharmacokinetics and pharmacodynamics of pediatric patients Explain how to appropriately dose pediatric medications Background In 1991, about 81% of medications lacked dosing information for children Medication errors are more common in pediatric patients than in adults USP MedMarx ® data of 2006-2007 2.5% of pediatric medication errors resulted in patient harm (Arch Pediatr Adolesc Med. 2009;163(12):1080-1086.) Preventing pediatric medication errors. Sentinel Event Alert. 2008;(39):1-4.
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Are Pediatric Patients Small Adults? · 12/23/2015 1 Are Pediatric Patients Small Adults? Maria Paulina Duarte, Pharm.D. PGY-1 Pharmacy Resident Mercy Hospital A Campus of Plantation
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12/23/2015
1
Are Pediatric Patients
Small Adults?
Maria Paulina Duarte, Pharm.D.
PGY-1 Pharmacy ResidentMercy Hospital A Campus of Plantation General Hospital
Goals and Objectives
�Understand the history and evolution of pediatric dosing and labeling
�Understand the pharmacokinetics
and pharmacodynamics of pediatric patients
� Explain how to appropriately dose
pediatric medications
Background
� In 1991, about 81% of medications lacked dosing information for children
�Medication errors are more common in pediatric patients than in adults
� USP MedMarx® data of 2006-2007� 2.5% of pediatric medication errors resulted in patient
� There was a belief that dosing could be calculated using body weight
�Conducting pediatric trials can be
difficult
� There was a lack of pediatric legislation to incentivize drug
companies to conduct pediatric trialsTemeck J. Pediatric Product Development in the U.S. http://www.fda.gov..November 2010. Accessed December 5, 2015.
Impact of the pediatric knowledge gap
�Children are excluded from receiving potential lifesaving therapies
�Children receiving unapproved drugs
based on adult studies resulting in negative outcomes
� Example
•Chloramphenicol
. Drug Research and Children. http://www.fda.gov. August 24, 2011. Accessed December 05, 2015.
Closing the Gap
“Over the past 15 years, we have
evolved from a view that we must
protect children from research to a
view that we must protect children
through research.”
- Michelle Roth-Cline, MD PhD
Roth-Cline M. Overview of the Ethical and Regulatory Framework for Research of Children (21 CFR 50 subpart D). http://www.fda.gov. September 9, 2013. Accessed December
17, 2015.
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Regulation and Legislation
Year Regulation/Legislation Description
1979 Product labels include pediatric use section • Packaged insert pediatric section
1994 Pediatric Use Labeling Rule
• Allowed labeling based on extrapolation of studies from adults
• Required manufacturers of new drugs to conduct pediatric studies
1997 FDA Modernization Act (FDAMA)
• Offered financial incentive for pharmaceutical companies to conduct pediatric studies
2002 Best Pharmaceutical for Children Act (BPCA)
• Encouraged more studies in children• Promoted the development of treatments for children
• Provided incentive for drug companies
2003 Pediatric Research Equity Act (PREA)
• Required drug companies to study their products in children under certain circumstances
• Drugs and biologics are included
Drug Research and Children. http://www.fda.gov. August 24, 2011. Accessed December 05, 2015.
2007- Food and Drug Administration Amendment Act
(FDAAA)� Established Pediatric Review Committee (PeRC)
�Required
� Development of age-appropriate
formulation
� New labeling mandates
� Post-marketing safety reporting
Temeck J. Pediatric Product Development in the U.S. http://www.fda.gov. November 2010. Accessed December 5, 2015.
2012-Food and Drug Administration Safety and Innovations Act (FDASIA)
�Required
� Sponsors to submit pediatric plans at
end of Phase 2
� Inclusion of neonates (birth-28 days)
� Allows
� Extensions for deferred studies
� Priority review for rare pediatric diseases
Tassinari, M. Pediatric Regulations 2012: Permanent Laws and New Provisions under FDASIA. wwww.fda.gov. Accessed December 18, 2015.
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“There have been more studies
conducted in children in the last five years than in the previous 30 years
combined.” -Ralph Kauffman, MD, Director of
medical research at Children’s Mercy
Hospital in Kansas City, MO.
. Drug Research and Children. http://www.fda.gov. August 24, 2011. Accessed December 05, 2015.
Age Ranges of Pediatric Subgroups
Pediatric subgroup Approximate age range
Newborn (Neonate) Birth to 28 days of age
Infant 1 month to 2 years of age
Child 2 years to 12 years of age
Adolescent 12 years to 16-21 years of age
Pediatric Exclusivity Study Age Group. http://www.fda.gov. Accessed December 10, 2015.
Pharmacokinetics
Pharmacokinetics is what the body does to the drug
METABOLISM
ABSORPTION
ELIMINATION
DISTRIBUTION
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Absorption: Gastric pH
�Neonatal period the gastric pH is basic� Neonatal 6-8
� Adult 2-3
�Gastric acid production reaches adult values around 3 years of age
Implications for drug therapy Drug example
Increased absorption of basic drugs Codeine
Increased absorption of acid-labile drugs Penicillin GErythromycinAmoxicillin
Decreased absorption of weak acidic drugs PhenobarbitalAcetaminophenPhenytoin
(Pharmaceutics. 2011;3(1):53-72.)
Absorption: Gastric Emptying
�Gastric emptying time is prolonged� Longer Time to Cmax
� Inconsistent or slower absorption
� Reaches adult function by 7-9 months of age
�Gastroesophageal reflux (GER)� May provide greater gastric volume of liquid available for reflux