Intro to Peds Student-Made Test Questions in Class

This act permitted manufacturers to label drugs for pediatric use on the basis of extrapolated efficacy data and PK/PD data specific to the pediatric population when disease and therapy response were considered similar to those of their adult counterparts.
a. Best Pharmaceuticals for Children Act
b. Pediatric Research Equity Act
c. The Pediatric Rule
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This act permitted manufacturers to label drugs for pediatric use on the basis of extrapolated efficacy data and PK/PD data specific to the pediatric population when disease and therapy response were considered similar to those of their adult counterparts.
a. Best Pharmaceuticals for Children Act
b. Pediatric Research Equity Act
c. The Pediatric Rule
c) The Pediatric Rule
The immaturity of neonatal epidermis results in __ drug permeability.
a. Increased
b. Decreased
a. Increased
Which property does body composition play a major role?
a. Absorption
b. Distribution
c. Excretion
b. Distribution
Body composition __ as we age.
a. Changes
b. Remains the same
a. Changes
________ enzymes metabolize the most drugs.
CYP3A4
Which of the following are true?
a. GFR is higher in newborns than in adults
b. Renal tubular absorption is similar in newborns and adults
c. GFR in newborns is low and gradually increases in the first year of life
d. Urine is filtered by the liver in neonates
c. GFR in newborns is low and gradually increases in the first year of life
Which of the following medication regulations offered a financial incentive of extended market exclusivity for 6 months for performing pediatric studies?
A. 1994 Pediatric Rule
B. 1997 Food and Drug Administration Modernization Act
C. 2002 Best Pharmaceuticals for Children Act
D. 2003 Pediatric Research Equity Act
B. 1997 Food and Drug Administration Modernization Act
Which of the following is TRUE regarding the immaturity of neonatal epidermidis?
A. Decreased surface area to body weight ratio
B. Greater skin hydration and blood flow
C. Thicker stratum corneum
D. Decreased drug permeability
B. Greater skin hydration and blood flow
There are __________ volumes of distribution for water soluble drugs in neonates compared with infants, older children and __________.
a. Smaller; adults aged 30 years old and older
b. Larger; adolescents
c. Smaller; adolescents
d. Larger; adults aged 30 years old and older
b. Larger; adolescents
Liver function is _____ in the neonate compared to the adult
a. Increased
b. Decreased
b. Decreased
Kidneys remain a major organ of elimination for many drugs in pediatric patients. Pediatric patients have reduced clearance. What effect does this have on half-life (compared to adults)? a. prolonged b. shorteneda. prolongedAt what point in development are infants motility patterns the same as adults? a. 24-26 months b. 12-14 months c. 6-8 months d. 8-10 monthsc. 6-8 monthsNeonates have _________volumes of distribution for water soluble drugs and ______ volumes of distribution for lipid soluble drugs.Larger, smallerT/F: Albumin and total protein concentration are higher in neonates.FalseWhich of the following CYP450 enzyme takes the longest to reach adult levels of activity? a. CYP3A4 b. CPY1A2 c. CYP2D6 d. CYP2C9b. CPY1A2Glomerular filtration rate increases rapidly in the first ______ weeks of life. a. 2 b. 4 c. 6 d. 8a. 2Which of the following results in enhanced drug permeability in neonates? a. Decreased surface area to body weight ratio b. Greater skin hydration and blood flow c. Thinner stratum corneum d. B and C e. All of the aboved. B and CAfter birth, a pediatric patient's percentage of total body water ____ and percentage of extracellular fluid ____.decreases, decreasesWhen comparing the liver function of a neonate to an adult, the neonate: a. Has reduces liver function and lower amounts of protein compared to an adult b. Usually have much lower plasma concentrations of active drugs that are highly protein bound c. Lacks the ability to metabolize certain bodily components such as bilirubin d. A and C e. All of the aboved. A and CWhat is the GFR (glomerular filtration rate) in a full term neonate? A. 2 ml/min/1.73 m^2 B. 10 ml/min/1.73 m^2 C. 20 ml/min/1.73 m^2 D. None of the answers are correct.C. 20 ml/min/1.73 m^2If a drug is contraindicated in all pediatric patients, in a specific pediatric age group(s), or in a subgroup of pediatric patients, the contraindication and reason for the contraindication should be stated first in the __________ as well as in the CONTRAINDICATIONS section.Pediatric Use SubsectionA mother comes into your pharmacy with her 3-year old child. She tells you that she can't get her daughter to take her antibiotic, as she hates the taste of it. You, as the pharmacist, hear your technician tell the mother to hold her daughter's nose closed to help mask the taste of the medication. T/F: This technique is likely to help the 3-year old take her medication. a. True; if she can't smell it, she isn't as likely to taste it b. True; The mother holding the child's nose will disorient the child long enough for the medication to be taken. c. False; our sense of odor develops around 5 to 7 years old so the child is too young for this technique to be beneficial. d. False; the technician should inform the mother nothing can help the medication taste better.c. False; our sense of odor develops around 5 to 7 years old so the child is too young for this technique to be beneficial.Changes in body composition occur with increasing age and significantly affect distribution of medications, with _______ volumes of distribution for water soluble drugs in neonates compared with infants, older children, and adolescents a. Larger b. Smallera. Larger30-40% of pediatric body composition (<6yoa) is composed of_____, and drastically changes throughout development a. Intracellular fluid b. Extracellular fluid c. Plasmaa. Intracellular fluidConcentrations of ______ mature to adult levels by 1 year of age, while concentrations of ______ mature to adult levels by 2 weeks of age. a. CYP3A4; CYP2D6 b. CYP2D6; CYP1A2 c. CYP1A2; CYP3A4 d. CYP2D6; CYP3A4a. CYP3A4; CYP2D6The GFR is 2-4 in neonates and it doubles in _____ a. 1 week b. 2 weeks c. 1 month d. 2 monthsa. 1 weekWhich of the following components is NOT included in the FDA label-approved indications of medications? a. Disease or illness the medication treats b. Route of administration c. Duration of therapy d. Age group in which the medication is usedc. Duration of therapyPediatric patients attain adult motility patterns by ________months of age a. 120-1,000 months b. 12-500 months c. 6-8 months d. 1-2 monthsc. 6-8 monthsT/F: Neonates are composed of a greater percentage of water than older children and adults.TrueWhich of the following is true regarding metabolism in pediatric patients? a) CYP3A4 concentrations remain fairly constant up till 1 year of age b) Nephrogenesis and maturation of kidneys is complete at 36 weeks c) they have much higher plasma concentrations of drugs that are highly protein bound d) liver function is increased in pediatric patients compared to adultsc) they have much higher plasma concentrations of drugs that are highly protein boundWhich of the following is true regarding elimination in pediatric patients? a. Kidneys remain a major organ of elimination for many drugs and/or metabolites b. Anatomic maturation of the kidneys is a static process c. Glomerular filtration rate decreases rapidly in the first 2 weeks of life d. Clearance is increased; half-life is shorteneda. Kidneys remain a major organ of elimination for many drugs and/or metabolitesWhat was the purpose of the 1997 Food and Drug Administration Modernization ACT ? a. Offered financial incentive of extended market exclusivity for 6 months for performing pediatric studies. b. Offered financial incentive of extended market exclusivity for 1 year for performing pediatric studies. c. Offered financial incentive of extended market exclusivity for 3 months for performing pediatric studies. d. Offered financial incentive of extended market exclusivity for 2 years for performing pediatric studies.a. Offered financial incentive of extended market exclusivity for 6 months for performing pediatric studies.Which of the following is a factor that determines the extent of drug absorption in a pediatric patient? a. Surface area of the GI tract b. The child's diet c. The patient's eye color d. The patient's exercise routinea. Surface area of the GI tractDue to the gastric pH of an infant being higher there will be (..........) intact drug available for absorptionmoreIn infants, Phase I and II reactions in the liver don't mature until approximately what age? a. 2 weeks b. 1 month c. 6 months d. 1 yearc. 6 monthsAt what age is nephrogenesis complete in the elimination stage of pediatric patients? a. 36 weeks b. 24 weeks c. 32 weeks d. 28 weeksa. 36 weeksWhich is true regarding absorption in pediatric patients? a. Drugs have an enhanced permeability due to the immaturity of the neonatal epidermidis. b. When using rectal administration of drugs, it is likely that the medication may not get fully absorbed before being expelled. c. Infants taste salty flavors at birth. d. The increased gastric pH does not have an effect on the chemical stability of the drug. e. All the above f. A & B g. A, B, & Df. A & BPediatric patients have __________ volumes of distribution for lipid-soluble drugs resulting in ______ dose requirements. a. Larger; higher b. Larger; lower c. Smaller; higher d. Smaller; lowerd. Smaller; lowerImpact of ontogenic changes in drug metabolism on drug disposition and action depends on all of the following except: a. Whether it is an active drug or a prodrug b. Half-life c. Therapeutic index d. Number of pathways for which drug serves as a substrateb. Half-lifeGlomerular filtration rate increases rapidly during which weeks after birth? a. 5-6 weeks b. 3-5 weeks c. 1-2 weeks d. 9-10 weeksc. 1-2 weeksWhich of the following is an appropriate format for pediatric dosing? a. .111 b. 0.20 c. 4.00 d. 0.8d. 0.8Immaturity of neonatal epidermidis results in enhanced drug permeability due to which of the following factors? a. Increased surface area to body weight ratio b. Greater skin hydration and blood flow c. Thinner stratum corneum d. All of the aboved. All of the aboveT/F: An infant's percentage of total body water is a higher percentage of their body weight compared to an adult's total body water.TrueT/F: Larger volumes of distribution for water soluble drugs in neonates compared with infants, older children, and adolescents.TrueT/F: Phase II reactions include oxidative metabolism and typically mature in infants right after birth (within 3 weeks postnatal).FalseWhich of the following is FALSE regarding drug elimination in pediatric patients? a. Pediatric patients have reduced clearance in comparison to adults. b. The half-lives of drugs are prolonged when taken by pediatric patients. c. Dosing intervals should be extended for drugs administered to pediatric patients. d. Pediatric patients have fully mature kidneys at the time of full-term birth.d. Pediatric patients have fully mature kidneys at the time of full-term birth.Which of the following is NOT a characteristic leading to enhanced topical drug permeability in neonates? a. Increased surface area to body weight ratio b. Greater skin hydration c. Thicker stratum corneum d. Greater blood flowc. Thicker stratum corneumWhich of the following contains the largest amount of fluid? a. Intracellular b. Interstitial c. Plasmaa. IntracellularThe impact of ontogenetic changes in drug metabolism on drug dispositions and action will depend on all of the following EXCEPT: A.) the nature of the chemical moiety B.)the molecular weight of the chemical C.) The therapeutic index D.) number of pathways for which the drug serves as a substrateB.)the molecular weight of the chemicalThere are larger volumes of distribution for __________ drugs in neonates compared with infants, older children, and adolescents. a. Water soluble b. Lipid solublea. Water solubleLiver function is __________ in the neonate as compared to the adult leading to ________ plasma concentrations of the drug. a. Decreased; higher b. Decreased; lower c. Increased; higher d. Increased; lowera. Decreased; higherIn pediatric patients, what is the major organ of elimination for many drugs and/or metabolites? a. Liver b. GI tract c. Kidney d. None of the abovec. KidneyThe Food and Drug Administration Modernization Act was passed in ____. a. 2002 b. 1997 c. 1994 d. 2003b. 1997Total body water ____ with age. Increases DecreasesdecreasesCYP____ is involved in the metabolism of more than 50% of available medications. CYP2D6 CYP2C19 CYP3A4 CYP1A2CYP3A4Functional and anatomic maturation of the kidneys: a. Stops after 2 years of age b. Stops after 5 years of age c. Continues throughout childhood d. Continues throughout adulthoodc. Continues throughout childhood________ _________controls the rate at which medications are distributed long the primary absorptive site.Intestinal Motility_________ volumes of distribution for lipid-soluble drugs resulting in lower dose requirements.SmallerCYP3A isoform switch after birth from CYP____ to CYP____ a. 3A7 to 3A4 b. 3A4 to 3A7 c. 2D6 to 3A4 d. 3A4 to 2D6a. 3A7 to 3A4T/F: Drug absorption in pediatrics is not affected by the surface area of the GI tract.FalseWhich of the following is considered smaller volumes of distribution? A. Drugs with a high pka B. Drugs with low molecular binding C. Drugs that are lipid-soluble D. None of the aboveC. Drugs that are lipid-solublePrimary drug metabolizing enzymes responsible for carrying out phase I reactions are ______. CYPs Lipase Amylase All of the aboveCYPsWhich of the following is not a way that a medication's use would be considered "off label"? a. Using an psychiatric medication to treat an anxiety disorder not indicated in its prescribing information. b. Using an antibiotic that has not been approved for use in children to treat a hospitalized child's meningitis. c. Using ophthalmic drops to treat an ear infection. d. All of the above are ways that a medication could be used off-label.d. All of the above are ways that a medication could be used off-label.T/F: Pediatric patients absorb medications through the epidermis to a greater degree than adults.TrueWhich of the following types of drugs would have a larger volume of distribution in pediatric patients? Water soluble Lipid solubleWater solubleWhen do Phase 2 reactions mature in a child? Immediately after birth 6 months old 1 year old 18 months old6 months oldT/F - Lipid-soluble drugs have a larger volume of distribution in pediatrics than in adults.FalseWhich of the following is NOT an appropriate adjustment for pediatric patients in regards to elimination of medications? a. Clearance reduced b. Half-life prolonged c. Dosing interval extended d. Dose increasedd. Dose increasedWhich of these is NOT considered off label? a. Using a drug through a different route of administration b. Using a drug for a different disease c. Using a drug for age groups not mentioned on the package insert d. Using a drug with a different label on itd. Using a drug with a different label on itRate of gastric emptying ___ dramatically during the first week of life. Increases DecreasesIncreasesT/F: Neonates are born with more ECF in comparison to ICFTrue"Extended FDAMA and additional 6 months of patent exclusivity for on-patent drugs being tested for pediatric use" describes which medication regulation? a. Best Pharmaceuticals for Children Act b. Pediatric Research Equity Act c. The Pediatric Rulea. Best Pharmaceuticals for Children ActT/F: Rectal administration is an efficient means of drug deliveryTrueThis Cytochrome P450 enzyme is present at adult levels after 2 weeks: CYP3A4 CYP2D6 CYP1A2 CYP5A1CYP2D6Which of the following is false about pediatric drug elimination by kidney? a. Nephrogenesis is complete by 36 weeks of age b. Maturation continues until 50 years of age c. GFR increases rapidly in the first 2 weeks of life d. Concentrating capacity is diminished at birthb. Maturation continues until 50 years of ageT/F: "Over 90% of drugs approved for adult use lack pertinent data to be labeled safe for use in pediatric patients."FalseAll of the following leads to enhanced drug permeability in topical route of administration EXCEPT: a. Thinner stratum b. Decreased surface area to body weight ratio c. Greater skin hydration d. Greater blood flowb. Decreased surface area to body weight ratioCYP450 enzymes are the primary metabolizers of Phase __ reactions, with CYP ___ being the most predominant isoform involved in the metabolism of over 50% of available medications. a. I, 3A4 b. II, 2D6 c. II, 1A2 d. I, 2C9a. I, 3A4T/F: Most marketed drugs are used in pediatric patients and are approved by the FDA for labeled use.FalseWhich of the following is an indication for the use of intramuscular dosing in neonates? a. If the patient is immunocompromised b. If the patient is underweight c. When an IV site is inaccessible d. IM dosing is never indicated for neonatesc. When an IV site is inaccessibleT/F: Neonates have larger volumes of distribution compared to infants and older children.TrueThe compartment containing the largest amount of fluid is ____. Intracellular Extracellular PlasmaIntracellularRate and extent of drug absorption is affected by developmental changes in a. Gastrointestinal tract b. Mucosal surfaces such as rectum and oral cavity c. Surface area of skin d. All of the aboved. All of the aboveConcentrations of CYP3A4 increase steadily throughout infancy, maturing to adult levels by ________. 6 months of age 9 months of age 1 year of age 5 years of age1 year of ageThis regulation was passed in 1994 and permitted manufacturers to label drugs for pediatric use on the basis of extrapolated efficacy data and additional PK/PD data specific to the pediatric population when disease and therapy response were considered similar to those of their adult counterparts. a. The Pediatric Rule b. Food and Drug Administration Modernization Act c. Best Pharmaceuticals for Children Act d. Pediatric Research Equity Acta. The Pediatric RuleWhich of the following characteristics of drug absorption is affected by developmental changes in surface area of the skin, gastrointestinal tract, and other mucosal surfaces? a. Rate b. Extent c. Potency d. Only A and B e. All of the Aboved. Only A and BAfter birth, CYP isoform switches from _____ to ______? a. 3A7 to 3A4 b. 3A4 to 3A7 c. 2C9 to 2C19 d. 2C19 to 2C9a. 3A7 to 3A4T/F: Concentration capacity in newborns is significantly diminished at birth.TrueDue to differences in clearance rates, are dosing intervals extended or shortened in pediatric patients? Shortened ExtendedExtended__________ fluid is greater in neonates than __________ fluid. a. Intracellular; extracellular b. Extracellular; intracellular c. Interstitial; intracellular d. Interstitial; extracellularb. Extracellular; intracellularIn neotates, the Vd for lipid soluble drugs is _______ than the Vd of water soluble drugs. Therefore, these lipid soluble drugs require a _______ dose. a. Larger; lower b. Larger; higher c. Smaller; lower d. Smaller; higherc. Smaller; lowerWhich of the following is false when comparing metabolism of pediatric patients to adults? a. Liver function is decreased in neonates versus adults b. Neonates have higher concentrations of albumin compared to adults c. Neonates exposed to drugs will have higher circulating protein-bound drugs compared to an adult d. Neonates are unable to metabolize bilirubinb. Neonates have higher concentrations of albumin compared to adultsOff-label medication use is defined as the use of a medication outside its FDA label-approved indications, including age group, disease/illness it treats, and ____. Male vs female patient Route of administration Drug's half-life Drug priceRoute of administrationWhich of the following is true regarding fluid distribution in neonates? a. The extracellular fluid compartment is greater than the intracellular fluid compartment b. Neonates undergo postnatal diuresis to even out distribution of fluid c. The intracellular fluid compartment is greater than the extracellular fluid compartment d. A and B e. All of the aboved. A and BWhich of the following is true regarding distribution in pediatric patients? a. Changes in body composition occur with increasing age b. Neonates have smaller volumes of distribution for water soluble drugs compared to infants, older children, and adolescents c. Neonates have larger volumes of distribution for lipid soluble drugs d. All of the abovea. Changes in body composition occur with increasing ageWhich of the following does NOT impact the ontogenic changes in drug metabolism on drug disposition and action? a. The nature of the chemical moiety b. The size of the molecule c. The therapeutic index of the drug d. The number of pathways for which the drug serves as a substrateb. The size of the moleculeWhich medication act provided potential requirements for the pediatric assessment of drug applications submitted to the FDA for approval in adults? A. Best Pharmaceuticals for Children Act B. Food and Drug Administration Modernization Act C. Pediatric Research Equity Act D. None of the aboveC. Pediatric Research Equity ActWhich of the following is not a reason for enhanced drug permeability in neonates? a. Increased surface area to body weight ratio b. Thinner stratum corneum c. Decreased blood flow d. Greater skin hydrationc. Decreased blood flowWhich medication regulation encouraged the pharmaceutical industry to perform pediatric studies to improve labeling for patented drug products used in children, by granting an additional 6 months patent exclusivity? a. The Pediatric Rule b. Food and Drug Administration Modernization Act c. Best Pharmaceuticals for Children Act d. Pediatric Research Equity Actc. Best Pharmaceuticals for Children ActAt what age do infants attain adult motility patterns? 3-5 months 6-8 months 9-12 months 12-18 months6-8 monthsT/F: The percentage of body weight that makes up the intracellular fluids decreases as a baby agesFalseWhich of the following is true about the impact of CYP3A4 development in pediatric patients? a. Genetic polymorphisms result in significant interindividual differences b. Activity concentrations are absent throughout fetal develop and extremely low in the neonatal population c. Involved in the metabolism of more than 50% of available medications d. Adult-level activity detected by 2 weeks of agec. Involved in the metabolism of more than 50% of available medicationsT/F: Neonates have increased liver function compared to adults.FalseT/F: The gastric pH of a neonate has a decreased effect on the stability of the drug and an increased effect on the ionization.FalseWhich of the following age classifications have a larger volume of distribution for water soluble drugs compared to the others? Adults Adolescents Children NeonatesNeonates_________ matures to adult level activity by 2 weeks of age. CYP 3A4 CYP 2D6 CYP 1A2 CYP 2C19CYP2D6When does glomerular filtration rate increase most rapidly? First 1-2 weeks First 5-6 weeks First 3-6 months First 8-10 monthsFirst 1-2 weeksWhat is the age range for labeling regulations for prescription drugs in pediatric patients 0-16 0-18 0-17 0-210-16In pediatric patients, CYP enzymes such as CYP3A4, CYP2D6, and CYP1A2 are often: A. Similar to regular adult levels of expression B. Overexpressed and steadily decreasing with age C. Underexpressed and steadily increasing with ageC. Underexpressed and steadily increasing with ageDosing must be considered in pediatric patients because drug half-life is prolonged, dosing intervals are extended, and drug clearance is ________. A. Increased B. ReducedB. Reduced