Population-Specific Considerations in Drug therapy (part 1) Flashcards

1
Q

name the “special” populations

A

racial and ethnic minorities
trans and gender diverse
rural americans
people w limited english proficiency
veterans
pediatrics
geriatrics

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2
Q

define teratogen

A

an agent that is present during critical periods of development and is able to produce a congenital (birth) defect

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3
Q

true or false

teratogens always affect the maternal organism to some extent

A

FALSE – may not affect the mom

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4
Q

A teratogen’s susceptibility to the embryo depends on what?

A

the development stage of the embryo

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5
Q

agents (teratogens) that may cause malformations may also increase embryonic ______

A

mortality

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6
Q

define congenital defect

A

the major and minor malformations either in STRUCTURE or FUNCTION that deviate from the norm

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7
Q

how long is the 1st trimester

A

from 0-12 weeks

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8
Q

week _____-_____ fetus is most vulnerable to birth defects

A

3-8

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9
Q

as mentioned, weeks 3-8 fetus is most vulnerable to birth defects.
what can you say about drugs taken AFTER THE ORGANS ARE FORMED?

A

they may not cause defects, but they may alter the GROWTH and FUNCTION of the organs

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10
Q

at which week do the kidneys begin to function and almost all organs are completely formed

A

week 10

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11
Q

week 5 – development of _____
week 6 — development of ___ and ____

A

week 5 – development of neural tube
week 6 – development of heart and major blood vessels

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12
Q

week 7 – development of ____
week 9 –

A

week 7 – development of arms and legs
week 9 — bones and muscles form, face and neck develop brain waves detected, skeleton formed, and fingers and toes are fully defines

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13
Q

what weeks are the second trimester

A

weeks 13-24

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14
Q

what weeks are the 3rd trimester

A

week 25-delivery

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15
Q

at what week can the fetus hear

A

week 14 – (2nd trimester)

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16
Q

at what week is the placenta fully formed

A

week 20

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17
Q

at what week does the fetus have a chance of survival outside the uterus

A

week 24

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18
Q

at what week can the fingers grasp, body begins to fill as fat is deposited under the skin, and eyebrows and eyelashes are present

A

week 16

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19
Q

what is happening at week 25

A

lungs continue to mature

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20
Q

delivery is ___ -____ weeks

A

37-42

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21
Q

how did the FDA used to categorize the risk of drugs for pregancy?

A

by letters – category A-D, and X

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22
Q

what is a category A risk

A

adequate and well controlled studies have failed to demonstrate a risk to the fetus in the first trimester and no evidence of risk in later trimesters

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23
Q

explain a category B risk

A

animal reporduction studies have failed to deomonstrate a risk to the fetus and there are NO ADEQUATE STUDIES IN PREGNANT WOMEN

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24
Q

explain a category C risk

A

animal reproductive studies have shown an adverse effect on the fetus and there are no studies in humans, BUT POTENTIAL BENEFITS MAY WARRANT USE OF THE DRUG IN PREGANT WOMEN DESPITE THE POTENTIAL RISK

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25
Q

explain a category D risk

A

no evidence of fetal risk based on adverse drug data from investigational or marketing experience or studies in humans, BUT potential benefits may warrant risk

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26
Q

explain a category X risk

A

studies in animals OR humans have demonstrated fetal abnormalities and/or evidence of human risk based on adverse drug reaction data from investigational or marketing experience, and the risks for the mother CLEARLY OUTWEIGH benefits

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27
Q

explain the CURRENT FDA pregancy labeling rule

A

eliminates letter risks
separates sections for PREGNANCY and for LACTATION
if available, contact information for a pregnancy registry is provided

28
Q

paraphrase the “standard statement” current FDA pregnancy and lactation labeling rule

A

all pregnancies have a background risk of birth defects, loss, or other adverse outcomes regardless of drug exposure. the fetal statement risk below describes x’s potential to increase the risk above the background risk

29
Q

each section of the label for pregnancy must contain which 3 core elements

A

-risk summary – probability of adverse outcome
-clinical considerations - info for prescribing and consequences of not treating mother’s condition
-data – detailed discussion of clinical trials and studies

30
Q

what is put in the “risk summary” category if only animal data is available?

A

risk is categorized as none, low, moderate, high, or unknown. does not give a specific probability

31
Q

do the FDA rules for pregnancy labeling apply to OTC products or only RX?

A

only RX

32
Q

TRUE OR FALSE

the labeling for the lactation section follows the same format as the pregnancy section

A

TRUE – risk, clinical considerations, and data

33
Q

in the lactation section, what information must be stated?

A

-amt of drug in breast milk and the potential effect on the infant
-ways to minimize exposure to the infant

34
Q

if the drug is undetectable in the breast milk and doesnt affect the quantity or quality of it nor does it adversely affect the breastfed child, what does the label state?

A

the use of “x” is compatible with breastfeeding

35
Q

WHEN NECESSARY, what additional info must be included

A

-potential for infertility
-need for pregancy testing or contraception when on the medication

36
Q

true or false

jardiance is not recommended during the 1st and 2nd trimesters of pregnancy

A

false – 2nd and 3rd

37
Q

true or false

we should avoid using drugs in nursing women, if possible

A

true

38
Q

if medications are essential in a nursing mother, what 4 rules should you follow?

A

-if the med is safe for use in infant it can be administered to mom

-choose a drug not excreted into breast milk

-alter time of drug regiment to allow nursing before taking the med and/or allow large amts of time between meds and nursing

-if mother must discontinue nursing in order to take med,breast milk can be extracted and stored to be used during the treatment period

39
Q

name 2 textbooks for pregnancy and lactation resources

A

Briggs – drugs on pregancy and lactation(updated quarterly)
Shepard – catalog of Teratogenic agents

40
Q

name 2 databases for pregnancy and lactation resources

A

TERIS (teratogen info system) – online version of Shepard book

LactMed

41
Q

besides the 2 textbooks and 2 databases mentioned, name 4 other sources for pregnancy and lactation

A

journals/case reports
motherrisk – a website/hotline
FDA reports/drug manufacturers
LexiComp

42
Q

explain how children differ from adults in regards to medication

A

pharmacokinetic/pharmodynamic differences
dosing
appropriate formulations
administration devices
counseling parents
importance of clinical presentation

43
Q

explain why clinical presentation is an important medication consideration in regards to pediatrics

A

children can’t talk or describe their symptoms – so we should be familiar with clinical presentation for common pediatric disordered like sepsis/meningits, RSV, otitis media

44
Q

why are dosing strategies different in children than adults?

A

ADME varies with age, and body composition changes with age

45
Q

explain how children’s body composition differs from adults

A

as you get older, fat content increases, water content decreases

46
Q

what does clearance mean? how does it change with age?

A

ability of the body to clear a drug

2 months-12 years – clearance is higher than average adult

47
Q

dosing in children <12 years is a function of ____, ____, or both

A

age, body weight, or both

48
Q

dosing in children is PREDOMINANTLY ___ based

A

weight

49
Q

as a general rule, weight based dosing should be used in children who weigh up to ______kg

A

40 kg

50
Q

if the weight based dosing exceeds the adult dose, what should you do?

A

use the adult dosing

51
Q

true or false

dose FREQUENCY in children may not be the same as in adults

A

true

52
Q

Give an example of how dosing is very different in children

A

amoxicillin – lot of different doses and size volumes available in liquid form

53
Q

true or false

certain medications should be avoided in children

A

true

54
Q

explain why certain medications should be avoided in children

A

Reye syndrome (sudden brain damage and liver function problems) has occurred with the use of aspirin to treat kids with chickenpox or flue. therefore, no longer recommended for children ESPECIALLY with flu or viral like symptoms

also, fluroquniolones (cipro) cause irreversible joint damage in pediatrics

55
Q

who publishes an article on preventing home medication administration errors in pediatrics?

A

American Academy of Pediatrics

56
Q

if available, what dosage forms should be used for children? what do you have to consider?

A

liquid solutions/suspensions or ODTs
most kids cant swallow tablets – may need to compound liquid formulation from tablets or capsules

57
Q

flavors can be added to pediatric medications to make them more tolerable.
name 2 suppliers of these flavorings

A

Flavor RX
Tasty meds

58
Q

what should you consider about pediatric inhalers?

A

may require spacers

59
Q

in a study, it was found that ____% of parents made at least 1 error in children’s medications
what can help to avoid this?

A

83.5%
pick the right size syringe for the dose and use pictograms (pictures) showing proper instructions
in the study, pictograms helped the parents to measure accurately

60
Q

for pediatric liquids, we should describe the dose in ___ not ____

A

mL not teaspoon or tablespoon

61
Q

if a parent wants to mix crushes tablet with yogurt, what should you counsel them on?

A

mix with only a spoonful to ensure complete administration

62
Q

true or false

it is okay for a parent to call a medication “candy” to get their kid to eat it

A

false

63
Q

name 2 laws that were about pediatric poison prevention

A

1970 – poison prevention act of 1970 – CHILD RESISTANT CLOSURES

2011 – OTC acetaminophen and RX liquids packaged with “flow restrictors”

64
Q

the “Healthy People 2030” goal is ____% reduction in ______

A

35% reduction in pediatric medication overdoses

65
Q

true or false

packaging tablets and capsules in blister packs can prevent pediatric overdoses

A

true

66
Q

what are 2 resources regarding safe medication use in pediatrics

A

american academy of pediatrics
ISMP (institute of safe medicine practices)

67
Q
A