Population-Specific Considerations in Drug therapy (part 1) Flashcards
name the “special” populations
racial and ethnic minorities
trans and gender diverse
rural americans
people w limited english proficiency
veterans
pediatrics
geriatrics
define teratogen
an agent that is present during critical periods of development and is able to produce a congenital (birth) defect
true or false
teratogens always affect the maternal organism to some extent
FALSE – may not affect the mom
A teratogen’s susceptibility to the embryo depends on what?
the development stage of the embryo
agents (teratogens) that may cause malformations may also increase embryonic ______
mortality
define congenital defect
the major and minor malformations either in STRUCTURE or FUNCTION that deviate from the norm
how long is the 1st trimester
from 0-12 weeks
week _____-_____ fetus is most vulnerable to birth defects
3-8
as mentioned, weeks 3-8 fetus is most vulnerable to birth defects.
what can you say about drugs taken AFTER THE ORGANS ARE FORMED?
they may not cause defects, but they may alter the GROWTH and FUNCTION of the organs
at which week do the kidneys begin to function and almost all organs are completely formed
week 10
week 5 – development of _____
week 6 — development of ___ and ____
week 5 – development of neural tube
week 6 – development of heart and major blood vessels
week 7 – development of ____
week 9 –
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
what weeks are the second trimester
weeks 13-24
what weeks are the 3rd trimester
week 25-delivery
at what week can the fetus hear
week 14 – (2nd trimester)
at what week is the placenta fully formed
week 20
at what week does the fetus have a chance of survival outside the uterus
week 24
at what week can the fingers grasp, body begins to fill as fat is deposited under the skin, and eyebrows and eyelashes are present
week 16
what is happening at week 25
lungs continue to mature
delivery is ___ -____ weeks
37-42
how did the FDA used to categorize the risk of drugs for pregancy?
by letters – category A-D, and X
what is a category A risk
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
explain a category B risk
animal reporduction studies have failed to deomonstrate a risk to the fetus and there are NO ADEQUATE STUDIES IN PREGNANT WOMEN
explain a category C risk
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
explain a category D risk
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
explain a category X risk
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
explain the CURRENT FDA pregancy labeling rule
eliminates letter risks
separates sections for PREGNANCY and for LACTATION
if available, contact information for a pregnancy registry is provided
paraphrase the “standard statement” current FDA pregnancy and lactation labeling rule
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
each section of the label for pregnancy must contain which 3 core elements
-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
what is put in the “risk summary” category if only animal data is available?
risk is categorized as none, low, moderate, high, or unknown. does not give a specific probability
do the FDA rules for pregnancy labeling apply to OTC products or only RX?
only RX
TRUE OR FALSE
the labeling for the lactation section follows the same format as the pregnancy section
TRUE – risk, clinical considerations, and data
in the lactation section, what information must be stated?
-amt of drug in breast milk and the potential effect on the infant
-ways to minimize exposure to the infant
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?
the use of “x” is compatible with breastfeeding
WHEN NECESSARY, what additional info must be included
-potential for infertility
-need for pregancy testing or contraception when on the medication
true or false
jardiance is not recommended during the 1st and 2nd trimesters of pregnancy
false – 2nd and 3rd
true or false
we should avoid using drugs in nursing women, if possible
true
if medications are essential in a nursing mother, what 4 rules should you follow?
-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
name 2 textbooks for pregnancy and lactation resources
Briggs – drugs on pregancy and lactation(updated quarterly)
Shepard – catalog of Teratogenic agents
name 2 databases for pregnancy and lactation resources
TERIS (teratogen info system) – online version of Shepard book
LactMed
besides the 2 textbooks and 2 databases mentioned, name 4 other sources for pregnancy and lactation
journals/case reports
motherrisk – a website/hotline
FDA reports/drug manufacturers
LexiComp
explain how children differ from adults in regards to medication
pharmacokinetic/pharmodynamic differences
dosing
appropriate formulations
administration devices
counseling parents
importance of clinical presentation
explain why clinical presentation is an important medication consideration in regards to pediatrics
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
why are dosing strategies different in children than adults?
ADME varies with age, and body composition changes with age
explain how children’s body composition differs from adults
as you get older, fat content increases, water content decreases
what does clearance mean? how does it change with age?
ability of the body to clear a drug
2 months-12 years – clearance is higher than average adult
dosing in children <12 years is a function of ____, ____, or both
age, body weight, or both
dosing in children is PREDOMINANTLY ___ based
weight
as a general rule, weight based dosing should be used in children who weigh up to ______kg
40 kg
if the weight based dosing exceeds the adult dose, what should you do?
use the adult dosing
true or false
dose FREQUENCY in children may not be the same as in adults
true
Give an example of how dosing is very different in children
amoxicillin – lot of different doses and size volumes available in liquid form
true or false
certain medications should be avoided in children
true
explain why certain medications should be avoided in children
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
who publishes an article on preventing home medication administration errors in pediatrics?
American Academy of Pediatrics
if available, what dosage forms should be used for children? what do you have to consider?
liquid solutions/suspensions or ODTs
most kids cant swallow tablets – may need to compound liquid formulation from tablets or capsules
flavors can be added to pediatric medications to make them more tolerable.
name 2 suppliers of these flavorings
Flavor RX
Tasty meds
what should you consider about pediatric inhalers?
may require spacers
in a study, it was found that ____% of parents made at least 1 error in children’s medications
what can help to avoid this?
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
for pediatric liquids, we should describe the dose in ___ not ____
mL not teaspoon or tablespoon
if a parent wants to mix crushes tablet with yogurt, what should you counsel them on?
mix with only a spoonful to ensure complete administration
true or false
it is okay for a parent to call a medication “candy” to get their kid to eat it
false
name 2 laws that were about pediatric poison prevention
1970 – poison prevention act of 1970 – CHILD RESISTANT CLOSURES
2011 – OTC acetaminophen and RX liquids packaged with “flow restrictors”
the “Healthy People 2030” goal is ____% reduction in ______
35% reduction in pediatric medication overdoses
true or false
packaging tablets and capsules in blister packs can prevent pediatric overdoses
true
what are 2 resources regarding safe medication use in pediatrics
american academy of pediatrics
ISMP (institute of safe medicine practices)
