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