WH Pharm Flashcards
In 2015, FDA replaced the ____ system of defining pregnancy risk with _____ _______ _______
category (A/B/C/D/X)
narrative risk summary
define teratogen
a term used to denote the result of a hazard assessment on a particular agent
teratogenic effect depends on six factors…can you name them?
physical/chem nature of drug dose duration frequency route of exposure gestational timing
What does ‘teratogen’ REALLY mean?
POTENTIAL
teratogenic potential
(it indicates a drug MAY have potential for producing developmental toxicity given appropriate conditions, as was observed with Thalidomide)
What is the baseline risk for congenital defects?
baseline risk due to any cause 3-4% (1 in 28 babies)
The extent to which drug will affect development of fetus depends on
Properties of drug,
dose,
route,
duration
Timing of exposure
Genetic composition and biologic susceptibility of mother and fetus (think about ETOH)
Name two high risk teratogen drugs
thalidomide
isotretinoin (Vit A derivative)
What is required of the female patient in order to be prescribed Isotretinoin?
She must agree to be on contraception
What percentage of exposed pregnancies have adverse events due to HIGH RISK teratogenic drugs?
25%
Name two moderate risk teratogenic drugs
carbamazepine
valproic acid
(often anti-epileptic drugs are moderate risk)
what is the risk of adverse event for moderate risk teratogen drugs?
“5 to 20-fold increase rate”
What must ALWAYS be addressed when considering pharmacological needs of female patients?
potential for conception
“We are ALWAYS in preconception planning”
In weeks 1 & 2 gestation, during blastogenesis, what is likely result of teratogen?
embryo is destroyed, pregnancy is terminated
In Days 18-60 gestation, during organogenesis, what is likely result of teratogen?
organ system abnormalities (heart or neural tube defects)
> 60 days of growth and maturation of gestation, what is likely result of teratogen?
CNS abnormalities
“For remainder of pregnancy, exposure to teratogens may result in growth retardation, CNS abnormalities or, in extreme cases, death.”
According to the Briggs “Bible” of drugs in pregnancy, what is the final word on quinolones?
use with caution, and only if no other option is available
“Briggs: Most would still say due to these concerns and animal data, quinolones should be used cautiously during pregnancy, especially during the first trimester.”
At what age should all women get osteoporosis screening? men?
all women >65 y/o
men >70 y/o
***** also ~
women 50-64 with risk factors
pts on steroids or anti-estrogen/anti-testosterone treatment
what is the primary screening tool for osteoporosis?
dexa scan
suspect osteoporosis in adults >50 yrs old with BMD T-score ______ at ______
-2.5
at femoral neck, total hip, or lumbar spine
list four pharmacologic agents used for treatment of osteoporosis
bisphosphonates (alendronate (Fosamax))
denosumab (Prolia)
raloxifene (Evista)
PTH and related peptide analogs
(Calcium and Vit D, supplement these if needed)
what type of osteoporosis pt cannot use bisphosphonates?
those with low eGFR
use denosumab (Prolia)
what type of osteoporosis pt should avoid Teriparatide?
those with elevated PTH
normal DEXA scan range - standard deviation from young healthy is the T-score _____________
+/- 1 from 0
OSTEOPENIA DEXA scan range - standard deviation from young healthy is the T-score _____________
1.0 - 2.5 standard deviations below 0
