WH Pharm

Question 1

In 2015, FDA replaced the ____ system of defining pregnancy risk with _____ _______ _______

Answer 1

category (A/B/C/D/X)

narrative risk summary

Question 2

define teratogen

Answer 2

a term used to denote the result of a hazard assessment on a particular agent

Question 3

teratogenic effect depends on six factors…can you name them?

Answer 3

physical/chem nature of drug
dose
duration
frequency
route of exposure
gestational timing

Question 4

What does ‘teratogen’ REALLY mean?

Answer 4

POTENTIAL
teratogenic potential

(it indicates a drug MAY have potential for producing developmental toxicity given appropriate conditions, as was observed with Thalidomide)

Question 5

What is the baseline risk for congenital defects?

Answer 5

baseline risk due to any cause 3-4% (1 in 28 babies)

Question 6

The extent to which drug will affect development of fetus depends on

Answer 6

Properties of drug,
dose,
route,
duration

Timing of exposure

Genetic composition and biologic susceptibility of mother and fetus (think about ETOH)

Question 7

Name two high risk teratogen drugs

Answer 7

thalidomide

isotretinoin (Vit A derivative)

Question 8

What is required of the female patient in order to be prescribed Isotretinoin?

Answer 8

She must agree to be on contraception

Question 9

What percentage of exposed pregnancies have adverse events due to HIGH RISK teratogenic drugs?

Answer 9

25%

Question 10

Name two moderate risk teratogenic drugs

Answer 10

carbamazepine

valproic acid

(often anti-epileptic drugs are moderate risk)

Question 11

what is the risk of adverse event for moderate risk teratogen drugs?

Answer 11

“5 to 20-fold increase rate”

Question 12

What must ALWAYS be addressed when considering pharmacological needs of female patients?

Answer 12

potential for conception

“We are ALWAYS in preconception planning”

Question 13

In weeks 1 & 2 gestation, during blastogenesis, what is likely result of teratogen?

Answer 13

embryo is destroyed, pregnancy is terminated

Question 14

In Days 18-60 gestation, during organogenesis, what is likely result of teratogen?

Answer 14

organ system abnormalities (heart or neural tube defects)

Question 15

> 60 days of growth and maturation of gestation, what is likely result of teratogen?

Answer 15

CNS abnormalities

“For remainder of pregnancy, exposure to teratogens may result in growth retardation, CNS abnormalities or, in extreme cases, death.”

Question 16

According to the Briggs “Bible” of drugs in pregnancy, what is the final word on quinolones?

Answer 16

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.”

Question 17

At what age should all women get osteoporosis screening? men?

Answer 17

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

Question 18

what is the primary screening tool for osteoporosis?

Answer 18

dexa scan

Question 19

suspect osteoporosis in adults >50 yrs old with BMD T-score ______ at ______

Answer 19

-2.5

at femoral neck, total hip, or lumbar spine

Question 20

list four pharmacologic agents used for treatment of osteoporosis

Answer 20

bisphosphonates (alendronate (Fosamax))
denosumab (Prolia)
raloxifene (Evista)
PTH and related peptide analogs

(Calcium and Vit D, supplement these if needed)

Question 21

what type of osteoporosis pt cannot use bisphosphonates?

Answer 21

those with low eGFR

use denosumab (Prolia)

Question 22

what type of osteoporosis pt should avoid Teriparatide?

Answer 22

those with elevated PTH

Question 23

normal DEXA scan range - standard deviation from young healthy is the T-score _____________

Answer 23

+/- 1 from 0

Question 24

OSTEOPENIA DEXA scan range - standard deviation from young healthy is the T-score _____________

Answer 24

1.0 - 2.5 standard deviations below 0

Question 25

OSTEOPOROSIS DEXA scan range - standard deviation from young healthy is the T-score _____________

Answer 25

2.5 or more below 0

Question 26

name four antiresorptive medications for the OP treatment of osteoporosis

Answer 26

bisphosphonates
denosumab
SERMs (tamoxifen, raloxifene)
estrogen

Question 27

name a SERM that is good for osteoporosis vertebral fracture

Answer 27

Raloxifene

Question 28

name an anabolic osteoporosis medication used to stimulate bone formation

Answer 28

teriparatide (Forteo) -

• it stimulates osteoblasts

Question 29

When it comes to bone strength/osteoporosis ~

Estrogen compounds are believed to have an osteoblast-_______ effect.
stimulating, inhibiting

Answer 29

stimulating.

Estrogen compounds are believed to have an osteoblast-stimulating effect.

When the amt of estrogen in blood falls to very low levels after menopause, the balance b/w bone-building of osteoblasts and bone-degrading activity of osteoclasts tips toward bone degradation.

Question 30

three drug classifications that affect the autonomic nervous system and affect uterine contractility (which is clinically most important in third trimester of pregnancy)

Answer 30

• muscarinic agonists
  - they stimulate contraction
• alpha agonists
  - they also stimulate contraction
• beta 2
  - they cause relaxation of the uterus

Question 31

what effect do calcium channel blockers have on uterine contractibility

Answer 31

uterine muscle relaxation (special caution for late trimester, near delivery time)

Question 32

after L&D, what three medication neonatal effects are commonly observed?

Answer 32

kernicterus
(can be observed with TMP/SMX and phenytoin)

resp depression
(often seen with benzos, opioids)

withdrawal
(ilicit drugs, antidepressants)

Question 33

prescribing and pregnancy -

what should be done for pts who may become pregnant?

Answer 33

pts should be screened for problematic prescriptions and OTC medications
make changes in advance of pregnancy, plan for accidental pregnancy

Question 34

how much alcohol is safe during pregnancy?

Answer 34

none.

no safe time
no safe amount

Question 35

What changes in pregnancy affect drug clearance?

Answer 35

cardiac output and volume of distribution

Question 36

In terms of medical management of pregnant patient, what is the most common consequence of changes in maternal physiology?

Answer 36

a decrease in total serum drug concentrations, due to increased Volume of Distribution (Vd)

Question 37

how to dose meds for pregnant patients:

Answer 37

start at lower end of usual adult dose range, titrate up based on monitoring (often ends up at the higher end of dose range)

Question 38

treatments for pregnant pts for

nausea/vomiting

Answer 38

first - nonpharm like spacing meals, avoiding triggers, ginger

second - vitamins, antihistamines

third - dopamine antagonist (metoclopramide)

fourth - serotonin antagonist (ondansetron) or corticosteroids (methylprednisolone, dexamethasone, prednisolone)