Precautionary Drugs & Monitored Laboratory Parameters

Question 1

The food and drug administration (FDA)

Answer 1

federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices

Question 2

risk factors

Answer 2

in 1979, the FDA established 5 letter risk categories to indicate the potential of a drug to cause birth defects if used during pregnancy

Question 3

risk evaluation and mitigation strategies (REMS)

Answer 3

a risk evaluation and mitigation strategy (REMS) is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks

Question 4

A

Answer 4

human studies did not show a risk to the developing fetus in pregnancy

Question 5

B

Answer 5

animal studies did not show a risk to the developing fetus in pregnancy, but there are no studies done in pregnant women

Question 6

C

Answer 6

animal studies did show a risk to the developing fetus in pregnancy but there are no studies done in pregnant women. Medicine should be given if the potential benefits justifies the potential risk to the fetus

Question 7

D

Answer 7

human studies did show harmful effects on the developing fetus but the benefits from use in pregnant women may be acceptable despite the risk (example: the medicine is used in a life threatening or serious illness)

Question 8

X

Answer 8

both human and animal studies show serious harmful effects on the developing fetus. the medicine is strictly prohibited in pregnancy. pharmacy technicians compounding a category X drug must: use hazardous drug (HD) or disposable equipment; double glove; make the compound using a powder containment hood

Question 9

isotretinoin

Answer 9

pregnancy test (MUST be completed before we fill their prescription - we use the iPLEDGE REMs program to verify that they have completed all required steps)

Question 10

clozaril (clozapine)

Answer 10

ANC: absolute neutrophil count
-a blood test that measures the amount of neutrophil granulocytes present in the blood. Neutrophils are the white blood cells that fight infection.

Question 11

coumadin (warfarin)

Answer 11

INR: international normalized ratio

- a blood test that checks how long it takes your blood to clot