Study Set Content:
Zolpidem (Ambien)
SCHEDULE IV
Tramadol
SCHEDULE IV
Barbiturates (Short acting)
SCHEDULE III
Difenoxin
SCHEDULE IV
Conventions in avoiding ambiguity
Careful use of
decimal point
Directions in
full english
Directions should be
specific
Use of
permanent ink
Avoid units such as
tsp/tbsp
Writing out numbers as
words
Use of
apothecary units
degree symbol
The FDA has established five categories to indicate the
potential of a drug to cause birth defects if used during
pregnancy.
FDA PREGNANCY CATEGORIES
The categories are determined by the
reliability of documentation and the
risk to benefit ratio
Adequate and well-controlled studies have failed
to demonstrate a risk to the fetus in the first
trimester of pregnancy (and there is no evidence
of risk in later trimesters)
CATEGORY A
Animal reproduction studies have shown an
adverse effect on the fetus and there are no
adequate and well-controlled studies in humans,
but potential benefits may warrant use of the drug
in pregnant women despite potential risks.
CATEGORY C
Animal reproduction studies have failed to
demonstrate a risk to the fetus and there are no
adequate and well-controlled studies in pregnant
women.
CATEGORY B
There is positive evidence of human fetal risk
based on adverse reaction data from
investigational or marketing experience or studies
in humans, but potential benefits may warrant use
of the drug in pregnant women despite potential
risks.
CATEGORY D
Studies in animals or humans have demonstrated
fetal abnormalities and/or here is positive
evidence of human fetal risk based on adverse
reaction data from investigational or marketing
experience, and the risks involved in use of the
drug in pregnant women clearly outweigh
potential benefits.
CATEGORY X
Levothyroxine
CATEGORY A
Folic acid
CATEGORY A
