Medication Exposure in Pregnancy Risk Evaluation Program

2009, FDA's new program to increase healthcare professionals' knowledge of drug risks during pregnancy

Pregnancy brings on the physiolgic changes in the

kidneys, liver and gastrointestinal tract(thus a compensatory change)

During pregnancy, the tone and motility of the bowel

decreases (allowing more drugs to be absorbed)

The cliniciian should assume that

any drug taken will reach the fetus

the development of birthdefects

produced by exposure to teratogens during embryonic period

exposure during the fetal period usually

disrupts FUNCTION rater than gross anatomy

It is important to note that lack of proof of teratogenicity

does not mean that a drug is safe

in 1983, the FDA established a system for classifying drugs according to their probable risk categories:

ABCD and X (A is the least dangerous)

The new proposed system under FDA will have three sections:

1.)Fetal risk summary, 2.) Clinical Considerations. 3.) Data

will describe what is known about a drugs' effects on the fetus and will offer a conclusion on safety during pregancy

Clinical Considerations

describe the likely effects if a drug is taken before a woman knows that she is pregnant.

will detail the evidence from human and animal studies that supports the information in the fetal risk summary

Any woman of reproductive age who takes a known teratogen must be

counseled about the risk and necessity of using at least one form of birth control

Drugs that do not enter breast milk are

ionized, polar, and protein bound

Although most drugs can de detected in milk

concentrations are usually too low to harm the nursing

Steps 1-3 taken to minimize the risk to the infant

1.) dosing immediately AFTER feeding 2.) avoiding drugs that have a long half life 3.) avoiding sustained release formulations

Steps 4-7 taken to minimize the risk to infant

4.) choosing drugs that tend to be excluded from milk 5.) choosing drugs that are least likely to effect infant 6.) avoiding hazardous 7.) using lowest EDfor shortest time

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Chapter 9 pharmacolo

drug therapy during pregnancy and breast feeding

Question	Answer
About 2/3 of pregnant women	take at least one medication
Medication Exposure in Pregnancy Risk Evaluation Program	2009, FDA's new program to increase healthcare professionals' knowledge of drug risks during pregnancy
Pregnancy brings on the physiolgic changes in the	kidneys, liver and gastrointestinal tract(thus a compensatory change)
During pregnancy, the tone and motility of the bowel	decreases (allowing more drugs to be absorbed)
True of False: more time is available for reabsorption of drugs that undergo enterohepatic recirculation. Therefore the effects are prolonged	true
Essentially all drugs can	cross the placenta
The cliniciian should assume that	any drug taken will reach the fetus
lipid soluble drugs cross the placenta readily, while drugs that are _______ have more difficulty	ionized, polar, protein bound
teratogenesis	the development of birthdefects
Gross malformations	produced by exposure to teratogens during embryonic period
exposure during the fetal period usually	disrupts FUNCTION rater than gross anatomy
It is important to note that lack of proof of teratogenicity	does not mean that a drug is safe
in 1983, the FDA established a system for classifying drugs according to their probable risk categories:	ABCD and X (A is the least dangerous)
The new proposed system under FDA will have three sections:	1.)Fetal risk summary, 2.) Clinical Considerations. 3.) Data
Fetal Risk Summary	will describe what is known about a drugs' effects on the fetus and will offer a conclusion on safety during pregancy
Clinical Considerations	describe the likely effects if a drug is taken before a woman knows that she is pregnant.
Data	will detail the evidence from human and animal studies that supports the information in the fetal risk summary
Any woman of reproductive age who takes a known teratogen must be	counseled about the risk and necessity of using at least one form of birth control
Drugs that are lipid soluble readily	enter breast milk
Drugs that do not enter breast milk are	ionized, polar, and protein bound
Although most drugs can de detected in milk	concentrations are usually too low to harm the nursing
Steps 1-3 taken to minimize the risk to the infant	1.) dosing immediately AFTER feeding 2.) avoiding drugs that have a long half life 3.) avoiding sustained release formulations
Steps 4-7 taken to minimize the risk to infant	4.) choosing drugs that tend to be excluded from milk 5.) choosing drugs that are least likely to effect infant 6.) avoiding hazardous 7.) using lowest EDfor shortest time

Created by: Hoopster

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