Teratogenesis, Pregnancy and Postpartum Issues Exam 3 Flashcards
Pre-embryonic stage teratogenic effects
- 0-14 days after fertilization
- exposure to a teratogen during this time usually produces an all or nothing effect.
Embryonic stage teratogenic effects
- 14 – 56 days after fertilization and period when organogenesis occurs.
- the embryo is most susceptible to the effects of teratogens.
- exposure may result in major structural anomalies.
Fetal stage teratogenic effects
- 57 days post-fertilization until term. Histogenesis and functional maturation occur.
- minor structural changes are possible during this time, but anomalies are more likely to involve growth and functional aspects.
Pregnancy Risk Categories: A
- Controlled studies show no risk.
- Adequate, well-controlled studies in pregnant women fail to demonstrate risk.
Pregnancy Risk Categories: B
- No evidence of risk in humans.
- Either animal-reproduction studies have not shown a fetal risk but there are no controlled studies in pregnant women OR animal reproduction studies have shown risk that was not confirmed in well-controlled
Pregnancy Risk Categories: C
- Risk cannot be ruled out.
- Either animal studies have shown harm to fetus and there are no controlled studies in women OR no human or animal studies are available.
Pregnancy Risk Categories: D
- Positive evidence of risk.
- Positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.
Pregnancy Risk Categories: X
- Contraindicated in pregnancy.
- Studies in animals or humans have demonstrated fetal abnormalities, OR there is evidence of fetal risk based on human experience OR both
- the risk of use of the drug in pregnant women clearly outweighs any possible benefit.
System for Thalidomide Education and Prescribing Safety (STEPS)
- Mandatory risk management program to reduce risk of pregnancy in those taking thalidomide
- Registration of all prescribers, patients, and pharmacies who prescribe, receive, and dispense thalidomide
- Patients must sign informed consent and complete a telephone survey
- Prescription must be filled within 7 days of the date written and no more than a 4-week supply can be dispensed at one time
- All patients are required to use contraceptive measures. Men must wear condoms because thalidomide may be present in sperm.
- Females must have a negative pregnancy test within 24 hours prior to starting therapy and monthly during treatment
iPLEDGE Program
- Mandatory computer-based risk management program for all isotretinoin products
- Requires all patients, prescribers, pharmacists, and wholesale distributors to register
- Patients must complete informed consent, pick up within (30 days for men and women who cannot get pregnant; 7 days for women of childbearing potential), not donate blood for one month after discontinuing, and not share medication with anyone
- Females of childbearing potential must have 2 negative preg tests before starting, negative preg test every month during treatment, receive counseling every month, use 2 forms of contraception, and fill prescription within 7 days of office visit
- Pharmacy must register with iPLEDGE, receive authorization from iPLEDGE for each prescription prior dispensing, write on prescription bag “Do not dispense after (expiration date)”, give medication guide with each prescription, and dispense only a 30day supply
What is the prenatal recommendation for multivitamin?
- should be taken daily
* to ensure proper nutritional requirements for fetal growth
What is the prenatal recommendation for iron?
- Requirements increase during pregnancy
* 27 mg/day
What can happen without sufficient amount of iron?
- anemia during infancy
- spontaneous abortion
- premature delivery
- delivery of a low-birth weight infant
What kind of supplements should a patient be on during pregnancy?
- multivitamin
- iron
- foalte
- calcium
- VitD
What is the prenatal recommendation for folate?
- all women of childbearing age should consume 0.4-0.9 mg of folic acid daily
- during pregnancy: recommendation is 0.6 mg/day
What can happen without sufficient amount of folate?
infant neural tube defects (NTDs)
What is the prenatal recommendation for Calcium / VitD?
1000 mg of calcium and 600 IU of vitamin D daily
What can happen without sufficient amount of calcium?
increase risk of hypertensive complications, including pre-eclampsia
What can happen without sufficient amount of calcium and vitD?
improper fetal skeletal development and organization