Drug Use in Pregnancy & Lactation Flashcards
What lab result determines pregnancy?
A positive human chorionic gonadotropin (hCG+) lab result confirms pregnancy
What typically happens during the first trimester?
The first trimester (0-12 weeks) is when most organ development occurs, making the embryo most susceptible to birth defects caused by teratogens during this time
What should be done to teratogenic drugs?
For a drug to be teratogenic, the drug has to cross placenta into the fetal circulation. Teratogenic drugs should be discontinued prior to pregnancy, if possible
What organization publishes guidelines for safe and effective drug use in conditions impacting women, including pregnancy?
The American College of Obstetricians and Gynecologists (ACOG)
What are some lifestyle management strategies to recommend to pregnant women?
This includes encouragement to stop using illicit drugs, alcohol and tobacco, each of which is teratogenic. Behavioral intervention is a safe and sometimes effective strategy for prenatal smoking cessation
What can folate deficiency cause?
Folate deficiency causes birth defects of the brain and spinal cord (neural tube defects)
What is the recommended folate requirement during pregnancy?
During pregnancy, folate requirements increase to 600 mcg DFE/day. Females of childbearing potential should increase their folic acid consumption from a combination of dietary supplements, fortified foods and their regular diet
What is the dangers of vitamin deficiency?
If deficient in calcium, the mother’s bone health will be sacrificed to provide for the baby
What is the calcium and vitamin D requirement for pregnant women?
Pregnant women from 19-50 years old require 1000 mg/day of calcium and 15 mcg/day (600 IU/day) of vitamin D
What is the interpretation of pregnancy category A?
Controlled studies in animals & women show no risk in the first trimester. Risk of fetal harm is remote
What is the interpretation of pregnancy category B?
Animal studies have not demonstrated a fetal risk, but no well-controlled studies are available in pregnant women
What is the interpretation of pregnancy category C?
Animal studies have shown harm to the fetus, but there are no well-controlled studies in pregnant women. Use only if potential benefit outweighs the risk
What is the interpretation of pregnancy category D?
Positive evidence of risk to the human fetus is available, but the benefits may outweigh the risk with life-threatening or serious diseases
What is the interpretation of pregnancy category X?
Studies in animals or humans show fetal abnormalities. The risks involved clearly outweigh potential benefits; use in pregnancy is contraindicated
What is required for the pregnancy section in package inserts?
A pregnancy risk summary is required for all medications that includes the risk of adverse developmental outcomes based on human and animal data and the drug’s pharmacology. Includes any dose adjustments, maternal/fetal adverse reactions and disease risks
Why should pregnant women be encouraged to participate in registries?
Pregnant women should be encouraged to participate in registries, which exist for select disease states and drugs. The registries collect health information from women who take prescription drugs and vaccines when pregnant and breastfeeding. Information is also collected on the newborn baby
What does the lactation section in package inserts include?
Includes whether the drug/metabolites are present in human milk, the effects on the breastfed infant, and the effects on milk production. If applicable, ways to minimize exposure and monitor for adverse reactions are included
What does the females & males of reproductive potential in package inserts include?
Includes any effects on fertility and requirements for pregnancy testing and contraception
What are the two immunizations are routinely recommended for pregnant patients?
The inactivated influenza vaccine is recommended during any trimester at the beginning of flu season. A single dose of Tdap should be administered during each pregnancy.
*All live vaccines are contraindicated in pregnant patients
What are key drugs that are teratogenic?
- Acne: isotretinoin, topical retinoids
- Antibiotics: quinolones, tetracyclines
- Anticoagulants: Warfarin
- Dyslipidemia, Heart Failure and HTN: Statins, RASS inhibitors
- Hormones: Most, including estradiol, progesterone, raloxifene, Duavee, testosterone, contraceptivees
- Migraine: dihydroergotamine, ergotamine
- Others: Hydroxyurea, Lithium, Methotrexate, Misoprostol, NSAIDs, Paroxetine, Ribavarin, Thalidomide, Topiramate, Weight Loss drugs, Valproic Acid/Divalproex
What does USP Chapter 800 say about teratogens?
Teratogens are hazardous drugs according to USP Chapter 800, and require special handling to avoid risk to healthcare workers
What is an example of a reputable, up-to-date resource for prescribing/dispensing to pregnant women?
Briggs’ Drugs in Pregnancy and Lactation
What is preeclampsia?
Preeclampsia is a complication of pregnancy that presents with elevated blood pressure and evidence of organ damage, most often to the kidneys or liver
When does preeclampsia present?
It usually presents after the first trimester of pregnancy and can occur in women with previously normal blood pressure
What happens when preeclampsia is not treated?
If not treated, preeclampsia can progress to eclampsia, which can lead to seizures and death
What is the only cure for preeclampsia?
The only cure for preeclampsia is delivery of the baby
What does the ACOG and ADA guideline recommend to prevent preeclampsia?
Recommends adding daily low-dose aspirin at the end of the first trimester for pregnant women at risk for preeclampsia (e.g. type 1 or 2 diabetes, renal disease, history of preeclampsia, chronic hypertension)