Audit Pregnancy Medication Safety

---
name: audit-pregnancy-medication-safety
description: Use when reviewing medication safety during pregnancy — e.g., "is ibuprofen safe in pregnancy", "can I take antidepressants while pregnant", "medications to avoid pregnancy", "OTC drugs safe during pregnancy"
source: ACOG Medication Safety in Pregnancy 2021; FDA Pregnancy Labeling Rule 2015 (PLLR); LactMed/TERIS database; Briggs Drugs in Pregnancy and Lactation 12th ed. 2021
tags: [pregnancy, medications, drug-safety, teratology, pharmacology, health]
verified: true
---

# Audit Pregnancy Medication Safety

Systematically review medications for fetal safety using established risk categories and evidence sources.

## Why This Is Best Practice

**Adopted by:** FDA (PLLR 2015), ACOG, TERIS — the FDA replaced A/B/C/D/X categories with narrative PLLR labels in 2015 for prescription drugs; OTC drugs still commonly referenced by old categories.
**Impact:** 90% of pregnant women take at least one medication during pregnancy (CDC 2012). Drug-related congenital anomalies account for ~1% of birth defects — most preventable with proper review (ACOG 2021). Conversely, undertreating serious conditions (epilepsy, depression, hypertension) causes greater harm than most medications.
**Why best:** No drug is proven completely safe in pregnancy. Structured review weighs teratogenic risk against the risk of untreated disease.

## Steps

1. **Collect all medications:** prescription, OTC, supplements, herbals — at every prenatal visit.
2. **Apply ACOG's risk-benefit framework:**
   - Risk of untreated maternal condition to fetus and mother
   - Risk of the medication to the fetus
   - Availability of safer alternatives
3. **Established safe options (use as first line):**
   - Analgesia: acetaminophen (avoid NSAIDs — see rules)
   - Nausea: doxylamine + B6 (Diclegis/Bonjesta); ginger; ondansetron (second line)
   - Heartburn: calcium carbonate antacids; famotidine; omeprazole (second trimester onward)
   - Allergy: loratadine, cetirizine (avoid first-trimester diphenhydramine)
   - Antibiotics: amoxicillin, azithromycin, cephalexin; avoid fluoroquinolones, tetracyclines
4. **Avoid — evidence of harm:**
   - **NSAIDs (ibuprofen, naproxen):** avoid after 20 weeks — cause fetal renal dysfunction and premature ductal closure
   - **ACE inhibitors / ARBs:** avoid all trimesters — renal dysgenesis, fetopathy
   - **Isotretinoin (Accutane):** absolutely contraindicated — causes severe fetal malformations; requires negative pregnancy test monthly
   - **Warfarin:** avoid first trimester and near delivery; use heparin/LMWH instead
   - **Valproate:** highest teratogenicity of all antiepileptics; neural tube defects 1–2%; avoid if possible
   - **Methotrexate, misoprostol (therapeutic doses), thalidomide:** absolutely contraindicated
5. **Check before prescribing:** use TERIS (teratogen database) or LactMed for evidence-based risk data.
6. **Document decisions** including risk-benefit rationale in chart.

## Rules

- No aspirin >100 mg/day after 36 weeks (except prescribed low-dose protocol).
- Herbal supplements are not "safe because natural" — valerian, blue cohosh, pennyroyal have documented pregnancy risks.
- Most antiepileptic drugs require specialist review; do not switch or stop without neurology input — seizure risk may outweigh drug teratogenicity.

## Examples

**Migraine patient (first trimester):** Acetaminophen 500–1,000 mg; avoid triptans in first trimester; avoid NSAIDs entirely; discuss with neurologist.
**Chronic hypertension on lisinopril:** Switch to labetalol or nifedipine immediately — ACE inhibitors cause fetal renal failure.

## Common Mistakes

- Assuming all OTC drugs are safe — ibuprofen is OTC and causes significant fetal harm after 20 weeks.
- Stopping psychiatric medication abruptly — untreated severe depression/anxiety causes more harm than SSRIs.
- Not checking supplements — fish oil in excess, vitamin A (retinol >10,000 IU), and licorice root are all harmful in pregnancy.

> **Health Disclaimer:** This skill provides reference guidance only and is not medical advice. Every medication decision in pregnancy requires individualized assessment by a licensed healthcare provider who can weigh your specific medical history, gestational age, and risk factors.