Introduction: This quiz set covers key concepts on prescribing during pregnancy, lactation and in patients with organ (renal and hepatic) failure, tailored for M.Pharm students studying Principles of Quality Use of Medicines. It emphasizes pharmacokinetic and pharmacodynamic changes in pregnancy, teratogenic risks, safe and contraindicated medicines in pregnancy and breastfeeding, mechanisms determining drug transfer into milk, and practical dose adjustment strategies for renal and hepatic impairment. Each question targets clinical decision-making, regulatory frameworks and specific drug examples you will encounter in practice, helping consolidate knowledge required for safe, evidence‑based medication use in these high‑risk populations.
Q1. Which pharmacokinetic change is most consistently observed during pregnancy and often necessitates dose adjustment of renally cleared drugs?
- Decreased hepatic blood flow
- Increased glomerular filtration rate (GFR)
- Decreased total body water
- Increased plasma albumin concentration
Correct Answer: Increased glomerular filtration rate (GFR)
Q2. Which regulatory labeling system replaced the FDA pregnancy letter categories (A, B, C, D, X) to provide narrative risk summaries for pregnant and lactating women?
- European Pregnancy Score (EPS)
- Pregnancy and Lactation Labeling Rule (PLLR)
- Teratogenicity Alphabet System (TAS)
- Maternal-Fetal Risk Index (MFRI)
Correct Answer: Pregnancy and Lactation Labeling Rule (PLLR)
Q3. Which anticonvulsant is most strongly associated with an elevated risk of neural tube defects and cognitive impairment when used in pregnancy?
- Carbamazepine
- Lamotrigine
- Valproate (valproic acid)
- Levetiracetam
Correct Answer: Valproate (valproic acid)
Q4. For long‑term anticoagulation in pregnancy, which agent is generally preferred because it does not cross the placenta?
- Warfarin
- Low molecular weight heparin (LMWH)
- Rivaroxaban
- Dabigatran
Correct Answer: Low molecular weight heparin (LMWH)
Q5. Exposure to ACE inhibitors during the second and third trimesters most often causes which fetal complication?
- Cleft palate
- Fetal renal dysplasia with oligohydramnios
- Limb defects
- Neural tube defects
Correct Answer: Fetal renal dysplasia with oligohydramnios
Q6. Which antibiotic is widely considered safe for use in pregnancy for common infections?
- Tetracycline
- Chloramphenicol
- Amoxicillin
- Fluoroquinolones
Correct Answer: Amoxicillin
Q7. Which physicochemical property most favors a drug’s transfer into human breast milk due to ion trapping?
- Being a highly hydrophilic strong acid
- High plasma protein binding
- Being a weak base
- Very large molecular weight (>800 Da)
Correct Answer: Being a weak base
Q8. Which of the following drugs is absolutely contraindicated in pregnancy because it is a known potent teratogen causing severe congenital malformations?
- Metformin
- Isotretinoin
- Amoxicillin
- Levothyroxine
Correct Answer: Isotretinoin
Q9. Which oral anticoagulant is considered compatible with breastfeeding due to negligible excretion into human milk?
- Rivaroxaban
- Warfarin
- Apixaban
- Edoxaban
Correct Answer: Warfarin
Q10. Which renal function estimate is most commonly recommended for drug dosing adjustments in adults with chronic kidney disease?
- Body mass index (BMI)
- Creatinine clearance calculated by Cockcroft–Gault equation
- Serum cystatin C alone
- Urine specific gravity
Correct Answer: Creatinine clearance calculated by Cockcroft–Gault equation
Q11. Which scoring system is most often used to stratify severity of chronic liver disease and guide drug dosing in hepatic impairment?
- MELD (Model for End‑Stage Liver Disease)
- APACHE II
- Child–Pugh classification
- Bilirubin Index Score (BIS)
Correct Answer: Child–Pugh classification
Q12. Which combination of properties makes a drug most likely to be removed by hemodialysis?
- High molecular weight, high protein binding, large volume of distribution
- Low molecular weight, low protein binding, small volume of distribution
- High lipophilicity, extensive tissue binding, high Vd
- Strongly protein bound and extensively metabolized hepatically
Correct Answer: Low molecular weight, low protein binding, small volume of distribution
Q13. Nitrofurantoin is generally avoided at which stage of pregnancy due to risk of neonatal hemolysis?
- First trimester only
- Second trimester only
- Near term (last weeks of pregnancy)
- It is contraindicated throughout pregnancy
Correct Answer: Near term (last weeks of pregnancy)
Q14. Which glycemic agent is the recommended first‑line pharmacologic treatment for gestational diabetes when dietary measures fail?
- Glyburide (glibenclamide)
- Metformin
- Insulin
- Sitagliptin
Correct Answer: Insulin
Q15. Which selective serotonin reuptake inhibitor (SSRI) has been associated with an increased risk of congenital cardiac defects when used in early pregnancy?
- Sertraline
- Fluoxetine
- Paroxetine
- Citalopram
Correct Answer: Paroxetine
Q16. Which characteristic of a drug reduces its excretion into breast milk and therefore lowers infant exposure?
- Low plasma protein binding
- High lipid solubility
- High molecular weight and high plasma protein binding
- Being a weak base with low pKa
Correct Answer: High molecular weight and high plasma protein binding
Q17. In severe hepatic impairment, which type of metabolic reaction is typically more affected and therefore may require dose reductions for drugs primarily using this pathway?
- Phase II conjugation reactions (glucuronidation)
- Phase I oxidative reactions (CYP‑mediated)
- Renal tubular secretion
- Glomerular filtration
Correct Answer: Phase I oxidative reactions (CYP‑mediated)
Q18. Which ACE inhibitor is considered relatively compatible with breastfeeding and is often preferred if an ACE inhibitor is clinically required postpartum?
- Lisinopril
- Enalapril
- Ramipril
- Telmisartan
Correct Answer: Enalapril
Q19. Maternal use of codeine can lead to severe neonatal respiratory depression due to which pharmacogenetic mechanism?
- Poor CYP3A4 metabolism resulting in accumulation of codeine
- Ultra‑rapid CYP2D6 metabolism converting codeine to high morphine levels
- Deficient UGT1A1 glucuronidation of morphine
- Inhibition of P‑glycoprotein in mammary epithelium
Correct Answer: Ultra‑rapid CYP2D6 metabolism converting codeine to high morphine levels
Q20. Which benzodiazepine is preferred in patients with significant hepatic impairment because it undergoes primarily phase II (glucuronidation) metabolism and has fewer active metabolites?
- Diazepam
- Clonazepam
- Lorazepam
- Chlordiazepoxide
Correct Answer: Lorazepam

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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