Pregnancy
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Questions and Answers

What is the primary means of metabolism for SSRIs during pregnancy?

  • Plasma protein binding
  • Hepatic CYP enzymes (correct)
  • Biliary excretion
  • Renal excretion

    • Which of the following is a known teratogen?

  • Aspirin
  • Vitamin D
  • Methimazole (correct)
  • Folic acid

    • What happens to GFR at the end of T2 and into T3 in pregnancy?

  • It decreases
  • It increases (correct)
  • It remains unchanged
  • It fluctuates

    • What percentage of pregnant women take a prescription medication?

    <p>8/10</p> Signup and view all the answers

    What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)?

    <p>To assess fetal risks associated with medication use</p> Signup and view all the answers

    What is the primary concern with lithium use during pregnancy?

    <p>Teratogenic effects</p> Signup and view all the answers

    What is the recommended method to convert creatinine values to mg/dL?

    <p>Divide by 88.4</p> Signup and view all the answers

    What is the primary reason for the increase in dose of SSRIs during pregnancy?

    <p>Induction of hepatic CYP enzymes</p> Signup and view all the answers

    What is the primary focus of the 'First Exposure program at the DLSPH' funding?

    <p>Expert opinions and testimony related to drug safety</p> Signup and view all the answers

    What is the main objective of the Pharmacotherapeutics Course in PharmD Program?

    <p>To study pharmacokinetic changes that occur in pregnancy</p> Signup and view all the answers

    What is the effect of pregnancy on serum creatinine concentrations?

    <p>Serum creatinine concentrations decrease</p> Signup and view all the answers

    What is the primary application of the systematic review by Pariente et al. (2016)?

    <p>Pharmacokinetic changes in pregnancy</p> Signup and view all the answers

    What is the title of the research article that discussed mean serum creatinine concentrations among women with singleton pregnancies?

    <p>Serum Creatinine Levels Before, During, and After Pregnancy</p> Signup and view all the answers

    What is the primary role of Jonathan Zipursky MD PhD FRCPC?

    <p>Assistant Professor, Temerty Faculty of Medicine University of Toronto</p> Signup and view all the answers

    What is the focus of the course discussed in the content?

    <p>Pharmacotherapeutics in pregnancy and lactation</p> Signup and view all the answers

    What is the primary goal of the course in terms of drug safety?

    <p>To introduce resources for drug safety in pregnancy and lactation</p> Signup and view all the answers

    What is the baseline risk of major congenital malformations at birth?

    <p>3% risk</p> Signup and view all the answers

    Which of the following is a risk factor for congenital malformations?

    <p>Drugs/Environmental exposures</p> Signup and view all the answers

    What is the purpose of the Bradford Hill criteria in assessing teratogenicity?

    <p>To assess the causality of a medication</p> Signup and view all the answers

    What is the purpose of the Shepard Criteria in assessing teratogenicity?

    <p>To evaluate the specificity of a medication's effect</p> Signup and view all the answers

    What is confounding by indication in the context of pharmacokinetics in pregnancy?

    <p>A bias that occurs when the clinical indication for a medication affects the outcome</p> Signup and view all the answers

    What is the purpose of propensity score methods in the context of pharmacokinetics in pregnancy?

    <p>To adjust for bias in a study</p> Signup and view all the answers

    What is the hierarchy of evidence in relation to pharmacokinetics in pregnancy?

    <p>Level 5: Expert opinion</p> Signup and view all the answers

    What is the critical period in development in relation to teratogenicity?

    <p>The period during which the fetus is most susceptible to teratogenic effects</p> Signup and view all the answers

    What percentage of opioids pass into breast milk?

    <p>1-7%</p> Signup and view all the answers

    Which opioid is characterized as particularly unsafe during lactation?

    <p>Codeine</p> Signup and view all the answers

    What is the primary metabolic pathway for morphine?

    <p>UGT2B7</p> Signup and view all the answers

    What is the primary concern with opioid use during lactation?

    <p>Neonatal CNS and respiratory depression</p> Signup and view all the answers

    What is the recommended approach to opioid use in breastfeeding?

    <p>First principles approach and population-based data</p> Signup and view all the answers

    What is the likelihood of infant harm related to small amounts of opioid passed through breast milk?

    <p>Low</p> Signup and view all the answers

    What is the name of the resource provided by the NIH for drug safety in pregnancy and lactation?

    <p>LactMed</p> Signup and view all the answers

    What was the outcome for infants born to mothers prescribed opioids in the ensuing 30 days?

    <p>No difference in hospitalization rates</p> Signup and view all the answers

    What is a limitation of the Relative Infant Dose (RID)?

    <p>It does not account for infant drug clearance</p> Signup and view all the answers

    Which of the following drugs is contraindicated in breastfeeding?

    <p>Lithium</p> Signup and view all the answers

    What is a key factor in determining the safety of a drug in lactation?

    <p>Infant drug clearance</p> Signup and view all the answers

    What is the primary method of studying drug safety in lactation?

    <p>First principles and PK studies</p> Signup and view all the answers

    What is a key consideration in managing drug therapy in breastfeeding women?

    <p>All of the above</p> Signup and view all the answers

    What is the primary concern with using opioids in breastfeeding women?

    <p>Infant sedation and respiratory depression</p> Signup and view all the answers

    What is a factor that affects the absorption of a drug in the infant?

    <p>Infant GI tract and proteases</p> Signup and view all the answers

    What is a limitation of using case studies to assess drug safety in lactation?

    <p>They are not generalizable to the larger population</p> Signup and view all the answers

    Study Notes

    Safety for Parent vs. Safety for Baby

    • 3% risk of major congenital malformations at birth
    • Risk factors: genetic abnormalities, consanguinity, drugs/environmental exposures, nutrition/resource poor settings, in utero infections, maternal age, and disease (e.g., diabetes)

    Steps to Assess Fetal Risk

    • Step 1: Baseline risk of congenital malformations
    • Step 2: Critical period in development
    • Step 3: Assessment of causality (Bradford Hill)
    • Step 3: Key Shepard Criteria:
      • Proven exposure at a critical time
      • Consistent findings in ≥ 2 epidemiologic studies
      • Specific syndrome
      • Rare exposures associated with rare defect
    • Step 4: Hierarchy of Evidence
    • Step 5: Confounding by indication

    Teratogen

    • Definition: Human teratogens are agents/substances/exposures that cause physical/functional defects (harmful effects) in the human fetus
    • Known teratogens:
      • Alcohol (ethanol)
      • Carbamazepine
      • Cytotoxic chemotherapy
      • DES
      • Isotretinoin
      • Lithium
      • Methimazole
      • Methotrexate
      • Misoprostol
      • Mycophenolate
      • Phenytoin
      • Thalidomide
      • Trimethoprim
      • Valproic acid
      • Warfarin

    Principles and Pitfalls of Drug Safety in Pregnancy

    • Risk evaluation and mitigation strategies (REMS)
    • Prescription drug use in pregnancy:
      • 8/10 pregnant women take a prescription medication
      • 9/10 pregnant women take any drug in pregnancy
    • Drug use in pregnancy by trimester
    • Case study: Ondansetron in pregnancy

    Pharmacokinetic Changes in Pregnancy

    • Physiological changes during pregnancy affect drug disposition
    • Table 1: Effects of pregnancy on drug disposition

    Neonatal Risks of Postpartum Opioid Use

    • Regulatory bodies focus on risks of neonatal CNS and respiratory depression related to opioids ingested via breastfeeding
    • Opioids pass into breast milk to varying degrees; RID between 1 – 7%
    • Opioid metabolism and passage into breast milk
    • Codeine was characterized as particularly unsafe during lactation due to a case of infant opioid toxicity

    Approaches to Opioid Use in Breastfeeding

    • First principles approach: Relative infant dose, volume ingested by infant, drug clearance
    • Population-based data: Infant harm related to small amounts of opioid passed through breast milk is unlikely

    Resources for Drug Safety in Pregnancy and Lactation

    • LactMed (NIH) and free app
    • Relative infant dose (RID)

    Contraindications in Breastfeeding

    • Chemotherapeutics
    • Radioisotopes
    • Lithium
    • Gold salts
    • Iodine
    • Oral retinoids
    • Amiodarone
    • Ergotamine
    • Bromocriptine (decrease production)
    • Drugs of abuse

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    Related Documents

    Drug Safety in Pregnancy and Lactation Lecture January 26, 2024 PDF

    Description

    This quiz covers the risks and complications associated with pregnancy, fetal development, and child safety. Topics include conception, fetal growth restriction, and neonatal drug withdrawal.

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