Podcast
Questions and Answers
What is the primary means of metabolism for SSRIs during pregnancy?
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?
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?
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?
What percentage of pregnant women take a prescription medication?
What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)?
What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)?
What is the primary concern with lithium use during pregnancy?
What is the primary concern with lithium use during pregnancy?
What is the recommended method to convert creatinine values to mg/dL?
What is the recommended method to convert creatinine values to mg/dL?
What is the primary reason for the increase in dose of SSRIs during pregnancy?
What is the primary reason for the increase in dose of SSRIs during pregnancy?
What is the primary focus of the 'First Exposure program at the DLSPH' funding?
What is the primary focus of the 'First Exposure program at the DLSPH' funding?
What is the main objective of the Pharmacotherapeutics Course in PharmD Program?
What is the main objective of the Pharmacotherapeutics Course in PharmD Program?
What is the effect of pregnancy on serum creatinine concentrations?
What is the effect of pregnancy on serum creatinine concentrations?
What is the primary application of the systematic review by Pariente et al. (2016)?
What is the primary application of the systematic review by Pariente et al. (2016)?
What is the title of the research article that discussed mean serum creatinine concentrations among women with singleton pregnancies?
What is the title of the research article that discussed mean serum creatinine concentrations among women with singleton pregnancies?
What is the primary role of Jonathan Zipursky MD PhD FRCPC?
What is the primary role of Jonathan Zipursky MD PhD FRCPC?
What is the focus of the course discussed in the content?
What is the focus of the course discussed in the content?
What is the primary goal of the course in terms of drug safety?
What is the primary goal of the course in terms of drug safety?
What is the baseline risk of major congenital malformations at birth?
What is the baseline risk of major congenital malformations at birth?
Which of the following is a risk factor for congenital malformations?
Which of the following is a risk factor for congenital malformations?
What is the purpose of the Bradford Hill criteria in assessing teratogenicity?
What is the purpose of the Bradford Hill criteria in assessing teratogenicity?
What is the purpose of the Shepard Criteria in assessing teratogenicity?
What is the purpose of the Shepard Criteria in assessing teratogenicity?
What is confounding by indication in the context of pharmacokinetics in pregnancy?
What is confounding by indication in the context of pharmacokinetics in pregnancy?
What is the purpose of propensity score methods in the context of pharmacokinetics in pregnancy?
What is the purpose of propensity score methods in the context of pharmacokinetics in pregnancy?
What is the hierarchy of evidence in relation to pharmacokinetics in pregnancy?
What is the hierarchy of evidence in relation to pharmacokinetics in pregnancy?
What is the critical period in development in relation to teratogenicity?
What is the critical period in development in relation to teratogenicity?
What percentage of opioids pass into breast milk?
What percentage of opioids pass into breast milk?
Which opioid is characterized as particularly unsafe during lactation?
Which opioid is characterized as particularly unsafe during lactation?
What is the primary metabolic pathway for morphine?
What is the primary metabolic pathway for morphine?
What is the primary concern with opioid use during lactation?
What is the primary concern with opioid use during lactation?
What is the recommended approach to opioid use in breastfeeding?
What is the recommended approach to opioid use in breastfeeding?
What is the likelihood of infant harm related to small amounts of opioid passed through breast milk?
What is the likelihood of infant harm related to small amounts of opioid passed through breast milk?
What is the name of the resource provided by the NIH for drug safety in pregnancy and lactation?
What is the name of the resource provided by the NIH for drug safety in pregnancy and lactation?
What was the outcome for infants born to mothers prescribed opioids in the ensuing 30 days?
What was the outcome for infants born to mothers prescribed opioids in the ensuing 30 days?
What is a limitation of the Relative Infant Dose (RID)?
What is a limitation of the Relative Infant Dose (RID)?
Which of the following drugs is contraindicated in breastfeeding?
Which of the following drugs is contraindicated in breastfeeding?
What is a key factor in determining the safety of a drug in lactation?
What is a key factor in determining the safety of a drug in lactation?
What is the primary method of studying drug safety in lactation?
What is the primary method of studying drug safety in lactation?
What is a key consideration in managing drug therapy in breastfeeding women?
What is a key consideration in managing drug therapy in breastfeeding women?
What is the primary concern with using opioids in breastfeeding women?
What is the primary concern with using opioids in breastfeeding women?
What is a factor that affects the absorption of a drug in the infant?
What is a factor that affects the absorption of a drug in the infant?
What is a limitation of using case studies to assess drug safety in lactation?
What is a limitation of using case studies to assess drug safety in lactation?
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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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