40 Questions
What is the primary means of metabolism for SSRIs during pregnancy?
Hepatic CYP enzymes
Which of the following is a known teratogen?
Methimazole
What happens to GFR at the end of T2 and into T3 in pregnancy?
It increases
What percentage of pregnant women take a prescription medication?
8/10
What is the purpose of Risk Evaluation and Mitigation Strategies (REMS)?
To assess fetal risks associated with medication use
What is the primary concern with lithium use during pregnancy?
Teratogenic effects
What is the recommended method to convert creatinine values to mg/dL?
Divide by 88.4
What is the primary reason for the increase in dose of SSRIs during pregnancy?
Induction of hepatic CYP enzymes
What is the primary focus of the 'First Exposure program at the DLSPH' funding?
Expert opinions and testimony related to drug safety
What is the main objective of the Pharmacotherapeutics Course in PharmD Program?
To study pharmacokinetic changes that occur in pregnancy
What is the effect of pregnancy on serum creatinine concentrations?
Serum creatinine concentrations decrease
What is the primary application of the systematic review by Pariente et al. (2016)?
Pharmacokinetic changes in pregnancy
What is the title of the research article that discussed mean serum creatinine concentrations among women with singleton pregnancies?
Serum Creatinine Levels Before, During, and After Pregnancy
What is the primary role of Jonathan Zipursky MD PhD FRCPC?
Assistant Professor, Temerty Faculty of Medicine University of Toronto
What is the focus of the course discussed in the content?
Pharmacotherapeutics in pregnancy and lactation
What is the primary goal of the course in terms of drug safety?
To introduce resources for drug safety in pregnancy and lactation
What is the baseline risk of major congenital malformations at birth?
3% risk
Which of the following is a risk factor for congenital malformations?
Drugs/Environmental exposures
What is the purpose of the Bradford Hill criteria in assessing teratogenicity?
To assess the causality of a medication
What is the purpose of the Shepard Criteria in assessing teratogenicity?
To evaluate the specificity of a medication's effect
What is confounding by indication in the context of pharmacokinetics in pregnancy?
A bias that occurs when the clinical indication for a medication affects the outcome
What is the purpose of propensity score methods in the context of pharmacokinetics in pregnancy?
To adjust for bias in a study
What is the hierarchy of evidence in relation to pharmacokinetics in pregnancy?
Level 5: Expert opinion
What is the critical period in development in relation to teratogenicity?
The period during which the fetus is most susceptible to teratogenic effects
What percentage of opioids pass into breast milk?
1-7%
Which opioid is characterized as particularly unsafe during lactation?
Codeine
What is the primary metabolic pathway for morphine?
UGT2B7
What is the primary concern with opioid use during lactation?
Neonatal CNS and respiratory depression
What is the recommended approach to opioid use in breastfeeding?
First principles approach and population-based data
What is the likelihood of infant harm related to small amounts of opioid passed through breast milk?
Low
What is the name of the resource provided by the NIH for drug safety in pregnancy and lactation?
LactMed
What was the outcome for infants born to mothers prescribed opioids in the ensuing 30 days?
No difference in hospitalization rates
What is a limitation of the Relative Infant Dose (RID)?
It does not account for infant drug clearance
Which of the following drugs is contraindicated in breastfeeding?
Lithium
What is a key factor in determining the safety of a drug in lactation?
Infant drug clearance
What is the primary method of studying drug safety in lactation?
First principles and PK studies
What is a key consideration in managing drug therapy in breastfeeding women?
All of the above
What is the primary concern with using opioids in breastfeeding women?
Infant sedation and respiratory depression
What is a factor that affects the absorption of a drug in the infant?
Infant GI tract and proteases
What is a limitation of using case studies to assess drug safety in lactation?
They are not generalizable to the larger population
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
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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