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?

8/10 Signup and view all the answers

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

To assess fetal risks associated with medication use Signup and view all the answers

What is the primary concern with lithium use during pregnancy?

Teratogenic effects Signup and view all the answers

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

Divide by 88.4 Signup and view all the answers

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

Induction of hepatic CYP enzymes Signup and view all the answers

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

Expert opinions and testimony related to drug safety Signup and view all the answers

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

To study pharmacokinetic changes that occur in pregnancy Signup and view all the answers

What is the effect of pregnancy on serum creatinine concentrations?

Serum creatinine concentrations decrease Signup and view all the answers

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

Pharmacokinetic changes in pregnancy 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?

Serum Creatinine Levels Before, During, and After Pregnancy Signup and view all the answers

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

Assistant Professor, Temerty Faculty of Medicine University of Toronto Signup and view all the answers

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

Pharmacotherapeutics in pregnancy and lactation Signup and view all the answers

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

To introduce resources for drug safety in pregnancy and lactation Signup and view all the answers

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

3% risk Signup and view all the answers

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

Drugs/Environmental exposures Signup and view all the answers

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

To assess the causality of a medication Signup and view all the answers

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

To evaluate the specificity of a medication's effect Signup and view all the answers

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 Signup and view all the answers

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

To adjust for bias in a study Signup and view all the answers

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

Level 5: Expert opinion Signup and view all the answers

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

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

What percentage of opioids pass into breast milk?

1-7% Signup and view all the answers

Which opioid is characterized as particularly unsafe during lactation?

Codeine Signup and view all the answers

What is the primary metabolic pathway for morphine?

UGT2B7 Signup and view all the answers

What is the primary concern with opioid use during lactation?

Neonatal CNS and respiratory depression Signup and view all the answers

What is the recommended approach to opioid use in breastfeeding?

First principles approach and population-based data Signup and view all the answers

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

Low Signup and view all the answers

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

LactMed Signup and view all the answers

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

No difference in hospitalization rates Signup and view all the answers

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

It does not account for infant drug clearance Signup and view all the answers

Which of the following drugs is contraindicated in breastfeeding?

Lithium Signup and view all the answers

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

Infant drug clearance Signup and view all the answers

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

First principles and PK studies Signup and view all the answers

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

All of the above Signup and view all the answers

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

Infant sedation and respiratory depression Signup and view all the answers

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

Infant GI tract and proteases Signup and view all the answers

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

They are not generalizable to the larger population 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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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.