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PHRM 100 – IMM > IMM 19, 25, and 26: Pregnancy and Lactation > Flashcards

IMM 19, 25, and 26: Pregnancy and Lactation Flashcards

1
Q

What is developmental toxicity?

A
  • growth alteration
  • strutural anomalies
  • functional neuro-behavioural deficits
  • death
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2
Q

What is parturition?

A

functional neuro-behavioural deficits or death

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3
Q

Developmental Toxicity

What are the 4 causes of structural anomalies?

A
  • genetic
  • chromosmal
  • multifactorial
  • unknown
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4
Q

Developmental Toxicity

What are the only preventable causes? (2)

A
  • drug-induced
  • drug deficient – untreated disease or folic acid deficiency
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5
Q

What are the 4 determinants of drug toxicity?

A
  • exposure in the critical period – if exposure occurs after structures is formed, it cannot cause the anomaly
  • specific anomaly or syndrome
  • consistent findings in 2 or more epidemiologic studies
  • rare exposure associated with a rare anomaly
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6
Q

Describe the drug dose relationship.

A
  • threshold dose or no-observed-effect-level (NOEL) often unknown
  • rarely quantified in terms of weight, body surface area, concentration
  • unable to determine incremental exposure vs. death – as dose increases, will severity of anomaly and/or frequency increase until lethal dose is reached
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7
Q

How should a medication be assessed?

A
  • is there human pregnancy data available
  • what about information for medications in the same class
  • does the drug cross the placenta and reach the embryo or fetus
  • what toxicity does it cause in animals
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8
Q

What factors should be considered when determining if a drug can cross the placenta? (7)

A
  • plasma concentration (systemic bioavailability)
  • molecular weight (< 600 Daltons)
  • plasma elimination half-life (↑ with time at maternal-fetal interface)
  • lipid solubility (cross membrane easier)
  • ionization at physiologic pH
  • plasma protein binding
  • placental metabolizing enzymes
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9
Q

What clinical factors should be considered with pregnant patients?

A
  • assessment of need for medication – what would happen if pregnant person did not take medication (ie. sepsis, seizure, exacerbation of disease, hospitalization, etc.)
  • is the pregnant person near term – does it affect labour process or neonate at birth
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10
Q

What are the FDA letter risk categories?

A

A, B, C, D, X

  • letters started being removed June 2015
  • do NOT account for changes to fetus
  • A & B were not absolutely safe
  • not all drugs labeled C were the same risk
  • no progression – lowest (A) to highest (X) risk
  • some products were labeled X because of no benefit
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11
Q

What don’t the FDA letter risk categories consider?

A
  • categories do not consider exposure timing, dose, route, duration, frequency
  • does not consider incidence, severity, reversibility
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12
Q

Labetalol

Pregnancy Risk

A

low risk

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13
Q

Nifedipine

Pregnancy Risk

A

low risk

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14
Q

What are the possible feeding options? (5)

A
  • parent milk
  • colactation
  • donor milk
  • formula
  • mixed feeding (combination of all)
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15
Q

What does lactation care consist of?

A
  • answer questions regarding feeding preferences/plan
  • breast/chestfeeding support
  • milk production
  • medication reviews
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16
Q

What are the benefits of human milk for a postpartum person? (4)

A

decreases risk of:

  • breast cancer
  • ovarian cancer
  • type II diabetes
  • heart disease
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17
Q

What are the benefits of human milk for an infant? (3)

A

decreases risk of:

  • infections – gastroenteritis, LRTI, acute otitis media
  • necrotizing enterocolitis in pre-term infants
  • sudden infant death syndrome
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18
Q

What is lactogenesis I?

A

secretory differentiation

  • mid-to-late pregnancy
  • differentiation of mammary epithelial cells into lactocytes in alveoli
  • can produce and secrete components of milk – ie. lactose, casein
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19
Q

What is lactogenesis II?

A

secretory activation

  • onset of copious milk production after delivery
  • continuum of changes in composition & volume
  • historically called colostrum or transitional milk
  • initially lactocytes are small with large intercellular spaces
  • medications, immunoglobulins, proteins, etc. easily transfer into milk from blood
  • progestin levels fall, lactocytes grow, intercellular gaps narrow
  • once closed, transfer of medications in plasma is greatly reduced
20
Q

What is lactogenesis III?

A

galactopoiesis

  • production and maintenance of mature milk
21
Q

Drug Entry Into Human Milk

What affects entry? (7)

A
  • plasma concentration (systemic bioavailability)
  • molecular weight
  • plasma elimination half-life
  • lipid solubility
  • ionization at physiologic pH
  • plasma protein binding
  • Vd
22
Q

Drug Entry Into Human Milk

How does plasma concentration (systemic bioavailability) affect entry?

A

if higher, more drug enters milk

23
Q

Drug Entry Into Human Milk

How does molecular weight affect entry?

A
  • drugs > 800 Daltons enter milk poorly
  • drugs < 300 Daltons enter milk easily
24
Q

Drug Entry Into Human Milk

How does ionization at physiologic pH affect entry?

A
  • pH of milk is lower than plasma
  • ion trap for basic drugs with a pKa >7.2
25
Q

Drug Entry Into Human Milk

How does plasma protein binding affect entry?

A
  • plasma proteins bind better than milk proteins
  • highly protein bound drugs do not concentrate in milk
26
Q

Drug Entry Into Human Milk

How does Vd affect entry?

A

if higher Vd (> 1 L/kg), lower levels in milk

27
Q

What other factors must be considered? (2)

A
  • oral bioavailability – drug exposure via milk depends on bioavailability of drug in infant (large molecular weight = poorly absorbed orally)
  • stability in GI tract of infant
28
Q

What is the milk/plasma (M/P) ratio?

A

ratio of concentration of drug in milk divided by concentration in plasma

  • unless plasma level is known, ratio is meaningless
  • M/P ratio between 1-5 may indicate drug accumulates in milk
29
Q

How do you calculate average milk concentration (mg/mL)?

A

average plasma concentration (mg/mL) x M/P

30
Q

How do you calculate average infant dose (mg/kg/day)?

A

average milk concentration (mg/mL) x 150 mL/kg/day

31
Q

What is relative infant dose (RID)?

A

daily infant dose via milk divided by lactating parent dose

(daily infant dose/daily lactating parent dose) x 100

  • calculated using parent weight commonly adjusted to a 70 kg female
  • calculated using daily infant milk intake – usually 150 mL/kg/day
  • < 10% of lactating parent daily dose is acceptable
  • do not use M/P ratio unless it is really low (less than 1)
32
Q

What risk does exposure from milk have on the infant?

A

exposure from milk is often less than in utero

  • fetal exposure can be > 10x that of milk
  • organogenesis is complete at birth
33
Q

What does the risk to the infant from exposure to milk depend on? (3)

A
  • choice of drug
  • volume of milk
  • infant’s current medical status
34
Q

How do we evaluate the infant? (7)

A
  • age
  • prematurity – glomerular filtration and tubular secretion are underdeveloped in neonates
  • weight/growth
  • infants pre-existing medical condition
  • infants current medications
  • infants exposure in utero
  • timing postpartum
35
Q

What age is risk the lowest in infants?

A

risk is lowest after 2 months, as renal excretion matures and as other nutrition is introduced

36
Q

What are some medications with potential for adverse effects? (5)

A
  • water soluble beta blockers – atenolol, acebutolol
  • lithium
  • narcotics and sedatives (ie. codeine, diazepam)
  • alcohol, substances, or medications used other than prescribed
  • hemolytic agents (ie. nitrofurantoin, SMX/TMP)
37
Q

How can lithium plasma levels change?

A

depending on hydration and renal function

  • infants at greater risk of toxicity are premature, become unwell, or dehydrated
38
Q

How should lithium be monitored throughout lactation?

A
  • lactating person’s lithium levels
  • clinical assessment of infant for adverse effects
  • routine infant lab monitoring
  • more commonly close clinical assessment and labs only if clinical concerns arise with medication exposure in milk
39
Q

What are the potential adverse effects of hemolytic agents?

A

increased susceptibility of neonatal red cell membrane increases risk of drug-induced hemolysis

  • not recommended < 1 month
40
Q

What drugs decrease milk supply? (6)

A
  • alcohol
  • estrogens
  • progesterone
  • cigarette smoking
  • pseudoephedrine
  • ergot alkaloids
41
Q

What drugs increase milk supply? (4)

A
  • dopamine antagonists – metoclopramide, domperidone
  • milk thistle (poor evidence)
  • fenugreek (poor evidence)
42
Q

Key Points

A
  • choose effective therapy
  • assess medications’ typical side effects in adults and pediatrics – try to limit number pf medications with CNS effects
  • always evaluate stage of lactation – milk volume and infant age
  • use relative infant dose (RID) – < 10% typically suitable
  • monitor infant – changes in growth, feeding, or sleep patterns, inform health care providers of medication(s) infant is exposed to via milk
43
Q

Vancomycin

A
  • suitable for use in lactation
  • may want to monitor infant for diarrhea – but easier to look for signs of dehydration such as lethargic/not waking to feed, sunken fontanel, pale skin, or diaper rash (hard to quantify loose stool in neonate)
44
Q

What is the lactation risk for loratadine?

A

L1

45
Q

What is fenugreek?

A

most commonly used herbal for increasing milk supply

  • conflicting data: most reports of benefit are anecdotal or in a population not reported to have concerns with milk supply – benefits may be due to chance, natural increase in maternal milk supply, other support provided etc.
  • not recommended to increase milk production
46
Q

What are the concerns about herbal medications?

A
  • quality and consistency of product purchased will vary
  • may put pregnant person and/or infant at risk of unknown adverse effects

PHRM 100 – IMM (22 decks)

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