jim mahowald, pharm.d. clinical coordinator st. cloud hospital inpatient pharmacy january 2013

Jim Mahowald, Pharm.D.Clinical Coordinator

St. Cloud Hospital Inpatient PharmacyJanuary 2013

ObjectivesReview a brief history of medications and

breastfeedingList resources that are helpful with

medications and breastfeedingDetail how to use a pharmacist as a referencePresent cases showing how medication issues

arise

© 2013 CentraCare Health System

Breastfeeding and Medications: History150 AD

Soranus told wet nurses to refrain from drugs/alcohol

1930’s – 1960’sdramatic decline in % of American mothers

breastfeeding (80% down to 28%)Reduction in length of time breastfeeding

Today > 50%Subsequent increases in parent questions

about safety/toxicityAnswers not always apparent


Parlodel Post Partum – Not AnymoreBromocriptine is contraindicated in women

who are breast-feeding their children because bromocriptine inhibits lactation. The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn based on postmarketing reports of stroke in this setting; therefore, do not use bromocriptine during lactation in postpartum women


Breastfeeding and Medications: WhyBreast milk possesses nutritional and

immunologic properties superior to infant formulas

American Academy of PediatricsPosition paper stating breastfeeding as the

best nutritional mode for infants for the 1st 6 months of life

Studies suggest significant psychologic benefits of breastfeeding for mother and infant


Breastfeeding and Medications: IssuesSeldom absolute answersNew drugs – not studied in these patientsRisks change during breastfeeding

Neonate and very young at most riskNearly all reported adverse effects have

occurred in infants < 6 months oldRecommendations based on toxicity data for

adults in most cases


Medications and BreastfeedingIndividual susceptibility

May differ from safety data in large populationData from animals may/may not translate to

humans Milk composition different resulting in changes in

elimination Greatest concern: human milk pH vs. cow’s milk pH Thalidomide

Need to know all medications patient takingDo not take without good cause


References AvailableDrugs in Pregnancy and Lactation (Briggs)MicromedexUp to DatePharmacist’s LetterPhamacists


Drugs in Pregnancy and Lactation (Briggs)In print for 25 years1200 medications citations90 agents listed as “teratogenic”

New and old medicationsReviews are “exhaustive”Assess the risk at different stages of development

EmbryoFetusNursing infant


Drugs in Pregnancy and Lactation (Briggs)Monographs

IntroductionAnimal Reproduction DataPlacental TransferReports of Human Pregnancy ExposureSummary

Important distinction: excretion into milk vs. effects on nursing infant

May include telephone # to join observational study


Drugs in Pregnancy and Lactation (Briggs)Provides tables with concentration of the

medication in breast milkMilk: plasma ratioSignificance: drug in present, not meant for

adviceDo not know

Maternal doseFrequency of doseTime of administration to samplingFrequency of nursing


Drugs in Pregnancy and Lactation (Briggs): DefinitionsCompatible: either the drug is not excreted

in clinically significant amounts into human breast milk or its use during lactation does not or is not expected to, cause toxicity in a nursing infant.

ExamplesAcetaminophenAcyclovirIbuprofenWarfarin


Drugs in Pregnancy and Lactation (Briggs): DefinitionsHold Breast Feeding: the drug may or may not

be excreted into human breast milk, but the maternal benefit of therapy far outweighs the benefits of breast milk to an infant. Breastfeeding should be held until maternal therapy is completed an the drug has been eliminated (or reached a low concentration) from her system.

Examples:Aminocaproic AcidMetronidazole (single dose)


Drugs in Pregnancy and Lactation (Briggs): DefinitionsNo (Limited)Human Data – Probably

Compatible: either there is no human data or the human data are limited. The available animal or other data suggest that the drug does not represent a significant risk to a nursing infant.

Examples:AlbuterolNaproxenOndansetron


Drugs in Pregnancy and Lactation (Briggs): DefinitionsNo (Limited) Human Data – Potential

Toxicity: either there is no human data or the human data are limited. The characteristics of the drug suggest that it could represent a clinically significant risk to a nursing infant. Breastfeeding is not recommended.

Examples:OmeprazoleSSRI’s: Paxil, Prozac, Zoloft


Drugs in Pregnancy and Lactation (Briggs): DefinitionsNo (Limited) Human data – Potential Toxicity

(Mother): either there is no human data or the human data are limited. The characteristics of the drug suggest that breastfeeding could represent a clinically significant risk to the mother such as further loss of essential vitamins or nutrients. Breastfeeding is not recommended.


Contraindicated: there my or may not be human experience, but the combined data (including animal data if available) suggest that the drug may cause severe toxicity in a nursing infant, or breastfeeding is contraindicated because of the maternal condition for which the drug is indicated. Women should not breastfeed if they are taking the drug or have the condition.

Examples:ChemotherapyCigarettes

Drugs in Pregnancy and Lactation (Briggs): Definitions


On-Line Databases via CentranetMicromedexFacts and ComparisonsPharmacist’s Letter


ReferencesPharmacistTraining

4 year degreePharmacology/Therapeutics CurriculumDrug Information rotationsContinuing Education

Hospital / Community based practice sites


OpportunitiesPharmacy profession still has little

involvement with pregnant patientsThere is an unmet demand for pharmacy

services in the care of these patients. Opportunities to work with maternal-fetal

medicine in clinical research involving the drug therapy of pregnant or breastfeeding women.


Patient Case24 y/o female presents with cellulitisCurrently breastfeeding 2 month old malePrescribed Doxycycline 100 mg PO BIDAppropriate?


Patient Case33 y/o female with h/o hypercholesterolemia

not controlled by diet aloneBreastfeeding and primary provider want to

start lipid lowering therapyStatin a good choice?


ConclusionsProviders need to be aware of animal study

resultsMore study is neededDecision should be individualized to the

patient and illnessPharmacy is always available to help


jim mahowald, pharm.d. clinical coordinator st. cloud hospital inpatient pharmacy january 2013

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