Transcript Antimicrobial Therapy What, Why, and How

Jim Mahowald, Pharm.D.
Clinical Coordinator
St. Cloud Hospital Inpatient Pharmacy
January 2013
Objectives
 Review a brief history of medications and
breastfeeding
 List resources that are helpful with medications and
breastfeeding
 Detail how to use a pharmacist as a reference
 Present cases showing how medication issues arise
© 2013 CentraCare Health System
Breastfeeding and Medications:
History
 150 AD
 Soranus told wet nurses to refrain from drugs/alcohol
 1930’s – 1960’s
 dramatic 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/toxicity
 Answers not always apparent
© 2013 CentraCare Health System
Parlodel Post Partum –
Not Anymore
 Bromocriptine 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was withdrawn based on postmarketing reports of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
© 2013 CentraCare Health System
Breastfeeding and Medications:
Why
 Breast milk possesses nutritional and immunologic
properties superior to infant formulas
 American Academy of Pediatrics
 Position 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
© 2013 CentraCare Health System
Breastfeeding and Medications:
Issues
 Seldom absolute answers
 New drugs – not studied in these patients
 Risks change during breastfeeding
 Neonate and very young at most risk
 Nearly all reported adverse effects have occurred in
infants < 6 months old
 Recommendations based on toxicity data for adults in
most cases
© 2013 CentraCare Health System
Medications and Breastfeeding
 Individual susceptibility
 May differ from safety data in large population
 Data from animals may/may not translate to humans
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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 taking
 Do not take without good cause
© 2013 CentraCare Health System
References Available
 Drugs in Pregnancy and Lactation (Briggs)
 Micromedex
 Up to Date
 Pharmacist’s Letter
 Phamacists
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation
(Briggs)
 In print for 25 years
 1200 medications citations
 90 agents listed as “teratogenic”
 New and old medications
 Reviews are “exhaustive”
 Assess the risk at different stages of development
 Embryo
 Fetus
 Nursing infant
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation
(Briggs)
 Monographs
 Introduction
 Animal Reproduction Data
 Placental Transfer
 Reports of Human Pregnancy Exposure
 Summary
 Important distinction: excretion into milk vs. effects
on nursing infant
 May include telephone # to join observational study
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation
(Briggs)
 Provides tables with concentration of the medication
in breast milk
 Milk: plasma ratio
 Significance: drug in present, not meant for advice
 Do not know
 Maternal dose
 Frequency of dose
 Time of administration to sampling
 Frequency of nursing
© 2013 CentraCare Health System
Drugs in Pregnancy and
Lactation (Briggs): Definitions
 Compatible: 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.
 Examples
 Acetaminophen
 Acyclovir
 Ibuprofen
 Warfarin
© 2013 CentraCare Health System
Drugs in Pregnancy and
Lactation (Briggs): Definitions
 Hold 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 Acid
 Metronidazole (single dose)
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation
(Briggs): Definitions
 No (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:
 Albuterol
 Naproxen
 Ondansetron
© 2013 CentraCare Health System
Drugs in Pregnancy and Lactation
(Briggs): Definitions
 No (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:
 Omeprazole
 SSRI’s: Paxil, Prozac, Zoloft
© 2013 CentraCare Health System
Drugs in Pregnancy and
Lactation (Briggs): Definitions
 No (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.
© 2013 CentraCare Health System
Drugs in Pregnancy and
Lactation (Briggs): Definitions
 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:
 Chemotherapy
 Cigarettes
© 2013 CentraCare Health System
On-Line Databases via Centranet
 Micromedex
 Facts and Comparisons
 Pharmacist’s Letter
© 2013 CentraCare Health System
References
 Pharmacist
 Training
 4 year degree
 Pharmacology/Therapeutics Curriculum
 Drug Information rotations
 Continuing Education
 Hospital / Community based practice sites
© 2013 CentraCare Health System
Opportunities
 Pharmacy profession still has little involvement with
pregnant patients
 There 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.
© 2013 CentraCare Health System
Patient Case
 24 y/o female presents with cellulitis
 Currently breastfeeding 2 month old male
 Prescribed Doxycycline 100 mg PO BID
 Appropriate?
© 2013 CentraCare Health System
Patient Case
 33 y/o female with h/o hypercholesterolemia not
controlled by diet alone
 Breastfeeding and primary provider want to start lipid
lowering therapy
 Statin a good choice?
© 2013 CentraCare Health System
Conclusions
 Providers need to be aware of animal study results
 More study is needed
 Decision should be individualized to the patient and
illness
 Pharmacy is always available to help
© 2013 CentraCare Health System