Medications and Breastfeeding: Pharmacists as Part of the M - PowerPoint Presentation

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Medications and Breastfeeding: Pharmacists as Part of the Mother’s Breastfeeding Team

Frank J. Nice, RPh, DPA, CPHP

301-840-0270

fjncat@hotmail.com

www.nicebreastfeeding.comSlide2

I have the following relevant financial relationship to disclose: Modest value relationship as author for Hale PublishingSlide3

Medications and Breastfeeding: Current Concepts

Only essential drugs

should be taken by the nursing mother. She should be knowledgeable of and be encouraged to report any adverse effects

For

newer drugs

, sufficient information is often unavailable. If information is available, it requires careful interpretation and evaluation

Recognizing the

benefits of continuing to nurse

, in most cases, drugs that have safe therapeutic levels can be given

The

long-term effects

of most drugs - on mothers as well as on their nurslings - often are not known

Use

all available resourcesSlide4

Drug Factors

General Guidelines

Most drugs

appear in breast milk to some degree

Levels of most drugs

in breast milk do not usually exceed

1% to 2%

of ingested maternal dosage

If the milk/plasma ratio

of drug and active metabolites is

less than 1:1

, it is

usually

safe to breastfeed

RID

: If infant dose is less than

10%

of maternal dose (

weight adjusted

), it is usually safe to breastfeed Slide5

Drug Factors

Pharmacokinetics

Volume of Distribution

(1-20 L/Kg)

pH

(breast milk more acidic)

Lipids

Protein-Bound Drugs

(>85%)

Molecular Size (Daltons) (>200-400)Active TransportSlide6

Maternal Factors

Pharmacodynamics

Mammary epithelium

may have drug - metabolizing capacity

Milk volume

is usually greatest in the early morning

Fat content

of milk is usually highest in the late morning

Stage of breastfeeding

is factorSlide7

Stages of Breastfeeding

Newborns feed every 1-2 hours (Why?)

Colostrum (0-3 days)

Transitional Milk (4-7 days)

Mature Milk (7-10 days)

Alveolar Spaces (0-7 days)Slide8

Infant Factors (See Handout)

Pharmacodynamics

Infant’s

ability to

absorb and metabolize

drugs

Infant’s

ability to detoxify and excrete drugs through metabolic enzymesMiscellaneous factorsSlide9

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No, it is not safe to breastfeed. You should wean your baby.

Is Drug X OK to take while breastfeeding?Slide10

Oops; we need

to ask some

questions here!

Lack of encouragement

and

informed counseling from

healthcare

professionals

(including pharmacists) on

medication use duringbreastfeeding is one of the main obstacles to successful breastfeedingSlide11

Questions To Ask In

Drug / Breastfeeding Situations

(See Handout)

What is the name, strength, and dosage of the drug?

Do you still have the prescription? Or, have you already filled it and are taking the drug?

Why is the drug being prescribed?

Do you feel you need to take the drug?

What does your doctor say regarding breastfeeding outcome and taking the drug?

What is the drug?Slide12

Questions To Ask In

Drug / Breastfeeding Situations

(See Handout)

How old is your baby?

Was your baby full-term or premature?

What is your baby's weight?

Is your baby currently receiving any medication?

Do you know how to hand-express breast milk or do you have access to a breast pump?

Is this your first breastfed baby? Slide13

Stepwise Approach To Minimizing Infant Drug Exposure

(See Handout)

1.   Withhold the drug

2.   Try nondrug therapy

3.   Delay therapy

4.   Choose drugs that pass poorly into breast milk

5. Choose more breastfeeding compatible

dosage formsSlide14

Stepwise Approach To Minimizing Infant Drug Exposure

(See Handout

)

6.

Choose an alternative route of

administration

7.    Avoid nursing at times of peak drug

concentrations in milk

8.    Administer drug immediately after

breastfeeding and / or before infant's longest sleep 9.    Temporarily withhold breastfeeding 10. Discontinue breastfeeding (wean)Slide15

Mrs. Maine and Daughter Acadia After BirthSlide16

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CASE STUDY

Mrs. Maine, a breastfeeding woman, presents a prescription to the pharmacist for an antibiotic to be filled. She is worried about taking this medication while breastfeeding and asks for the pharmacist’s recommendation. She wants to know if the antibiotic is safe to take while breastfeeding her baby, Acadia. Slide17

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CASE STUDY (continued)

After the pharmacist asks the mother several questions about herself and her baby, the mother states that she will be back in two hours to pick up her filled prescription if you determine that the drug is usually safe to take while breastfeeding.

What questions should the pharmacist have asked the mother?Slide18

Questions to Ask Mrs. Maine

Are you breastfeeding (Duh: in case patient did not tell you she was breastfeeding)?

Mother’s DOB and Acadia’s DOB

Mother’s weight and Acadia’s weight

Any allergies (including drugs) for mother

and

Acadia

Are mother and Acadia taking any other medications, including OTCs, herbals, and vitamins?Slide19

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CASE STUDY (continued)

From the mother, the pharmacist was able to obtain the following information:

The mother weighs 110 pounds (50 Kg). The mother and baby have no drug allergies. Her baby is seven months old, taking no medications, and weighs 22 pounds (10 Kg). Breastfeeding is going very well.Slide20

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CASE STUDY (continued)

The prescription is for: Xybotic, 1000 mg every twelve hours for five days

(2000 mg per day)Slide21

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CASE STUDY (continued)

Will the pharmacist be able to fill the prescription as written with enough assurance that when Mrs. Maine takes Xybotic, it should be safe for her to continue to breastfeed Acadia while taking the drug?Slide22

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CASE STUDY (continued)

The pharmacist is unable to find any research or case study reports regarding Xybotic while breastfeeding. (Why?)

What is the next step?Slide23

Next Step

The pharmacist runs a computer search on Xybotic.

The pharmacist chooses to search Micromedex.

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CASE STUDY (continued)

The pharmacist runs a Micromedex search on Xybotic and comes up with the following information:

Xybotic is 90 percent bound to plasma protein, has a fairly low fat solubility, has a volume of distribution of 1400 L, has a molecular mass (size) of 300 Daltons, peaks in plasma in one hour, and has a half-life of four hours.

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CASE STUDY (continued)

Protein: +

Fat Solubility: +

Daltons: +/-

Volume of Distribution: +

Peak: Avoid breastfeeding 0-2 hours after dose, if possible

Half-Life: Should not accumulate in baby (Why?)

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Relative Infant Dose (RID)

If RID is less than 10%, medication is “usually” compatible with breastfeeding

Calculation:

Baby’s weight adjusted dose /

Mother’s weight adjusted dose =

RID (expressed as %)Slide27

Relative Infant Dose (RID)

The pharmacist also is able to find a drug reference in Micromedex that states when five mothers took Xybotic, an average of 0.01 mg of the drug appeared in 1 mL (10 mg/L) of breast milk {or 150 mL/Kg (baby)/day}

Doing the calculations for the RID:

Baby’s weight adjusted dose: 1 mg/Kg/day (10 mg drug dose daily from ingested milk / 10 Kg child’s weight)

Mother’s weight adjusted dose: 40mg/Kg/day (2000 mg daily drug dose / 50 Kg mother’s weight)

Baby/Mother Percentage (RID) (1/40) = 2.5% Slide28

Photo Courtesy of NIH

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CASE STUDY (continued)

What recommendation should the pharmacist provide to Mrs. Maine as she is counseled?

What should the pharmacist do if the drug was not compatible with breastfeeding?Slide30

Recommendation

OK to breastfeed while taking Xybotic

Observe for possible adverse effects in child (diarrhea or possible allergic reaction)

Not necessary, but can avoid breastfeeding until 2 hours after taking drug

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What Else Could The Pharmacist Do?

Look for breastfeeding compatible alternative in the same drug category (e.g., Hale and LactMed suggest alternatives) (see Handouts)

If no alternative drug, go through the Stepwise Approach (see Handout)

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Prescription Drugs

Nonnarcotic Analgesics:

Acetaminophen, ibuprofen, and NSAIDs with short half-lives are the drugs of choice

Narcotic Analgesics:

Codeine and similar narcotics (except for patients who are rapid metabolizers) are the drugs of choice

General and Epidural Anesthetics:

These may decrease latching and maintenance of feeding

Anti-Infectives:

Most are compatible; monitor for allergic reactions

Antihistamine/Decongestants: May decrease milk production (especially if breastfeeding after six months); maintain adequate fluid intake when usedSlide34

Prescription Drugs

Bronchodilators:

Inhalants are the most compatible form to use

Corticosteroids:

Usually compatible; inhalants are the most compatible form to use

Antihypertensives:

Each drug category has compatible drugs

Diuretics:

Usually compatible; maintain adequate fluid intake when used

Cardiac Drugs: Each drug category has compatible drugsSlide35

Prescription Drugs

Anticoagulants:

Heparin and warfarin are compatible

Antidiabetics:

Insulin and metformin are the drugs of choice

Thyroid/Anti-Thyroid Drugs:

Thyroid is compatible; check individual anti-thyroid drugs for compatibility

Hormone Contraceptives:

May decrease milk supply and affect milk quality and milk components; wait 6 months before using

Gastrointestinal Drugs: Antacids, H2 antagonists, and proton pump inhibitors are compatible: e.g., Pepcid, Zantac, Tagamet, Prilosec OTCSlide36

Prescription Drugs

Psychotherapeutic Drugs:

Recommend that if antidepressant taken during pregnancy, continue while breastfeeding. Also, may be started during breastfeeding. Benefit-risk analysis favorable and condoned by AAP and APA

(See next slide for antidepressant drugs of choice)

Benzodiazepines:

Single, low dose, short half-life drugs compatible; oxazepam is drug of choice

Antiepileptics:

Most are compatible based on benefit-risk analysis. Combination drug treatment may cause poor sucking feeding.

Radiopharmaceuticals:

Can test milk samples and/or follow established guidelines for individual agentsMiscellaneous: All vaccines, except smallpox (due to baby breastfeeding, physical nearness to vaccine site) are compatibleSlide37

Antidepressant Drugs of Choice

1. Sertraline (Zoloft)

2. Escitalopram (Lexapro)

3. Paroxetine (Paxil)

4. Venlafaxine (Effexor)

5. Fluvoxamine (Luvox)

6. Citalopram (Celexa)

7. Fluoxetine (Prozac)Slide38

Adverse Effects(Overall Rate: 1%)

Psychotherapeutics (Antidepressants, Sedatives,

Antipsychotics): 31%

Antimicrobials: 17%

Anticonvulsants: 16%

Analgesics (NSAIDs, Opioids): 12%

Hormonal Drugs: 5%

Iodides: 5%

Cardiovascular Drugs: 4%

GIT Drugs: 2%Antihistamines: 2%Chemotherapeutics: 2%Slide39

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Adverse Effects

Psychotherapeutics (Antidepressants, Sedatives,

Antipsychotics):

Drowsiness

Antimicrobials:

Diarrhea

Anticonvulsants:

Drowsiness, sedation, poor feeding

Analgesics (NSAIDs, Opioids): Drowsiness, sedationHormonal Drugs: Decreased milk supply, volume, quantityIodides: Thyroid suppressionCardiovascular Drugs: Weakness, hypotension, bradycardiaGIT Drugs: GIT upsetAntihistamines:

Irritability, drowsiness

Chemotherapeutics:

Toxic effects of treatmentSlide40

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Adverse Effects

(References)

Anderson PO, Pochop SL, Manoguerra AS: Adverse drug reactions in breastfed infants: less than imagined. Clin Ped: 42 (4), 325-40: 2003

Ito S, Blajchman A, Stephenson M, et al: Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol: 168 (5), 1393-9: 1993Slide41

Codeine Rapid Metabolizers13-day breastfed baby dies from morphine overdose in breast milk in mother taking codeine

How did that ever happen?

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Codeine Rapid Metabolizers

A 13-day old breastfed infant died from morphine overdose when the mother took codeine to treat episiotomy pain.

After the death, a genetic test showed the mother to be a rapid metabolizers of codeine.

The chance of being a rapid metabolizers ranges from less than 1 per 100 to 28 per 100 people.

Only a genetic test can tell if a person is affected, but there is only limited information about using this test for codeine metabolism to morphine.

In most cases, codeine is, and continues to be, appropriate treatment for pain while breastfeeding.

It should be used at the lowest dose for the shortest period of time.

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Codeine Rapid Metabolizers (continued)

The mother in this case noted excess drowsiness in herself, so the physician lowered the dose, but the drowsiness continued.

The mother continued to take the codeine for an extended time.

During this time, her baby also began to experience similar signs because of the high level of morphine in the breast milk.

After 13 days, the baby experienced depression and died.

It seems apparent that the mother was not counseled properly on the potential adverse effects of codeine (rapid metabolizers or not) on her breastfed child.

A mother should never have a breastfed baby in respiratory depression before realizing the medication she is taking has led to the outcome.

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CONSIDERATIONS: OTC Medications

Analgesics

Cough, Cold, and Allergy Preparations

Cough and Cold Lozenges and Sprays

Nasal Preparations

Asthma Preparations

Antacids and Digestive Aids

Laxatives / Stool Softeners

Anti-Diarrheal Preparations

Nausea and Vomiting / Motion Sickness PreparationsHemorrhoidal PreparationsSleep PreparationsStimulantsAppetite Suppressants

Insulin Preparations

Artificial Sweeteners

Miscellaneous OTCsSlide45

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OTC

BREASTFEEDING COUNSELING GUIDELINES

Avoid taking OTC medications for which

safer products are available.

Avoid taking OTC medications for which

little breastfeeding information

is available.

Avoid taking

combination OTCs, which are those with multiple ingredients (it is better for the mother to take an OTC that has the one or two specific ingredients that will treat her specific condition; there is no need for the mothers or nurslings to be exposed to unnecessary ingredients).Slide46

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OTC

BREASTFEEDING COUNSELING GUIDELINES

Avoid taking

extra strength

forms of OTC medications (there is no need for the nursling to be exposed to extra amounts of a drug when it is not needed).

Avoid taking

long-acting

OTC medications (there is no need for the nursling to be exposed to a drug for a longer period of time, especially if an adverse reaction is possible in the nursling).

The mother should know about possible side effects that might occur in her nursling, as well as herself.If possible, as with prescription drugs, the mother should use a nondrug approach for treating her symptoms.Slide47

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CONSIDERATIONS (See Nice Articles and Books):

Herbals (Major Galactogogues)

Chaste Tree

Fennel

Fenugreek

Garlic

Goat's Rue

Milk Thistle / Blessed ThistleSlide48

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CONSIDERATIONS (See Nice Articles and Books):

Herbals (Minor Galactogogues)

Anise

Borage

Alfalfa

Caraway

Coriander

Dandelion

DillMarshmallowNettleHopsOat StrawRed CloverRed RaspberryVervainSlide49

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CONSIDERATIONS (See Nice Articles and Books):

Herbals

Analgesics

Bugleweed, Comfrey

Headache (Migraine) Agents

Feverfew

Anti-Anxiety Agents

Indian Snakeroot, Kava Kava, Passionflower, St. John’s Wort, Valerian Stimulants

Ginseng Root, Siberian Ginseng, Ginkgo Biloba, Angelica Root / Dong Quai

Sleep Preparations

Melatonin (Not Herbal)

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CONSIDERATIONS (See Nice Articles and Books):

Herbals

Cough, Cold, and Allergy Products

Coltsfoot, Echinacea, Elder Flower

Gastrointestinal Agents

Aloe, Buckthorn, Cascara Sagrada, Chamomile, Flaxseed, Licorice, Psyllium Seed, Rhubarb, Senna

Nausea and Vomiting Preparations

Ginger

Lipid Lowering Agents Soy LecithinUrinary Tract Preparations Goldenrod, Petasites, Uva UrsiSlide51

CONSIDERATIONS: Recreational Drugs

Amphetamine / Methylphenidate

Marijuana

Cocaine

Phencyclidine

Narcotics

Caffeine

Alcohol

NicotineSlide52

Recommendations for Recreational Drug Use (See Handout)

Drugs’ Effects

Social Considerations

Physician Recommendations

Alcohol Use Facts

PLUS: Do

NOT

want social services taking baby away from mother

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RECREATIONAL DRUGS

Amphetamine / Methylphenidate

Levels in breast milk difficult to obtain due to

large volume of distribution

Possibility of

irritability or poor sleep pattern

Abuse

: hypertension, palpitations, tachycardia, over stimulation, motor incoordination, tremor, restlessnessSlide54

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RECREATIONAL DRUGS

Cocaine

Apnea and seizures

in breastfed infant who ingested cocaine which was applied topically as anesthetic

Abuse

: tachycardia, tachypnea, hypertension, irritability, tremulousness

One of

most dangerous

of all drugs of abuse Slide55

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RECREATIONAL DRUGS

Phencyclidine

Potent

hallucinogen

Long half-life of metabolites

One of most dangerous

of all drugs of abuse Slide56

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RECREATIONAL DRUGS

Narcotics

Codeine, Morphine, Meperidine, Heroin

Large doses

can cause

dependence and withdrawal symptoms

in nurslings

Use

proper withdrawal techniquesSlide57

Wean Breastfed Baby Off Narcotics

There are several ways to “wean” a baby off narcotics to avoid withdrawal symptoms:

Use of

Diluted Tincture of Opium (DTO)

in the infant, which would be the least preferred

Gradually wean

the baby and maintain the narcotic dose level, which is better, but not the most preferred

Gradually reduce the narcotic dose while maintaining breastfeeding, which the best optionDuring these processes, the mother may use Suboxone or methadone.Methadone can be used safely at doses above 100 mg daily for over 30 days, if necessary, while the mother is breastfeedingSlide58

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RECREATIONAL DRUGS

Caffeine

Even though

clearance of caffeine

in infants is markedly reduced, amounts of caffeine ingested by breastfeeding children is small, if reasonable amounts of coffee, tea, or colas are used by mother

(1 to 2 cups per day)

Mothers of newborns, and in particular of

premature newborns

, should avoid caffeine Note: Caution if taking theophylline also (Why?)Slide59

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RECREATIONAL DRUGS

Alcohol (See Handout)

1 to 2

cocktails, glasses of wine, or bottles of beer: Usually insignificant levels

Odor of alcohol

in milk may cause infants to consume significantly less milk

Excessive, chronic

drinking: Mild sedation to deep sleep, hypoprothrombinemic bleeding

Caution: Intoxicated mothers should not breastfeed; chronic alcoholics should not breastfeed Because of rational use of alcohol is possible during breastfeeding, the use of Alcohol Breast Milk Tests is a complete waste of money, time, and effort.Slide60

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RECREATIONAL DRUGS

Marijuana

Tetrahydrocannabinol (THC)

concentrated in breast milk and is absorbed by the nursing baby

Long-term effects

may occur (both mother and baby)Slide61

Schedule I Controlled Substances

Substances have a

high potential for abuse

, have

no currently accepted medical use

in treatment in the U.S., and have a

lack of accepted safety

for use under medical supervision

Marijuana is Schedule I

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Marijuana Consequences

CONSEQUENCES

Mother also potentially

abusing other drug substances

: marijuana users usually do

Exposure to

marijuana smoke is potentially hazardous and toxic as is cigarette smoke

Current evidence indicates that marijuana during lactation may adversely affect

neurodevelopment, especially during critical brain growth during adolescent maturation

Marijuana impacts neuropsychiatric, behavioral, and executive functioning, which may affect future adult productivity and lifetime outcomes (delinquency, depression, and substance abuse)Law passed in States, which makes recreational use of marijuana legal render toxicology interpretation complex (is mother using recreational and/or medical marijuana “legally” or illicitly and thus exposing breastfed baby to “legal” or illicit marijuana?)62Slide63

Hopalong CassidySlide64

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RECREATIONAL DRUGS

From both a philosophical and scientific

viewpoint, recreational drugs of abuse should be

contraindicated during breastfeeding

as they are hazardous, not only to the nursling, but to the mother as well. Slide65

fjncat@hotmail.comSlide66

Thank YOU for your attention and participation

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