Breastfeeding and the Pharmacist's Role in Maternal Medication Management: Identifying Barriers and the Need for Continuing Education

Abstract

Breastfeeding offers a multitude of benefits for infants, mothers, and society. Exclusive breastfeeding of infants is recommended for at least the first 6 months of life. Although transfer of drug into breastmilk can occur, most medications are safe to use during breastfeeding. Pharmacists, regarded as the most accessible health care professionals, recognize their role as medication specialists for breastfeeding women. Unfortunately, a lack of formal and continuing education on medication use during lactation often results in pharmacists providing the unnecessary recommendation to disrupt breastfeeding during medication use. In addition to lack of education, other barriers pharmacists experience in providing optimal patient care during lactation include difficulty identifying breastfeeding status and inconsistency in recommendations between scientific resources. Pharmacists must voice their need for additional continuing education and take action to close the knowledge gap and address barriers to providing care.

Introduction

Breastfeeding is recommended by all major organizations as the best source of nutrition for most infants.^1–4 In 2012, the American Academy of Pediatrics published its policy on breastfeeding, which stated infants should be exclusively breastfed for approximately 6 months with continuation of up to 12 months or longer.³ Healthy People 2030⁵ set the objective to increase the proportion of infants who are exclusively breastfed at 6 months to 42.4%. In 2017, 84% of infants were breastfed for any duration, according to the CDC's National Immunization Survey.⁶ However, only 46.9.% of infants were exclusively breastfed through 3 months and only 25.6% of infants were exclusively breastfed through 6 months.⁶ Barriers to breastfeeding in the United States include lack of knowledge, social norms, poor family and social support, embarrassment, lactation problems, employment and childcare, and barriers related to health services.⁷ These breastfeeding rates are concerning, as many benefits of breastfeeding exist for the infant, mother, and society.

Benefits of Breastfeeding

Breastfeeding offers numerous physical and neurological benefits for infants. Potential benefits for infants include a reduced risk of diseases, such as childhood leukemia, hypertension, necrotizing enterocolitis, otitis media, respiratory illnesses, severe lower respiratory infections, sudden infant death syndrome, and type I and II diabetes.¹ In 2001, the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial of over 17,000 mother-infant pairs, found infants who were breastfed were 46% less likely to develop atopic dermatitis and 40% less likely to develop a gastrointestinal infection in the first year of life.⁸ On the other hand, infants who are not breastfed are found to be 3 times more likely to be hospitalized owing to lower respiratory tract infections and are twice as likely to develop otitis media and diarrhea as compared with infants who are breastfed.⁹ It is also suggested that infants who are not breastfed experience a 37% greater risk of asthma, a 23% to 37% greater risk of type I diabetes, and a 60% greater risk of type II diabetes.⁹

Regarding neurological benefits, an increased frequency of breastfed meals and duration of exclusive breastfeeding during the first year of life have a positive association with enhanced memory performance, early language, and motor skills. This has been shown to continue into childhood and adolescence.¹⁰ It has been hypothesized that long-chain polyunsaturated fatty acids found in breast milk, including docosahexaenoic acid and arachidonic acid, are the components of breast milk that significantly contribute to the beneficial neurological effects of breastfeeding.¹¹ A follow-up of PROBIT cohorts in 2008 discovered that infants who are breastfed have a 5.9-point higher IQ later in life.¹² Although the increase in IQ is remarkable, the initial PROBIT cohort followed up infants from 1996–1997, before the supplementation of docosahexaenoic acid and arachidonic acid in infant formula in 2002.^8,13 This may diminish the IQ benefit seen in the PROBIT trial.

In addition to benefits to the infant, breastfeeding offers many benefits for the mother, both postpartum and long term. Immediate benefits of breastfeeding for the mother include uterine involution and reduced postpartum bleeding.¹⁴ Exclusive breastfeeding suppresses progesterone and estrogen, which induces lactational amenorrhea and offers 96% protection against pregnancy during the first 6 months postpartum.^14,15 Breastfeeding may lead to a more rapid weight loss to pregestational conditions and possible reduction in risk for postpartum depression.¹⁴ A 2005 study found that breastfeeding mothers reported reduced rates of anxiety, negative mood, and stress as compared with formula-feeding mothers.¹⁶ Literature supports a wide range of long-term maternal benefits associated with breastfeeding. Breastfeeding leads to lower rates of chronic disease, including obesity, type II diabetes, hypertension, hyperlipidemia, and cardiovascular disease.^17–19 Breastfeeding has been estimated to reduce a mother's risk of breast cancer by 4% for each year of breastfeeding.⁹ Similarly, breastfeeding may also offer protection for ovarian cancer by lowering a woman's relative risk for ovarian cancer by approximately 2% for each month of breastfeeding.²⁰

Society is benefitted by breastfeeding, as well. Breastfeeding results in positive economic impacts caused by lower levels of infant and maternal illness, thus decreasing health care costs.²¹ An analysis published in 2010 reported potential cost savings for the United States if 90% of families would exclusively breastfeed for the first 6 months.²² It was found that the United States would save $13 billion (in 2007 dollars) per year when factoring both direct and indirect costs associated with additional illnesses and diseases.²² Breastfeeding is also more sustainable and environmentally friendly than formula feeding owing to the lack of manufacturing, waste generated by disposable storage containers, and required transportation.⁷

Medication Use During Breastfeeding

Medication use during breastfeeding is common, with an estimated 96% of breastfeeding women using 1 or more medications while breastfeeding.²³ Drug transfer into breast milk occurs primarily via passive diffusion.^24,25 Time to maximum concentration and drug half-life may also affect how much drug is in the breastmilk at the time of the infant's feeding.²⁵ Factors that increase the likelihood of medication transfer into breastmilk are a low molecular weight, high lipophilicity, low protein binding, and weakly basic pH.^24–26 The milk to plasma ratio, typically found in the drug monograph, is a useful tool to evaluate the relative degree of drug excretion into the breast milk. A ratio less than 1 indicates a drug does not accumulate in the breast milk, whereas a value between 1 and 5 suggests a drug may be sequestered into the breast milk.^24,25 Bioavailability is an important consideration for assessing appropriateness of a drug during lactation. Poor oral bioavailability of medications would minimize the risk to the infant, even if it was present in large quantities in the breast milk, owing to minimal gastrointestinal absorption; however, the infant may experience GI symptoms, such as diarrhea and constipation.^25,26

Fortunately, the use of maternal medications while breastfeeding seldom negatively impacts infants and the avoidance or discontinuation of medication for this reason should be rare.^27,28 The mother's medication serum concentration is the most important factor in infant exposure to a medication.²⁵ A dose of medication to an infant less than 10% the maternal dose is believed to be safe.²⁹ However, a misconception regarding medication use while breastfeeding commonly practiced by patients and providers is “when in doubt, don't breastfeed.”²⁷ The process of pumping to collect breastmilk, then discarding the breastmilk to prevent infant drug exposure while the mother is taking short courses of medication is often referred to as “pump and dump” and is not a necessary practice in most situations.²⁵ Even brief disruptions of breastfeeding can result in substantial negative effects on the infant, as well as decrease mother's milk supply, and should be avoided.²⁷ Instead of defaulting to “pump and dump,” pharmacists must be able to use knowledge of drug pharmacodynamics and pharmacokinetics, and consider infant-specific factors and the mother's breastfeeding goals to assess a drug's safety for use during breastfeeding.

Pharmacist's Role

Expanding the role of the pharmacist is vital to the success of breastfeeding mothers. Pharmacists are regarded as the most accessible health care professional owing to their extended hours of availability and ease of access.³⁰ As primary health care professionals, pharmacists have frequent contact with breastfeeding women who often try to self-medicate for minor illness and ailments, thus the need for an expanded role. Women often admit to searching for their own information, resulting in conflicting sources.³¹ This leads to increased anxiety and fear, which can be solved by properly educated pharmacists.³¹

Codeine is an example of a prescription medication that has the potential to result in significant harm to a breastfeeding infant. A case report published in 2007 details the death of a neonate caused by morphine poisoning from breastmilk following the mother's use of codeine for postpartum pain in a CYP2D6 ultrarapid metabolizer.³² However, the plausibility of this case report was challenged in a 2020 mini-review suggesting that, among other factors, only small amounts of opioid would pass into breastmilk regardless of the mother's CYP2D6 phenotype.³³ This demonstrates how making clinical recommendations and interventions regarding prescription medication use and breastfeeding, such as whether or not to avoid codeine in the breastfeeding patient, is regarded as a complex and complicated task. It is imperative that pharmacists provide education not only on prescription medications, but also on OTC medications.³¹ The most common recommendations made by pharmacists to lactating women involve treating headache, nausea/vomiting, indigestion, sore or cracked nipples, and insufficient milk.³⁴ In addition to searching for their own information, breastfeeding women are found to self-medicate between 17% and 52% of the time.³⁰ This presents a perfect opportunity for pharmacists and pharmacy staff from a variety of practice settings to provide ongoing support to breastfeeding mothers.³⁰

Pharmacists have the ability to make a positive impact within the breastfeeding population by ensuring safe medications are dispensed and administered at an appropriate time.³⁵ Community pharmacists strongly agree they have a role in breastfeeding and patient care.³¹ More than 90% of pharmacists self-reported playing a significant role in multiple patient care areas: having a trusting relationship with breastfeeding patients; checking medication history of breastfeeding patients at every visit; providing information on how to limit the transfer of medications through breast milk; following up on medication use; providing evidence-based information for the safety of medications during breastfeeding; stressing the importance of medication adherence; mentally supporting breastfeeding women; and advising women to visit a doctor, based on specific symptoms they may be experiencing.³¹

The need for proper identification, consultation, and education is vital to the success of breastfeeding mothers throughout all aspects of care. Although the impact that community pharmacists make with breastfeeding mothers may be more apparent, inpatient and ambulatory care pharmacists can also play a critical role in ensuring medication safety in this patient population. Recent literature has shown that pharmacists in these 2 settings have made a positive impact on patient care through a variety of interventions. Ninety percent of patients in the primary care setting reported increased satisfaction, understanding, and feeling of safety with their medications when pharmacists are involved on interdisciplinary teams.³⁶ Expanding opportunities exist for primary care pharmacists to play a substantial role in transitional care management.³⁷ Pharmacist-performed comprehensive medication management has shown improved outcomes in a multitude of practice settings.³⁶ In addition, pharmacist-led medication reconciliation programs have been proven effective at improving posthospital health care utilization, leading to a 19% reduction in all-cause readmission rates, a 28% reduction in all-cause ED visits, and 67% reduction in adverse drug effect–related hospital revisits.^36,38 Among other opportunities for interventions, comprehensive medication reviews and reconciliations performed by pharmacists upon hospital admission, hospital discharge, and at outpatient appointments provide an opportunity to intervene on unsafe medication use in breastfeeding mothers. The positive impacts produced by pharmacists that are observed in all patient populations within the inpatient and ambulatory care settings support the pharmacist's role in improving patient outcomes for breastfeeding patients in these settings, as well.

Barriers to Patient Care

Currently, community pharmacists feel they are unable to offer adequate information and recommendations about medications during lactation.³⁴ Identification of major barriers is key to resolving this current lapse in the health care system regarding breastfeeding mothers. In addition to time constraints and challenges with reimbursement that can hinder pharmacist-led patient care services, several unique barriers exist that prevent pharmacists from providing optimal care to lactating patients. The most frequently reported barriers to providing pharmaceutical care during breastfeeding are difficulty identifying the woman's status and lack of education regarding preconception, pregnancy, and breastfeeding.³¹ Inconsistency of recommendations between resources is another barrier for pharmacists and may lead to contradicting information provided to lactating women from one pharmacist to the next.²⁷

Identifying Breastfeeding Status. One major barrier preventing pharmacists from serving in their role as medication specialists for lactating women is the pharmacist's difficulty determining which patients need this counseling and then forming a meaningful relationship with them. A 2009 survey taken by 36 community pharmacists in Rhode Island found that pharmacists have differing opinions on methods for determining that a patient is breastfeeding: 61% believe women should self-disclose, 33% believe pharmacists should look for prenatal vitamins on the patient's chart, 33% believe the physician should inform the pharmacy, and 45% believe there should be an opportunity to disclose breastfeeding information on a signature waiver.³⁹ Regardless of which method is “correct,” pharmacists lack consistent methods for identifying patients who are breastfeeding. In the same survey, only 15% of pharmacists self-reported asking women if they are currently breastfeeding and 58% of pharmacists self-reported never asking women if they are breastfeeding.³⁹ Clearly, lack of identification of breastfeeding patients is a significant problem within community pharmacy, which can prevent pharmacists from providing appropriate patient care interventions to these breastfeeding patients. When asked common roles of a pharmacist related to lactation (Table 1), greater than 85% of surveyed retail pharmacists in Belgium in 2019 self-reported currently practicing just 2 roles (advising breastfeeding women with severe symptoms to visit a doctor and to visit a doctor if their symptoms worsen or insufficiently respond to OTC medication).³¹

Table 1.

Roles of a Pharmacist Related to Lactation³¹

Having a trusting relationship with breastfeeding women

Checking the medication history of breastfeeding women at every visit

Providing information on how to limit the transfer of medicines in breastmilk as much as possible

Following up medication use of breastfeeding women

Providing evidence-based information on the safety of specific medicines

Discussing the importance of medication adherence

Mentally supporting breastfeeding women

Advising breastfeeding women with symptoms of a (severe) condition to visit a doctor

Advising breastfeeding women to visit a doctor if symptoms worsen/insufficiently respond to (OTC) medicines

Lack of Education. Pharmacists feel as though their formal education did not provide them with enough training to adequately provide proper care to patients in the area of maternal-fetal medicine.³⁵ One example consistently mentioned as a main concern in interviews with 30 West Australian community pharmacists is a lack of knowledge and confidence in discussing the use of complementary medicine during lactation.³⁰ In addition, even qualified pharmacists report not feeling comfortable providing advice on OTC medications to breastfeeding women, according to a 2014 cross-sectional survey of 273 pharmacists across British Columbia, Qatar, and Uganda.³⁵ A list of a few commonly used medications and their effect on lactation can be found in Table 2. Only 30% of Belgian community pharmacists believe they have sufficient knowledge about the passage of medicines into breastmilk.³¹ This discomfort suggests a lack of knowledge and education on maternal medication use, which can be dangerous for the breastfeeding infant.

Table 2.

Example Medications and Their Effect on Lactation ^*

Drug Class	Medication	Lactation Risk26†	Effects on Lactation
Analgesic/anesthetic	Acetaminophen, ibuprofen24	L1	Small amounts are excreted into breastmilk. Clinical symptoms in infants after exposure are atypical.
	Aspirin42	L2	Excreted into the breastmilk. High maternal doses can lead to metabolic acidosis in breastfed infants. Acetaminophen or ibuprofen preferred.
	Bupivacaine, lidocaine24	L2	Slight amounts excreted into breastmilk. Poor oral absorption by infant makes local administration safe (epidural).
Anxiolytic	Diazepam24	L3	Can cause sedation in infants. Preferred to use sedative with a shorter half-life.
	Lorazepam, temazepam24	L3	Can be used in lactation. Preferred over sedatives with longer half-life.
	Oxazepam24	L2
Allergy	Cetirizine43	L2	Small oral administration to breastfeeding mother is probably acceptable. Larger or more prolonged doses may cause effects in infant.
	Diphenhydramine44	L2	Small doses not known to cause adverse effects to infant. Larger or more frequent dosing may cause effects on milk supply. Alternatives include fexofenadine or loratadine.
	Prednisone45	L2	Small amounts of drug in breastmilk. Ingesting large doses seen to decrease lactation temporarily.
Antibiotic/antifungal	Amoxicillin46	L1	Low concentrations in breast milk not expected to cause adverse effects in infant. Can occasionally cause diarrhea or thrush.
	Cephalexin, cefdinir24	L1	Generally safe for the breastfed infant. Can occasionally cause diarrhea or thrush.
	Fluconazole47	L2	Small amounts excreted into breastmilk. Generally safe for breastfed infants.
	Tetracycline24	L3	Concerns for dental enamel staining and bone deposition with infant exposure. However, short-term use is likely acceptable when no alternative is available.

^* Please consider patient-specific factors along with drug pharmacokinetics and pharmacodynamics when making clinical decisions for breast-feeding women.

^† L1 = compatible, L2 = probably compatible (limited studies), L3 = probably compatible (no controlled studies).

Historically, pharmacists have received limited education on the management of breastfeeding issues, including medication safety.²⁷ The American College of Clinical Pharmacy (ACCP) Pharmacotherapy Didactic Curriculum Toolkit provides pharmacy schools with guidance for didactic pharmacotherapy development.⁴⁰ In the 2019 update, lactation is categorized as a tier-one topic listed under the category gynecologic and obstetric conditions.⁴⁰ A tier-one topic is defined as “students should receive education and training on this topic to prepare them to provide collaborative, patient-centered care upon graduation and licensure.”⁴⁰ ACCP addresses the importance of teaching student pharmacists about breastfeeding. However, better standardization is needed within pharmacy school curricula to address this gap in knowledge for graduating pharmacy practitioners.

These conclusions point to a gap in education; there is a need for continuing education for practicing pharmacists focused on this specific topic area of maternal medication management during breastfeeding. Although overall conclusions found pharmacists' knowledge and counseling towards breastfeeding is currently insufficient, pharmacists acknowledge their lack of education and are still committed to playing an important role in counseling these patients.³¹ One survey found most pharmacists self-reported continuing education would be of value.³⁴ In another study, more than two-thirds of pharmacists stated continuing education would produce positive outcomes for infants and lactating women.³⁵ Although a pharmacist's impact on medication safety in breastfeeding patients may look different depending on their practice setting (community vs inpatient vs ambulatory care), future continuing education would ideally provide pharmacists in all settings with baseline knowledge on interpreting drug pharmacokinetics and pharmacodynamics, using drug resources, and considering patient-specific goals to make appropriate recommendations on a drug's safety while breastfeeding.

Variation in Resource Recommendations. An important tool for all pharmacists making maternal medication recommendations to lactating patients and health care professionals is scientific resources. Seventy percent of pharmacists report having the ability to efficiently use scientific resources to determine medication appropriateness in lactation.³¹ A multitude of resources are available for pharmacists to obtain information on medication use during lactation. Table 3 outlines these resources and their number of safe-rated drugs for lactation. Saferated can be defined as medications considered by the respective resource as having minimal risk of negative effects and suggesting that breastfeeding may continue. LactMed is an internet-based database published by the National Library of Medicine/National Institutes of Health and regarded by the American Academy of Pediatrics (AAP) as “the most comprehensive, up-to-date source of information regarding the safety of maternal medications when the mother is breastfeeding.”³ Other references available to pharmacists include AAP's “The Transfer of Drugs and Other Chemical Substances Into Human Milk,” Drugs in Pregnancy and Lactation, Medications and Mothers' Milk (aka Hales Meds), Physician's Desk Reference (PDR), the World Health Organization and United Nations database, drug reference databases (i.e., Micro-medex, Lexi-Comp), the respective pharmacy chain's intranet, package inserts, and drug monographs.²⁵

Table 3.

Sources Available and Their Number of Safe-Rated Drugs²⁷

Source Available	Safe-Rated Drug (in Comparison)
Medications and Mothers’ Milk (MMM), aka Hales Meds	Highest number
LactMed	Highest number
Micromedex	Number close to AAP list
Drugs in Pregnancy and Lactation (DPL)	Number close to AAP list
Lexi-Comp	Fewest and lacked safe listing even for drugs widely accepted
Physician’s Desk Reference (PDR)	Fewest and lacked safe listing even for drugs widely accepted

Although pharmacists may exhibit confidence in consulting scientific resources to make maternal medication decisions for lactating women, recommendations between references are not always equivalent.²⁵ Medications & Mother's Milk and LactMed were found to provide the greatest quantity of safe-rated drugs among all the lactation resources.²⁷ A comparison of 2 popular retail pharmacy databases, Lexi-Comp and PDR, discovered these references had the fewest number of safe-rated drugs and also lacked safety listings even in medications that are widely accepted as being safe.²⁷ More specifically, Lexi-Comp and PDR frequently provided recommendations that would unnecessarily disrupt breastfeeding.²⁷ Unfortunately, many resources do not contain up-to-date research to make safe and accurate consultation recommendations for lactating patients.²⁷ This variation between resources is a barrier preventing pharmacists in providing optimal patient care to lactating patients, leading to inconsistency in recommendations from one pharmacist to another, and may cause a pharmacist to default to the assumption of “when in doubt, don't breastfeed.”^27,39 It is ultimately the pharmacist's responsibility to review data behind the recommendations and consult multiple resources before making a final recommendation for a patient.⁴¹

Conclusion

Breastfeeding provides many important benefits to both the infant and the mother. Pharmacists serve an important role in medication management of breastfeeding women to prevent adverse effects from occurring in the infant due to medication transfer through breastmilk. Barriers exist that prevent pharmacists from providing optimal patient care to breastfeeding women, including identification of breastfeeding patients, variation in resource recommendations, and lack of education. By expressing this need to leadership of pharmacy organizations and authoring additional opinion publications, the pharmacy profession must begin to voice their need for and support of additional continuing education on medication management in breastfeeding patients. Expanded access to continuing education for pharmacists is necessary to improve overall knowledge regarding safe medication use in breastfeeding, provide strategies for identifying patient lactation status, and teach effective use of scientific resources for making maternal drug recommendations. Local and national pharmacy associations representing all practice settings should incorporate breastfeeding into their member education opportunities. Practicing pharmacists need to take action to bridge the knowledge gap in order to offer accurate education to health care providers and, ultimately, to best support breastfeeding patients.

ABBREVIATIONS

AAP

American Academy of Pediatrics

ACCP

American College of Clinical Pharmacy

CDC

Centers for Disease Control and Prevention

ED

emergency department

GI

gastrointestinal

OTC

over-the-counter

PDR

Physician's Desk Reference

PROBIT

Promotion of Breastfeeding Intervention Trial