BREASTFEEDING MEDICINE

Volume 10, Number 3, 2015 Public Health and Public Policy

ª Mary Ann Liebert, Inc.
DOI: 10.1089/bfm.2014.0144

Delphi Survey of International Pharmacology Experts:

An Attempt to Derive International Recommendations
for Use of Medicine in Breastfeeding Women

Lisa H. Amir,1 Kath Ryan,2 and Clare Barnett1

Abstract

Introduction: There are currently no common guidelines used by health professionals to aid decision-making
around the use of medicines during breastfeeding. Several specialized books, Web sites, and drug information
services exist; however, all use slightly different criteria to derive their ‘‘safety hierarchy.’’ The aim of this
study was to build consensus among international experts in pharmacology and breastfeeding to develop an
agreed-upon classification system for safety of medicine use in breastfeeding women.
Study Method: A three-round Web-based Delphi qualitative research design was used.
Results: Seventeen experts in pharmacy/pharmacology and breastfeeding identified 15 key parameters that are
used to inform decisions about medicines and breastfeeding. The most important parameters about the infant
were the age and health of the child, and those of the medicine were the safety profile and experience of use in
infants. The experts had a clear understanding of the complexity of decision-making when prescribing for
breastfeeding women. Although the current number or letter classification systems do not incorporate important
considerations such as infant age, a longer ‘‘descriptive text’’ incorporating all considerations may be im-
practical in busy clinical practice.
Conclusions: Although clinicians and lay people would appreciate a simple classification scheme, in practice,
decision-making about the safety of medicines for breastfeeding women is complex.

Introduction issues. In addition, those searching for information on

M aternal medicines rarely cause adverse effects in
breastfeeding infants.1 With the exception of illicit
drugs, radioactive substances, and antineoplastic medicines,
medications can usually be prescribed to a breastfeeding
woman while she continues to breastfeed.2 Temporary ces-
sation of breastfeeding or a ‘‘pump and dump’’ approach is
associated with significant, and often underappreciated, ad-
verse effects for maternal and infant health, including the
removal of maternal antibodies, hormones, and fatty acids
from the infant’s diet, disruption of maternal milk supply,
disruption of the mother–infant relationship, and potential
risks associated with replacement feeds such as contamina-
tion of infant formula with bacteria or environmental toxins.3
However, many professionals continue to recommend tem-
porary or complete cessation of breastfeeding or avoidance of
medication ‘‘to be on the safe side.’’
Historically, health professionals have received little for-
mal education on breastfeeding medicine and medication
breastfeeding and safety of medicines are met with a con-
fusing array of information sources.4 There are currently no
common guidelines used by health professionals to aid de-
cision-making around the use of medicines during breast-
feeding. Several specialized books, Web sites, and drug
information services exist; however, all use slightly different
criteria to derive their ‘‘safety hierarchy.’’
Many of the current guidelines use a categorical system for
stratifying risk and providing recommendations. The publi-
cation Medications and Mother’s Milk5 is well known among
lactation experts and uses a five-tiered system (Table 1). In the
past, the American Academy of Pediatrics used three cate-
gories (‘‘compatible,’’ ‘‘may be of concern,’’ and ‘‘significant
effects’’),6 but more recently it has avoided individual guid-
ance for each medicine, instead referring to LactMed, which
does not feature a ratings system.2,7 LactMed is a free online
resource from the National Library of Medicine; it provides a
summary at the top of each monograph.7 Medication Safety in
Pregnancy & Breastfeeding8 and Drugs During Pregnancy

1
Judith Lumley Centre, La Trobe University, Melbourne, Victoria, Australia.
2
School of Nursing and Midwifery, La Trobe University, Bundoora, Victoria, Australia.

168
MEDICINES AND BREASTFEEDING: DELPHI STUDY 169

Table 1. Classification Scheme Used by Hale5

Classification Description
L1 (safest) Drug that has been taken by a large number of women without observed adverse effects
in the infant. Controlled studies in breastfeeding women fail to demonstrate a risk to the
infant, and the possibility of harm to the breastfeeding infant is remote, or the product
in not orally bioavailable in an infant.
L2 (safer) Drug that has been studied in a limited number of breastfeeding women without an increase
in adverse effects in the infant and/or the evidence of a demonstrated risk that is likely
to follow use of the medication in a breastfeeding woman is remote.
L3 (moderately safe) There are no controlled studies in breastfeeding women; however, the risk of untoward
effects to a breastfed infant is possible, or controlled studies show only minimal
nonthreatening adverse effects. Drugs should only be given if the potential benefit justifies
the potential risk to the infant. (New medications that have absolutely no published data
are automatically categorized in this category, regardless of how safe they may be.)
L4 (possibly hazardous) There is positive evidence of risk to a breastfed infant or to breastmilk production, but the
benefits from use in breastfeeding mothers may be acceptable despite the risk to the infant
(e.g., if the drug is needed in a in life-threatening situation or for a serious disease for which
safer drugs cannot be used or are ineffective).
L5 (contradicated) Studies in breastfeeding mothers have demonstrated that there is a significant and documented
risk to the infant based on human experience, or it is a medication that has a high risk
of causing significant damage to an infant. The risk of using of the drug in breastfeeding
women clearly outweighs any possible benefit from breastfeeding. The drug is
contraindicated in women who are breastfeeding an infant.

and Lactation9 also avoid categories and provide short
monographs synthesizing information on the medicine to fa-
cilitate individual interpretation of the evidence. The Austra-
lian Perinatal Psychotropic Medicine Information Service uses
two categories: ‘‘caution’’ and ‘‘contraindicated.’’10 Also in
Australia, the Royal Women’s Hospital11 and the Australian
Medicines Handbook12 each have their own classification
system. Not only are there many different categorization sys-
tems, but each system uses slightly different criteria for de-
termining a medicines safety profile. Akus and Bartick4
evaluated 10 resources used in the United States for breast-
feeding and medicines; of the 14 medications surveyed, there
was no agreement between all resources on a medication’s
safety, and many resources failed to include the most up-to-
date information in their analysis.
Medication safety in breastfeeding is ideally evaluated via
clinical evidence of maternal milk levels, infant plasma con-
centration, and observed clinical effects. However, such
studies are often unfeasible. Instead, recommendations may be
based on pharmacokinetic parameters of the medicine, such as
its molecular size, protein binding capacity, and bioavailabil-
ity.13 Interpretation of this evidence is not straightforward, and
the weight given to clinical versus pharmacokinetic factors
may ultimately influence whether a medication is labeled safe
by a particular resource. Consequently a medicine classified as
low risk in one resource may receive a higher risk categori-
zation in another.
Decision-making for health professionals is further com-
plicated by pharmaceutical companies’ reluctance to provide
recommendations without a clinical evidence base. The Food
and Drug Administration (FDA) have announced changes to
their medicine labeling requirements, requiring pharma-
ceutical companies to provide a risk summary for both
pregnancy and lactation.14 The current A, B, C, D, and X
pregnancy categories will be removed in favor of a mono-
graph detailing the potential risks to milk production and the
infant, clinical considerations to consider when prescribing,
and an overview of data on which the recommendations are
based.14
It is unclear what information should be communicated to
health professionals and women to aid decision-making for
breastfeeding and medicines. The aim of this study was to
build consensus among international experts in pharmacol-
ogy and breastfeeding to develop an agreed-upon classifica-
tion system for safety of medicine use in breastfeeding
women.
Materials and Methods
A three-round Web-based Delphi qualitative research de-
sign was used. The key feature of the Delphi technique is the
recruitment of an expert panel, which is then systemi-
cally surveyed about a specific question or issue.15,16 Initial
statements are derived from background research and anal-
ysis of the literature. Panel members provide researchers with
individual responses to statements that are then compiled,
summarized, and fed back to the group. The process re-
peats until consensus (a predetermined level of agreement) is
reached. The Delphi technique offers advantages over tradi-
tional consensus building (e.g., face-to-face meetings) in
that it promotes anonymity within the group, is cost-
effective, limits geographical barriers, and supports reflective
responses.17–20
Ethics approval for this study was obtained from the Fa-
culty of Health Science Human Research Ethics Committee
at La Trobe University, Melbourne, VIC, Australia (protocol
number FHEC 13/193).
Panel selection
Experts were identified based on a history of publications
on breastfeeding, lactation, and medications and/or interna-
tional prominence in breastfeeding and medicine education
170
and training. Sixteen international experts were initially
identified. In August 2013, an invitation letter was sent via
e-mail providing a summary of the study design, its objec-
tives, and the anticipated time commitment. Experts were
also asked to nominate colleagues they felt would positively
contribute to the study. This snowball recruitment method
ensured greater diversity among the panel. Twelve additional
experts were invited to participate based on panel recom-
mendations. A positive response to the invitation letter served
as informed consent.
Delphi process
In all three rounds, questionnaires were distributed elec-
tronically by a secure, password-protected, Web-based soft-
ware program designed for creating and publishing surveys
(Qualtrics, Provo, UT). Questionnaires were initially pre-
tested on academics with expertise in pharmacology and
lactation who were not participating in the study. Overall, the
questionnaires balanced the needs of building consensus with
allowing innovative ideas to surface in the early stages of the
study. Experts were given 3 weeks to respond to each survey.
Questionnaires were emailed on Day 0 of each round, and
reminder e-mails were sent at Days 7, 10, and 14 for nonre-
sponders. Nonresponders from a round were eligible for in-
clusion in subsequent rounds of the survey. Data were
analyzed using descriptive statistics. Mean ranks, range, and
percentage agreement were obtained for each parameter
using the Qualtrics statistical program and Microsoft
(Redmond, WA) Excel.
Round 1
Round 1 included several open-ended questions exploring
current medicines and breastfeeding classification systems
and their strengths and weaknesses. Participants were asked to
name and describe the current classification systems for safety
of medicine use in breastfeeding that they ‘‘know and/or use
regularly.’’ Participants were then asked exploratory ques-
tions regarding important maternal, infant, and medicine
parameters they consider when deciding on the safety and
compatibility of a medicine in breastfeeding. Information on
the proposed FDA pregnancy and breastfeeding labeling
system (as described above) was also presented for opinion.
The Round 1 questionnaire was sent in September 2013.
Responses obtained in Round 1 were summarized. Ma-
ternal, infant, and pharmacology parameters were standard-
ized and formated into a 5-point Likert rating scale. Two
authors (L.H.A. and C.B.) performed the qualitative thematic
analysis. Parameters were tabulated in a Microsoft Excel
spreadsheet and grouped according to their meaning; like
statements (e.g., health of infant, comorbidities of baby, and
any health problems in baby) were condensed into a single
term. Following refinement, 31 parameters were fed back to
participants in Round 2.
Round 2
Participants were asked to rate the degree of importance
they place on the 31 infant, mother, and medicine parameters
obtained from responses in Round 1 using a 5-point Likert
scale (from 1 = unimportant to 5 = very important). Para-
meters were divided into three categories (infant parameters,
AMIR ET AL.
mother parameters, and medicine parameters), and experts
were asked to rank the three most important parameters in
each category.
Participants were provided suggested modifications to the
criteria in Hale’s Medication and Mother’s Milk5 and asked
their agreement with proposed changes: ‘‘Do you agree with
the following statements related to expanding the L3 ‘Mod-
erately Safe’ category to include descriptive subcategories?
(e.g., L3a—new medication no studies available; however,
medicine likely to be safe based on pharmacokinetic profile;
L3b—controlled studies show minimal nonthreatening ad-
verse effects in infant; L3c—no controlled studies in
breastfeeding; risk to infant unknown).’’ A 5-point Likert
scale was used (1 = strongly disagree; 2 = disagree; 3 = nei-
ther agree nor disagree; 4 = agree; 5 = strongly agree). Parti-
cipants were also invited to explain their reasoning and
propose additional modifications.
We also suggested a risk calculator and asked participants’
opinions. One possibility to improve the current decision-
making capacity of clinicians would be to introduce a risk
calculator, allowing for decisions to be tailored to the indi-
vidual infant, the mother, and the medicine being prescribed.
An example of such a risk calculator currently being used is the
New Zealand Cardiovascular Risk Calculator (see below).
Further details can be found on the National Prescribing Ser-
vice Web site.21 A medicine and breastfeeding risk calculator
would be based on categories relative to the infant, mother, and
medicine (e.g., gestational age, relative infant dose, or medi-
cine molecular weight). Participants were asked to agree/dis-
agree with statements about the use of a risk calculator (5-point
Likert scale) and to select up to four options as being the most
important factors, labeling them 1 to 4.
Round 3
Round 3 sought to obtain consensus on parameters ex-
plored in Round 2 through rating and ranking techniques. The
15 most important infant, mother, and medicine parameters
from Round 2 were fed back to the panel to allow for con-
vergence of opinions on key parameters.
Results
Sixteen experts were initially invited to participate in the
study, of whom 12 expressed an interest in being involved. Ten
additional experts were sent invitations based on snowball
recommendations, of whom five participated in the study.
The final panel was composed of 17 experts based in Aus-
tralia, the United Kingdom, the United States, and Norway
(listed in Acknowledgments, with permission). Participants
came from either a pharmacy or pharmacology background,
with the majority having a master or doctorate degree in
addition to their primary tertiary qualifications. All experts
were working in the field of breastfeeding and pharmaco-
therapy, including primary research, advisory services, and
teaching of health professionals. Responses were received
from 13 participants for Round 1, 14 for Round 2, and 12 for
Round 3.
Contemporary classification systems
Round 1 explored contemporary classification systems and
the key advantages and disadvantages of current systems.
MEDICINES AND BREASTFEEDING: DELPHI STUDY 171

Medicines and Mother’s Milk5 was the most commonly listed position, muscle tone, colour, sucking reflex, sleep patterns,
classification system (mentioned by 13 participants). One etc, regular assessment by independent health care personnel,
participant mentioned the Australian publications, Ther- appropriate blood, urine, milk tests (only when appropriate
apeutic Guidelines,22 which use ‘‘a simple four category and necessary), appropriate communication options for
questions/concerns including links to quality, peer-reviewed
classification that ranges from compatible to caution for a
information and advice, knowledge of ‘warning signs’ and
drug about which we have little data but whose effects are of appropriate responses to them.
little concern to avoid..The fourth category is avoid based
on high transfer to milk and concerning side effects.’’ One
participant mentioned the Swedish categories,23 adding, ‘‘I Table 2. Parameters Listed in Round 1
am not sure if it was ever implemented. It has all the disad-
vantages of any classification system.’’ Number
of participants
LactMed, Briggs’ Drugs in Pregnancy and Lactation, and the mentioning
American Academy of Pediatrics were also mentioned, al- Parameter (n = 13)
though they do not provide a classification system. In-
dependence from the pharmaceutical industry was seen as a Maternal and infant characteristics
benefit of both LactMed and Medicines and Mother’s Milk.5 Age of infant 13
The simplicity of numerical risk categories had a mixed re- Health of infant 10
sponse, with some experts believing it enabled healthcare Overall balance between the benefits 5
practitioners to provide advice: ‘‘with a quick glance at the L of breastfeeding and advantages
risk number, clinicians can have an overall idea of suitability.’’ of medicine versus the risk
Another said, ‘‘Simple, easy to follow, authoritative.’’ Others of formula and potential
effects of medicine
believed that the categories could lead to uninformed decision- Number of breastfeeds 5
making as it ‘‘leads to a cessation of thought about the topic— per day/volume of milk
just quote the category—does not take infant age into account Maternal need for medicine 4
[and] can lead to [poor] advice.’’ Other comments included, Monitoring for infant 3
‘‘Some users think only L1 drugs can be taken while breast- Gestational age 2
feeding,’’ and ‘‘L3 and L4 are gray areas.’’ One participant Infant renal and hepatic function 2
explained, ‘‘L3 particularly can be confusing. A drug can be Mother’s health 2
placed in L3 because of completely lacking excretion data but Mother’s wishes regarding 2
be pharmacologically unable to penetrate milk to any degree. breastfeeding
The L3 [rating] probably implies a greater risk than is necessary. Infant weight 1
Strategies available to reduce 1
Small gripe for what I consider the best available.’’ exposure of infant to medicine
Classification systems were further explored in Round 2, Risk associated with 1
with the majority of experts (9/14) believing that separating stopping breastfeeding
hazards associated with breastmilk production and hazards Exposure to medicine in pregnancy 1
that directly affect the infant would be beneficial. Medicine characteristics
Safety profile of medicine 13
Key parameters Relationship between clinical 6
In Round 1, participants listed the maternal, infant, and dose and medicine in breastmilk
Alternative medicines available 5
medicine parameters that they considered important (Table Experience of medicine use in infants 5
2). Participants rated these in Rounds 2 and 3, as described in Dose of medicine required 4
Materials and Methods. Absolute/relative infant dose 3
Based on respondent ratings, 15 key infant, maternal, and Pharmacokinetics 3
medicine characteristics were identified as being important in Duration of treatment required 2
making decisions about medicines and breastfeeding (Table Route and timing of medicine 2
3). Consensus was reached on the three most important pa- administration
rameters in the decision-making process. The ‘‘overall bal- Gastrointestinal absorption of medicine 2
ance between the benefits of breastfeeding and advantages of Postmarket experience with medicine 2
medicine versus the risks of formula and the potential adverse Quality of and quantity 2
of data available on medicine
effects of medicine’’ was considered the most important Molecular weight of medicine 1
parameter, followed by the age of the infant and the safety Protein binding capacity of medicine 1
profile of the medicine. These three parameters had the Effect of medicine on lactation 1
highest rankings in rounds 2 and 3 and had mean Likert Time to peak blood/milk level 1
scores of > 4.40. Half-life of medicine 1
As ‘‘monitoring of infant available’’ was important to Passage of medicine across 1
some respondents, in Round 2 we asked, ‘‘What does this infant blood–brain barrier
mean to you?’’ Respondents explained that they meant Infant blood level 1
clinical observations as well as testing where applicable. One Polypharmacy 1
response shows the detail involved: In response to the question,‘‘What do you think are the most
important parameters for health professionals and women to
A huge range of parameters which MAY include ongoing consider when deciding on the safety and compatibility of medicine
regular visual assessment of alertness, growth, energy, dis- use in breastfeeding?’’
172 AMIR ET AL.

Table 3. Infant, Maternal, and Medicine Parameters Important for the Decision-Making Process
Mean Standard Mean
Rank Parameter rank deviation Likert score
1 Overall balance between the benefits of breastfeeding 1.7 1.89 4.83
and advantages of medicine versus the risks of
formula and the potential adverse effects of medicine
2 Age of infant 3.8 1.93 4.75
3 Safety profile of medicine 4.7 2.54 4.42
4 Experience of medicine use in infants 5.5 3.50 3.75
5 Health of infant 5.9 3.57 3.83
6 Relationship between clinical dose and medicine in breastmilk 7 2.58 4.00
7 Mother’s wishes regarding breastfeeding 8.1 5.11 4.25
8 Number of breastfeeds per day/volume of milk consumed per day 8.8 2.35 3.92
9 Half-life of medicine 8.9 3.07 3.92
10 Monitoring of infant available 9.3 2.75 3.83
11 Gastrointestinal absorption of medicine 10.1 3.63 4.17
12 Alternative medicines available 10.7 1.77 3.75
13 Protein binding capacity of medicine 10.9 4.65 3.33
14 Quality and quantity of data available on medicine 11 4.22 4.00
15 Strategies available to reduce exposure of infant to medicine 13.6 1.35 3.00

Proposed FDA labeling
Experts were asked their opinion on the FDA recommen-
dations, as well as their impact, utilization, and practical ap-
plication. There was universal agreement that the new
descriptive labeling was an improvement on the current sys-
tem. However, many experts were wary of the practicality of
such a system, citing pharmaceutical medicolegal consider-
ations and the time constraints of clinicians as reasons for
the proposed medication monographs failure: ‘‘it [the FDA
medicine monograph] looks like a significant improvement.
unfortunately medico-legal considerations may trump clinical
experience hence very conservative recommendations’’ and
‘‘personally I think some of these labels will be over long, and
most doctors will not read it all’’ were typical comments.
Risk calculator
The respondents mostly agreed that ‘‘The risk calculator
would improve how risk is communicated to clinicians’’ (11/
13). However, most ‘‘neither agreed nor disagreed’’ with the
other statements about the use of a risk calculator. Comments
ranged from positive, such as
A well designed risk calculator should be a feasible option, if it
is user friendly. A sample isn’t provided, so can’t comment on
whether this one might be ‘‘too complicated.’’ Presuming the
calculator factors in individual characteristics, it absolutely
should provide an individual mother/baby risk assessment.
to more negative:
The decision on breastfeeding while taking medications is a
multifactorial individualised decision. I don’t think a risk
assessment such as that above can cover all the factors.
and
The whole survey seems premised on the use of one medi-
cation at a time. My impression is that many if not most
adverse reactions occur in infants whose mothers are taking
more than one medication, particularly CNS [central nervous
system] depressant drugs, at the same time.
Discussion
Main findings
This study identified 15 key parameters that are used by
experts to inform decisions about medicines and breast-
feeding (Table 3). The highest ranking item was about risk
versus benefit, so is not actually a parameter. The most im-
portant parameters about the infant were the age and health of
the child, and those of the medicine were the safety profile
and experience of use in infants. Qualitative feedback from
participants suggests that prescribing for breastfeeding wo-
men is a nuanced process that requires careful consideration
and that a single ‘‘one size, fits all’’ classification system
might lead to uninformed and incorrect decision-making by
clinicians.
Strengths and limitations
To our knowledge this is the first attempt to explore
expert opinions on the decision-making process involved
in medicines for breastfeeding women. Our panel included
key decision-makers in this field, including the authors of
several of the key texts on the topic. The study was con-
ducted via Web-based communication and maintained
anonymity among participants. The demographic charac-
teristics of the group indicate that participants had the
required skills and experience to make informed contri-
butions to the discussion.
A three-round Delphi approach was undertaken. This al-
lowed experts to complete the study in a timely manner
without developing survey ‘‘fatigue.’’ The three rounds al-
lowed us to formulate a list of key parameters that inform
breastfeeding and medicine use decisions, but further work is
needed to determine how these parameters might be used by
clinicians when prescribing medicines to mothers. In particu-
lar, we explored the idea of constructing a ‘‘risk calculator’’
MEDICINES AND BREASTFEEDING: DELPHI STUDY
similar to those used for cardiovascular risk scores.21 A risk-
model approach was seen by experts as an improvement on the
current classification systems; however, the complexity of
constructing such a model was beyond the scope of this study.
A limitation of this study was that the panel was com-
posed mostly of experts from English-speaking and devel-
oped countries. This may restrict the applicability of our
findings to other countries; however, we believe that the
decision-making criteria for medicines and breastfeeding
are universal, and although the medical conditions and
medications may change between countries, the principles
underlying the decision-making process should stay the
same.
Study implications
The importance of breastfeeding is well established;
however, clinicians are still reluctant to prescribe medicines
during breastfeeding, leading to many women temporarily or
permanently stopping breastfeeding during illness or not
taking beneficial medicines while breastfeeding. Establishing
a clear set of internationally recognized parameters to inform
the decision-making process could be the first step to im-
proving breastfeeding mothers’ access to, and experience
with, medicines.
Our results show that pharmacology experts have a clear
understanding of the complexity of decision-making when
prescribing for breastfeeding women. It remains a challenge
to translate this complexity into clear messages that can be
accessed by time-poor clinicians and are meaningful for
women and their families. Although the current number or
letter classification systems do not incorporate important
considerations such as infant age, a longer ‘‘descriptive text’’
incorporating all considerations may be impractical in busy
clinical practice. More work is needed on establishing a
balance between these two scenarios. This study provides a
starting point for such work.
Conclusions
Although clinicians and lay people would appreciate a
simple classification scheme, in practice, decision-making
about the safety of medicines for breastfeeding women is
complex. One participant summarised the issues in this way:
There needs to be a greater education of the public and
medical profession about the mechanics of breastfeeding (it
is not possible for a mother to stop for 2 days, and then just
start up again) and the health and economic benefits of
breastfeeding. The message needs to be that hardly any drugs
are a problem for breastfeeding mums, and that it is almost
never necessary to stop breastfeeding because of maternal
medications. We need a good easy-to-understand informa-
tion source that mothers and health care professionals can
access 24/7.
Acknowledgments
This study would not have been possible without the ex-
perts who contributed their time to the process. We would
like to acknowledge Phillip Anderson, Cheston Berlin, Del-
wyn Cupitt, Tom Hale, Ken Ilett, Majella Hill, Wendy Jones,
Sue Jordan, Debra Kennedy, Judith Kristensen, Yuan Loke,
Treasure McGuire, Frank Nice, Hedvig Nordeng, Hilary
173
Rowe, Tricia Taylor, and Rodney Whyte for their contribu-
tion. Funding was received from the Faculty of Health Sci-
ences, La Trobe University (2013).
Disclosure Statement
No competing financial interests exist.
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