Breastfeeding Final PDF

The pharmaceutical care
of breastfeeding mothers
C
ontents
About this package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.1 Aims and objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.2 Breastfeeding – an introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.3 The Pharmaceutical Care Model Schemes . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.4 Infant formulae and follow-on milks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2 Breastfeeding in Scotland: advantages, disadvantages and statistics . . . . . . . . . . 19
2.2 Advantages of breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.3 Disadvantages of breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.4 Breastfeeding statistics in Scotland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3 Influences on, and support for, breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . 31
3.2 Influences on breastfeeding behaviours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.3 National breastfeeding initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
3.4 Supporting breastfeeding mothers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3.5 The pharmacist’s role in supporting breastfeeding women . . . . . . . . . . . . . . . . . 38
4 Conditions affecting breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.2 Physiology of breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.3 Common breastfeeding problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5 Medicines use during breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
5.2 The dilemma of medicines in breastmilk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
5.3 Pharmacists’ responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.4 Pharmacology of the transfer of medicines in breastmilk . . . . . . . . . . . . . . . . . . . 62
5.5 Specialist sources of information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
5.6 Systematic searching . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
5.7 Levels of evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
5.8 Involving parents in decision making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
5.9 Practical application of pharmacological data . . . . . . . . . . . . . . . . . . . . . . . . . 71
5.10 The safety of medicines passing through breastmilk . . . . . . . . . . . . . . . . . . . . . 72
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
1 About UK Medicines Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
2 Reference guide to the safety of drugs passing through breastmilk . . . . . . . . . . . . 83
3 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
5 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
6 Breast attachment – demonstration sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
© 2006 NHS Education for Scotland

About this package

This package has been written by Dr Wendy Jones who is recognised within the UK
as a pharmacist with specialist knowledge in breastfeeding and the use of medicines
in breastfeeding mothers. It was reviewed by a variety of individuals with pertinent
knowledge in the subject area.
The pack has been designed to meet the education and training needs of all pharma-
cists who deliver services to breastfeeding mothers, as well as other health profession-
als who require to have a broad knowledge of the use of medicines in breastfeeding
mothers. To this extent, the activities, case scenarios and examples given throughout
the package have a strong focus in promoting multidisciplinary team working to
address the issues that these patients may encounter. There will also be an e-learning
programme available on the NES website (www.nes.scot.nhs.uk) which is open to
pharmacists, nurses and any other interested healthcare professionals.
Aim
The aim of this training pack is to enable you to promote breastfeeding through your
working practice, taking into account common breastfeeding problems and the use of
medicines for breastfeeding mothers.
It supports the delivery of care that is evidence based and up-to-date, while providing
you with many additional sources of useful information.
This course should take about 10 hours to complete.
Format
The pack is organised into five main chapters plus an appendix. The initial three
chapters provide the background information and support for breastfeeding mothers,
whereas the last two chapters focus on the use of medicines in breastfeeding mothers.
While it may be more useful to focus on Chapters 4 and 5, it is also important that
pharmacists understand the statistics and principles of breastfeeding, as well as the
support mechanisms available for mothers, allowing the pharmacist to recommend
these to the mother when appropriate.
Chapter 1 introduces the background to breastfeeding, breastmilk substitutes and
pharmaceutical care.
Chapter 2 discusses the all important issues of breastfeeding, covering the advantages
and disadvantages as well as the statistics of breastfeeding within Scotland compared to
other countries.
Chapter 3 covers initiatives and support mechanisms that have been set up to encour-
age mothers to breastfeed for as long as possible. It then goes on to discuss the role
that the pharmacist has in supporting breastfeeding women.
Chapter 4 begins the journey of the use of medicines in breastfeeding mothers. It
focuses mainly on problems that can occur for the mother or her child during breast-
feeding and how these can be treated appropriately.
Chapter 5 deals with the more difficult subject of the safe use of medicines by breast-
feeding mothers. It covers the dilemmas that can occur in relation to medicine use,
how medicines can transfer into breastmilk and how and where the pharmacist can
seek support and advice in these situations. This chapter provides the pharmacist with
principles, examples and resources to be able to provide advice on the safe use of medi-
cines during breastfeeding. Information on the specialist pharmacy support system of
the United Kingdom Medicines Information service, with some of their background
material, is added as an appendix.
Workbook
Inserted, after this section, you will find a separate workbook. This workbook will assist
your own professional development by allowing you to:
t record your responses to activities
t apply your learning through completion of the case scenarios
t compare your answers with suggested responses at the back of the workbook
t note down any new learning needs arising during this course.
Please take the workbook out of the binder when studying the training pack and mak-
ing notes. You can insert it at the point where you stopped, using it as a ‘bookmark’.
When the workbook is at the back of the binder, you have completed the package!
Activities
Throughout the main text, you will be prompted to complete workbook activities, with
the relevant pages indicated in brackets. In your workbook, you will find the actual
activity with space below to record your response. Some of the activities will require
that you look at a document or access a particular website.
By completing these activities, you will find that the practical tips and learning points
from them will prove extremely valuable in your day to day work. You will find sug-
gested responses to most of the activities on the tinted page section at the back of the
workbook.
Case scenarios
There are several case scenarios in the workbook, which allow you to apply your
learning to practice in a structured way. They introduce the concept of pharmaceutical
care to breastfeeding mothers within a multidisciplinary setting. Completing the case
scenarios will encourage you to think in terms of pharmaceutical care planning and
documenting this as you process the information given.
Multiple choice questionnaire

On completion of the package, the multiple choice questionnaire (at the end of the
workbook) should then be attempted and returned to the NES Pharmacy Office, either as
a paper copy or electronically online (see the instructions on page 36 of the workbook).
ABOUT THIS PACKAGE
How this package can assist your CPD

At the beginning of each chapter, the aims and objectives describe what you should
be able to do when you complete that particular chapter. This helps you monitor your
progress through the pack. We suggest that you also note down in the workbook (on
pages 33 and 34) or on your personal CPD record, any specific future learning needs
which arise as you study each chapter. If you find the information you need is not in the
package, you can use some of the appendices, or check websites listed throughout the
package to see if any of these sources might help you to fill these gaps.
Keeping up to date
The information is accurate at time of publication but you may wish to keep up to date
with completed and ongoing current research by checking the websites of the organisa-
tions detailed within the pack.
Acknowledgements
We gratefully acknowledge the hard work and effort made by all who contributed to
this package, whether by writing, editing, peer reviewing, piloting or, in many cases,
participating in all four stages.
Lead author
Dr Wendy Jones, PhD, MRPharmS who is self employed and currently contracted to
work with East Hampshire Primary Care Trust as practice support pharmacist and sup-
plementary prescriber. Her PhD was entitled Community pharmacy support for lactating
mothers requiring medication and she is currently running the Drugs in Breastmilk
Helpline of the Breastfeeding Network.
Editorial
Alex Mathieson, Freelance Writer and Editor (Edinburgh).
Design
Omnis Partners, Publishing Consultants (Glasgow).
Contributing reviewers
Fiona Needleman (Southern General Hospital, Glasgow)
Peter Mulholland (Southern General Hospital, Glasgow)
Dr Morag Martindale (Ardblair Medical Practice, Blairgowrie)
Linda Wolfson (The Queen Mother’s Hospital, Glasgow)
Duncan Hill (Community Pharmacist, Glasgow – at the time of development)
Special thanks are also due to:
Pharmacists who participated in the pilot exercise, namely Lynne Davidson, Gayle
Finnie, Sharon Potts, Lesley MacGillivray, Gayle McKnight, Laura Murray, Fiona
Ritchie, Valerie Sillito, Jennifer Murray and Maria Tracey.
Credits
Cover photo by Tom Merton/GettyImages.
Chapter photos courtesy of Health Education Board of Scotland.
Chapter stories courtesy of www.breastfeeding.nhs.uk, a website coordinated by the
Department of Health.
Disclaimer
While every precaution has been taken in the preparation of these materials, neither
NHS Education for Scotland nor external contributors shall have any liability to any
person or entity with respect to liability, loss or damage caused or alleged to be caused
directly or indirectly by the information therein.
1 Introduction
10 THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
Angela Malonney, 33, has two children, Charlotte (5) and

Danny (9 weeks). She is an artist and adult education lecturer.
I gave up breastfeeding Charlotte after three weeks because it was really painful and difficult.
I kept checking books to see if she was feeding correctly. I realise now the problem was that
I had so much milk I had become so engorged and she couldn’t latch on. When I had Danny
the pain and discomfort was exactly the same but this time I had a lot of encouragement from
my midwife – that’s what kept me going. For instance when I got engorged and had very hard,
lumpy breasts I rang Angela who suggested I use an electric breast pump to ease off the milk.
That, plus hot and cold flannels, did the trick.
I’ve been very fortunate because I’ve had real continuity of care with Angela whereas when
Charlotte was born I saw lots of different midwives. I saw Angela during my pregnancy, she
delivered Danny at home and now I can call her whenever I need help or advice. It really helps
when a midwife knows the history of the baby.
I wanted to breastfeed because it’s the healthiest option for the baby, plus it’s so convenient.
It’s on tap. Sterilising all those bottles used to drive me up the wall with Charlotte. Even when
Danny had thrush of the mouth which made my nipples feel as if they’d been rubbed against
sandpaper it didn’t make me want to stop!
My partner Darren is very supportive and encouraging – he actually went and got the breast
pump for me when I was having problems. A couple of my friends have breastfed and they’ve
been very encouraging too, offering to come round and check everything is going OK. It’s
important to have that kind of back up – friends as well as professionals who you can ring just
to give you that little bit of encouragement.
When I failed to continue with my daughter I felt very guilty and upset, like I’d cheated her out
of something. This time round I’m much more relaxed about the whole thing and I’m sure that’s
partly why it’s worked out so much better. I’d say to any mother that just because you’ve had a
bad experience breastfeeding your first baby, it doesn’t mean it’s going to happen again.
And to anyone having problems I’d say, don’t be afraid to seek help and advice and stick at it
because once you’ve got over the tricky bit it’s plain sailing.
I feel such closeness with my baby – it’s one-to-one, skin-to-skin contact rather than having a
plastic bottle in-between you. My mother bottle-fed me because that was the fashionable thing
to do in those days. Now that’s changing and the feeling is that breast is best again. If there’s an
embarrassment it comes mainly from men. Feeding in public isn’t easy because it’s a man-made
world – if the world was designed by women, it would be a lot easier!
11
1 Introduction
Welcome to this distance learning pack about breastfeeding and the use of medicines
by breastfeeding women.
The pack aims to support pharmacists, who are particularly well placed to provide
information based on best available evidence and consistent and positive support for
breastfeeding.
The focus of the pack is very specifically on breastfeeding and the safety of medicines
that may pass through the mother’s breastmilk to babies. (Throughout the pack, the
baby will be referred to as ‘he’.) The pack does not deal with issues around bottle feed-
ing and the use of artificial formula – signposts to excellent sites that can provide this
information are provided in the reference section.
1.1 Aims and objectives

The aim of this training pack is to enable you to promote breastfeeding through your
working practice, taking into account common breastfeeding problems and the use
of medicines for breastfeeding mothers. The pack is firmly embedded in an ethos of
multi-disciplinary team working and the use of evidence-based information.
The objectives are to:
t assist you in delivering pharmaceutical care to mothers in your day-to-day practice
t set out the health implications of increasing breastfeeding initiation rates
t provide an overview of conditions that might affect a mother during breastfeeding
t explore how you can contribute to a multi-disciplinary, patient-focused model of care
t demonstrate dilemmas in providing evidence-based information on the safety of
drugs used during lactation
t explore the significance of professional judgement in individual circumstances.
Now go to Activity 1.1a in your Workbook, then Activity 1.1b (page 1)
1.2 Breastfeeding – an introduction

Breastfeeding is recognised as having many health advantages for mother and baby.
Formula milk is a substitute and can provide adequate nutrition, but it cannot replicate
the myriad additional nutritional and immunological properties of breastmilk.
Breastmilk has the right balance of fats, carbohydrate, long-chain fatty acids and
proteins, combined with additional factors to improve bioavailability such as lactoferrin,
which aids absorption of the relatively small amount of iron in breastmilk. Physi-
ological processes ensure that each mother produces milk which is ideal for her baby
whether he is born in Scotland, Iceland or the Sahara Desert, or is born prematurely or
at term. Breastmilk also varies throughout the day and with the age of the baby.
Perceptions of difficulties in breastfeeding, however, have influenced the way in which

many women approach feeding their babies. Breastfeeding in Western cultures is now
a learned skill, rather than an instinct. Breastfeeding experts have commented that
many women ‘hope’ to breastfeed, but ‘expect’ failure. The expertise of health care
professionals in helping mothers to initiate pain-free and effective breastfeeding is
inextricably linked with the success or failure of the breastfeeding experience (Renfrew
et al, 2000), but mothers may be given incorrect information, conflicting advice and
even criticism from health care professionals and society in general.
The uncertainties these issues pose in mothers’ minds are reflected in breastfeeding
statistics. In 1991, Scottish breastfeeding rates were among the lowest in Western
Europe. A target was set by the then-Scottish Office in 1994 to increase the percentage
of mothers still breastfeeding at six weeks of life from 30% to 50% by 2005. By 2000,
63% of mothers initiated breastfeeding and 40% of them continued at six weeks –
a significant improvement, but still some way short of the 2005 target.
On or around the seventh day after birth, all babies in the UK are tested for phenylke-
tonuria (PKU) by a blood sample collected from a heel prick. People with PKU are
missing an enzyme that breaks down phenylalanine, one of the building blocks of
the protein found in a normal diet. It can be serious if left untreated, causing mental
impairment. However, PKU can be treated successfully by controlling levels of pheny-
lalanine in the diet. In Scotland, the opportunity is taken to collect feeding data at the
same time as the test is conducted. This enables collection of data on the percentage of
babies breastfed, presented by hospital, postcode and post district. This information is
recorded on the blood test card known as the Guthrie card. This data is available on the
Breastfeeding in Scotland website (www.breastfeed.scot.nhs.uk/). Figure 1.1 shows
breastfeeding rates from Guthrie data collected at seven days.
Figure 1.1 Breastfeeding in Scotland at infant age 7 days, 1990-2004
50%
45%
40%
35%
30% 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
This information was made available by the National Neonatal Inborn Errors Screening Laboratory, Stobhill Hospital, and was
taken from the Breastfeeding in Scotland website (www.breastfeed.scot.nhs.uk/).
INTRODUCTION 13
These figures highlight the need for a co-ordinated approach to promoting breastfeed-
ing that focuses on providing:
t effective support and encouragement for women who wish to breastfeed
t consistent professional advice
t activities to change cultural attitudes, including work in schools.
This learning pack is designed to ensure that you can make a meaningful contribution
to this approach.
1.3 Pharmaceutical Care Model Schemes

Pharmaceutical Care Model Schemes (PCMS), which were active in Scotland until
March 2006, set in place a number of principles which underpin pharmaceutical care.
The principles are designed to identify new ways of working that will help community
pharmacists to apply their drug therapy skills to improve patient care. PCMS operate
around a framework that builds on best practice (see Box 1.1).
Box 1.1 Pharmaceutical Care Model Schemes

Pharmaceutical Care sets out to optimise the benefits of, and minimise the risks
associated with, medicines and improve health based on available information and
data. Pharmaceutical Care Model Schemes (PCMS) offer an opportunity to put
Pharmaceutical Care into practice.
The acronym CASEH describes the issues that are central to Pharmaceutical Care:
Compliance, and the patient’s understanding of the condition or medication
Appropriate medication or dose, to optimally manage the condition or symptoms
Safety, focusing on side-effects, interactions and toxicity
Effectiveness, identifying evidence that shows the medicines are achieving
expected outcomes
Health improvement or self help, including smoking-cessation initiatives and
working with support agencies.
(taken from Pharmaceutical Care Training Initiative: Implementation Pack)
The PCMS model can be used to support breastfeeding and is a central driver of the
pack. There will be opportunities within the pack for you to work through completed
care plans following the PCMS model and to complete some yourself.
Now go to Activity 1.2 in your Workbook (page 2)

1.4 Infant formulae and follow-on milks

This pack is heavily biased towards the promotion of breastfeeding, with little informa-
tion offered on the place of formula milks. The results of the 2000 Infant Feeding
Survey (Hamlyn et al, 2000) showed that 37% of new babies in Scotland did not receive
any breastmilk. It must be presumed that at least some mothers believed formula milk
was as good as breastmilk.
Mothers should not feel pressurised into breastfeeding, but should be presented with
sufficient information to make an informed decision. However, as was mentioned in
Section 1.2 (see also Chapter 2), the health advantages for mother and baby of breast-
feeding are overwhelming. National and international experts have recommended that
exclusive breastfeeding for six months should be encouraged and supported by all
health care professionals.
Pharmacists sell formula milk for those who have decided to use it to nourish their babies.
We cannot ignore their needs. The important message from this pack is to promote
breastfeeding as a healthy option, but to remain patient focused in all discussions about
infant feeding, and refer to local experts such as midwives and health visitors when
your knowledge is insufficient. Inter-professional working and respect for professional
responsibilities should provide you with opportuni-
ties to gain increased satisfaction from your role as a
pharmacist in relation to breastfeeding mothers.
Pharmacists and mothers need to be able to access
accurate, independent information on infant for-
mula. It is not the intention of this pack to provide
such information, but it can be obtained from the
following websites:
t Department of Health – ‘Bottle feeding’
www.dh.gov.uk/assetRoot/04/08/44/54/
04084454.pdf
t ‘Preparing a bottle using powdered formula’
www.babyfriendly.org.uk/pdfs/botenglish.pdf
INTRODUCTION 15
t NHS Greater Glasgow – ‘Infant Feeding Poli-

cies and Guidelines for Health Professionals’
(an excellent booklet covering all aspects of
breast and bottle feeding together with prob-
lems and how to solve them): www.show.scot.
nhs.uk/ggpct/staff/Breastfeeding%20Book.
pdf
Promoting breastfeeding over breastmilk substitutes

The Royal Pharmaceutical Society of Great Britain (RPSGB) Medicines, Ethics and
Practice guide, in line with the WHO International Code of Marketing of Breastmilk
Substitutes published in 1981, prohibits advertising of formula milks in pharmacies
by window display or by special pricing promotion. Advertising and promotion of baby
milks is controlled under the Infant Formula and Follow-on Formula Regulations 1995.
Infant formula is defined as ‘a food intended for particular nutritional use by infants
in good health during the first four to six months of life and satisfying by itself the
nutritional requirements of such infants’.
The following activities are prohibited at any place where infant formula is sold by retail:
t advertising
t special displays of free samples and discounting
t any other promotional activity to induce the sale of an infant formula.
Much more positive is the potential role pharmacists have in promoting breastfeeding,
a role acknowledged in the national strategy for pharmaceutical care in Scotland, The
Right Medicine. The strategy emphasises that pharmacists have a key part to play in
ensuring health gains for the population, which includes the promotion and support of
breastfeeding.
NHS Health Scotland and local health promotion units now include pharmacies in
public health and health promotion campaigns. Activities and initiatives are part of a
multi-disciplinary approach to health
promotion. Some of these focus on
more traditional areas of pharmaceuti-
cal practice, such as smoking cessation
programmes (see, for instance, www.
show.scot.nhs.uk/glasgowpharmacy
healthpromotion/), but opportunities
also exist to contribute to and develop
multi-disciplinary approaches to infant
feeding.
There is an annual National Breastfeeding Awareness Week in the UK, generally

in May. The Department of Health (DoH) in England makes available a variety of
resources to highlight the health benefits of breastfeeding through a national publicity
campaign. You could take this opportunity to develop health promotion displays.
The DoH resources are available in
England and Wales and requests from
Scotland may be considered on an in-
dividual basis. NHS Health Scotland
has additional resources – a variety of
leaflets are available to download from
www.healthscotland.com. These can
be recommended to women to view
or printed off for mothers who do not
have access to the internet.

2 Breastfeeding in Scotland: advantages,
disadvantages and statistics
Cheryl Kaye is 24 and has three children, Francesca (7)

Georgina (5) and Jacob (3 months) who was a pre-term baby,
weighing 2 pounds 7 and a half ounces.
I tried to breastfeed all three. Francesca, my first, was premature and when it came to putting
her to the breast she just wouldn’t feed. I kept trying even after the midwives put her on neu-
traprem (a special formula for premature babies) but gave up after three weeks. I wish now that
someone had encouraged me to keep going.
Georgina on the other hand was full-term and I had no trouble at all breastfeeding her apart
from getting mastitis, which very nearly made me stop. She was proper greedy so I did it for six
months. Jacob was born at 29 weeks and I started expressing milk six hours after he was born.
He was in special care for six weeks and I had to express my breastmilk every four hours to give
to Jacob.
My mother tried to breastfeed for a little while and so did my sister, but no one has particularly
influenced me – they didn’t need to, it was something I just knew I wanted to do. I’d read about
it being best for the baby. It feels the right thing – I don’t understand how some people shrug
it off as dirty. I try to encourage other mothers but even though I say it’s the very best thing you
can give your baby because the milk gives antibodies – your antibodies – they won’t try. I tell
them you don’t even know which cow the powdered milk comes from, at least you know where
your milk comes from.
When he was about two and a half months Jacob lost a little weight and the GP advised me to
put him on formula. “It’s obvious he’s not getting enough and as a pre-term baby he needs to
gain weight,” she said, even though I told her I thought breastmilk was supposed to be best and
I didn’t want him to get constipated. But she insisted. I was upset and spoke to my community
midwife who in turn spoke to my GP. After that we all agreed to wait and see and as a compro-
mise I added fortifier to my (expressed) breastmilk to give him added calories. A week later he’d
put on six ounces. I’m so glad I didn’t give in and put him on formula. Even my husband had
been urging me to because he thought it was better to know exactly how much Jacob was taking.
I love the bond that breastfeeding brings, it makes you feel so close to your baby and so special.
19
2 Breastfeeding in Scotland: advantages,

disadvantages and statistics

The aim of this chapter is to help you understand why breastfeeding is important for
the mother and baby’s health, and to enable you to recognise factors that prevent some
mothers initiating breastfeeding or continuing for as long as they would like.
t consider the advantages and disadvantages of breastfeeding for mother and baby
t examine the benefits of breastfeeding in economic terms for the NHS
t look at statistics on breastfeeding in Scotland
t understand how breastfeeding is promoted nationally and locally.
Now go to Activity 2.1 in your workbook (page 3)
2.2 Advantages of breastfeeding

Breastfeeding is known to have many benefits for mother and child. The vast majority
of women can produce enough breastmilk to successfully feed their infants.
Breastfeeding advantages for infants

Despite extensive research by formula manufacturers, the exact replication of all the
constituents of breastmilk has not been possible to achieve. Breastmilk changes from
day to day, throughout the day, from mother to mother and varies depending on where
in the world the baby is born.
It contains antibodies and immunoglobulins to protect against infection and boost the
baby’s immune system, human lactoferrin to facilitate absorption of iron, enzymes,
growth modulators, hormones, long-chain polyunsaturated fatty acids, minerals and
trace elements in a highly bio-available form which suits the needs of the newborn.
The quality of breastmilk generally remains high even if the mother’s diet is not ideal.
Babies who are exclusively breastfed have reduced risk of many illnesses, such as those
described below.
Respiratory infection Consultations for respiratory illness and infection are
significantly lower for babies who are predominantly breastfed for two months or are
breastfed partially for six months.
A study in Dundee (Wilson et al, 1998) found that bottle-fed infants were at almost
twice the risk of developing respiratory illness at any time during the first seven years
of life. The study also found solid feeding before 15 weeks was associated with an
increased probability of wheeze during childhood.
In a study of 2602 children in Australia, Oddy (2003) found that hospital, doctor or
clinic visits and hospital admissions for respiratory illness and infection in the first
year of life were significantly lower among babies who were predominantly breastfed.
The health benefits of breastfeeding A meta-analysis of studies from developed countries

concluded that the risk of severe respiratory tract illness
in industrialised countries are
resulting in hospitalisation is more than tripled among
sometimes questioned on the infants who are not breastfed, compared with those
who are exclusively breastfed for four months (Galton
grounds that modern, hygienically
Bachrach et al, 2003).
prepared infant formulae are Middle ear infection Infants who are breastfed have
safe and nutritionally complete. fewer episodes of otitis media and those who are par-
tially breastfed have reduced incidence. Forty-seven per
Uncertainties increase about this cent of approximately 1000 children studied in the US
view as more is learned about the in 1994 had at least one episode of otitis media during
the first year of life, but infants exclusively breastfed
complex composition of breastmilk. for four or more months had half the mean number
The complexity of breastmilk of acute otitis media episodes of those not breastfed at
all. The recurrent otitis media rate in infants exclusively
implies that it possesses numerous breastfed for six months or more was 10%, but was
functions of biological importance… 20.5% in infants who breastfed for less than four
months (Duncan, 1993; Aniansson G et al, 1994).
Williams AF (1994). Is breastfeeding
beneficial in the UK? Statement of the Urinary tract infection A study of hospitalised infants
standing committee on nutrition of the showed that those who were bottle-fed were five times
British Paediatric Association. Arch. Dis. as likely to have a urinary tract infection at the time of
Child. 71:376-380. admission than those who were breastfed (Pisacane et
al, 1992).
Asthma Children aged six years who were breastfed for four months are less likely
to be asthma sufferers, regardless of their mother’s asthma status (Oddy et all, 1999;
Oddy et al, 2002; Mitka, 1999).
Atopy Breastfeeding for six months is associated with less eczema and other atopic
illnesses during the first three years of life, and there is evidence of significantly less
atopy in adolescence (Saarinen and Kajosaari 1995; Lucas, 1990).
Crohn’s disease A meta-analysis of studies on Crohn’s disease and ulcerative colitis
supported the association between breastfeeding and lower risk; it should be empha-
sised, however, that few of the identified studies were deemed sufficiently robust to
justify inclusion in the analysis (Calkins and Mendeloff, 1986).
Diabetes Frequency in the diagnosis of type 2 diabetes has doubled over recent years.
There would appear to be some evidence in humans that exposure to artificial formula
can trigger the auto-immune process that leads to type 1 diabetes (Gerstein, 1994;
Karjalainen J et al, 1992; Virtanen et al, 1991).
Neonatal necrotising enterocolitis (NNEC) This potentially lethal condition is rare
in babies born at more than 30 weeks gestation, but is a cause of serious morbidity
and mortality in vulnerable pre-term babies. It is six to ten times more common in
exclusively formula-fed babies, and provision of breastmilk helps to protect the baby
(Lucas and Cole, 1990).
Increase in intelligence There has been much controversy on whether breastfeeding
can be shown to increase the intelligence quotient (IQ) of children. It is difficult to
Breastfeeding in Scotland: advantages, disadvantages and statistics 21
control for confounding variables that may have an impact on intelligence and cogni-
tive functioning, such as socio-economic class. Mortensen et al (2002), however, found
a significant positive association between duration of breastfeeding and intelligence in
two independent samples of young Danish adults born between 1959 and 1961. The
association was independent of a wide range of possible confounding factors.
Anderson et al (1999) compiled a meta-analysis of 20 observational studies comparing
intelligence of formula-fed and breast-fed infants which involved evaluating the cogni-
tive development of 10,000 children per feeding category at ages ranging from infancy
to adolescence. They calculated a 5.3-point IQ difference in cognitive development
favouring breast-fed children; after adjustment for co-variates, the difference remained
3.2 points. The IQ advantage increased with duration of breastfeeding, reaching a
plateau at four to six months. Low birth weight infants received the greatest benefits.
The conclusion offered by the authors was that ‘breastfeeding [is] associated with
significantly higher scores for cognitive development than [is] formula feeding”. Uauy
and Peirano (1999) criticised the studies in that none were randomised, but com-
mented that the burden of evidence should be placed on manufacturers of breastmilk
substitutes.
Reduced need for general practitioner (GP) services In a study in Greater Glasgow
of 935 babies during the first six months of their lives (The Baby Check Trial 1996-98)
(McConnachie et al, 2004), breast-fed babies had 15% fewer GP consultations than
those fed on artificial formula. The authors point out that their ‘findings add to previ-
ous research linking breastfeeding with reduced morbidity in infancy, and for that
reason breastfeeding should continue to be promoted in primary care’.
Breastfeeding advantages for the mother

Pre-menopausal breast cancer is 22% lower among women who have breastfed. In the
UK, 2,400 women under the age of 55 die annually from cancer of the breast. Translat-
ing the statistics into human terms, if all of these women had breastfed for three
months or more, 400 deaths could have been prevented. Post-menopausal cancers
are also reduced (Collaborative Group on Hormonal Factors in Breast Cancer, 2002;
United Kingdom National Case-Control Study Group, 1993; Newcomb et al, 1994), and
a 20-25% risk reduction for ovarian cancer has been demonstrated for women who
breastfed for at least two months for every birth (Rosenblatt et al, 1993).
Polatti et al (1999) found bone mineral density decreased among 308 women during
the time they breastfed fully for six months, but then increased so that by 18 months,
the level was higher than baseline. Bone mineral density is linked to risk of hip
fracture, with the higher the density, the less the risk. In a study of women aged more
than 65 years, those who had given birth but had not breastfed were twice as likely
to experience a hip fracture as those who had not given birth or had breastfed. Paton
et al (2003) investigated the possible deleterious long-term effects of pregnancy and
lactation on bone mineral density and found that women who breastfed had higher
adjusted total-body bone mineral content and total-hip bone mineral density than did
parous non-breastfeeders.
Breastfeeding advantages for the NHS

Paediatric gastro-enteritis It was estimated in 1995 that the NHS in England and
Wales spent £35 million per year treating gastro-enteritis in bottle-fed infants. A saving
of £500,000 would have been made in costs of treating paediatric gastro-enteritis with
each 1% increase in breastfeeding for a minimum of 13 weeks. Babies who are formula
fed or breastfed for a limited time are five times more likely to be admitted to hospital
with gastro enteritis than those exclusively breastfed for a minimum of thirteen weeks
(Department of Health data).
Using data on prevalence of breastfeeding and Howie data, Broadfoot calculated the
cost to NHS Scotland of gastro-enteritis as a result of babies not being breastfed for
a minimum of 13 weeks as £3.82m per annum (Broadfoot, 1995; Howie, 1990). In
the Greater Glasgow area in 1992, the cost of admitting babies with vomiting and/or
diarrhoea was £204,500 and took up 1,382 bed days. Forsyth (1992) confirmed that the
protection offered by breastfeeding continues beyond the period of breastfeeding.
2.3 Disadvantages of breastfeeding

It is reasonable to say that there are no disadvantages of breastfeeding for the child. For
some mothers, the disadvantages include:
t inability to measure the volume of milk the baby has consumed
t no-one else can feed the baby
t breastfeeding can be painful, messy and tiring
t breastfeeding can be difficult to establish
t breast-fed babies wake more often during the night to feed
t it is more difficult for breastfeeding mothers to return to work
t the mother may need to modify her diet.
It would be inappropriate to attempt to coerce a
Disadvantages of breastfeeding mother into breastfeeding if she is truly unhappy at the
prospect. She needs to be comfortable with her chosen
are those factors perceived by the
method of feeding her baby, and it is a decision only she
mother as an inconvenience to her can make, in consultation with her partner, family and
friends. You can, however, offer her information on the
since there are no
benefits of breastfeeding for herself and her baby and
known disadvantages to the discuss common ‘myths’ surrounding breastfeeding
that may help her to make an informed decision (see
normal infant.
Box 2.1).
Lawrence R. (1999) Breastfeeding: a Guide
for the Medical Profession. 5th Edition. St
Louis, MO: Mosby.
Box 2.1 Common myths about breastfeeding

Pharmacists may be aware of many myths surrounding breastfeeding. They often
perpetuate the misperception that breastfeeding is difficult, and include the following.
Breastfeeding hurts
Breastfeeding should not hurt – if it does, there is a problem with optimal position-
ing and attachment and the mother should be referred to her midwife, health visitor
or drop-in group.
Bottle feeding is more convenient
Many women perceive difficulties in finding facilities where they can breastfeed in
privacy. New Scottish legislation should make this less of a problem. A mother who
is breastfeeding does not have to remember to take along bottles in case the baby is
hungry, find a way to warm the bottle if that is what her baby is used to, or get up at
night to make a bottle of formula.
Breastfeeding is tiring
Having a new baby is tiring, regardless of the way he is being fed. New mothers
should take opportunities to rest when they can, particularly while they are being
disturbed during the night to meet the baby’s needs.
You can’t see how much milk the baby takes if you are breastfeeding
As long as the baby appears satisfied, is producing appropriate wet and dirty nap-
pies and is gaining weight, it isn’t necessary to worry about the volume of milk. The
breasts will continue to make the milk the baby needs.
Breastfeeding ties you to the baby so you can’t go out or go back to work
It is possible to express milk to leave for the baby, to freeze quantities of milk in
advance and to continue to feed after returning to work. Being a mother produces
its own ties.
The goodness of breastmilk diminishes over time
Breastmilk continues to be a valuable source of nutrition well into the second year of
life and beyond. Milk produced in the evenings may be lower in volume than in the
morning, but it contains more fat to satisfy the baby and enable him to sleep longer
overnight.
You can’t breastfeed if you have had breast implants or breast surgery
Breast implants should not pose any problems in breastfeeding as the implant
is generally placed behind the area where milk is produced. Feeding after surgery
varies and is best explored with the relevant healthcare professionals caring for the
woman, but it does not automatically preclude feeding.
Drinking fizzy drinks gives your baby wind if you are breastfeeding
It is difficult to understand where this myth originated. Do the bubbles come out
with the milk? This myth has been circulating for over 25 years with no scientific
foundation.
You will develop sore nipples if you have red hair and sensitive skin
This makes one wonder how the Celtic races survived if they were unable to nourish
their young. Red-haired women are no more prone to sore nipples than anyone else.
The influence of peer supporters – women who have breastfed their babies and have
been trained to support breastfeeding women in the area in which they live – has been
shown to help to overcome the reluctance of women who find themselves in a bottle-
feeding culture. A list of support groups in Scotland that can be accessed by all mothers
can be found on the Breastfeeding in Scotland website (www.breastfeed.scot.nhs.uk/
breastfeeding_groups.htm).
The list was last updated in August
2003, so local sources of information
may need to be consulted.
There are contra-indications to breast-
feeding, but these are very rare. Some
rare medical conditions and metabolic
disorders, such as galactosaemia and
maple syrup urine disease, may make
breastfeeding more challenging for
mothers and health care professionals,
but few problems are insurmountable.
A limited number of medications that are essential for the mother and have limited
alternatives, such as gold preparations, may be harmful to the baby, and illicit drugs
used recreationally, such as cocaine, are also harmful.
The mother’s HIV status is also significant. If the mother is HIV positive or is suffer-
ing from AIDS, the government recommends that the baby should be delivered by
caesarian section, should not be breastfed and should receive anti-retroviral therapy. It
is possible to express breastmilk and pasteurise it before giving it to the baby.
2.4 Breastfeeding statistics in Scotland

This section provides some statistics that will help you to understand some of the fac-
tors affecting mothers’ decisions to start breastfeeding, continue, and stop.
Initiation of breastfeeding
The proportion of women initiating breastfeeding has increased over the past 20 years
after reaching a low in 1975, but still lags behind other parts of the UK. Figure 2.1
shows the variation in initiation in Scotland and England/Wales.
Influences on initiation of breastfeeding are many and varied. Data from the National
Infant feeding Survey 2000 suggest the following are significant.
Maternal age There is a strong association between maternal age and the initiation of
breastfeeding in Scotland, as there is in other parts of the UK. Older mothers are more
likely to initiate breastfeeding than mothers aged less than 20 years.
Parity Twenty-six per cent of mothers who had bottle-fed a previous child switched to
breastfeeding with a subsequent child, although there is a noticeably rapid decline in
breastfeeding over the first week, with 37% of mothers who formula fed before switch-
ing to formula. Eighty-six per cent of mothers who had successfully breastfed before
were still breastfeeding at six weeks.
Figure 2.1 Breastfeeding initiation in Scotland and England /Wales

England/Wales
Scotland
80%
70%
60%
50%
40%
30%
20%
10%
0% 1980 1985 1990 1995 2000
Socio-economic class There is a strong relationship between the duration of breast-

feeding and socio-economic status, with 75% of women in higher-paid occupations still
breastfeeding at six weeks compared to 53% in lower-paid occupations.
Age at which the mother completes full-time education Those who continue in
education beyond 18 years are more likely to breastfeed than those who complete their
education sooner.
Ethnicity White women who initiate breastfeeding continue to do so for a shorter
duration than those from other ethnic groups.
Full data on the Infant Feeding Survey 2000 can be accessed via the Department of
Health website, www.dh.gov.uk/publicationsandstatistics/publications/publications
statistics/publicationsstatisticsarticle/fs/en?content_id=4079223&chk=upj4sr
Prevalence of breastfeeding
The prevalence of breastfeeding in Scotland has increased, with 40% continuing to
breastfeed at six weeks in 2000 compared to 36% in 1995 and 30% in 1990. However,
provisional data from the Child Health Surveillance Programme: Pre-school (CHSP‑PS)
(www.isdscotland.org), which covers approximately 84% of Scotland’s pre-school
population, show that 35.9% of mothers of babies born in 2004 were breastfeeding
their babies at 6-8 weeks (Figure 2.2
overleaf). We must also remember that
the target set for 2005 was 50%.
Figure 2.2 Prevalence of breastfeeding

in Scotland at age six weeks
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
Infant Feeding Survey data suggest that more
1990 1995 2000 2004
than 90% of women who give up breastfeed-
ing before the baby is two weeks old claim they felt they had given up before they
would have liked. Figure 2.3 shows the proportion of women who stated they would
have liked to have breastfed for longer, plotted against the time at which they gave up.
It can be seen that this only reaches 50% at the 4-6 month time period.
Figure 2.3 Proportion of women who would have liked to

have breastfed longer
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
<1 1–2 2–6 6 weeks – 4–6 >6
0% week weeks weeks 4 months months months
Mother’s awareness of health benefits

The 2000 Infant Feeding Survey collected data for the first time on women’s aware-
ness of the health benefits of breastfeeding. Eight-eight per cent of Scottish women
said they were aware of benefits. Perhaps not surprisingly, 83% of mothers planning to
breastfeed could name benefits, compared to only 60% of those planning to bottle-feed.
Reasons given for stopping breastfeeding

Reasons given for stopping breastfeeding have varied since the last survey was con-
ducted. Responses for the UK are shown in Figure 2.4.
The most common reasons cited for stopping within the first two weeks after leaving
hospital are ‘insufficient milk’, ‘sore nipples’, and ‘problems with baby rejecting the
breast or not latching on’. Most of the problems could be attributed to poor positioning
and attachment, which can be rectified with the help of knowledgeable breastfeeding
experts.
Figure 2.4 Reasons given for stopping breastfeeding in the first two weeks
1995
2000
Insufficient milk
Painful breasts/
nipples
Baby wouldn’t suck
Took too long/tiring
Mother ill
Didn’t like
breastfeeding
Domestic reasons
Baby ill
0% 5% 10% 15% 20% 25% 30% 35% 40%
Support for mothers

Sources of most helpful support in Scotland cited in the Infant Feeding Survey are
shown in Figure 2.5. Pharmacists were not listed as providing support at that time, but
should strive through multi-disciplinary team working to become more pro-active in
the future. In doing so, they may become recognised as a readily accessible source of
support for women.
Figure 2.5 Sources of helpful support for mothers in Scotland
Books and leaflets

20%
Health visitor
37%
Family and friends

31%
Midwife
GP 6%
6%
Now go to Activity 2.2 in your Workbook (page 3), followed by Activity 2.3 (page 4)
3 Influences on, and support for,
breastfeeding
Elise Barraclough, 17, single parent, baby McKenzie (3 weeks).

I couldn’t have done it without my mother. I probably wouldn’t have even thought of it if I
hadn’t seen her breastfeed my sister, Evie. Like most people I’d probably have thought, “It’s
easier with the bottle because it means you can give the baby to someone and get out for the
night”. My mother told me all about the advantages of breastfeeding and when I saw how close
she and Evie were, I thought “It must be good, I want that closeness with McKenzie.”
Mother didn’t try and twist my arm; she just told me breastfeeding was a lot healthier for the
baby and that I’d lose weight quicker. Also the midwife gave me a breastfeeding video and that
encouraged me, especially since it stops you getting breast cancer. Only my mother and my
aunt have breastfed – none of my friends. When I told them I was going to breastfeed they said,
“What will you do in public?” I told them there were lots of places like Boots and Mothercare
with mother and baby rooms.
After McKenzie was born I had a few problems. On the second night it was really difficult
because my milk was coming through. I went to Mother’s room and said “I can’t do it” and she
just sat with me, calming me down, showing me how to help him latch on. My breasts were sore
and my nipples sensitive so mother gave me some Savoy cabbage leaves to put in my bra, which
soothed them.
It’s getting easier all the time and I plan to carry on until I go back to school after Easter. I’d
like to be able to express enough for him during the day but if I can’t do that I’ll just carry on
mornings and evenings. I also belong to a parentcraft group for teenage girls. I’m the only
breastfeeding mother and I’m told it has encouraged some of them to give it a go.
Only my Nan wasn’t happy at first. Because I’m young I guess she didn’t like the idea of me
getting my boobs out in public and of people laughing or disapproving. But I’m quite strong and
I don’t care what people think. Now my Nan sees how discreet I can be and she’s fine about it.
My male friends don’t mind and McKenzie’s father, who I’m not with anymore, thinks it’s a
good idea. He told me, “Do what ever is best for the baby.”
31
3 Influences on, and support for, breastfeeding

The aim of this chapter is to enable you to examine barriers and opportunities to sup-
porting breastfeeding women in your day-to-day practice.
t look at influences on breastfeeding behaviour
t understand national breastfeeding initiatives
t enable you to provide effective support to breastfeeding mothers
t understand the pharmacist’s role in supporting breastfeeding women
3.2 Influences on breastfeeding behaviours

The intention to initiate breastfeeding can be influenced by many people, from the
woman’s next-door neighbour to the government. The mother may be subjected to
a variety of viewpoints on breastfeeding, with the relative strength of advantages and
disadvantages varying according to the predilections of the source.
The following are significant influencers of women’s decisions.
Partner The mother’s partner can be supportive or negative, depending on his past
experiences. Many men wish to be involved closely in raising their baby, while others
see their role to ‘provide’ while the mother ‘nurtures.’ Sixteen per cent of mothers in
the Infant Feeding Survey said they felt pressurised into breastfeeding by their partner,
while 17% said they felt similarly pressurised to bottle feed. Influences on fathers may
generally be assumed to be similar to those perceived by mothers.
Family and friends Eighty-two per cent of mothers
The art of breastfeeding has who had been breastfed as babies planned to breastfeed
their own babies, while only 56% of those who had been
been all but lost. Most of the entirely formula fed intended to. Mothers are also more
information women are now likely to breastfeed if their friends do so.
Health care professionals All health care professionals
given is complete poppycock,
should aim to provide non-conflicting, evidence-based,
based on the teaching at the turn patient-focused information. A broadening evidence-
base for practice, coupled with greater awareness of the
of the century, which supposed
importance of breastfeeding in health care professional
the breast was a bottle. Health training programmes and widening access to UNICEF
Baby-Friendly standards and associated education,
professionals don’t realise how
should mean that health care professionals are able to
desperately the women in their achieve these objectives. The reality, however, may be
somewhat different, and advice of questionable quality
care need information and
and information based on tradition rather than evidence
support. is still being offered to women.
McConville B (1994) Mixed Messages: our
breasts in our lives. London: Penguin.
Pharmacists In a small study in Renfrew in 2004 (Holt et al, 2004), pharmacists and
staff in five pharmacies were questioned in an attempt to identify community phar-
macy staff education and training needs in promoting breastfeeding. The area served
by the pharmacies had an identified breastfeeding rate at six weeks of 26% (compare
this to the national target of 50% by 2005). The study found:
t pharmacists reported that they seldom received enquiries about drug safety dur-
ing breastfeeding, or reports of breastfeeding problems
t all of them thought this was an important area in which pharmacists should be
involved
t six assistants out of 15 reported being asked about the safety of medicines at least
once a month
t three assistants had been asked about breastfeeding problems
t three assistants thought that the information they had available was sufficient
t some staff were concerned about adding pressure to mothers in what they
believed was a personal choice
t almost all agreed that they needed further information about common problems
in breastfeeding.
The authors reported that the study, although limited in size, demonstrated that
pharmacy staff would welcome training opportunities to contribute to breastfeeding
targets, despite currently being inactive in this area. The study represents a ‘snapshot’
of experiences, and further research may provide conclusions that can more readily be
generalised.
It is widely acknowledged that pharmacy services should be based on evidence, but it
would be naïve to believe that personal experiences do not inform many of our day-to-
day practices as pharmacists. Intense feelings about infant feeding can be particularly
strong among pharmacists who are mothers. For instance, a pharmacist replying to
a questionnaire which formed part of a study into beliefs and attitudes of GPs, phar-
macists and mothers about breastfeeding and the safety of drugs in breastmilk (Jones,
2000) stated: ‘having personal experience [of breastfeeding] puts you in a unique and
understanding position and however much you make colleagues read or study, it is not
the same. Having successfully breastfed two children to six months gives me an ability
to identify with mothers’ fears.’
Society and the media In Scotland, negative attitudes to breastfeeding can be
detected not only in the low incidence and duration, but also in the response of society
and the media towards breastfeeding mothers.
The 2000 Infant Feeding Survey noted that although women in the UK are now
more likely to breastfeed in public, 26% of women with a baby aged 4-5 months have
reported difficulty in finding a place to breastfeed, while 8% have never fed in public.
Interestingly, 35% of bottle-feeding mothers had similarly never attempted to feed their
baby away from home.
Influences on, and support for, breastfeeding 33
Law The Consultation paper that

launched the Breastfeeding (Scotland)
Bill in 2002 (www.elaine-smith.co.uk/
consultation.php) quoted research
suggesting that while media reports
highlight hostility to mothers who
breastfeed in public settings (Martin
and O’Hare, 1999), the media in
general represents bottle feeding as
‘normal, unproblematic and associated
with “ordinary” families, whilst breast-
feeding is represented as problematic,
humorous and associated with middle
class or celebrity mothers.’ (Henderson et al, 2000).
A mother who bottlefeeds her baby in public, the document continues, attracts little or
no attention, ‘but the breastfeeding mother often experiences negative comment or is
asked to stop feeding and resume feeding in the public toilets.’ The document claims
this has a negative affect on breastfeeding both in the short and long terms and causes
distress to mother and baby. Embarrassment is commonly sited as a major factor for
choosing not to breastfeed (Hamlyn et al, 2002).
The Breastfeeding (Scotland) Bill aimed to make it an offence to prevent a child being
breastfed in public or on licensed premises, and to require premises to make provision
to support breastfeeding. It supported the right of all mothers to feed their babies in
public places without criticism. The Bill was passed in November 2004 and received
Royal Assent to become law in Scotland on 18 March 2005.
This law has implications for you as a pharmacist and
It is important that every child in the premises on which you work. If you haven’t already
done so, you might consider defining an area as a quiet
Scotland gets the best start in life,
place to breastfeed. This will not only provide a welcom-
and breastfeeding protects babies ing environment for breastfeeding mothers, but will
also emphasise to them that you are prepared to support
from a host of potential health
their breastfeeding and the health benefits it brings to
problems. mother and baby.
Deputy Health Minister Rhona Brankin, MSP, The Scottish Executive is now developing an Infant
May 2005 (www.scotland.gov.uk/News/ Feeding Strategy for Scotland in conjunction with the
Releases/2005/05/09114219) Scottish Breastfeeding Group. This will aim to increase
breastfeeding rates across the country.
3.3 National breastfeeding initiatives

Government policy has consistently supported breastfeeding as the best way to ensure
a healthy start for infants
In the 1970s, with breastfeeding rates falling, the Committee on Medical Aspects of
Nutrition Policy (COMA) Working Party was set up to review infant feeding. Fifty one
per cent of mothers in England and Wales breastfed at birth in 1974. By 1980, this had
increased to 67%, with Scotland’s rate identified for the first time as 50%. The results
of the 1985 survey showed no increase in initiation and that early discontinuation
was high. It is against this background that various initiatives designed to increase
incidence and prevalence of breastfeeding have been implemented.
UNICEF breastfeeding initiatives

The Baby Friendly Hospital Initiative was launched in 1992, with the UK joining in
November 1994. The objective was to reverse the negative impact that many maternity
hospital practices had had on infant feeding world-wide. The initiative proposed ten
research-based ‘steps’ that would act as standards of good practice (Box 3.1).
Box 3.1 The ten steps to successful breastfeeding

Hospitals receiving the award must:
1 Have a written breastfeeding policy that is routinely communicated to all health
care staff.
2 Train all health care staff in the skills necessary to implement this policy.
3 Inform all women (face to face and through leaflets) about the benefits and
management of breastfeeding.
4 Help mothers initiate breastfeeding within half an hour of delivery.
5 Show mothers how to breastfeed and how to maintain lactation (by expressing
milk) even if they should be separated from their infants.
6 Give newborn infants no food or drink unless ‘medically’ indicated and must
demonstrate an absence of promotion of formula milks.
7 Practice ‘rooming in’. All mothers should have their infant cots next to them 24
hours a day.
8 Encourage breastfeeding on demand
9 Give no artificial teats or pacifiers to breastfeeding infants.
10 Foster the establishment of breastfeeding support groups and refer mothers to
them.
From: The Baby Friendly Hospital Initiative
A need for a similar initiative in the community was soon identified to ensure that
breastfeeding was promoted throughout the health care system and across primary and
secondary care. A ‘seven-point plan’ was launched in May 1998 (Box 3.2), calling for
consistent advice and communication among all health care personnel (including GPs
and pharmacists) coming into contact with pregnant and newly delivered mothers.
Box 3.2 The seven steps to successful breastfeeding

Health care settings should:
1 Have a written breastfeeding policy that is routinely communicated to all health
care staff.
2 Train all staff involved in the care of mothers and babies in the skills necessary
to implement the policy.
3 Inform all pregnant women about the benefits and management of breastfeed-
ing.
4 Support mothers to initiate and maintain breastfeeding.
5 Encourage exclusive and continued breastfeeding, with appropriately timed
introduction of complementary foods.
6 Provide a welcoming atmosphere for breastfeeding families.
7 Promote co-operation between health care staff, breastfeeding support groups
and the local community.
From: The Baby Friendly Hospital Initiative
Pharmacists can be a useful source Organisations find the process of becoming accredited
through the Baby Friendly Hospital Initiative challeng-
of help and advice, particularly if
ing and demanding, but recognise that it stands as a
they know where to refer parents benchmark for good practice.
who have difficulties… breastmilk
is the optimal form of nutrition for
the majority of infants.
Mason, P (2000) Infant milk: an update,
Pharmaceutical Journal 264: 471-5
3.4 Supporting breastfeeding mothers

All health care professionals should follow similar guidance when supporting breast-
feeding mothers to minimise conflicting advice and confusion. They should:
t focus on the needs of the mother and baby
t encourage the mother to achieve effective feeding by correct positioning and at-
tachment of the baby at the breast
t avoid interfering with the baby’s natural feeding pattern
t recognise that breastfeeding is a very sensitive issue and encourage the mother
to have confidence in herself, despite the conflicting advice she may be receiving
from several sources.
Expressing and storing breastmilk

Many pharmacies stock breast pumps, a variety of which – hand pumps, battery or
electrically operated – are on the market. You should be able to offer advice on the use
of breast pumps you stock, but it may be more appropriate to refer the mother to a
breastfeeding specialist. Stocking pumps that local midwives and health visitors recom-
mend is sensible, and you will find it helpful to discuss use of the pumps with them.
There is also a ‘breast reliever’ available on the
Drug Tariff, but this should not be recommended
for use as it is not possible to sterilise it effectively.
Attempts to have it removed from the Tariff have
so far been unsuccessful (personal communication,
Jenny Warren).
Women should be taught how to hand express if
their baby is delivered in a Baby Friendly Hospital,
but it may be time consuming if they need to
express regularly to allow them to go back to work.
The NHS Health Scotland booklet ‘Breastfeeding
– Getting off to a good start’ (www.hebs.scot.nhs.
uk/services/pubs/pdf/BreastFeeding.pdf) con-
tains excellent information on how to express milk.
The Breastfeeding Network website
has a comprehensive leaflet called
‘Expressing and Storing Breastmilk’
(www.breastfeedingnetwork.org.uk),
and the UNICEF baby friendly
leaflet ‘Breastfeeding Your Baby’
(www.babyfriendly.org.uk/pdfs/
bfyb_english2.pdf) has some valuable
information on pumps and expressing.
You might find that some mothers
attempt to buy a breast pump because
they have been told they must express
and discard their milk while taking
medication. This gives you a good
opportunity to discuss options with
the woman and check the information
she has been given.
Now go to Case Scenario 3.2 in your Workbook (page 5)

Returning to work
Under EC and Scottish law, employers have to take positive steps wherever possible to
enable women to continue breastfeeding at work by providing adequate rest periods
and facilities for storage of milk. The feasibility of this will vary according to the moth-
er’s working environment.
There are definite advantages to em-
ployers of encouraging breastfeeding.
Babies who continue to be breastfed
are more likely to remain in good
health, meaning their mothers are less
likely to be absent from work to care
for sick children. In a study in the US,
one-day maternal absences were three
times more common among mothers
of formula-fed infants.
Mothers may consider building up a
store of expressed milk in the freezer
prior to returning to work. The Scottish Breastfeeding Group have produced an excel-
lent book, ‘Breastfeeding and Returning to Work’, which is available via the website
(www.scotland.gov.uk/library2/doc15/bfrw-OO.asp)
Introducing solids
Many women believe their milk is insufficient in quantity and quality at around four
months as the baby’s weight gain slows. They can be reassured that this is perfectly
normal. Introducing solids into the baby’s diet should be delayed until six months,
according to Department of Health Infant Feeding Recommendations (Scottish guide-
lines are still under development). Milk is all the baby needs to satisfy his nutritional
needs before this point.
Weaning should be baby-led, with a variety of foods offered. Breastfeeds can provide
all the additional fluid the baby needs until significant meals are taken. The transfer
from milk to solids should be gradual over a period of months as the baby becomes
accustomed to different flavours and textures. Feeds will be dropped or shortened as
the baby’s appetite for solids develops, although breastfeeding may continue for as long
as mother and child desire. Sudden cessation of breastfeeding leads to engorgement of
the breasts and may require analgesics and additional support.

The role of voluntary breastfeeding supporters

Voluntary breastfeeding supporters, generally women who have breastfed, have un-
dergone specialised training to advise and assist other mothers in their communities.
They can provide telephone support, visit mothers in their homes to watch feeds, and
run local support groups. They are not medically qualified, but have become specialists
in breastfeeding through access to ongoing study days and resources.
Many volunteers set up drop-in sessions in which mothers can gain mutual support
and have face-to-face contact with someone who may be able to help them with
breastfeeding difficulties. Professionals and volunteers work together to facilitate these
groups in many instances.
Support from other health professionals

It is essential that mothers with problems are referred to their midwife or health visitor.
Sixty per cent of mothers cite their health visitor as the most useful source of advice
about feeding after the birth of their baby. There will be a specialist breastfeeding
co-ordinator with a specific interest in dealing with problems in most Baby Friendly
Hospitals.
Consistent information should be supplied across the primary health care team to sup-
port women and their babies. If you are concerned that a baby may be ill, you should
offer information on how to manage symptoms in the immediate term and refer
mother and baby to the GP or health visitor.
3.5 The pharmacist’s role in supporting breastfeeding women

Advice on medications
Pharmacists are experts on medicines and are easily accessible to patients and fellow
health care professionals for discussions on safety of medicines, side-effects and contra-
indications. Breastfeeding poses many challenges and complications in relation to
drug therapy, and these are considered in detail in the next chapter. The pharmacist’s
role in supporting breastfeeding women, however, is to provide accessible information
on breastfeeding and its benefits and specific information on the safe use of medicines
(prescribed and OTC) during breastfeeding. You should also provide information on
other sources of support and offer health promotion guidance at every opportunity.
Multi-disciplinary working
Multi-disciplinary working is the cornerstone of primary care teams. Professionals
within the team who will have a particular interest in the impact of medications on
breastfeeding include the GP, midwife, health visitor, practice nurse and, of course,
the pharmacist. Meeting together as a team locally, perhaps twice a year, will help to
ensure a consistent, evidence-based approach to breastfeeding from all members, mini-
mising confusion to the mother arising from conflicting advice. Members of the team
who attend a workshop or conference focusing on breastfeeding issues can be asked to
write a short synopsis of learning points or share their experience at the meeting, and
new evidence and its relevance to combined practice can be identified and discussed.
If team meetings are neither possible nor practical in your area, you should regularly
consult with prescribers and other health care professionals on aspects of medicines
safety for specific patients. This is particularly important when evidence is limited or
is open to different interpretations. Team working is empowering, particularly to com-
munity pharmacists who tend to work in isolation from the rest of the primary care
team on a day-to-day basis. Team working builds bridges that facilitate discussion over
differences of opinion or on methods of disseminating information.
Dealing with inter-disciplinary difficulties

Occasions are likely to arise when the advice given to a mother by a health care profes-
sional differs from what you understand as current, evidence-based information.
It is important that you do not denigrate either the health care professional or the in-
formation the mother has been given. She will need to maintain a trusting relationship
with the professional, whether GP, health visitor, other pharmacist or support worker,
and you will have to work closely with the professional in question, particularly a GP.
This is about mutual trust and valuing each other’s knowledge and contribution to
primary care team working, and is also an issue about behaving ethically.
You may find that as a result of completing this pack, or through your own personal
interest or study, you have different information on breastfeeding from other health care
workers. Another professional basing his or her practice and advice on different informa-
tion does not necessarily imply that he or she is wrong; rather, it signals that the person
has a different viewpoint and has possibly accessed different information sources.
If a mother reports conflicting information, it is important to explain your own sources
and be sure they are accurate. Your views should be discussed with the other profes-
sional if possible before responding to the mother. If the issue relates to the safety of
a drug during lactation, it would be useful to provide the source of the information on
which you were basing your opinion to the professional (normally the GP in such an
instance, but possibly a dentist, nurse prescriber or pharmacist supplementary pre-
scriber) and to provide input on the pharmacology of the drug. Discussing the situation
with the professional and arriving at an agreed course of action will protect the patient
from being placed in the sensitive position of having to adjudicate on the advice of two
respected professionals.
Contact under these circumstances may also provide an opportunity to discuss your
role in the provision of information to the primary health care team. Being proactive
may add significantly to your professional roles and responsibilities and may demon-
strate to local GPs, midwives, volunteer supporters and mothers in the area that you
are a valuable resource of breastfeeding information and advice.
You must demonstrate to the mother that while you understand why the other profes-
sional has said, for example, that a particular drug is not safe during breastfeeding and
that she must stop breastfeeding, you have different sources on which to base your
information and, if appropriate, that you have discussed the issue with the professional.
Provide information to the mother in a non- judgemental, supportive manner so she

can reach her own decision on the action she wants to take. There may be occasions
when your information is rejected as the mother perceives the other professional to be
in a more authoritative position, and she has every right to do this. Alternatively, she
may ask you for some evidence to back up your advice.
As in any other concordant discussion, the woman must make the final decision on
whether to take the drug and, if so, whether to carry on breastfeeding. Try to remain
impartial and patient-focused throughout the discussion, and remember that the
mother probably has informal networks that will either reinforce or undermine her
decision.
Professional responsibility
Pharmacists demonstrate professional responsibility for their actions with regard to
dispensing, counter prescribing and counselling patients on a day-to-day basis. Our
work is guided by the Royal Pharmaceutical Society Medicines, Ethics and Practice
Guide for pharmacists. We are required to work within our sphere of competence.
Continuing education (CE) allows us to develop areas of special interest and the
continuing professional development (CPD) cycle allows us to highlight gaps in our
knowledge, determine how we intend to fill the void and then reflect on the effective-
ness of the activity (Figure 3.1)
Figure 3.1 RPSGB CPD cycle

Reflection
on practice
What do I need to
know/be able to do?
Evaluation
Planning
(reflection on learning)
How can I learn?
What have I learned?
How is it benefiting my practice?
Action
Implementation
If you need to access information on a medicine prescribed for a breastfeeding mother,

it provides an opportunity for you to undertake appropriate CPD activity to improve
practice for the future. You can record your learning in the RPSGB CPD website
portfolio when a convenient opportunity presents.
Phrasing of information to parents

The way in which information is presented has a considerable impact on the way it is
perceived. For instance, a teratology risk of 3% is generally seen as being less accept-
able than a 97% chance of having an unaffected baby. This has a parallel with food
industry labelling, where ‘90% fat free’ is a positive-sounding message that perhaps
disguises the fact that the product has a 10% fat content.
Evidence-based data can be transmitted with confidence and in a positive manner.
Information should be pitched at a level appropriate to the person’s understanding,
with complex medical jargon and abbreviations avoided. If you are unsure of the
information you should be giving, take time out to consult other sources rather than be
tentative or inaccurate with the person. There are very few instances when an instant
answer is essential.
Counselling skills
Counselling skills are those involved with listening to the patient rather than providing
information or advice, a role with which pharmacists are more familiar. It has a com-
mon base with many of the principles underpining concordance.
Counselling involves listening to the patient in a non-judgmental and empathetic man-
ner. The skills of reflection and clarification of information are important in ensuring
the mother is able to explore the situation fully. Counselling and empathetic listening
are certainly needed as patients look to pharmacists for positive information on which
to base their future actions.
Being aware of the mother’s body language may allow you to judge how she has
received the information. For instance, she may avoid eye contact as a means of ignor-
ing the information or may turn away to block the discussion. Alternatively, she may
visibly relax, smile and make good eye contact if she is receptive to the advice.
Listening carefully to the woman’s explanation for seeking you out for consultation is
important. It is possible that she is seeking your ‘approval’ for an action she has already
decided upon, or is looking to get the confidence she needs to act in a way that may be
at odds with advice previously given.
Clinical governance
Good clinical governance demands a standard operating procedure on highlighting
the safety of any medicine dispensed or sold to pregnant or breastfeeding women. A
protocol covering access to sources of information would be invaluable to locums or
part-time staff working in the pharmacy.
This requires breastfeeding mothers to be identified, but there seems to be some
reluctance among pharmacy staff to make enquiries of women into what they may see
as a highly personal subject. Although the WWHAM questions do not specifically ask
whether the patient is pregnant or breastfeeding, there is no reason why such queries,
appropriately asked, cannot be absorbed into everyday practice. Opportunities to edu-
cate staff on how to identify potential breastfeeding women and how to ask questions
sensitively should be pursued.
4 Conditions affecting breastfeeding
Sarah Elliott, 21, mother of Brittney (3), Joshua (2), and twins
Connor and Callum (5 months) lives with her partner Pete. She
is part of Doncaster’s breastfriends peer support scheme.
I only breastfed Brittney for two weeks because I was living with my mother-in-law at the time
and I was embarrassed that people could see my breasts. One night I didn’t feel well and I sat
up feeding her all night long crying. The next morning my sister-in-law made up four bottles of
formula and took her off my hands. I didn’t breastfeed her again after that.
But when I discovered I was pregnant with Joshua four months later I was determined to breast-
feed longer this time because I couldn’t face the idea of making up another bottle. My partner
was all for it.
Joshua was born five weeks early on the kitchen floor. I tried him on the breast before the
ambulance came but his blood sugar was so low that in hospital they gave him Nutroprem. I told
them to give it to him in a cup. He breastfed brilliantly after that but when he was two days old he
got jaundice and wouldn’t eat. He ended up in special care being fed through a tube but when he
came out the following day he went straight back on the breast and fed brilliantly from then on.
I fed him for 16 months until I found out I was pregnant again – this time with twins! I’d so
enjoyed breastfeeding Joshua that I had every intention of feeding the twins in the same way.
They were born at 33 weeks and taken straight to special care so I had to express my milk to be
given in a tube. I couldn’t hold them for four days and a couple of nurses warned me it would
be very hard to breastfeed but I’m quite stubborn and if someone says it’ll be difficult it makes
me even more determined. I told them, “I’m not going home without my babies and my babies
aren’t going home until they’re totally breastfed.”
I’ve had some weird reactions. When Joshua was tiny a friend and her partner came over but the
moment I started breastfeeding her partner got up to go. Later he told her, “I can’t believe she
got her tits out while I was there.” I was stunned. It was my house and my baby. Then I was with
my sister-in-law in the Asda cafe when Joshua needed feeding. “No one wants to look at you
while you’re feeding,” she told me and suggested I found a baby room. So I went to customer
services to ask them where I could feed but the lady behind the desk told me it was perfectly OK
to do it in the cafe.
She even walked me to where I was sitting. “It’s great she’s breastfeeding isn’t it” she said to my
sister-in-law who obviously didn’t think so. “Actually I bottle fed mine and I can’t believe you don’t
provide a room,” she said. I got really upset then and went and sat in the car feeding Joshua and
crying while my sister-in-law sat finishing her meal. But my attitude changed after that – I was
determined that nothing like this would ever put me off breastfeeding in public again.
When I’m out I won’t breastfeed both the babies at once because its too revealing but I’m happy
to do it just about anywhere. I was shopping recently and I saw this woman bottle feeding and
it looked like it was a chore rather than something she was enjoying. I love the closeness that
breastfeeding gives you; also it’s so convenient and it helps you get your figure back.
45
4 Conditions affecting breastfeeding

This chapter aims to set out the physiological principles underlying breastfeeding
before exploring some of the more common conditions that can have an adverse effect
on breastfeeding.
The objectives are to help you understand:
t how breastmilk is produced
t the importance of positioning and attachment in ensuring successful breastfeeding
t the normal pattern of baby feeding
t the common conditions affecting breastfeeding
4.2 Physiology of breastfeeding

Pharmacists may be asked for information on many of
The majority of common the conditions that affect breastfeeding in the early days.
Mothers value the fact that pharmacists are accessible
breastfeeding problems can be
health care professionals and are readily available with-
overcome by understanding the out an appointment. You will get a better understanding
of problems associated with breastfeeding by under-
basic physiological principles
standing how breastfeeding works. The structure of the
of breastfeeding and how to breast is shown in Figure 4.1.
implement practical guidance on Figure 4.1 The structure of the breast
positioning and attachment in alveolus (enlarged)

order to achieve pain-free, effective alveolus (acinus)
feeding.
ductile
Clinical Effectiveness Information Bulletin, myoepithelial cell
April 2003, Focus on Promoting and lactiferous (mammary) duct
Supporting Breastfeeding lactiferous sinus (ampulla)
nipple (mammary papilla)

areola
lobe
From: Breastfeeding and Human Lactation, Riordan J and Auerbach KG. Jones
and Bartlett, Massachusetts 1993.
Breastmilk production
Milk is produced by glandular epithelial cells within the breast and is stored between
feeds in small clusters of sac-like spaces called alveoli. Production is controlled by two
hormones – prolactin and oxytocin. Oxytocin controls the ejection of the milk from the
breast, while prolactin controls the production of breastmilk.
Oxytocin is released from the posterior pituitary gland when the baby suckles from the
breast and causes the release of milk. It causes the milk to be ejected from both breasts,
and the opposite one from which the baby is feeding will drip milk simultaneously.
The mother may feel the ‘let-down’ of the milk as a tightening of her breasts. Some
perceive it as sharp, needle-like pains, others as mildly painful, but many women
experience no sensation at all.
Oxytocin release also stimulates the uterus to contract, which facilitates uterine involu-
tion and control of post-partum bleeding. Cramps, commonly known as ‘after-pains’,
can be troublesome in the first few days after birth and are stronger with subsequent
births. Some mothers may require regular analgesics to cope with the discomfort, but
can be reassured that experiencing some pain is normal.
As maternal levels of oestrogen and progesterone fall after delivery, the anterior
pituitary gland, no longer under the hormones’ inhibition, releases large amounts of
prolactin. Plasma prolactin levels are regulated by the frequency, intensity and duration
of nipple stimulation. If a mother does not breastfeed, prolactin levels return to non-
pregnant levels by seven days.
The continued removal of milk is also important to continued production once lacta-
tion is established, emphasising the importance of effective breastfeeding. Breastmilk
contains a whey protein which inhibits milk synthesis through a negative feedback
mechanism. Feeding from the breast removes the protein and allows more milk to be
produced. Decreased removal of the protein reduces supply. Cutting down on the fre-
quency of feeds or adding supplementary bottles consequently lowers milk production.
Positioning and attachment

The milk drains via ducts into the lactiferous sinuses. Removal from the sinuses is ef-
fected by rhythmical pressure exerted by the baby’s tongue. The sinuses are positioned
in the area behind the nipple, which explains why the baby has to open his mouth
wide to compress the breast, and not the nipple. The baby’s tongue produces waves of
compression rather than actual movement.
The majority of common breastfeeding problems can be overcome by a clear under-
standing of the importance of achieving correct positioning and attachment of the baby
to the breast. It enables pain-free and effective feeding with good weight gain and a
satisfied, contented baby. Nipple trauma, pain on feeding, poor weight gain, frequent
feeding, an unsettled baby, non-infective mastitis and poor milk supply are all linked
with less than optimal positioning and attachment. It is a vital skill for mothers to
acquire and, in a society in which breastfeeding has not been the norm in recent genera-
tions, they may need skilled support from health care professionals to help them do so.
Conditions affecting breastfeeding 47
One of the most valuable aspects of your role as a pharmacist is to recognise ‘symp-
toms’ described by a mother which may suggest problems with positioning and to
signpost her to appropriate skilled support locally. Figure 4.2 demonstrates how to
recognise if the baby is well attached. While it is very unlikely that you will be able to
assess this, the diagrams may help you to explain the problem to the mother and to
reassure her that pain-free breastfeeding can be achieved with appropriate help. A card
with these diagrams is included as appendix 6 (page 95) and can be taken out of this
pack and used for demonstration purposes.
Figure 4.2 Attachment
Good attachment at the breast Baby poorly attached to the breast
Baby compressing lactiferous sinuses behind the Baby not compressing lactiferous sinuses and is
nipple; this will result in pain-free feeding for the nipple feeding, which will produce pain and damage
mother and the baby will be satisfied as he can for the mother and will not enable the baby to
remove all the milk from the breast extract the milk from the breast effectively.
From: Royal College of Midwives (2002) Successful Breastfeeding 3rd Edition. London: Churchill, Livingstone.
If the baby is properly attached to the breast, the mouth will be wide open and the
lower lip further away from the base of the nipple than the top. The chin will be tucked
tightly into the breast, but the nipple will be clear.
Baby’s feeding pattern

The baby’s feeding pattern changes throughout the feed, with long, vigorous sucks
as the foremilk (milk stored in the sinus since the last feed) is consumed followed
by rhythmic sucking interspersed with resting pauses (Figure 4.3 overleaf). The fat
concentration of the milk increases with the duration of the feed, while the volume
diminishes. Allowing the baby to come away from the breast when he decides allows
him to determine when he is satisfied, having accessed the high-fat milk.
Figure 4.3 Pattern of normal breastfeed

Hungry Satisfied
Pause, Pause, Pause,
resting resting resting
Foremilk Hindmilk Low quality

Vigorous, Rhythmic Rhythmic Rhythmic Rhythmic Flutter or
stimulating suckling, suckling, suckling, suckling, butterfly
active feeding active feeding active feeding active feeding suckling
Volume reduces
Fat levels increase
If the baby is removed from the breast after an arbitrary time period (ten minutes each
side used to be advised), there is no means of assessing where he had reached in the
cycle of the feed. He might have accessed more volume of milk but a lower fat content,
so will be physically full but unsatisfied (the equivalent for an adult might be eating a
large plate of salad with no carbohydrate). Too much foremilk can cause diarrhoea with
frothy, often green motions due to ingestion of too much lactose, which has a rapid
transit time through the baby’s gut. Babies will often also appear unsatisfied and pos-
sibly colicky. Referral to a specialist to observe the feeding technique is advised.
The mother should be encouraged to allow her baby to come off the first breast before
offering the second. She can be reassured that it does not matter if her baby wants
to feed from only one breast at an individual feed, when she can use a pad on the
alternate breast to absorb any milk secretion. Similarly, it does not matter if he feeds
from both breasts at each feed. The baby will adjust his pattern of feeding to satisfy his
needs.
An understanding of the importance of correct positioning and attachment of the baby
at the breast, and how breastfeeding works, prepares us to understand some of the
more common breastfeeding problems encountered.
4.3 Common breastfeeding problems

Increased initiation and prevalence of breastfeeding may lead to more women asking
you and fellow-pharmacists about common conditions affecting breastfeeding. The
main conditions are now discussed.
Sore and cracked nipples

The most likely cause of sore and cracked nipples is trauma caused by the baby’s feed-
ing action, generally due to poor attachment of the baby to the breast. It is difficult to
correct this without watching a full breastfeed, observing the way the baby is brought
towards and comes off the breast and noting the appearance of the nipple. This is prob-
ably not practical within a community pharmacy, so the mother should be referred to
her health visitor, midwife, voluntary breastfeeding worker or drop-in support group in
the area for specialist support.
In the meantime, you can reassure her that the pain she is experiencing is not an
inevitable part of breastfeeding and that there are means of achieving pain-free feeding.
What would not be helpful would be to sell her a nipple shield or a cream to alleviate
the pain. Nipple shields reduce the stimulation of the nipple and provide a physical
barrier between the nipple and the baby’s mouth. This causes a lowered milk supply
and results in the baby needing to feed more often. Mothers may then opt to supple-
ment his feeds with formula or even cease breastfeeding due to the level of pain.
Healing can only occur when incorrect positioning and attachment have been rectified
– otherwise, further damage will occur at each subsequent feed. There is no evidence
that nipple shields will correct a positioning problem which is causing painful feeding,
and they should not be made available for self selection. Any stocked (if keeping stock
is perceived as appropriate after discussion with other local health care professionals)
should be kept ‘behind the counter’ so that use can be discussed before a sale.
No pharmaceutical preparation has been shown to heal the damage to the nipple ef-
fectively or to reduce pain without correct positioning having been achieved. Even badly
damaged nipples heal remarkably quickly under these circumstances. There is evidence,
however, that applying an inert barrier that is permeable to air but impermeable to
water over the lesion in between feeds will promote moist wound healing. Several alter-
natives have been suggested, including petroleum jelly and an oil-based nipple cream.
Moist wound healing products are necessary to prevent the cracks from healing from
the outside, with consequent scab formation. Scabs stick to breast pads and remove
new skin cells with them, deepening the crack further. It can be helpful to show the
mother the diagrams in Figure 4.2 (page 47) to explain the cause of her pain.
Nipple pain is not normal, and the cause should be determined. Nipple discomfort
may be caused by an allergic reaction to breast pads which presents typically as a red,
inflamed area reflecting the shape of the pad. Switching to another manufacturer’s
pad or using a folded handkerchief may relieve the symptoms, with a short course of
antihistamines if necessary. This is a comparatively rare situation, but should be borne
in mind as a differential diagnosis.
If, despite all measures suggested, the mother continues to report sore nipples, she
should be referred for help in dealing with the cause of the problem rather than the
symptom.
The use of Hoffman breast shells to prepare nipples ante-natally has not been shown to
be beneficial (Alexander et al, 1992). Mothers who believe their nipples are non-protractile
should be referred to the midwife for assessment, but can be reassured that the baby will
probably be able to release the nipple and that they will be able to breastfeed. Reminding
mothers or mothers-to-be that breastfeeding should not hurt and to ask for help if it does
will be beneficial.

Engorgement
Many women experience temporary swollen, hot and sore breasts around two to five days
after delivery, as milk production begins. This is not clinically significant and indicates
that the baby’s consumption of milk and the mother’s production are temporarily out of
balance. Frequent breastfeeding of unrestricted duration should be encouraged, ensur-
ing that the baby is correctly positioned at the breast to enable effective removal of milk.
Breasts can feel very full before a feed at any stage during lactation. This is not the
same as engorgement, which is due not just to milk production, but also to increased
blood flow to the breast as a result of the action of prolactin, which is no longer inhib-
ited by placental oestrogen. Milk engorgement is almost always iatrogenic and rarely
occurs when babies are allowed to feed on demand day and night.
The application of cold compresses after feeding may result in some improvement in
symptoms, as may showering or bathing before a feed. If the baby is separated from
the mother for any reason, such as either being admitted to hospital, mechanical
expression using a breast pump or hand expression may be necessary.
Engorgement of the breast accompanied by pathological symptoms of raised tempera-
ture, aches and pains is abnormal, and may result from ineffective milk removal or
restricted feeds. Treatment involves care with correct positioning (which may be dif-
ficult if the breast is overfull), frequent feeds or expression of the milk and analgesics
to reduce the pyrexia.
If the baby is experiencing difficulty latching on to the breast, the removal of some milk
by hand expression or gentle application of heat will soften the swollen tissues. This is
a period in which nipple damage can occur by allowing the baby to feed to remove the
milk while paying insufficient attention to correct attachment.
Medication should not routinely be used to suppress milk supply. A mother who chooses
not to breastfeed should be supported with simple analgesics while her milk decreases.
Engorgement can also occur at later stages if the mother stops breastfeeding abruptly,
leading to a build up of milk in the lactiferous sinuses. If untreated, this can lead to
blocked ducts and/or mastitis. If the breast is engorged, the mother should feed the
baby or express the milk until she is comfortable and the negative feedback of the whey
protein reduces the supply (see page 46).
Insufficient milk
Insufficient milk is one of the most common reasons given by mothers for stopping
breastfeeding sooner than they would have otherwise intended. Results from the Infant
Feeding Survey show that 29% of women cite ‘lack of milk’ as the main reason for
stopping breastfeeding in the first two weeks of the baby’s life. But the true incidence
of failure to produce enough breastmilk to satisfy the baby is 0.2-1%, suggesting that
the perception of having insufficient milk is usually incorrect. There is some evidence
that ‘rules’ such as the frequency of feeding recommended by health care professionals
and relatives may have had an impact on supply in the past (Renfrew et al, 2000).
Mothers may need support to gauge how contented the baby is. If he comes away from
the breast looking satisfied and sleeps for a reasonable period (bearing in mind that no
two babies have the same sleep pattern), and is producing several very wet and dirty
nappies with motions that are generally mustard in colour, he is probably getting suf-
ficient milk. The frequency of bowel motions varies for breast-fed babies from several
times a day to every other day. The colour and form of the faeces are different to that of
formula-fed infants.
Milk supply is often judged by periodic visits to health clinics to have the baby weighed,
but illness, use of antibiotics and ‘growth spurts’ may produce a temporarily abnormal
weight pattern. Weight gain should be measured over a prolonged period and not be
judged on one isolated measurement in the absence of any other symptoms of concern
(Williams, 2002). Child development growth charts in current use are largely based
on studies of formula-fed children from more than 20 years ago, and formula-fed
babies tend to put weight on faster than their breast-fed counterparts. So, although it
is widely accepted that breastmilk provides babies with the best possible combination
of nutrients, charts may appear to suggest that many breast-fed children are failing to
thrive – even after just two or three months.
The new WHO standards on The latest WHO study of 8,440 children from six
countries found that target weights for two and three-
growth provide a much better
year-olds were 15% to 20% too high (De Onis et al,
description of the physiological 2004). The researchers believe that current overfeeding
of babies could explain in part why levels of obesity and
growth and they establish that
overweight in children are rising. WHO will release new
breast-fed infants are the biological growth charts based on breast-fed babies in Summer
2006 (de Onis et al, 2004).
norm. Paediatricians will be able
True milk insufficiency is a potentially life-threatening
to congratulate parents on having situation for the baby, and maternal concerns must not
exclusively breastfed their infants be ignored. The best advice you can offer as a pharmacist
is encouragement to the mother to seek expert help,
instead of spending time as they do which should involve watching a full breastfeed to assess
now in trying to reassure them that positioning and attachment and effective milk removal.
The Infant Feeding Report 2000 showed that on leaving
the apparent growth faltering of
hospital, 32% of breastfeeding mothers report that
the baby is not a reason for concern their baby appeared hungry. Fifteen per cent were still
reporting the same thing at 4-5 months, with 6% also
and is due to the imperfections of
commenting on poor weight gain. Weight gain is of
the growth chart that are being considerable concern to many mothers. ‘Does he sleep
well?’ and ‘How much weight has he gained?’ are often
used for their growth.
the first questions about a new baby asked by family and
De Onis M et al (2004) The WHO Multicentre friends. This can sap a new mother’s confidence, as can
Growth Reference Study (MGRS): rationale, a baby who wants to feed frequently and never appears
planning, and implementation. Food & satisfied.
Nutrition Bulletin 25: 1, supplement 1. http://
www.unu.edu/unupress/food/Unupress.htm
So what can pharmacy staff do to allay maternal fears about insufficient weight gain?
You can:
t allow the mother to voice her concerns and listen empathetically
t offer positive support and remind her of the benefits of breastfeeding
t refer the mother to a breastfeeding specialist to check on optimal attachment
t suggest that she visit a local breastfeeding support group (see www.breastfeed.
scot.nhs.uk/breastfeeding_groups.htm).
Suggesting that she gives the baby formula supplements or begins weaning before six
months are not recommended courses of action.
Mastitis
Mastitis is an inflammation of the breast tissue and may or may not be accompanied
by infection. If milk is not removed from the breast, pressure in the alveoli rise to
the point where milk substances are forced into the surrounding tissues. The true
incidence of mastitis is unknown; figures of up to 33% have been quoted, but it is
generally accepted as being less than 10%. The vast majority of cases occur in the
second and third week postpartum.
More information on mastitis can be
accessed at the WHO website (www.
who.int/reproductive-health/docs/
mastitis/mastitis.pdf).
Non-infective mastitis may result from
milk stasis from poor drainage, sud-
den changes in the baby’s feeding pat-
tern, trauma from pressure of clothing,
fingers holding the breast or knocks.
Infective mastitis, which is less common, is caused by infections either in the outer
skin of the breast or within the glandular tissue. Unless treated effectively, this may
result in abscess formation requiring surgical drainage.
Factors that make mastitis more likely include:
t difficulties with positioning and attachment resulting in less than perfect drainage
t pressure from tight-fitting clothing or from fingers supporting the breast during
breastfeeding
t sudden changes in the baby’s feeding pattern leaving the breasts overfull.
The first sign of mastitis is a red, swollen, usually painful area in the breast. The
redness and swelling represent the body’s reaction to the protein in the milk leaking
into surrounding tissue. It is not necessarily associated with a bacterial infection, and
antibiotics do not need to be prescribed immediately.
The breast may feel lumpy and hot to the touch. The mother may also experience flu-
like symptoms – increased temperature and shivering – and may feel tearful and tired.
Prompt action to drain the breast of milk as completely as possible at frequent intervals,
combined with ibuprofen as an anti-inflammatory if not contra-indicated for the
mother, will often halt progress of the symptoms. Draining the breast is best achieved
by frequent feeding, with additional drainage achieved either through hand expression
or by using a breast pump.
Research shows that even with antibiotic treatment, resolution of symptoms is more
rapid if accompanied by help to drain the breast optimally (Thomson et al, 1984). Use
of ibuprofen as an anti-inflammatory, together with effective drainage, has been found
to be as effective as antibacterial treatment. Inch and Fisher (1995) suggest that the
benefit of antibiotics in mastitis is due to their anti-inflammatory action rather than
antibacterial properties. Referral to a health visitor or voluntary group may help the
mother achieve more effective drainage.
If symptoms continue to develop despite increased drainage, or the mother feels
worse, oral antibiotic treatment may be necessary. WHO recommends flucloxacillin
250 – 500mg four times a day or amoxycillin 250-500mg three times a day or, in the
case of penicillin allergy, erythromycin 250-500mg four times a day or cefalexin 250-
500mg four times a day. Frequent drainage of the breast should continue throughout
the treatment period and breastfeeding does not need to be interrupted. The safety of
antibiotics during breastfeeding is discussed in Chapter 5.
Thrush of the nipple/breast

The incidence of thrush affecting breastfeeding appears to be increasing, possibly
because of the use of antibiotics around the time of delivery, particularly with caesarian
sections. There also appears to be an association between cracked nipples followed
by mastitis treated with antibiotics and the development of thrush in the breast. It is
assumed that nipple trauma and antibiotic exposure predisposes to the overgrowth of
candida in the breast.
All treatments for nipple thrush are unlicensed. Left untreated, however, breast thrush
causes so much pain that very few mothers can continue to breastfeed, resulting in loss
of benefits to mother and baby. The risks and benefits of prescribing therefore need to
be carefully considered (see Box 4.1 overleaf).
Box 4.1 Prescribing outside of licence

Independent nurse prescribers are currently only allowed to prescribe from a limited
formulary and are not permitted to prescribe outside of the licence application.
However, nurse limitations will change with new legislation in 2006.
Supplementary prescribers are allowed to prescribe outside of licence within the
context of an agreed clinical management plan. Advising the mother to purchase
products does not reduce liability, as the recommendation is considered within the
same legal context as the supply of a prescription, meaning the pharmacist takes
joint responsibility for the use of the products.
It can be very difficult to differentiate thrush from other conditions affecting breast-
feeding. It should be noted that some professionals deny the existence of intra-mam-
mary thrush – it is an area of controversy in diagnosis and treatment.
Signs include sudden onset of breast or nipple pain after a period of pain-free breast-
feeding, loss of colour of the nipple or the areola or nipple developing a deep red hue,
and cracked nipples that do not heal despite attention to positioning and attachment
(Brent, 2001).
Symptoms that allow differential diagnosis are:
t shooting pains deep within the breast after a feed has finished, which may con-
tinue for an hour; women may describe these as feeling ‘as if the baby has razor
blades in his mouth’, as ‘extreme agony right through to the back’, and as ‘the
worst pain ever experienced’
t pain in both breasts
t lack of temperature (apyrexia)
t absence of red area on the breast
t itching of the areola
t extreme sensitivity of the nipple so that the mother may experience extreme
discomfort from clothes or showers
t loss of pigment in the areola.
The baby may or may not show oral symptoms, and they are unlikely to be as clear as
those seen in text books. Breast-fed babies frequently develop plaques between the
cheeks and gums or high in the palate rather than just on the tongue. They may also
pull away from the breast while continuing to grasp the nipple. This behaviour would
suggest that they are experiencing oral discomfort while suckling but remain hungry
and are therefore reluctant to stop feeding.
Bacterial infections can develop in the cracks left by thrush. These are usually obvious
as sloughy yellow areas within the crack or a swollen, very red nipple, and are best
treated with a topical antibiotic such as fusidic acid or neomycin (available as eye oint-
ment), rather than systemic antibiotics.
Thrush on the surface of the nipple can be treated by applying a small amount of
miconazole cream 2% to the nipple after every feed. Any residual cream should be
gently wiped off before the next feed, but should not be washed off as this will remove
the natural moisture from the skin, causing further damage.
The baby should be treated concurrently, regardless of whether or not symptoms are
obvious, as there will be transfer of candida organisms between mother and baby at
each feed. Practical experience has shown that the best treatment is miconazole oral
gel 24mg/ml applied to all surfaces of the baby’s mouth four times a day. This is more
frequent than is recommended by the manufacturers in the patient information leaflet
(PIL) but appears to be necessary, bearing in mind the frequency of feeds in the early
days. The gel should be applied gently to prevent choking. Nystatin suspension ap-
pears to produce slower rates of cure and does not adhere as effectively to oral mucosa
(Hoppe et al, 1997).
If the mother continues to describe pain deep within the breast that has not been cured
by topical treatment and care with positioning, it may be necessary to treat with oral
fluconazole (Box 4.2). The safety of all medicines used to treat thrush are discussed
more fully in Chapter 5.
Box 4.2 Treatment of breast thrush with oral fluconazole

t An initial loading dose of 150-400mg is required followed by 100-200mg daily
for at least ten days. The dose depends on how long the mother has had
symptoms and whether she has recently had antibiotics. Longer courses may
be necessary to clear long-standing infection, but if there has been no response
within ten days, prudence suggests that the diagnosis should be reconsidered
before continuing.
t Topical treatment of mother and baby should continue throughout the course
of the oral therapy.
t Although fluconazole is not licensed to be given during breastfeeding, it is
licensed to be given directly to babies in doses ten times higher than that
which passes through breastmilk, so is unlikely to produce problems. The level
of fluconazole passing into breastmilk is reported as 400 microgrammes per
kg per day, while the paediatric dose is 6mg per kg per day to start followed by
3mg per kg per day (Lawrence, 1998). This is given every 72 hours in premature
infants and every 48 hours in the neonate (less than four weeks old) due to the
extended half life of 88.6 hours in the neonate (Hoppe, 1997).
t It has also been studied in babies of <1000g born prematurely and at risk of
severe fungal infections, without adverse effects. The safety profile of the drug
may therefore be assumed to be greater than the recommendation that it
should not be used during lactation suggests.
t The prescriber has to take ultimate responsibility for the prescribing decision
outside of licence.
Side effects of fluconazole for the mother and baby are

generally gastrointestinal symptoms – nausea, diarrhoea
and abdominal cramps. The literature states that no
complications from exposure to breastmilk have been
found, although anecdotal reports of abdominal pain and
rashes in the baby have been highlighted by breastfeeding
specialists in the UK. These are transitory and have not
been reported to produce pathological symptoms requiring
treatment of the baby.
Treatment of breast thrush is not a licensed indication for
oral fluconazole, but it is being used world-wide to cure
symptoms associated with the diagnosis. The prescriber
should be aware of his or her prescribing responsibility
and needs sufficient data to support the decision to treat.
The Breastfeeding Network leaflet ‘Thrush and breastfeed-
ing’ provides information on safety; it can be accessed at:
www.breastfeedingnetwork.org.uk
If there has been no improvement in the symptoms of thrush after a week, there
should be a reappraisal of all the symptoms to ensure that the diagnosis has been
made correctly. Thrush can be confused with:
t Raynaud’s syndrome
t white spot or galactocele
t eczema due to a reaction to breast pads,
t ‘tongue tie’ in the baby causing continued nipple trauma
t continued imperfect positioning and attachment
t unresolved engorgement
t sub-clinical mastitis
t sensitivity or allergy to sterilising solutions if the mother is expressing her milk
using a breast pump.
Mothers may report re-occurrence of symptoms soon after completing a course of
fluconazole. A further course of treatment may be justified, depending on the severity,
but some women report pain that is greatly reduced (although still present) for up to
a month after treatment. Individual decisions are necessary, taking into account the
mother’s wishes regarding a further course of treatment.
There is no evidence for the effectiveness of using a single oral over-the counter (OTC)
treatment of fluconazole, which could lead to resistance. Single dosage should be
reserved for vaginal thrush, as per the product licence.
Now go to Case Scenario 4.4 (page 10), then Activity 4.5 and 4.6 (page 11)
5 Medicines use during breastfeeding
Tahmina Rahimi fled with her husband, Alesha, from

Afghanistan last year. They live in Birmingham and have a
6-month-old baby girl Raheen.
Where I come from 85 per cent of women breastfeed their babies until they are two-years-old
but because I’m now in England where breastfeeding isn’t so popular I’ll probably continue until
Raheen is 12 months.
I like breastfeeding because it’s natural and the milk protects the baby from disease. At ante-na-
tal classes I learnt from the midwife that it helps the mother too by making you go back to your
former shape quicker and it protects against breast cancer. It’s also so much easier. You don’t
need to warm up the milk and you can do it anywhere.
I’ve had no problems breastfeeding and if I’m out shopping I’ll try to find a separate room to do
it. If there isn’t a separate room then I’ll use my scarf. I’ve breastfed in many places in the city
centre and people are often very helpful asking me if I want a cold drink.
In Muslim countries you can’t feed a baby in public because Muslim men don’t like other people
– particularly men – looking at their wives. It makes them feel uncomfortable. There are no
special places for mothers to feed but that’s not really a problem since most women are based
at home anyway.
People think that because I’m a Muslim I don’t want to breastfeed in public but if I was in my
country I’d follow my own culture; here I follow British culture and I like it. It’s very easy to
breastfeed, no one minds and no one looks.
I was very surprised therefore to discover that most mothers use bottles here. I asked the
midwife why they don’t breastfeed when they know it’s best for their baby and she told me that it
was because most women go back to work and a lot think that it may change the shape of their
breasts.
Everyone encourages me. Even mothers who are bottle-feeding tell me I’m doing very well. I
asked one of the mothers why she wasn’t doing it as she knew it was so good for the baby. She
was a single mother and said she had to go back to work.
My health visitor told me that to breastfeed for six months was enough but if I could do it for
a year that was better. So when Raheen was six- months old I told my husband I thought it
was perhaps enough but he said, “No, carry on for a year, it’s better.” He too thinks it’s very
important to give mother’s milk to the baby.
59
5 Medicines use during breastfeeding

The aim of this chapter is to provide information to enable you to make professional
decisions on the safety of medicines passing to babies through their mother’s breastmilk.
t consider dilemmas posed for mothers, prescribers and pharmacists
t consider the pharmacology of the transfer of medicines passing through breastmilk
t look at the licensing of medicines for use in lactation and the implications for
pharmacists and prescribers
t highlight sources of information on the safety of medicines used during lactation
t help you understand the levels of evidence for research information
5.2 The dilemma of medicines in breastmilk

The majority of women purchase or are prescribed medication during breastfeeding.
In a retrospective study in 1995, 54% of breastfeeding mothers recollected purchasing
medicines from a pharmacy for themselves, but only 11% recollected being asked if
they were breastfeeding.
The question professionals need to ask themselves when considering prescribing or rec-
ommending a medicine to a breastfeeding woman is – ‘what is the potential risk of expos-
ing the baby to the drug passing through breastmilk?’ It is also important to consider the
implications of interruption of breastfeeding, temporarily or permanently. The decision
should be made in full consultation with the mother. It is obviously unethical to endanger
a baby by applying blanket recommendations, as each situation is individual. Mothers
may also have to deal with the consequences of being told to stop breastfeeding abruptly
or to express their milk for a period. In some circumstances, however, the risks of expos-
ing a baby to a drug (such as a cytotoxic) make cessation of breastfeeding necessary.
There are two dilemmas with various associated issues in prescribing for breastfeeding
women that pharmacists must consider.
How essential is this particular medicine for a mother who is breastfeeding?
Key questions that need to be asked are the following:
t Is it licensed for use with breastfeeding women (See Box 5.1)?
t Is it possible to substitute a drug that would safely allow her to continue to breast-
feed?
t Would she opt not to take medication to allow her to continue to feed, and would
this be appropriate?
Can we prescribe this medicine for a breastfeeding mother without jeopardising the
safety of her baby?
The key question that needs to be asked is, would it be safer to suggest that the mother
stops and that the baby is formula fed?
Box 5.1 Licensing of medicines

The manufacturer of a medicinal product must obtain a marketing authorisation
from the Licensing Authority prior to promoting and selling a medicine. Part of the
application for marketing authorisation includes a clinical expert report, the content
of which is governed by European Community legislation. This states that ‘…the
Expert report on the pharmaco-toxicological (pre-clinical) documentation should in-
clude reference by the expert to the consequences of the use of the medicinal product
before and during pregnancy and during lactation. Therefore it would seem prudent
to include a safety assessment of suckling young in a mother animal who has been
given the drug.’ The clinical expert should also discuss ‘the possible utilisation during
pregnancy and breastfeeding’, and a statement should appear in the summary of
product characteristics. There are no stated pharmacokinetic data requirements.
Animal studies can provide a limited amount of safety data, and exposing a baby
to a drug with unknown consequences for research purposes is clearly unethical.
In general, little information on the safety of drugs that may pass into a mother’s
breastmilk is available. The cost to manufacturers of generating sufficient data to
prove unequivocally that a drug would not harm a breastfeeding baby is proving
prohibitive, and manufacturers are tending to opt instead for a blanket recommen-
dation not to prescribe to breastfeeding women. Care should be taken in prescribing
any ‘black triangle’ drug for a breastfeeding mother, as there will be even less
established safety records from which to make a judgement on efficacy.
I was unwilling to take any drugs and Research undertaken in Canada in 1993 (Ito, 1993)
showed that 15% of breastfeeding women prescribed
endured ‘flu, sinusitis and a tooth
antibiotics chose not to take the medicine rather
infection without any drugs for three than expose their baby to a risk, even though they
had been assured the risk was minimal. In a retro-
and a half years. I don’t feel leaflets
spective study undertaken in the south of England
give enough detail and so little is in 1995 (Jones, 2000), 58% of women advised to
give up breastfeeding on commencing medication
known about a wide range of drugs on
reported that they refused to take the medication
the market… I don’t think it is worth instead. It was clear from comments made by some
of the mothers that they felt the drug would ‘pollute’
the risk. I personally believe everything
their breastmilk.
mothers take reaches their babies Other mothers are posed with different dilemmas
so you should only take what is as a result of temporarily interrupting breastfeeding,
resulting in difficulties in expressing breastmilk,
absolutely necessary and then for as possible lower milk supplies due to problems with
short a time as possible. expressing, or refusal of the baby to go back to the
breast.
Mother in a retrospective study of breastfeeding
and medications (Jones, 2000)
Medicines use during breastfeeding 61
The prescriber should be able to make an informed decision on the safety of the
proposed drug regime of choice for the mother-baby pair. He or she should be able to
determine the likely side-effects and safety of the drug for the baby, while considering
the appropriateness of treatment for the mother.
Questions the prescriber should ask before prescribing on prescription or over the
counter include the following.
t How severe is the mother’s illness?
t What will happen if the mother is not treated?
t What information is available on the passage of this drug into breastmilk?
t Is this drug licensed to be used by a breastfeeding mother?
t Is this drug licensed as a paediatric formulation?
t Are there alternative treatments licensed for use by a breastfeeding mother or
with a known safety profile?
t Are there alternative sources of information I can consult?
t Do I have time to consult medical information sources, or is it imperative that
treatment is commenced at once?
t How old is the baby?
t Was he born at term or prematurely?
t Is the baby in good health?
t How often is the baby feeding?
The standard reference texts commonly available to GPs and pharmacists hold limited
data to allow determination of safety of drugs in breastmilk, but any drug that passes
through breastmilk and is absorbed by the baby has to be metabolised by the hepatic
and renal systems, which may not be fully mature until at least six weeks of age. Ex-
tended half lives of drugs in babies may lead to accumulation and increased side-effects.
5.3 Pharmacists’ responsibilities

Pharmacists have developed skills in:
t pharmacology and pharmacokinetics
t assessing the bio-availability of drugs
t identifying possible side effects and contra- indications.
Professional knowledge is used to establish the safety of medicines in particular situ-
ations – in this case, breastfeeding. When we undertake a pharmaceutical assessment
to inform patients of the balance of risk of benefit for herself and her baby of taking a
drug and continuing to breastfeed, we are required to take responsibility for the accu-
racy of the information we provide and its use. We can use specialist contacts and may
consult with other health care professionals (with the patient’s consent) to ensure the
information we give is accurate. All sources of information and advice offered should
be recorded so that in the event of any adverse events, details of the consultation are
available. These records can be stored on the PMR as long as it is regularly backed-up;
otherwise, they should be kept in a hard-back book or other secure manner.
Difficulties arise when the drug of choice is being used outside of licence or off label
(the implications of providing information about the safety of a drug to a breastfeeding
mother outside of the drug’s licence application is explained in Box 4.1 (page 54). Phar-
macist colleagues in secondary care are more accustomed to using medicines outside
of the licence application on a regular basis, often following consultation with a senior
medical colleague and/or extensive searches of databases to assess risk to the patient.
It is not ethical to make an uninformed ‘guess’ at the risk, which would not only be a
dereliction of duty to the patient, but would also place the pharmacist in jeopardy of a
charge of professional misconduct or even prosecution.
In the event of an adverse drug reaction to a medicine used outside of licence, if the
pharmacist can demonstrate that a peer in possession of similar knowledge might
reach the same conclusion and act in a similar way, it is likely that he or she would not
be deemed negligent.
Every pharmacist has a limit to his or her knowledge, skills, experience and sphere of
competence, and appropriate referral to health care professionals and support workers
to deal with specific issues is a core component of the pharmacist’s role. The benefits
of multi-disciplinary team working were set out in Chapter 3, Section 3.5, and all
pharmacists should see referrals not only as an appropriate action in the patient’s best
interests, but also as an opportunity to strengthen team working and increase their
knowledge base.
5.4 Pharmacology of the transfer of medicines in breastmilk

Determination of the level of a drug in breastmilk or in infant plasma is not routinely
carried out in clinical practice – rather, it is a research tool used to inform particular
studies.
Measurement of the levels of any drug in breastmilk is a far from exact science. Conse-
quently, assessment of risk for the breastfeeding infant becomes very difficult.
Determination of the levels requires many variables to be taken into account. These
include:
t whether the drug has reached a steady state (in general, it takes five drug half lives
to reach this state)
t whether the level is measured pre or post feed: if the drug level is measured post-
feed, it may be concentrated in a small volume of milk remaining in the breast
t the duration of lactation: colostrum (the milk made in the first few days after
delivery) is high in protein, low in fats and gradually changes through transition
milk to mature milk, which is low in protein and high in fats (the level of fats in
breastmilk significantly affects the absorption of fat-soluble drugs)
t the time of day the milk was sampled: fat levels in breastmilk vary diurnally, with
very low levels in the early morning, rising to a peak mid-morning, then decreas-
ing to the lowest level in early evening
t the time elapsed since the medication was taken and whether the peak plasma
level has been reached or exceeded
t the volume of milk consumed by the infant per feed.
Reports on the levels of medication in breastmilk rarely quote these details or appear to
take them into consideration. Safety cannot be ascertained from data provided in some
research papers.
Pharmacokinetic principles
In the absence of data in readily available texts, it may be worthwhile to consider phar-
macokinetic principles to theoretically determine the extent of the passage of a drug
into breastmilk. The following information should be considered.
The size of the drug molecule The larger the molecule, the harder it is for it to pass
into breastmilk. For example, heparins (molecular weight 6,000-20,000), warfarin
(molecular weight 308) and insulin (molecular weight > 6,000), which have molecular
weights greater than 200, are restricted from passing into breastmilk. Heparin and
insulin are also not absorbed from the gastrointestinal tract, so any that might have
passed into milk could not be absorbed by the baby. Large molecular weight drugs can
therefore safely be taken by breastfeeding mothers.
The solubility of the drug The greatest passage of drugs into breastmilk occurs
by simple diffusion. Water soluble materials pass through pores in the basement
membranes and para-cellular spaces. Extra-cellular fluid varies with age, being highest
at birth (50%) and falling to 20-25% at one year. Water soluble drugs such as penicillin
(milk:plasma ratio (see overleaf) 0.03-0.13) and phenytoin (milk:plasma ratio 0.18-0.45)
are usually acidic. From the low milk:plasma ratios, it can be seen that acidic, water
soluble drugs do not pass readily into mature breastmilk, although they pass more
readily by simple diffusion, immediately after birth.
Fat solubility Un-ionised drugs that are lipid soluble usually dissolve in and pass
through the lipid membrane of the alveolar epithelium of the breast. The average
body fat contents of infants and neonates are significantly lower than in more mature
babies and adults – 3% in premature infants, 12% in term neonates, 30% in 12-month
olds and 18% in adults. Because of the relative deficit of fat tissue storage sites, drugs
causing central nervous system (CNS) sedation (even in the relatively low doses found
in breastmilk) have a greater effect on neonates than infants of one year. Many neu-
roleptic drugs such as benzodiazepines, cocaine and barbiturates have a high affinity
for lipid-rich tissue and pass readily into breastmilk.
The extent of plasma protein binding of the drug The more drug that is bound,
the less is free to diffuse through the alveolar membrane. If a drug binds strongly
to milk proteins, however, it may accumulate in milk. Milk protein concentration is
0.9% in mature milk, and this therefore has a minimal effect. Drug displacement of
unconjugated bilirubin may result in kernicterus and brain damage in the infant and a
theoretical risk exists with some drugs (such as co-trimoxazole). Protein bound drugs
are inactive – for example, most penicillins are tightly bound to albumin and penetrate
breastmilk poorly. Drugs with high protein binding are the drugs of choice for admin-
istration to lactating mothers.
Drug half life The half life of a drug is defined as the time taken for the serum con-
centration to decrease by 50%. It is determined by the rate of absorption, metabolism
and excretion. A drug with a short half life has to be taken more frequently than one
with a long one. As stated above, approximately five half lives have to elapse before
steady state is reached; similarly, after five half lives, almost all (98%) of the drug
has been eliminated from the body. Infants, in general, do not metabolise or excrete
medication as fast as adults due to
immaturity of the hepatic system. The
infant may therefore begin to ac-
cumulate a drug with a long half life.
On this basis, treatment for a lactating
mother with drugs with a shorter half
life is preferable. Information on the
half life may be available in Martin-
dale (2004) or in the ABPI Summary
of Product Characteristics (accessible
at www.emc.medicines.org.uk).
Immaturity of the infant’s hepatic and renal function The renal excretion of drugs
by infants is lowest in newborns aged 3-9 days, but rises quickly within three months.
Any drug to which a newborn may be exposed should be monitored; for instance,
pethidine has a half life in an adult of three hours, but in a newborn it may be as long
as 23 hours. The premature infant’s liver may be overwhelmed by breakdown products
of haemoglobin due to the natural destruction of red blood cells present in the foetus
during pregnancy. Even healthy neonates may have acetylation and oxidation processes
hampered during the first week or so due to immature hepatic enzymes.
Peak plasma level The point at which the maximum drug level is reached in maternal
plasma generally corresponds to the highest rate of entry into milk. This is generally
reached two hours after an oral dose of non-sustained release medication, or about 20
minutes after an intravenous injection.
Milk:plasma ratio This measurement refers to the concentration of the protein free
fractions of a drug found in milk and plasma. Fluoxetine has a Milk:plasma ratio of
0.286, meaning that the level in the milk is 28.6% that of the medication in the ma-
ternal plasma. The Milk:plasma ratio of dexamphetamine is quoted as 2.8-7.5, which
means the level in the milk is approximately 3-7.5 times that in the plasma – that is, it
becomes concentrated in milk.
Breastmilk production Most breastmilk is manufactured as the baby feeds, with
very little being stored in the breast. If the baby feeds when the mother’s plasma level
of the drug is high, exposure via milk will commensurately be higher. As stated above,
the variability of milk composition day to day and during any day will alter the passage
of drugs into milk. As the level of drug in the plasma falls, the reverse passage will
permit flow from the milk back into the plasma. The level falls again with time after
the peak plasma concentration is passed. If possible, the mother should feed or express
immediately prior to the next dose of the drug to minimise the amount of drug passing
to the infant.
5.5 Specialist sources of information

UK Medicines Information (MI)
Centres are available locally and nation-
ally. (See inside cover of your BNF.)
MI pharmacists will search databases
for available information and research
where the information is not available
immediately. UK MI Central Medicines
in Pregnancy and Breastfeeding site
can be accessed at www.ukmicentral.
nhs.uk/drugpreg/guide.htm (see
Appendix 5).
Some specialist texts contain data required to make professional decisions (Box 5.2).
These are not generally available in community pharmacies, but you may wish to
consider purchasing one in the light of the information in this pack.
Box 5.2 Specialist texts

t Hale (2006) Medications and Mothers’ Milk 12th Edition. Pharmasoft. ISBN
09772268-3-2. Cost approx £33, available from UNICEF Baby Friendly
(www.babyfriendly.org.uk/resource.asp).
t Briggs, Freeman and Yaffe (2005) Drugs in Pregnancy and Lactation, 7th Edition.
Lippincott Williams and Wilkins. ISBN 0781756510. Cost approx £76.
t Lee, Inch and Finnigan (2000) Therapeutics in Pregnancy. Radcliffe Medical Press.
ISBN 1857752694. Cost approx £24.
Internet use by patients and professionals is increasing. Validity of data and the authority
of the site should be examined critically, but useful sites include those shown in Box 5.3.
Box 5.3 Useful internet sites

UKMI
www.ukmi.nhs.uk/
West Midlands and Trent are national specialist MI Centres for drugs in lactation for
high risk situations such as prematurity
www.ukmicentral.nhs.uk/drugpreg/guide.htm
Dr Thomas Hale
http://neonatal.ttuhsc.edu/lact/
Motherisk (based at the Hospital for Sick Children in Toronto, this is a world-wide
centre for excellence on research on safety of drugs in pregnancy and lactation)
www.motherisk.org/updates/sept00.php3
The Breastfeeding Network
Advice on short-term use to treat acute conditions and safety of treatment for chronic
conditions such as epilepsy and asthma may be sought from local MI and other centres.
5.6 Systematic searching

Here are a couple of examples of how you can conduct a systematic search to ensure
the safety of a medicine for a breastfeeding mother.
Anti-epileptic medication
Sodium valproate A mother asks you if she can breastfeed while taking her anti-epi-
leptic medication. You need to gather full details of the drug and dose regime, the age
of her baby and any special circumstances such as premature birth or the baby taking
medication. You should ask if the mother is taking any other drugs for concurrent
conditions.
The first reference source likely to be consulted is the British National Formulary (BNF).
There is no reference to breastfeeding under Section 4.8.1, ‘Control of Epilepsy’. In Ap-
pendix 5, which focuses on breastfeeding, there is reference to the amount of sodium
valproate in breastmilk being ‘too small to be harmful’ to the baby.
If you wish more details, you can telephone your local Medicine Information Centre,
normally situated in the local hospital pharmacy department. They have access to a
variety of reference sources, which might include the following.
t Briggs et al, Drugs in Pregnancy and Lactation, states: ‘[sodium valproate is]
excreted in low concentrations, measured up to 15% of the corresponding level in
the mother’s serum with no adverse effects in the nursing infant reported.’
t Hale, Medications and Mother’s Milk, reports that in a study of one mother receiv-
ing 250mg sodium valproate twice daily, milk levels ranged from 0.18 to 0.47 mg
per litre, which is regarded as low. Hale states that no paediatric concerns have
been published with respect to valproate passing through breastmilk. It recom-
mends, however, that the infant should be closely monitored for liver and platelet
changes.
t The BNF (March 2004, p243) cites under ‘cautions (liver toxicity)’ that liver
dysfunction is common in infants under three years who are exposed to valproate.
The warning may be seen as over-cautious when the dose (according to the
BNF) to be given directly to the child is 20mg per kilogramme – significantly
greater than that reported by Hale as passing through breastmilk. Although other
side-effects are unlikely, it may be worth raising the mother's awareness of blood
disorders, platelet levels and pancreatitis.
t Further data may be sought by searching Medline or other electronic databases.
Entering the search terms ‘valproate’ and ‘breastfeeding’ into Medline produces
24 research papers with abstracts indicating low transfer of valproate into breast-
milk and safety in use during lactation.
You would be entitled to conclude, after searching these sources, that sodium valproate
is safe to be taken by a breastfeeding mother.
Asthma medication
A mother asks if she will be able to breastfeed her baby. She is 38 weeks pregnant and
uses beclometasone inhaler 200microgrammes twice daily and salbutamol inhaler
when necessary for shortness of breath. She has needed 40mg prednisolone daily for
five days for acute exacerbations. You should check the safety of all three medications.
Beclometasone
t There is no caution in the BNF under beclometasone, and Appendix 5 (corticoster-
oids) states ‘the amount of inhaled drugs in breastmilk is probably too small to be
harmful.
t Hale says that minimal plasma levels are attained and are unlikely to produce
clinical significance in a breastfeeding infant.
Salbutamol
t The BNF states salbutamol is ‘probably present in [breast]milk…manufacturer
advises avoid unless potential benefit outweighs risk – the amount of inhaled
drug in breastmilk is probably too small to be harmful.’
t Hale says that when used orally, significant plasma levels are attained and transfer
to breastmilk is possible. When inhaled, less than 10% is absorbed, and although
small amounts are probably secreted into breastmilk, no confirmatory reports
exist. It is unlikely, it states, that pharmacological doses are transferred to the
infant, and the drug is commonly used to treat paediatric asthma.
Prednisolone
t BNF Appendix 5 (corticosteroids) says: ‘Systemic effects in infants unlikely with
maternal dose of prednisolone up to 40mg daily. Monitor infant's adrenal func-
tion with higher doses.’
t Hale advises that if possible, the mother should wait for four hours after taking
the drug before feeding her infant and to limit the duration of exposure, again if
possible. The theoretical infant dose is 23.4 microgrammes per kg per day. Short-
term use is safe, with 40mg for five days being unlikely to cause problems for
the infant, allowing the mother to continue to breastfeed. Stopping breastfeeding
should be the last resort in view of the link between asthma and formula milk.
Accessing several sources has provided information of varying depth to produce an-
swers to inform both prescriber and mother. Specificity of the information needed may
vary depending on the drug, health and age of the baby and the need for a particular
drug to treat the mother, and the sources necessary to provide a full picture for mother
and prescriber will also differ.
5.7 Levels of evidence

Few clinical trials are conducted into the safety of drugs passing through breastmilk.
The level of evidence available needs to be taken into consideration when making a
clinical decision.
The Scottish Intercollegiate Guidelines Network (SIGN) was formed in 1993 to
improve the quality of health care for patients in Scotland by developing national,
evidence-based clinical guidelines for effective practice. The grading system they use
(Box 5.4) is commonly employed by practitioners in Scotland to evaluate the strength of
a recommendation for practice.
SIGN states that guideline recommendations are graded to differentiate between those
based on strong evidence and those based on weak evidence. The judgement is made
on the basis of an objective assessment of the design and quality of each study and a
more subjective judgement on the consistency, clinical relevance and external validity
of the whole body of evidence. The aim, SIGN claims, is to produce a recommenda-
tion that is evidence-based, but which is relevant to the way in which health care is
delivered.
The grading does not relate to the importance of the recommendation, SIGN empha-
sises, but to the strength of the supporting evidence and, in particular, to the predictive
power of the study designs from which the data were obtained. The grading assigned
to a recommendation therefore indicates to us the likelihood of the predicted outcome
being achieved if the recommendation is implemented.
Box 5.4 SIGN grading system

Levels of evidence
1++ High quality meta-analyses, systematic reviews of randomised controlled trials
(RCTs), or RCTs with a very low risk of bias
1+ Well conducted meta- analyses, systematic reviews of RCTs, or RCTs with a low
risk of bias
1– Meta- analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++ High quality systematic reviews of case-control or cohort studies
High quality case-control or cohort studies with a very low risk of confounding,
bias, or chance and a high probability that the relationship is causal
2+ Well conducted case control or cohort studies with a low risk of confounding,
bias, or chance and a moderate probability that the relationship is causal
2– Case control or cohort studies with a high risk of confounding, bias, or chance
and a significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
Grades of recommendation
A At least one meta analysis, systematic review, or RCT rated as 1++, and directly
applicable to the target population; or
A systematic review of RCTs or a body of evidence consisting principally of
studies rated as 1+, directly applicable to the target population, and demon-
strating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the
target population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the
target population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
There are few, if any, studies on the safety of drugs in breastfeeding which would meet
the criteria required for evidence required by SIGN. Evidence is based (at best) on case
reports involving less than 20 participants (Grade of recommendation 3) or on expert
opinion (Level of evidence 4).
Pharmacological evaluation of safety may be reinforced by limited case studies, but the
quality of evidence required to support prescribing decisions is not available in this
area, nor is likely to be in the future.
The Cochrane Collaboration (www.
cochrane.org/) has performed some
meta-analyses on relevant treatments
such as ‘Interventions for preventing
and treating nipple pain’, but national
funding needs to be made available
to support ongoing independent re-
search, rather than relying on industry
sponsorship and the risk of bias it
introduces.
5.8 Involving parents in decision making

Each mother and baby pair is unique. No two consultations regarding medicines to be
taken during breastfeeding will be the same.
Medicines use during pregnancy and breastfeeding has a background risk. The final
decision to take the medicine should be the mother’s, and she will require sufficient
information presented in a form she can access readily to make an informed choice.
You need to explore with her the relative risks of:

t taking the medicine and carrying on breastfeeding
t switching to an alternative medicine treatment
t taking the drug and temporarily or permanently stopping breastfeeding
t not taking the medication
t breastfeeding at times when drug levels in the breastmilk are at their lowest.
All of these need to be related to her own individual circumstances, bearing in mind
the condition for which she requires medication, the potential benefits of the medica-
tion and the maturity of her baby. The professional input of pharmacists is invaluable
to parents on these issues, and is potentially part of a lifetime of pharmaceutical care.
Patient information leaflets (PILs) can be a source of confusion for mothers. If
manufacturers do not include safety during breastfeeding in their licence application,
a statement advising against use or referral to a doctor must be included, which may
contradict information supplied by you or the GP. As you might recognise from per-
sonal experience, patients often perceive written information as having more authority
than verbal. You should check the wording of the patient information leaflet so you can
reassure the mother about any discrepancy in advance.
Anecdotally, some health care professionals recommend that breastfeeding women
should take no medication or, if required to do so, should discontinue breastfeeding.
This may lead to many difficulties and discomfort for mother and baby as well as loss
of potential health benefits to both.
Mothers generally accept that the ultimate responsibility for informing pharmacists
and GPs that they are breastfeeding lies with them. But in the spirit of recommenda-
tions in The Right Medicine, you and your staff might feel a need to be more proactive
about asking.
We know that every year, 600,000 people across Scotland visit their local community
pharmacist. According to the Department of Health, the average pharmacy practice
would expect to have:
t 50 pregnant women
t 300 under fives
t 1,000 people with chronic diseases
t an unknown number of breastfeeding women.
We don’t know how many women may be breastfeeding, and this may well be an area
where improved pharmaceutical input would enhance patient care, particularly in
socially disadvantaged areas where breastfeeding would have financial as well as health
benefits.
5.9 Practical application of pharmacological data

Undertaking a risk assessment may seem a complicated process to some, but it is not
as difficult as it might at first seem. If you are unsure, it would be wise to consult the
local MI centre to confirm your understanding.
As we have seen in Section 5.4, data on the Milk:plasma ratio, half life of the drug and
extent of plasma binding can be used to arrive at a judgement of the extent to which a
drug passes into breastmilk. Maternal and infant factors, drug safety profile and pos-
sible side-effects for mother and baby also have to be taken into consideration.
The following worked examples are designed to help you gain confidence in making
judgments.
Imipramine
Milk:plasma ratio is 0.5-1.5
Plasma half life is 8-16 hours
Plasma protein binding is 90%
Imipramine is metabolised to the active metabolite desipramine. Since the milk plas-
ma ratio crosses 1, milk levels might be expected to approximate to those of maternal
serum, but 90% is plasma protein bound and unable to pass into breastmilk. Levels in
breastmilk may therefore be assumed to be relatively low.
The half life of the drug is 8-16 hours, so there is no opportunity to minimise transfer
by feeding immediately before taking the drug if it is taken more than once a day
(babies would be expected to feed at least every three hours in the early months). This
is supported by a single published case study of one mother who received 200mg
imipramine at night and had her blood and milk levels monitored over the following
24 hours. They fell from 29 microgrammes per litre of breastmilk after one hour to 18
microgrammes per litre after 23 hours. It is suggested the baby would receive a dose
of 30 microgrammes per kilogram per day at a maternal therapeutic dose, significantly
less than the 1.5mg/kg recommended for older infants.
The BNF recommendation for imipramine is: ‘caution in breastfeeding, but amounts
too small to be harmful’, and UK Medicines Information (www.ukmicentral.nhs.uk/
drugpreg/antidepressants.asp) states that imipramine is considered safe to be used
during breastfeeding. No paediatric
side-effects have been reported from
the drug being taken by a breastfeed-
ing mother, although in theory it
could cause the baby to be drowsy and
experience a dry mouth. If the baby
exhibited drowsiness or significant
weight loss, his blood levels could be
monitored, or the mother could stop
the drug to see if the baby’s behaviour
returned to normal.
Diclofenac
Milk:plasma ratio has not been determined
Plasma half life is 1.1 hours
Plasma protein binding is 99.7%
Because of the very high plasma binding, very little drug is available to pass into breast-
milk; consequently, no milk:plasma ratio has been determined.
The half life is very short and the mother could be advised to feed just before taking
the tablet to minimise transfer further. In a study of six women receiving 100mg as a
single dose daily, the levels of drug in the breastmilk were undetectable (limit of detec-
tion quoted as less than 19 nanogramms per ml).
Non-steroidal drugs as a class are often transferred into breastmilk at very low levels,
which helps to justify their widespread use for immediate postpartum pain. UK
Medicines Information states that diclofenac is suitable for use in lactation and levels
in breastmilk are low.
Ranitidine
Milk:plasma ratio is 1.9-6.7
Half life is 2-3 hours
Plasma protein binding is 15%
Pharmacological data and the milk:plasma ratio would suggest that this drug can
readily concentrate in breastmilk, and plasma protein binding data indicate that much
of the drug is free to pass into breastmilk. A single case study, however, showed
that following a 150mg dose given to the mother twice a day for two days, an infant
consuming one litre of breastmilk per day would ingest 2.6mg in 24 hours, compared
to a paediatric dose of 1mg per kg three times a day when used for gastro-oesophageal
reflux in infants from one month to two years.
Although the drug appears to concentrate in breastmilk, we can deduce through phar-
macological data that it reaches sub-therapeutic levels, and no paediatric concerns have
been reported. UK Medicines Information reports briefly that ‘minor adverse effects
may be anticipated on theoretical grounds’.
Now go to Activity 5.2 in your Workbook (page 12), then to Case Scenario 5.3 (page 14)
5.10 The safety of medicines passing through breastmilk

The aim of this section is to provide you with some information on commonly used
drugs and the safety of their passage through breastmilk. Pharmacological data are
included to help you get a better understanding of the information. You can use the
section (and Appendix 2) as a reference source in the future, but you must ensure the
information hasn’t been superseded by new advice.
Polypharmacy
Where a mother is taking several drugs, you need to consider the pharmacokinetics
of each drug and assess the impact of the combination on the baby. For instance, if
the mother is prescribed three drugs that may potentially cause drowsiness, is it more
likely that the baby will become drowsy and fail to feed frequently. This situation
requires a considered response.
If you feel you are moving towards the boundaries of your professional competence
and experience, you must discuss the case with someone such as a medical informa-
tion (MI) pharmacist, rather than advise inappropriately – you should recognise the
limits of your experience and err on the side of caution rather than leave a baby at risk
of a ‘cocktail’ of drugs in breastmilk, the effects of which are unknown. MI pharma-
cists have access to a wide range of texts and literature sources and are networked with
national MI centres at Trent and the West Midlands which specialise in questions on
the safety of drugs in breastmilk.
Over-the-counter (OTC) medicines

Many OTC medicines state that they should not be used in lactation, with some
referring the patient to the GP or pharmacist for information. As was noted in Box 5.1,
where a manufacturer does not have data on passage into breastmilk with supporting
evidence of safety when making a licence application, use cannot be recommended. It
is therefore important that pharmacy staff incorporate the possibility of the mother
breastfeeding her child into the WWHAM protocol, ensuring she leaves the pharmacy
with information on the safety and appropriateness of the medication for herself and
her baby. You must be prepared to take professional responsibility for information so
provided. Contact your local Medicines Information Centre for advice if unsure.
OTC medicines that may be of concern in breastfeeding

Medicines that pose difficulties when used by a breastfeeding mother are rare, and
most side-effects are transient. Examples include drowsiness with sedating antihista-
mines, and possible constipation with co-codamol 8/500.
In a study by Motherisk in 1995 of 838 calls analysed where a baby had been exposed to
a drug passing through his mother’s breastmilk, 11% reported side-effects in the baby,
but none were severe enough to require medical referral. All resolved when the drug
was stopped.
Anderson (2003) searched the literature for adverse events stemming from drugs in
breastmilk and identified 100 case reports, of which he regarded 53 as ‘possible’ and
47 as ‘probable’. Of these, 78% were in infants younger than two months. The absolute
incidence of adverse events is likely to be low, he suggested.
Cough remedies Most remedies are likely to pose no difficulties during breastfeeding.
Exceptions are products containing codeine for cough suppression which may produce
sedation or constipation, and those containing aspirin because of the possible risk of
Reye’s syndrome. Pseudoephedrine has been reported to lower and even inhibit breast-
milk production completely (Khalidah et al, 2003) so is best avoided during breastfeed-
ing. The effect seems to be more pronounced in mothers with well-established lactation,
possibly due to lowering of prolactin levels, although the measured effect is low.
Laxatives It has been hypothesised that high use of stimulant laxatives may produce
diarrhoea in breast-fed infants, but this has not been demonstrated in trials (Shelton,
1980). It would nevertheless be sensible to advise bulk-forming laxatives.
Antihistamines Although non-sedating antihistamines are not licensed to be used
during breastfeeding, levels passing through breastmilk are low, and cetirazine and
loratadine can safely be used. Chlorpheniramine can be used in the short term, but
longer-term use may result in the baby becoming sleepy and not feeding as well or as
frequently as he should, resulting in weight loss.
Travel sickness products Although many anti-travel sickness products cause drowsi-
ness, this is unlikely to be a problem with short-term use.
Herbal remedies Although little data are available on the transfer of herbal products
into breastmilk, some remedies are used more frequently than others and produce
more frequent enquiries. St John’s Wort seems safe to use in the absence of contra-
indications due to maternal or infant medication. One study showed the level of hyper-
icin in breastmilk was below the level of detection, and no problems were identified in
the infants.
Anecdotally, Echinacea seems to be safe in breastfeeding, although there are no pub-
lished studies or pharmacological data available. Excessive use of Ginseng tea has been
noted to have a virulising effect on a baby. The link with the herb was unproven, but
prudence might suggest restricting use to low levels if essential.
Guide to safety of medicines passing through breastmilk

Healthcare teams face many difficulties in managing mothers requiring medication.
The need to treat depends on many factors, including the severity of the mother’s
illness, the need for long-term or acute therapy, the age of the baby and the volume of
milk being consumed.
This section considers issues in relation to medicines for breastfeeding mothers for:
t acute, short-term conditions that arise during the period of breastfeeding
t long-term conditions that require regular medication.
Acute conditions
When treating an acute condition, the prescriber (GP, pharmacist counter prescribing
or nurse prescriber) will need to consider whether the mother is suffering from a self-
limiting condition that will resolve without medication. Some mothers will choose not
to take medication to avoid exposing their baby to any ‘pollutant’ (Ito, Koren, Einarson,
1993). Mothers can be reassured, however, that in the majority of cases, medications
can be safely prescribed (Hale, 2004).
Some acute conditions for which treatments may be required are presented below.
Bacterial infection Antibiotics can be used safely during breastfeeding, although the
baby may exhibit loose bowel motions and/or symptoms of colic.
Fungal infection The prescribing of fluconazole in breast candida was discussed in
Box 4.2 (page 55). Topical antifungals can be used elsewhere on the body but need to be
used with care on the nipple (page 54).
Antihistamines for acute allergic reaction Chlorpheniramine is generally more effec-

tive in resolving the irritation and inflammation of an acute allergy. There are unlikely
to be any effects on the baby when used short term. Long-term allergies such as hay-fe-
ver are best treated with non-sedating antihistamines, use of which is discussed below.
Coughs and colds Most cough remedies are likely to pose few difficulties during
breastfeeding. However, there is very little evidence for the benefits of commercial
cough and cold remedies (Rutter, 2004). Coughs and colds may effectively be managed
by combinations of paracetamol, ibuprofen and steam inhalation.
Vaccination This is obviously not an ‘acute condition’, but because vaccines are used
on single occasions in many instances, they have been included here. Vaccines have, by
definition, poor bio-availability. They are often given to babies directly. There are nev-
ertheless many queries each year about whether mothers need to stop breastfeeding to
receive vaccinations for influenza, pneumococcus or hepatitis. All of these are licensed
to be given directly to children. Taking the poor bio-availability into consideration,
these products are safe to be used by breastfeeding mothers.
Pain relief The safety of analgesics is discussed below. In general, maternal pain can
be adequately resolved using tried and trusted regimes. Only rarely are newer agents
necessary. The safety of sumatriptan to treat migraine has been evaluated in limited
studies (Hale, 2004), but the short half life of 1.3 hours enables mothers to feed imme-
diately before taking medication and to delay feeds until levels are lower. Even without
timing of feeds, Hale suggests that the transfer is three microgrammes per kg per day,
with no paediatric concerns reported.
Long-term conditions
A variety of conditions exist that require
medication throughout the time
mothers are breastfeeding. Treatment
may also have been needed during
pregnancy or therapy may have been
suspended temporarily due to risk
to the baby, but has been resumed
after delivery. Ideally, discussion on the safety of drugs passing through breastmilk
should take place before delivery to enable practitioners to gather information from
the variety of sources referred to in this resource. The National Service Framework for
Children, Young People and Maternity Services (www.dh.gov.uk/PolicyAndGuidance/
HealthAndSocialCareTopics/ChildrenServices/ChildrenServicesInformation/fs/en),
Section 10.5 states that;
t mothers who are taking medicines need particular advice about breastfeeding
t current sources available to healthcare professionals may lead to women being
advised unnecessarily not to breastfeed, because of the medicines they are taking
t women who are taking medicines receive specialist advice, based on best available
evidence, in relation to breastfeeding.
This is particularly relevant to the treatment of long-term conditions, as mothers may be
unnecessarily advised not to initiate breastfeeding or to stop in order to take medication.
Common conditions
Some common conditions that can affect lactating women are now described.
Asthma Corticosteroid and beta agonist (long and short acting) inhalers produce low
levels of drug in the maternal system so can be used safely with minimal risk of transfer
to the baby. Short courses of oral prednisolone (up to 80mg per day) have been studied
with no adverse effect on the baby (Hale, 2004). Long-term courses should be kept as
low as possible for the safety of mother as well as the baby. The risk of formula feeding
and asthma should also be considered (Oddy et al, 2003; Galton Bachrach et al, 2003).
Inflammatory bowel disease This predominantly presents in the age group 18-40, so
may affect lactating women. Standard treatments involve oral steroids (see information
above for asthma), mesalazine (which is poorly absorbed from the gastrointestinal tract,
although it has been reported to cause watery diarrhoea in one breastfed infant (Hale,
2004) ), and azathioprine use of which appears to be more controversial. Hale (2004)
reports two small studies where the levels secreted into breastmilk were deemed to be
too low to produce clinical effects in the infants, or where blood counts measured in
the babies remained normal with reported above-average growth rates. Theoretically,
the baby would be expected to receive 2.7 microgrammes per kg per day. The drug has
a half life of 0.6 hours, so avoiding breastfeeding for three hours after taking the drug
would suggest minimal transfer. Caution is advised, and monitoring of the baby would
be a sensible precaution. Again, the link between formula feeding and inflammatory
bowel disease should be considered (Calkins and Mendeloff, 1986).
Thyroid diseases – under and over activity Although under-active thyroid disease is
less common in young women, supplementation with levothyroxine is common after
surgery for thyrotoxicosis. If the level of levothyroxine is too low, levels of prolactin and
milk production is low. Routine monitoring after delivery is recommended to ensure
adequate milk production. Monitoring and the safety of carbimazole and propothiour-
acil are discussed below.
Management of mothers who mis-use drugs This is difficult because of the risks
associated with street drugs and the risks of transfer of hepatitis and HIV infection. The
random and sometimes chaotic lifestyles of people addicted to drugs can also make
formula feeding risky. Each individual should be made aware of the advantages of breast-
feeding and the need to use prescription drugs only, rather than any obtained illicitly.
Post-natal depression (PND) PND is diagnosed in 10-15% of mothers, many of
whom need medication for their condition to help ensure the child does not experience
lack of stimulation and poor response from the mother and the mother can enjoy the
experience of motherhood. The safety of antidepressants is discussed below.
Epilepsy The risk of unplanned pregnancies for a women of childbearing age taking
anti-epileptic medication is high. The amount of the drug passing through breastmilk,
however, is lower, as the placenta is a poor filter of many drugs in comparison with
breast tissue. Sodium valproate has been discussed in Section 5.5. Polypharmacy may
be necessary to control symptoms of epilepsy and the risk of managing medication
to enable breastfeeding should be borne in mind. Few if any problems have been cat-
egorically linked with drugs passing through breastmilk, but lack of clinical data makes
prescribing difficult.
In all women requiring long-term medication, the risks of the drug need to be weighed
against the risks of artificial feeding for mother and baby. Non-licensing of a drug by
a drug manufacturer cannot be taken as an indicator of potential harm, but should be
seen as compliance with UK legislation and lack of availability of clinical trials.
Simple reference guide

A simple reference guide to the safety of drugs passing through breastmilk is provided
in Appendix 2. It does not take into consideration special situations like prematurity,
difficulties with the infant’s hepatic or renal systems, or polypharmacy. It does, however,
provide a quick and easy method of accessing data on commonly prescribed drugs.
Much of the information is taken from Hale (2004), supported by Briggs et al (2004),
Lee et al (2000), and searches of the Midwifery Information and Resource Service
(MIDIRS) (www.midirs.org/), together with recommendations by the WHO on breast-
feeding and maternal medication (www.who.ch/child-adolescent-health).
Information on the following is
included:
t anaesthetics – local and general
t analgesics
t anthelmintics
t antibiotics
t antidepressants
t oral contraceptives
t dental fillings
t loperamide
t drugs of misuse
t alternative and complementary
remedies
t thyroid medication
t drugs that inhibit lactation
t drugs that stimulate lactation.
Conclusion
The aims of this pack were to provide you with sufficient information to allow you to:
t promote breastfeeding in your work practice
t assess common breastfeeding problems
t consider the use of medicines for breastfeeding mothers
t encompass multi-disciplinary team working, using evidence-based information to
reduce conflicting advice
t make professional judgements in individual circumstances.
The pack has emphasised the promotion of breastfeeding as a health promotion issue,
which is a cornerstone of the new pharmacy contract. Local and national initiatives
have been set up to address health inequalities, and the initiation of breastfeeding
features among them.
The hope is that you and fellow-pharmacists can enhance your professional reputation
and satisfaction by adopting an inter-disciplinary, evidence-based approach to this area
of child and maternal health. It may be a new area for you and many pharmacists, but
it is one that is likely to prove rewarding professionally and commercially as the reputa-
tion of individual pharmacists, pharmacies and the pharmacy profession grow in the
perceptions of patients and customers.

Appendices
Contents
1 About UK Medicines Information ............................................................................................................ 81
2 Reference guide to the safety of drugs passing through breastmilk ................................................ 83
3 References . ................................................................................................................................................... 88
4 Bibliography ................................................................................................................................................. 91
5 Resources ...................................................................................................................................................... 92
6 Breast attachment – demonstration sheet............................................................................................. 95
appendices 81
1 About UK Medicines Information
The UKMi Central website (www.ukmicentral.nhs.uk/aboutukm/) is a collaborative

venture between the Trent and West Midlands regional Medicines Information serv-
ices. This reflects the long history of co-operation between these neighbouring regions,
which includes co-production of the UK Drugs in Lactation Advisory Service.
Its aim is to improve communication between Midlands MI services and their users,
and specifically to:
t speed delivery of information to users
t make specialist information more easily available
t enhance awareness of the facilities the services can provide
t provide a central mechanism for local MI centres and related services, such as
formulary pharmacists disseminate information of wider interest/relevance.
What is the Medicines Information service?

The NHS Medicines Information (MI) service is a speciality within the Pharmacy
service that supports the safe, effective and efficient use of medicines by provision
of information and advice. The service is available to all health care professionals in
primary and secondary care.
Principal aims are to:
t support medicines management within NHS organisations
t support pharmaceutical care of individual patients
The service operates to defined national standards. Services are co-ordinated nationally
by the UK Medicines Information Pharmacists’ Group.
Who provides the service?

The service is provided by qualified NHS pharmacists who have undertaken additional
training in the speciality.
What information is provided?

The MI service provides information and advice on all aspects of the therapeutic use
of medicines. These include adverse effects, drug interactions, use in special patient
groups (elderly, pregnant and breast feeding women etc), identification, availability and
support, pharmacoeconomics and pharmaceutical aspects (e.g. stability, formulation
and compatability).
What resources are available?

MI services have access to a wide range of biomedical and pharmaceutical sources of
information such as computerised databases, references texts, journals, in-house data,
specialist opinion, the pharmaceutical industry and national specialist information and
advisory services developed as part of the UK Medicines Information network.
What services are provided?

Regional MI services (Trent and West Midlands) provide:
t enquiry-answering services for health care professionals
t proactive information such as bulletins, new product summaries, current awareness
t medicines management support for pharmacy and general managers via horizon
scanning, patent expiry data, new product data etc.
t support for local MI centres via secondary referral of enquiries, training pro-
grammes, quality assurance etc.
t a central resource for data relating to medicines.
Who uses the service?

Current users include hospital doctors, general practitioners, hospital and community
pharmacists, health authority professional advisers, hospital and community nurses, al-
lied health professionals, dentists, pharmaceutical/prescribing advisers at PCGs/PCTs,
drug and therapeutics committees, pharmacy managers and other policy makers.
How can I contact the service?

Medicines Information Centres in the UK are organised as a network of regional and
local centres. They may be contacted by telephone (see inside cover of your BNF), letter,
e-mail or by personal visit.
appendices 83
2 Reference guide to the safety of drugs passing through breastmilk
Application
Drug
Milk plasma ratio Half life Plasma Comments Safety in breastfeeding
protein
binding
Local anaesthetics
Lidocaine
0.4 1.8 hours 70% No evidence of sufficient levels Safe in breastfeeding.
reaching breastmilk.
General anaesthetics
Propofol
Unknown (transfer Anaesthesia time 99% See comments. Generally considered
likely to be very is very short (3-10 safe in breastfeeding.
low) minutes)
Alcohol
1 0.24 hours 0 Occasional, social drinking is Generally considered
unlikely to cause any harm avoid safe in breastfeeding
co-sleeping if either the mother on occasional, low
or father have drunk alcohol. level.
Chronic, excessive consumption
is dangerous to the baby.
Analgesics
Paracetamol
0.91-1.42 2 hours 25% Safe in breastfeeding.
Ibuprofen
Not defined as 1.8-2.5 hours > 99% Safe in breastfeeding.
transfer so low
Codeine
1.3-2.5 2.9 hours 7% Colic and constipation in the Generally considered
baby reported. safe in breastfeeding.
4 case reports of neonatal
apnoea with 60mg codeine.
Morphine
1.1-3.6 1.5-2 hours 35% Poor oral bioavailability so Generally considered
levels reaching the infant safe in breastfeeding in
through breastmilk are unlikely therapeutic use.
to lead to clinically significant
levels.
Pethidine
0.84-1.59 3.2 hours 65-80% The half life is extended only to Generally considered
neonates. safe in breastfeeding.
Aspirin
0.03-0.08 2.5-7 hours 88-93% Remote risk of association with Not generally
Reye’s syndrome. considered safe in
Safe as antiplatelet. breastfeeding.
Anthelmintics
Mebendazole
Ratio unknown 2.8-9 hours High Poorly absorbed orally. Generally considered
safe in breastfeeding.
Piperazine
No data No data No data Poorly absorbed orally. Generally considered
safe in breastfeeding.
Antibiotics
Amoxycillin
0.014-0.043 1.7 hours 18% Penicillins are all safe to take Generally considered
during breastfeeding. safe in breastfeeding.
Cefaclor
Unknown 0.5-1 hour 25% Cephalosporins are all safe to Generally considered
take during breastfeeding. safe in breastfeeding.
Tetracycline
0.58-1.28 6-12 hours 25% Drug forms a chelate with the Long courses e.g.
calcium in the milk and is not for acne should be
absorbed by the baby. avoided. Short courses
generally safe.
Gentamicin
0.11-0.44 2-3 hours <10- Aminoglycocides are not Generally considered
30% absorbed from the gut so any safe in breastfeeding.
passing through breastmilk will
not be absorbed by the baby.
Erythromycin
0.92 1.5-2 hours 84% Macrolides are safe to be taken Generally considered
during breastfeeding. safe in breastfeeding.
Metronidazole
1.15 8.5 hours 10% Said to cause milk to taste Generally considered
unpleasant. safe in breastfeeding.
Ofloxacin
0.98-1.66 5-7 hours 32% Quinolones can cause problems Avoid if possible but
in the joints of juvenile animals consider benefit:risk.
exposed to them directly.
The relevance to breastfeeding is
unknown.
Short maternal courses are
unlikely to pose problems, other
antibiotics are preferable.
Ciprofloxacin
>1 4.1 hours 40% As above. Avoid if possible but
consider benefit:risk.
Trimethoprim
1.25 8-10 44% Safe in breastfeeding.
hours(neonate up
to 40 hours)
Vancomycin
Not determined 5.6 hours 10-30% Oral bioavailability is poor Probably safe but no
so absorption is likely to be studies.
minimal.
appendices 85
Antidepressants
Imipramine
0.5-1.5 8-16 hours 90% No adverse effects have been Generally considered
noted in case reports. safe in breastfeeding.
Fluoxetine
0.286-0.67 2-3 days 94.5% Some evidence of excessive Generally considered
somnolence in newborn if safe in breastfeeding.
exposed in utero.
Citalopram
1.16-3 36 hours 80%. No information on Generally considered
escitalopram. safe in breastfeeding.
Paroxetine
0.056-1.3 21 hours 95% Some evidence of neonatal Generally considered
withdrawal syndrome if exposed safe in breastfeeding.
in utero.
Sertraline
0.89 26-65 hours 98% This may be the SSRI of choice
for most breastfeeding mothers.
Venlafaxine
Not confirmed 5 hours 27% The dose transferred to the Use with caution.
(2.5 in study of 3 infant is relatively high and
mothers) although no adverse reports
have been reported it may
be wise to use this drug with
caution.
Contraceptives
Progesterone only contraceptives
Transfer into milk is low. Safe in breastfeeding.
Progesterone only depot injections and implants
Reports that very early Safe in breastfeeding.
progesterone diminishes
breastmilk production.
Combined oral contraceptive pills
Oestrogen has an inhibitory Should be avoided in
effect on prolactin and can breastfeeding.
dramatically reduce milk
production.
Emergency hormonal contraception
Safe in breastfeeding.
Dental fillings
Amounts of mercury absorbed Safe in breastfeeding.
are minute and passage into
breastmilk has not been
shown to have any health
consequences.
Loperamide
0.5 10.8 hours Not 4mg dose reported to Safe in breastfeeding.
reported produce a milk level of 0.27
microgrammes per litre.
Drugs of misuse
Heroin
2.45 1.5-2 hours 35% Sufficient quantities of heroin To be discouraged in
excreted into breastmilk to breastfeeding mothers.
cause addiction in the baby.
Methadone
0.68 13-55 hours 89% Daily doses of methadone of up Generally considered
to 80mg appear to be relatively safe in breastfeeding
safe. Neonatal abstinence <80mg/day.
syndrome due to exposure in
utero.
Cannabis
8 25-57 hours 99.9% In animals shown to inhibit Occasional recreation
prolactin and decrease milk use would not appear
production but not been to produce a significant
reported in humans. risk to infants but few
long term studies.
Cocaine
Not determined 0.8 hours 91% Milk may be positive for 36 This drug is not
hours, very toxic to infants. safe to be taken by a
breastfeeding mother.
Ecstasy
No studies Derivation from amphetamines To be discouraged in
suggests that it has the breastfeeding mothers.
potential to pass into breastmilk Discard milk for at
in large amounts. least 24 hours after
consumption.
Alternative and complementary remedies
Homeopathic
Very little data on Seek advice from qualified Homeopathic remedies
transfer practitioners. unlikely to be harmful.
Herbal remedies
Very little data on Seek advice from qualified Safety varies – no
transfer practitioners. evidence of harm from
echinacea or St John’s
Wort.
Smoking
Babies whose mothers smoke Common exposure but
are more likely to suffer from best avoided.
colic and breastmilk production
is lower in mothers who smoke.
Passive smoking is associated
with early onset wheeze.
Risk of cot death increased.
Nicotine replacement therapy
Not licensed to be used by Safer than exposure to
breastfeeding mothers but nicotine from smoking.
nicotine exposure is much lower
than with smoking.
appendices 87
Thyroid medication
Levothyroxine
Not determined 6-7 days 99% Replaces physiological Safe in breastfeeding.
insufficiency.
Too low a level inhibits prolactin
and produces poor milk supply.
Carbimazole
0.3-0.7 6-13 hours 0% Sub clinical levels of the active Generally considered
metabolite methimazole enter safe in breastfeeding
milk following doses of 30mg <30mg/day.
per day carbimazole.
Propylthiouracil
0.1 1-2 hours 90% Secreted into breastmilk in Safe in breastfeeding.
amounts too low to produce
side effects.
Vaccinations
Poor oral bioavailability Safe in breastfeeding.
produces low absorption.
Oral Polio vaccine
May reduce the production Safe in breastfeeding
of antibodies by the infant in after infant > 6 weeks
response to its own dose if old.
given before 6 weeks.
Drugs which inhibit lactation
Bromocriptine
Not determined 50 hours 90-96% Not recommended for routine Not advised.
suppression of lactation. Some
fatalities recorded in mothers
taking it.
Cabergoline
No data on The dose to irreversibly inhibit Breastfeeding after use
transfer into lactation is 1mg as a single dose unlikely to be possible.
breastmilk on the first day post partum,
reported or 250 microgrammes (half a
tablet) every 12 hours for 2 days.
Drugs which stimulate lactation
Metoclopramide
0.5-4.06 5-6 hours 30% extra-pyramidal symptoms and Generally safe but not
severe depression reported. first choice to stimulate
prolactin.
Domperidone
0.25 7-14 hours 93%. Useful to stimulate breastmilk Safe in breastfeeding.
production if mother has been
expressing long term. Refer to
specialist breastfeeding expert
for support.
3 References
Alexander J et al (1992) Randomised controlled trial of breast shells and Hoffman’s

exercises for inverted and non-protractile nipples. British Medical Journal 304: 6833,
1030-2.
Anderson JW et al (1999) Breastfeeding and cognitive development: a meta-analysis.
Am J Clin Nutr 70: 525-35.
Anderson P (2003) Adverse drug reactions in breast-fed infants: less than imagined.
Clin Paed 42: 325-40.
Aniansson G et al (1994). A prospective cohort study on breast feeding and otitis media
in Swedish infants. Pediatr Infect Dis J 13: 183-8.
Brent N (2001) Thrush in the breastfeeding dyad: results of a survey on diagnosis and
treatment. Clin Paed 40: 503-6.
Briggs GG, Freeman RK, Yaffe SY (2004) Drugs in Pregnancy and Lactation 7th Ed.
Baltimore: Williams and Wilkins.
Broadfoot M (1995) Economic consequences of breastfeeding for less than three
months. New Generation Digest December 5.
Calkins BM, Mendeloff AI (1986) Epidemiology of inflammatory bowel disease.
Epidem Rev.8: 60-9.
Collaborative Group on Hormonal Factors in Breast Cancer (2002). Breast cancer and
breastfeeding: collaborative re-analysis of individual data from 47 epidemiological stud-
ies in 30 countries, including 50 302 women with breast cancer and 96 973 women
without the disease. Lancet 360: 187-95.
De Onis M et al (2004) The WHO Multicentre Growth Reference Study (MGRS):
rationale, planning, and implementation. Food & Nutrition Bulletin 25: 1, suppl 1.
http://www.unu.edu/unupress/food/Unupress.htm
Duncan B et al (1993) Exclusive breast feeding for at least four months protects against
otitis media. Pediatrics 5: 867-72.
Forsyth JS (1992) Is it worthwhile breastfeeding? Eur J Clin Nutr 46: S19.
Galton Bachrach VR et al (2003) Breastfeeding and the risk of hospitalisation for respi-
ratory disease in infancy. A meta-analysis. Arch Pediatr Adolesc Med 157: 237-43.
Gerstein HC (1994) Cows’ milk exposure and type 1 diabetes mellitus. Diabetes Care 17:
13-9.
Hale T. (2004) Medications in Mothers’ Milk (2004) Texas: Pharmasoft.
Hamlyn B et al (2002) Infant Feeding Survey 2000. London: Dept of Health.
Henderson L, Kitzinger J, Green J (2000). Representing infant feeding: content
analysis of British media portrayals of bottle feeding and breastfeeding. British Medical
Journal 321:1196-8.
Holt M et al (2004) Encouraging breastfeeding in community pharmacies in Renfrew.
International Journal of Pharmacy Practice (special supplement – Pharmacy Practice
Research) 12: R74.
appendices 89
Hoppe JE et al (1997) Treatment of oropharyngeal candidiasis in immunocompetent

infants: a randomised multicentre study of miconazole gel vs nystatin suspension. Paed
Infec Dis 16: 288-93.
Howie PW et al (1990). Protective effect of breastfeeding against infection. British
Medical Journal 300: 11-6.
Inch S, Fisher C (1995) Mastitis: infection or inflammation? The Practitioner 239: 472-6.
Ito S et al (1993) Prospective follow-up of adverse reactions in breast-fed infants
exposed to maternal medication. Amer J Obstet Gynecol 168: 1383-9.
Ito S, Koren G, Einarson TR (1993) Maternal non-compliance with antibiotics during
breast-feeding. Ann Pharmacother 27: 40-2.
Jones W (2000) The role of the community pharmacist in supporting breastfeeding mothers
requiring medication. PhD thesis, University of Portsmouth.
Khalidah A et al (2003) Pseudoephedrine: effects on milk production in women and
estimation of infant exposure via breastmilk. British Journal of Clinical Pharmacology 56:
1, 18.
Karjalainen J et al (1992) A bovine albumin peptide as a possible trigger of insulin-
dependent diabetes mellitus. New Engl J Med 327: 302-7.
Lawrence R (1998) Breastfeeding: a Guide for the Medical Profession, 5th Ed. St Louis,
MO: Mosby.
Lee A, Inch S, Finnegan D (2000) Therapeutics in Pregnancy and Lactation. Oxford:
Radcliffe Medical Press.
Lucas A et al (1990) Early diet of pre-term infants and development of allergic or atopic
disease: randomised prospective study. British Medical Journal 300: 837-40.
Lucas A, Cole TJ (1990) Breastmilk and neonatal necrotising enterocolitis. Lancet 336:
1519-22.
Martin I, O’Hare IP (1999) Breastfeeding mother in bus ban. Scotland on Sunday
August 8.
Martindale (2004) The Complete Drug Reference, 34th Ed. London: Pharmaceutical Press.
Mitka M (1999). Why the rise in asthma? New insights, few answers. JAMA 281; 23,
2171-2.
McConnachie A et al (2004) Modelling consultation rates in infancy: influence of ma-
ternal and infant characteristics, feeding type and consultation history. Br J Gen Pract
54: 505, 598-603.
Mortensen EL et al (2002) The association between duration of breastfeeding and adult
intelligence. JAMA 287: 2365-71.
Newcomb PA et al (1994) Lactation and a reduced risk of pre-menopausal breast
cancer. New Engl J Med 330: 81-7.
Oddy WH et al (1999) Association between breastfeeding and asthma in six year-old
children: findings of a prospective birth cohort study. British Medical Journal 319: 815-9.
Oddy WH et al (2002) Maternal asthma, infant feeding, and the risk of asthma in
childhood. J Allergy Clin Immunol 110: 65-7.
Oddy WH et al (2003) Breast feeding and respiratory morbidity in infancy: a birth
cohort study. Archives of Disease in Childhood 88: 224-8.

Paton LM et al (2003) Pregnancy and lactation have no long-term deleterious effect on
measures of bone mineral in healthy women: a twin study. Am J Clin Nut 77: 707-14.
Pisacane A, Graziano L, Zona G (1992) Breastfeeding and urinary tract infection. J
Pediatr 120: 87-9.
Polatti F et al (1999) Bone mineral changes during and after lactation. Obstet Gynecol
94: 52-6.
Renfrew M, Woolridge MW, McGill HR (2000) Enabling Women to Breastfeed: a review
of practices which promote or inhibit breastfeeding with evidence-based guidance for practice.
London: The Stationery Office.
Rosenblatt KA et al (1993). Lactation and the risk of epithelial ovarian cancer – the
WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Int J Epidemiol 22:
499-503.
Rutter P (2004) Community Pharmacy. Edinburgh: Churchill Livingstone.
Saarinen UM, Kajosaari M (1995) Breastfeeding as prophylaxis against atopic disease:
prospective follow-up study until 17 years old. Lancet 346: 1065-9.
Shelton MG (1980) Standardized senna in the management of constipation in the
puerperium: a clinical trial. S Afr Med J 57: 3, 78-80.
Thomson et al (1984) Course and treatment of mik stasis, non-infectious inflammation
of the breast and infectious mastitis. Am J Obstet.Gynecol 149: 5, 492-5.
Uauy R, Peirano P (1999) Breast is best: human milk is the optimal food for brain
development. Am J Clin Nutr 70: 433-4.
United Kingdom National Case-Control Study Group (1993) Breast feeding and risk of
breast cancer in young women. British Medical Journal 307: 17-20.
Virtanen SM et al (1991). Infant feeding in children seven years of age with newly
diagnosed IDDM. Diabetes Care 14: 415-7.
Williams AF (2002) Growth charts for breastfed infants. Acta Pediatrica 91:1282-3.
Wilson AC et al (1998). Relation of infant diet to childhood health: seven year follow up
cohort of children in Dundee infant feeding study. British Medical Journal 316: 21-5.
appendices 91
4 Bibliography
Briggs GG, Freeman RK, Yaffe SY (2005) Drugs in Pregnancy and Lactation 7th Ed.
Baltimore: Lippincott Williams and Wilkins.
Hale T. Medications and Mothers’ Milk (2006) Texas: Pharmasoft.
Hamlyn B et al (2002) Infant Feeding Survey 2000. London: Dept of Health.
Humphrey S (2003) The Nursing Mother’s Herbal. Minneapolis: Fairview.
Lawrence R (1998) Breastfeeding: a Guide for the Medical Profession, 5th Ed. St Louis,
MO: Mosby.
Renfrew M, Woolridge MW, McGill HR (2000) Enabling Women to Breastfeed: a review
of practices which promote or inhibit breastfeeding with evidence-based guidance for practice.
London: The Stationery Office.
Riordan J, Auerbach KG (1993) Breastfeeding and Human Lactation Boston MA: Jones
and Bartlett.
Royal College of Midwives (2002) Successful Breastfeeding Edinburgh: Churchill Living-
stone.
5 Resources
Publications
The following are available via the publications section of the NHS Health Scotland
website: www.healthscotland.com/publications/
Off to a good start: All you need to know about breastfeeding your baby
Breastfeeding and returning to work: Off to a good start
Breastfeeding and returning to work: A simple guide
Good for you! And your baby too (fold-out card)
Evidence into action: Nutrition in the under fives
From the Scottish Executive can be obtained through the web address: www.scotland.
gov.uk/library2/doc15/bfrw-00.asp
Breastfeeding and returning to work
American Academy of Pediatrics, The Transfer of Drugs and Other Chemicals Into
Human Milk, Pediatrics 2001;108(3): 776-789
http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776
Websites
Breastfeeding in Scotland
Breastfeeding in Scotland
www.breastfeed.scot.nhs.uk/
Scottish Health Statistics
www.isdscotland.org
Ready Steady Baby
www.hebs.com/readysteadybaby
National Breastfeeding Awareness Week
www.breastfeeding.nhs.uk/nb_nbaw.asp
Others
www.bbc.co.uk/parenting/your_kids/babies_feeding.shtml
www.lanarkshirebreastfeeding.org.uk/
Voluntary organisations
The Breastfeeding Network
National Childbirth Trust
www.nctpregnancyandbabycare.com
La Leche League GB
www.laleche.org.uk
Association of Breastfeeding Mothers
www.abm.me.uk
appendices 93
Medicines Information
UK Medicines Information
www.ukmicentral.nhs.uk/
Scottish Intercollegiate Guidelines
www.sign.ac.uk
National electronic Library for Medicines (formerly known as DrugInfoZone)
www.druginfozone.nhs.uk
NHS Scotland e-Library
www.elib.scot.nhs.uk
Medline
www.ncbi.nlm.nih.gov/entrez/
Other specific sites with information on medicine use during breastfeeding
WHO Child and Adolescent Health and Development
www.who.ch/child-adolescent-health
American Academy of Pediatrics, Breastfeeding Initiatives
www.aap.org/breastfeeding/
Motherisk, Canada
www.motherisk.org
Breastfeeding pharmacology website operated by Dr Thomas Hale
http://neonatal.ttuhsc.edu/lact/
UNICEF UK Baby Friendly Initiative
www.babyfriendly.org.uk
6 Breast attachment – demonstration sheet
From: Royal College of Midwives (2002) Successful Breastfeeding 3rd Edition. London: Churchill, Livingstone.

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The pharmaceutical care

© 2006 NHS Education for Scotland

About this package

Multiple choice questionnaire

How this package can assist your CPD

Angela Malonney, 33, has two children, Charlotte (5) and

1.1 Aims and objectives

Now go to Activity 1.1a in your Workbook, then Activity 1.1b (page 1)

1.2 Breastfeeding – an introduction

Perceptions of difficulties in breastfeeding, however, have influenced the way in which

Figure 1.1 Breastfeeding in Scotland at infant age 7 days, 1990-2004

1.3 Pharmaceutical Care Model Schemes

Box 1.1 Pharmaceutical Care Model Schemes

Now go to Activity 1.2 in your Workbook (page 2)

1.4 Infant formulae and follow-on milks

t NHS Greater Glasgow – ‘Infant Feeding Poli-

Promoting breastfeeding over breastmilk substitutes

There is an annual National Breastfeeding Awareness Week in the UK, generally

Now go to Activity 1.3 in your Workbook (page 2)

Cheryl Kaye is 24 and has three children, Francesca (7)

2 Breastfeeding in Scotland: advantages,

2.1 Aims and objectives

Now go to Activity 2.1 in your workbook (page 3)

2.2 Advantages of breastfeeding

Breastfeeding advantages for infants

The health benefits of breastfeeding A meta-analysis of studies from developed countries

Breastfeeding advantages for the mother

Breastfeeding advantages for the NHS

2.3 Disadvantages of breastfeeding

Box 2.1 Common myths about breastfeeding

2.4 Breastfeeding statistics in Scotland

Figure 2.1 Breastfeeding initiation in Scotland and England /Wales

0% 1980 1985 1990 1995 2000

Socio-economic class There is a strong relationship between the duration of breast-

Figure 2.2 Prevalence of breastfeeding

Figure 2.3 Proportion of women who would have liked to

Mother’s awareness of health benefits

Reasons given for stopping breastfeeding

Baby wouldn’t suck

Took too long/tiring

Support for mothers

Figure 2.5 Sources of helpful support for mothers in Scotland

Books and leaflets

Family and friends

Elise Barraclough, 17, single parent, baby McKenzie (3 weeks).

3 Influences on, and support for, breastfeeding

3.1 Aims and objectives

3.2 Influences on breastfeeding behaviours

Law The Consultation paper that

3.3 National breastfeeding initiatives

UNICEF breastfeeding initiatives

Box 3.1 The ten steps to successful breastfeeding

Box 3.2 The seven steps to successful breastfeeding

Now go to Activity 3.1 in your Workbook (page 5)

3.4 Supporting breastfeeding mothers

Expressing and storing breastmilk

Now go to Case Scenario 3.2 in your Workbook (page 5)

Now go to Activity 3.3 in your Workbook (page 5)

The role of voluntary breastfeeding supporters

Now go to Activity 3.4 in your Workbook (page 6)

Support from other health professionals

Now go to Case Scenario 3.5 in your Workbook (page 6)

3.5 The pharmacist’s role in supporting breastfeeding women