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
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Breastfeeding in Scotland: advantages, disadvantages and statistics . . . . . . . . . . 19 2.1 Aims and objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.2 Advantages of breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.3 Disadvantages of breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 2.4 Breastfeeding statistics in Scotland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
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Influences on, and support for, breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . 31 3.1 Aims and objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
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Conditions affecting breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 4.1 Aims and objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 4.2 Physiology of breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 4.3 Common breastfeeding problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
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Medicines use during breastfeeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 5.1 Aims and objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 pharmacists who deliver services to breastfeeding mothers, as well as other health professionals 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 encourage 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 breastfeeding and how these can be treated appropriately.
THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
Chapter 5 deals with the more difficult subject of the safe use of medicines by breastfeeding 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 medicines 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:
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record your responses to activities apply your learning through completion of the case scenarios compare your answers with suggested responses at the back of the workbook note down any new learning needs arising during this course.
Please take the workbook out of the binder when studying the training pack and making 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 suggested 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 organisations 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 supplementary 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.
THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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
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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!
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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 feeding 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:
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assist you in delivering pharmaceutical care to mothers in your day-to-day practice
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explore the significance of professional judgement in individual circumstances.
set out the health implications of increasing breastfeeding initiation rates provide an overview of conditions that might affect a mother during breastfeeding explore how you can contribute to a multi-disciplinary, patient-focused model of care demonstrate dilemmas in providing evidence-based information on the safety of drugs used during lactation
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. Physiological 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.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 phenylketonuria (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 phenylalanine 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
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These figures highlight the need for a co-ordinated approach to promoting breastfeeding that focuses on providing:
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effective support and encouragement for women who wish to breastfeed consistent professional advice 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)
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1.4
THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
Infant formulae and follow-on milks This pack is heavily biased towards the promotion of breastfeeding, with little information 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 breastfeeding 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 opportunities 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 formula. 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
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‘Preparing a bottle using powdered formula’ www.babyfriendly.org.uk/pdfs/botenglish.pdf
INTRODUCTION
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NHS Greater Glasgow – ‘Infant Feeding Policies and Guidelines for Health Professionals’ (an excellent booklet covering all aspects of breast and bottle feeding together with problems 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:
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advertising special displays of free samples and discounting 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 pharmaceutical 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.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 individual 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.
Now go to Activity 1.3 in your Workbook (page 2)
2 Breastfeeding in Scotland: advantages, disadvantages and statistics
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 neutraprem (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 compromise 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.
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2 Breastfeeding in Scotland: advantages, disadvantages and statistics 2.1
Aims and objectives 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. The objectives are to:
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consider the advantages and disadvantages of breastfeeding for mother and baby examine the benefits of breastfeeding in economic terms for the NHS look at statistics on breastfeeding in Scotland 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.
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The health benefits of breastfeeding in industrialised countries are sometimes questioned on the grounds that modern, hygienically prepared infant formulae are safe and nutritionally complete. Uncertainties increase about this view as more is learned about the complex composition of breastmilk. The complexity of breastmilk implies that it possesses numerous functions of biological importance… Williams AF (1994). Is breastfeeding beneficial in the UK? Statement of the standing committee on nutrition of the British Paediatric Association. Arch. Dis. Child. 71:376-380.
A meta-analysis of studies from developed countries concluded that the risk of severe respiratory tract illness resulting in hospitalisation is more than tripled among infants who are not breastfed, compared with those who are exclusively breastfed for four months (Galton Bachrach et al, 2003).
Middle ear infection Infants who are breastfed have fewer episodes of otitis media and those who are partially breastfed have reduced incidence. Forty-seven per cent of approximately 1000 children studied in the US in 1994 had at least one episode of otitis media during the first year of life, but infants exclusively breastfed for four or more months had half the mean number of acute otitis media episodes of those not breastfed at all. The recurrent otitis media rate in infants exclusively breastfed for six months or more was 10%, but was 20.5% in infants who breastfed for less than four months (Duncan, 1993; Aniansson G et al, 1994). Urinary tract infection A study of hospitalised infants showed that those who were bottle-fed were five times as likely to have a urinary tract infection at the time of 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 emphasised, 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 cognitive 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 cognitive 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 commented 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 previous 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. Translating 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.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 t t t t t t
inability to measure the volume of milk the baby has consumed no-one else can feed the baby breastfeeding can be painful, messy and tiring breastfeeding can be difficult to establish breast-fed babies wake more often during the night to feed it is more difficult for breastfeeding mothers to return to work the mother may need to modify her diet.
Disadvantages of breastfeeding are those factors perceived by the mother as an inconvenience to her since there are no known disadvantages to the normal infant. Lawrence R. (1999) Breastfeeding: a Guide for the Medical Profession. 5th Edition. St Louis, MO: Mosby.
It would be inappropriate to attempt to coerce a mother into breastfeeding if she is truly unhappy at the prospect. She needs to be comfortable with her chosen method of feeding her baby, and it is a decision only she can make, in consultation with her partner, family and friends. You can, however, offer her information on the benefits of breastfeeding for herself and her baby and discuss common ‘myths’ surrounding breastfeeding that may help her to make an informed decision (see Box 2.1).
Breastfeeding in Scotland: advantages, disadvantages and statistics
23
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 positioning 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 nappies 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.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 bottlefeeding 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 breastfeeding, 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 suffering 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 factors 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 switching to formula. Eighty-six per cent of mothers who had successfully breastfed before were still breastfeeding at six weeks.
Breastfeeding in Scotland: advantages, disadvantages and statistics
25
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 breastfeeding 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%.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
Figure 2.2 Prevalence of breastfeeding in Scotland at age six weeks 45% 40% 35% 30% 25% 20% 15% 10% 5%
Infant Feeding Survey data suggest that more than 90% of women who give up breastfeeding 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. 0%
1990
1995
2000
2004
Figure 2.3 Proportion of women who would have liked to have breastfed longer 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
6 months
Breastfeeding in Scotland: advantages, disadvantages and statistics
27
Mother’s awareness of health benefits The 2000 Infant Feeding Survey collected data for the first time on women’s awareness 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 conducted. 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%
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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% GP 6%
Midwife 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
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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.”
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3
Influences on, and support for, breastfeeding
3.1
Aims and objectives The aim of this chapter is to enable you to examine barriers and opportunities to supporting breastfeeding women in your day-to-day practice. The objectives are to:
t t t t
3.2
look at influences on breastfeeding behaviour understand national breastfeeding initiatives enable you to provide effective support to breastfeeding mothers understand the pharmacist’s role in supporting breastfeeding women
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.
The art of breastfeeding has been all but lost. Most of the information women are now given is complete poppycock, based on the teaching at the turn of the century, which supposed the breast was a bottle. Health professionals don’t realise how desperately the women in their care need information and support. McConville B (1994) Mixed Messages: our breasts in our lives. London: Penguin.
Family and friends Eighty-two per cent of mothers who had been breastfed as babies planned to breastfeed their own babies, while only 56% of those who had been entirely formula fed intended to. Mothers are also more likely to breastfeed if their friends do so. Health care professionals All health care professionals should aim to provide non-conflicting, evidence-based, patient-focused information. A broadening evidencebase for practice, coupled with greater awareness of the importance of breastfeeding in health care professional training programmes and widening access to UNICEF Baby-Friendly standards and associated education, should mean that health care professionals are able to achieve these objectives. The reality, however, may be somewhat different, and advice of questionable quality and information based on tradition rather than evidence is still being offered to women.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 pharmacy 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 during 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 t t
three assistants had been asked about breastfeeding problems
t
almost all agreed that they needed further information about common problems in breastfeeding.
three assistants thought that the information they had available was sufficient some staff were concerned about adding pressure to mothers in what they believed was a personal choice
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-today 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, pharmacists 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 breastfeeding 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.
It is important that every child in Scotland gets the best start in life, and breastfeeding protects babies from a host of potential health problems. Deputy Health Minister Rhona Brankin, MSP, May 2005 (www.scotland.gov.uk/News/ Releases/2005/05/09114219)
This law has implications for you as a pharmacist and the premises on which you work. If you haven’t already done so, you might consider defining an area as a quiet place to breastfeed. This will not only provide a welcoming environment for breastfeeding mothers, but will also emphasise to them that you are prepared to support their breastfeeding and the health benefits it brings to mother and baby. The Scottish Executive is now developing an Infant Feeding Strategy for Scotland in conjunction with the Scottish Breastfeeding Group. This will aim to increase breastfeeding rates across the country.
34
3.3
THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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.
Influences on, and support for, breastfeeding
35
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 breastfeeding. 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 of help and advice, particularly if they know where to refer parents
Organisations find the process of becoming accredited through the Baby Friendly Hospital Initiative challenging and demanding, but recognise that it stands as a 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
Now go to Activity 3.1 in your Workbook (page 5)
3.4
Supporting breastfeeding mothers All health care professionals should follow similar guidance when supporting breastfeeding mothers to minimise conflicting advice and confusion. They should:
t t
focus on the needs of the mother and baby
t t
avoid interfering with the baby’s natural feeding pattern
encourage the mother to achieve effective feeding by correct positioning and attachment of the baby at the breast 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.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 recommend 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) contains 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)
Influences on, and support for, breastfeeding
37
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 mother’s working environment. There are definite advantages to employers 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 excellent 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 guidelines 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.
Now go to Activity 3.3 in your Workbook (page 5)
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
The role of voluntary breastfeeding supporters Voluntary breastfeeding supporters, generally women who have breastfed, have undergone 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.
Now go to Activity 3.4 in your Workbook (page 6)
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 support 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.
Now go to Case Scenario 3.5 in your Workbook (page 6)
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 contraindications. 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-
Influences on, and support for, breastfeeding
39
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 community 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 professional 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 information 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 information 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 professional 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 prescriber) 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 demonstrate 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 professional 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.
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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.
Now go to Activity 3.6 in your Workbook (page 7)
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 effectiveness 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 (reflection on learning) What have I learned? How is it benefiting my practice?
Planning How can I learn?
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.
Influences on, and support for, breastfeeding 41
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 acceptable 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 common base with many of the principles underpining concordance. Counselling involves listening to the patient in a non-judgmental and empathetic manner. 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 ignoring 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 educate staff on how to identify potential breastfeeding women and how to ask questions sensitively should be pursued.
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4 Conditions affecting breastfeeding
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 breastfeed 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
4.1
Aims and objectives 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 t t t
4.2
how breastmilk is produced the importance of positioning and attachment in ensuring successful breastfeeding the normal pattern of baby feeding the common conditions affecting breastfeeding
Physiology of breastfeeding The majority of common
breastfeeding problems can be overcome by understanding the basic physiological principles of breastfeeding and how to implement practical guidance on positioning and attachment in order to achieve pain-free, effective feeding. Clinical Effectiveness Information Bulletin, April 2003, Focus on Promoting and Supporting Breastfeeding
Pharmacists may be asked for information on many of the conditions that affect breastfeeding in the early days. Mothers value the fact that pharmacists are accessible health care professionals and are readily available without an appointment. You will get a better understanding of problems associated with breastfeeding by understanding how breastfeeding works. The structure of the breast is shown in Figure 4.1. Figure 4.1 The structure of the breast alveolus (enlarged) alveolus (acinus) ductile
myoepithelial cell lactiferous (mammary) duct lactiferous sinus (ampulla) nipple (mammary papilla) areola lobe
From: Breastfeeding and Human Lactation, Riordan J and Auerbach KG. Jones and Bartlett, Massachusetts 1993.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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 involution 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 nonpregnant levels by seven days. The continued removal of milk is also important to continued production once lactation 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 frequency 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 effected 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 understanding 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 generations, 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 ‘symptoms’ 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 nipple; this will result in pain-free feeding for the mother and the baby will be satisfied as he can remove all the milk from the breast
Baby not compressing lactiferous sinuses and is nipple feeding, which will produce pain and damage for the mother and will not enable the baby to 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.
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
Figure 4.3 Pattern of normal breastfeed Satisfied
Hungry Pause, resting Foremilk
Pause, resting
Pause, resting
Hindmilk
Vigorous, Rhythmic stimulating suckling, active feeding Volume reduces
Low quality Rhythmic suckling, active feeding
Rhythmic suckling, active feeding
Rhythmic suckling, active feeding
Flutter or butterfly suckling
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 possibly 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 feeding 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 probably 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.
Conditions affecting breastfeeding 49
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 supplement 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 effectively 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 alternatives 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.
Now go to Case Scenario 4.1 in your Workbook (page 8)
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THE PHARMACEUTICAL CARE OF BREASTFEEDING MOTHERS
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, ensuring 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 inhibited 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 temperature, aches and pains is abnormal, and may result from ineffective milk removal or restricted feeds. Treatment involves care with correct positioning (which may be difficult 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).
Conditions affecting breastfeeding 51
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 sufficient 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 growth provide a much better description of the physiological growth and they establish that breast-fed infants are the biological norm. Paediatricians will be able to congratulate parents on having exclusively breastfed their infants instead of spending time as they do now in trying to reassure them that the apparent growth faltering of the baby is not a reason for concern and is due to the imperfections of the growth chart that are being used for their growth. De Onis M et al (2004) The WHO Multicentre Growth Reference Study (MGRS): rationale, planning, and implementation. Food & Nutrition Bulletin 25: 1, supplement 1. http:// www.unu.edu/unupress/food/Unupress.htm
The latest WHO study of 8,440 children from six countries found that target weights for two and threeyear-olds were 15% to 20% too high (De Onis et al, 2004). The researchers believe that current overfeeding of babies could explain in part why levels of obesity and overweight in children are rising. WHO will release new growth charts based on breast-fed babies in Summer 2006 (de Onis et al, 2004). True milk insufficiency is a potentially life-threatening situation for the baby, and maternal concerns must not be ignored. The best advice you can offer as a pharmacist is encouragement to the mother to seek expert help, which should involve watching a full breastfeed to assess positioning and attachment and effective milk removal. The Infant Feeding Report 2000 showed that on leaving hospital, 32% of breastfeeding mothers report that their baby appeared hungry. Fifteen per cent were still reporting the same thing at 4-5 months, with 6% also commenting on poor weight gain. Weight gain is of considerable concern to many mothers. ‘Does he sleep well?’ and ‘How much weight has he gained?’ are often the first questions about a new baby asked by family and friends. This can sap a new mother’s confidence, as can a baby who wants to feed frequently and never appears satisfied.
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So what can pharmacy staff do to allay maternal fears about insufficient weight gain? You can:
t t t t
allow the mother to voice her concerns and listen empathetically offer positive support and remind her of the benefits of breastfeeding refer the mother to a breastfeeding specialist to check on optimal attachment 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.
Now go to Case Scenario 4.2 in your Workbook (page 8)
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, sudden changes in the baby’s feeding pattern, 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 t
difficulties with positioning and attachment resulting in less than perfect drainage
t
sudden changes in the baby’s feeding pattern leaving the breasts overfull.
pressure from tight-fitting clothing or from fingers supporting the breast during breastfeeding
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 flulike symptoms – increased temperature and shivering – and may feel tearful and tired.
Conditions affecting breastfeeding 53
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 250500mg 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.
Now go to Case Scenario 4.3 in your Workbook (page 9)
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.
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It can be very difficult to differentiate thrush from other conditions affecting breastfeeding. It should be noted that some professionals deny the existence of intra-mammary 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 breastfeeding, 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 continue 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 t t t t
pain in both breasts
t
lack of temperature (apyrexia) absence of red area on the breast itching of the areola extreme sensitivity of the nipple so that the mother may experience extreme discomfort from clothes or showers 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 ointment), 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 appears 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
Conditions affecting breastfeeding 55
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 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 neuroleptic 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 administration to lactating mothers.
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Drug half life The half life of a drug is defined as the time taken for the serum concentration 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 accumulate 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 Martindale (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 maternal 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.
Medicines use during breastfeeding 65
5.5
Specialist sources of information UK Medicines Information (MI) Centres are available locally and nationally. (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 www.breastfeedingnetwork.org.uk 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.
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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-epileptic 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 Appendix 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 receiving 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 recommends, 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 breastmilk 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.
Medicines use during breastfeeding 67
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 (corticosteroids) 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 function 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. Shortterm 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 answers 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.
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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 recommendation 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 emphasises, 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
Medicines use during breastfeeding 69
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 demonstrating 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 research, 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.
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You need to explore with her the relative risks of:
t t t t t
taking the medicine and carrying on breastfeeding switching to an alternative medicine treatment taking the drug and temporarily or permanently stopping breastfeeding not taking the medication 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 medication 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 personal 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 recommendations 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 t t t
50 pregnant women 300 under fives 1,000 people with chronic diseases 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.
Medicines use during breastfeeding 71
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 possible 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 plasma 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 breastfeeding 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.
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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 breastmilk; 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 detection 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 pharmacological 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.
Medicines use during breastfeeding 73
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 information (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 pharmacists 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 antihistamines, 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 breastmilk production completely (Khalidah et al, 2003) so is best avoided during breastfeeding. 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.
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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 drowsiness, 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 contraindications due to maternal or infant medication. One study showed the level of hypericin 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 published 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 t
acute, short-term conditions that arise during the period of breastfeeding 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 selflimiting 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).
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Antihistamines for acute allergic reaction Chlorpheniramine is generally more effective 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-fever 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 nevertheless 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 immediately 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 t
mothers who are taking medicines need particular advice about breastfeeding
t
women who are taking medicines receive specialist advice, based on best available evidence, in relation to breastfeeding.
current sources available to healthcare professionals may lead to women being advised unnecessarily not to breastfeed, because of the medicines they are taking
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.
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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 propothiouracil 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 breastfeeding 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 categorically linked with drugs passing through breastmilk, but lack of clinical data makes prescribing difficult.
Medicines use during breastfeeding 77
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 breastfeeding and maternal medication (www.who.ch/child-adolescent-health). Information on the following is included:
t t t t t t t t t t
anaesthetics – local and general
t t t
thyroid medication
analgesics anthelmintics antibiotics antidepressants oral contraceptives dental fillings loperamide drugs of misuse alternative and complementary remedies drugs that inhibit lactation drugs that stimulate lactation.
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Conclusion The aims of this pack were to provide you with sufficient information to allow you to:
t t t t
promote breastfeeding in your work practice
t
make professional judgements in individual circumstances.
assess common breastfeeding problems consider the use of medicines for breastfeeding mothers encompass multi-disciplinary team working, using evidence-based information to reduce conflicting advice
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 reputation of individual pharmacists, pharmacies and the pharmacy profession grow in the perceptions of patients and customers.
Now go to Activity 5.4 in your Workbook (page 20)
Appendices
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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 services. 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 t t t
speed delivery of information to users make specialist information more easily available enhance awareness of the facilities the services can provide 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 t
support medicines management within NHS organisations 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.
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What services are provided? Regional MI services (Trent and West Midlands) provide:
t t t
enquiry-answering services for health care professionals
t
support for local MI centres via secondary referral of enquiries, training programmes, quality assurance etc.
t
a central resource for data relating to medicines.
proactive information such as bulletins, new product summaries, current awareness medicines management support for pharmacy and general managers via horizon scanning, patent expiry data, new product data etc.
Who uses the service? Current users include hospital doctors, general practitioners, hospital and community pharmacists, health authority professional advisers, hospital and community nurses, allied 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 protein binding
Safety in breastfeeding Local anaesthetics
Lidocaine 0.4
1.8 hours
70%
No evidence of sufficient levels Safe in breastfeeding. reaching breastmilk. General anaesthetics
Propofol Unknown (transfer likely to be very low) Alcohol 1
Anaesthesia time 99% is very short (3-10 minutes)
See comments.
Generally considered safe in breastfeeding.
0.24 hours
Occasional, social drinking is unlikely to cause any harm avoid co-sleeping if either the mother or father have drunk alcohol. Chronic, excessive consumption is dangerous to the baby.
Generally considered safe in breastfeeding on occasional, low level.
0
Analgesics Paracetamol 0.91-1.42 Ibuprofen Not defined as transfer so low
2 hours
25%
Safe in breastfeeding.
1.8-2.5 hours
> 99%
Safe in breastfeeding.
Codeine 1.3-2.5
2.9 hours
7%
Colic and constipation in the baby reported. 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 breastfeeding. Safe as antiplatelet.
Generally considered safe in breastfeeding.
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Anthelmintics Mebendazole Ratio unknown
2.8-9 hours
High
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 during breastfeeding.
Generally considered safe in breastfeeding.
Cefaclor Unknown
0.5-1 hour
25%
Cephalosporins are all safe to take during breastfeeding.
Generally considered safe in breastfeeding.
Tetracycline 0.58-1.28
6-12 hours
25%
Drug forms a chelate with the calcium in the milk and is not absorbed by the baby.
Long courses e.g. for acne should be avoided. Short courses generally safe.
Gentamicin 0.11-0.44
2-3 hours
1
4.1 hours
40%
As above.
Trimethoprim 1.25 Vancomycin Not determined
Poorly absorbed orally.
Generally considered safe in breastfeeding.
Generally considered safe in breastfeeding.
Avoid if possible but consider benefit:risk.
8-10 44% hours(neonate up to 40 hours)
Safe in breastfeeding.
5.6 hours
Probably safe but no studies.
10-30% Oral bioavailability is poor so absorption is likely to be minimal.
appendices 85
Antidepressants Imipramine 0.5-1.5
8-16 hours
90%
No adverse effects have been noted in case reports.
Generally considered safe in breastfeeding.
Fluoxetine 0.286-0.67
2-3 days
94.5%
Some evidence of excessive somnolence in newborn if exposed in utero.
Generally considered safe in breastfeeding.
Citalopram 1.16-3
36 hours
80%.
No information on escitalopram.
Generally considered 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.
5 hours
27%
The dose transferred to the infant is relatively high and although no adverse reports have been reported it may be wise to use this drug with caution.
Venlafaxine Not confirmed (2.5 in study of 3 mothers)
Use with caution.
Contraceptives Progesterone only contraceptives Transfer into milk is low.
Safe in breastfeeding.
Reports that very early progesterone diminishes breastmilk production.
Safe in breastfeeding.
Oestrogen has an inhibitory effect on prolactin and can dramatically reduce milk production.
Should be avoided in breastfeeding.
Progesterone only depot injections and implants
Combined oral contraceptive pills
Emergency hormonal contraception
Amounts of mercury absorbed are minute and passage into breastmilk has not been shown to have any health consequences. 0.5
10.8 hours
Not 4mg dose reported to reported produce a milk level of 0.27 microgrammes per litre.
Safe in breastfeeding. Dental fillings Safe in breastfeeding.
Loperamide Safe in breastfeeding.
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Drugs of misuse Heroin 2.45
1.5-2 hours
35%
Sufficient quantities of heroin excreted into breastmilk to 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
