Section 4.

1: Hospital Self-Appraisal 31

Annex 4:
WHO/NMH/NHD/09.01
WHO/FCH/CAH/09.01

Acceptable medical reasons for use

of breast-milk substitutes

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32 Section 4.1: Hospital Self-Appraisal

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Section 4.1: Hospital Self-Appraisal 33

Preface
A list of acceptable medical reasons for supplementation was originally developed by WHO and
UNICEF as an annex to the Baby-friendly Hospital Initiative (BFHI) package of tools in 1992.

WHO and UNICEF agreed to update the list of medical reasons given that new scientific evidence had
emerged since 1992, and that the BFHI package of tools was also being updated. The process was led
by the departments of Child and Adolescent Health and Development (CAH) and Nutrition for Health
and Development (NHD). In 2005, an updated draft list was shared with reviewers of the BFHI
materials, and in September 2007 WHO invited a group of experts from a variety of fields and all
WHO Regions to participate in a virtual network to review the draft list. The draft list was shared with
all the experts who agreed to participate. Subsequent drafts were prepared based on three inter-related
processes: a) several rounds of comments made by experts; b) a compilation of current and relevant
WHO technical reviews and guidelines (see list of references); and c) comments from other WHO
departments (Making Pregnancy Safer, Mental Health and Substance Abuse, and Essential Medicines)
in general and for specific issues or queries raised by experts.

Technical reviews or guidelines were not available from WHO for a limited number of topics. In those
cases, evidence was identified in consultation with the corresponding WHO department or the external
experts in the specific area. In particular, the following additional evidence sources were used:
-The Drugs and Lactation Database (LactMed) hosted by the United States National Library of
Medicine, which is a peer-reviewed and fully referenced database of drugs to which breastfeeding
mothers may be exposed.
-The National Clinical Guidelines for the management of drug use during pregnancy, birth and the
early development years of the newborn, review done by the New South Wales Department of Health,
Australia, 2006.

The resulting final list was shared with external and internal reviewers for their agreement and is
presented in this document.

The list of acceptable medical reasons for temporary or long-term use of breast-milk substitutes is
made available both as an independent tool for health professionals working with mothers and
newborn infants, and as part of the BFHI package. It is expected to be updated by 2012.

Acknowledgments

This list was developed by the WHO Departments of Child and Adolescent Health and Development
and Nutrition for Health and Development, in close collaboration with UNICEF and the WHO
Departments of Making Pregnancy Safer, Essential Medicines and Mental Health and Substance
Abuse. The following experts provided key contributions for the updated list: Philip Anderson, Colin
Binns, Riccardo Davanzo, Ros Escott, Carol Kolar, Ruth Lawrence, Lida Lhotska, Audrey Naylor,
Jairo Osorno, Marina Rea, Felicity Savage, María Asunción Silvestre, Tereza Toma, Fernando
Vallone, Nancy Wight, Anthony Williams and Elizabeta Zisovska. They completed a declaration of
interest and none identified a conflicting interest.

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34 Section 4.1: Hospital Self-Appraisal

Introduction
Almost all mothers can breastfeed successfully, which includes initiating breastfeeding within the first
hour of life, breastfeeding exclusively for the first 6 months and continuing breastfeeding (along with
giving appropriate complementary foods) up to 2 years of age or beyond.

Exclusive breastfeeding in the first six months of life is particularly beneficial for mothers and infants.

Positive effects of breastfeeding on the health of infants and mothers are observed in all settings.
Breastfeeding reduces the risk of acute infections such as diarrhoea, pneumonia, ear infection,
Haemophilus influenza, meningitis and urinary tract infection (1). It also protects against chronic
conditions in the future such as type I diabetes, ulcerative colitis, and Crohn’s disease. Breastfeeding
during infancy is associated with lower mean blood pressure and total serum cholesterol, and with
lower prevalence of type-2 diabetes, overweight and obesity during adolescence and adult life (2).
Breastfeeding delays the return of a woman's fertility and reduces the risks of post-partum
haemorrhage, pre-menopausal breast cancer and ovarian cancer (3).

Nevertheless, a small number of health conditions of the infant or the mother may justify
recommending that she does not breastfeed temporarily or permanently (4). These conditions, which
concern very few mothers and their infants, are listed below together with some health conditions of
the mother that, although serious, are not medical reasons for using breast-milk substitutes.

Whenever stopping breastfeeding is considered, the benefits of breastfeeding should be weighed

against the risks posed by the presence of the specific conditions listed.

INFANT CONDITIONS
Infants who should not receive breast milk or any other milk except specialized
formula
„ Infants with classic galactosemia: a special galactose-free formula is needed.
„ Infants with maple syrup urine disease: a special formula free of leucine, isoleucine and
valine is needed.
„ Infants with phenylketonuria: a special phenylalanine-free formula is needed (some
breastfeeding is possible, under careful monitoring).

Infants for whom breast milk remains the best feeding option but who may need other
food in addition to breast milk for a limited period
‡ Infants born weighing less than 1500 g (very low birth weight).
‡ Infants born at less than 32 weeks of gestation (very preterm).
‡ Newborn infants who are at risk of hypoglycaemia by virtue of impaired metabolic
adaptation or increased glucose demand (such as those who are preterm, small for
gestational age or who have experienced significant intrapartum hypoxic/ischaemic stress,
those who are ill and those whose mothers are diabetic (5) if their blood sugar fails to
respond to optimal breastfeeding or breast-milk feeding.

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Section 4.1: Hospital Self-Appraisal 35

MATERNAL CONDITIONS
Mothers who are affected by any of the conditions mentioned below should receive treatment
according to standard guidelines.

Maternal conditions that may justify permanent avoidance of breastfeeding

„ HIV infection6: if replacement feeding is acceptable, feasible, affordable, sustainable and safe
(AFASS) (6). Otherwise, exclusive breastfeeding for the first six months is recommended.

Maternal conditions that may justify temporary avoidance of breastfeeding

‡ Severe illness that prevents a mother from caring for her infant, for example sepsis.
‡ Herpes simplex virus type 1 (HSV-1): direct contact between lesions on the mother's breasts and
the infant's mouth should be avoided until all active lesions have resolved.
‡ Maternal medication:
- sedating psychotherapeutic drugs, anti-epileptic drugs and opioids and their combinations
may cause side effects such as drowsiness and respiratory depression and are better avoided
if a safer alternative is available (7);
- radioactive iodine-131 is better avoided given that safer alternatives are available - a mother
can resume breastfeeding about two months after receiving this substance;
- excessive use of topical iodine or iodophors (e.g., povidone-iodine), especially on open
wounds or mucous membranes, can result in thyroid suppression or electrolyte abnormalities
in the breastfed infant and should be avoided;
- cytotoxic chemotherapy requires that a mother stops breastfeeding during therapy.

Maternal conditions during which breastfeeding can still continue, although health
problems may be of concern
† Breast abscess: breastfeeding should continue on the unaffected breast; feeding from the
affected breast can resume once treatment has started (8).
† Hepatitis B: infants should be given hepatitis B vaccine, within the first 48 hours or as soon as
possible thereafter (9).
† Hepatitis C.
† Mastitis: if breastfeeding is very painful, milk must be removed by expression to prevent
progression of the condition(8).
† Tuberculosis: mother and baby should be managed according to national tuberculosis guidelines
(10).
† Substance use7 (11):
- maternal use of nicotine, alcohol, ecstasy, amphetamines, cocaine and related stimulants has
been demonstrated to have harmful effects on breastfed babies;
- alcohol, opioids, benzodiazepines and cannabis can cause sedation in both the mother and
the baby.
Mothers should be encouraged not to use these substances, and given opportunities and support
to abstain.

6
The most appropriate infant feeding option for an HIV-infected mother depends on her and her infant’s individual circumstances, including her health status,
but should take consideration of the health services available and the counselling and support she is likely to receive. Exclusive breastfeeding is recommended
for the first six months of life unless replacement feeding is AFASS. When replacement feeding is AFASS, avoidance of all breastfeeding by HIV-infected
women is recommended. Mixed feeding in the first 6 months of life (that is, breastfeeding while also giving other fluids, formula or foods) should always be
avoided by HIV-infected mothers.
7
Mothers who choose not to cease their use of these substances or who are unable to do so should seek individual advice on the risks and benefits of
breastfeeding depending on their individual circumstances. For mothers who use these substances in short episodes, consideration may be given to avoiding
breastfeeding temporarily during this time.

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36 Section 4.1: Hospital Self-Appraisal

References
(1) Technical updates of the guidelines on Integrated Management of Childhood Illness (IMCI). Evidence and
recommendations for further adaptations. Geneva, World Health Organization, 2005.

(2) Evidence on the long-term effects of breastfeeding: systematic reviews and meta-analyses. Geneva, World
Health Organization, 2007.

(3) León-Cava N et al. Quantifying the benefits of breastfeeding: a summary of the evidence. Washington, DC,
Pan American Health Organization, 2002 (http://www.paho.org/English/AD/FCH/BOB-Main.htm, accessed 26 June
2008).

(4) Resolution WHA39.28. Infant and Young Child Feeding. In: Thirty-ninth World Health Assembly, Geneva, 5–
16 May 1986. Volume 1. Resolutions and records. Final. Geneva, World Health Organization, 1986
(WHA39/1986/REC/1), Annex 6:122–135.

(5) Hypoglycaemia of the newborn: review of the literature. Geneva, World Health Organization, 1997
(WHO/CHD/97.1; http://whqlibdoc.who.int/hq/1997/WHO_CHD_97.1.pdf, accessed 24 June 2008).

(6) HIV and infant feeding: update based on the technical consultation held on behalf of the Inter-agency Task
Team (IATT) on Prevention of HIV Infection in Pregnant Women, Mothers and their Infants, Geneva, 25–27
October 2006. Geneva, World Health Organization, 2007
(http://whqlibdoc.who.int/publications/2007/9789241595964_eng.pdf, accessed 23 June 2008).

(7) Breastfeeding and maternal medication: recommendations for drugs in the Eleventh WHO Model List of
Essential Drugs. Geneva, World Health Organization, 2003.

(8) Mastitis: causes and management. Geneva, World Health Organization, 2000 (WHO/FCH/CAH/00.13;
http://whqlibdoc.who.int/hq/2000/WHO_FCH_CAH_00.13.pdf, accessed 24 June 2008).

(9) Hepatitis B and breastfeeding. Geneva, World Health Organization, 1996. (Update No. 22).

(10) Breastfeeding and Maternal tuberculosis. Geneva, World Health Organization, 1998 (Update No. 23).

(11) Background papers to the national clinical guidelines for the management of drug use during pregnancy,
birth and the early development years of the newborn. Commissioned by the Ministerial Council on Drug Strategy
under the Cost Shared Funding Model. NSW Department of Health, North Sydney, Australia, 2006.
http://www.health.nsw.gov.au/pubs/2006/bkg_pregnancy.html

Further information on maternal medication and breastfeeding is available at the following United States National
Library of Medicine (NLM) website:
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

For further information, please contact:

Department of Nutrition for Health and Department of Child and Adolescent Health and
Development Development
E-mail: [email protected] E-mail: [email protected]
Web: www.who.int/nutrition Web: www.who.int/child_adolescent_health

Address: 20 Avenue Appia, 1211 Geneva 27, Switzerland

UNICEF/WHO BFHI Section 4: Hospital Self-Appraisal and Monitoring 2009