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Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA)
Summary
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CMA can develop in exclusively and partially breast-fed infants as well as in formula-fed infants and when cow’s milk is introduced at weaning.
Consider prescribing 2-3 tins of infant formula initially to confirm tolerance and acceptance of the formula.
Repeat prescriptions should be reviewed every 3-6 months as CMA can resolve.
If a baby is on Nutramigen® Lipil 1, they can be moved onto Nutramigen® Lipil 2 at six months of age.
Generally, infant formulas are not required for children beyond 2 years of age. If a child remains on an infant formula beyond 2 years of age consider a
referral to a paediatric dietitian for review.
Endorse prescription for formula feed with ‘ACBS’.
A requirement of between 9 and 14 x 400g tins per month is reasonable (dependent upon age & weight of the child and size of the tin).
For repeat prescriptions consider prescribing for 2 week intervals to reduce waste and problems with the storage of numerous tins.
For non IgE mediated CMA, consider reintroduction of dairy products after six months of CMA. A paediatric dietitian will be able to advise on the best
way to do this.
Introduction
This formulary has been developed to aid in the prescribing of specialised paediatric formula used by GPs in primary care. It is not intended to replace
recommendations and requests for prescriptions made by consultant paediatricians and paediatric dietitians working in primary, secondary or tertiary care.
Whilst this formulary is for prescribing specialised paediatric formula, breast milk is the optimal milk for infants. Breast feeding should be promoted and
encouraged. Further information on infant feeding can be found in the Infant Feeding Guideline 0-2 years for Health Professionals1. Appropriate prescribing of
paediatric formula ensures the most clinically appropriate product is chosen for every patient in the most cost effective way and the prescribing is only
continued for as long as is clinically necessary.
Background
In 2011, the National Institute for Health and Care Excellence (NICE) published Clinical Guideline (CG) 116 on the Diagnosis and Assessment of Food Allergy
in Children and Young People in Primary Care and Community Settings2. The guideline identifies when to consider referral to secondary care (figure 1).
Algorithms have been produced showing the different presentation of CMA in infancy and for the diagnosis and management of CMA in primary care (figure 2
& 3)3.
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014 Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 1 of 8
Figure 1: Referral to secondary or specialist care2
Based on the allergy-focused clinical history4, consider referral to secondary or specialist care in any of the following circumstances:
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The child or young person has:
o faltering growth in combination with one or more gastrointestinal symptoms
o not responded to a single-allergen elimination diet
o had one or more acute systemic reactions
o had one or more severe delayed reactions
o confirmed IgE-mediated food allergy and concurrent asthma
o significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer
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There is:
o persisting parental suspicion of food allergy (especially in children or young people with difficult or perplexing symptoms) despite a lack of
supporting history
o strong clinical suspicion of IgE-mediated food allergy but allergy test results are negative
o clinical suspicion of multiple food allergies.
This formulary is intended to help determine which hypoallergenic formula should be prescribed for the treatment of CMA (see Table 1).
Contact details for the Dietitians in Worthing and St Richards
Worthing & Southlands Dietitians
St. Richards Dietitians
Tel: 01903 205111 ext 5669
Tel: 01243 831498
Fax: 01903 285235
Fax: 01243 831497
Email: [email protected]
Email: [email protected]
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014 Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 2 of 8
Figure 2: Different presentations of cow’s milk allergy in infancy5
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014 Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 3 of 8
Figure 3: Diagnosis and management of mild to moderate non-IgE CMA in UK primary care5
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014 Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 4 of 8
Quantities / Volumes of Feed to Prescribe to Infants
For infants up to 6 months of age the volume of feed prescribed should be roughly the same as the volume of milk the infant is currently taking. As a guide,
for infants under the age of 3 months, a 400g tin of formula should last 2-3 days and for infants 4-12 months a tin should last 2 days. Volume guide is based
on providing the infant’s fluid requirement. It is advisable to initially prescribe enough formula for one week to assess tolerance and palatability.
Repeat prescribing for two weeks at a time (rather than monthly) will help to reduce any wastage if formula milk has to be changed for any reason. Consider
using the repeat dispensing service available from community pharmacies to help facilitate this - the process by which patients can obtain supplies of their
repeat medicines over a defined period of time, without the need to contact their GP practice on each occasion a new supply is required.
http://psnc.org.uk/services-commissioning/essential-services/repeat-dispensing/
Extensively Hydrolysed Formula
For formula fed infants, the first line treatment for CMA is a 2-6 week trial of an extensively hydrolysed formula (eHF) 3, 6, 7 and a milk and soya free weaning
diet if solids have been introduced. If the first line formula is not tolerated by the infant or rejected due to taste, then a second line formula could be trialled.
Infants on an exclusion diet should be assessed by a paediatric dietitian. Once established on the diet, the infant should be reviewed by a paediatric dietitian
at least every 6 months to reassess nutritional adequacy of the diet. The paediatric dietitian will reassess energy and calcium intake, monitor growth and
make recommendations regarding food challenge or reintroduction of cow’s milk. Infants with CMA need formula until 2 years of age. Occasionally, it may
need to be continued for longer if their diet is nutritionally inadequate or they are experiencing faltering growth.
Soya infant formula
Soya infant formula is not suitable for infants less than 6 months of age8 and is not first line choice of formula for the treatment of CMA3. If infants refuse to
drink extensively hydrolysed formula and the infant is over 6 months of age and there is an absence of sensitisation to soya, a soya infant formula can be
used.
Amino Acid Formula
There are some situations when it is more appropriate to prescribe an amino acid formula as first line treatment of CMA. This can be started in primary care,
followed by a referral to secondary care to a paediatrician and/or paediatric dietitian. Amino acid formula should be prescribed when an infant has3:
• symptoms of CMA on breast milk and a formula is required
• multiple allergies
• anaphylaxis to cow’s milk
• Heiner’s syndrome
• eosinophilic oesophagitis
• severe gastro-intestinal and/or skin presentation, usually in association with faltering growth.
Lactose Free Formula
Lactose free formula should not be prescribed for the treatment of CMA.
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014 Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 5 of 8
Table 1: Prescribing Extensively Hydrolysed, Soya and Amino Acid Formula
Name of
Age Restrictions/information
Formula
First Choice in GREEN Nutramigen® Lipil 1 Hydrolysate formula
(Mead Johnson)
400g tin
cow’s milk
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
allergy
First Choice in
cow’s milk
allergy
GREEN
Nutramigen® Lipil 2
(Mead Johnson)
GREEN
Similac® Alimentum
(Abbott)
GREEN
Aptamil Pepti® 1
(Milupa)
GREEN
Aptamil Pepti® 2
(Milupa)
GREEN
Althera®
(SMA)
GREEN
Infasoy
(Cow & Gate)
Not suitable for
infants under 6m.
Second
Choice in
cow’s milk
allergy
Suitable for infants
from birth.
Second
Choice in
cow’s milk
allergy
Suitable for infants
from birth.
Second
Choice in
cow’s milk
allergy
Not suitable for
infants under 6m.
Second
Choice in
cow’s milk
allergy
Suitable for infants
from birth.
Third Choice
in cow’s milk
allergy
Not suitable for
infants under 6m.
Consider prescribing quantities for two week repeat prescriptions
intervals to help reduce waste.
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Suitable for infants from birth.
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Babies can be moved onto Nutramigen Lipil 2 at six months of age.
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As a sole source of nutrition or as a nutritional supplement for
infants and young children with cows’ milk protein allergy and other
conditions where an extensively hydrolysed formula is indicated.
Hydrolysate formula
400g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Not suitable for infants under 6 months.
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For the dietary management of infants and young children with
cows’ milk protein allergy and other conditions where an
extensively hydrolysed formula is indicated.
Hydrolysate formula
400g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Suitable for infants from birth.
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As a sole source of nutrition or as a nutritional supplement for
infants and young children with cows’ milk protein allergy and other
conditions where an extensively hydrolysed formula is indicated.
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Suitable for infants
from birth.
Hydrolysate formula
400g tin, 900g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Suitable for infants from birth.
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Contains Lactose.
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As a sole source of nutrition or as a nutritional supplement for
infants and young children with cows’ milk protein allergy and other
conditions where an extensively hydrolysed formula is indicated.
Hydrolysate formula
900g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Not suitable for infants under 6 months.
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Contains Lactose.
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For the dietary management of infants and young children with
cows’ milk protein allergy and other conditions where an
extensively hydrolysed formula is indicated.
Hydrolysate formula
450g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Suitable for infants from birth.
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As a sole source of nutrition or as a nutritional supplement for
infants and young children with cows’ milk protein allergy and other
conditions where an extensively hydrolysed formula is indicated.
Soya formula
900g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Not suitable for infants under 6 months.
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014
Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 6 of 8
Third Choice
in cow’s milk
allergy
Wysoy
(SMA)
Soya formula
430g tin, 860g tin
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It is worth only prescribing 2-3 tins of infant formula initially to
confirm tolerance and acceptance.
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Not suitable for infants under 6 months.
Pepti Junior®
(Cow & Gate)
Hydrolysate formula
450g tin
R = Restricted to be prescribed only on the advice of a Consultant
Paediatrician or Paediatric Dietitian.
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Suitable for infants from birth
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Contains MCT
Pregestimil® Lipil
(Mead Johnson)
Hydrolysate formula
400g tin
R = Restricted to be prescribed only on the advice of a Consultant
Paediatrician or Paediatric Dietitian.
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Suitable for infants from birth
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Contains MC
Pepdite®
(SHS)
Hydrolysate formula
400g tin
R = Restricted to be prescribed only on the advice of a Consultant
Paediatrician or Paediatric Dietitian.
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Suitable for infants from birth
Pepdite® 1+
(SHS)
Hydrolysate formula
400g tin
R = Restricted to be prescribed only on the advice of a Consultant
Paediatrician or Paediatric Dietician.
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Not suitable for child under 1 year
MCT Pepdite®
(SHS)
MCT-enhanced formula
400g tin
R = Restricted to be prescribed only on the advice of a Consultant
Paediatrician or Paediatric Dietitian.
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Suitable for infants from birth
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Contains MCT
MCT Pepdite® +1
(SHS)
MCT-enhanced formula
400g tin
R = Restricted to be prescribed only on the advice of a Consultant
Paediatrician or Paediatric Dietitian.
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Not suitable for child under 1 year
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Contains MCT
GREEN
Nutramigen AA®
(Mead Johnson)
Amino acid-based formula
400g tin
Refer to a Consultant Paediatrician or Paediatric Dietitian if prescribing
this formula.
Other preparations with similar name please check if this is the
correct formula.
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Suitable for infants from birth.
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Severe cow’s milk allergy, multiple food allergy and other GI
disorders where an amino acid based diet is specifically indicated.
GREEN
Neocate LCP®
(SHS)
Amino acid-based formula
400g tin
Refer to a Consultant Paediatrician or Paediatric Dietitian if prescribing
this formula.
Other preparations with similar name please check if this is the
correct formula.
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Suitable for infants from birth.
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Severe cow’s milk allergy, multiple food allergies, and other GI
disorders where an amino acid based diet is specifically indicated.
GREEN
Not suitable for
infants under 6m.
No
colour
code
No
colour
code
No
colour
code
No
colour
code
No
colour
code
No
colour
code
First Choice For amino acid
formula
Suitable for infants
from birth.
First Choice For amino acid
formula
Suitable for infants
from birth.
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014
Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 7 of 8
First Choice For amino acid
formula
GREEN
SMA Alfamino®
Powder
Amino acid-based formula
400g tin
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Refer to a Consultant Paediatrician or Paediatric Dietitian if
prescribing this formula.
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Suitable for infants from birth.
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Severe cow’s milk allergy, multiple food allergies and other GI
disorders where an amino acid based diet is specifically indicated.
No
colour
code
Neocate Advance®
(SHS)
Amino acid-based formula
100g sachet, 15x50g
R = Restricted on the advice of a Consultant Paediatrician or Paediatric
Dietitian.
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Not suitable for child under 1 year.
No
colour
code
Neocate Active®
(SHS)
Amino acid-based supplement
15x63g sachet
R = Restricted on the advice of a Consultant Paediatrician or Paediatric
Dietitian.
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Not suitable for child under 1 year.
Suitable for infants
from birth.
Glossary
Amino acid formula (AAF)
Infant formula based on synthetic amino acids
Extensively hydrolysed
formula (eHF)
Cow’s milk-based formula treated with enzymes in order to break down most
of the proteins that cause symptoms in allergic infants
IgE-mediated reaction
An allergic reaction which is acute and frequently has rapid onset
Medium Chain Triglyceride
(MCT)
A glycerine ester combined with medium-chain triglycerides each having 8 to
10 carbon atoms. Once hydrolysed, these fatty acids can be absorbed
directly into the portal system
Non-IgE-mediated reaction
These reactions are generally characterised by delayed and non-acute
reactions
References:
th
1. Western Sussex Hospitals NHS Foundation Trust. Infant Feeding guideline 0-2 years for Health Professionals 6
Ed (2013). Available at: http://www.westernsussexhospitals.nhs.uk/services-and-treatments/treatments-andtherapies/diet-nutrition/chichester-dietitians/infant-feeding-guidelines/
2. National Institute of Health & Care Excellence. Diagnosis and assessment of food allergy in children and young
people in primary care and community settings. London; 2011.http://www.nice.org.uk/CG116.
3. Venter, C et al. Diagnosis and management of non IgE mediated cow’s milk allergy in infancy – a UK primary
care practical guide. Clinical and Translational Allergy 2013: 3:23
4. Royal College of Paediatrics & Child Health http://www.rcpch.ac.uk
5. Venter et al. Clinical and Translational Allergy 2013 3:23 doi:10.1186/2045-7022-3-23.
6. Koletzko, S et al. Diagnostic Approach and Management of Cow’s-milk Protein Allergy in infants and children:
ESPHGAN GI Committee Practical Guidelines. J Pediatr Gastroenterol Nutr 2012:55 (2)221-229
7. Fiocchi, A et al. World Allergy Organisation (WAO) DRACMA Guidelines. Pediatr Allergy Immunol. 2010:2 21
(suppl21):1-125.
8. Department of Health (2004) Chief Medical Officer’s update 37. Advice issued on soya-based infant formulas
Formulary for Prescribing Specialised Paediatric Formula for the Treatment of Cow’s Milk Allergy (CMA) June 2014
Version 1
Author: Penny Barnard (Specialist Dietitian, Paediatrics, WSHFT) in conjunction with the MMT at CWS CCG
Page 8 of 8