Guidelines for
Prescribers:
Prescribing
infant formula
July
2011
Version 1
Executive summary
1. The PCT promotes breastfeeding as the best form of nutrition for infants and this should be
promoted/ supported wherever possible.
2. In general all cases of milk intolerance should be referred for specialist advice with the exception
of simple cases of secondary lactose intolerance for which a lactose free formula should be
advised and a re-challenge in 3-4 months.
3. Lactose free milks can be bought at a similar cost to standard infant formula and prescribers
should consider the need to prescribe, however they are less commonly used and may have to
be ordered. The PCT supports the position that an initial prescription is appropriate to allow
parents time to source further supplies from the retailer of their choice. Most pharmacies and
many supermarkets can obtain stock in a few days.
4. Soya products should not be prescribed unless advised by a consultant due to the high
incidence of soya sensitivity in infants intolerant of cow’s milk protein (10-35%) and never under
6 months of age unless on specialist advice e.g. for galactosaemia. Infants of vegan mothers
who choose not to breast feed may be given soya milks but not at NHS expense.
5. Consultants are asked to diagnose and advise on suitable formula and the length of treatment
for all specialist infant formula.
6. Powdered milks should be the norm. Liquid feeds are a convenience product and should be
purchased if needed.
7. Specialist milks other than those for lactose intolerance should not be initiated in primary care
and then only for short term. If longer term use is required specialist opinion must be sought and
there should be a clear plan for weaning and discontinuation should be included in the care plan
from secondary care. Without written guidance to the contrary the recommended the maximum
ages detailed in this guidance should be applied.
Decision Aid for use in Primary care
Lactose Intolerance
CMPi (less severe)
CMPi (Severe)
Sx
Diarrhoea and colic
Transient nature
usually secondary to
GI insult
Diagnosis confirmed
by improvement
within 2-3 days of
starting lactose free
diet, resolution within
2 weeks,
Sx
•Frequent regurgitation or
vomiting, gastro-oesophageal
reflux
• Diarrhoea or Constipation (with /
without perianal rash)
• Blood in stool
• Atopic dermatitis
• Urticaria unrelated to acute
infections, drug intake or other
causes
•Runny nose, chronic cough or
wheeze
• Persistent distress or colic for > 3
hrs per day on at least 3 days per
week over > 3 week
Sx
Any of le less sever Sx plus
•Failure to thrive due the GI or
dermatological symptoms
•Iron deficiency anaemia
•Exudative or severe atopic
dermatitis
•Acute laryngeal or bronchial
obstruction- difficulty breathing
•Protein losing enteropathy
(Hypoalbuminaemia)
•Confirmed enteropathy
(endoscopic or histological)
•Anaphylactic shock
necessitating immediate referral
Treatment
Referral for secondary care
evaluation, diagnosis & support
Treatment
Referral for secondary care
evaluation, diagnosis & support
Breast fed -Exclusion of milk from
mothers diet with calcium
supplementation (e.g.Sandocal
1000 daily)
Breast fed -Exclusion of milk from
mothers diet with calcium
supplementation (e.g. Sandocal
1000 daily)
Extensively hydrolysed feed
Nutramigen 1 or 2
Aptamil Pepti for at least 2 weeks
If not resolved
Amino Acid based feed
Nutramigen AA or
Neocate LCP for at least 2 weeks
Amino Acid based feed for at
least 2-4 weeks
Neocate LCP
Nutrmigen AA
Treatment
Low lactose formula
(SMA LF Enfamil Olac) pre-weaning
Weaned infants
avoid solids
containing lactose.
Similar cost to
standard milks so
could be purchased
after initial
prescription
Duration
Most infants should
be able to revert to a
normal diet in 4-6
weeks but may last
3-6 months.
Longer term use
under specialist
supervision only
Duration
With a specialist confirmed
diagnosis continue until 18 months
age
Duration
With a specialist confirmed
diagnosis continue until 18
months age or longer on advice
of consultant
Multiple food allergy or very sensitive to single allergen (i.e. cow’s milk)
Neocate LCP used up to 1 year
Neocate Advance is sometimes used in over 1yrs up to 2 years where there is proven allergy
Neocate active (Age 1 to 2 years for multiple food allergy.
Faltering growth (Need to see faltering growth on a growth chart)
Infatrini (Weight range 2 - 8kg e.g. approx birth to 1 year)
SMA High energy (age birth to 18 months)
discontinue as soon as faltering growth is resolved
Prem and low birth weight (up to 6 months of age)
Nutriprem 2 or SMA gold prem 2
Introduction
This document is intended to be used by prescribers with the objectives of:
 Providing guidance on the nature, prescribing and supply of Milk substitutes for babies by primary
care
 Maintaining an awareness that breast milk is considered best for babies and not initiating a change
from breast to formula milk if the mother is happy to continue breast feeding the infant
Whilst the public may be given access to this document it is not intended for use by parents or carers
Scope
These guidelines are produced by the Medicines Management Department of Stockport Managed Care
on behalf of NHS Stockport. The contents reflect the current research evidence available, guidance and
good clinical practice. It is not intended to remove or reduce professional accountability rather to support
clinical and financial governance. It has been produced at the request of GPs seeking clarity on the
prescription of infant formula or milk substitutes for babies and young children. Such products may only
be prescribed in restricted circumstances for ACBS conditions when they are then regarded as drugs.
Prescribing doctors must be satisfied that there is a clear diagnosis and that the child is adequately
monitored with support of hospital supervision if necessary.
Please note every effort has been made to ensure the information in this document is correct, however
errors may occur and prices for individual products are subject to change between revisions. Where
there is any doubt information should be checked with individual manufacturer’s recommendations,
published literature or other specialist sources. SMC Medicines Management Department will be happy
to offer advice to prescribers if requested
Principles of prescription supply We recognise that infants often present to GP practices with
suspected intolerance to their current infant formula and it is not always appropriate to wait for a
diagnosis from secondary care referral but rather it is necessary to treat empirically.
Lactose intolerance
Symptoms of lactose intolerance include diarrhoea and colic which persists for more than 2 weeks,
abdominal bloating, increased wind, perianal redness and irritation and possibly damage to the perianal
tissue. The symptoms are transient and usually secondary to a GI insult e.g. rotavirus infection. Blood or
slime in the stools is not a feature of lactose intolerance. Most children should be able to revert back to
normal formula once the GI insult has resolved i.e. within 4-6 weeks. Lactose free formula can be
purchased at a similar price to standard formula and GP should consider whether prescription is actually
necessary; advice to us LF formula with appropriate safety netting may be all that is needed. Symptoms
usually resolve in 2-3 days when lactose is removed from the diet and achievement of this confirms
diagnosis.
Long term use is not usually necessary for lactose intolerance secondary to insult but primary lactose
intolerance can occur due to an inability to produce lactase. Long term need for a lactose free diet
should require dietetic referral. LF infant formula should not be used beyond 18 months and infants can
be weaned onto proprietary lactose free milks purchased at supermarkets from 12 months old.
Suitable products
Used from birth to maximum 18 months
requirement 4-8 tins a month
SMA LF (SMA) £5.60 per 400g
Enfamil lactose free (Mead Johnson) £4.85 per 400g
Parents can be asked to purchase some or all of the quantity needed. GPs may wish to prescribe a
small quantity initially to allow parents time to secure a supply source for the future as shops may need
to order stock.
Cow’s Milk Protein intolerance (CMPi)
The symptoms of CMPi are more extensive and include
• Frequent regurgitation, gastro-oesophageal reflux
• Vomiting
• Diarrhoea
• Constipation (with / without perianal rash)
• Blood in stool
• Iron deficiency anaemia
• Atopic dermatitis
• Urticaria unrelated to acute infections, drug intake or other causes.
• Runny nose
• Chronic cough unrelated to infection
• Wheezing
• Persistent distress or colic for > 3 hrs per day on at least 3 days per week for over > 3 weeks
Breast fed infants
Breast fed infants can display symptoms, though usually less severe, as some cow’s milk proteins from
the mothers diet may be expressed in breast milk. Mothers should be encouraged to continue feeding
whilst following a milk free diet and given additional calcium. Babies should be weaned onto a cow’s
milk free diet but referral to secondary care is still indicated to exclude other conditions and for
appropriate dietary advice.
Infants with CMPi should be given a CMP free diet for at least 6 months, using a suitable formula and
referred for diagnosis, dietician support and advice on duration of treatment and the need for and timing
of re-challenge to test if the intolerance has resolved. Most children grow out of their intolerance by 1824 months of age.
Suitable products
Used from birth to maximum 18 months
requirement 4-8 tins a month
Nutramigen (Mead Johnson)
Aptamil Pepti (Aptamil) Contains some lactose
Pepti Junior (Cow & Gate)
Wysoy and Infasoy can be used over 6 months of age on specialist advice and can be purchased for the
same cost as standard milks and therefore should not be prescribed.
Other Specialist infant formula
Secondary care will lead in prescribing for several special groups of infants

Pre-term and low birth weight infants ( may also require iron and vitamin supplements)




Disease specific conditions
Complex food intolerances
Faltering growth
Complex medical cases
All such prescribing should be initiated by secondary care. The letter should include details of all
planned monitoring and follow up intended and guidance for the GP on when the formula should be
stopped. The following guidance is offered as prescribing support to GPs
Multiple food allergy or very sensitive to single allergen (i.e. cow’s milk)
Suitable products
Used until 18months of age unless the specialist advised otherwise



usually 6-8 tins per month
Neocate LCP used up to 1 year
Neocate Advance is sometimes used in over 1yrs up to 2 years where there is proven allergy
Neocate active (Age 1 to 2 years for multiple food allergy. Only use beyond 2 years where there
is faltering growth on specialist advice)
Faltering growth (Need to see faltering growth on a growth chart)
Suitable Products
Until normal growth is seen


Requirement is for approx 600ml/day
Infatrini (Weight range 2 - 8kg e.g. approx birth to 1 year)
SMA High energy (age birth to 18 months)
NB discontinue as soon as faltering growth is resolved
Prem and low birth weight (up to 6 months of age)
Suitable Products
Use up to 6 months of age


Requirement is for 3-4 per month
Nutriprem 2
SMA gold prem 2
References
Department of Health: CMO’s Update 37 (2004). Advice issued on soya-based infant formulas.Available from:
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4070176.pd
f
Department of Health (2009). Birth to Five. Available from:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_107303
Paediatric Group Position Statement on the use of Soya Protein for Infants. British Dietetic Association: February
2004.
Food Standards Authority & Department of Health (2005). Guidance for health professionals on safe preparation,
storage and handling of powdered infant formula. Available from:
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063693.pdf
Vandenplas Y et al: Guidelines for the diagnosis and management of cow’s milk protein allergy in infants. Arch.
Dis. Child. 2007 10: 902-8