Appropriate Prescribing of Specialist Infant Formulae in Staffordshire

Transcription

Appropriate Prescribing of Specialist Infant Formulae in Staffordshire
Burton Hospitals NHS Foundation Trust
Cannock Chase Clinical Commissioning Group
East Staffordshire Clinical Commissioning Group
North Staffordshire Combined Healthcare
North Staffordshire Clinical Commissioning Group
South East Staffordshire and Seisdon Clinical Commissioning Group
Staffordshire and Stoke on Trent NHS Partnership Trust
Stafford and Surrounds Clinical Commissioning Group
Stoke on Trent Clinical Commissioning Group
University Hospital of North Midlands
Appropriate Prescribing of Specialist
Infant Formulae in Staffordshire
Guidelines
Document Number
Version
Ratified By and Date
Name of Approving Body(s) and
Dates
Job Title of Document Author
Name of Responsible Committee
Executive Director
Date Issued
Expiry Date (Maximum Two Years)
Target Audience
V2
Area Prescribing Committee
Area Prescribing Group
Area Prescribing Group 30th October 2015
Area Prescribing Committee 25th November 2015
Medicines Management Group SSOTP 21st
December 2015
SSOTP Paediatric Dietetic Team in Partnership
with UHNM Paediatric Dietetic Team
Adapted and adopted from East Staffordshire
Clinical Commissioning Group with permission
from Central Eastern Commissioning Support
Unit Medicines Management Team
Nutrition and Effectiveness Group
Director of Operations
1st January 2016
1st January 2017
Children’s Services
This document may be made available in a different format
by contacting the Author of the Document
Version Control - Review and Amendment Log
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 1
Version
Type of Change
Description of Change
Date
V1.1
Consultation with
Paediatric Dietetic
Team
2013-2014 Development of ‘Care Pathway for the
Diagnosis and Management of Lactose
Intolerance and Cow’s Milk Allergy in Children
(including Gastro-oesophageal Reflux)’
changes to document made and pathways
amended to include MAP pathway.
Discussions and consultation with UHNS and
Mid Staffordshire Foundation Trust.
28-11Agree with the document in principle. Confirm
sign off from Area Prescribing committee and
2014
Area Prescribing Group to take to SSOTP
Safety and Effectiveness Sub Committee.
V1.2
Consultation with
Children’s Safety
and Effectiveness
Group
V1.3
Consultation with
Area Prescribing
Group
18-12-14
V1.4
Consultation with
Nutrition and
Effectiveness
Group
19-01-15
V1.5
Consultation with
SSOTP Medicines
Management
Group
19-02-15
V1.6
Consultation with
Paediatric Dietetic
Team
19-02-15
V1.7
Consultation with
Children’s Safety
and Effectiveness
Group
25-02-15
V1.8
Consultation with
Area Prescribing
Committee
25-02-15
29-04-15
To take for further consultation with GPs at
JMOC 11-03-15 and then review again at APC
in April 2015.
V1.9
Consultation with
Safety and
Effectiveness Sub
Committee
27-02-15
29-05-15
Approved pending approval at APC in April
2015 following further consultation and
amendments through JMOC.
V1.10
Consultation with
Joint Medicines
Optimisation
Committee
11-03-15
15-04-15
Review of evidence base for secondary lactose
intolerance and GORD. Amendments made
including not recommending lactose free
formulae. Change colour coding of prescribing.
Review guidelines ‘Appropriate Prescribing of
Specialised Infant Formulae in South
Staffordshire’ adopted by Area Prescribing
Group 12-12-14 so there is one guidance
document on this subject in Staffordshire
Agreed to adopt format of one document for
Staffordshire adopted by APC 12-12-14 with
amendments of inclusion of MAP guidelines
and ‘Formulae to be started under care of
Dietitian’. Removal of ‘Formulae started in
Secondary Care’
Approved agreed to take forward to North
Staffordshire and Stoke on Trent Area
Prescribing Committee.
Amendment of editing Appendices added to
main document. Inclusion of ‘Althera’ as an
Extensively Hydrolysed Formula as now in
BNF.
Approved with note to review training capacity
across Health Visiting Team.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 2
Version
V2
V2
Type of Change
Description of Change
Date
Consultation with
Allied Prescribing
Group and Dr
Ahmed
Paediatrician
19-06-15
Consultation with
Area Prescribing
Committee
25-11-15
09-10-15
Change of consultant to paediatrician. Under
GORD removal of ‘medication such as
ranitidine or proton pump inhibitors’. Change of
rice milk not to be started before 5 years of age
to 4.5 years of age. Change of stopping
prescription of formula for CMPA from 2 years
of age to 1 year of age if tolerating suitable
alternatives. Changes made based on
reviewed evidence. EHF and AAF added to
MAP Guidelines Appendix 2.
Agreed to accept amendments and adopt this
revised document.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 3
Burton Hospitals NHS Foundation Trust
Cannock Chase Clinical Commissioning Group
East Staffordshire Clinical Commissioning Group
North Staffordshire Combined Healthcare
North Staffordshire Clinical Commissioning Group
South East Staffordshire and Seisdon Clinical Commissioning Group
Staffordshire and Stoke on Trent NHS Partnership Trust
Stafford and Surrounds Clinical Commissioning Group
Stoke on Trent Clinical Commissioning Group
University Hospital of North Midlands
DOCUMENT SUMMARY
Document Title
Document Status
Date of
Publication
Key Points
Appropriate Prescribing of Specialist Infant Formulae in
Staffordshire Guidelines
New
Revision
x
1/11/2015
These guidelines aim to provide a consistent approach to the prescribing of
specialised infant formulae in Staffordshire. These guidelines aim to assist GPs and
Health Visitors with information on the use of prescribable infant formula in the
situation when breastfeeding cannot be continued for a medical reason.
Breastfeeding will always be promoted as the first-line option for feeding any infant
under 6 months old. The guidelines are targeted at infants 0-12 months. However,
some of the prescribable items mentioned here can be used beyond this age and
advice on this is included in the guidelines. The guidelines advise on:
• Over-the-counter (OTC) products available where appropriate
• Initiating prescribing of specialised infant formulae
• Quantities to prescribe of specialised infant formulae
• Which products to prescribe for cow’s milk protein allergy (CMPA), Gastrooesophageal Reflux Disease (GORD), Secondary Lactose Intolerance, faltering
growth, Pre-term Infants.
• Triggers for reviewing and discontinuing prescriptions
• When onward referral for dietetic advice and/or secondary/specialist care should
be considered.
Available Support
Training provided to Staffordshire and Stoke on Trent NHS
Partnership Trust (SSOTP) Health Visitors.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 4
Contents
Page
1.
Introduction
6
2.
Purpose
6
3.
Quantities of formulae to Prescribe
7
4.
Do’s and Don’ts of Prescribing Specialised infant formulae
8
5.
Cow’s Milk Protein Allergy
9
6.
Gastro-oesophageal Reflux Disease (GORD)
13
7.
Secondary Lactose Intolerance
14
8.
Faltering Growth
15
9.
Pre-term Infants
16
10.
Comparative Costs of Specialised Infant Formulae
18
11.
References
20
Appendices
Appendix 1 – Quick Reference Guide Specialised Infant Formulae
Appendix 2 - The Milk Allergy in Primary Care (MAP) Guidance
http://cowsmilkallergyguidelines.co.uk/
Appendix 3 – Monitoring Compliance
Colour Key used on the following pages:
Over the counter products (OTC) to be used initially
Prescribe as first-line
Prescribe as second-line
Prescribe in primary care only as recommended by Paediatric Dietitian or
Paediatrician
Should not routinely be prescribed
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 5
Burton Hospitals NHS Foundation Trust
Cannock Chase Clinical Commissioning Group
East Staffordshire Clinical Commissioning Group
North Staffordshire Combined Healthcare
North Staffordshire Clinical Commissioning Group
South East Staffordshire and Seisdon Clinical Commissioning Group
Staffordshire and Stoke on Trent NHS Partnership Trust
Stafford and Surrounds Clinical Commissioning Group
Stoke on Trent Clinical Commissioning Group
University Hospital of North Midlands
Appropriate Prescribing of Specialist
Infant Formulae in Staffordshire
Guidelines
1.
Introduction
Whilst these guidelines advise on appropriate prescribing of specialist infant
formulae, breast milk remains the optimal milk for infants. This should be
promoted and encouraged where it is clinically safe to do so and the mother is
in agreement.
2.
Purpose of these Guidelines
These guidelines aim to assist GPs and Health Visitors with information on
the use of prescribable infant formulae. The guidelines are targeted at infants
0-12 months. However, some of the prescribable items mentioned here can
be used beyond this age and advice on this is included in the guidelines. The
guidelines advise on:
•
Over-the-counter (OTC) products available where appropriate
•
Initiating prescribing
•
Quantities to prescribe
•
Which products to prescribe for different clinical conditions
•
Triggers for reviewing and discontinuing prescriptions
•
When onward referral for dietetic advice and/or secondary/specialist
care should be considered.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 6
3.
Quantities of Formulae to Prescribe
When any infant formula is prescribed the guide below should be used for powdered
formula:
Age of child
Under 6 months
6-12 months
Over 12 months
Number of tins for 28 days
13 x 400g tins
or
6 x 900g tins
7-13 x 400g tins or
3-6 x 900g tins
7 x 400g tins
3 x 900g tins
or
These amounts are based on:
• Infants under 6 months being exclusively formula fed and drinking up to 150180ml/kg/day of a normal concentration formula. In exceptional circumstances
200ml/kg/day is needed to accommodate lost formula through
vomiting/spillage. If significant vomiting continues consider referral to
paediatrician.
• Infants 6-12 months may not require less formula as solid food intake
increases due to the use of formula in food such as cereal and puddings, as a
cow’s milk substitute.
• Children over 12 months drinking the 600mls of milk or milk substitute per day
recommended by the Department of Health.
•
•
•
4.
For liquid high energy formula:
Prescribe an equivalent volume of formula to the child’s usual intake
until an assessment has been performed and recommendations made
by a paediatric dietitian/paediatrician.
Some children may require more, e.g. those with faltering
growth.
Review recent correspondence from the paediatric dietitian/paediatrician.
Dos and Don’ts of Prescribing Specialist Infant Formulae
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 7
Do
Don’t
Do promote and encourage breastfeeding where it is clinically
safe and the mother is in agreement.
Do check any formula prescribed is appropriate for the age of the
infant.
Do check the amount of formula prescribed is appropriate for the
age of the infant (see page 2) and/or refer to the most recent
correspondence from the paediatric dietitian/paediatrician.
Do review any prescription where the child is over 1 year old
and/or the formula has been prescribed for more than 1 year or
when greater amounts of formula are being prescribed.
Do review the prescription if the patient is prescribed a formula
for Cow’s Milk Protein Allergy (CMPA) but able to eat any of the
following foods – cow’s milk, cheese, yogurt, ice cream, custard,
chocolate, cakes, cream, butter, margarine, ghee.
Do prescribe only 1 or 2 tins or equivalent initially as a trial until
compliance/tolerance is established. Note: 1 tin will last
approximately 3 days. Refer to page 5 for ongoing prescription
volume guide.
Do remind parents/guardian to follow the advice given by the
formula manufacturer regarding safe storage of the feed once
mixed or opened.
Do refer where appropriate to secondary or specialist care - see
advice for each condition.
Do refer where appropriate to the paediatric dietitians.
Do seek prescribing advice if needed in primary care from the
Medicines Optimisation Team.
Do seek prescribing advice if needed in secondary care from the
local Medicines Information
Do prescribe Nutriprem 2 Liquid® or SMA Gold Prem 2 Liquid®
until 4 weeks corrected age at this point prescription can be
changed to a powdered version if clinically indicated.
Don’t add infant formulae to the repeat prescription in primary
care, unless a review process is established to ensure the correct
product and quantity is prescribed
Don’t prescribe lactose-free formulae (SMA LF®, Enfamil O-Lac®)
for infants with CMPA. Lactose is a carbohydrate not a protein.
Prescribe an Extensively Hydrolysed Formula instead.
Don’t prescribe soya formula (Infasoy®, SMAWysoy®) for those
with CMPA or secondary lactose intolerance. It should not be
prescribed or recommended at all in those under 6 months due to
high phyto-oestrogen content.
Don’t suggest milk and formulae made from goat’s milk, sheep’s
milk or mammalian milks for those with CMPA or secondary
lactose intolerance.
Don’t suggest rice milk for children under 4.5 years of age due to
the high arsenic content.
Don’t suggest Infant Gaviscon® more than 6 times in 24 hours or
where the infant has diarrhoea or a fever, due to its sodium
content.
Don’t prescribe low lactose/lactose-free formulae for lactose
intolerance.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 8
5.
Cow’s Milk Protein Allergy (CMPA)
Symptoms and diagnosis
• Refer to NICE guideline CG116 ‘Food Allergy in Children and Young
People’ Feb 2011 for full details. http://guidance.nice.org.uk/CG116
•
Refer to Appendix 2 – Milk Allergy in Primary Care (MAP) Guidelines.
Background to the Guidelines can be found in ‘Diagnosis and
management of non-IgE mediated cow’s milk allergy in infancy – A UK
primary care practical guide’ Venter et al. Clinical and Translational
Allergy 2013, 3:23 http://www.ctajournal.com/content/3/1/23
Symptoms of cow’s milk protein allergy can include:
•
Skin symptoms (pruritus, erythema, urticaria, atopic dermatitis).
•
Acute angioedema of the lips and face, tongue and palate, and around
the eyes.
•
GI symptoms (diarrhoea, bloody stools, nausea and vomiting,
abdominal distension and /or colicky pain, constipation, Gastrooesophageal reflux disease (GORD).
•
Recurrent wheeze or cough, nasal itching, sneezing, rhinorrhoea or
congestion.
•
Anaphylaxis.
•
Faltering growth.
NICE recommends further investigation with a skin prick test or specific IgE
antibody blood test if IgE-mediated allergy is suspected. When non-IgE
mediated allergy is likely, trial elimination for 2 to 6 weeks of the suspected
allergen. Most infants with CMPA develop symptoms within 1 week of
introduction of CMP-based formula.
Onward referral
Most infants with CMPA can be managed in primary care until weaned.
Referral to a paediatric dietitian should be made at diagnosis for all
infants who will require a cow’s milk free diet. Breastfeeding mothers
following a milk free diet should be referred to the paediatric dietitian
who will advise on both the mother’s and the infant’s diet. Refer to secondary
or specialist care paediatrician if any of the following apply:
•
Faltering growth with one or more gastrointestinal symptoms.
•
Acute systemic reactions or severe delayed reactions.
•
Significant atopic eczema where multiple or cross-reactive food
allergies are suspected by the parent or carer.
•
Possible multiple food allergies.
•
Persisting parental suspicion of food allergy despite a lack of
supporting history (especially where symptoms are difficult or
perplexing).
Treatment
•
Breast milk is the ideal choice for most infants with CMPA.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 9
•
•
•
•
•
•
If symptoms persist in the exclusively breast-fed infant, a maternal milk
(+/- soya) free diet is indicated for a minimum trial of 2 weeks and with
immediate referral to paediatric dietitian.
Breastfeeding mothers on a milk free diet may require supplementation
with milk-free 1000mg calcium per day.
If breastfeeding is not occurring, extensively hydrolysed formulae
(EHF) are the first choice, unless the infant has a history of
anaphylactic symptoms.
Amino acid formulae (AAF) should normally be started as
recommended by a paediatric dietitian or paediatrician. They are
suitable only when EHF does not resolve symptoms and/or when there
is evidence of severe (anaphylactic) allergy. Please note these
formulae can cause green stools. This is not a cause for concern
unless accompanied by other symptoms.
If breastfeeding mothers do not wish to or are unable to follow a milk
free diet, or are following a milk free diet and symptoms persist, an
AAF will be needed if top-ups are required and can be prescribed in
primary care.
If a patient has a history of anaphylactic reaction to cow’s milk, AAF
may be started in primary care, with immediate onward referral to
paediatric dietitian and secondary care paediatrician.
Cow’s Milk Protein Allergy (CMPA)
Extensively
Hydrolysed
Formulae
(lactose-free)
First-line
Extensively
Hydrolysed
Formulae
(Containing lactose)
Second-line
Similac Alimentum
(Abbott Nutrition)*
Birth to 12 months
*Nutramigen 1 with LGG® (previously called Nutramigen Lipil 1®)
(Mead Johnson) may be a more appropriate first-line feed for
children birth to six months.
*Nutramigen 2 with LGG® (previously called Nutramigen Lipil 2®)
(Mead Johnson) may be a more appropriate first-line feed for
children aged 6 months to 2 years.
Althera (SMA Nestle)
Pepti 1® (Milupa Aptamil)
Birth to 12 months
Birth to 6 months
Pepti 2® (Milupa Aptamil)
6 months to 2 years. Not needed if
tolerating suitable milk free OTC
products and weaned to appropriate
diet as recommended by paediatric
dietitian.
Above formulae can be tried if the infant/child is not tolerating firstline products because of taste.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
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Extensively
Hydrolysed
Formulae with
Medium Chain
Triglycerides
Prescribe in primary
care only as
recommended by
Paediatric Dietitian
or Paediatrician
Pregestimil Lipil® (Mead
Johnson)
Birth to 2 years. Not needed if
tolerating suitable milk free OTC
products and weaned to appropriate
diet as recommended by paediatric
dietitian.
Pepti – Junior®
(Cow&Gate)
Birth to 2 years. Not needed if
tolerating suitable milk free OTC
products and weaned to appropriate
diet as recommended by paediatric
dietitian.
Above formulae are used where CMPA is accompanied by
malabsorption.
Alfamino (SMA / Nestle)
Amino Acid
Formulae
Prescribe in primary
care only as
recommended by
Paediatric Dietitian
or Paediatrician
Nutramigen® Puramino
(Mead Johnson)
Neocate LCP® (Nutricia)
Birth until able to tolerate over the
counter products
Birth until able to tolerate over the
counter products
Birth until able to tolerate over the
counter products
These are not infant formulae
For over 1 year olds only
NeocateActive®
unflavoured (Nutricia)
Neocate Active®
To only be started if
blackcurrant flavour
recommended by Paediatric
Neocate Advance®
Dietitian
unflavoured
(Nutricia)
Neocate Advance®
banana/vanilla flavour
(Nutricia)
1. If a patient presents with clear anaphylactic reaction to
cow’s milk these formulae should be commenced in
primary care, with immediate onward referral to secondary
or specialist care.
2. If formula top-ups are needed for a child who is otherwise
breastfed (mother on a milk free diet) AAF will be required.
Review and discontinuation of treatment and challenges with cow’s milk
•
Review prescriptions regularly to check that the formula prescribed is
appropriate for the child’s age.
•
Quantities of formula required will change with age – see guide to
quantities required (page 6) and/or refer to the most recent
correspondence from the paediatric dietitian.
•
Avoid adding to the repeat prescription for these reasons, unless a
review process is established.
•
Challenging with cow’s milk - refer to NICE guidelines on which
children should be challenged with cow’s milk in secondary care
setting.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
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•
•
•
Prescriptions should be stopped when the child has outgrown the
allergy (see notes 1 and 5 below).
Review the need for the prescription if you can answer ‘yes’ to any of
the following questions:
o
Is the patient over 1 year of age?
o
Has the formula been prescribed for more than 1 year?
o
Is the patient prescribed more than the suggested
quantities of formula according to their age?
o
Is the patient prescribed a formula for CMPA but able to
eat any of the following foods – cow’s milk, cheese,
yogurt, ice-cream, custard, chocolate, cakes, cream,
butter, margarine, ghee?
Children with multiple or severe allergies may require prescriptions beyond
2 years in severe cases. This should always be at the suggestion of the
paediatric dietitian/paediatrician.
Notes:
1. Soya formula (Infasoy®, SMA Wysoy®) should not routinely be used for
patients with CMPA. It should not be prescribed or recommended for
those under 6 months due to high phyto-oestrogen content. It should
only be advised in patients over 6 months who do not tolerate first-line
EHF since there is a risk that infants with CMPA may also develop or
concurrently have allergy to soya. It is more likely that children will
tolerate soya formula from 1 year. Parents should be advised to
purchase soya formula as it is a similar cost to cow’s milk formula and
readily available. From 2 years supermarket calcium enriched soya, oat
milk, coconut, hemp milk alternatives may be suitable as an alternative.
Alpro® Junior 1+ soya milk may be suitable from 1 year. The paediatric
dietitian will advise on suitable over-the-counter products for appropriate
ages.
2. EHF and AAF have an unpleasant taste and smell, which is better
tolerated by younger patients. Unless there is anaphylaxis, advise
parents to introduce the new formula gradually by mixing with the usual
formula in increasing quantities until the transition is complete. Serving
in a closed cup or bottle or with a straw (depending on age) may
improve tolerance. In some cases the formula will need to be flavoured
e.g. with the minimum amount of milk free milkshake flavouring. Care
should be taken and ingredients checked in those with multiple
allergies.
3. Prescribe 1 or 2 tins initially as a trial until compliance/tolerance is
established to avoid waste. Note: one tin will last approximately 3
days. Refer to page 7 for ongoing prescription guide.
4. Rice milk is not suitable for children under 4.5 years due to its arsenic
content (Food Standards Agency 2009).
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
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5. A significant number of infants may be able to tolerate milk products
from 1 year onwards.
6. Milk-free calcium supplementation may be needed for infants
depending on volume and type of formula taken. Breastfeeding
mothers on a milk-free diet may also need a milk free calcium
supplement. The dietitian will advise.
7. Lactose-free formulae (SMA LF®, Enfamil O-Lac with LIPIL®) are not
suitable for those with CMPA.
8. Goat, sheep, and other mammalian milks are also not suitable for
those with CMPA.
6.
Gastro-Oesophageal Reflux Disease (GORD)
Symptoms and diagnosis
• GORD is the passage of gastric contents into the oesophagus causing
troublesome symptoms and/or complications.
• Symptoms may include regurgitation of a significant volume of feed,
reluctance to feed, distress/crying at feed times and/or small volumes of
feed being taken. Ideally symptoms should be observed by a Health
Visitor.
• Diagnosis is made from history that may include effortless vomiting (not
projectile) after feeding, usually in the first 6 months of life, and usually
resolves spontaneously by 12-15 months age.
• It should be noted that two thirds of babies have some degree of reflux at
some time during infancy.
• Overfeeding needs to be ruled out by establishing the volume and
frequency of feeds. Average requirements of formula are 150mls/kg/day
for babies up to 6 months, and should be offered spread over 6-7 feeds.
Note: If the baby is vomiting more formula will be required to replace
vomited volumes.
Onward referral
• Infants with faltering growth and/or other complications as a result of
GORD should be referred to paediatric services without delay.
Treatment
• If the infant is thriving and not distressed reassure parents and monitor.
• In breastfed infants a breastfeeding assessment should be carried out by a
person with appropriate expertise to check positioning and technique.
• In formula fed infants provide advice on avoidance of overfeeding,
positioning during and after feeding and activity after feeding. If no
improvement trial with feed thickener e.g. Carobel®.
• If the above advice is not successful offer alginate therapy (Infant
Gaviscon®) for 1 to 2 weeks and stop the feed thickener.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
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•
If alginate therapy is successful continue but try stopping at intervals to
see if the infant has recovered.
If a patient presents on OTC thickened formulae do not advise a separate
thickener.
If symptoms do not improve refer to NICE guidance NG1 (2015) for further
guidance.
•
•
Review and discontinuation of treatment
• Review after one month. If no improvement, consider CMPA (see MAP
guidelines Appendix 2)
• Infants with GORD will need regular review to check growth and
symptoms.
• GORD will usually resolve spontaneously between 12-15 months.
Gastro-Oesophageal Reflux Disease (GORD)
Feed
thickener
to be
purchased
First-line
Feed
Thickener
should not
routinely
be
prescribed
Cow & Gate Instant Carobel®
(Cow &Gate)
Birth to 18 months
Added to standard formula and
breast milk
Cow & Gate Instant Carobel®
(Cow &Gate)
Birth to 18 months
Only prescribe if unable to
purchase or and if there is a
clinical need.
Notes
1.
Over the counter (OTC) thickened formulae and formula thickened with
Carobel® will require the use of a large hole (fast-flow) teat.
7.
2.
Infant Gaviscon® contains sodium, and should not be given more than
6 times in 24 hours or where the infant has diarrhoea or a fever. N.B.
Each half of the dual sachet of Infant Gaviscon® is identified as ‘one
dose’. To avoid errors, prescribe with directions in terms of ‘dose’.
3.
Pharmacists should advise about appropriate doses of OTC products.
Secondary Lactose intolerance
Symptoms and diagnosis
• Can occur following an infectious gastrointestinal illness but may be
present alongside newly or undiagnosed coeliac disease/CMPA.
• Symptoms include abdominal bloating and/or increased (explosive) wind.
If these symptoms persist consider CMPA and follow MAP guidelines.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
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•
•
•
Treatment
Regular feeding should not be interrupted and should be carried on after
initial rehydration.
Regular milk (lactose) containing formulae are appropriate in the vast
majority of cases.
If parents wish to trial a lactose-free formula these can be purchased OTC
and should not be prescribed in primary care. Note this may delay
diagnosis of CMPA.
Notes
Primary lactase deficiency/absense is an inherited condition and runs in
families. The intolerance to lactose is progressive, but symptoms usually start
after the age of 2 years, although may not be noticeable until adulthood.
Lactose free formula is not needed in infancy for this condition.
8.
Faltering Growth
Symptoms and diagnosis
• Diagnosis is made when the growth of an infant falls below the 0.4th
centile or crosses 2 centiles downwards on a growth chart or weight is 2
centiles below length centile.
• The height/length of an infant should be measured to properly interpret
changes in weight using appropriate growth charts to be able to diagnose
faltering growth.
• It is essential to rule out possible disease related/medical or social causes
for the faltering growth e.g. iron deficiency anaemia, severe troublesome
constipation, GORD or a child safeguarding issue. If identified appropriate
action should be taken.
Onward referral
• Infants with faltering growth should be referred to a paediatric dietitian and
paediatrician without delay.
Treatment
• Prescribe an equivalent volume of high energy formula to the child’s usual
intake of regular formula until an assessment has been performed and
recommendations made by a paediatric dietitian/paediatrician.
Review and discontinuation of treatment
The team to whom the infant is referred should indicate who is responsible
for review and discontinuation. If the team hands responsibility back to the
GP this should be with an indication of what the goal is and at which point
discontinuation can occur.
• All infants on high energy formula will need growth (weight and
height/length) monitored to ensure catch up growth occurs.
•
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 15
•
Once this is achieved the formula should be weaned and gradually
discontinued to minimise excessive weight gain.
Faltering Growth
Similac High Energy®
High Energy 120/200ml bottle
Formula
(Abbott Nutrition)
Birth up to 18 months or 8kg
On commencement refer to
paediatric dietitian
First-line
High Energy
Formula
Prescribe as
Second-line
High Energy
Formula
Prescribe in
primary care
only as
recommended
by Paediatric
Dietitian or
Paediatrician
Infatrini® 100/200ml
bottle (Nutricia)
Birth up to 18 months or 8kg
SMA high Energy ®
250ml bottle (SMA)
Birth up to 18 months or 8kg
Infatrini Peptisorb®
200ml bottle (Nutricia)
Birth up to 18 months or 8kg
N.B. This formula is suitable for infants with faltering growth
and intolerance to whole protein feeds e.g. short bowel
syndrome, Intractable malabsorption, inflammatory bowel
disease, bowel fistulae.
Notes
• Where all nutrition is provided via NG/NJ/PEG tubes, the paediatric
dietitian will advise on appropriate monthly amounts of formula required
which may exceed the guideline amounts for other infants. These formulae
are not suitable as a sole source of nutrition for infants over 8kg or 18
months of age.
• Do not add formula to repeat prescriptions as on-going need for formula
and amount required will need to be checked with each prescription
request.
• Manufacturer’s instructions regarding safe storage once opened and
expiry of ready to drink formulae should be adhered to. Note: this may
differ from manufacturer to manufacturer.
9.
Pre-term Infants and Nutrient Enriched Discharge Formulae
Indications
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 16
•
•
•
Small percentage of these infants will have had their nutrient-enriched post
discharge formula continued on discharge from the neonatal unit. This
should be prescribed as a ready to feed presentation until 4 weeks
corrected age. At this point parents/carer should be advised to commence
on standard OTC cow’s milk formula of their choice or changed to a
powdered version of nutrient enriched discharge formula (only if clinically
indicated).
It is started for babies born before 35 weeks gestation, or small for
gestational age.
These formulae should not be used in primary care to promote weight gain
in patients other than babies born prematurely.
Onward referral
• These infants should already be under regular review by the
paediatricians.
• If there are concerns regarding growth whilst the infant is on these
formulae, refer to the paediatric dietitian.
• If there are concerns regarding growth at 6 months corrected age or at
review one month after these formulae are stopped, refer to the paediatric
dietitian.
Review and discontinuation of treatment
• The Health Visitor should monitor growth (weight, length and head
circumference) while the baby is on these formulae.
• In the exceptional circumstances infants remain on Nutrient Enriched
discharge formula these products should be discontinued by 6 months
corrected age.
• Not all babies need these formulae for the full 26 weeks from expected
date of delivery (EDD).
• If there is excessive weight gain at any stage up to 6 months corrected
age, stop the formula.
Pre-term Infants
Nutrient
Enriched Post
Discharge
Formulae to
be started
only as
recommended
by Secondary
Care
SMA Gold Prem2®liquid
(SMA)
Nutriprem2® liquid
(Cow& Gate)
SMA Gold Prem2®powder
(SMA)
Up to 4 weeks corrected age
at this point patients can be
changed to a powdered
version if clinically indicated.
From 4 weeks corrected age
up to a maximum of 6 months
corrected age
Nutriprem2® powder
(Cow&Gate)
6 months corrected age = EDD + 26 weeks
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 17
10.
Comparative Costs of Prescribable Infant Formulae
Cow’s Milk Protein Allergy
Product
Extensively
Hydrolysed
Formulae
(lactose-free)
First-line
Extensively
Hydrolysed
Formulae
(Containing
lactose)
Second-line
Extensively
Hydrolysed
Formulae with
Medium Chain
Triglycerides
prescribe in
primary care
only as
recommended
by Paediatric
Dietitian or
Paediatrician
Similac
Alimentum
Presentation/
Price
400g tin £9.10
Price/100g Cost/100kca
l
£2.28
£0.43
Nutramigen 1
with LGG®
Nutramigen 2
with LGG®
400g tin £10.66
£2.67
£0.57
Althera (SMA
Nestle)
Pepti1®
450g tin £10.68
£2.37
£0.47
400g tin £9.54
£2.38
£0.48
Pepti1®
900g Eazypack
£21.46
£2.38
£0.48
Pepti2®
900g Eazypack
£20.48
£2.27
£0.48
Pregestimil Lipil®
400g tin £11.82
£2.96
£0.59
Pepti-Junior®
450g tin £12.58
£2.80
£0.53
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 18
Cow’s Milk Protein Allergy
Product
Amino Acid
Formulae
Prescribe in
primary care
as
recommended
by Paediatric
Dietitian or
Paediatrician
Alfamino (SMA/
Nestle)
Nutramigen®
Puramino
NeocateLCP®
NeocateActive®
unflavoured or
blackcurrant
flavour
Neocate
Advance®
unflavoured
Neocate
Advance®
banana/vanilla
flavour
Presentation/
Price
400g tin £23
£5.75
£1.14
400g tin £26.27
400g tin £6.57
£1.32
400g tin £28.30
£7.08
£1.49
15 x 63g sachets
£66.60
£7.05
£1.48
10 x 100g
sachets £58.60
£5.86
£1.47
15 x 50g sachets
£46.35
£6.18
£1.55
High Energy Formulae – Faltering Growth
Product
Presentation/
Price
Similac High
200mls £2.10
High Energy
Energy®
Formula
First-line
Similac High
48 x 60mls £31.20
Energy®
Infatrini®
200mls £2.17
High Energy
Formula
Infatrini®
100mls £1.12
Prescribe as
Second-line
SMA High
250mls £2.17
Energy®
High Energy
Formula
prescribe in
primary care
only as
recommended
Infatrini
Peptisorb®
Price/100g Cost/100kcal
200mls £3.32
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Cost/100kcal
£1.04
£1.08
£1.09
£1.12
£0.95
£1.66
Page 19
by Paediatric
Dietitian or
Paediatrician
Pre-term Infant Formulae
Product
NutrientEnriched Post
Discharge
Formula
to be started
only as
recommended
by Secondary
Care
11.
Presentation/
Price
250mls £2.10
Price/100g
Cost/100kcal
N/A
£1.15
200mls-£1.68
N/A
£1.12
SMA
Gold Prem2®
400g £5.03
£1.26
£0.24
Nutriprem 2®
900g £11.24
£1.25
£0.25
SMA
Gold Prem 2
liquid®
Nutriprem 2
liquid®
References:
Cow’s milk protein allergy
Committee on Hypoallergenic Formulas and the European Society for
Paediatric Gastroenterology, Hepatolgy and Nutrition (ESPGHAN) Committee
on Nutrition. Arch Dis Child 1990; 81:80-84.
Dietary products used in infants for treatment and prevention of food allergy.
Joint statement of the European Society for Paediatric Allergology and Clinical
Immunology (ESPACI)
Food Hypersensitivity. Diagnosing and managing food allergy and intolerance.
(2009). Edited by Isabel Skypala and Carina Venter. Published by WileyBlackwell.
NICE Clinical Guideline 116 Food Allergy in Children and Young People. 2011
http://publications.nice.org.uk/food-allergy-in-children-and-young-peoplecg116/guidance
Venter 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
http://www.ctajournal.com/content/3/1/23
Vandenplas Y, Koletzo S et al. Guidelines for the diagnosis and management
of cow’s milk protein allergy in infants. Arch Dis Child 2007;92:902-908
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 20
World Allergy Organisation DRACMA guidelines 2010 (Diagnosis and
Rationale Against
Cow’s Milk Allergy)
http://www.worldallergy.org/publications/WAO_DRACMA_guidelines.pdf
Host A. Frequency of cow’s milk allergy in childhood. Ann Allergy Immunol
2002; 89 (suppl): 33-37.
Soya formula
Department of Health: CMO’s Update 37 (2004). Advice issued on soya
based infant formula. Paediatric group Position Statement on Use of Soya
Protein for Infants. British Dietetic Association: October 2010.
http://www.steppyorks.nhs.uk/presentations/unit1/PaediatricGroupGuidelineS
oyInfantFormulas.pdf
Rice milk
Food Standard Agency statement on arsenic levels in rice milk (2009)
http://www.food.gov.uk/multimedia/pdfs/fsis0209arsenicinrice.pdf
Gastro-oesophageal reflux disease
NICE clinical guideline 1 ‘Gastro-oesophageal reflux disease: recognition,
diagnosis and management in children and young people’ Published: 14
January 2015
Secondary lactose intolerance
NICE clinical Guidance 84 ‘Diarrhoea and vomiting in children’ Published:
April 2009
Guarino, A; Albano, F; Ashenazi, A et al (2008) European Society for
Paediatric Gastroenterology, Hepatology and Nutrition/European Society for
Paediatric Infectious Diseases Evidence-based Guidelines for the
Management of Acute Gastroenteritis in Children in Europe. Journal of
Paediatric Gastroenterology and Nutrition. 46:S81-S184
Buller HA, Rings EH, Montgomery RK, Grand RJ. Clinical aspects of lactose
intolerance in children and adults. Scand J Gastroenterology 1991; 188
(suppl): 73-80.
Pre-term
European Food Safety Authority 2004
General
Clinical Paediatric Dietetics 3rd Edition (2007). Edited by Vanessa Shaw and
Margaret Lawson. Published by Blackwell Publishing.
Department of Health (2009) Birth to Five.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publications
PolicyAndGuidance/ DH_107303
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 21
Department of Health report on Health and Social Subjects No 45. 1994.
Weaning and the weaning diet. The Stationary Office.
Acknowledgements:
•
•
•
•
•
•
•
•
•
•
Allied Prescribing Committee North Staffordshire
Area Prescribing Group South Staffordshire
Burton Hospital Foundation Nutrition and Dietetic Service
Burton Hospital Foundation Trust Paediatrician Paediatrician
East Staffordshire Clinical Commissioning Group
North Staffordshire and Stoke on Trent Clinical Commissioning Group
Paediatric Dietitians of Staffordshire and Stoke on Trent Partnership
Trust NHS
Paediatric Dietitians of University Hospitals North Midlands
Stafford and Surrounds Clinical Commissioning Group
UNICEF Implementation Team Staffordshire and Stoke on Trent NHS
Partnership Trust
This document has been adapted from ‘Appropriate prescribing of
specialist infant Formulae’ written by Central Eastern Commissioning
Support Unit Medicines Management Team, PrescQuipp NHS; Bulletin
67, July 14, 2.2.
Acknowledgments of the original document:
•
Judith Harding, Prescribing Support Dietitian, Medicines Management
Team, Central Eastern Commissioning Support Unit
•
Maddy Leriti and Zoe Wood, London Procurement Partnership
Paediatric Project. Pharmacy and Medicines Use Work stream.
•
Leanne Fishwick, Dietetic Team Lead, Paediatrics and Food First
Project, SEPT Community Health Services, Bedfordshire.
•
Rob Ives, Paediatric Dietitian, Feeding and Swallowing Team, North
East London Foundation Trust.
•
The Paediatric Dietitians of North East London Foundation Trust.
•
Group
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 22
Staffordshire and Stoke on Trent NHS Partnership Trust
University Hospital of North Midlands
North Staffordshire Combined Healthcare
North Staffordshire Clinical Commissioning Group
Stoke on Trent Clinical Commissioning Group
APPENDICES
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 23
Appendix 1 page 1 of 2
Staffordshire and Stoke on Trent NHS Partnership Trust
University Hospital of North Midlands
North Staffordshire Combined Healthcare
North Staffordshire Clinical Commissioning Group
Stoke on Trent Clinical Commissioning Group
Adapted from the guidance written by Central Eastern Commissioning
Support Unit Medicines Management Team and PrescQIPP July 2014
ALL CONDITIONS
How much powdered infant formula should I prescribe monthly?
Under 6 months
6 -12 month
13 x 400g tins OR 6 x 900g tins
7-13 x 400g tins or 3-6 x 900g tins
Over 12 months
7 x 400g tins or 3 x
900g tins
COW’S MILK PROTEIN ALLERGY (CMPA)
Symptoms include:
• Skin symptoms, e.g. pruritus, erythema, urticaria, atopic dermatitis, acute angioedema.
• Gastro-intestinal symptoms, e.g. diarrhoea, bloody stools, nausea and vomiting, abdominal distention
and/or colicky pain, constipation or gastro-oesophageal reflux disease (GORD).
• Respiratory symptoms e.g. cough/wheeze, nasal itching, sneezing, rhinorrhea
or congestion.
Refer
infants
anaphylaxis
or faltering
Refer
infants
withwith
anaphylaxis
or faltering
growth
growth
to
paediatric
services
without
delay
• Also anaphylaxis and faltering growth.
to paediatric services witout delay…………………
DO NOT PRESCRIBE SOYA FORMULA – see guidance
®
FIRST-LINE
FORMULA
Similac Alimentum (up to 12 months)*
®
*Nutramigen 1 with LGG (previously called Nutramigen Lipil 1) (Mead Johnson) may be
a more appropriate first line feed for children birth to six months.
®
*Nutramigen 2 with LGG (previously called Nutramigen Lipil 2) (Mead Johnson) may be
a more appropriate first line feed for children aged six months to 2 years.
• Breastfeeding mothers may require a milk (+/-Soya) free diet and calcium supplementation.
• Refer to paediatric dietitians on diagnosis and refer to latest correspondence before issuing
prescriptions.
Review the need for prescribing if answer is yes to any of the following questions:
Can the patient tolerate cow’s milk, or dairy products? Is the patient over 1 years of age? Has the formula
been prescribed for more than one year? Is the quantity prescribed greater than the recommended
amount for the child’s age?
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
• GORD presents with a history of effortless vomiting after feeding, usually in the first 6 months of
life.
•
•
•
•
Over feeding should be ruled out by establishing the volume and frequency of feeds.
Give reassurance and advice on positioning.
Refer patients with faltering growth to
Recommend Carobel® to thicken feeds
paediatric services without delay
Stop feed thickener if prescribing Infant Gaviscon®
INITIALLY RECOMMEND OVER
THE COUNTER FEED THICKENER
Cow& Gate® Instant Carobel® (Cow &Gate) thickened
Formula will require a large hole/fast flow teat.
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 24
Appendix 1 page 2 of 2
Staffordshire and Stoke on Trent NHS Partnership Trust
DO NOT PRESCRIBE THICKENING FORMULAE – see guidance
University Hospital of North Midlands
North Staffordshire Combined Healthcare
North Staffordshire Clinical Commissioning Group
Stoke on Trent Clinical Commissioning Group
SECONDARY LACTOSE INTOLERANCE
Usually occurs following an infectious GI illness (but can occur alongside new or
undiagnosed coeliac disease and last for a few weeks only). Symptoms include:
• Abdominal bloating.
• Increased explosive wind.
Regular feeding should not be interrupted and should be carried on after initial rehydration. Regular
milk (lactose) containing formulae are appropriate in the vast majority of cases
DO NOT PRESCRIBE LACTOSE-FREE FORMULAE – see guidance
Nutrient Enriched Post
®
®
Discharge Formulae to be SMA Gold Prem2 Liquid or Nutriprem2 Liquid (Cow&Gate),
started as recommended SMA Gold Prem2®powder, Nutriprem2® powder
(Cow&Gate)
by Secondary Care
DO NOT PRESCRIBE POWDER FORMULA UNLESS CLINICALLY INDICATED FROM 4 WEEKS
CORRECTED AGE ONLY (26 WEEKS EDD)
Refer to the full Appropriate Prescribing of Specialist infant Formulae in
Staffordshire guidelines for more details and second-line choices.
Nutrition and Dietetic Service Staffordshire and Stoke on Trent NHS Partnership Trust
Civic Centre Riverside Stafford ST16 3AQ Tel: 0300 1240109
Adapted with kindness and permission from: Nutrition and Dietetic Service
Burton hospital Foundation Trust, Outwoods House, Belvedere Road, Burton On Trent and South
Staffordshire Allied Prescribing Group Guidelines Dec 2014
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 25
Appendix 2 – Must be reviewed with the whole Guidelines
®
eHF (Extensively Hydrolysed Formulae) – such as Similac Alimentum®, * Nutramigen 1 with LGG (previously called Nutramigen Lipil 1)®* Nutramigen 2 with LGG (previously called Nutramigen Lipil 2
®
®
AAF (Amino Acid Formulae) such as Alfamino , Nutramigen Puramino, Neocate LCP
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
®
Page 26
Appendix 2 – Must be reviewed with the whole Guidelines
®
eHF (Extensively Hydrolysed Formulae) – such as Similac Alimentum®, * Nutramigen 1 with LGG (previously called Nutramigen Lipil 1)®* Nutramigen 2 with LGG (previously called Nutramigen Lipil 2
®
®
AAF (Amino Acid Formulae) such as Alfamino , Nutramigen Puramino, Neocate LCP
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
®
Page 27
Appendix 3
MONITORING COMPLIANCE
Name of Procedural Document Appropriate Prescribing of Infant Formulae in Staffordshire
Monitoring Officer
Paediatric SSOTP Dietitians and Audit Team
Reporting Arrangements
Audit each year
Element to be Monitored - NSLA Criteria
Tool
Change in Practice and
Ref
Standard Criteria
Lessons to be Shared
Timeframe
1
Referrals into Paediatric Dietetic Team
Infant Formulae Prescribed
Milk Allergy Audit
tool
Training to Health
Visitors
2015-2016
2
CCG prescribing of infant formulae
CCG prescribing
records
Medicine Optimisation
Teams (MOT)
2015-2017
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V2 Final
Page 28
Nominated
Lead
Team Lead
paediatric
dietitians
CCG MOT
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines
V1 Final
Page 29