guidelines on prescribing specialist infant formulas in ... · aaf top ups can be maintained if no...

Oxfordshire Clinical Commissioning Group

Guidelines on Prescribing Specialist Infant Formulas in Primary Care v1. Approved APCO September 2017. Review September 2019.

Guidelines on Prescribing Specialist

Infant Formulas in primary care

Contents

1. Introduction

2. Prescribing Guidance 2.1 Quantities to Prescribe 2.2 Prescription Management

3. Cow’s Milk Protein Allergy (CMPA)

3.1 Background Information 3.2 Diagnosis and Initial Management of CMPA

3.2.1 IgE mediated CMPA

3.2.2 Non-IgE mediated CMPA and Home Reintroduction

3.3 Ongoing Management of Confirmed Mild to Moderate CMPA 3.4 Product choices

3.4.1 Extensively Hydrolysed Formula (EHf) 3.4.2 Amino Acid Formula (AAf) 3.4.3 Products Not Suitable for Prescribing in CMPA

3.5 Prescription Management 3.6 Reintroducing Cow’s Milk 3.7 Weaning

4. Gastro-oesophageal Reflux Disease (GORD)

5. Secondary Lactose Intolerance

6. Faltering Growth

7. Preterm Infants

8. Metabolic Products

9. References and Acknowledgements

10. Appendices

10.1 Appendix 1 – Suspected Cow’s Milk Allergy (CMA) in the 1st Year of Life (iMAP) 10.2 Appendix 2 – Primary Care Management of Mild to Moderate Non-IgE CMA (iMAP) 10.3 Appendix 3 – Parent leaflet: The iMAP Milk Allergy Guideline– Initial Fact Sheet 10.4 Appendix 4 – Parent leaflet: The Early Home Reintroduction to confirm the diagnosis of cow’s milk

allergy 10.5 Appendix 5 – The iMAP Milk Ladder 10.6 Appendix 6 - Infant Formula products – quick reference guide 10.7 Appendix 7 – Summary of Guidelines on prescribing specialist infant formula in primary care

2 Guidelines on Prescribing Specialist Infant Formulas in Primary Care v1. Approved APCO September 2017. Review September 2019.

1. Introduction

These guidelines outline recommendations for the safe, appropriate and cost-effective prescribing of specialist infant formula for children up to the age of 18 months in the Oxfordshire area. It covers:

Over-the-counter (OTC) products available wherever appropriate

Quantities to prescribe

Which products to use for different clinical conditions

Initiating, reviewing and discontinuing prescriptions

When to refer to dietitians and/ or secondary or specialist care

For allergy related queries please contact consultant-led paediatric allergy advice service via [email protected].

Breast milk remains the optimal nutrition for infants and should be promoted, supported and encouraged where it is clinically safe.

2. Prescribing Guidance

2.1 Quantity of Powdered Formula to Prescribe

When prescribing powdered infant formulas please refer to the table below for suggested quantity to

prescribe per month:

Age of child Suggested quantity of powdered formula to prescribe per month

400g tin 900g tin

< 6 months Highest requirement at 4-6 months prior to weaning

Up to 12 tins Up to 5 tins

6 – 12 months 6 – 12 tins 3 – 5 tins

> 12 months Up to 6 tins Up to 3 tins

2.2 Prescription Management

1. Only prescribe 1-2 tins initially as “acute” prescription to assess tolerance and to avoid waste.

Review recent correspondence from the paediatrician or paediatric dietitian.

2. Add formula to repeat prescribing template only if tolerance and diagnosis are confirmed, and a

regular, robust review process is established to ensure that the formula and quantity prescribed are

appropriate for the child’s age and nutritional requirements.

3. Prescribing specialist formula for children over 18 months will be low priority unless specifically

requested from a specialist (paediatrician or dietitian) and reason for continued use is provided, in

line with Clinical Commissioning Policy 250.

4. DO NOT prescribe the following on NHS prescriptions. Parents should be advised to purchase these

as their costs are similar to that of cow’s milk formula, in line with Clinical Commissioning Policy 88

and 250:

Soya formula - Wysoy®

mailto:[email protected]

http://www.oxfordshireccg.nhs.uk/policies-and-procedures/250-milk-products/30380

http://www.oxfordshireccg.nhs.uk/policies-and-procedures/088d-optimising-self-care-by-appropriate-use-of-over-the-counter-medicines-restricted-prescribing-list/29267



Lactose free formula - Aptamil® LF, SMA® LF, Enfamil® O-Lac

Pre-thickened formula - Cow and Gate® Anti-reflux, Aptamil® Anti-reflux, SMA® PRO Anti-

reflux

Thickening formula - SMA® Staydown (replaced by SMA® PRO Anti-reflux), Enfamil® AR

5. DO NOT prescribe ready-to-feed liquids as they have no clinical advantage and are usually

substantially more expensive. These should only be prescribed on specialist’s request when there is

a clinical need e.g. if the patient is tube or PEG (percutaneous endoscopic gastrostomy) fed.

6. Prescriptions must be endorsed ‘ACBS’.

3. Cow’s Milk Protein Allergy (CMPA)

3.1 Background Information

CMPA is the commonest food allergy in the first year of life with a prevalence of 2-3 %. Most infants

with CMPA develop symptoms within one week of introduction of a cow’s milk protein (CMP) - based

formula and improve within 1-2 weeks of a CMP elimination diet. However, this can take up to 6 weeks.

Most children with a diagnosis of CMPA have mild to moderate symptoms which can be managed in

primary care. Severe CMPA should be managed in conjunction with a paediatrician with an interest in

allergy. For detailed assessment of severity of CMPA refer to iMAP CMPA algorithm for symptoms

presentation (see appendix 1) and algorithm for diagnosis and management (see appendix 2).

3.2 Diagnosis and Initial Management of CMPA

There are two main types of cow’s milk allergy: acute Immunoglobulin E (IgE) mediated reactions

(symptom onset within minutes up to 2 hours) and the delayed non-IgE mediated reactions (2-72hrs

onset). The table below depicts recognised clinical features of CMPA. For detailed guidance on

obtaining an allergy focused history, see NICE CG116: Food Allergy in Children and iMAP allergy

focused clinical history for suspected CMPA in infancy.

Download the iMAP Milk Allergy Guideline– Initial Fact Sheet (see Appendix 3) for parents whose

infants are showing mild to moderate symptoms of delayed non Ig-E mediated reaction to CMP.

Acute IgE-mediated Delayed non-IgE-mediated

The skin

Pruritus Pruritus

Erythema Erythema

Acute urticaria – localised or generalised Atopic dermatitis Acute angioedema of lips, face and around the eyes

The gastrointestinal

system

Oral pruritus Gastro-oesophageal reflux

disease Colicky abdominal pain Loose or frequent stools

Vomiting Blood and/or mucus in stools

Diarrhoea Abdominal pain

Infantile colic Food refusal or aversion

Constipation Perianal redness

https://www.allergyuk.org/assets/000/001/296/iMAP_Final_Algorithms-May_2017_1_original.pdf?1502804801



https://www.nice.org.uk/guidance/cg116?unlid=13954656420169974550

https://www.allergyuk.org/assets/000/001/293/iMAP-Allergy-focused_History_original.pdf?1502804761

https://www.allergyuk.org/assets/000/001/293/iMAP-Allergy-focused_History_original.pdf?1502804761

https://static-content.springer.com/esm/art%3A10.1186%2Fs13601-017-0162-y/MediaObjects/13601_2017_162_MOESM1_ESM.pdf


The respiratory

system (usually in

combination with

one or more of skin

and GI symptoms)

Upper respiratory tract symptoms (nasal itching, sneezing, rhinorrhoea or congestion

(with or without conjunctivitis), signs or symptoms of anaphylaxis e.g. laryngeal

oedema with drooling and hoarse voice and tongue swelling.

Lower respiratory tract symptoms (cough, chest tightness, wheezing or shortness of

breath)

Note: this list is not exhaustive. The absence of these symptoms does not exclude food allergy.

3.2.1 IgE mediated CMPA (symptom onset within minutes up to 2 hours)

AAf = amino acid formula; EHf = extensively hydrolysed formula

Yes

Severe

Immediate reactions with severe respiratory +/- CVS

(cardiovascular system) signs and symptoms.

Anaphylaxis -> A&E. Allergy referral and commence on

AAf and dairy free weaning with dietetic support.

Mild to moderate

More than one of the following symptoms: acute pruritus,

erythema, urticaria, angioedema, acute flaring of atopic

dermatitis, vomiting, diarrhoea, acute rhinitis

Acute Onset symptoms: IgE mediated

Any immediate symptoms on EHf feeds?

Recurrence of

immediate symptoms

despite maternal dairy

free diet*?

Refer to specialist for allergy

testing to confirm CMPA and

plan for reintroduction, AAf

may be needed. Do not

perform Home

Reintroduction. Refer to

dietitians for weaning support.

Continue EHf.

Refer for allergy

testing and

Reintroduction

plan. Refer to

dietitian for

weaning support.

**Note: if no delayed symptoms prior to a mild/moderate acute reaction there is no need for maternal dairy exclusion. Rarely

there may be minor immediate symptoms such as redness, hives after breast feeds. Maternal dairy free diet will be required in

these cases.

Mixed/ formula feeding: Urgent referral

to paediatric allergy service.

Formula feeding: Specialist to recommend/

commence AAf exclusively;

Mixed feeding: AAf as top-ups if required.

Maternal dairy free diet* if persistent GI

symptoms and atopic dermatitis. Specialist

follow up and Reintroduction plan.

Exclusively formula feeding: Trial EHf;

Mixed feeding**: EHf top-ups if needed

+ maternal dairy free diet* if persistent GI

symptoms or active atopic dermatitis with

breast feeding** (see notes below).

Refer for allergy testing

to confirm CMPA. Do

not Perform Home

Reintroduction. Refer

to dietitians for weaning

support.

Continue maternal dairy free diet*.

Refer for allergy testing and

Reintroduction plan. If top-up

formula required refer to paediatric

allergy service for AAf. Refer to

dietitians for weaning support.

* Breastfeeding mothers on a milk free diet may require supplementation with 1000mg calcium and 10mcg Vitamin D per day.

No

No

Exclusively breastfed:

Maternal dairy free diet*

for 2 - 4 weeks.

Yes


3.2.2 Non-IgE mediated CMPA (symptoms onset 2-72hrs) and Home Reintroduction


¥ Early Home Reintroduction to confirm diagnosis - mild-moderate symptoms only

EHf should be continued for a minimum of 2 weeks and if symptoms have improved, it is vital that

parents perform Home Reintroduction after 2-4 weeks of starting EHf, in order to confirm the diagnosis.

If symptoms return, CMPA is confirmed and EHf should be resumed. If symptoms do no return with the

Home Reintroduction, CMPA is ruled out.

How the Reintroduction is carried out is dependent on whether the infant is exclusively breastfed or

mixed/ bottle-fed. iMAP’s parent leaflet on “The Early Home Reintroduction to confirm diagnosis” can be

downloaded to share with parents (see appendix 4).

Improvement in 2-4 weeks

Yes No Yes No


** Do not perform Home Reintroduction in those with severe symptoms.

Symptoms return

Resume maternal dairy free diet and if

symptoms settle - CMPA confirmed. AAf

top ups can be maintained if no weight

gain concerns. Refer to specialist for

faltering growth and persistent

symptoms.

Mixed/ formula feeding**

Urgent referral to paediatric

allergy service. Exclusive formula

feeding: Specialist to commence or

recommend AAf.

Mixed feeding: Maternal dairy free

diet and AAf for faltering growth.

Refer to dietitians.

Improvement in 2-4 weeks

Symptoms return

Resume EHf and if

symptoms return -

CMA now confirmed.

No return of

symptoms

Not CMPA

¥Home Reintroduction

using standard formula to

confirm diagnosis, done

within 2-4 weeks of

elimination diet.

No return

of

symptoms

Not CMPA

Exclusively breastfed**

Urgent referral to

paediatric allergy

service and dietetians.

CM free maternal diet*

for 2-4 weeks. AAf may

be advised if top-ups

needed.

Mixed/ formula feeding

Formula fed: Trial EHf; mixed

feeding: CM free maternal diet*

+ EHf top-ups if needed. Refer to

dietitians.

Refer to paediatric

allergy service if CMPA

still suspected. If not

resume normal

maternal diet.

Refer to paediatric

allergy service for

AAf if CMPA still

suspected. If not

resume normal diet.

Delayed Onset symptoms: Non-IgE mediated

Severe

Severe, persisting symptoms of more than one of the

following: vomiting, diarrhoea, +/- faltering growth,

significant blood +/- mucus in stools, severe atopic

dermatitis

¥Home Reintroduction to

confirm diagnosis i.e.

maternal normal dairy diet for

1-2weeks, after 2-4 weeks of

dairy exclusion.

Exclusively breastfed CM free maternal diet*

for 2-4 weeks. AAf may be advised if top-ups

needed. Non-urgent referral to dietitians for

weaning advice.

Mild to moderate

Several of the following symptoms: vomiting, reflux,

loose/ frequent stools, constipation, colic, blood +/-

mucus in stools, rhinitis, wheeze, cough, pruritus,

erythema, moderate persistant atopic dermatitis.



3.3 Ongoing Management of Confirmed Mild to Moderate CMPA


3.4 Product Choices

3.4.1 Extensively Hydrolysed Formula (EHf)

EHf is the first line treatment for mild to moderate CMPA in primary care. These formulas are tolerated

by 90% of infants with CMPA. There is emerging evidence that tolerance to cow’s milk occurs sooner

on sustained exposure to EHf, so early diagnosis and a switch from standard formula to EHf will

eliminate allergen sooner, improve symptoms control and could facilitate natural resolution of CMPA.

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Product Age group Notes Cost/ 100g (June 2017)

EHf – 1st line choices for mild to moderate CMPA

Similac® Alimentum

From birth Most cost-effective EHf. Lactose free. £2.28

Althera® From birth Contains lactose. May be used where gastrointestinal symptoms are not present, or if there is a palatability issue.

£2.37

Aptamil Pepti® 1 From birth – 6 months

Contains lactose. May be used where gastrointestinal symptoms are not present, or if there is a palatability issue.

£2.47

Aptamil Pepti® 2 Over 6 months £2.35

Confirmed Mild-moderate CMPA

Negative


Allergy clinic for IgE

testing or skin prick test

Allergy clinic for IgE

testing or skin prick

Current atopic

dermatitis during

CM free diet

No current atopic

dermatitis and no

history at any

stage of acute

onset symptoms.

Home

Reintroduction

with support from

health visitors or

dietitians as per

iMAP ladder.

Negative

and no history at

any stage of acute

onset symptoms.

Mixed/ formula fed

Continue EHf; or AAf as per advice

from secondary care if intolerant to

EHf

Or

Exclusively breast-fed

Marternal dairy free diet* + AAf

as advised by specialist if

needed as top-ups.

Liaise with paediatric

allergy service

regarding re-challenge.

History of acute onset

symptoms at any time.

Positive

IgE mediated Non-IgE mediated

Refer to specialist

paediatritian, may need

supervised challenge.

CM free diet for at least 6 months and until 9-12 months of

age (with weaning support from dietitians). Test for

acquired tolerance depending on status of atopic

dermatitis and history of acute onset symptoms.

Follow up with serial IgE

testing and later planned and

Supervised Challenge in

secondary care or

specialist setting to test for

acquired tolerance. Dietietic

referral required.


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Nutramigen 1 with LGG®

From birth – 6 months

Lactose free. Contains a unique probiotic Lactobacillus rhamnosus GG (LGG®).

£2.75

Nutramigen 2 with LGG®

Over 6 months £2.75

EHf with MCT (medium chain triglycerides)– Initiated by secondary Care only

Pregestimil Lipil® From birth Suitable only when CMPA is also accompanied by fat malabsorption.

£3.05

Pepti Junior® From birth £2.90

NB: Infatrini® Peptisorb is a high calorie EHf for mild to moderate CMPA with poor intake and poor

weight gain but no significant growth faltering. See also section 6.

3.4.2 Amino Acid Formula (AAf)

In AAf, the milk protein is broken down into individual amino acids. AAf is suitable only if at least one of the following criteria is met:

Persistent symptoms after 4 weeks on EHf;

Severe CMPA such as faltering growth and severe GI symptoms;

A history of anaphylactic reaction to cow’s milk formula;

Persistent symptoms in breast fed infants unresponsive to maternal dairy free diet for 4 weeks, or mother does not wish to continue breastfeeding.

AAf should only be prescribed on advice or recommendation of a Paediatric Consultant. GPs can

contact the consultant-led paediatric allergy advice service via [email protected] for

specialist advice on appropriateness of AAf before starting it in new patients.

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AAf – Secondary Care Recommendation/ Initiation only

Alfamino® From birth up to 18 months old, or when able to tolerate OTC products

Most cost-effective AAf. Has higher vitamin A content.

£5.75

Nutramigen® PurAmino

Gluten and lactose free. Previously known as Nutramigen® AA.

£6.77

Neocate LCP®

From birth - 1 year Can be used as a sole source of nutrition up to the age of 1 year.

£7.18

Other AAf

Neocate® Junior

From 1 year – 10 years

Neocate® Junior will replace Neocate® Active and Neocate® Advance over a period of 12 months, from April 2017 to April 2018. These are high calorie formulas and will not be required automatically by all infants over 1 year. Suitable as a sole source of nutrition or as a supplement.

£ 7.18 (unflavoured/ vanilla/ strawberry)



3.4.3 Products Not Suitable for Prescribing in CMPA

1. Soya products: Wysoy®

Soya products should NOT be routinely prescribed for infants with CMPA, in particularly those under 6 months due to high phytoestrogen content. It may be used in infants over 6 months who do not tolerate first line EHf due to issues with palatability. There is a risk of co-sensitisation to soya in infants with predominantly GI symptoms of CMPA. It is more likely that children will tolerate soya formula from 1 year, and parents should be advised to purchase soya formula or Alpro Soya Growing Up Drink (1+ Years) from 1 year of age as these are similar costs to cow’s milk formula, in line with Clinical Commissioning Policy 88 and 250.

2. Lactose free formula: Aptamil® LF, SMA® LF and Enfamil® O-Lac.

Lactose intolerance is not the same as CMPA and these formulas are cow’s milk based. EHf or AAf

should not be prescribed for transient lactose intolerance.

3. Rice milk: Unsuitable under age of 5yrs due to arsenic content.

4. Other mammalians milk e.g. Goat’ milk, Sheep milk products have similar protein composition to

cow’s milk so are not suitable for treating CMPA.

3.5 Prescription Management

1. Try a formula for a minimum of two weeks and maintain for at least four weeks before further

changes.

2. Specialist formulas may be prescribed for infants with CMPA usually for no longer than 6 – 12

months. All children on EHf should be reviewed by GPs at 12 months and then 18 months as

appropriate. For those who are on AAf, GPs should review latest correspondence from the specialist or

dietitian as there may be changes in formula or quantity.

3. Parents of all children with non-IgE CMPA should be advised on graded dairy introduction using the iMAP milk ladder (see appendix 5) after 6 months of exclusion. This is a test for acquired tolerance and helps resolution if certain dairy products are well tolerated. The iMAP milk ladder (see appendix 5) should be shared with parents as it contains useful practical pointers to support parents at home. iMAP milk ladder recipes can be downloaded here. 4. Review prescriptions regularly and refer to latest correspondence from specialist for any change in

formula or quantity. Review and consider stopping prescription if the patient meets one or more of the

following criteria:

On the formula for more than a year

The quantity of formula prescribed is higher than recommended above (see section 2.1)

Patient can eat cow’s milk containing foods such as cow’s milk, cheese, yogurt, ice-cream,

custard, cakes, chocolate, cream, ghee and etc.

Over 18 months old. Please note children with multiple or severe allergies may require

prescriptions beyond 18 months old. This should always be on the recommendation of the

paediatric dietitian or consultant.






https://ctajournal.biomedcentral.com/articles/10.1186/s13601-017-0162-y


Please send a new referral or liaise with appropriate services if the child is already under the care of a

paediatric dietitian or paediatric allergist.

3.6 Reintroducing Cow’s Milk Products

1. Note that this is different from the Early Home Reintroduction usually performed 2 – 4 weeks after

introducing EHf, which is aimed at confirming CMPA diagnosis (see section 3.2.2).

2. Children on long-term EHf or AAf should be reintroduced to dairy on a graded approach, to establish

if they have acquired tolerance to CMP. About 60 – 75% of children outgrow CMPA by 2 years of age,

rising to 85-90% at 3 years of age.

3. For exclusively breastfed infants who have been symptom-free for at least 6 months:

- Re-introduce dairy products to maternal diet from 9-12 months and if tolerated, use the iMAP

milk ladder (see appendix 5) for graded dairy re-introduction. iMAP milk ladder recipes can be

downloaded here.

4. For formula only and mixed formula/ breast-fed children who have been symptom-free for at least

6 months:

- Re-introduce cow’s milk products using the the iMAP milk ladder (see appendix 5) around 9-12

months old and every 2 months thereafter until tolerated. iMAP milk ladder recipes can be

downloaded here.

5. All children with IgE CMPA should have a plan of dairy reintroduction from Paediatric allergist when

safe. No Home Reintroductions should be performed in these patients.

3.7 Weaning

When an infant with CMPA reaches 6 months and starts to be weaned, it is important that an adequate

calcium intake is achieved, particularly whilst remaining on a CM-free weaning diet. Refer to community

or paediatric dietitian for support at this stage.





https://www.allergyuk.org/assets/000/001/294/iMAP-Recipes_%28Final%29_original.pdf?1502804763


4. Gastro-oesophageal Reflux Disease (GORD)

GORD is the passage of gastric contents into the oesophagus causing troublesome symptoms and/ or complications. About 50% of infants have some degree of reflux at some time. In most infants it is physiological and with minimal effect so most parents can be reassured. Regurgitation of feeds is worse with higher volumes of feed but improves with thickened feeds.

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Product Age group

Notes Cost/ 100g (June 2017)

Cow & Gate® Anti-reflux

From birth

Readily available to purchase OTC in most pharmacies and major supermarkets. *N/B: SMA® Staydown will be available for a further few months (replaced by SMA® PRO Anti-reflux).

£1.28 (R*)

Aptamil® Anti-reflux £1.44 (R)

SMA® Staydown* £1.22 (R)

SMA® PRO Anti-reflux

£1.25 (R)

Enfamil® AR This may need to be ordered in specially at the pharmacy

£1.73 (R)

R* = Retail price

Refer to specialist paediatric

No

Bottlefed

Breastfed

No improvement

Review

Trial with Infant Gaviscon® offered on a spoon for 1-

2 weeks, up to max 6 times a day

Refer to specialist

paediatrician care

Cow and Gate® Anti-reflux,

Aptamil® Anti-reflux,

SMA Staydown®,

SMA® PRO Anti-reflux,

Enfamil AR®.

If symptoms persist, STOP the thickening

formula and trial Infant Gaviscon® for 1 -2

weeks. DO NOT prescribe separate

thickeners, antacids, PPIs or ranitidine

with thickening formula.

Trial using Carobel® to thicken standard

formula or one of the following for 1 - 2

weeks. These are available OTC and

should be purchased by parents:

Continue with treatment and review regularly to check growth

and symptoms. Trial stopping treatment at intervals and by 12

months as 90% of children usually outgrow GORD by then.

Once vomiting resolves return to standard formula.

Symptoms: effortless vomiting after feeding (not projectile) usually in the first 6 months e.g. regurgitation

of a significant volume of feed, reluctance to feed, distress/ crying at feed times, small volumes of feed

being taken

Rule out over feeding: check volume and frequency

of feeds - average requirement in babies <6 months is

150ml/kg/day and should be spread over 6-7 feeds.

Advise on feeding position and activity following a feed.

Does the infant have faltering growth?

The infant is thriving

and NOT distressed

The infant is thriving BUT distressedReassure and monitor, symptoms are likely

to improve over time, usually by 12 months.

Provide advice on avoidance of

overfeeding, positioning during and after

feeding, and activity after feeding.

If infant is clearly overfed, advise

restriction of volumes of feed

Yes

Yes

Improvement


5. Secondary Lactose Intolerance

Primary lactose intolerance is rare and is caused by an inherited deficiency of lactase which breaks

down lactose. Primary lactase deficiency usually develops after the age of two years, when

breastfeeding or bottle-feeding has stopped. The symptoms may not be noticeable until adulthood.

Secondary lactose intolerance is due to impaired lactase activity in the intestinal brush border and it is

neither immune mediated nor a feature of atopy. Secondary lactose intolerance in children occurs post

gastroenteritis and rarely following other gut insults such as prolonged courses of antibiotics. Symptoms

are usually self-limiting.

Parents of breastfed babies with lactose intolerance should be advised to purchase lactase enzyme

drops (e.g. Colief®). This should not be prescribed on the NHS. Exclusion of lactose from the maternal

diet is unnecessary as lactose is present in breast milk independent of diet. More severe or persistent

symptoms suggestive of lactose intolerance will need paediatric assessment if lactase is ineffective.

Alternative diagnosis such as CMPA will need to be considered for persistent gastrointestinal

symptoms.

Parents qualifying for Healthy Start vouchers can use these to purchase lactose free formula where the

packaging states that the milk is based on cow’s milk and can be used from birth, e.g. SMA® LF and

Enfamil® O-Lac.

Traffic Light


Enfamil® O-Lac

From birth to 1 year

Lactose, sucrose and fructose free cow’s milk formula. May need to be ordered in specially at the pharmacy.

£2.30 (R*)

SMA® LF From birth up to 1 year

Not suitable for those who are allergic to cows' milk protein. Available to purchase OTC in pharmacies and major supermarkets.

£1.40 (R)

Aptamil® LF From birth to 1 year

£1.50 (R)

Lactofree® From 1 year £0.14/ 100ml (R)

R* = Retail price

Symptoms: abdominal bloating, increased (explosive) wind, loose green stools for > 2 weeks.

Diagnosis is confirmed if symptoms resolved within 48 hours of withdrawing lactose from diet.

Trial OTC lactose-free formula for 2 weeks. These can be bought at a similar cost to standard

formula: <12 months: Aptamil LF®, SMA LF®, Enfamil O-Lac® (may need to pre-order from

pharmacies) >12 months: LF full fat milk (e.g. Lactofree® brand) can be bought in supermarkets

Not lactose Intolerance

Consider alternative

diagnosis e.g. CMPA.

Refer to specialist care.

Note: Rarely symptoms may

last up to 3 months

Continue LF formula for up to 8 weeks gradually then re-

introduce standard formula/milk into diet. If symptoms return

restart LF formula until normal dairy tolerated.

There is a need to await natural resolution. Referral needed

if symptoms do not improve on LF formula.

Lactose Intolerance confirmed

Symptoms improved Symptoms not improved


6. Faltering Growth

Faltering growth is when an infant falls below the 0.4th centile or crosses 2 centiles downwards from

initial centile on a growth chart. Refer to paediatric services without delay. Specialist formula for

children with faltering growth should only be prescribed in primary care following assessment and

recommendations from a Consultant Paediatrician or Paediatric Dietitian.

GPs can access specialist advice via [email protected].

Traffic Light

Product Age group Notes Cost/ 100ml (June 2017)

SMA® PRO High Energy

From birth up to 18 months or 8kg.

Refer to paediatric services without delay. All infants will need growth monitoring to ensure catch up growth is achieved. Discontinue when on an appropriate diet as per dietitian advice.

£0.99

Similac® High Energy

£1.07

Infatrini® £1.16

Infatrini® Peptisorb

From birth up to 18 months or 9kg. Suitable for infants with faltering growth and intolerance to whole protein feeds, e.g. short bowel syndrome, intractable malabsorption, inflammatory bowel disease, bowel fistulae

£1.77

7. Preterm Infants

Pre-term infants will have been commenced on a pre-term formula (eg Nutriprem®) in hospital prior to

discharge. Pre-term formula should not be commenced in primary care unless recommended by a

specialist. The GP can continue prescribing the pre-term formula, until the baby is 6 months corrected

age i.e. Expected Delivery Date (EDD) + 26 weeks. At this stage the GP should review the prescription

and switch to a standard term formula which should be purchased by parents.

If there is a concern about growth, the baby should be referred back to the neonatal unit for advice. Not all babies require pre-term formula for the full 26 weeks from EDD. If there is excessive weight gain at any stage up to 6 months corrected age, the pre-term formula may be discontinued and a change made to a standard formula. Ready to feed liquids are substantially more expensive than the powder and should not be prescribed in primary care unless there is a clinical need e.g. the baby is immunocompromised, tube fed or there has been a specific request by secondary care.

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Product Age group Notes Cost/ 100 kcals (June 2017)

Nutriprem® 2

powder From birth to 6 months (corrected age)

GP to review and stop prescription at 6 months corrected age or if excessive weight gain.

£0.26

SMA® PRO Gold Prem 2 powder

£0.23



Traffic Light

Product Age group Notes Cost/ 100 kcals (June 2017)

Nutriprem® 2 liquid Only prescribe if the infant is immune-compromised, tube fed or as directed by secondary care.

£1.16

SMA® PRO Gold Prem 2 liquid

£1.12

8. Metabolic Products

Children under Dietetic Care may need to have other specialist formulas for reasons other than CMPA. Two examples of these could include formulas or products for metabolic patients and hydrolysed or amino acid based formulas for gastroenterology symptoms or treatment.

9. References and Acknowledgement

References: Bernie Canani R et al. (2013) Formula selection for management of children with cow’s milk allergy influences the rate of acquisition of tolerance: a prospective multicentre study. J Pediatr, 163 (3):771-7. Buller HA, Rings EH, Montgomery RK,Grand RJ. (1991) Clinical aspects of lactose intolerance in children and adults. Sc and J Gastroenterolgy Suppl,188:73-80.

Food Standard Agency statement on arsenic levels in rice milk (2009) http://webarchive.nationalarchives.gov.uk/20120403220542/http://www.food.gov.uk/multimedia/pdfs/fsis0209arsenicinrice.pdf Milk Allergy in Primary Care (MAP) Guidelines: Venter C, Brown T, Shah N, Walsh J Fox AT. (2013) Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy - a UK primary care practical guide, Clinical and Translational Allergy, 3:23. www.cowsmilkallergyguidelines.co.uk/the-map-guideline/

Venter et al. (2017) Better recognition, diagnosis and management of non-IgE-mediated cow’s milk allergy in infancy: iMAP—an international interpretation of the MAP (Milk Allergy in Primary Care) guideline, Clinical Translational Allergy, 7:26. https://ctajournal.biomedcentral.com/articles/10.1186/s13601-017-0162-y NICE (2011) Food Allergy in Children and Young People. https://www.nice.org.uk/guidance/cg116. NICE (2015) Gastro-oesophageal reflux disease in children and young people. NG1 www.nice.org.uk Acknowledgement: This guideline has been produced by the Medicines Optimisation Team, Oxfordshire Clinical Commissioning Group in consultation with: Dr Felicitas Obetoh, Paediatrician with Interest in Allergy, Paediatric Allergy Clinic, Oxford University Hospitals NHS Trust

http://webarchive.nationalarchives.gov.uk/20120403220542/http:/www.food.gov.uk/multimedia/pdfs/fsis0209arsenicinrice.pdf

http://webarchive.nationalarchives.gov.uk/20120403220542/http:/www.food.gov.uk/multimedia/pdfs/fsis0209arsenicinrice.pdf

http://www.cowsmilkallergyguidelines.co.uk/the-map-guideline/


https://www.nice.org.uk/guidance/cg116

https://www.nice.org.uk/guidance/ng1?unlid=149969625201672210456


Dr Kenny McCormick, Neonatal consultant, Oxford Newborn Care Unit, Oxford University Hospitals NHS Trust Katheryn Clarke and colleagues, Community Paediatric Dietetics Team, Oxford University Hospitals NHS Foundation Trust Suzanne Bradshaw, Prescribing Support Dietitian, Oxfordshire Clinical Commissioning Group This guideline has been based on the following documents: PrescQIPP Bulletin 146, November 2016: Appropriate prescribing of specialist infant formulae (foods for special medical purposes) Central London Community Healthcare, Paediatric Dietetics Service, August 2015: Primary Care Specialist Infant Formulae Prescribing Guidance Pan Mersey Area Prescribing Committee, November 2014: Pan-Mersey Prescribing Guidelines for Specialist Infant Formula Feeds in lactose Intolerance and Cow’s Milk Protein Allergy. Ipswich and East Suffolk Clinical Commissioning Group, September 2015: Recommendations for Prescribing Specialist Infant Formula 2015/16.

https://www.prescqipp.info/infant-feeds/send/93-infant-feeds/3141-bulletin-146-infant-feeds

https://www.prescqipp.info/infant-feeds/send/93-infant-feeds/3141-bulletin-146-infant-feeds


Appendix 1: Suspected Cow’s Milk Allergy (CMA) in the 1st Year of Life


Appendix 2: Primary Care Management of Mild to Moderate Non-IgE CMA


Appendix 3: Initial factsheet for parents


Appendix 4: The Early Home Reintroduction to Confirm Diagnosis – leaflet for parents


Appendix 5: The iMAP Milk Ladder


Appendix 6: Infant Formula products – quick reference guide

ALL CONDITIONS - Suggested Prescribing Quantities of Powdered Formula per month

< 6months 6 -12 months >12 months

13 x 400g tin OR 6 x 900g tins 7-13 x 400g tins OR 3-6 x 900g tins 7 x 400g tins OR 3 x 900g tins

Milk Type Proprietary Brand Suitable for Cost / Original pack (T = Trade; R = Retail)

Cost / 100g or 100ml

Supply Route

Cow’s Milk Protein Allergy (CMPA)

Extensively Hydrolysed Formula (EHf)

Nutramigen LGG1 < 6m £10.99 (400g)T £2.75 FP10

Nutramigen LGG2 > 6m £10.99 (400g) T £2.75 FP10

Aptamil Pepti 1 < 6m £19.70 (800g) T £2.47 FP10

Aptamil Pepti 2 > 6m £9.35 (400g) T £2.35 FP10

Similac Alimentum 0 – 18m £9.10 (400g) T £2.28 FP10

Althera 0 – 18m £10.68 (450g) T £2.37 FP10

Pregestimil Lipil From birth £12.19 (400g) T £3.05 FP10

Pepti Junior From birth £13.06 (450g) T £2.90 FP10

Amino Acid Formulas (AAf)

SMA Alfamino From birth £23.00 (400g) T £5.75 FP10

Nutramigen PurAmino From birth £27.09 (400g) T £6.77 FP10

Neocate LCP From birth £28.70 (400g) T £7.18 FP10

Neocate Junior From 1 year to 10 years

£28.70 (400g) T £7.18 FP10

Review need if child is 18 months, has been prescribed for >1 year, able to eat cheese, yoghurt, chocolate, or butter

Gastro-oesophageal Reflux Disease

Anti-Reflux Cow & Gate Anti-reflux From birth £11.21 (900g) R £1.28 OTC

Aptamil Anti-reflux From birth £13.49 (900g) R £1.44 OTC

*SMA Staydown From birth £10.99 (900g) R £1.22 OTC

SMA PRO Anti-reflux From birth £10.00 (800g) R £1.25 OTC

**Enfamil AR From birth £6.90 (400g) R £1.73 OTC

* Being replaced by SMA PRO Anti-reflux and is available for further few months. ** may have to be specially ordered at the pharmacy

Secondary Lactose intolerance

Lactose-free SMA LF < 12m £6.00 (430g) R £1.40 OTC

Enfamil O-Lac < 12m £9.21 (400g) R £2.30 OTC

Aptamil LF < 12m £5.99 (400g) R £1.50 OTC

Lactofree >12m £1.35 (1000ml) R £0.14 Shops

Symptoms usually resolve within 8 weeks. Lactose free milk is available in supermarkets for infants > 12 months

Faltering Growth

High energy SMA PRO High Energy Birth – 18m/ 8kg £1.97 (200ml) T £0.99 FP10

Similac High Energy Birth – 18m/ 8kg £2.13 (200ml) T £1.07 FP10

Infatrini Birth – 18m/ 8kg £2.23 (200ml) T £1.11 FP10

Infatrini Peptisorb Birth – 18m/ 9kg £3.54 (200ml) T £1.77 FP10

Ensure that there is a clear goal and discontinuation point

Pre-term

Initiated in secondary care

Nutriprem 2 powder Birth – 6m (corrected age)

£11.67 (900g) T £0.26 FP10

SMA PRO Gold Prem 2 powder

Birth – 6m (corrected age)

£4.92 (400g) T £0.23 FP10

Nutriprem 2 liquid Birth – 6m (corrected age)

£1.74 (200ml) T £1.12 FP10

SMA PRO Gold Prem 2 liquid

Birth – 6m (corrected age)

£2.05 (250ml) T £1.16 FP10

These milks are not suitable for infants > 6months (corrected age). Do not prescribe ready to use liquid unless essential

Guidelines on Prescribing Specialist Infant Formulas in Primary Care v1. Approved APCO September 2017. Review September 2019.

Appendix 7: Summary of guidelines (NOT TO BE USED FOR DIAGNOSIS)

Summary of Guidelines on prescribing specialist infant formula in primary care (NOT TO BE USED FOR DIAGNOSIS) For diagnosis and prescribing please see the full OCCG guidelines.

Some children may require more, e.g. those with faltering growth. Review recent correspondence from the paediatrician or paediatric dietitian.

All conditions: How much powdered infant formula should I prescribe monthly?

Under 6 months 6 – 12 months Over 12 months

400g tin 900g tin 400g tin 900g tin 400g tin 900g tin

Up to 12 tins Up to 5 tins 6 – 12 tins 3 – 5 tins Up to 6 tins Up to 3 tins

Cow’s Milk Protein Allergy

(CMPA):

IgE symptoms (<2hrs onset) [See page 4 of the full guidelines for diagnosis algorithm] – Skin symptoms: urticaria, pruritus, angioedema; respiratory: difficulty in breathing and swallowing, hoarse cry, acute wheeze or anaphylaxis.

Non-IgE symptoms (2-72hrs onset) [See page 5 of the full guidelines for diagnosis algorithm] - Skin symptoms: pruritus, erythema, urticaria, atopic dermatitis; GI symptoms: diarrhoea, bloody stools, vomiting, abdominal distention, colicky pain, constipation, GORD; Respiratory symptoms: recurrent wheeze/ cough, nasal itching, sneezing or congestion and rhinorrhoea. Growth faltering.

Most infants with CMPA develop symptoms within 1- 2 weeks of introduction. Mild – moderate non-IgE CMPA can be managed in primary care. Early diagnosis and treatment is very important. Download The iMAP Milk Allergy Guideline– Initial Fact Sheet for parents whose infants fall under this group.

Breast milk is the best choice for most infants with CMPA. Breastfeeding mothers may require a dairy free diet and daily 1000mg calcium and 10 mcg Vitamin D supplementation.

Refer to paediatric community or paediatric dietitians for weaning advice before infant is 6 months of age. Always review the latest clinic correspondence before issuing each prescription to ensure any recommended changes are implemented.

First line: Extensively Hydrolysed formula (EHf) Soya milk, lactose-free (LF) formula, rice milk or other mammalians milk are not suitable in CMPA

Most cost-effective: Similac Alimentum

Other options: Althera, Aptamil Pepti 1&2, Nutramigen 1&2 with LGG

To confirm diagnosis, perform Early Home Reintroduction in infants with mild-moderate non-IgE CMPA (2 – 72 hours). Not safe for immediate symptoms of IgE CMPA. At diagnosis EHf should be continued for at least 2 -4 weeks and if symptoms improve, Home Reintroduction should be performed after 2-4 weeks of starting EHf to confirm the diagnosis of CMPA. Download iMAP’s parent leaflet on The Early Home Reintroduction to confirm diagnosis to support parents at home.

Second line: Amino Acid formula (AAf) Secondary care initiation or recommendation only. Consultant-led email advice: [email protected].

Most cost-effective: Alfamino

Other options: Nutramigen PurAmino, Neocate LCP, Neocate Junior

Reintroduction: Patients should be evaluated after at least six months of exclusion of dairy products to assess acquired tolerance to CMP. Download iMAP milk ladder and recipes to support parents reintroduce CM at home, provided there is no history of immediate allergic reactions or other indications for referral to secondary care.

Review the need for specialised formula prescription regularly and consider STOPPING if any of the following applies: Can the patient tolerate any dairy foods? Is the patient over 18 months old (continue treatment if specifically indicated by specialists)? Has the formula been prescribed for more than one year? Is the quantity prescribed more than the recommended amount?

Refer infants with anaphylaxis or faltering growth to secondary care

urgently.

https://www.allergyuk.org/assets/000/001/299/iMAP_Patient_Factsheet_original.pdf?1502805714

https://www.allergyuk.org/assets/000/001/298/Home_Reintroduction_Protocol_to_Confirm_or_Exclude_Diagnosis_original.pdf?1502805714


https://www.allergyuk.org/assets/000/001/297/iMAP_Final_Ladder-May_2017_original.pdf?1502804928

https://www.allergyuk.org/assets/000/001/294/iMAP-Recipes_%28Final%29_original.pdf?1502804763


Gastro-oesophageal

Reflux Disease (GORD)

GORD presents with a history of effortless vomiting after feeding (up to two hours), usually in the first six months of life. [See page 10 of the full guidelines for more details]

Over feeding should be ruled out by establishing the volume and frequency of feeds.

Give reassurance and advice on positioning post-feeds.

Infant Gaviscon can be given up to a maximum of six times per day.

Initially recommend adding Carobel (available from pharmacies) to current standard formula, or trial anti-reflux formula (available from pharmacies/ supermarkets) for 1-2 weeks and review symptoms.

Cow and Gate Anti-reflux, Aptamil Anti-reflux, SMA PRO Anti-Reflux, Enfamil AR

Secondary Lactose

Intolerance

Secondary lactose intolerance usually occurs following an infectious GI illness (but can occur alongside new or undiagnosed coeliac disease) and is usually self-limiting. [See page 11 of the full guidelines for more details]

Symptoms include abdominal bloating, increased explosive wind and loose green stools.

Resolution of symptoms within 48 hours of withdrawal of lactose from the diet confirms diagnosis.

Initially recommend over-the-counter lactose-free (LF) formula for two weeks. Continue LF formula for up to eight weeks if symptoms improved. Symptoms usually resolve within this time but in rare cases may take up to three months.

0 – 12 months: Enfamil O-Lac, SMA® LF, Aptamil LF

Over 12 months: Lactofree

Faltering Growth

Faltering growth cannot be detected without using a growth chart. Diagnosis is usually made when an infant falls below the 0.4th centile or crosses 2 centiles downwards on a weight or height centile. [See page 12 of the full guidelines for more details] Consultant-led email advice: [email protected].

First line: High-energy formula Secondary care initiation or recommendation only. Discontinue when on an appropriate diet as per dietitian advice.

Most cost-effective: SMA PRO High Energy

Other options: Similac High Energy, Infatrini, Infatrini Peptisorb (high calorie EHf)

Pre-term

These infants will have had their pre-term formula commenced on discharge from the neonatal unit and will be under regular review by the paediatricians. Pre-term formula should not be commenced in primary care unless recommended by a specialist. GPs should discontinue these formulas after the infants are six months corrected age or if there is excessive weight gain. [See page 12 of the full guidelines for more details]

Started in secondary care: Pre-term formula DO NOT prescribe liquid formula unless immune-compromised, tube fed or clinically indicated by secondary care.

Nutriprem 2 powder, SMA PRO Gold Prem 2 powder

Nutriprem 2 liquid, SMA PRO Gold Prem 2 liquid

This quick reference guide has been adapted from PrescQipp B146: Specialist infant feeds quick reference guide.

Refer to secondary care without delay.

Refer infants with faltering growth to secondary care without delay.


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