Hertfordshire Guidelines for Prescribing Specialist Infant Feeds

Transcription

1 Hertfordshire Guidelines for Prescribing Specialist Infant Feeds CONTENTS PAGE Introduction 2 Guidance on volumes of specialist infant feed to prescribe 2 Cow s Milk Protein Allergy (CMPA) 3 Secondary lactose intolerance 9 Faltering growth 10 Preterm infants 11 Gastro-oesophageal reflux (GOR) 12 Dos and Don ts of prescribing specialist infant formulae 13 Comparative cost of specialist infant formulae 14 National and local spend 15 Acknowledgements 16 References 17 Appendices Appendix 1 Cow s milk protein allergy frequently asked questions Appendix 2 Initial advice for those needing a milk free diet Appendix 3 MAP home milk challenge guidance for parents Appendix 4 MAP milk ladder guidance for parents Appendix 5 Information leaflet - Help, my child is not eating Glossary ehf AAF CMP CMPA GOR extensively hydrolysed formula amino acid formula cow s milk protein cow s milk protein allergy gastro-oesophageal reflux Colour Key for Specialist Infant Formulae products Use as first line Use if first line is unsuccessful Secondary care initiation. Not to be routinely started in primary care. If commenced in primary care, ensure infant is referred to paediatrician and paediatric dietitian Available to purchase over-the-counter at a similar cost to standard infant formula (should not be routinely prescribed) 1

2 Introduction These guidelines have been produced for use in primary care to provide clarity on which specialist infant formulae and in which clinical circumstances these products can be prescribed. Appropriate prescribing will also help reduce prescription costs. Providing infant formulae which is inappropriate on prescription is considered to be inequitable prescribing since the prescription is supplied effectively at no charge but there is no equivalent support available for breast feeding mothers or parents that purchase their own infant formulae from supermarkets or over the counter at pharmacies. Some patients may be eligible for supply of milk via the Healthy Start Scheme. For more information, refer to Healthy Start: The guidance is targeted at infants 0-12 months of age. However some of the prescribable preparations listed can be used past this age and advice on this is included. Whilst these guidelines advise on appropriate prescribing of specialist infant formula, breast milk remains the optimal milk for infants. This should be promoted and supported wherever possible, when it is clinically safe and the mother is in agreement. The guidelines advise on o Over-the-counter (OTC) products where appropriate o When to initiate a specialist infant feed in primary care o Recommended quantities to prescribe. It is advisable to prescribe to only prescribe 1-2 tins of formula initially to assess tolerance/acceptance. o Which products to use for different clinical conditions o Triggers for reviewing and discontinuing prescriptions o When to make a referral for dietetic advice and/or secondary/specialist care o Information for parents/carers Quantities of specialist formulae to prescribe When any infant formula is prescribed the guide below should be used: Powder Formula Age of Infant Under 6 months 6 12 months Over 12 months Number of tins for 28 days and Basis for Recommendation 13 x 400g tins OR 6 x 900g tins Infants <6 months are exclusively formula fed and drink (on average) 150ml/kg/day of a normal concentration formula x 400g tins OR 3-6 x 900g tins Infants aged 6-12 months require less formula as solid food intake increases 7 x 400g tins OR 3 x 900g tins The Department of Health recommends infants >12 months drink 600ml of milk or milk substitute per day Liquid High Energy Formula Prescribe an equivalent volume of formula to the child s usual intake until the assessment has been performed and recommendations made by the paediatrician or paediatric dietitian. Always review recent correspondence from the paediatric dietitian/paediatrician Some infants may require more than the quantities stated above e.g. those with faltering growth 2

3 COWS MILK PROTEIN ALLERGY (CMPA) Symptoms and Diagnosis NICE Clinical Guideline 116 (February 2011) Food Allergy in children and young people covers the diagnosis and assessment in primary care and community settings The NICE care pathway covers initial recognition to referral to specialist services Refer to NICE guidelines for history taking and symptoms. Suspect CMPA after careful allergy focused clinical history taking. Symptoms differ if the allergy is IgE-mediated or non-ige mediated (see management flow chart of suspected CMPA, Page 6) Most babies presenting with colic, restlessness and/or crying do not have CMPA. Seek health visitor advice to ensure problems with feeding technique and formula reconstitution are addressed. Infantile colic is often defined by the rule of three : crying for more than three hours a day, for more than 3 days a week, and for longer than three weeks in an infant who is well-fed and otherwise healthy. If IgE mediated CMPA is suspected, NICE recommends referral to secondary/specialist care for further investigation with a serum specific IgE antibody blood test or a skin prick test. Onward referral All infants with CMPA should be referred to a paediatric dietitian to support the management of the infant in primary care. Dietetic advice should be sought on the diagnostic home milk challenge, weaning, review periods, milk ladder and any other issues with specialist infant formulae. Refer to secondary/specialist care if any of the following apply: - o Faltering growth with one or more gastrointestinal symptoms o Acute systemic reactions or severe delayed reactions o Significant atopic eczema where multiple or cross-reactive food allergies are suspected o Possible multiple food allergies o Persisting parental suspicion of food allergy despite a lack of supporting history (especially where symptoms are difficult or perplexing) o If IgE-mediated CMPA is suspected Treatment For exclusively breast-fed infants, a strict exclusion of cow s milk and containing foods from the maternal diet is indicated for a minimum of 2 weeks. Calcium (1000mg) and vitamin D (10mcg) supplementation may be required for mothers on a cow s milk free diet. For formula-fed infants, extensively hydrolysed formulae (ehfs) are the 1 st choice unless the infant has a history of anaphylactic symptoms. Trial an ehf for a minimum of 2 weeks. Amino acid formulae (AAF) should normally be started in secondary/specialist care or on the advice of a dietitian. They are suitable only when an ehf does not resolve symptoms and/or there is evidence of severe (anaphylactic) allergy. Only 10% of infants with CMPA should require management with an AAF. 90% should improve with an ehf. If the infant has a history of anaphylactic reaction to cow s milk, an AAF can be started in primary care, with immediate referral to secondary/specialist care. EHF and AAF have an unpleasant bitter taste and smell, which is better tolerated by younger patients. Unless there is anaphylaxis, advise that the new formula is introduced gradually by 3

4 mixing with the usual formula in increasing quantities until transition complete. Serving in a bottle, closed cup or with a straw may improve compliance or use a minimal amount of milkshake flavouring take care to check ingredients if child has multiple allergies. Specialist Infant Formulae used in CMPA Only prescribe 1-2 tins initially to assess tolerance/ acceptance and to avoid waste Infants who do not tolerate one formula due to palatability may accept another formula Specialist Infant Formula for CMPA Age Range Size of tin 3 rd line Cost (NHS*) per tin Recommended quantity prescribed per month EXTENSIVELY HYDROLYSED FORMULAE ehf (Lactose Free) 1 st CHOICE in PRIMARY CARE Nutramigen 1 st Lipil 1 Birth to 6 months 400g tins line Nutramigen Lipil 2 6 months to 2yrs 400g tins 2 nd (<6m) tins line Similac Alimentum Birth to 2yrs 400g 9.10 (>6m) 7 13 tins 400g tins Aptamil Pepti 1 Birth to 6 months 900g tins Aptamil Pepti 2 6 months to 2yrs 900g tins Pepti contains lactose - can be tried if 1 st /2 nd line products cannot be tolerated because of taste SOYA FORMULA ONLY IN INFANTS OVER 6 MONTHS TO BE BOUGHT OVER THE COUNTER (OTC) 4 th line after Infasoy Over 6 months ONLY due 900g 8.14 (RRP 9.30) 1 st /2 nd /3 rd line to high phyto-oestrogen Do not prescribe - Wysoy 430g 5.20 ehfs content parent to buy OTC 860g 9.91 (RRP 12.95) Soya formula should NOT be routinely used for CMPA. NOT to be used in under 6 months. Only to be used in over 6 months when 1 st /2 nd /3 rd line ehfs cannot be tolerated. Risk that CMPA infant may also develop soya allergy. Advise parents to purchase soya formula as similar cost to standard cow s milk formula and readily available. Soya formulae should not be prescribed on the NHS. Infant > 1 year more likely to tolerate soya formula. Alpro Junior 1+ soya milk may be suitable from 1 year From 2 years, supermarket calcium enriched soya or oat milk may be suitable as alternative milk source Dietitian will advise on suitable over the counter (OTC) products for appropriate ages. EXTENSIVELY HYDROLYSED FORMULA ehf (with medium chain triglycerides) SPECIALIST INITIATION Pepti-Junior Birth to 2yrs/able 450g (<6m) tins Pregestamil Lipil to tolerate CMP 400g (>6m) 7 13 tins These are used where CMPA is accompanied by malabsorption SPECIALIST INITIATION ONLY AMINO ACID FORMULAE (AAF) USUALLY SPECIALIST/DIETITIAN INITIATION - reserved for when ehf does not resolve symptoms or when history of anaphylaxis **PurAmino /Nutramigen AA Birth to 2yrs/able 400g (<6m) tins Neocate LCP to tolerate CMP 400g (>6m) 7 13 tins Neocate Active >1 year 15 x 63g 4.44/sachet 56 sachets or as Neocate Active is a high calorie formula and will not be required automatically by all infants over 1 year. It is not suitable as a sole source of nutrition. recommended by dietitian Neocate Advance (unflavoured) >1 year 10x100g 5.76/sachet Neocate Advance (banana & vanilla) >1 year 15x50g 2.99/sachet Quantity to be Neocate Advance is a sole source of nutrition for tube fed only patients aged 1-10yrs. It is a high calorie product and will not be required automatically by all infants >1 year recommended by dietitian Neocate Spoon >1 year 15x37g 2.53/sachet See information on Page 5 regarding calcium intake when the patient reaches 6 months and starts to be weaned * NHS product costs obtained from Dictionary of Medicines and Devices Oct 2014 **PurAmino is the new product name for Nutramigen AA from 1 st March

5 Breast milk is the ideal choice for most infants with CMPA. The following are not recommended: - Lactose free formulae (SMA LF, Enfamil O-Lac ) are not suitable for treating CMPA. Do not advise sheep, goat or mammalian milk as an alternative due to cross sensitivity. Rice milk is not suitable for children under 5 years due to the arsenic content. Weaning and Calcium Intake Daily volumes of CMPA required to meet calcium RNI ehf ehf with MCT AAF CMPA formula Age Range Calcium content (mg) Per 100g Per 100ml Daily volume intake required to meet RNI (524mg)in 6-12months Daily volume intake required to meet RNI (352mg) in 12-24months Nutramigen Lipil 1 0-6m N/A N/A Nutramigen Lipil m ml 375ml Similac Alimentum 0-24m ml 495ml Aptamil Pepti 1 0-6m N/A N/A Aptamil Pepti m ml 560ml Pepti- Junior ,050ml 705ml 0-24m Pregestamil Lipil ml 450ml PurAmino / Nutramigen AA 0-24m ml 550ml Neocate LCP ml 535ml 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 milk-free weaning diet. Once weaning has been established, the volume of CMPA formula that the infant requires per day is reduced. The recommended intake for an infant >6 months on standard formula is ml per day. See table above for the daily volumes required for each of the CMPA formulae to meet the RNI (Reference Nutrient Intake) for calcium for infants aged 6-12 months and months. Therefore if the infant is not taking these daily volumes, there is the potential risk that there may be insufficient calcium intake from the CMPA formula feed and it is unlikely that the shortfall would be made up by dietary intake from solid food since calcium-containing dairy products which would normally be used in a weaning diet would not be tolerated. Nutramigen Lipil 2 has the highest calcium content of all the ehfs and it may therefore be useful in ensuring adequate levels of calcium can be achieved in the daily volume of CMPA formula that the infant can consume without affecting the weaning process. Review, 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 page 2 and 4 and/or refer to the most recent correspondence from the paediatric dietitian. For the above reasons, avoid adding to the repeat prescription list. Try to align the repeat interval to the review date with the dietitian. CMPA children should be reviewed at least every 6 months as paediatric allergy will often resolve as child acquires tolerance. 5

6 Refer to NICE guidelines CG116 or see Management Flow Charts for CMPA for when children are challenged with cow s milk in secondary setting (supervised challenge) and when the challenge can be performed at home under the supervision of a dietitian (reintroduction at home). Prescriptions should be stopped when the child has grown out of the allergy % children outgrow CMPA by 2 years, rising to 85-90% by 3 years Review the need to continue with the prescription if the answer is YES to any of the following questions: - Is the patient over 2 years of age? Has the formula been prescribed for more than 1 year? Is the patient prescribed more than the suggested quantities of formula according to their age? Is the patient prescribed a formula for CMPA but able to eat any of the following foods cow s milk, cheese, yoghurt, ice-cream, custard, chocolate, cakes, cream, butter, margarine or ghee? Children with multiple or severe allergies may require prescriptions beyond 2 years. This should always be on the recommendation of the paediatric dietitian/specialist. 6

7 MANAGEMENT FLOW CHART OF SUSPECTED CMPA IN AN INFANT < 12 MONTHS IN PRIMARY CARE Adapted from the MAP (milk allergy in primary care) guideline. For full details see (registration required): Also refer to NICE guideline CG116 Food Allergy in Children and Young People Feb 2011: Take an allergy focused clinical history and family history of atopy Non IgE-mediated CMPA DELAYED onset symptoms (2-72 hours after ingestion of CMP formula fed, exclusively breast fed or at onset of mixed feeding)) IgE-mediated CMPA ACUTE onset symptoms (mostly within minutes of ingestion of CMP and mostly formula fed or at onset of mixed feeding) MILD TO MODERATE SYMPTOMS One, or often, more than one of: GI Skin - *Colic - Pruritus - Vomiting - Erythema - Reflux - Significant atopic - Constipation eczema - Loose or frequent stools - Food refusal/aversion - Blood and/or mucus in stools (in an otherwise well infant) Respiratory Catarrhal airway symptoms (usually with one or more of the above symptoms) Can be managed in Primary Care See Management Flow Chart for Mild to Moderate Non IgE-mediated CMPA (page7) *Colic (infantile) is often defined by the rule of three : crying for more than three hours a day, for more than three days per week, and for longer than three weeks in an infant who is well-fed and otherwise healthy SEVERE SYMPTOMS one or more persisting severe symptoms: GI - Diarrhoea and vomiting - Significant blood and/or mucus in stools - Irregular/uncomfortable stools - Food refusal/aversion - Faltering growth Skin -Severe atopic eczema If formula fed: - initiate trial of AAF *PurAmino/Nutramigen AA (0-2 years) Only prescribe 1-2 tins initially to assess tolerance/acceptance and until infant seen by secondary care and paediatric dietitians. See page 4 for tips on improving palatability of feed. Ensure URGENT referral to secondary care paediatrician Ensure URGENT referral to paediatric dietitian SEVERE IgE-mediated CMPA ANAPHYLAXIS -Immediate reaction with severe respiratory and/or CVS signs and symptoms. -Rarely a severe GI presentation Emergency treatment and hospital admission If breast fed: advise breast feeding mother to exclude all cow s milk from maternal diet and to take daily calcium (1000mg) and vitamin D (10mcg) supplements *PurAmino is the new product name for Nutramigen AA from 1 st March 2015 MILD TO MODERATE SYMPTOMS - Immediate onset of one or more symptoms: GI Respiratory - Diarrhoea - Acute rhinitis - Vomiting - Conjunctivitis - Abdominal pain/ *colic Skin -Acute pruritus, erythema, urticaria, angioedema, acute flaring of atopic eczema If formula fed: initiate trial of ehf 1 st line: Nutramigen Lipil 1 (<6 months) Nutramigen Lipil 2 (>6 months) 2 nd line: Similac Alimentum (0-2 years) Only prescribe 1-2 tins initially to assess tolerance/acceptance and until infant seen by secondary care and paediatric dietitians. See page 4 for tips on improving palatability of feed. Referral to paediatric dietitian required. IgE testing needed to confirm diagnosis referral to secondary care paediatrician required. If diagnosis confirmed (which may require a Supervised Challenge) follow-up serial IgE testing and later a planned and Supervised Challenge will be conducted to test for acquired tolerance 7 7

8 MANAGEMENT FLOW CHART FOR MILD TO MODERATE NON IgE-MEDIATED CMPA IN PRIMARY CARE: No initial IgE Skin Prick Tests or Serum Sepcific IgE Assays necessary. Adapted from the MAP (milk allergy in primary care) guideline. For full details see (registration required): Exclusively Breast-Fed Strict exclusion of cow s milk from maternal diet for 2-4 weeks Daily calcium (1000mg) and vitamin D (10mcg) supplements Referral to paediatric dietitian If CMPA, most symptoms will settle well within the 2-4 weeks exclusion period Formula-Fed or Mixed Feeding (Breast and Formula) Strict Cow s milk protein free diet for 2-4 weeks Formula fed: Initiate trial of ehf 1 st line: Nutramigen Lipil 1 (<6 months) Mixed feeding: Trial of a cow s milk Nutramigen Lipil 2 (> 6 months) free maternal diet with ehf top-ups 2 nd line: Similac Alimentum (0-2 years) if needed 3 rd line: Aptamil Pepti 1 (<6 months) } contains Referral to paediatric dietitian Aptamil Pepti 2 (< 6 months) } lactose 4 th line (>6 months ONLY): SOYA FORMULAE - Infasoy and Wysoy (parent to buy OTC) No improvement or symptoms do not settle CMPA still suspected: Need to consider other maternal foods e.g. egg. Refer to secondary care paediatrician CMPA no longer suspected: Return to usual maternal diet. Refer to secondary care paediatrician if symptoms persist Improvement of symptoms need to confirm diagnosis Diagnostic Home Milk Challenge (to be done between 2-4 weeks of starting cow s milk exclusion diet) If breast fed: Re-try cow s milk in maternal diet gradually over one week } Refer to guidelines on page 15) If formula fed: Re-try standard cow s milk formula gradually over one week } with support of dietitian No return of symptoms - NOT CMPA SYMPTOMS RETURN If breast fed: Exclude cow s milk from maternal diet again (with support of dietitian) If symptoms settle: CMPA NOW CONFIRMED - Continue with maternal cow s milk free diet and daily calcium (1000mg) & vitamin D (10mcg) supplementation - Use an AAF if top-up formula feeds needed seek dietitian advice first: PurAmino /Nutramigen AA or Neocate LCP (both products for use in 0-2 years) SYMPTOMS RETURN If formula fed: Return to the ehf again. (with support of dietitian) If symptoms settle: CMPA NOW CONFIRMED - Continue to prescribe the ehf until infant has grown out of allergy or they are 2 years old Continue with cow s milk free diet until 9-12 months of age and for at least 6 months with the support of dietitian A planned REINTRODUCTION or SUPERVISED CHALLENGE is then needed to determine if tolerance is achieved: Does the child have CURRENT ECZEMA or ANY history at ANY time of acute onset symptoms? No improvement or symptoms do not settle CMPA still suspected: -Seek dietitian advice - Consider a trial of an AAF PurAmino /Nutramigen AA or Neocate LCP (0-2 years) - Refer to secondary care paediatrician CMPA no longer suspected: Stop ehf and return to standard formula. - Refer to secondary care paediatrician if symptoms persist *PurAmino is the new product name for Nutramigen AA from 1 st March 2015 No current eczema (and no history at any stage of acute onset symptoms) No need to check Serum Specific IgE or perform Skin Prick Test REINTRODUCTION at home using a MILK LADDER to test for tolerance (see Page 19) with the support of dietitian Current eczema Refer to secondary care paediatrician Check Serum Specific IgE or Skin Prick Test to cow s milk NEGATIVE POSITIVE History of acute onset symptoms at ANY time Refer to secondary care paediatrician for management to check Serum Specific IgE or perform Skin Prick Test NEGATIVE POSITIVE or tests not available A SUPERVISED CHALLENGE may be needed (managed by secondary care paediatrician) 8 8

9 FLOW CHART FOR MANAGING SECONDARY LACTOSE INTOLERANCE Has the infant had the following symptoms persisting for more than 2 weeks? Usually occurs following an Abdominal bloating infectious gastrointestinal Increased (explosive) wind) illness but may present Loose green stools alongside new or undiagnosed coeliac disease >12 months of age <12 months of age Advise LACTOSE FREE full fat cow s milk (LACTOFREE brand can be purchased at supermarkets). Use in conjunction with a milk free diet provide patient leaflet (Appendix 2) If bottle fed: advise LACTOSE FREE formula to be purchased from supermarket or pharmacy: Aptamil LF,SMA LF or Enfamil O-Lac If weaned, use in conjunction with a milk free diet provide patient leaflet (Appendix 2) NOTE: Lactose intolerance in young infants is rare. Cow s milk protein allergy (CMPA) should always be considered as an alternative diagnosis If exclusively breast fed: Lactose intolerance in exclusively breast fed infants is rare. If symptoms are present, consider cow s milk protein allergy (CMPA). Refer to CMPA section of guidelines Encourage breastfeeding mother may benefit from referral to breastfeeding counsellor Note: Use of lactase drops is not common practice Review after 2 weeks have symptoms improved? YES NO Consider alternative diagnosis e.g. cow s milk protein allergy. Continue lactose free formula or lactose free milk for up to 8 weeks to allow resolution of symptoms. Rarely symptoms may last up to 3 months. Then advise parents to slowly start to re-introduce standard formula/milk into the diet. Have symptoms returned on commencement of standard infant formula/milk? NO No further action needed YES Return to lactose free formula or lactose free milk Primary lactose intolerance is less common than secondary lactose intolerance and does not usually present until later childhood or adulthood. Referral to paediatric dietitian 9

10 FLOW CHART FOR MANAGING FALTERING GROWTH Faltering growth in an infant is indicated when: Weight falls below the bottom (0.4 th ) centile OR Weight crosses 2 centile downwards on a growth chart OR Weight is 2 centiles below length centile (low weight for height) No catch up from low birth weight Crossing down through length/height centiles as well as weight Ensure UK WHO growth charts are used to detect faltering growth Rule out underlying medical condition e.g. iron deficiency anaemia, constipation, GORD. If a child protection issue is suspected, take appropriate action. Infants with faltering growth should be referred to the paediatric services without delay. Check feeding pattern including feed volumes and tolerance. Is the infant weaned? YES NO Follow local Child Protection Procedures Referral to paediatrician Consider prescribing an equivalent volume of high energy formula to the child s usual intake of standard formula until an assessment has been performed and recommendations made by the paediatrician and/or paediatric dietitian 1 st line: SMA High Energy (birth up to 18 months or 8kg) Refer any infant that is weaned to a paediatric dietitian for advice on a high calorie and high protein diet. If the problem is related to food refusal/fussy eating, provide simple advice on managing behavioural aspects (see information leaflet Help, my child isn t eating ). Consider referral for behaviour intervention and involve health visitors to observe mealtimes. Following referral to paediatrician and paediatric dietitian, the following high energy formulae may be initiated (usually secondary care) and continued in primary care: - 2 nd line: Similac High Energy (birth up to 18 OR Infantrini months or 8kg) Secondary Care initiation ONLY: Infantrini Peptisorb (birth up to 18 months or 8kg) this is suitable for infants also with intolerance to whole protein foods e.g. short bowel syndrome, intractable malabsorption, inflammatory bowel disease or bowel fistulae. NOTE: High energy formulae should be used until 18 months or 8kg. After this time, if the child is growing well, the prescription should be stopped All infants on high energy formulae will need growth (weight and length/height) monitoring to ensure catch up growth and appropriate discontinuation of formula to minimise weight gain. 10

11 FLOW CHART FOR MANAGING PRE-TERM INFANTS Infant will have had their pre-term formula commenced in hospital before discharge. These formulae should not be used in primary care to promote weight gain in patients other than babies born prematurely. Babies born <34 weeks gestation, weighing <2kg at birth will be initiated on: - Nutriprem 2 powder Birth up to a maximum OR of 3-6 months SMA Gold Prem 2 powder *corrected age Secondary care initiation only and prescribing to be continued by GP in primary care until infant reaches 3-6 months *corrected age. Growth (weight, length and head circumference) monitored by Health Visitor Any concerns with baby s growth whilst on preterm infant formulae, refer to paediatrician and paediatric dietitian (see management glow chart for faltering growth) The preterm formula should be stopped if there is excessive weight gain. POWDER formula only to be prescribed. Nutriprem 2 or SMA Gold Prem 2 liquids should NOT BE ROUTINELY prescribed unless there is a clinical need in rare instances e.g. immunocompromised infant. This reason and duration should be clearly indicated by secondary care. Cost per 100kcals is 1.12 to 1.15 for the liquid compared to 23p to 25p for the powder formula. Pre-term formula to be prescribed until the infant reaches 3-6 months *corrected age. [*corrected age - this is actual age plus the number of weeks premature added on] Then change to a standard term formula thereafter if there are no concerns with growth 11

12 FLOW CHART FOR MANAGING GASTRO-OESOPHAGEAL REFLUX (GOR) Gastro-oesophageal reflux (GOR) is the passage of gastric contents into the oesophagus causing troublesome symptoms and/or complications. Symptoms may include regurgitation of significant volume of feed, reluctance to feed, distress/crying at feed times, small volumes of feed being taken. Diagnosis is made from a history of effortless vomiting (not projectile) after feeding, usually in the first 6 months of age, and usually resolves spontaneously by months. Note that 50% of infants have some degree of reflux at some time. Does the infant have faltering growth? Yes Refer to paediatric services No Rule out overfeeding establish the volume and frequency of feeds. Average requirements for infant 0-6months = 150ml/kg/day formula over 6-7 feeds Provide advice on feeding positioning and activity following a feed Is infant thriving and not distressed? No Yes In clearly overfed infants, advise restriction of volume of feeds Offer reassurance that symptoms are very likely to improve over time. Symptoms tend to become less frequent and less problematic after 6 months of age. By months of age, only 5% of infants have regurgitation occurring once or more a day Is infant not settled and with troublesome symptoms? Yes Breast fed Trial a thickening alginate agent e.g. *Infant Gaviscon offered on a spoon before feeds (up to maximum 6 times a day) Refer to a Health Visitor for guidance on supporting a breast fed infant with GOR Review after one month Improvement - Continue with treatment and review regularly to check growth and symptoms. - Trial stopping treatment at 12 months, since GOR can spontaneously resolve at months. No improvement Refer to paediatrician for further investigation Yes Bottle fed Trial one of the following: - 1) A thickening alginate agent e.g.*infant Gaviscon (up to maximum 6 times a day) OR 2) A pre-thickened anti-reflux formula which can be purchased over the counter (OTC): Cow and Gate Anti- Reflux Birth to Aptamil Anti-Reflux 1 year These pre-thickened feeds contain carob and require a large hole/ fast flow teat. 3) OR a thickening formulae - reacts with stomach acids to thicken in the stomach (not in bottle) so no need for a large hole/fast flow teat. SMA Stay Down Advise to purchase OTC Enfamil AR Birth to 18 months - Do NOT use with separate thickeners, antacids, PPIs or ranitidine. - Alert parents to the different procedure for making up feed - need to be made up with fridge cooled pre-boiled water. Prescribing Notes: *Infant Gaviscon contains sodium and should not be given >6 times in 24 hours or when the infant has diarrhoea or a fever. One dose = half a dual sachet. Prescribe with directions in terms of doses to avoid errors. Proton pumps inhibitors (PPIs), ranitidine, domperidone and metoclopramide are not recommended to be initiated in primary care. 12

13 DOS AND DON TS OF PRESCRIBING SPECIALIST INFANT FORMULAE DO DO NOT Promote and encourage breast-feeding wherever possible where it is clinically safe Check any formula prescribed is appropriate for the age of the infant Check the quantity of formula prescribed is appropriate for the age of the infant (see page 2) and refer to the most recent correspondence from the paediatric dietitian Review any prescriptions where: - Child is over 2yrs Infant feed has been prescribed for more than 1 year Larger quantities of formula are being prescribed than would be expected CMPA infant feed is being prescribed but the infant is able to eat cow s milk, cheese, yoghurt, ice cream, custard, chocolate, cakes, cream, butter, margarine or ghee Prescribe 1 or 2 tins/bottles initially until compliance/tolerance is established Remind parent to follow the manufacturer s advice regarding safe storage of the feed once reconstituted or opened Provide parent with relevant patient information (See Appendices) Refer where appropriate to the paediatric dietitians and/or secondary/specialist care (as indicated in the management flow charts) Seek prescribing advice if needed in primary care from the CCG Pharmacy & Medicines Optimisation Team (PMOT) Seek prescribing advice if needed in secondary care from the hospital Medicines Information Centre Add infant feeds to the repeat prescriptions in primary care, unless a review process is in place to ensure the correct product and quantity is prescribed for the age of the infant. Prescribe lactose free formulae (Aptamil LF, SMA LF, Enfamil O-Lac ) for infants with CMPA Routinely prescribe soya formulae (Infasoy, SMA Wysoy ) for those with CMPA or secondary lactose intolerance. Not to be used at all in infants under 6 months due to the high phytoestrogen content. Suggest milk or formulae made from goat, sheep or mammalian milks for infants with CMPA or secondary lactose intolerance. Suggest rice milk for children under 5 years due to the high arsenic content Prescribe thickening formulae (SMA Staydown, Enfamil AR ) with separate thickeners or in conjunction with medication such as antacids, ranitidine or proton pumps inhibitors since the formulae requires stomach acids to thicken and reduce reflux. Suggest Infant Gaviscon is used more than 6 times in 24 hours or where the infant has diarrhoea or a fever, due to the sodium content Prescribe Nutriprem 2 liquid or SMA Gold Prem 2 liquid unless secondary care has specifically stated a clinical need e.g. immunocompromised infant. 13

14 Comparative Costs of Specialist Infant Formulae PRODUCT Manufacturer Presentation Pack Pack Size (g or ml) COST* per Pack COW'S MILK PROTEIN ALLERGY (CMPA) HYDROLYSED (ehf) FORMULA 1 st choice for CMPA COST per 100g or ml COST per 100kcal Nutramigen Lipil 1 Mead Johnson Powder Tin Nutramigen Lipil 2 Mead Johnson Powder Tin Similac Alimentum Abbott Powder Tin Aptamil Pepti 1 Aptamil Powder Tin Powder EaZypack Aptamil Pepti 2 Aptamil Powder EaZypack COW'S MILK PROTEIN ALLERGY (CMPA) ehf with medium chain triglycerides (initiated by secondary care) when CMPA is accompanied by malabsorption Pepti Junior Cow & Gate Powder Tin Pregestamil LIPIL Mead Johnson Powder Tin COW'S MILK PROTEIN ALLERGY (CMPA) AMINO ACID BASED FORMULA only when ehfs are not effective/tolerated Neocate LCP Nutricia Powder Tin PurAmino /Nutramigen AA Mead Johnson Powder Tin Neocate Active Nutricia Powder Sachets 15x Neocate Advance Nutricia unflavoured 10x Neocate Advance Nutricia banana&vanilla 15x Neocate Spoon Nutricia Powder Sachets 15x HIGH ENERGY FORMULA for Faltering Growth Liquid bottle Infatrini Nutricia Liquid bottle Liquid Tube feed SMA High Energy SMA Nutrition Liquid Carton Similac HE Abbott Liquid bottle Liquid bottle PRE-TERM INFANT FORMULA Nutriprem 2 POWDER Cow & Gate Powder EaZypack Nutriprem 2 LIQUID Cow & Gate Liquid Bottle SMA Gold Prem 2 Powder SMA Nutrition Powder Tin SMA Gold Prem 2 LIQUID SMA Nutrition Liquid Carton *Cost obtained from Dictionary of Medicines and Devises (DM&D) prices October 2014 ** PurAmino is the new product name for Nutramigen AA from 1 st March 2015 Use as 1 st line Use when 1 st line unsuccessful Secondary care initiation. Not routinely started in primary care. Ready to feed liquid not to be routinely prescribed instead of powder feed only in rare clinical circumstances this reason and the duration should be clearly stated by secondary care The following are available to buy over-the-counter at high street pharmacies or supermarkets and are similar cost to standard infant formula do NOT routinely prescribe on NHS prescription. COW'S MILK PROTEIN ALLERGY (CMPA) SOYA BASED FORMULA 4 th line when 1 st /2 nd /3 rd line ehf not tolerated Infasoy Cow & Gate Powder Tin 900g 9.30 Prices listed Wysoy SMA Nutrition Powder EaZypack 860g are approximate LACTOSE FREE FORMULA for Secondary Lactose Intolerance retail prices at Aptamil LF Aptamil Powder Tin 400g 5.50 pharmacies SMA LF SMA Nutrition Powder Tin 430g 6.00 and supermarkets. *Enfamil O-Lac Mead Johnson Powder Tin 400g 6.60 THICKENING FORMULA for Gastro-Oesophageal Reflux SMA Staydown SMA Nutrition Powder Tin 900g *Enfamil AR Mead Johnson Powder tin 400g 4.65 *May need to be ordered from pharmacy 14

15 National and Local Spend These guidelines consider both clinical and cost effectiveness in its recommendations. Some products may not be the least expensive but are considered the most appropriate first line product for the condition. Below are some notes on the spend data for each condition: - CMPA By using the first line CMPA product (ie an EHF and not an AAF) could save over 18 million nationally annually. Local annual savings are in the region of 250k for ENHCCG and 235k for HVCCG. This represents the biggest cost saving in the guidelines. Secondary lactose intolerance Soya based infant formulae are similar in cost to standard infant formulae and are readily available to buy over the counter (OTC) from pharmacies and supermarkets. Parents/carers should be advised to purchase OTC. Cost savings can be achieved by not routinely prescribing these products in primary care. Local annual prescribing spend for this indication - 7.4k for ENHCCG and 8k for HVCCG. Faltering growth It is important that the feed is discontinued when weight goals are reached to avoid excessive weight gain. Potential cost savings can be realised by regular review of patient and appropriate cessation of treatment to minimise weight gain. Local annual prescribing spend for this indication - 56k for ENHCCG and 111k for HVCCG. Pre-term It is important to ensure that these products are only commenced in secondary care and that they are discontinued when the infant reaches 6 months corrected age. The liquid preparations should not be routinely prescribed but should be reserved for when there are clinical reasons eg immunocompromised infant. Potential cost savings can be realised by appropriate cessation of treatment and appropriate prescribing of the liquid preparations. Local annual prescribing spend for this indication - 59k for ENHCCG and 57 for HVCCG. GORD The pre-thickened formulae and the thickening preparations (thicken on reaction with stomach acids) are similar in price to standard infant formulae and is readily available from the community pharmacy. Parents/carers should be advised to purchase OTC. Cost savings can be achieved by not routinely prescribing these products in primary care. Local annual prescribing spend for this indication - 2.8k for ENHCCG and 1.2k for HVCCG. 15

16 Acknowledgements This guideline has been based on the following documents with special thanks to the authors for their permission to reproduce some of the contents: - PrescQIPP Bulletin 67, July Appropriate prescribing of specialist infant formulae Medicines Management Team, Central Eastern Commissioning Support Unit, on behalf of Basildon and Brentwood Clinical Commissioning Group. Appropriate prescribing of specialist infant formulae Medicines Management Team, Ipswich and East Suffolk Clinical Commissioning Group. Recommendations for prescribing specialist Infant Formula This guideline has been produced by the Pharmacy & Medicines Optimisation Team, Herts Valleys Clinical Commissioning Group and East & North Herts Clinical Commissioning Group in consultation with: - Paediatric Department, West Hertfordshire Hospitals Trust and East & North Hertfordshire Hospitals Trust Dietitian Team, West Hertfordshire Hospitals Trust, East & North Hertfordshire Hospitals Trust and Hertfordshire Community Trust Pharmacy Team, West Hertfordshire Hospitals Trust and East & North Hertfordshire Hospitals Trust References Cow s Milk Protein Allergy NICE Clinical Guideline 116 Food Allergy in Children and Young People Venter et a. 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 Food Hypersensitivity. Diagnosing and managing food allergy and intolerance.(2009). Edited by Isabel Skypala and Carina Venter. Published by Wiley Blackwell. World Allergy Organisation DRACMA guidelines 2010 (Diagnosis and Rationale against Cow s Milk Allergy) 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) Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child 1990; 81:80-84 Host A. Frequency of cow s milk allergy in childhood. Ann Allergy Immunol 2002; 89(suppl):33-37 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: Soya Formula Department of Health: CMO s Update 37 (2004). Advice issued on soya based infant formula. Paediatric Group of the British Dietetic Association Paediatric Group Position Statement on the use of Soya Protein for infants, February 2004 Rice Milk Food Standard Agency statement on arsenic levels in rice milk (2009) icinriceresearch Secondary Lactose Intolerance 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 Gastro-esophageal reflux Paediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society of Paediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and the European Society of Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). Journal of Ped Gastroenterology and Nutrition 2009; 49: General Clinical Paediatric Dietetics 3 rd Edition (2007). Edited by Vanessa Shaw and Margaret Lawson. Blackwell Publishing. Department of Health (2014) Birth to Five. Department of Health report on Health and Social Subjects No Weaning and the Weaning Diet. HMSO. 16

17 Appendix 1 CMPA Frequently Asked Questions Cow s Milk Protein Allergy (CMPA) Frequently Asked Questions Q: Can goat s milk formula be used as a treatment for CPMA A: No: Goat s milk and sheep s milk are not advised due to cross reactivity with cow s milk Q: What happens when an infant reaches 1 year of age and is still CMPA? A: - If soya is tolerated: Children over 1 year of age can use Alpro Junior 1+ soya milk instead of formula (this can be used in cooking from 6 months). Available to purchase in supermarkets. - If soya is not tolerated: Continue with specialist formula (ensure child has review appointment with the paediatric dietician and, if necessary, the specialist paediatrician). Q: What happens when an infant reaches 2 years of age and still has a cow s milk protein and soya allergy? A: The specialist formula milk should no longer be required and the child can go onto a supermarket milk substitute i.e. oat, coconut, almond, hazelnut or hemp milk. Rice milk is not suitable for children under 5 years due to the high arsenic content Further advice and support can be sought from the paediatric dietician. Q: Are vitamin and mineral supplements required? A: The Department of Health recommends that a supplement containing vitamin A, C and D in the form of vitamin drops is given to: All breastfed infants from 6 months of age Infants under 1 year of age who are taking less than 500ml of formula daily All children from 1 5 years The Health Visitor can provide advice on vitamin drops and where to get them. The child will be entitled to free vitamin drops if the family is eligible for the Healthy Start scheme. Q: What are Neocate Active and Neocate Advance? A: These are highly specialised hypoallergenic amino acid products and should only be initiated and advised by secondary care. They should not be prescribed in infants under the age of 1 year. They are not designed as follow on from Neocate LCP and will not be required automatically by all infants over 1 year on an amino acid formula. Neocate Active is a high calorie formula and is not suitable as sole source of nutrition. Neocate Advance is a high calorie product and is used as a sole source of nutrition for tube fed infants aged 1-10 years. Q: What is Neocate Spoon? A: This is a hypoallergenic amino acid based food. It is not to be used as a drink/formula. It is suitable for infants from 6 months of age who have multiple food allergies. It should only be initiated and used under the direction of a paediatric dietician. A: Why is soya formula not routinely advised? Q: Soya formula is no longer indicated for cow s milk allergic infants under the age of 6 months due to its phytooestrogen content and the increased risk of sensitisation to soya protein (as per Chief Medical Officer Statement, 2004). Parents wishing to feed their infant (over the age of 6 months) on a soya based formula should be advised of the risks and advised to purchase the formula over the counter. These soya formulae (Infasoy, Wysoy ) are available from pharmacies and supermarkets at a similar cost to standard infant formula. Q: Can lactose free products be used in CMPA? A: No: These products contains cow s milk protein and are therefore not suitable. 17

18 Appendix 2 Patient Information Initial advice for those needing a milk free diet Patient Information Initial advice for those needing a milk free diet If you (if you are breastfeeding) or your child needs a milk free diet because of cow s milk protein allergy or lactose intolerance, the following foods should be avoided: Milk cow s, goat s, sheep s All types of cheese Yogurt Milk powder Butter Cream Milk drinks Margarine Ice cream Artificial cream Crème fraiche Fromage frais Food labels that list any of the ingredients below should also be avoided, as this indicates that the food contains milk: Caseins Skimmed milk powder Whey syrup Caseinates Milk solids Milk sugar Hydrolysed casein Ghee Butter fat Sodium caseinate Non-fat milk solids Lactose Skimmed milk Whey Buttermilk Lactoglobulin Whey solids Hydrolysed whey Whey powder Whey sugar Whey syrup sweetener The following foods are examples (not a complete list) of processed foods which may contain milk and will need to be checked: Breakfast cereals Baked goods, e.g. rolls Soups Pancakes, batters Baby foods Ready made meals Processed meats, e.g. luncheon meat, sausages Puddings and custards Pasta and pizzas Cakes, biscuits, crackers Instant mashed potato Chocolate/confectionery Sauces and gravies Crisps ALWAYS CHECK FOOD LABELS CAREFULY. IF IN DOUBT, LEAVE IT OUT! If your child has cow s milk allergy, a special infant formula may be prescribed (e.g. Nutramigen Lipil, Similac Alimentum ). These are made from extensively hydrolysed (broken down to small particles) milk protein which should not cause an allergic reaction. If your child has lactose intolerance, a milk free diet may be needed for a few weeks until this resolves. A lactose free formula may be recommended for you to purchase from pharmacies if your child is below 1 year of age. If your child is over 1 year, you are recommended to use a lactose free milk (Lactofree ) which can be purchased from most supermarkets. 18

19 Appendix 3 MAP home milk challenge guidance for parents 19

20 20

21 Appendix 4 MAP milk ladder guidance to parents to re-introduce milk at home and to determine tolerance 21

22 22

23 Appendix 5 Patient Information Leaflet Help, my child isn t eating Patient Information Leaflet Help, my child isn t eating Mealtimes are a time for learning about food and eating should be an enjoyable experience. Eating together as a family encourages the child to copy eating and drinking behaviour. It is also a social time for families, so eating together should be encouraged. Make sure your child is sitting in an appropriate chair and is sitting with the rest of the family. Use brightly coloured bowls and plates. These may make the meal look more appealing. A calm, relaxed environment for eating and drinking may be helpful for some children, especially if they are easily distracted, however, some children benefit from some background noise. Try both approaches to find out which works best for your child. Never leave your child unsupervised whilst he or she is eating or drinking. Give your child lots of positive praise when he or she does eat and ignore any food refusal. Calmly offer the food three times before telling your child the meal is over, then remove the meal without any further comment. Limit mealtimes to no longer than 30 minutes. Try not to show your concern or make negative comments in front of your child. It is a good idea for children to use their fingers to play with their food. Do not worry if they make a mess. If your child stops eating at a meal, try to encourage him or her to take a little more. If this is successful, show that you are pleased and give positive verbal reinforcement. Never use food as a reward. Try not to rush a meal, as your child may be slow to eat, but try not to let the meal drag on for too long half an hour is about right. Your dietitian will advise you on how to increase the energy density of your child s meal so the mealtime can be reduced, if necessary. NEVER force feed your child. Avoid fluids just before and during meals, as this will reduce your child s appetite. Often children are not hungry because they have had too much juice during the day and night. Try to avoid giving more than 1 ½ pints of fluid during the day. Children over the age of one year should not be given drinks during the night. Offer regular meals and snacks at set times, as this is better than letting your child pick through the whole day. 23