Prescribing Guidelines for Lactose Intolerance and Cows Milk Protein Allergy

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1 Prescribing Guidelines for and Cows Milk Protein Allergy Aim To clarify which products and in which circumstances milk substitutes can be prescribed for babies and young children in primary care, as well as to give a guide to prescribing quantities and duration of treatment. Background NICE produced guideline 116 in Feb 2011 relating to Food allergy in children and young people, it covers the diagnosis and assessment of food allergy in children and young people in primary care and community settings. The care pathway from NICE which covers initial recognition to referral to specialist is attached. Summary It is important to distinguish between CMPA and intolerance for effective. A limited range of products (foods/milk substitutes) can be prescribed as drugs, and these are defined in Borderline substances. Any prescription written needs to be marked ACBS It is acknowledged that infants will present to Health Visitors and GP practices with suspected intolerances to infant formula and it will not always be appropriate to wait for a diagnosis from secondary care but rather it is necessary to treat empirically. Soya based formulas are not recommended for prescribing to infants, especially those under 6 months of age.the reason for this is the risk that the baby may develop a secondary soya allergy. Soya milk also contains phytoestrogens which are an unproven health risk, particularly for male babies. (Babies of vegan mothers who choose not to breast feed may be given soya milk but not at the expense of the NHS). tose free milks can be bought at a similar cost to standard infant formula and prescribers should consider the need to prescribe at the expense of the NHS. The NHS Tees formulary lists suitable formulas which are available from pharmacies and many supermarkets will stock on demand.* Healthy start vouchers can be used towards free infant formulas well as standard formula milk. *Parents should be directed towards a pharmacy to purchase free milk; Boots for example keep the milk in the dispensary rather than on the open shelves. Many supermarkets do not routinely stock free infant formula milk but will order it in on an individual basis, pharmacies can obtain stock the same day if not currently stocked. Key Points for Cow s Milk Protein allergy Adverse reactions to foods, mainly cow s milk protein, are most common in the first year of life (1). In infancy the main atopic symptoms are atopic dermatitis, gastrointestinal (GI) symptoms (, blood in stools, vomiting, abdominal distension, colic and constipation) and recurrent wheeze. CMPA may be caused by two distinct immune pathologies: IgE- and non IgEmediated. Acute IgE-mediated reactions (usually within 2 hours) include rash or urticaria, wheeze or vomiting. Delayed reactions may be non IgE-mediated or mixed (>2 hours) including eczema, colic, (see NICE Box 1) Prescribing Guidance for tose intolerance and CMPA KT Feb 14 review Feb16 Draft

2 Suspect CMPA when: a child has one or more signs and symptoms, especially if persistent symptoms affecting different organ systems; when a child has not responded to treatment for atopic eczema reflux or chronic GI symptoms including constipation (2). Breast fed infants can display symptoms, as some cow s milk proteins from the mothers diet may be expressed in breast milk. Infants with CMPA should be referred to a paediatric dietitian for diagnosis, support and advice on the need for, and the timing of, re-challenge to cows milk to test if the allergy has resolved. Most children grow out of their allergy by months of age. Key Points for tose intolerance is defined as a non-immune mediated adverse reaction to food i.e. it is not due to allergy but to a lack of the enzyme lactase. Primary intolerance is rare; generally intolerance is secondary to gastroenteritis and is transient, usually lasting around 4 to 6. Should be treated with a free formula not a hypoallergenic milk free formula see decision aid for suitable formulas. tose free formula can be purchased at a similar price to standard formula and GP should consider whether prescription is actually necessary; advice to use a free infant formula with appropriate safety netting may be all that is required. usually resolve in 2-3 days when is removed from the diet and achievement of this confirms diagnosis. From the age of 1 year, infants continuing to require free milk should be weaned onto proprietary free milks purchased at supermarkets. (tose free infant formula should not be required beyond 18 months). tose free milk is more cariogenic than standard formula as it contains glucose in place of.. Managing Breast milk is the ideal choice for the infant with CMPA with maternal exclusion of cow s milk and supplementation with calcium (to provide 1000mg calcium daily) for a minimum trial of two. For bottle fed infants an appropriate hypoallergenic formula is required. These formulas vary in palatability and should be introduced as soon as possible. If not accepted initially introduce with incremental mixing with the standard formula. Give a minimum trial of two. It is advisable to inform parents /guardians that these formulas contain glucose, so that they may pay special attention to dental hygiene as new teeth appear. The paediatric dietitian will review and inform the GP of all planned monitoring, the follow up intended and guidance given to parents on weaning and the plan to stop formula milk. Typically the paediatric dietitians will usually recommend challenging with small amounts of cows milk from the age of months. In cases of IgE mediated allergy challenges need to be under medical supervision. By the age of 18months most infants a will have been recommended to (gradually) switch to normal cow s milk or if this is not tolerated, a commercially available liquid milk substitute (soya or oat) using varieties fortified with calcium Prescribing Guidance for tose intolerance and CMPA KT Feb 14 review Feb16 Draft

3 Managing Breast milk remains the ideal choice for the infant with intolerance. Breast fed babies with intolerance can be prescribed Colief at a dose of four drops per feed for 4-6 or until symptoms have resolved. For bottle fed babies, free formula milks are available at a similar price to standard formula. See NHS Tees formulary for details of products available. As intolerance is generally temporary, babies should be re-challenged after 4 to 6 to test if the intolerance has resolved. Re-challenge by introducing an increasing amount of standard formula into the free milk and monitoring for symptoms Other Specialist infant formula Secondary care will lead in prescribing for several special groups of infants and young children. Pre-term and low birth weight infants ( may also require iron and vitamin supplements) Disease specific conditions Complex food intolerances Faltering growth Complex medical cases All such prescribing should be initiated by secondary care. The letter should include details of all planned monitoring and follow up intended and guidance for the GP on when the formula should be stopped. Unsettled Babies For infants who appear unsettled, colicky etc. but are not allergic or intolerant to cow s milk, there are a range of commercially available milks designed to be easier to digest as well as a range of anti colic medicines which parents may wish to try but should not be prescribed. Produced in conjunction with the paediatric dietitians across NHS Tees especial thanks to the support from Susanna Earnshaw Lead Paediatric Dietitian for North Tees and Hartlepool NHS Foundation Trust. REFERENCES 1. Vandenplas Y et al: Guidelines for the diagnosis and of cow s milk allergy in infants. Arch Dis Child 2007;92: NICE Clinical Guideline 116 Food Allergy in children and young people 3. BDA Paediatric Group (2008) Paediatric Group Position Statement on the use of Soya protein for infants. British Dietetic Association; London. Prescribing Guidance for tose intolerance and CMPA KT Feb 14 review Feb16 Draft

4 Prescribing Guidance for tose intolerance and CMPA KT Feb 14 review Feb16 Draft Whey based: Aptamil Pepti (Milupa) contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adj ust of age (if allergy persists), and beyond for older patients with se Whey based: Aptamil Pepti 1 and 2 (Milupa) -contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adj ust of age (if allergy persists), and beyond for older patients with se Whey based: Aptamil Pepti (Milupa) contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency Whey based: Aptamil Pepti (Milupa) contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adj ust of age (if allergy persists), and beyond for older patients with se Whey based: Aptamil Pepti 1 and 2 (Milupa) -contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adjust of Whey based: Aptamil Pepti (Milupa) contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adj ust of age (if allergy persists), and beyond for older patients with se Whey based: Aptamil Pepti 1 and 2 (Milupa) -contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adj ust of age (if allergy persists), and beyond for older patients with se Whey based: Aptamil Pepti (Milupa) contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency Whey based: Aptamil Pepti (Milupa) contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adj ust of age (if allergy persists), and beyond for older patients with se Whey based: Aptamil Pepti 1 and 2 (Milupa) -contains.if symptoms do not after 2 or the child. confirmed or Iron deficiency For a minimum trial of 2 4 are usually transient : free formula within 4-6 of GI after two on Review repeat prescription quantity at 3 month intervals and adjust of to revert back to normal formula within 4 to 6 of GI insult but if symptoms do not after two on free diet, consider alternative diagnosis. use free milk available from most supermarkets

5 NHS Tees Infant ry These amounts are based on infants under 6 months being exclusively formula fed and drinking 150ml/kg/day of standard concentration formula,infants 6-12 months requiring less formula as solid food intake increases and children over 12 months will need 300ml milk substitute. Product Indication Age suitability Additional Information Re-challenge with cow s milk tose Free Infant SMA LF tose From Birth Enfamil O- intolerance tose intolerance Extensively Hydrolysed Infant Nutramigen lipil1 Cow s Milk Protein Nutramigen lipil 2 Allergy Aptamil Pepti 1 Aptamil Pepti 2 CMPA and unable to tolerate taste of Nutramigen Amino-Acid Based Infant Neocate LCP Cows Milk Protein Nutramigen AA Allergy (se ) Soya Based Infant Infasoy Wysoy Infants with Cows milk protein allergy that are unable to tolerate other formula From Birth From birth From 6 months From birth From 6mths From birth From birth From 6months From 6months From 12mths a commercially available free milk should be sourced from a supermarket Healthy start vouchers can be used to pay for free milk. More cariogenic than standard formula Website has information on introducing formula to baby. More cariogenic than standard formula Prescribe if above not tolerated due to taste More cariogenic than standard formula Prescribe if above not tolerated after a trial of a minimum of two, or if symptoms se. More cariogenic than standard formula Only prescribe if other milks are not tolerated as potential health risk of phytoestrogens for babies fed predominately on soya milk, also high incidence of soya allergy in children with CMPA. Do not prescribe for infants of vegan parents at the cost of the NHS. Health Start vouchers can not be used to purchase soya milk. More cariogenic than standard formula. 4 to 6 starting with 1oz/30ml standard formula in one bottle of free formula a day increasing incrementally IgE mediated allergy will be challenged under the medical supervision. Non IgE the dietitians will advice usually at the age of 12-18months Starting with 1oz/30ml whole milk in one bottle of milk free formula per day increasing incrementally until a full feed of cows milk is tolerated From 12-18mths commercially available soya or oat milk is available in most supermarkets. Prescribing Guidance for tose intolerance and CMPA KT Feb 14 review Feb16 Draft

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9 Appendix1 How Much Milk is required? A study on a babies milk consumption showed such variation that it would be inappropriate and misleading to provide a single mean recommended volume. (Aust Paediatr J Jun;24(3):186-90) The Merck Online Medical Library also provides infant calorie requirements of 50 to 55 calories per pound of body weight per day for 0 to 6 months of age and 45 calories per pound per day for 12-month-old infants. (A very rough guide to calorie content of baby milk is 1calorie per ml or 20 calories per oz) A rough guide to volume requirements is 150ml-200ml/kg/day or 2.5 times the weight in pounds. A baby who weighs 5kg (12 lb), for example, would drink approximately 875ml (30 oz) of formula per day. Prescribers should refer to manufacturer s guidance on individual products Comparative Costs of Infant Based on Chemist +Druggist Oct 13 Standard Product Presentation Cost per 100g Prescribe Routinely SMA First Milk 5.99/450g 1.33 No SMA Extra Hungry 5.99/450g 1.33 No Cow & Gate First milk 4.79/400g 1.20 No Cow & Gate Follow On 4.79/400g 1.20 No tose Free Product Presentation Cost per 100g Prescribe Routinely SMA LF 5.90/430g 1.37 No Enfamil O- 6.02/400g 1.50 No Thickening formula and Comfort milks Product Presentation Cost per 100g Prescribe Routinely SMA Stay Down 9.67/900g 1.07 No Enfamil AR 4.51/400g 1.12 No Cow &Gate Comfort 11.49/900g 1.27 No Cow s Milk Protein allergy Extensively Hydrolysed Product Presentation Cost per 100g Prescribe Routinely Nutramigen Lipil /400g 3.67 Yes Nutamigen lipil /400g 3.67 Yes Aptamil pepti /400g 3.58 Yes Aptamil pepti /900g 3.41 Yes Se Cow s Milk Protein allergy Amino Acid based Nutramigen AA 36.12/400g 9.03 Yes Neocate LCP 41.10/400g Yes(very rarely required) Page 9

10 Mead Johnson Nutrition Special Feeding Guides Enfamil O- tose-free formula for intolerance. Suitable for use from birth onwards. Enfamil AR Pre-thickened formula for infant reflux. Suitable for use from birth onwards. Nutramigen LIPIL 1 Extensively hydrolysed, hypoallergenic formula for infants with cow s milk allergy. Suitable for use from birth onwards.

11 Nutramigen LIPIL 2 Extensively hydrolysed, hypoallergenic formula for infants with cow s milk allergy. Suitable for use from 6 months of age. Nutramigen AA Hypoallergenic amino acid based formula for infants with se/multiple food allergy. Suitable for use from birth onwards. Feeding Guide : This table is a guide only, feed your baby on demand unless your healthcare professional advises you otherwise. Use the chart below for the correct amounts of boiled water and powder. Pregestimil Lipil Extensively hydrolysed, hypoallergenic formula for infants with cow s milk allergy and / or fat malabsorption. Suitable from 6 months of age onwards.

12 Preparation guidelines. Keeping hungry tummies full When preparing Neocate LCP for your little one, please follow the guidelines on the tin. Although, always follow any specialist guidance that your Healthcare Professional gives you as they will make recommendations on your baby s individual requirements. Don t alter the recipe unless your Healthcare Professional advises you to. Your doctor or dietitian should also tell you the appropriate amount of Neocate LCP to give your child. Guide to the average amount of formula to give your baby from 0 12 months: Approx. age of baby Approx. weight of baby Level scoops of Neocate Cooled boiled water (ml) Birth 3.5 kg months 6 kg months 7.5 kg months 8.5 kg months 9.5 kg Number of feeds in 24 hrs Your baby may need more or less than the amounts suggested, based on advice from your Healthcare Professional.

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