Prescribing Commissioning Policy May Diagnosis and management of Cow s Milk Protein Allergy (CMPA) and Lactose Intolerance

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1 Prescribing Commissioning Policy May 2018 Diagnosis and management of Cow s Milk Protein Allergy (CMPA) and Lactose Intolerance NHS Eastern Cheshire, NHS South Cheshire and NHS Vale Royal Clinical Commissioning Groups have agreed principles for the prescribing of infant formula for Cow s Milk Protein Allergy (CMPA) and lactose intolerance. For CMPA, extensively hydrolysed formula (EHF) is first line as it is less costly than amino acid formula (AAF). AAF should be initiated only on the advice of paediatricians, specialist paediatric nurses or paediatric dietitians. Prescriptions should be reviewed regularly, and changed or stopped depending on nutritional requirements and age. For lactose intolerance, parents should be advised to exclude all lactose from the diet and to purchase lactose-free formula. While this policy advises on recommendations for specialised infant formula, breast milk remains the optimal milk for infants. This should be promoted and encouraged where it is clinically safe to do so and the mother is in agreement. This policy aims to assist primary care with information on the use of specialised infant formula milks (both prescribable and over the counter products). The guidelines are targeted at infants aged 0-12 months, although some formula presentations may be suitable beyond this age on specialist advice. This policy relates to infants and children with cow s milk protein allergy (CMPA) that is immediate (IgE mediated) or delayed (non-ige mediated), and to lactose intolerance. The document supports local implementation of the NICE Clinical Guideline 116: Food allergy in children and young people (Feb 2011). Suspected CMPA Resources for Parents Where CMPA is suspected, parents can be given an initial fact sheet from the Allergy UK website whilst awaiting a confirmed diagnosis: Type 1 / IgE Mediated CMPA Symptoms Type 1 / IgE mediated CMPA will present immediately with one or more of the following symptoms: skin symptoms such as hives, urticaria, erythema, pruritis or atopic dermatitis acute angioedema of lips, face, tongue, palate, and around the eyes GI symptoms such as diarrhoea, bloody stools, nausea, vomiting, abdominal distension and / or colicky pain, constipation or gastro-oesophageal reflux 1

2 recurrent wheeze or cough, nasal itching, sneezing, rhinorrhoea or congestion anaphylaxis faltering growth Diagnosis and Management Diagnosis is made from an allergy focused history and sometimes supported by skin prick or blood tests. Most infants who have symptoms of an IgE mediated CMPA will present as an emergency or require rapid referral to a paediatrician or the local paediatric allergy service for diagnosis followed by referral to a paediatric dietitian. Ongoing prescriptions can be provided by primary care on the recommendation of the paediatrician, specialist nurse or paediatric dietitian. For those who do not present as an emergency, primary care clinicians can initiate treatment with EHF milk at the point of referral while the infant is waiting to be seen by the paediatric dietitian. AAF milks should not be initiated in primary care without secondary care input, but can be prescribed at the request of a paediatrician, specialist nurse or paediatric dietitian once the patient has shown a satisfactory response to a trial of AAF. Type 4 / non-ige Mediated CMPA Type 4 / non-ige mediated CMPA is more common than type 1 / IgE mediated CMPA and for most patients will be the working diagnosis, with the condition being confirmed by response to an exclusion diet rather than by skin prick testing or any other specific test. Symptoms Delayed non-ige mediated CMPA can present at any age in both breast-fed and bottle- fed infants with one or more of the following symptoms: skin symptoms such as eczema that does not respond to standard treatment, hives, urticaria, erythema or pruritis GI symptoms such as diarrhoea, bloody stools, nausea, vomiting, abdominal distension and / or colicky pain, constipation or gastro-oesophageal reflux that does not respond to treatment constant inconsolable crying and colicky symptoms that are more protracted than normal infantile colic recurrent wheeze or cough, nasal itching, sneezing, rhinorrhoea or congestion faltering growth fussy, difficult feeders often with back arching Diagnosis and Management Non-IgE mediated CMPA can usually be managed in primary care, however referral to a paediatric dietitian is still required for advice regarding ongoing treatment. GPs can initiate treatment with EHF milk at the point of referral while the infant is waiting to be seen by the paediatric dietitian. AAF milks should not be initiated in primary care, but can be prescribed by the GP at the request of a paediatrician, specialist nurse or paediatric dietitian once the patient has shown a satisfactory response to a trial of AAF. Diagnosis is made from the history and a two to four week trial of excluding cow s milk protein from either the maternal diet if breast feeding (including exclusion of all dairy products and 2

3 foods which have cow s milk protein as an ingredient) or changing to EHF in formula fed infants. A challenge with normal formula or re-introduction of cow s milk to the maternal diet should be undertaken after two to four weeks to assist diagnosis. The patient will need specific dietary advice. The Early Home Reintroduction to Confirm the Diagnosis of Cow s Milk Allergy leaflet provides information on how to reintroduce milk containing products back into the diet: Breastfeeding women may require a dietetic referral and / or treatment with a combination of calcium 1000 micrograms and vitamin D 10 micrograms daily if they are following a milk-free diet in the longer term. If required, breastfeeding women should be encouraged to purchase calcium and vitamin D supplements from a community pharmacy. If this is not suitable or appropriate then a prescription can be given. Breast-fed infants may require a small amount of EHF on prescription for supplementary feeds which can be initiated by a GP with or without recommendation from a specialist. If symptoms don t improve, or only improve slightly, a referral is indicated to consider alternative diagnoses. Skin prick tests and blood tests are not useful in non-ige mediated CMPA. Non-IgE mediated CMPA should not be confused with lactose intolerance. Lactose-free formulas should not be given to infants with CMPA as they are not always cow s milk protein free. Lactose Intolerance Lactose intolerance can be congenital, which is extremely rare and is caused by a deficiency in the enzyme lactase. It can usually be managed by GPs in primary care. Primary lactose intolerance is due to reducing levels of the enzyme lactase and is more common in the Asian population and generally presents in older children or young adults with bloating, wind and abdominal pain. More common is secondary lactose intolerance. It usually presents in children with protracted diarrhoea (>3 weeks duration) after an initial infective gastroenteritis e.g. rotavirus. It is temporary and usually improves over a period of 2-3 months. Diagnosis is made from the history and response to a lactose-free diet. Note that the stool test for reducing substances is no longer offered in local laboratories. A lactose-free formula is recommended and these are available to purchase from pharmacies, supermarkets or online. Parents should be advised to exclude all milk products from the diet and purchase the lactose-free formula milks. When symptoms have been settled for 2-3 months, regular formula milk and dairy products can be re-introduced. Please note that Colief is not recommended for prescribing, although it is available to purchase. Secondary lactose intolerance may also occur when there are underlying inflammatory bowel problems such as CMPA and coeliac disease, so if symptoms continue on a lactose- free diet then referral to a paediatrician is recommended. 3

4 Specialised Infant Formula Products for CMPA and Lactose Intolerance The following tables show the locally recommended products for each indication. Cow s Milk Protein Allergy (CMPA) Recommended Product First Line Products Clinicians are expected to select the most cost-effective product. Extensively Hydrolysed Formula (EHF) e.g. Similac Ailimentum o 0-2 years Aptamil Pepti 1 o 0 6months Aptamil Pepti 2 o 6months 2years Althera o 0 2years Nutramigen 1 with LGG o 0-6 months Nutramigen 2 with LGG o 6 months - 2 years Nutramigen 3 with LGG o 1 year plus Pepti Junior o 0-2 years Cow s Milk Protein Allergy (CMPA) Recommended Product Second Line Products Clinicians are expected to select the most cost-effective product. Amino Acid Formula (AAF) e.g. Alfamino o From birth Nutramigen Puramino o From birth Neocate LCP o From birth Neocate Junior o From 12months Comment EHF products are suitable for initiation in primary care whilst awaiting referral (Type 1 CMPA) or as a trial of treatment (Type 4 CMPA) Comment Second line products are NOT suitable for initiation in primary care. They are only to be prescribed on the advice of a specialist allergy clinic / paediatric dietitian Lactose Intolerance Note: Parents should be advised to purchase lactose-free milk Recommended Product Comment SMA LF Breastfeeding mothers should be advised Enfamil O-Lac with Lipil to follow a lactose-free diet and to Aptamil LF purchase lactose-free milk. 4

5 The following products are not recommended routinely for use in either CMPA or lactose intolerance: Soya milks and other soya products are not suitable for infants under 6 months due to the high phyto-oestrogen content and should not be prescribed, although they may be purchased as part of a lactose- free or cow s milk protein-free diet in older infants (from 6months) and children. Rice milk is not suitable for children under 5 years of age due to the high arsenic content Milk from goats, sheep and other mammals is not a suitable alternative to cow s milk as they contain similar proteins and lactose. Initiating Treatment Prescribe a limited quantity (sufficient for around 2 weeks) initially to establish response and compliance. Advise parents / carers that the extensively hydrolysed and amino acid formulas have an unpleasant taste and smell and are best served in a bottle, closed cup or through a straw (depending on the age of the infant /child). Review quantities on repeat prescriptions regularly as requirements change with age and intake of other foods. Quantities on Prescription The table below shows estimated quantities of powdered formula to prescribe per month, although some infants may need more (e.g. for faltering growth). Liquid preparations are more costly and are not generally recommended, except on specialist dietetic advice. Age Amount of formula to Rationale prescribe for 28 days 0-6 months 13 x 400g tins or 12 x 450g tins or 6 x 900g tins 6-12 months 7-13 x 400g tins or 6-12 x 450g tins or 3-6 x 900g tins solid intake increases Over 1 year 7 x 400g tins or 6 x 450g tins or 3 x 900g tins *On average a maximum of 4.5grams is required per 30ml of water. Exclusively formula fed infants / drink around 150ml/kg/day* Formula requirement reduces as Recommended intake of milk / milk substitute is 600ml per day Calcium supplementation may need to be considered for infants on these formulas depending on volumes taken. Dietitians will be able to make recommendations to GPs where supplements are required. 5

6 Reviewing and Stopping Treatment Type 1 / IgE Mediated CMPA Infants and children with type 1 IgE mediated allergy or multiple food allergies should undergo reintroduction of dairy products more cautiously with hospital supervised oral food challenges. Challenges should not be undertaken at home without prior advice from hospital health professionals. Type 4 / non-ige Mediated CMPA Infants and children with type 4 (non IgE mediated) CMPA and lactose intolerance can be challenged with dairy products at an appropriate age when the symptoms have been stable for a period of time (6 months to 1 year for CMPA and 2-3 months for secondary lactose intolerance). Start the slow reintroduction as per the Milk Ladder (recipes to support the use of the Milk Ladder are also available): Type 1 and 4 Mediated CMPA Specialist milk formulas are not generally needed in children aged 2 or more except on the specific advice of a dietitian or consultant. The specialist infant formula can be stopped when: The infant / child can tolerate dairy foods (e.g. chocolate, yoghurt, ice cream, cakes, butter, ghee) or The child is aged over 1 year and able to tolerate a calcium-fortified milk alternative from the supermarket e.g. Alpro Soya Growing Up Drink, oat milk, coconut milk etc. This policy is based on NICE Clinical Guideline 116: Food allergy in children and young people (Feb 2011): 6