Recommendations for Prescribing Specialist Infant Formula

Transcription

1 Recommendations for Prescribing Specialist Infant Formula Produced jointly by Medicines Management, West Suffolk Clinical Commissioning Group and Paediatric Dietitians, West Suffolk NHS Foundation Trust 1 1

2 Contents Introduction 3 Flow Charts - Managing cow s milk protein allergy 4 - Diagnostic milk challenge guidelines 5 - Home milk challenge guidance for parents 6 - Cow s milk protein allergy frequently asked questions 8 - Managing secondary lactose intolerance 9 - Managing faltering growth 10 - Managing preterm infants 11 Guidance on volumes of feed to prescribe 12 Information sheet Help my child is not eating 13 Referrals to Nutrition and Dietetics 14 West Suffolk Paediatric Dietetic Outpatient Referral Form 16 - available to download from: References 17

3 Introduction 1. This guideline has been produced for use in primary care to provide clarity on the prescription of specialist infant formula and to help reduce prescription costs. 2. The guidance is targeted at infants 0 12 months of age, however some of the prescribable items mentioned can be used past this age and advice on this is included. 3. These guidelines have been produced by the Paediatric Dietetic team at Ipswich Hospital and are supported by the Paediatric Dietetic team at West Suffolk Hospital and by Medicines Management in Ipswich and East Suffolk Clinical Commissioning Group and West Suffolk Clinical Commissioning Group. 4. 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. 5. Healthy Start vouchers can be used to buy infant formula that is based on cow s milk and says on the packaging that it can be used from birth. The vouchers cannot be used on soya or goat s milk formulas or any follow-on formulas that say they are for babies aged six months or older. 6. It is advisable to only prescribe 1 2 tins of formula initially to assess tolerance. 7. To make a referral to a Paediatric Dietitian please use the referral form on page 15. Key Use as first line Use if first line unsuccessful Should only be used in patients under secondary care. If started in primary care, these patients should be referred to the Paediatricians and Paediatric Dietitians Available to purchase over the counter (should not be routinely prescribed) 3

4 No improvement Prescription of infant formula in infants with suspected cow s milk protein allergy (CMPA) Take an allergy focused clinical history and family history of atopy (refer to NICE and MAP guidelines) Mild to moderate symptoms One or more of the following: GI Skin Vomiting Eczema Reflux Pruritus Loose or frequent stools Erythema Constipation Blood and/or mucus in stools Respiratory Rhinitis Wheeze Cough Severe onset symptoms Persisting symptoms of one or more of the following: GI Skin Vomiting Severe eczema Diarrhoea Faltering growth Respiratory Acute laryngoedema Anaphylaxis If breast fed Remove cow s milk from maternal diet for 4 weeks If formula fed Trial of Extensively Hydrolysed formula (ehf) for 4 weeks Casein based: Nutramigen Lipil 1 (<6 months) Nutramigen Lipil 2 (>6 months) Similac Alimentum (0-12 months) Whey-based: Aptamil Pepti 1 (<6 months) Aptamil Pepti 2 (>6 months) SMA Althéra (0-12 months) Improvement Refer to Paediatrician and Paediatric Dietitian If breastfed maternal cow s milk free diet with calcium and vitamin D supplement* If formula fed amino acid formula (AAF) SMA Alfamino (0-18 months) Nutramigen Puramino (0-18 months) Neocate LCP (0-18 months) IgE mediated (immediate onset) Do not retry cow s milk Refer for SPT or Specific IgE blood test (RAST) Continue prescription for ehf Non IgE mediated (delayed reaction) If breastfed retry milk in maternal diet gradually over 1 week If formula fed retry standard formula (refer to Diagnostic Milk Challenge Guidelines on page 5) Prescribing Notes: * Calcium supplement should provide 1000mg calcium and 10mcg vitamin D (if not already taking a supplement) Prescribe 1 2 tins of formula initially to assess tolerance/acceptance Review repeat prescriptions every 2 3 months (refer to table for guidance of volumes of feed see page 12) Refer to Paediatric Dietitian and Paediatrician Refer to Paediatric Dietitian Symptoms do not return: Not CMPA Symptoms return: Cow s milk free diet If formula fed Continue to prescribe ehf If breastfed Maternal milk free diet with calcium and vitamin D supplement* Try using amino acid formula if top ups required Formula should not be required in a child over 2 years of age Soya formula should not be prescribed in infants <6 months. If soya required >6 months of age parents to buy over the counter (unless advised by secondary care) 4

5 Diagnostic Milk challenge guidelines (Non-IgE mediated allergy) This guideline is designed to help confirm the initial diagnosis of CMPA (after a short period of milk exclusion) for Non-IgE mediated allergy only. Do not use these guidelines if you suspect an IgE mediated allergy. Do not challenge if the infant is unwell or if infant has a current eczema flare up. Do not challenge if the infant has commenced any new medication which may affect the gastro-intestinal tract e.g. antibiotics. Do not introduce any other foods during the challenge. If symptoms return this confirms the diagnosis and the challenge should be stopped. For those infants with confirmed CMPA please refer to the Paediatric Dietitian and consider referral to a Paediatrician. The table below is a guide only. It is to be used for those infants fully formula fed or those taking formula to compliment breast feeds. Days Volume of boiled water (mls) Cow s milk formula No. of scoops Hypoallergenic formula No. of scoops 1 150mls mls mls mls mls 5 0 To add standard formula to morning bottle only. If no symptoms occur after replacing 1 whole bottle (by day 5) with standard formula the infant may continue to consume standard formula in all bottles. For exclusively breast fed infants reintroduce cow s milk and cow s milk containing foods into the maternal diet over a 1 week period. If symptoms have not returned in 2 weeks they do not have a CMPA. If symptoms are obvious during the first 5 days STOP the challenge and return to the prescribed formula and/or a maternal milk free diet if breast fed. Adapted from the Milk Allergy in Primary Care (MAP) guideline: Venter, C. et al. (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 5

6 Home milk challenge guidance for parents It is important to try your baby with milk now. This is to make sure that any improvement in their symptoms is due to cutting out milk (and they have a cow s milk protein allergy) rather than for any other reason. Do NOT start this challenge if your child has had a positive blood test (RAST) to cow s milk. Do NOT start this challenge if your child is unwell, e.g. Has a cold or any other lung infections or breathing problems Any tummy/bowel problems e.g. tummy ache or loose nappies Any teething signs that are upsetting your child Eczema has flared up Do NOT start this challenge if your child is having any medication which may upset their tummy, e.g. antibiotics. Do NOT try any other new foods during this challenge. Try to write down what your child eats and drinks during the challenge. Also note any symptoms e.g. sickness, loose nappies, rashes or any changes in their eczema. Home challenge This will depend on whether your baby is breastfeeding or having formula. For a formula fed child (those taking only formula or a mixture of formula and breast feeds): Follow the advice in the table below: each day increase the amount of cow s milk formula given in baby s FIRST bottle of the day. If you see any obvious symptoms e.g. sickness, tummy pains, a rash, itching, STOP the challenge. Go back to the previous formula baby was taking and inform your GP. If you have not seen any symptoms in your child by day 5 (when you have completely replaced one bottle a day with cow s milk formula) you can try giving cow s milk formula for each feed they would usually have from a bottle. If you have also been avoiding milk whilst breastfeeding, milk and milk products can be reintroduced into your diet. If you do not see any symptoms within 2 weeks of your baby having more than 150mls cow s milk formula per day, then your baby does not have a cow s milk protein allergy. Days Volume of boiled water Cow s milk formula No. of scoops Hypoallergenic formula No. of scoops 1 150mls 1 in 1 st bottle of day 4 in 1 st bottle of day 2 150mls 2 in 1 st bottle of day 3 in 1 st bottle of day 3 150mls 3 in 1 st bottle of day 2 in 1 st bottle of day 4 150mls 4 in 1 st bottle of day 1 in 1 st bottle of day 5 150mls 5 in 1 st bottle of day 0 in 1 st bottle of day 6

7 For a fully breast fed infant: Start using cow s milk and cow s milk containing foods in your own diet over 1 week. If you see any obvious symptoms, e.g. sickness, tummy pains, a rash, itching in your child, STOP and go back to your milk free diet and inform the GP. If you do not see any symptoms in your child then you can go on drinking cow s milk and eating cow s milk containing products, e.g. cheese and yoghurt. In some children symptoms of a cow s milk protein allergy may appear at a later time. This may be when you wean your child or if you start using cow s milk formula. If this happens then contact your GP. 7

8 Frequently asked questions about Cow s Milk Protein Allergy (CMPA): Q. Can goats milk formula be used as a treatment for CMPA? A. No: Goat s milk and sheeps milk are not advised due to the 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 can use Alpro Junior 1+ soya milk instead of formula (this can also be used in cooking from 6 months). Available for purchase in supermarkets. If soya is not tolerated: continue prescription of specialist formula (ensure child has review appointment with paediatric dietitian) Q. What happens when an infant reaches 2 years of age and still has a cow s milk protein and soya allergy? A. The 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 the age of 4½ years. Q. Are vitamin and mineral supplements required? A. The Department of Health recommends that a supplement containing vitamin A and D is given to: All breastfed infants from six months of age Babies under one year of age who are taking less than 500ml of formula daily All children from 1 5 years Children on a milk free diet may require a calcium supplement. This will be advised by the Paediatric Dietitian. Q. What are Neocate Active and Neocate Advance? A. These are highly specialised products and should only be advised by secondary / tertiary care. They should not be prescribed in infants under the age of 1 year. They are not designed as a follow on from Neocate LCP. 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 six months of age who have multiple food protein allergies. This should only be used under direction of a Paediatric Dietitian. Q. Why is soya formula not advised? A. Soya formula is no longer indicated for cow s milk allergic infants under the age of six months due to its phyto-oestrogen content and the increased risk of sensitisation to soya protein (as per Chief Medical Officer Statement, 2004). Parents wishing to feed their infant on a soya based formula should be advised of the risks and advised to purchase the formula over the counter. Soya formula may be prescribed in exceptional circumstances, i.e. galactosaemia or when ehf or amino acid based formulas are refused. Q. Can lactose free products be used in cow s milk protein allergy? A. No. These products contain cow s milk protein and are therefore not suitable. 8

9 Flow chart for Managing Secondary Lactose Intolerance Has the infant had symptoms such as: Abdominal bloating Usually occurs Increased wind following an infectious Loose green stools gastrointestinal illness for more than 2 weeks? Note: Lactose intolerance in young infants is rare and Cow s milk protein allergy should always be considered as an alternative diagnosis >12 months of age 0-12 months of age Yes Advise Lactose free full fat milk (can be purchased at supermarkets). Use in conjunction with a milk free diet. Yes Bottle fed Yes Advise to purchase lactose free formula from supermarket/chemist SMA LF, Enfamil O-Lac, Aptamil Lactose Free. If weaned use in conjunction with a milk free diet Breast fed Lactose intolerance in exclusively breastfed infants is rare. If symptoms are present, consider cow s milk protein allergy. (See CMPA flow chart for advice). Breastfeeding should always be encouraged and the mother may benefit from referral to a breastfeeding counsellor. 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 then advise parents to slowly start to re-introduce standard formula/milk into diet. Have symptoms returned on commencement of standard infant formula/milk? Yes Return to lactose free formula or lactose free milk and refer to paediatric dietitian No No further action needed. Note: Use of lactase drops is not common practice. 9

10 Flow chart for managing Faltering Growth For infants with faltering growth: Weight crossing 2 centiles downwards. Weight falls below the 0.4 th 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. Rule out underlying medical condition. No Refer to paediatrician. Yes Check feeding pattern, including feed volumes and tolerance. Is infant weaned? Yes No Consider high calorie infant formula: SMA High Energy Infatrini Similac High Energy Involve health visitors to observe mealtimes. Give simple advice around managing any behavioural aspects. (see information sheet, Help my child isn t eating ). Ensure parents/carers are given advice on high calorie foods. Suitable for infants up to 18 months or 8kg. Refer to paediatric dietitian and paediatrician. Monitor growth (length and weight) to ensure catch up growth and discontinue when appropriate to minimise excessive weight gain. 10

11 Flow chart for managing Preterm Infants Infant already on formula on discharge from hospital. Preterm formula only to be started in primary care if mother stops or reduces breast feeds. (under 6 months corrected age) Infants born prior to 34 weeks and <2kg at birth will require prescription for: Nutriprem 2 powder or SMA Gold Prem 2 powder Powdered formula only to be prescribed. Nutriprem 2 or SMA Gold Prem 2 liquids should not routinely be prescribed unless there is a clinical need, e.g. immunocompromised infant, or as directed by secondary care. Growth should be monitored by the Health Visitor. Any concerns with baby s growth should be referred to the paediatric dietitian and paediatrician. (See faltering growth pathway) Use up to 6 months corrected age. i.e. 6 months plus the number of weeks premature added on. Change to a standard term formula thereafter if no concerns with growth. 11

12 Guidance on Volumes of Feed to Prescribe for Infants Infants less than 6 months of age: 150ml/kg/day or similar quantities to current feed. As a general rule a 400g tin should last 3.5 days (8-10x 400g tins per month). Infants over 6 months of age: Formula Size of tin Cost per tin Cost per 100ml Maximum per month PIP code Hydrolysed Nutramigen Lipil 2 Milupa Aptamil Pepti 2 Milupa Aptamil Pepti 2 Similac Alimentum SMA Althéra Pepti Junior 400g 400g 800g 400g 450g 450g Amino Acid based Nutramigen Puramino Neocate LCP SMA Alfamino Neocate Active (unflavoured)* Neocate Active (blackcurrant)* Neocate Spoon* 400g 400g 400g 63g sachet 63g sachet 37g sachet per sachet 4.44 per sachet 2.62 per sachet sachets 56 sachets 28 sachets Soya based SMA Wysoy SMA Wysoy Infasoy 430g 860g 900g Formula Size of bottle Cost per bottle Cost per 100ml Maximum per month PIP code SMA High Energy Infatrini Similac High Energy 250ml 200ml 200ml All prices correct as per MIMS April * These products should only be used under the guidance of a paediatric dietitian. These volumes are a guide only, some individuals may require more. N.B. Neocate Advance is for use in tube fed infants only (under guidance of the paediatric dietitian). If a child is having artificial nutritional support the Paediatric Dietitian will be involved in the care and will provide guidance on the appropriate monthly prescription. 12

13 Help, my child isn t eating Mealtimes are a time for learning about food and eating and 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 may benefit from background noise. Try both approaches to find out what 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 once 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 1½ 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. Prepared by Paediatric Dietitians 13

14 Referrals to Nutrition and Dietetic Service Any patient that requires a dietetic referral should have the referral discussed with the parents / carers of the infant and the referral should contain the following information (in addition to standard patient information): Reason for referral / diagnosis (if cow s milk protein allergy please state if IgE or non-ige mediated) Relevant social history, including if the child is a child in need or on a child protection plan Weight and height / length Language requirements / need for interpreter Please note that referrals regarding cow s milk protein allergy will not be accepted until a confirmed diagnosis has been made, using the infant feeding prescribing guidelines. Please state if IgE or non-ige mediated. For any queries regarding dietetic referrals please contact the Dietetic Department on The referral form should be completed and returned to the address shown on the referral form or faxed to the department. 14

15 DEPARTMENT OF NUTRITION AND DIETETICS West Suffolk Hospital Hardwick Lane Bury St Edmunds Suffolk IP33 2QZ Tel: Fax: Paediatric Dietetic Outpatient Referral Form Please fax or post referral through to the Paediatric Dietitians. Please telephone ( ) to confirm receipt. Referrer: Name: Designation: Organisation: Address: Child: Surname: Forename/s: DOB: Hospital No: Address: Postcode: Tel No: Date: Signature: Child s GP details: Postcode: Tel No: Mobile No: Parent/Carer names: Aware of referral: School/Pre-school: Health Visitor/School Nurse: Consultant/s: Other agencies involved: Medical history and current medication: Results of relevant investigations: Current weight and height and growth history (Please include copy of centile chart if possible): Reason for referral: Background information (Please include any relevant social history, including child protection issues, which may affect eating behaviours or ability of the family to comply with dietetic advice): NB. Please note that all incomplete referrals will be returned to the referrer 15

16 References 1. Clinical Paediatric Dietetics, 3 rd edition, Blackwell publishing, East of England Perinatal network Enteral feeding of preterm infants on the Neonatal Unit, December Buller HA, Rings EH, Montgomery RK, Grand RJ. Clinical aspects of lactose intolerance in children and adults. Scand J Gastroenterology Suppl 1991: 188: COT (2003); Phytoestrogens and health. FSA 5. Food Hypersensitivity. Diagnosing and managing food allergy and intolerance. Isabel Skypala and Carina Venter. Wiley-Blackwell Paediatric Group of the British Dietetic Association Paediatric Group Position Statement on the use of Soya Protein for infants, February NICE guideline: Food allergy in children and young people: Diagnosis and assessment of food allergy in children and young people in primary care and community settings, February BNF for children Published by BMI Group by Pharmaceutical Press, RCPCH Publications Ltd. 9. Vandenplaas et al; Guidelines for the diagnosis and management of cow s milk protein allergy in infants; Arch Dis Child 2007; Host et al 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 1999; Bedfordshire Community Health Services Countywide guidelines for prescribing specialist infant formula in Primary Care; April Venter et al. Diagnosis and management of non-ige mediated cow s milk allergy in infancy a UK primary care practical guide. Clinical and Translational Allergy 2013; 3: Ludman, S; Shah, N, Fox, A: Managing Cow s Milk Allergy in Children. BMJ 2013; 347: F

17 Produced jointly by Medicines Management, West Suffolk Clinical Commissioning Group and Paediatric Dietitians, West Suffolk NHS Foundation Trust. Next review date: April 2016