Appropriate Prescribing of Specialist Infant Formulae in Staffordshire
Transcription
Appropriate Prescribing of Specialist Infant Formulae in Staffordshire
Burton Hospitals NHS Foundation Trust Cannock Chase Clinical Commissioning Group East Staffordshire Clinical Commissioning Group North Staffordshire Combined Healthcare North Staffordshire Clinical Commissioning Group South East Staffordshire and Seisdon Clinical Commissioning Group Staffordshire and Stoke on Trent NHS Partnership Trust Stafford and Surrounds Clinical Commissioning Group Stoke on Trent Clinical Commissioning Group University Hospital of North Midlands Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines Document Number Version Ratified By and Date Name of Approving Body(s) and Dates Job Title of Document Author Name of Responsible Committee Executive Director Date Issued Expiry Date (Maximum Two Years) Target Audience V2 Area Prescribing Committee Area Prescribing Group Area Prescribing Group 30th October 2015 Area Prescribing Committee 25th November 2015 Medicines Management Group SSOTP 21st December 2015 SSOTP Paediatric Dietetic Team in Partnership with UHNM Paediatric Dietetic Team Adapted and adopted from East Staffordshire Clinical Commissioning Group with permission from Central Eastern Commissioning Support Unit Medicines Management Team Nutrition and Effectiveness Group Director of Operations 1st January 2016 1st January 2017 Children’s Services This document may be made available in a different format by contacting the Author of the Document Version Control - Review and Amendment Log Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 1 Version Type of Change Description of Change Date V1.1 Consultation with Paediatric Dietetic Team 2013-2014 Development of ‘Care Pathway for the Diagnosis and Management of Lactose Intolerance and Cow’s Milk Allergy in Children (including Gastro-oesophageal Reflux)’ changes to document made and pathways amended to include MAP pathway. Discussions and consultation with UHNS and Mid Staffordshire Foundation Trust. 28-11Agree with the document in principle. Confirm sign off from Area Prescribing committee and 2014 Area Prescribing Group to take to SSOTP Safety and Effectiveness Sub Committee. V1.2 Consultation with Children’s Safety and Effectiveness Group V1.3 Consultation with Area Prescribing Group 18-12-14 V1.4 Consultation with Nutrition and Effectiveness Group 19-01-15 V1.5 Consultation with SSOTP Medicines Management Group 19-02-15 V1.6 Consultation with Paediatric Dietetic Team 19-02-15 V1.7 Consultation with Children’s Safety and Effectiveness Group 25-02-15 V1.8 Consultation with Area Prescribing Committee 25-02-15 29-04-15 To take for further consultation with GPs at JMOC 11-03-15 and then review again at APC in April 2015. V1.9 Consultation with Safety and Effectiveness Sub Committee 27-02-15 29-05-15 Approved pending approval at APC in April 2015 following further consultation and amendments through JMOC. V1.10 Consultation with Joint Medicines Optimisation Committee 11-03-15 15-04-15 Review of evidence base for secondary lactose intolerance and GORD. Amendments made including not recommending lactose free formulae. Change colour coding of prescribing. Review guidelines ‘Appropriate Prescribing of Specialised Infant Formulae in South Staffordshire’ adopted by Area Prescribing Group 12-12-14 so there is one guidance document on this subject in Staffordshire Agreed to adopt format of one document for Staffordshire adopted by APC 12-12-14 with amendments of inclusion of MAP guidelines and ‘Formulae to be started under care of Dietitian’. Removal of ‘Formulae started in Secondary Care’ Approved agreed to take forward to North Staffordshire and Stoke on Trent Area Prescribing Committee. Amendment of editing Appendices added to main document. Inclusion of ‘Althera’ as an Extensively Hydrolysed Formula as now in BNF. Approved with note to review training capacity across Health Visiting Team. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 2 Version V2 V2 Type of Change Description of Change Date Consultation with Allied Prescribing Group and Dr Ahmed Paediatrician 19-06-15 Consultation with Area Prescribing Committee 25-11-15 09-10-15 Change of consultant to paediatrician. Under GORD removal of ‘medication such as ranitidine or proton pump inhibitors’. Change of rice milk not to be started before 5 years of age to 4.5 years of age. Change of stopping prescription of formula for CMPA from 2 years of age to 1 year of age if tolerating suitable alternatives. Changes made based on reviewed evidence. EHF and AAF added to MAP Guidelines Appendix 2. Agreed to accept amendments and adopt this revised document. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 3 Burton Hospitals NHS Foundation Trust Cannock Chase Clinical Commissioning Group East Staffordshire Clinical Commissioning Group North Staffordshire Combined Healthcare North Staffordshire Clinical Commissioning Group South East Staffordshire and Seisdon Clinical Commissioning Group Staffordshire and Stoke on Trent NHS Partnership Trust Stafford and Surrounds Clinical Commissioning Group Stoke on Trent Clinical Commissioning Group University Hospital of North Midlands DOCUMENT SUMMARY Document Title Document Status Date of Publication Key Points Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines New Revision x 1/11/2015 These guidelines aim to provide a consistent approach to the prescribing of specialised infant formulae in Staffordshire. These guidelines aim to assist GPs and Health Visitors with information on the use of prescribable infant formula in the situation when breastfeeding cannot be continued for a medical reason. Breastfeeding will always be promoted as the first-line option for feeding any infant under 6 months old. The guidelines are targeted at infants 0-12 months. However, some of the prescribable items mentioned here can be used beyond this age and advice on this is included in the guidelines. The guidelines advise on: • Over-the-counter (OTC) products available where appropriate • Initiating prescribing of specialised infant formulae • Quantities to prescribe of specialised infant formulae • Which products to prescribe for cow’s milk protein allergy (CMPA), Gastrooesophageal Reflux Disease (GORD), Secondary Lactose Intolerance, faltering growth, Pre-term Infants. • Triggers for reviewing and discontinuing prescriptions • When onward referral for dietetic advice and/or secondary/specialist care should be considered. Available Support Training provided to Staffordshire and Stoke on Trent NHS Partnership Trust (SSOTP) Health Visitors. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 4 Contents Page 1. Introduction 6 2. Purpose 6 3. Quantities of formulae to Prescribe 7 4. Do’s and Don’ts of Prescribing Specialised infant formulae 8 5. Cow’s Milk Protein Allergy 9 6. Gastro-oesophageal Reflux Disease (GORD) 13 7. Secondary Lactose Intolerance 14 8. Faltering Growth 15 9. Pre-term Infants 16 10. Comparative Costs of Specialised Infant Formulae 18 11. References 20 Appendices Appendix 1 – Quick Reference Guide Specialised Infant Formulae Appendix 2 - The Milk Allergy in Primary Care (MAP) Guidance http://cowsmilkallergyguidelines.co.uk/ Appendix 3 – Monitoring Compliance Colour Key used on the following pages: Over the counter products (OTC) to be used initially Prescribe as first-line Prescribe as second-line Prescribe in primary care only as recommended by Paediatric Dietitian or Paediatrician Should not routinely be prescribed Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 5 Burton Hospitals NHS Foundation Trust Cannock Chase Clinical Commissioning Group East Staffordshire Clinical Commissioning Group North Staffordshire Combined Healthcare North Staffordshire Clinical Commissioning Group South East Staffordshire and Seisdon Clinical Commissioning Group Staffordshire and Stoke on Trent NHS Partnership Trust Stafford and Surrounds Clinical Commissioning Group Stoke on Trent Clinical Commissioning Group University Hospital of North Midlands Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines 1. Introduction Whilst these guidelines advise on appropriate prescribing of specialist infant formulae, 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. 2. Purpose of these Guidelines These guidelines aim to assist GPs and Health Visitors with information on the use of prescribable infant formulae. The guidelines are targeted at infants 0-12 months. However, some of the prescribable items mentioned here can be used beyond this age and advice on this is included in the guidelines. The guidelines advise on: • Over-the-counter (OTC) products available where appropriate • Initiating prescribing • Quantities to prescribe • Which products to prescribe for different clinical conditions • Triggers for reviewing and discontinuing prescriptions • When onward referral for dietetic advice and/or secondary/specialist care should be considered. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 6 3. Quantities of Formulae to Prescribe When any infant formula is prescribed the guide below should be used for powdered formula: Age of child Under 6 months 6-12 months Over 12 months Number of tins for 28 days 13 x 400g tins or 6 x 900g tins 7-13 x 400g tins or 3-6 x 900g tins 7 x 400g tins 3 x 900g tins or These amounts are based on: • Infants under 6 months being exclusively formula fed and drinking up to 150180ml/kg/day of a normal concentration formula. In exceptional circumstances 200ml/kg/day is needed to accommodate lost formula through vomiting/spillage. If significant vomiting continues consider referral to paediatrician. • Infants 6-12 months may not require less formula as solid food intake increases due to the use of formula in food such as cereal and puddings, as a cow’s milk substitute. • Children over 12 months drinking the 600mls of milk or milk substitute per day recommended by the Department of Health. • • • 4. For liquid high energy formula: Prescribe an equivalent volume of formula to the child’s usual intake until an assessment has been performed and recommendations made by a paediatric dietitian/paediatrician. Some children may require more, e.g. those with faltering growth. Review recent correspondence from the paediatric dietitian/paediatrician. Dos and Don’ts of Prescribing Specialist Infant Formulae Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 7 Do Don’t Do promote and encourage breastfeeding where it is clinically safe and the mother is in agreement. Do check any formula prescribed is appropriate for the age of the infant. Do check the amount of formula prescribed is appropriate for the age of the infant (see page 2) and/or refer to the most recent correspondence from the paediatric dietitian/paediatrician. Do review any prescription where the child is over 1 year old and/or the formula has been prescribed for more than 1 year or when greater amounts of formula are being prescribed. Do review the prescription if the patient is prescribed a formula for Cow’s Milk Protein Allergy (CMPA) but able to eat any of the following foods – cow’s milk, cheese, yogurt, ice cream, custard, chocolate, cakes, cream, butter, margarine, ghee. Do prescribe only 1 or 2 tins or equivalent initially as a trial until compliance/tolerance is established. Note: 1 tin will last approximately 3 days. Refer to page 5 for ongoing prescription volume guide. Do remind parents/guardian to follow the advice given by the formula manufacturer regarding safe storage of the feed once mixed or opened. Do refer where appropriate to secondary or specialist care - see advice for each condition. Do refer where appropriate to the paediatric dietitians. Do seek prescribing advice if needed in primary care from the Medicines Optimisation Team. Do seek prescribing advice if needed in secondary care from the local Medicines Information Do prescribe Nutriprem 2 Liquid® or SMA Gold Prem 2 Liquid® until 4 weeks corrected age at this point prescription can be changed to a powdered version if clinically indicated. Don’t add infant formulae to the repeat prescription in primary care, unless a review process is established to ensure the correct product and quantity is prescribed Don’t prescribe lactose-free formulae (SMA LF®, Enfamil O-Lac®) for infants with CMPA. Lactose is a carbohydrate not a protein. Prescribe an Extensively Hydrolysed Formula instead. Don’t prescribe soya formula (Infasoy®, SMAWysoy®) for those with CMPA or secondary lactose intolerance. It should not be prescribed or recommended at all in those under 6 months due to high phyto-oestrogen content. Don’t suggest milk and formulae made from goat’s milk, sheep’s milk or mammalian milks for those with CMPA or secondary lactose intolerance. Don’t suggest rice milk for children under 4.5 years of age due to the high arsenic content. Don’t suggest Infant Gaviscon® more than 6 times in 24 hours or where the infant has diarrhoea or a fever, due to its sodium content. Don’t prescribe low lactose/lactose-free formulae for lactose intolerance. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 8 5. Cow’s Milk Protein Allergy (CMPA) Symptoms and diagnosis • Refer to NICE guideline CG116 ‘Food Allergy in Children and Young People’ Feb 2011 for full details. http://guidance.nice.org.uk/CG116 • Refer to Appendix 2 – Milk Allergy in Primary Care (MAP) Guidelines. Background to the Guidelines can be found in ‘Diagnosis and management of non-IgE mediated cow’s milk allergy in infancy – A UK primary care practical guide’ Venter et al. Clinical and Translational Allergy 2013, 3:23 http://www.ctajournal.com/content/3/1/23 Symptoms of cow’s milk protein allergy can include: • Skin symptoms (pruritus, erythema, urticaria, atopic dermatitis). • Acute angioedema of the lips and face, tongue and palate, and around the eyes. • GI symptoms (diarrhoea, bloody stools, nausea and vomiting, abdominal distension and /or colicky pain, constipation, Gastrooesophageal reflux disease (GORD). • Recurrent wheeze or cough, nasal itching, sneezing, rhinorrhoea or congestion. • Anaphylaxis. • Faltering growth. NICE recommends further investigation with a skin prick test or specific IgE antibody blood test if IgE-mediated allergy is suspected. When non-IgE mediated allergy is likely, trial elimination for 2 to 6 weeks of the suspected allergen. Most infants with CMPA develop symptoms within 1 week of introduction of CMP-based formula. Onward referral Most infants with CMPA can be managed in primary care until weaned. Referral to a paediatric dietitian should be made at diagnosis for all infants who will require a cow’s milk free diet. Breastfeeding mothers following a milk free diet should be referred to the paediatric dietitian who will advise on both the mother’s and the infant’s diet. Refer to secondary or specialist care paediatrician if any of the following apply: • Faltering growth with one or more gastrointestinal symptoms. • Acute systemic reactions or severe delayed reactions. • Significant atopic eczema where multiple or cross-reactive food allergies are suspected by the parent or carer. • Possible multiple food allergies. • Persisting parental suspicion of food allergy despite a lack of supporting history (especially where symptoms are difficult or perplexing). Treatment • Breast milk is the ideal choice for most infants with CMPA. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 9 • • • • • • If symptoms persist in the exclusively breast-fed infant, a maternal milk (+/- soya) free diet is indicated for a minimum trial of 2 weeks and with immediate referral to paediatric dietitian. Breastfeeding mothers on a milk free diet may require supplementation with milk-free 1000mg calcium per day. If breastfeeding is not occurring, extensively hydrolysed formulae (EHF) are the first choice, unless the infant has a history of anaphylactic symptoms. Amino acid formulae (AAF) should normally be started as recommended by a paediatric dietitian or paediatrician. They are suitable only when EHF does not resolve symptoms and/or when there is evidence of severe (anaphylactic) allergy. Please note these formulae can cause green stools. This is not a cause for concern unless accompanied by other symptoms. If breastfeeding mothers do not wish to or are unable to follow a milk free diet, or are following a milk free diet and symptoms persist, an AAF will be needed if top-ups are required and can be prescribed in primary care. If a patient has a history of anaphylactic reaction to cow’s milk, AAF may be started in primary care, with immediate onward referral to paediatric dietitian and secondary care paediatrician. Cow’s Milk Protein Allergy (CMPA) Extensively Hydrolysed Formulae (lactose-free) First-line Extensively Hydrolysed Formulae (Containing lactose) Second-line Similac Alimentum (Abbott Nutrition)* Birth to 12 months *Nutramigen 1 with LGG® (previously called Nutramigen Lipil 1®) (Mead Johnson) may be a more appropriate first-line feed for children birth to six months. *Nutramigen 2 with LGG® (previously called Nutramigen Lipil 2®) (Mead Johnson) may be a more appropriate first-line feed for children aged 6 months to 2 years. Althera (SMA Nestle) Pepti 1® (Milupa Aptamil) Birth to 12 months Birth to 6 months Pepti 2® (Milupa Aptamil) 6 months to 2 years. Not needed if tolerating suitable milk free OTC products and weaned to appropriate diet as recommended by paediatric dietitian. Above formulae can be tried if the infant/child is not tolerating firstline products because of taste. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 10 Extensively Hydrolysed Formulae with Medium Chain Triglycerides Prescribe in primary care only as recommended by Paediatric Dietitian or Paediatrician Pregestimil Lipil® (Mead Johnson) Birth to 2 years. Not needed if tolerating suitable milk free OTC products and weaned to appropriate diet as recommended by paediatric dietitian. Pepti – Junior® (Cow&Gate) Birth to 2 years. Not needed if tolerating suitable milk free OTC products and weaned to appropriate diet as recommended by paediatric dietitian. Above formulae are used where CMPA is accompanied by malabsorption. Alfamino (SMA / Nestle) Amino Acid Formulae Prescribe in primary care only as recommended by Paediatric Dietitian or Paediatrician Nutramigen® Puramino (Mead Johnson) Neocate LCP® (Nutricia) Birth until able to tolerate over the counter products Birth until able to tolerate over the counter products Birth until able to tolerate over the counter products These are not infant formulae For over 1 year olds only NeocateActive® unflavoured (Nutricia) Neocate Active® To only be started if blackcurrant flavour recommended by Paediatric Neocate Advance® Dietitian unflavoured (Nutricia) Neocate Advance® banana/vanilla flavour (Nutricia) 1. If a patient presents with clear anaphylactic reaction to cow’s milk these formulae should be commenced in primary care, with immediate onward referral to secondary or specialist care. 2. If formula top-ups are needed for a child who is otherwise breastfed (mother on a milk free diet) AAF will be required. Review and 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 guide to quantities required (page 6) and/or refer to the most recent correspondence from the paediatric dietitian. • Avoid adding to the repeat prescription for these reasons, unless a review process is established. • Challenging with cow’s milk - refer to NICE guidelines on which children should be challenged with cow’s milk in secondary care setting. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 11 • • • Prescriptions should be stopped when the child has outgrown the allergy (see notes 1 and 5 below). Review the need for the prescription if you can answer ‘yes’ to any of the following questions: o Is the patient over 1 year of age? o Has the formula been prescribed for more than 1 year? o Is the patient prescribed more than the suggested quantities of formula according to their age? o Is the patient prescribed a formula for CMPA but able to eat any of the following foods – cow’s milk, cheese, yogurt, ice-cream, custard, chocolate, cakes, cream, butter, margarine, ghee? Children with multiple or severe allergies may require prescriptions beyond 2 years in severe cases. This should always be at the suggestion of the paediatric dietitian/paediatrician. Notes: 1. Soya formula (Infasoy®, SMA Wysoy®) should not routinely be used for patients with CMPA. It should not be prescribed or recommended for those under 6 months due to high phyto-oestrogen content. It should only be advised in patients over 6 months who do not tolerate first-line EHF since there is a risk that infants with CMPA may also develop or concurrently have allergy to soya. It is more likely that children will tolerate soya formula from 1 year. Parents should be advised to purchase soya formula as it is a similar cost to cow’s milk formula and readily available. From 2 years supermarket calcium enriched soya, oat milk, coconut, hemp milk alternatives may be suitable as an alternative. Alpro® Junior 1+ soya milk may be suitable from 1 year. The paediatric dietitian will advise on suitable over-the-counter products for appropriate ages. 2. EHF and AAF have an unpleasant taste and smell, which is better tolerated by younger patients. Unless there is anaphylaxis, advise parents to introduce the new formula gradually by mixing with the usual formula in increasing quantities until the transition is complete. Serving in a closed cup or bottle or with a straw (depending on age) may improve tolerance. In some cases the formula will need to be flavoured e.g. with the minimum amount of milk free milkshake flavouring. Care should be taken and ingredients checked in those with multiple allergies. 3. Prescribe 1 or 2 tins initially as a trial until compliance/tolerance is established to avoid waste. Note: one tin will last approximately 3 days. Refer to page 7 for ongoing prescription guide. 4. Rice milk is not suitable for children under 4.5 years due to its arsenic content (Food Standards Agency 2009). Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 12 5. A significant number of infants may be able to tolerate milk products from 1 year onwards. 6. Milk-free calcium supplementation may be needed for infants depending on volume and type of formula taken. Breastfeeding mothers on a milk-free diet may also need a milk free calcium supplement. The dietitian will advise. 7. Lactose-free formulae (SMA LF®, Enfamil O-Lac with LIPIL®) are not suitable for those with CMPA. 8. Goat, sheep, and other mammalian milks are also not suitable for those with CMPA. 6. Gastro-Oesophageal Reflux Disease (GORD) Symptoms and diagnosis • GORD is the passage of gastric contents into the oesophagus causing troublesome symptoms and/or complications. • Symptoms may include regurgitation of a significant volume of feed, reluctance to feed, distress/crying at feed times and/or small volumes of feed being taken. Ideally symptoms should be observed by a Health Visitor. • Diagnosis is made from history that may include effortless vomiting (not projectile) after feeding, usually in the first 6 months of life, and usually resolves spontaneously by 12-15 months age. • It should be noted that two thirds of babies have some degree of reflux at some time during infancy. • Overfeeding needs to be ruled out by establishing the volume and frequency of feeds. Average requirements of formula are 150mls/kg/day for babies up to 6 months, and should be offered spread over 6-7 feeds. Note: If the baby is vomiting more formula will be required to replace vomited volumes. Onward referral • Infants with faltering growth and/or other complications as a result of GORD should be referred to paediatric services without delay. Treatment • If the infant is thriving and not distressed reassure parents and monitor. • In breastfed infants a breastfeeding assessment should be carried out by a person with appropriate expertise to check positioning and technique. • In formula fed infants provide advice on avoidance of overfeeding, positioning during and after feeding and activity after feeding. If no improvement trial with feed thickener e.g. Carobel®. • If the above advice is not successful offer alginate therapy (Infant Gaviscon®) for 1 to 2 weeks and stop the feed thickener. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 13 • If alginate therapy is successful continue but try stopping at intervals to see if the infant has recovered. If a patient presents on OTC thickened formulae do not advise a separate thickener. If symptoms do not improve refer to NICE guidance NG1 (2015) for further guidance. • • Review and discontinuation of treatment • Review after one month. If no improvement, consider CMPA (see MAP guidelines Appendix 2) • Infants with GORD will need regular review to check growth and symptoms. • GORD will usually resolve spontaneously between 12-15 months. Gastro-Oesophageal Reflux Disease (GORD) Feed thickener to be purchased First-line Feed Thickener should not routinely be prescribed Cow & Gate Instant Carobel® (Cow &Gate) Birth to 18 months Added to standard formula and breast milk Cow & Gate Instant Carobel® (Cow &Gate) Birth to 18 months Only prescribe if unable to purchase or and if there is a clinical need. Notes 1. Over the counter (OTC) thickened formulae and formula thickened with Carobel® will require the use of a large hole (fast-flow) teat. 7. 2. Infant Gaviscon® contains sodium, and should not be given more than 6 times in 24 hours or where the infant has diarrhoea or a fever. N.B. Each half of the dual sachet of Infant Gaviscon® is identified as ‘one dose’. To avoid errors, prescribe with directions in terms of ‘dose’. 3. Pharmacists should advise about appropriate doses of OTC products. Secondary Lactose intolerance Symptoms and diagnosis • Can occur following an infectious gastrointestinal illness but may be present alongside newly or undiagnosed coeliac disease/CMPA. • Symptoms include abdominal bloating and/or increased (explosive) wind. If these symptoms persist consider CMPA and follow MAP guidelines. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 14 • • • Treatment Regular feeding should not be interrupted and should be carried on after initial rehydration. Regular milk (lactose) containing formulae are appropriate in the vast majority of cases. If parents wish to trial a lactose-free formula these can be purchased OTC and should not be prescribed in primary care. Note this may delay diagnosis of CMPA. Notes Primary lactase deficiency/absense is an inherited condition and runs in families. The intolerance to lactose is progressive, but symptoms usually start after the age of 2 years, although may not be noticeable until adulthood. Lactose free formula is not needed in infancy for this condition. 8. Faltering Growth Symptoms and diagnosis • Diagnosis is made when the growth of an infant falls below the 0.4th centile or crosses 2 centiles downwards on a growth chart or weight is 2 centiles below length centile. • The height/length of an infant should be measured to properly interpret changes in weight using appropriate growth charts to be able to diagnose faltering growth. • It is essential to rule out possible disease related/medical or social causes for the faltering growth e.g. iron deficiency anaemia, severe troublesome constipation, GORD or a child safeguarding issue. If identified appropriate action should be taken. Onward referral • Infants with faltering growth should be referred to a paediatric dietitian and paediatrician without delay. Treatment • Prescribe an equivalent volume of high energy formula to the child’s usual intake of regular formula until an assessment has been performed and recommendations made by a paediatric dietitian/paediatrician. Review and discontinuation of treatment The team to whom the infant is referred should indicate who is responsible for review and discontinuation. If the team hands responsibility back to the GP this should be with an indication of what the goal is and at which point discontinuation can occur. • All infants on high energy formula will need growth (weight and height/length) monitored to ensure catch up growth occurs. • Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 15 • Once this is achieved the formula should be weaned and gradually discontinued to minimise excessive weight gain. Faltering Growth Similac High Energy® High Energy 120/200ml bottle Formula (Abbott Nutrition) Birth up to 18 months or 8kg On commencement refer to paediatric dietitian First-line High Energy Formula Prescribe as Second-line High Energy Formula Prescribe in primary care only as recommended by Paediatric Dietitian or Paediatrician Infatrini® 100/200ml bottle (Nutricia) Birth up to 18 months or 8kg SMA high Energy ® 250ml bottle (SMA) Birth up to 18 months or 8kg Infatrini Peptisorb® 200ml bottle (Nutricia) Birth up to 18 months or 8kg N.B. This formula is suitable for infants with faltering growth and intolerance to whole protein feeds e.g. short bowel syndrome, Intractable malabsorption, inflammatory bowel disease, bowel fistulae. Notes • Where all nutrition is provided via NG/NJ/PEG tubes, the paediatric dietitian will advise on appropriate monthly amounts of formula required which may exceed the guideline amounts for other infants. These formulae are not suitable as a sole source of nutrition for infants over 8kg or 18 months of age. • Do not add formula to repeat prescriptions as on-going need for formula and amount required will need to be checked with each prescription request. • Manufacturer’s instructions regarding safe storage once opened and expiry of ready to drink formulae should be adhered to. Note: this may differ from manufacturer to manufacturer. 9. Pre-term Infants and Nutrient Enriched Discharge Formulae Indications Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 16 • • • Small percentage of these infants will have had their nutrient-enriched post discharge formula continued on discharge from the neonatal unit. This should be prescribed as a ready to feed presentation until 4 weeks corrected age. At this point parents/carer should be advised to commence on standard OTC cow’s milk formula of their choice or changed to a powdered version of nutrient enriched discharge formula (only if clinically indicated). It is started for babies born before 35 weeks gestation, or small for gestational age. These formulae should not be used in primary care to promote weight gain in patients other than babies born prematurely. Onward referral • These infants should already be under regular review by the paediatricians. • If there are concerns regarding growth whilst the infant is on these formulae, refer to the paediatric dietitian. • If there are concerns regarding growth at 6 months corrected age or at review one month after these formulae are stopped, refer to the paediatric dietitian. Review and discontinuation of treatment • The Health Visitor should monitor growth (weight, length and head circumference) while the baby is on these formulae. • In the exceptional circumstances infants remain on Nutrient Enriched discharge formula these products should be discontinued by 6 months corrected age. • Not all babies need these formulae for the full 26 weeks from expected date of delivery (EDD). • If there is excessive weight gain at any stage up to 6 months corrected age, stop the formula. Pre-term Infants Nutrient Enriched Post Discharge Formulae to be started only as recommended by Secondary Care SMA Gold Prem2®liquid (SMA) Nutriprem2® liquid (Cow& Gate) SMA Gold Prem2®powder (SMA) Up to 4 weeks corrected age at this point patients can be changed to a powdered version if clinically indicated. From 4 weeks corrected age up to a maximum of 6 months corrected age Nutriprem2® powder (Cow&Gate) 6 months corrected age = EDD + 26 weeks Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 17 10. Comparative Costs of Prescribable Infant Formulae Cow’s Milk Protein Allergy Product Extensively Hydrolysed Formulae (lactose-free) First-line Extensively Hydrolysed Formulae (Containing lactose) Second-line Extensively Hydrolysed Formulae with Medium Chain Triglycerides prescribe in primary care only as recommended by Paediatric Dietitian or Paediatrician Similac Alimentum Presentation/ Price 400g tin £9.10 Price/100g Cost/100kca l £2.28 £0.43 Nutramigen 1 with LGG® Nutramigen 2 with LGG® 400g tin £10.66 £2.67 £0.57 Althera (SMA Nestle) Pepti1® 450g tin £10.68 £2.37 £0.47 400g tin £9.54 £2.38 £0.48 Pepti1® 900g Eazypack £21.46 £2.38 £0.48 Pepti2® 900g Eazypack £20.48 £2.27 £0.48 Pregestimil Lipil® 400g tin £11.82 £2.96 £0.59 Pepti-Junior® 450g tin £12.58 £2.80 £0.53 Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 18 Cow’s Milk Protein Allergy Product Amino Acid Formulae Prescribe in primary care as recommended by Paediatric Dietitian or Paediatrician Alfamino (SMA/ Nestle) Nutramigen® Puramino NeocateLCP® NeocateActive® unflavoured or blackcurrant flavour Neocate Advance® unflavoured Neocate Advance® banana/vanilla flavour Presentation/ Price 400g tin £23 £5.75 £1.14 400g tin £26.27 400g tin £6.57 £1.32 400g tin £28.30 £7.08 £1.49 15 x 63g sachets £66.60 £7.05 £1.48 10 x 100g sachets £58.60 £5.86 £1.47 15 x 50g sachets £46.35 £6.18 £1.55 High Energy Formulae – Faltering Growth Product Presentation/ Price Similac High 200mls £2.10 High Energy Energy® Formula First-line Similac High 48 x 60mls £31.20 Energy® Infatrini® 200mls £2.17 High Energy Formula Infatrini® 100mls £1.12 Prescribe as Second-line SMA High 250mls £2.17 Energy® High Energy Formula prescribe in primary care only as recommended Infatrini Peptisorb® Price/100g Cost/100kcal 200mls £3.32 Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Cost/100kcal £1.04 £1.08 £1.09 £1.12 £0.95 £1.66 Page 19 by Paediatric Dietitian or Paediatrician Pre-term Infant Formulae Product NutrientEnriched Post Discharge Formula to be started only as recommended by Secondary Care 11. Presentation/ Price 250mls £2.10 Price/100g Cost/100kcal N/A £1.15 200mls-£1.68 N/A £1.12 SMA Gold Prem2® 400g £5.03 £1.26 £0.24 Nutriprem 2® 900g £11.24 £1.25 £0.25 SMA Gold Prem 2 liquid® Nutriprem 2 liquid® References: Cow’s milk protein allergy Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatolgy and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child 1990; 81:80-84. 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) Food Hypersensitivity. Diagnosing and managing food allergy and intolerance. (2009). Edited by Isabel Skypala and Carina Venter. Published by WileyBlackwell. NICE Clinical Guideline 116 Food Allergy in Children and Young People. 2011 http://publications.nice.org.uk/food-allergy-in-children-and-young-peoplecg116/guidance 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, 3:23 http://www.ctajournal.com/content/3/1/23 Vandenplas Y, Koletzo S et al. Guidelines for the diagnosis and management of cow’s milk protein allergy in infants. Arch Dis Child 2007;92:902-908 Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 20 World Allergy Organisation DRACMA guidelines 2010 (Diagnosis and Rationale Against Cow’s Milk Allergy) http://www.worldallergy.org/publications/WAO_DRACMA_guidelines.pdf Host A. Frequency of cow’s milk allergy in childhood. Ann Allergy Immunol 2002; 89 (suppl): 33-37. Soya formula Department of Health: CMO’s Update 37 (2004). Advice issued on soya based infant formula. Paediatric group Position Statement on Use of Soya Protein for Infants. British Dietetic Association: October 2010. http://www.steppyorks.nhs.uk/presentations/unit1/PaediatricGroupGuidelineS oyInfantFormulas.pdf Rice milk Food Standard Agency statement on arsenic levels in rice milk (2009) http://www.food.gov.uk/multimedia/pdfs/fsis0209arsenicinrice.pdf Gastro-oesophageal reflux disease NICE clinical guideline 1 ‘Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people’ Published: 14 January 2015 Secondary lactose intolerance NICE clinical Guidance 84 ‘Diarrhoea and vomiting in children’ Published: April 2009 Guarino, A; Albano, F; Ashenazi, A et al (2008) European Society for Paediatric Gastroenterology, Hepatology and Nutrition/European Society for Paediatric Infectious Diseases Evidence-based Guidelines for the Management of Acute Gastroenteritis in Children in Europe. Journal of Paediatric Gastroenterology and Nutrition. 46:S81-S184 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. Pre-term European Food Safety Authority 2004 General Clinical Paediatric Dietetics 3rd Edition (2007). Edited by Vanessa Shaw and Margaret Lawson. Published by Blackwell Publishing. Department of Health (2009) Birth to Five. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publications PolicyAndGuidance/ DH_107303 Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 21 Department of Health report on Health and Social Subjects No 45. 1994. Weaning and the weaning diet. The Stationary Office. Acknowledgements: • • • • • • • • • • Allied Prescribing Committee North Staffordshire Area Prescribing Group South Staffordshire Burton Hospital Foundation Nutrition and Dietetic Service Burton Hospital Foundation Trust Paediatrician Paediatrician East Staffordshire Clinical Commissioning Group North Staffordshire and Stoke on Trent Clinical Commissioning Group Paediatric Dietitians of Staffordshire and Stoke on Trent Partnership Trust NHS Paediatric Dietitians of University Hospitals North Midlands Stafford and Surrounds Clinical Commissioning Group UNICEF Implementation Team Staffordshire and Stoke on Trent NHS Partnership Trust This document has been adapted from ‘Appropriate prescribing of specialist infant Formulae’ written by Central Eastern Commissioning Support Unit Medicines Management Team, PrescQuipp NHS; Bulletin 67, July 14, 2.2. Acknowledgments of the original document: • Judith Harding, Prescribing Support Dietitian, Medicines Management Team, Central Eastern Commissioning Support Unit • Maddy Leriti and Zoe Wood, London Procurement Partnership Paediatric Project. Pharmacy and Medicines Use Work stream. • Leanne Fishwick, Dietetic Team Lead, Paediatrics and Food First Project, SEPT Community Health Services, Bedfordshire. • Rob Ives, Paediatric Dietitian, Feeding and Swallowing Team, North East London Foundation Trust. • The Paediatric Dietitians of North East London Foundation Trust. • Group Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 22 Staffordshire and Stoke on Trent NHS Partnership Trust University Hospital of North Midlands North Staffordshire Combined Healthcare North Staffordshire Clinical Commissioning Group Stoke on Trent Clinical Commissioning Group APPENDICES Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 23 Appendix 1 page 1 of 2 Staffordshire and Stoke on Trent NHS Partnership Trust University Hospital of North Midlands North Staffordshire Combined Healthcare North Staffordshire Clinical Commissioning Group Stoke on Trent Clinical Commissioning Group Adapted from the guidance written by Central Eastern Commissioning Support Unit Medicines Management Team and PrescQIPP July 2014 ALL CONDITIONS How much powdered infant formula should I prescribe monthly? Under 6 months 6 -12 month 13 x 400g tins OR 6 x 900g tins 7-13 x 400g tins or 3-6 x 900g tins Over 12 months 7 x 400g tins or 3 x 900g tins COW’S MILK PROTEIN ALLERGY (CMPA) Symptoms include: • Skin symptoms, e.g. pruritus, erythema, urticaria, atopic dermatitis, acute angioedema. • Gastro-intestinal symptoms, e.g. diarrhoea, bloody stools, nausea and vomiting, abdominal distention and/or colicky pain, constipation or gastro-oesophageal reflux disease (GORD). • Respiratory symptoms e.g. cough/wheeze, nasal itching, sneezing, rhinorrhea or congestion. Refer infants anaphylaxis or faltering Refer infants withwith anaphylaxis or faltering growth growth to paediatric services without delay • Also anaphylaxis and faltering growth. to paediatric services witout delay………………… DO NOT PRESCRIBE SOYA FORMULA – see guidance ® FIRST-LINE FORMULA Similac Alimentum (up to 12 months)* ® *Nutramigen 1 with LGG (previously called Nutramigen Lipil 1) (Mead Johnson) may be a more appropriate first line feed for children birth to six months. ® *Nutramigen 2 with LGG (previously called Nutramigen Lipil 2) (Mead Johnson) may be a more appropriate first line feed for children aged six months to 2 years. • Breastfeeding mothers may require a milk (+/-Soya) free diet and calcium supplementation. • Refer to paediatric dietitians on diagnosis and refer to latest correspondence before issuing prescriptions. Review the need for prescribing if answer is yes to any of the following questions: Can the patient tolerate cow’s milk, or dairy products? Is the patient over 1 years of age? Has the formula been prescribed for more than one year? Is the quantity prescribed greater than the recommended amount for the child’s age? GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) • GORD presents with a history of effortless vomiting after feeding, usually in the first 6 months of life. • • • • Over feeding should be ruled out by establishing the volume and frequency of feeds. Give reassurance and advice on positioning. Refer patients with faltering growth to Recommend Carobel® to thicken feeds paediatric services without delay Stop feed thickener if prescribing Infant Gaviscon® INITIALLY RECOMMEND OVER THE COUNTER FEED THICKENER Cow& Gate® Instant Carobel® (Cow &Gate) thickened Formula will require a large hole/fast flow teat. Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 24 Appendix 1 page 2 of 2 Staffordshire and Stoke on Trent NHS Partnership Trust DO NOT PRESCRIBE THICKENING FORMULAE – see guidance University Hospital of North Midlands North Staffordshire Combined Healthcare North Staffordshire Clinical Commissioning Group Stoke on Trent Clinical Commissioning Group SECONDARY LACTOSE INTOLERANCE Usually occurs following an infectious GI illness (but can occur alongside new or undiagnosed coeliac disease and last for a few weeks only). Symptoms include: • Abdominal bloating. • Increased explosive wind. Regular feeding should not be interrupted and should be carried on after initial rehydration. Regular milk (lactose) containing formulae are appropriate in the vast majority of cases DO NOT PRESCRIBE LACTOSE-FREE FORMULAE – see guidance Nutrient Enriched Post ® ® Discharge Formulae to be SMA Gold Prem2 Liquid or Nutriprem2 Liquid (Cow&Gate), started as recommended SMA Gold Prem2®powder, Nutriprem2® powder (Cow&Gate) by Secondary Care DO NOT PRESCRIBE POWDER FORMULA UNLESS CLINICALLY INDICATED FROM 4 WEEKS CORRECTED AGE ONLY (26 WEEKS EDD) Refer to the full Appropriate Prescribing of Specialist infant Formulae in Staffordshire guidelines for more details and second-line choices. Nutrition and Dietetic Service Staffordshire and Stoke on Trent NHS Partnership Trust Civic Centre Riverside Stafford ST16 3AQ Tel: 0300 1240109 Adapted with kindness and permission from: Nutrition and Dietetic Service Burton hospital Foundation Trust, Outwoods House, Belvedere Road, Burton On Trent and South Staffordshire Allied Prescribing Group Guidelines Dec 2014 Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 25 Appendix 2 – Must be reviewed with the whole Guidelines ® eHF (Extensively Hydrolysed Formulae) – such as Similac Alimentum®, * Nutramigen 1 with LGG (previously called Nutramigen Lipil 1)®* Nutramigen 2 with LGG (previously called Nutramigen Lipil 2 ® ® AAF (Amino Acid Formulae) such as Alfamino , Nutramigen Puramino, Neocate LCP Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final ® Page 26 Appendix 2 – Must be reviewed with the whole Guidelines ® eHF (Extensively Hydrolysed Formulae) – such as Similac Alimentum®, * Nutramigen 1 with LGG (previously called Nutramigen Lipil 1)®* Nutramigen 2 with LGG (previously called Nutramigen Lipil 2 ® ® AAF (Amino Acid Formulae) such as Alfamino , Nutramigen Puramino, Neocate LCP Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final ® Page 27 Appendix 3 MONITORING COMPLIANCE Name of Procedural Document Appropriate Prescribing of Infant Formulae in Staffordshire Monitoring Officer Paediatric SSOTP Dietitians and Audit Team Reporting Arrangements Audit each year Element to be Monitored - NSLA Criteria Tool Change in Practice and Ref Standard Criteria Lessons to be Shared Timeframe 1 Referrals into Paediatric Dietetic Team Infant Formulae Prescribed Milk Allergy Audit tool Training to Health Visitors 2015-2016 2 CCG prescribing of infant formulae CCG prescribing records Medicine Optimisation Teams (MOT) 2015-2017 Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V2 Final Page 28 Nominated Lead Team Lead paediatric dietitians CCG MOT Appropriate Prescribing of Specialist Infant Formulae in Staffordshire Guidelines V1 Final Page 29