Oxfordshire Clinical Commissioning Group Guidelines on Prescribing Specialist Infant Formulas in primary care Contents 1. Introduction 2. Prescribing Guidance 2.1 Quantities to Prescribe 2.2 Prescription Management 3. Cow s Milk Protein Allergy (CMPA) 3.1 Background Information 3.2 Diagnosis and Initial Management of CMPA 3.2.1 IgE mediated CMPA 3.2.2 Non-IgE mediated CMPA and Home Reintroduction 3.3 Ongoing Management of Confirmed Mild to Moderate CMPA 3.4 Product choices 3.4.1 Extensively Hydrolysed Formula (EHf) 3.4.2 Amino Acid Formula (AAf) 3.4.3 Products Not Suitable for Prescribing in CMPA 3.5 Prescription Management 3.6 Reintroducing Cow s Milk 3.7 Weaning 4. Gastro-oesophageal Reflux Disease (GORD) 5. Secondary Lactose Intolerance 6. Faltering Growth 7. Preterm Infants 8. Metabolic Products 9. References and Acknowledgements 10. Appendices 10.1 Appendix 1 Suspected Cow s Milk Allergy (CMA) in the 1 st Year of Life (imap) 10.2 Appendix 2 Primary Care Management of Mild to Moderate Non-IgE CMA (imap) 10.3 Appendix 3 Parent leaflet: The imap Milk Allergy Guideline Initial Fact Sheet 10.4 Appendix 4 Parent leaflet: The Early Home Reintroduction to confirm the diagnosis of cow s milk allergy 10.5 Appendix 5 The imap Milk Ladder 10.6 Appendix 6 - Infant Formula products quick reference guide 10.7 Appendix 7 Summary of Guidelines on prescribing specialist infant formula in primary care
1. Introduction These guidelines outline recommendations for the safe, appropriate and cost-effective prescribing of specialist infant formula for children up to the age of 18 months in the Oxfordshire area. It covers: Over-the-counter (OTC) products available wherever appropriate Quantities to prescribe Which products to use for different clinical conditions Initiating, reviewing and discontinuing prescriptions When to refer to dietitians and/ or secondary or specialist care For allergy related queries please contact consultant-led paediatric allergy advice service via oxon.paedsallergyadvice@nhs.net. Breast milk remains the optimal nutrition for infants and should be promoted, supported and encouraged where it is clinically safe. 2. Prescribing Guidance 2.1 Quantity of Powdered Formula to Prescribe When prescribing powdered infant formulas please refer to the table below for suggested quantity to prescribe per month: Age of child Suggested quantity of powdered formula to prescribe per month 400g tin 900g tin < 6 months Up to 12 tins Up to 5 tins Highest requirement at 4-6 months prior to weaning 6 12 months 6 12 tins 3 5 tins > 12 months Up to 6 tins Up to 3 tins 2.2 Prescription Management 1. Only prescribe 1-2 tins initially as acute prescription to assess tolerance and to avoid waste. Review recent correspondence from the paediatrician or paediatric dietitian. 2. Add formula to repeat prescribing template only if tolerance and diagnosis are confirmed, and a regular, robust review process is established to ensure that the formula and quantity prescribed are appropriate for the child s age and nutritional requirements. 3. Prescribing specialist formula for children over 18 months will be low priority unless specifically requested from a specialist (paediatrician or dietitian) and reason for continued use is provided, in line with Clinical Commissioning Policy 250. 4. DO NOT prescribe the following on NHS prescriptions. Parents should be advised to purchase these as their costs are similar to that of cow s milk formula, in line with Clinical Commissioning Policy 88 and 250: Soya formula - Wysoy 2
Lactose free formula - Aptamil LF, SMA LF, Enfamil O-Lac Pre-thickened formula - Cow and Gate Anti-reflux, Aptamil Anti-reflux, SMA PRO Antireflux Thickening formula - SMA Staydown (replaced by SMA PRO Anti-reflux), Enfamil AR 5. DO NOT prescribe ready-to-feed liquids as they have no clinical advantage and are usually substantially more expensive. These should only be prescribed on specialist s request when there is a clinical need e.g. if the patient is tube or PEG (percutaneous endoscopic gastrostomy) fed. 6. Prescriptions must be endorsed ACBS. 3. Cow s Milk Protein Allergy (CMPA) 3.1 Background Information CMPA is the commonest food allergy in the first year of life with a prevalence of 2-3 %. Most infants with CMPA develop symptoms within one week of introduction of a cow s milk protein (CMP) - based formula and improve within 1-2 weeks of a CMP elimination diet. However, this can take up to 6 weeks. Most children with a diagnosis of CMPA have mild to moderate symptoms which can be managed in primary care. Severe CMPA should be managed in conjunction with a paediatrician with an interest in allergy. For detailed assessment of severity of CMPA refer to imap CMPA algorithm for symptoms presentation (see appendix 1) and algorithm for diagnosis and management (see appendix 2). 3.2 Diagnosis and Initial Management of CMPA There are two main types of cow s milk allergy: acute Immunoglobulin E (IgE) mediated reactions (symptom onset within minutes up to 2 hours) and the delayed non-ige mediated reactions (2-72hrs onset). The table below depicts recognised clinical features of CMPA. For detailed guidance on obtaining an allergy focused history, see NICE CG116: Food Allergy in Children and imap allergy focused clinical history for suspected CMPA in infancy. Download the imap Milk Allergy Guideline Initial Fact Sheet (see Appendix 3) for parents whose infants are showing mild to moderate symptoms of delayed non Ig-E mediated reaction to CMP. The skin The gastrointestinal system Acute IgE-mediated Pruritus Erythema Acute urticaria localised or generalised Acute angioedema of lips, face and around the eyes Oral pruritus Colicky abdominal pain Vomiting Diarrhoea Delayed non-ige-mediated Pruritus Erythema Atopic dermatitis Gastro-oesophageal reflux Loose or frequent stools Blood and/or mucus in stools Abdominal pain Infantile colic Food refusal or aversion Constipation Perianal redness 3
The respiratory system (usually in combination with one or more of skin and GI symptoms) Upper respiratory tract symptoms (nasal itching, sneezing, rhinorrhoea or congestion (with or without conjunctivitis), signs or symptoms of anaphylaxis e.g. laryngeal oedema with drooling and hoarse voice and tongue swelling. Lower respiratory tract symptoms (cough, chest tightness, wheezing or shortness of breath) Note: this list is not exhaustive. The absence of these symptoms does not exclude food allergy. 3.2.1 IgE mediated CMPA (symptom onset within minutes up to 2 hours) Acute Onset symptoms: IgE mediated Mild to moderate More than one of the following symptoms: acute pruritus, erythema, urticaria, angioedema, acute flaring of atopic dermatitis, vomiting, diarrhoea, acute rhinitis Severe Immediate reactions with severe respiratory +/- CVS (cardiovascular system) signs and symptoms. Anaphylaxis -> A&E. Allergy referral and commence on AAf and dairy free weaning with dietetic support. Exclusively formula feeding: Trial EHf; Mixed feeding**: EHf top-ups if needed + maternal dairy free diet* if persistent GI symptoms or active atopic dermatitis with breast feeding** (see notes below). Any immediate symptoms on EHf feeds? Yes No Refer to specialist for allergy Continue EHf. testing to confirm CMPA and Refer for allergy plan for reintroduction, AAf testing and may be needed. Do not Reintroduction perform Home plan. Refer to Reintroduction. Refer to dietitian for dietitians for weaning support. weaning support. Exclusively breastfed: Maternal dairy free diet* for 2-4 weeks. Recurrence of immediate symptoms despite maternal dairy free diet*? Yes Refer for allergy testing to confirm CMPA. Do not Perform Home Reintroduction. Refer to dietitians for weaning support. No Mixed/ formula feeding: Urgent referral to paediatric allergy service. Formula feeding: Specialist to recommend/ commence AAf exclusively; Mixed feeding: AAf as top-ups if required. Maternal dairy free diet* if persistent GI symptoms and atopic dermatitis. Specialist follow up and Reintroduction plan. Continue maternal dairy free diet*. Refer for allergy testing and Reintroduction plan. If top-up formula required refer to paediatric allergy service for AAf. Refer to dietitians for weaning support. * Breastfeeding mothers on a milk free diet may require supplementation with 1000mg calcium and 10mcg Vitamin D per day. **Note: if no delayed symptoms prior to a mild/moderate acute reaction there is no need for maternal dairy exclusion. Rarely there may be minor immediate symptoms such as redness, hives after breast feeds. Maternal dairy free diet will be required in these cases. AAf = amino acid formula; EHf = extensively hydrolysed formula 4
3.2.2 Non-IgE mediated CMPA (symptoms onset 2-72hrs) and Home Reintroduction Delayed Onset symptoms: Non-IgE mediated Mild to moderate Several of the following symptoms: vomiting, reflux, loose/ frequent stools, constipation, colic, blood +/- mucus in stools, rhinitis, wheeze, cough, pruritus, erythema, moderate persistant atopic dermatitis. Severe Severe, persisting symptoms of more than one of the following: vomiting, diarrhoea, +/- faltering growth, significant blood +/- mucus in stools, severe atopic dermatitis Mixed/ formula feeding Formula fed: Trial EHf; mixed feeding: CM free maternal diet* + EHf top-ups if needed. Refer to dietitians. Exclusively breastfed CM free maternal diet* for 2-4 weeks. AAf may be advised if top-ups needed. Non-urgent referral to dietitians for weaning advice. Improvement in 2-4 weeks Improvement in 2-4 weeks Yes No Yes No Mixed/ formula feeding** Urgent referral to paediatric allergy service. Exclusive formula feeding: Specialist to commence or recommend AAf. Mixed feeding: Maternal dairy free diet and AAf for faltering growth. Refer to dietitians. Exclusively breastfed** Urgent referral to paediatric allergy service and dietetians. CM free maternal diet* for 2-4 weeks. AAf may be advised if top-ups needed. Home Reintroduction using standard formula to confirm diagnosis, done within 2-4 weeks of elimination diet. Refer to paediatric allergy service for AAf if CMPA still suspected. If not resume normal diet. Home Reintroduction to confirm diagnosis i.e. maternal normal dairy diet for 1-2weeks, after 2-4 weeks of dairy exclusion. Refer to paediatric allergy service if CMPA still suspected. If not resume normal maternal diet. Symptoms return Resume EHf and if symptoms return - CMA now confirmed. No return of symptoms Not CMPA Symptoms return Resume maternal dairy free diet and if symptoms settle - CMPA confirmed. AAf top ups can be maintained if no weight gain concerns. Refer to specialist for faltering growth and persistent symptoms. No return of symptoms Not CMPA * Breastfeeding mothers on a milk free diet may require supplementation with 1000mg calcium and 10mcg Vitamin D per day. ** Do not perform Home Reintroduction in those with severe symptoms. AAf = amino acid formula; EHf = extensively hydrolysed formula Early Home Reintroduction to confirm diagnosis - mild-moderate symptoms only EHf should be continued for a minimum of 2 weeks and if symptoms have improved, it is vital that parents perform Home Reintroduction after 2-4 weeks of starting EHf, in order to confirm the diagnosis. If symptoms return, CMPA is confirmed and EHf should be resumed. If symptoms do no return with the Home Reintroduction, CMPA is ruled out. How the Reintroduction is carried out is dependent on whether the infant is exclusively breastfed or mixed/ bottle-fed. imap s parent leaflet on The Early Home Reintroduction to confirm diagnosis can be downloaded to share with parents (see appendix 4). 5
3.3 Ongoing Management of Confirmed Mild to Moderate CMPA Confirmed Mild-moderate CMPA Exclusively breast-fed Marternal dairy free diet* + AAf as advised by specialist if needed as top-ups. Or Mixed/ formula fed Continue EHf; or AAf as per advice from secondary care if intolerant to EHf Non-IgE mediated IgE mediated No current atopic dermatitis and no history at any stage of acute onset symptoms. Home Reintroduction with support from health visitors or dietitians as per imap ladder. * Breastfeeding mothers on a milk free diet may require supplementation with 1000mg calcium and 10mcg Vitamin D per day. AAf = amino acid formula; EHf = extensively hydrolysed formula 3.4 Product Choices 3.4.1 Extensively Hydrolysed Formula (EHf) EHf is the first line treatment for mild to moderate CMPA in primary care. These formulas are tolerated by 90% of infants with CMPA. There is emerging evidence that tolerance to cow s milk occurs sooner on sustained exposure to EHf, so early diagnosis and a switch from standard formula to EHf will eliminate allergen sooner, improve symptoms control and could facilitate natural resolution of CMPA. Traffic Light CM free diet for at least 6 months and until 9-12 months of age (with weaning support from dietitians). Test for acquired tolerance depending on status of atopic dermatitis and history of acute onset symptoms. Current atopic dermatitis during CM free diet Allergy clinic for IgE testing or skin prick test Negative and no history at any stage of acute onset symptoms. History of acute onset symptoms at any time. Allergy clinic for IgE testing or skin prick Positive Refer to specialist paediatritian, may need supervised challenge. Follow up with serial IgE testing and later planned and Supervised Challenge in secondary care or specialist setting to test for acquired tolerance. Dietietic referral required. Negative Liaise with paediatric allergy service regarding re-challenge. Product Age group Notes Cost/ 100g (June 2017) EHf 1st line choices for mild to moderate CMPA Similac From birth Most cost-effective EHf. Lactose free. 2.28 Alimentum Althera From birth Contains lactose. May be used where 2.37 gastrointestinal symptoms are not present, or if there is a palatability issue. Aptamil Pepti 1 From birth 6 Contains lactose. May be used where 2.47 Aptamil Pepti 2 months Over 6 months gastrointestinal symptoms are not present, or if there is a palatability issue. 2.35 6
Traffic Light Product Age group Notes Cost/ 100g (June 2017) Nutramigen 1 From birth 6 Lactose free. Contains a unique 2.75 with LGG Nutramigen 2 with LGG months Over 6 months probiotic Lactobacillus rhamnosus GG (LGG ). 2.75 EHf with MCT (medium chain triglycerides) Initiated by secondary Care only Pregestimil Lipil From birth Suitable only when CMPA is also 3.05 Pepti Junior From birth accompanied by fat malabsorption. 2.90 NB: Infatrini Peptisorb is a high calorie EHf for mild to moderate CMPA with poor intake and poor weight gain but no significant growth faltering. See also section 6. 3.4.2 Amino Acid Formula (AAf) In AAf, the milk protein is broken down into individual amino acids. AAf is suitable only if at least one of the following criteria is met: Persistent symptoms after 4 weeks on EHf; Severe CMPA such as faltering growth and severe GI symptoms; A history of anaphylactic reaction to cow s milk formula; Persistent symptoms in breast fed infants unresponsive to maternal dairy free diet for 4 weeks, or mother does not wish to continue breastfeeding. AAf should only be prescribed on advice or recommendation of a Paediatric Consultant. GPs can contact the consultant-led paediatric allergy advice service via oxon.paedsallergyadvice@nhs.net for specialist advice on appropriateness of AAf before starting it in new patients. Traffic Light Product Age group Notes Cost/ 100g (June 2017) AAf Secondary Care Recommendation/ Initiation only Alfamino From birth up to 18 months old, or when able to tolerate OTC products Nutramigen PurAmino Most cost-effective AAf. Has higher vitamin A content. Gluten and lactose free. Previously known as Nutramigen AA. Neocate LCP From birth - 1 year Can be used as a sole source of nutrition up to the age of 1 year. Other AAf Neocate Junior From 1 year 10 years Neocate Junior will replace Neocate Active and Neocate Advance over a period of 12 months, from April 2017 to April 2018. These are high calorie formulas and will not be required automatically by all infants over 1 year. Suitable as a sole source of nutrition or as a supplement. 5.75 6.77 7.18 7.18 (unflavoured / vanilla/ strawberry) 7
3.4.3 Products Not Suitable for Prescribing in CMPA 1. Soya products: Wysoy Soya products should NOT be routinely prescribed for infants with CMPA, in particularly those under 6 months due to high phytoestrogen content. It may be used in infants over 6 months who do not tolerate first line EHf due to issues with palatability. There is a risk of co-sensitisation to soya in infants with predominantly GI symptoms of CMPA. It is more likely that children will tolerate soya formula from 1 year, and parents should be advised to purchase soya formula or Alpro Soya Growing Up Drink (1+ Years) from 1 year of age as these are similar costs to cow s milk formula, in line with Clinical Commissioning Policy 88 and 250. 2. Lactose free formula: Aptamil LF, SMA LF and Enfamil O-Lac. Lactose intolerance is not the same as CMPA and these formulas are cow s milk based. EHf or AAf should not be prescribed for transient lactose intolerance. 3. Rice milk: Unsuitable under age of 5yrs due to arsenic content. 4. Other mammalians milk e.g. Goat milk, Sheep milk products have similar protein composition to cow s milk so are not suitable for treating CMPA. 3.5 Prescription Management 1. Try a formula for a minimum of two weeks and maintain for at least four weeks before further changes. 2. Specialist formulas may be prescribed for infants with CMPA usually for no longer than 6 12 months. All children on EHf should be reviewed by GPs at 12 months and then 18 months as appropriate. For those who are on AAf, GPs should review latest correspondence from the specialist or dietitian as there may be changes in formula or quantity. 3. Parents of all children with non-ige CMPA should be advised on graded dairy introduction using the imap milk ladder (see appendix 5) after 6 months of exclusion. This is a test for acquired tolerance and helps resolution if certain dairy products are well tolerated. The imap milk ladder (see appendix 5) should be shared with parents as it contains useful practical pointers to support parents at home. imap milk ladder recipes can be downloaded here. 4. Review prescriptions regularly and refer to latest correspondence from specialist for any change in formula or quantity. Review and consider stopping prescription if the patient meets one or more of the following criteria: On the formula for more than a year The quantity of formula prescribed is higher than recommended above (see section 2.1) Patient can eat cow s milk containing foods such as cow s milk, cheese, yogurt, ice-cream, custard, cakes, chocolate, cream, ghee and etc. Over 18 months old. Please note children with multiple or severe allergies may require prescriptions beyond 18 months old. This should always be on the recommendation of the paediatric dietitian or consultant. 8
Please send a new referral or liaise with appropriate services if the child is already under the care of a paediatric dietitian or paediatric allergist. 3.6 Reintroducing Cow s Milk Products 1. Note that this is different from the Early Home Reintroduction usually performed 2 4 weeks after introducing EHf, which is aimed at confirming CMPA diagnosis (see section 3.2.2). 2. Children on long-term EHf or AAf should be reintroduced to dairy on a graded approach, to establish if they have acquired tolerance to CMP. About 60 75% of children outgrow CMPA by 2 years of age, rising to 85-90% at 3 years of age. 3. For exclusively breastfed infants who have been symptom-free for at least 6 months: - Re-introduce dairy products to maternal diet from 9-12 months and if tolerated, use the imap milk ladder (see appendix 5) for graded dairy re-introduction. imap milk ladder recipes can be downloaded here. 4. For formula only and mixed formula/ breast-fed children who have been symptom-free for at least 6 months: - Re-introduce cow s milk products using the the imap milk ladder (see appendix 5) around 9-12 months old and every 2 months thereafter until tolerated. imap milk ladder recipes can be downloaded here. 5. All children with IgE CMPA should have a plan of dairy reintroduction from Paediatric allergist when safe. No Home Reintroductions should be performed in these patients. 3.7 Weaning When an infant with CMPA reaches 6 months and starts to be weaned, it is important that an adequate calcium intake is achieved, particularly whilst remaining on a CM-free weaning diet. Refer to community or paediatric dietitian for support at this stage. 9
4. Gastro-oesophageal Reflux Disease (GORD) GORD is the passage of gastric contents into the oesophagus causing troublesome symptoms and/ or complications. About 50% of infants have some degree of reflux at some time. In most infants it is physiological and with minimal effect so most parents can be reassured. Regurgitation of feeds is worse with higher volumes of feed but improves with thickened feeds. Symptoms: effortless vomiting after feeding (not projectile) usually in the first 6 months e.g. regurgitation of a significant volume of feed, reluctance to feed, distress/ crying at feed times, small volumes of feed being taken Does the infant have faltering growth? No Rule out over feeding: check volume and frequency of feeds - average requirement in babies <6 months is 150ml/kg/day and should be spread over 6-7 feeds. Advise on feeding position and activity following a feed. The infant is thriving BUT distressed Bottlefed Trial using Carobel to thicken standard formula or one of the following for 1-2 weeks. These are available OTC and should be purchased by parents: Cow and Gate Anti-reflux, Aptamil Anti-reflux, SMA Staydown, SMA PRO Anti-reflux, Enfamil AR. If symptoms persist, STOP the thickening formula and trial Infant Gaviscon for 1-2 weeks. DO NOT prescribe separate thickeners, antacids, PPIs or ranitidine with thickening formula. Yes Yes The infant is thriving and NOT distressed Refer to specialist paediatric Breastfed Trial with Infant Gaviscon offered on a spoon for 1-2 weeks, up to max 6 times a day Review Improvement If infant is clearly overfed, advise restriction of volumes of feed Reassure and monitor, symptoms are likely to improve over time, usually by 12 months. Provide advice on avoidance of overfeeding, positioning during and after feeding, and activity after feeding. No improvement Refer to specialist paediatrician care Continue with treatment and review regularly to check growth and symptoms. Trial stopping treatment at intervals and by 12 months as 90% of children usually outgrow GORD by then. Once vomiting resolves return to standard formula. Traffic Light Product Cow & Gate Antireflux Aptamil Anti-reflux SMA Staydown* SMA PRO Antireflux Age group From birth Notes Readily available to purchase OTC in most pharmacies and major supermarkets. *N/B: SMA Staydown will be available for a further few months (replaced by SMA PRO Anti-reflux). Cost/ 100g (June 2017) 1.28 (R*) 1.44 (R) 1.22 (R) 1.25 (R) R* = Retail price Enfamil AR This may need to be ordered in specially at the pharmacy 1.73 (R) 10
5. Secondary Lactose Intolerance Primary lactose intolerance is rare and is caused by an inherited deficiency of lactase which breaks down lactose. Primary lactase deficiency usually develops after the age of two years, when breastfeeding or bottle-feeding has stopped. The symptoms may not be noticeable until adulthood. Secondary lactose intolerance is due to impaired lactase activity in the intestinal brush border and it is neither immune mediated nor a feature of atopy. Secondary lactose intolerance in children occurs post gastroenteritis and rarely following other gut insults such as prolonged courses of antibiotics. Symptoms are usually self-limiting. Parents of breastfed babies with lactose intolerance should be advised to purchase lactase enzyme drops (e.g. Colief ). This should not be prescribed on the NHS. Exclusion of lactose from the maternal diet is unnecessary as lactose is present in breast milk independent of diet. More severe or persistent symptoms suggestive of lactose intolerance will need paediatric assessment if lactase is ineffective. Alternative diagnosis such as CMPA will need to be considered for persistent gastrointestinal symptoms. Parents qualifying for Healthy Start vouchers can use these to purchase lactose free formula where the packaging states that the milk is based on cow s milk and can be used from birth, e.g. SMA LF and Enfamil O-Lac. Symptoms: abdominal bloating, increased (explosive) wind, loose green stools for > 2 weeks. Diagnosis is confirmed if symptoms resolved within 48 hours of withdrawing lactose from diet. Trial OTC lactose-free formula for 2 weeks. These can be bought at a similar cost to standard formula: <12 months: Aptamil LF, SMA LF, Enfamil O-Lac (may need to pre-order from pharmacies) >12 months: LF full fat milk (e.g. Lactofree brand) can be bought in supermarkets Symptoms improved Symptoms not improved Lactose Intolerance confirmed Continue LF formula for up to 8 weeks gradually then reintroduce standard formula/milk into diet. If symptoms return restart LF formula until normal dairy tolerated. There is a need to await natural resolution. Referral needed if symptoms do not improve on LF formula. Not lactose Intolerance Consider alternative diagnosis e.g. CMPA. Refer to specialist care. Note: Rarely symptoms may last up to 3 months Traffic Light Product Age group Notes Cost/ 100g (June 2017) Enfamil O- Lac From birth to 1 year Lactose, sucrose and fructose free cow s milk formula. May need to be 2.30 (R*) ordered in specially at the pharmacy. SMA LF From birth up to Not suitable for those who are allergic 1.40 (R) 1 year to cows' milk protein. Available to Aptamil LF From birth to 1 purchase OTC in pharmacies and 1.50 (R) year major supermarkets. Lactofree From 1 year 0.14/ 100ml (R) R* = Retail price 11
6. Faltering Growth Faltering growth is when an infant falls below the 0.4 th centile or crosses 2 centiles downwards from initial centile on a growth chart. Refer to paediatric services without delay. Specialist formula for children with faltering growth should only be prescribed in primary care following assessment and recommendations from a Consultant Paediatrician or Paediatric Dietitian. GPs can access specialist advice via oxon.paediatricadvice@nhs.net. Traffic Light Product Age group Notes Cost/ 100ml (June 2017) SMA PRO Refer to 0.99 High Energy From birth up to 18 months or 8kg. paediatric Similac High services without 1.07 Energy Infatrini delay. All infants will need growth 1.16 Infatrini Peptisorb From birth up to 18 months or 9kg. Suitable for infants with faltering growth and intolerance to whole protein feeds, e.g. short bowel syndrome, intractable malabsorption, inflammatory bowel disease, bowel fistulae monitoring to ensure catch up growth is achieved. Discontinue when on an appropriate diet as per dietitian advice. 1.77 7. Preterm Infants Pre-term infants will have been commenced on a pre-term formula (eg Nutriprem ) in hospital prior to discharge. Pre-term formula should not be commenced in primary care unless recommended by a specialist. The GP can continue prescribing the pre-term formula, until the baby is 6 months corrected age i.e. Expected Delivery Date (EDD) + 26 weeks. At this stage the GP should review the prescription and switch to a standard term formula which should be purchased by parents. If there is a concern about growth, the baby should be referred back to the neonatal unit for advice. Not all babies require pre-term formula for the full 26 weeks from EDD. If there is excessive weight gain at any stage up to 6 months corrected age, the pre-term formula may be discontinued and a change made to a standard formula. Ready to feed liquids are substantially more expensive than the powder and should not be prescribed in primary care unless there is a clinical need e.g. the baby is immunocompromised, tube fed or there has been a specific request by secondary care. Traffic Light Product Age group Notes Cost/ 100 kcals (June 2017) Nutriprem 2 From birth GP to review and stop prescription 0.26 powder SMA PRO Gold Prem 2 powder to 6 months (corrected age) at 6 months corrected age or if excessive weight gain. 0.23 12
Traffic Light Product Age group Notes Cost/ 100 kcals (June 2017) Nutriprem 2 liquid Only prescribe if the infant is 1.16 SMA PRO Gold Prem 2 liquid immune-compromised, tube fed or as directed by secondary care. 1.12 8. Metabolic Products Children under Dietetic Care may need to have other specialist formulas for reasons other than CMPA. Two examples of these could include formulas or products for metabolic patients and hydrolysed or amino acid based formulas for gastroenterology symptoms or treatment. 9. References and Acknowledgement References: Bernie Canani R et al. (2013) Formula selection for management of children with cow s milk allergy influences the rate of acquisition of tolerance: a prospective multicentre study. J Pediatr, 163 (3):771-7. Buller HA, Rings EH, Montgomery RK,Grand RJ. (1991) Clinical aspects of lactose intolerance in children and adults. Sc and J Gastroenterolgy Suppl,188:73-80. Food Standard Agency statement on arsenic levels in rice milk (2009) http://webarchive.nationalarchives.gov.uk/20120403220542/http://www.food.gov.uk/multimedia/pdfs/fsis 0209arsenicinrice.pdf Milk Allergy in Primary Care (MAP) Guidelines: Venter C, Brown T, Shah N, Walsh J Fox AT. (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. www.cowsmilkallergyguidelines.co.uk/the-map-guideline/ Venter et al. (2017) Better recognition, diagnosis and management of non-ige-mediated cow s milk allergy in infancy: imap an international interpretation of the MAP (Milk Allergy in Primary Care) guideline, Clinical Translational Allergy, 7:26. https://ctajournal.biomedcentral.com/articles/10.1186/s13601-017-0162-y NICE (2011) Food Allergy in Children and Young People. https://www.nice.org.uk/guidance/cg116. NICE (2015) Gastro-oesophageal reflux disease in children and young people. NG1 www.nice.org.uk Acknowledgement: This guideline has been produced by the Medicines Optimisation Team, Oxfordshire Clinical Commissioning Group in consultation with: Dr Felicitas Obetoh, Paediatrician with Interest in Allergy, Paediatric Allergy Clinic, Oxford University Hospitals NHS Trust 13
Dr Kenny McCormick, Neonatal consultant, Oxford Newborn Care Unit, Oxford University Hospitals NHS Trust Katheryn Clarke and colleagues, Community Paediatric Dietetics Team, Oxford University Hospitals NHS Foundation Trust Suzanne Bradshaw, Prescribing Support Dietitian, Oxfordshire Clinical Commissioning Group This guideline has been based on the following documents: PrescQIPP Bulletin 146, November 2016: Appropriate prescribing of specialist infant formulae (foods for special medical purposes) Central London Community Healthcare, Paediatric Dietetics Service, August 2015: Primary Care Specialist Infant Formulae Prescribing Guidance Pan Mersey Area Prescribing Committee, November 2014: Pan-Mersey Prescribing Guidelines for Specialist Infant Formula Feeds in lactose Intolerance and Cow s Milk Protein Allergy. Ipswich and East Suffolk Clinical Commissioning Group, September 2015: Recommendations for Prescribing Specialist Infant Formula 2015/16. 14
Appendix 1: Suspected Cow s Milk Allergy (CMA) in the 1 st Year of Life 15
Appendix 2: Primary Care Management of Mild to Moderate Non-IgE CMA 16
Appendix 3: Initial factsheet for parents 17
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Appendix 4: The Early Home Reintroduction to Confirm Diagnosis leaflet for parents 19
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Appendix 5: The imap Milk Ladder 21
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Appendix 6: Infant Formula products quick reference guide ALL CONDITIONS - Suggested Prescribing Quantities of Powdered Formula per month < 6months 6-12 months >12 months 13 x 400g tin OR 6 x 900g tins 7-13 x 400g tins OR 3-6 x 900g tins 7 x 400g tins OR 3 x 900g tins Milk Type Proprietary Brand Suitable for Cost / Original pack (T = Trade; R = Retail) Cost / 100g or 100ml Supply Route Cow s Milk Protein Allergy (CMPA) Nutramigen LGG1 < 6m 10.99 (400g)T 2.75 FP10 Extensively Hydrolysed Formula (EHf) Amino Acid Formulas (AAf) Nutramigen LGG2 > 6m 10.99 (400g) T 2.75 FP10 Aptamil Pepti 1 < 6m 19.70 (800g) T 2.47 FP10 Aptamil Pepti 2 > 6m 9.35 (400g) T 2.35 FP10 Similac Alimentum 0 18m 9.10 (400g) T 2.28 FP10 Althera 0 18m 10.68 (450g) T 2.37 FP10 Pregestimil Lipil From birth 12.19 (400g) T 3.05 FP10 Pepti Junior From birth 13.06 (450g) T 2.90 FP10 SMA Alfamino From birth 23.00 (400g) T 5.75 FP10 Nutramigen PurAmino From birth 27.09 (400g) T 6.77 FP10 Neocate LCP From birth 28.70 (400g) T 7.18 FP10 Neocate Junior From 1 year to 10 28.70 (400g) T 7.18 FP10 years Review need if child is 18 months, has been prescribed for >1 year, able to eat cheese, yoghurt, chocolate, or butter Gastro-oesophageal Reflux Disease Anti-Reflux Cow & Gate Anti-reflux From birth 11.21 (900g) R 1.28 OTC Aptamil Anti-reflux From birth 13.49 (900g) R 1.44 OTC *SMA Staydown From birth 10.99 (900g) R 1.22 OTC SMA PRO Anti-reflux From birth 10.00 (800g) R 1.25 OTC **Enfamil AR From birth 6.90 (400g) R 1.73 OTC * Being replaced by SMA PRO Anti-reflux and is available for further few months. ** may have to be specially ordered at the pharmacy Secondary Lactose intolerance Lactose-free SMA LF < 12m 6.00 (430g) R 1.40 OTC Enfamil O-Lac < 12m 9.21 (400g) R 2.30 OTC Aptamil LF < 12m 5.99 (400g) R 1.50 OTC Lactofree >12m 1.35 (1000ml) R 0.14 Shops Symptoms usually resolve within 8 weeks. Lactose free milk is available in supermarkets for infants > 12 months Faltering Growth High energy SMA PRO High Energy Birth 18m/ 8kg 1.97 (200ml) T 0.99 FP10 Similac High Energy Birth 18m/ 8kg 2.13 (200ml) T 1.07 FP10 Infatrini Birth 18m/ 8kg 2.23 (200ml) T 1.11 FP10 Infatrini Peptisorb Birth 18m/ 9kg 3.54 (200ml) T 1.77 FP10 Ensure that there is a clear goal and discontinuation point Pre-term Initiated in secondary care Nutriprem 2 powder SMA PRO Gold Prem 2 powder Nutriprem 2 liquid SMA PRO Gold Prem 2 liquid Birth 6m (corrected age) Birth 6m (corrected age) Birth 6m (corrected age) Birth 6m (corrected age) 11.67 (900g) T 0.26 FP10 4.92 (400g) T 0.23 FP10 1.74 (200ml) T 1.12 FP10 2.05 (250ml) T 1.16 FP10 These milks are not suitable for infants > 6months (corrected age). Do not prescribe ready to use liquid unless essential 23
Appendix 7: Summary of guidelines (NOT TO BE USED FOR DIAGNOSIS) Summary of Guidelines on prescribing specialist infant formula in primary care (NOT TO BE USED FOR DIAGNOSIS) For diagnosis and prescribing please see the full OCCG guidelines. Some children may require more, e.g. those with faltering growth. Review recent correspondence from the paediatrician or paediatric dietitian. All conditions: Under 6 months 6 12 months Over 12 months How much powdered infant formula should I prescribe monthly? 400g tin 900g tin 400g tin 900g tin 400g tin 900g tin Up to 12 tins Up to 5 tins 6 12 tins 3 5 tins Up to 6 tins Up to 3 tins IgE symptoms (<2hrs onset) [See page 4 of the full guidelines for diagnosis algorithm] Skin symptoms: urticaria, pruritus, angioedema; respiratory: difficulty in breathing and swallowing, hoarse cry, acute wheeze or anaphylaxis. Non-IgE symptoms (2-72hrs onset) [See page 5 of the full guidelines for diagnosis algorithm] - Skin symptoms: pruritus, erythema, urticaria, atopic dermatitis; GI symptoms: diarrhoea, bloody stools, vomiting, abdominal distention, colicky pain, constipation, GORD; Respiratory symptoms: recurrent wheeze/ cough, nasal itching, sneezing or congestion and rhinorrhoea. Growth faltering. Cow s Milk Protein Allergy (CMPA): Most infants with CMPA develop symptoms within 1-2 weeks of introduction. Mild moderate non-ige CMPA can be managed in primary care. Early diagnosis and treatment is very important. Download The imap Milk Allergy Guideline Initial Fact Sheet for parents whose infants fall under this group. Breast milk is the best choice for most infants with CMPA. Breastfeeding mothers may require a dairy free diet and daily 1000mg calcium and 10 mcg Vitamin D supplementation. Refer to paediatric community or paediatric dietitians for weaning advice before infant is 6 months of age. Always review the latest clinic correspondence before issuing each prescription to ensure any recommended changes are implemented. First line: Extensively Hydrolysed formula (EHf) Most cost-effective: Similac Alimentum Soya milk, lactose-free (LF) formula, rice milk or other mammalians Other options: Althera, Aptamil Pepti 1&2, Nutramigen milk are not suitable in CMPA 1&2 with LGG To confirm diagnosis, perform Early Home Reintroduction in infants with mild-moderate non-ige CMPA (2 72 hours). Not safe for immediate symptoms of IgE CMPA. At diagnosis EHf should be continued for at least 2-4 weeks and if symptoms improve, Home Reintroduction should be performed after 2-4 weeks of starting EHf to confirm the diagnosis of CMPA. Download imap s parent leaflet on The Early Home Reintroduction to confirm diagnosis to support parents at home. Second line: Amino Acid formula (AAf) Secondary care initiation or recommendation only. Consultant-led email advice: oxon.paedsallergyadvice@nhs.net. Refer infants with anaphylaxis or faltering growth to secondary care urgently. Most cost-effective: Alfamino Other options: Nutramigen PurAmino, Neocate LCP, Neocate Junior Reintroduction: Patients should be evaluated after at least six months of exclusion of dairy products to assess acquired tolerance to CMP. Download imap milk ladder and recipes to support parents reintroduce CM at home, provided there is no history of immediate allergic reactions or other indications for referral to secondary care. Review the need for specialised formula prescription regularly and consider STOPPING if any of the following applies: Can the patient tolerate any dairy foods? Is the patient over 18 months old (continue treatment if specifically indicated by specialists)? Has the formula been prescribed for more than one year? Is the quantity prescribed more than the recommended amount?
Gastrooesophageal Reflux Disease (GORD) Secondary Lactose Intolerance Faltering Growth GORD presents with a history of effortless vomiting after feeding (up to two hours), usually in the first six months of life. [See page 10 of the full guidelines for more details] Over feeding should be ruled out by establishing the volume and frequency of feeds. Give reassurance and advice on positioning post-feeds. Infant Gaviscon can be given up to a maximum of six times per day. Initially recommend adding Carobel (available from pharmacies) to current standard formula, or trial anti-reflux formula (available from pharmacies/ supermarkets) for 1-2 weeks and review symptoms. Cow and Gate Anti-reflux, Aptamil Anti-reflux, SMA PRO Anti-Reflux, Enfamil AR Secondary lactose intolerance usually occurs following an infectious GI illness (but can occur alongside new or undiagnosed coeliac disease) and is usually self-limiting. [See page 11 of the full guidelines for more details] Symptoms include abdominal bloating, increased explosive wind and loose green stools. Resolution of symptoms within 48 hours of withdrawal of lactose from the diet confirms diagnosis. Initially recommend over-the-counter lactose-free (LF) formula for two weeks. Continue LF formula for up to eight weeks if symptoms improved. Symptoms usually resolve within this time but in rare cases may take up to three months. 0 12 months: Enfamil O-Lac, SMA LF, Aptamil LF Over 12 months: Lactofree Faltering growth cannot be detected without using a growth chart. Diagnosis is usually made when an infant falls below the 0.4th centile or crosses 2 centiles downwards on a weight or height centile. [See page 12 of the full guidelines for more details] Consultant-led email advice: oxon.paediatricadvice@nhs.net. First line: High-energy formula Secondary care initiation or recommendation only. Discontinue when on an appropriate diet as per dietitian advice. Refer infants with faltering growth to secondary care without delay. Refer to secondary care without delay. Most cost-effective: SMA PRO High Energy Other options: Similac High Energy, Infatrini, Infatrini Peptisorb (high calorie EHf) These infants will have had their pre-term formula commenced on discharge from the neonatal unit and will be under regular review by the paediatricians. Pre-term formula should not be commenced in primary care unless recommended by a specialist. GPs should discontinue these formulas after the infants are six months corrected age or if there is excessive weight gain. [See page 12 of Pre-term the full guidelines for more details] Started in secondary care: Pre-term formula Nutriprem 2 powder, SMA PRO Gold Prem 2 powder DO NOT prescribe liquid formula unless immune-compromised, tube Nutriprem 2 liquid, SMA PRO Gold Prem 2 liquid fed or clinically indicated by secondary care. This quick reference guide has been adapted from PrescQipp B146: Specialist infant feeds quick reference guide. 25