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Policy statement on Prescribing of Infant Milks (and including Formulary Milks) Breastfeeding should be strongly encouraged as providing the safest, most nutritionally adequate form of feeding for most infants. A change from breast milk to formula milk should not be initiated if the mother is happy to continue breast feeding. Consider supplementing breast feeding with formula milks if necessary. Mid-Essex Clinical Commissioning Group only commissions primary care prescribing of infant formula milks on a restricted basis in accordance with the following policy. Where breast feeding is not in place, parents should purchase appropriate infant formula milks. For those qualifying for ‘Healthy Start’ support (http://www.healthystart.nhs.uk/healthy-startvouchers/do-i-qualify/), vouchers may be spent on infant formula milk that is based on cows’ milk and says on the packaging that it can be used from birth. This therefore includes lactose-free milks which are derived from cow’s milk. For infants who appear unsettled, colicky etc. there are a range of commercially available milks designed to be easier to digest which parents are able to purchase but should not be prescribed. Similarly, infants presenting with reflux symptoms should be advised that there are commercial products to purchase but they are not recommended for prescribing within NHS Mid Essex. Soya-based infant formula was originally developed for babies who can't have infant formula based on cows' milk because, for example, they have a milk allergy. Other types of formula that are more suitable for these babies are now available. Soya-based infant formula must not be given to infants under 6 months of age due to the phyto-oestrogen content. It also contains glucose, and glucose is more harmful to babies’ and small children’s teeth than the lactose in infant formula made with cows' milk. Prescribing of soya milks by GPs is not supported for all ages. Infants may develop lactose intolerance; for example secondary to an infectious gastrointestinal illness. Symptoms include: abdominal bloating, wind, increased (explosive) and loose, green stools. Lactose intolerance should be suspected in infants who have had symptoms that persist for more than 2 weeks. Diagnosis is the resolution of symptoms, usually within 48 hours, once lactose is removed from the diet. Lactose free infant formulas can be bought at a similar cost to standard infant formula. Prescribing of lactose free infant formulas by GPs is not supported. Pre-term infants will have had their formula commenced in hospital. It is started for babies born before 34 weeks gestation and is continued until the child reaches their 6 months corrected age. At this age children should then be moved onto standard infant formula. Infant milks for pre-term infants can be bought at a similar cost to standard infant formula. Prescribing of special formula milks for pre-term infants by GPs is not supported. In certain conditions some foods have characteristics of drugs and the Advisory Committee on Borderline Substances advises as to the circumstances in which such substances may be regarded as drugs. The Advisory Committee's recommendations are listed in the Drug Tariff. . Prescriptions, where issued, must be in accordance with the Committee's advice and endorsed "ACBS". Approved by: Mid Essex Area Prescribing Committee Chairman: Dr Alan Jackson Date; January 2014 Review date: January 2016 Prescribing of all infant feeds in children must meet ACBS criteria and will only be supported until the infant is 1 year of age, unless a shorter or longer period is indicated within this policy or there are exceptional clinical circumstances. If NHS prescribing of infant milks is appropriate, a sufficient quantity to support all the nutritional needs of the child must be prescribed; it is not appropriate to expect parents to purchase some. If special formula milks are required after this age, parents are then expected to purchase these milks. Please note that Neocate Active® and Neocate Advance® are not indicated in children under 1 year of age and therefore prescribing is not supported unless there are exceptional clinical circumstances. Cows’ Milk Protein Allergy (CMPA)- Extensively hydrolysed formula for infants with a suspected cows’ milk protein allergy (CMPA) will be used first line. e.g. Nutramigen® Lipil 1 or 2 or Aptamil Pepti®1 or 2. Prescription of CMPA-hydrolysed formula milks may be initiated by GPs but must not be continued without a referral and confirmation of diagnosis from a paediatrician or paediatric gastro-enterologist or dietician. Prescriptions will initially be for a 2 week trial period (for tolerance); however it may take 4-6 weeks for symptoms to resolve. Infants who do not tolerate one formula may tolerate another. Therefore it is worth prescribing only 1 or 2 tins initially and if not tolerated or taken after perseverance, try another comparable formula. Amino Acid formula should only be prescribed when hydrolysed formulas do not resolve symptoms or when there is evidence of severe/multiple allergy. These are highly specialised products and CMPA-Amino Acid formula milks e.g. Neocate® LCP, Nutramigen® AA must only be initiated by secondary/tertiary care second line. GPs should only initiate if hydrolysed formula has not been tolerated after a reasonable trial and if they have made a formal referral to a paediatrician and it is not clinically appropriate to wait for a specialist recommendation. GPs should only accept continued prescribing of these products after benefit has been demonstrated and in line with an agreed treatment plan. Faltering growth-prescribing of high energy formula milks is indicated when the weight of an infant falls below the bottom centile (0.4th) or crosses 2 centiles downwards on a growth chart. It is important to rule out possible disease-related/ medical and social causes for the faltering growth. High energy formula milks must only be initiated in secondary care after assessment by a paediatrician to rule out medical causes. Before referral to secondary care ensure parents/carers are offered food first advice on suitable high calorie foods if the infant is weaned. All infants on a high energy formula must have growth (weight and length/height) monitoring to ensure catch up growth and appropriate discontinuation of formula to minimise excessive weight gain. Stop high energy formula at 18months of age or if patient over 8kg - If concerns with weight refer to Paediatric Dietitian. The volumes of feed to prescribe for infants The guidelines below are a guide only for infants from 6 months of age. Individual requirements may vary and GPs should prescribe sufficient to meet the dietary needs of the child. Please bear in mind requirements will gradually reduce after weaning depending on how much solid food is being taken. By 1 year of age, the milk requirement should be decreasing and prescribing of infant formulas must cease unless there are clinically exceptional circumstances. For infants under 6 months of age the volume prescribed should be roughly the same as the volume of milk they are currently taking (NOTE: most commonly used shop bought formulas are in 900g tins). As a guide, for a child taking 150ml/kg/day a 400g tin should last 3.5 days (therefore 8x400g tins a month; 4x900g tins a month). Approved by: Mid Essex Area Prescribing Committee Chairman: Dr Alan Jackson Date; January 2014 Review date: January 2016 Mid Essex FORMULARY for Infant formula milk products Please note the nutritional reference value for calcium in a child < 1 yr is 525mg /day (1 to 3 yrs 350mg), formula may not provide a sufficient daily dose and supplementation may need to be considered ♦Infant formulas to be considered for GP initiation where there is a clear and definite reaction to milk and whilst awaiting a secondary care referral. Any improvement should be seen within 1-2 weeks. Use 1st line Secondary/Tertiary care Use 2nd line only if 1st Purchase only initiation only treatment unsuccessful N.B: DO NOT PLACE THESE PRODUCTS ON A PATIENTS REPEAT PRESCRIPTION LIST. A review of growth and quantities prescribed should occur regularly. Extensively hydrolysed Infant Formula-Use in Cows’ Milk Protein Allergy (CMPA) The taste of hydrolysed formulae is unpleasant and it has a bitter smell therefore compliance can be improved by using a bottle, closed cup or a straw. Younger infants take hydrolysed formulas more readily than older infants. Introduction of a new formula to babies who do not have a severe reaction is best done by mixing it with their current formula and gradually changing over. For breast fed babies whose mothers wish to change, this may be achieved by mixing with expressed breast milk, given by someone other than the mother until the infant is used to it. Infants who refuse Nutramigen (first line choice) may tolerate Aptamil-Pepti, however infants who have a systemic reaction to Nutramigen are unlikely to tolerate alternative extensively hydrolysed formula and will need an Amino Acid formula. It is therefore worth prescribing only 1 or 2 tins initially to ensure acceptance of the product. Continue formula until child has grown out of allergy or they are 2 years old. Do not advise sheep or goats milk due to cross reactivity. Beyond 2 years calcium enriched soya milk can be used as an alternative source of milk . Product Criteria for Stopping Number of tins per Indicated Age month-guide only Range 1st Line *Continue formula until infant has grown out From birth to 6 ♦Nutramigen® Lipil 1 of allergy or they are 2 years old. Local policy months Mead Johnson supports prescribing of such milks on the NHS until the child is one year old, following which 7x400G 1st Line From 6 months if this is still needed, the milk should be Nutramigen®Lipil-2 to 2 yrs* purchased. Mead Johnson At 6 months change prescription to ♦Aptamil-Pepti ® 1* From birth to 6 Nutramigen®Lipil 2 unless a dietician has Aptamil months ♦Aptamil-Pepti® 2** advised otherwise. The same for Apatmil3x900g From 6 months Pepti ® 1 and 2. Aptamil to 2 yrs* These children should be reviewed every 6 ♦Pepti-Junior 6x450G From birth until 2 months as paediatric allergy will often Cow & Gate yrs* resolve. They will require secondary/tertiary care input to establish this. Refer to NICE guidelines (2011) for which children should be challenged with cows’ milk in secondary care setting ** Aptamil Pepti contains lactose, so will not be tolerated by all infants with CMPA, some infants may have a degree of lactose intolerance particularly if gut symptoms are present. Infants may accept this when Nutramigen has been refused. If infants have suffered a reaction to Nutramigen however Aptamil Pepti® is also unlikely to be suitable.Amino Acid Formula –GPs may only initiate if hydrolysed formula not tolerated after reasonable trial and if they have made a formal referral to a paediatrician, and it is not clinically appropriate to wait for a specialist recommendation. Specialist Initiation ♦Neocate LCP SHS Specialist Initiation Nutramigen AA Mead Johnson These formulas are stopped when the infant has grown out of the allergy. They will require secondary/tertiary care input to establish this. 7x400G Birth until infant has grown out of allergy (up to 12m) 7x400G Birth until infant has grown out of allergy (up to 12m) Faltering growth High Energy Formula milks are indicated when the weight of an infant falls below the bottom centile (0.4th) or crosses 2 centiles downwards on a growth chart. It is important to rule out possible disease-related/ medical and social causes for the faltering growth. Specialist initiation 1st line Before commencing a high energy formula 68x250ml From birth to 18 SMA High Energy ensure parents/carers are offered food first months or 8 kg Ready to feed advice on suitable high calorie foods if the infant is weaned. Any infant being considered 168x100ml or Infatrini ready to From birth to 18 for a high calorie formula should be referred feed 86 x 200ml months or 8 kg to a paediatrician to rule out medical causes. Nutricia NOTE: All infants on a high energy formula will 140x120ml Similac High Energy From birth to 18 need growth (weight and length/height) Abbott months or 8 kg monitoring to ensure catch up growth and appropriate discontinuation of formula to minimise excessive weight gain Metabolic Disorders - follow specialist unit recommendation Tertiary Care recommendation – prescribe initially as per recommendation then confirm with paediatrician/dietitian as to possibility of changing to formulary milks The following types of infant formula milks (and some examples of these milks) are not recommended for prescribing on the NHS as they may be purchased at a similar price to standard formula milks. Product Prescribing on the NHS not recommended Number of tins per Indicated Age month-guide only Range Lactose Free Formula SMA LF Lactose free infant formulas can be bought at 6x430G From birth to 2 SMA a similar cost to standard infant formula and yrs therefore prescribing on the NHS is not Enfamil Lactofree 7x400G From birth to 2 supported. Mead Johnson yrs Other Specialised Formula Pre-term infants These children will have had their formula commenced in hospital. It is started for babies born before 34 weeks gestation. For advice on vitamin supplementation please see East of England Perinatal guidance SMA Gold Prem 2 Pre-term infant formulas can be bought at a <6 months SMA similar cost to standard infant formula and corrected age therefore prescribing on the NHS is not Nutriprem 2 <6 months supported.. Any infant discharged on these Cow and Gate corrected age formula should have their growth (this includes weight, length and head circumference) monitored by the health visitor. These formulas should be stopped if there is excessive weight gain. Approved by: Mid Essex Area Prescribing Committee Chairman: Dr Alan Jackson Date; January 2014 Review date: January 2016