The return of Similac Sensitive and Total Comfort

The return of Similac Sensitive and Total Comfort Coming 1/3/2017

So many formula choices!!

So why do we need 2 more?

Let’s talk about that, shall we?

These formulas used to be on WIC, then in 2014 Abbott reformulated three formulas to be 19 calories per ounce. Similac Sensitive Similac Total Comfort Similac for Spit-Up

According to WIC rules, WIC formulas must meet the Standard of Identity set by FDA, unless they are a medical formula. Standard of Identity for infant formulas: Must provide at least 20 calories per fluid ounce standard dilution Must provide at least 10 mg iron per liter standard dilution Must not require the addition of any ingredient other than water prior to being served Must meet the FDA definition and requirements for infant formula Must be designed for oral or tube feeding use Uh-oh!

So, 19 calorie Abbott Formulas didn’t meet the requirements. Similac Sensitive Similac Total Comfort Removed from WIC in February 2014 Similac for Spit-Up Kept as a medical formula, requiring a medical documentation form

Since then, we have been listening to the concerns of WIC families, health care providers and you.

What we learned… These formulas are rebated after all. That means they cost the program less than we originally thought. There are situations where babies that didn’t tolerate standard formula may have been able to use these less expensive alternative formulas, instead of more expensive medical formulas. We can provide them with medical documentation. $

What is the difference between standard, alternative, or medical formulas? For example Alternative Standard • • 20 kcal/oz Rebated No MDF Healthy, full term infants • No tolerance issues • 19 kcal/oz • Rebated • MDF required • Healthy full term infants • Minor or temporary formula intolerance Medical • Kcal specific to each formula • No rebate • MDF required • Infants with medical conditions

What are they made of? Similac Advance Gerber Good Start Soy Similac Sensitive Similac Total Comfort Protein Milk-based (60% casein and 40% whey) Soy protein Milk-based (82% casein and 18% whey) Milk-based (100% partially hydrolyzed whey) Carbohydrate 100% lactose Lactose free 53% maltodextrin 43% sucrose 2% lactose from prebiotic 76% corn syrup solids 20% sucrose 2% lactose from prebiotic Vegan, not indicated for prematurity An alternative to standard milk-based formulas. For mild tolerance symptoms such as fussiness and gas due to lactose sensitivity. Suitable for infants with lactose sensitivity. Formula with partially hydrolyzed whey protein that is an alternative to standard milk-based formulas with intact protein. For mild tolerance symptoms such as fussiness and gas due to lactose sensitivity. Wording from manufacturer

So when would you assign Similac Sensitive or Total Comfort, rather than the standard Similac Advance or Gerber Good Start Soy?

First - what we know about formula intolerance has not changed Lactose intolerance in infants is rare. Primary lactase deficiency will present as severe diarrhea within the first few days of life. Secondary lactase deficiency is temporary, usually due to an insult to the GI tract, it resolves with time. Parents reporting their baby is “not tolerating” the formula usually appears around 2 months and generally resolves by 6 -7 months. If infant presents with protein intolerance, allergy-don’t mess around! These formulas are not appropriate for protein allergies.

Assign Similac Sensitive or Total Comfort Only to healthy full term infants For formula intolerance that doesn’t require a lactose “free” formula When the family has a completed med doc form requesting it When the family’s medical provider is willing to complete a med doc form requesting it Do not assign for protein allergy

What assessment would you do? What formulas have you tried? Tell me about how you mix up a bottle of formula? What do you do with the formula after you mix it? How much do you put in each bottle and how much does baby drink? How can you tell if the baby is hungry or full? Describe what a poopy diaper looks like? How does your baby act after they drink Similac Advance?

Check in at the mid-cert The infant mid certification appointment is an ideal time to check in and trial back to a different formula. Talk with your WIC nutritionist to see if an infant on a medical formula may tolerate an alternative formula as they get older.

Medical Documentation will be required for alternative formulas A new section on the Medical Documentation form (MDF) will be used just for alternative infant formulas Updated Current forms will be sent in December forms can be used if needed

Health Care Providers will use this section of the MDF for alternative formulas 19 kcal/oz alternative Condition, not medical diagnosis Formula amount and length of issuance default to maximum unless the HCP says differently

New back of the MDF Sections for standard, alternative, and medical formulas Describes WIC formulas characteristics and medical reasons to use formulas Note: Contract = rebated The med doc form is still being finalized, so you may see minor changes from this version.

Med Doc Requirements Same as any formula that needs med doc Food package must be assigned by a CPA Can issue one month without med doc Completed form must be reviewed and signed by your WIC nutritionist No special formula trial or experiment required

This change may be a great time to reach out to providers in your area with some new Med Doc forms and the Provider Tool Kit.

Available to assign in TWIST starting 1/3/2017 Similac Sensitive Powder Ready 12 ounce can (template) to feed 32 ounce bottle (template) Ready to feed 8 ounce bottle 6 -pack (available by searching in the modify screen) Concentrate is not available in a retail version Similac Total Comfort Powder 12 ounce can only – (template)

Making a switch from one formula to another There is no need to switch if the baby is doing fine on their current formula Might be good to try it rather that switch all at once (Consider modifying the package to provide some of both formulas during the transition) If no benefits have been spent, select the new template, forecast, and re-issue If spent benefits, will need to modify this month, then select template and forecast for future months, and reissue

Finding the formula ü Make sure families can find the formula since stores have no minimum stocking levels. ü Powdered must be purchased in the 12 ounce cans, not the larger tub size. ü If not available in the grocery section, go to the pharmacy and order the formula. This takes a few days. ü These formulas are not available from the formula warehouse.

Resources for staff and participants We want to support the great work of WIC staff to promote infant cues and developmental feeding Consider revisiting training materials: Infant formula module Infant formula decision process job aid What is normal, when to refer job aid Participant handouts: common infant problems (now available to order on Shopify)

What would you do? Talk through these case studies

Case Study 1 - Donnie Mom reports that four month old Donnie has been fussy and gassy ever since he had a tummy bug a month ago. His poops are back to normal and he seems to be gaining weight, but mom worries that the Similac Advance formula is causing a problem. She said her friend recommended Similac Sensitive because it worked for her baby. She hasn’t talked to her doctor about changing because she can get the formula at the grocery store. What assessment would you do? What suggestions would you make? Would you switch formulas for Donnie?

Case Study 2 - Penny Michelle is here for Penny’s first WIC appointment. Penny is a little over a month old. She is mostly breastfeeding Penny, but will be returning to work in a couple of weeks and will be supplementing with formula. She did the same thing with her older child and found that Similac Advance didn’t work. Similac Total Comfort worked well, but she ended up having to use Nutramigen from WIC. Her doctor has given her a med doc for Similac Total Comfort for Penny. What assessment would you do? What suggestions would you make? What formula would you assign Penny?

Case Study 3 - Mikey is seen for the first time at 6 weeks of age. Mom, Karen, reports concerns regarding hives, crying, gas and sometimes blood in Mikey’s diaper. Mom is requesting a new formula today to see if that might help. Mikey has an appointment to see the doctor early next week. What assessment would you do? What suggestions would you make? What formula would you assign?

Questions? Talk to your local agency nutritionist. They will be the expert on the participants you are serving. Talk with your state nutrition consultant Thank you for helping us out! You’re the best!