Getting RUTF on the WHO list of Essential medicines - Call to sign a letter of support - repost

ear friends,
RUTF is not an essential medicine ! - It is not even one product, but many locally produced RUTF based on peanuts, chickpea, and other foods are known: which one should go on the list ?
RUTF are extremely helpful for managing childhood malnutrition in emergencies. But in normal health care - even in community-based mnagement of malnutrition - it is not essential. Shall we distract families from using their local resources and preparing diets for their children which are nutritious and promote growth and health ? - There is no evidence for a sustained success of RUTF-administration when it comes to re-introduce family foods. Or has anybody data on outcomes one year after the last RUTF-administration ?
On the essential medicine list are lifesaving and essential medicines for disease management. And RUTF is not such a medicine.
Could those who propose putting RUTF on the ED-list provide a conflict of interest statement please. We can also not ignore the ‚commercialization of malnutrition‘-aspect.
Sorry for a frank statement, but the proposal is diverting our attention from managing childhood malnutrition with food instead of commercial dietary products.
Regards,
Michael

I totally agree that RUTF can be added to WHO list of essential medicine

Dear Michael,

Thanks for sharing your concerns,

The contents of RUTF are standardised and it’s basically the same caloric and nutritious /vitamins/minerals values despite the different trade names.

RUTF is not a substitute for good nutrition for all family members at various growth periods; this is why we focus on Infant and Young Child Feeding and the first 1000-Days in health and nutrition services. RUTF is only indicated when a child fits admission criteria for severe acute malnutrition, a medical status that can lead to death if left untreated.

As a matter of life or death in any given context especially in developing countries, RUTF is lifesaving, please note that in many countries acute malnutrition is endemic and has specific seasonal pattern, it exist with spikes in specific months, it is not only happening in emergencies.

There are plenty of technical resources my colleagues can share on the RUTF revolution since early 1990 and its efficacy in the treatment of severe acute malnutrition. It saves millions of children every year, if you are familiar with the metabolic status of acute malnutrition, you can notice that food alone will not treat severely malnourished children, but they have to take this balanced medicine to gradually move them out of “severe” status.

No one can guarantee the commercialization aspect of RUTF, the same is applicable to drugs on the EM list, which have thousands of trade name and companies that we can’t control (but governments and UN agencies can). We do care about the medicine itself and its indication to save lives and treat patients.

Having RUTF on the EML is a great advocacy tool that will enable the government to prioritize acute malnutrition treatment and make it more integrated within the health services, the cost of SAM treatment has been reduced over the last two decades but it is still high, in many cases governments alone especially in developing countries can’t afford it, but when adding it to the list, donors and aid agencies will provide the support, and with time, new local companies can produce it locally with a cheaper price like any medicine which can cover the local need of each country. Developed countries may not need to produce it in large quantities, but when they have it on the list, they can spare some quantities to deal with sporadic cases that may occur among under 5 children.

Your point in promoting balanced family diet and food diversity is very valid at preventive stages as I mentioned before, or when the child reach to a cut-off points at risk ( WHZ or MUAC), but if the child reached to WHZ <-3 or <115 MUAC, RUTF is the treatment and it shouldn’t be delayed.

Sincerely,

Sameh

Thank you Sameh for the explanation. RUTF Is a life saving commodity and should not only be included in the EML but should be one of the UN life saving commodities. When you are involved in the management of children with SAM, you would understand the value of RUTF in Saving lives of children under five.

In Nigeria, we have commenced the process of including it in the country's EML As well as inclusion of Inpatient Management of SAM In the Standard Treatment Guidelines

I support the inclusion of RUTF in the EML. I suggest that we start advocacy for the inclusion as one of the UN Life Saving Commodities. One in five U5 children with SAM will die if they are not treated. If contraceptives are on the list, then why not RUTF?

Chris

Dear Sonja

Thanks for your message and very good advocacy initiative to try and get RUTF onto an 'essential' list - I was just wondering why the essential medicines list has been chosen, rather than the essential supplies list?
The reason i'm asking is because when I was in Ethiopia for a number of years and intimately involved with RUTF supplies/local production, etc. we started talking to various people about the possibility of including RUTF onto the essential medicines list. We were very strongly advised to advocate for inclusion onto the essential supplies list instead, for two main reasons:
- If the product is considered a medicine, then it has to be produced under pharmaceutical conditions - this would considerably increase the price of any locally produced product (and possibly for imported also)
- If classified as a medicine, RUTF would have to be approved for usage by the relevant country authority (at the time it was the Drug Administration and Control Authority) which can take a number of years - a local version of ORS took over 5 years to be registered with DACA.

Perhaps in many countries these limitations would not be an issue - but in some they may. Are there contingency plans for countries with very strict rules and regulations around medicines?

Many thanks

Emily

Dear Michael,

It’s important to differentiate prevention of malnutrition (stunting, wasting, underweight, etc.) and treatment of Severe Acute Malnutrition (SAM) defined as a MUAC <115mm and/or WFH <-3 SD and/or nutritional oedema.

Based on the current available evidence, WHO recommends the use of RUTF for the community management of SAM children who don’t require inpatient care. Thus, it’s my understanding that RUTF is an essential lifesaving treatment for SAM children, which is not intended to be a sustainable solution for fighting malnutrition but a punctual treatment reserved to SAM children.

The WHO essential medicines list contains not only drugs but also compounds such as ORS, and products such as activated charcoal, condoms or water for injection, so I think RUTF can fit in WHO's list.

Regards,

Dear colleagues and friends,
thank you for the clarifications about the use of RUTF. On the WHO-list you don't even find F75 nor F100. What do you expect to be listed there ? - Just RUTF ? - If yes, which description / recipe ? - It cannot be just a brand name.
Kind regards.

Dear Michael,

Please refer to Sonja's post and its attachment. I am quoting the below from ACF's call to WHO( found on WHO website, please clink on the links on Sonja's post):

Anatomical Therapeutic Chemical (ATC) code of the medicine:

No ATC code for the product described. RUTF is intended to cover the special nutrient needs (macronutrient and micronutrients) of children with severe acute malnutrition.
5. Formulation(s) and strength(s) proposed for inclusion; including adult and paediatric (if appropriate).

Formulation:

RUTF is a lipid-based nutrient-rich product.
It consists of a lipid matrix with a complex of vitamins and minerals.
The lipid-based matrix is constituted of peanut paste (or chickpea paste), vegetable oil, sugar and milk powder and a complex of vitamins and minerals.

The following is the nutrient content of 100g of the product (RUTF):

? Energy content is between 520-550 kcal/100 g
? Proteins content 10-12% total energy( equivalent to 12.8-16.2% by weight)
? Lipids content: 45-60% total energy (equivalent to 25.8-36.3% by weight)
? N-6 fatty acids represent 3 to 10% of total energy
? N-3 fatty acids represent 0.3 to 2.5% of total energy
? Trans-fatty acids represent less than 3% of total fat
? Fibres content is below 5%
? Vitamin A(retinol) between 0.8 and 1.2mg RE
? Vitamin D (Cholecalciferol)between 15 and 20 mcg
? Vitamin C (Ascorbic acid) 50 mg minimum
? Vitamin E (Tocopherol) 20 mg minimum
? Vitamin K (Phytonadione) between 15 and 30 mcg
? Vitamin B1 (thiamine) 0.5 mg minimum
? Vitaminb2 (riboflavin) 1.6 mg minimum
? Vitamin B6 Pyridoxine 0.6 mg minimum
? Vitamin B12 Cyanocobalamin 1.6 mcg minimum
? Vitamin B9 (folic acid) 200 mcg minimum
? Vitamin B3 (niacin) 5 mg minimum
? Vitamin B5 (pantotenic acid) 3 mg minimum
? Vitamin B7 (biotin) 60 mcg minimum
? Sodium below 290 mg
? Potassium between 1100 and 1400 mg
? Calcium between 300 and 600 mg
? Phosphorous between 300 and 600 mg
? Magnesium between 80 and 140 mg
? Iron between 10 and 14 mg
? Zinc between 11 and 14 mg
? Copper between 1.4 and 1.8 mg
? Selenium between 20 and 40 mcg
? Iodine between 70 and 140 mcg

Strength:

The recommendation is 150 to 220 kcal/ kg body weight/ day of RUTF for young children from 6 months of age who have SAM without medical complications.

Hope that helps,

Regards,Sameh

Dear Sameh
Thank you for this clarification. By stipulating that the RUTF contain peanut or chickpea paste and milk powder, it excludes RUTFs that do not have those ingredients. Which brings us back to Michael's concerns about conflict of interest and commercialisation.
What does it mean that countries that are attempting to make RUTFs which is adapted to local tastes and available products?
Many thanks.
Bindi

Sonja, I think on an earlier version of your post you had a link to a guidance document ACF created with some of the potential benefits and drawbacks to inclusion of RUTF on the EML. Can you post a link to that document?

Dear colleagues,

Thanks for your useful comments. I agree with Paul on the issue of LOS, although many countries I know have standardized an average LOS 6-8 weeks treatment in the absence of SFP programme in their CMAM guidelines, but on the ground it is not common to achieve this recommended LOS.

I think the specification of RUTF as peanut/chickpeas paste-based in the call might carries a potential reference to commercial brands, but this is common and sometimes unavoidable with drugs and medical supplies (and vaccines) I believe.

ACF and the technical committee can respond to all these concerns in details, but the assumption (I think) is that RUTF that are based on chickpeas and peanut paste have been tested worldwide for decades and we all know and used them in our programmes.

Nutritionists, please let us think about the lifesaving aspect of that call, the additional millions of children that would benefit from that inclusion and how this step would affect the CMAM programme/ health/nutrition integration and SDGs. Technicalities are extremely important and I believe the WHO committee with our colleagues in ACF will have a very through discussion, tests, researches and will involve all agencies before reaching to a decision, so from that perspective, I totally support the call.

Kind regards,

Sameh

An important discussion with major implications.

A couple of points from the Asia perspective

RUTF is less accepted in Asia vs Africa - there is major resistance in India and Bangladesh - the debate is long standing and complex and is not the subject of the post.Asia has a considerable burden of SAM and needs to scale up CMAM urgently. There have been a few trials with products of the same energy density and with all micro nutrients as the prototype RUTF not using peanuts but 2 products 1.rice and lentil based and 2. chick pea based which have been successfully trialled in Bangladesh- results yet to published but have been shared in meetings publicly a couple of years ago. Taking from the point made by Paul Binns does this statement by ACF cover such products?

There is great sensitivity around calling RUTF "Food"- the adjective "therapeutic" gets lost - fear of RUTF displacing all local foods is often cited as the main opposition to the product itself. Perhaps introducing it within the medicine list is a wise option making it clear that this is a therapeutic product.

Having said this in the recent years when RUTF was being bought into Bangladesh by various agencies it was done through the Ministry of Food because the regulations around bringing it as a medication would have been extremely complicated.

RUTF in India is in all likelihood registered as a Nutriceutical and not as a food- there are local companies making them.

I hope more practitioners working on SAM using RUTF in different contexts in Asia are able to add to this important discussion.

I would really be interested in finding out more about what prompted ACF to conduct the study on whether RUTF should be added to the EML. I would think that even if this was done and all agreed, it would not necessarily change the way RUTF is accepted or used by different countries.

Dear friends and colleagues,
first, when you go for listing of RUTF on the EML I would like to suggest to list F75, F100, and F135 as well;
second, the nutrient description is almost in every nutrient the same as that for 'plumpynut'; that means that no RUTF could be considered except it has the required nutrient contents. But most of our colleagues working with locally made RUTF may not be able to provide such a detailed nutrient analysis of their stuff. Therefore, standardization is good - but it needs to be manageable. And it should not exclude all products except one for which the company can afford to get all nutrient analyses done.
Sorry, but we are to provide expert advice and not to advertise for one product.

Dear Colleagues,

I am happy to see you speak your concerns and to see that we have the opportunity to discuss. My first point is just to say a big thank you for opening the debate. The other option-not having a debate- was not very helpful.

Today some 20 factories produce RUTF worldwide. This application to add RUTF on the EML as a miscellaneous item is not to profit to one of those factories or one brand or one group. It might even increase the demand and invite and engage more actors in the offer.

Getting RUTF on the Essential Medicine List as a miscellaneous item will not unlock on its own the barriers to treatment for the greatest caseload of SAM children-the one that do not need to be hospitalized. It might however be a step towards it.

We decided to prioritize unlocking some of the barriers to treatment for the greatest caseload first: SAM cases that do not need to be hospitalized. Does that mean that we cannot in parallel try to unlock the barriers for those that need hospitalization?
WHO accepts applications for what should be on the international Essential Medicine List. Dr. Krawinkel asked a very good question: why not include F75 and F100? We believe this should be done too.

There are so many barriers to treatment today and one action alone will not -unfortunately for all of us- mean that tomorrow a small SAM child will wake up suffering less from his condition. It might however be one of the many actions that will help address those barriers.

We are co-reponsible and co-actors of the options that are made available to remove some of those barriers to treatment. I would like to invite you all to engage in this subject as this concerns us all.

Kind regards,

Yara Sfeir
Senior Nutrition and Health Advisor
Action Contre la Faim Action Against Hunger France
ysf@actioncontrelafaim.org

 

Dear all,
I also totally agree that RUTF can be added to WHO list of essential medicine. There is no matter for adding it

Many Thanks
KALUFENYE NGENGELE Emmanuel
Nutritionniste et Diététicien
E-mail: yakututendwe@yahoo.fr
emkalufenye@gmail.com
yakututendwe@outlook.com
Skype: kalufenye.ngengele.emmanuel
Tel: +243997267477,

Yes, It's an essential therapeutic food in management of Malnutrition. As it is not in the essential drug list, there are many practical problems in getting it into the clinical practice.
Also because of that, it's impossible to get it into the essential hospital drug list.
Further, it should be modified to the country needs and people's taste.

The addition of RUTF and EVEN f-100, F-75 ETC into the essential medicine list will be of great impact to saving lives.many under five children and immunocompromised individuals die poorly its non-existence.
their packages may also modify to ensure easy handling and preparation devoid of contamination.
i vehemently support the inclusion of these products into the EML with due respect to safe lives.
the hospital where i work as nutrition, technical officer, its shocking to find poor children die mercilessly.Thus the need to find appropriate placement for these RUTF.
thanks.

I have been following the comments posted here. I would like to know if anyone has commented on the Patent and if this might better or hinder the process.

Hello all
Just ask yourself what would be the practical solution faced with this problem on the ground:
A week ago we discharged a 4 month old infant. Unfortunately its mother's milk has completely dried up to the point where, after discharge, the child no longer receives any nourishment/food, in a situation of advanced poverty for this woman living alone who doesn't even have the means to purchase formula milk.
Eventually she returned to the General Reference Hospital to see if we can help with F100 therapeutic milk so that her child can survive.
Thank you

Hello all,
Maybe this question is outdated, I also agree to adding RUTF to EML, however, how will this be funded in some countries, especially knowing that RUTF is expensive to procure. Will there be a need to start advocating for funding, release of funds and monitoring to ensure funds are not diverted as is common in some countries?
I ask because there are countless policies, agreements, decisions yet things remains unchanged without the support of development partners.

My thoughts on the issue is why push for RUTF to be listed in EML when it is uknown that it is not a medicine. I hope and believe that WHO, who is party to both pharmaceutical drugs standards and codex standards for food will always do the needful not to create friction in slotting food items into medicine list. Is there any harm of having Essential Food/Nutriceutical List for sake of harmonious professional health operations?

Food in the first instance is life saving. Getting it in the form that is therapeutic has not taken away its nature which recently Codex Committee on Food for Specially Dietary Uses is busy developing a guideline on RUTF. Let us limit the professional friction. Again where will the dice be cast: is it on pharmaceutical standard or food standard? Let's leave the technicality of its prescription to SAM management or treatment which is not the contentious issue because we all know RUTF's usefulness in the management of SAM cases. In this situation whose profession the dice fall on will be raised and this is what makes every profession come on board in the health care delivery.

So my humble submission will be instead of WHO Expert Committee longing/stressing /calling for conviction of why RUTF will be accepted into EML as an item, why not change EML to Essential Commodity List (ECL) to be all encompassing or simply establish/create Essential Food/Nutraceutical List (EFL or EF/NL) which will be equally useful in national food formulary for easy procurement and cost.

I wish my humble opinion will be considered. Thanks