What the new malnutrition guidelines mean for implementers and producers

The World Health Organization’s new guidelines on the treatment of malnutrition are a step in the right direction to simplify the process and ensure more starving children are saved with fewer resources, implementers, and malnutrition treatment, manufacturers say. The guidelines, released last month, are the first update to WHO recommendations for treating children with wasting, which means they are low weight for their height. Globally more than 45 million children are wasted, and treatment has traditionally reached about 20% of them. The guidelines are incredibly technical, so many organizations couldn’t immediately shed light on what they mean for the malnutrition programs they implement. But after weeks of internal consultations with their medical and nutrition experts, a picture of the document’s biggest changes — and how they will affect their operations — is emerging. Among new advice is a gradual decrease in the dosage of ready-to-use therapeutic foods, or RUTFs, which are high calorie peanut-based pastes used to treat malnutrition. “I think this is really important. It means more kids are going to have access to treatment without breaking the bank with more RUTF, so a similar amount of RUTF can go further,” said Kevin Phelan, nutrition advisor at The Alliance for International Medical Action, or ALIMA. “We’re going to continue to analyze the implications.” ALIMA had a key role in providing WHO with evidence such an approach could be effective. Its “OptiMA” research, conducted in the Democratic Republic of the Congo, treated all acutely malnourished children the same without distinguishing between severe and moderate. It tapered the amount of RUTF children received as their health improved, and used a simplified metric to discharge them from treatment. ALIMA has already scaled that approach to other locations, so Phelan said it won’t take long to implement parts of the new WHO guidelines. But the process has to be explained to health ministries, which are often hesitant to greenlight a modified approach that hasn’t been officially endorsed by WHO. The new guidelines are a huge step towards making health ministries more apt to take up simplified protocols, said Will Moore, CEO of the Eleanor Crook Foundation, which funded the guideline review process. “It’s just a fact that what the WHO recommends when it comes to these lifesaving interventions is going to be by and large what governments are going to be comfortable doing,” Moore said. “You can only get so far without a really firm recommendation when it comes to scaling something new, and I think everybody recognizes that.” There are about 10 countries already “moving forward in a significant way” with some of the simplified approaches even in the absence of explicit WHO endorsement, he said. Simplifying treatment delivery Another major update in the guidelines are recommendations for treating children with moderate acute malnutrition, known as MAM. Some organizations want to treat them before they get even sicker and become severely malnourished. “I think this is really important. It means more kids are going to have access to treatment without breaking the bank with more RUTF, so a similar amount of RUTF can go further.” --— Kevin Phelan, nutrition advisor, ALIMA The guidelines recommend “specially formulated foods,” which include fortified products for treating kids with MAM. “It just makes it much more justifiable for calling for MAM treatment, especially in humanitarian context,” Phelan said. “As it stands now, oftentimes that’s unfortunately overlooked. So I think the clear call for the [specially fortified foods] in these guidelines really important.” The International Rescue Committee has also conducted studies of simplified protocols that fed into the guideline review process, and Mesfin Teklu Tessema, IRC senior director of health, said the organization would continue to do such research. He praised the guidelines for being a step toward simplifying treatment to help reach the 80% of malnourished kids who don’t get RUTFs. The guidelines also endorse community health workers delivering malnutrition treatment so children can receive treatment at home instead of at the clinic. Moore called this a huge development. “When we take a step back and look at the 30-year trajectory of treatment, for a long time, treatment was just highly medicalized. Kids had to be treated as inpatients, which limited our ability to scale treatment in so many ways.” But WHO has since recognized that inpatient care is riskier and more costly. Development of RUTFs along with a practice known as community management of acute malnutrition, or CMAM, over 20 years ago was “one of the most important moments in the history of malnutrition,” Moore said. This made it easier for health systems to deliver and mothers and kids to access. “Twenty years ago, when CMAM was beginning to be talked about, you had very respected but overly conservative voices in the health sector establishment saying that this was a dangerous move and demedicalizing treatment, moving away from inpatient care, was going to kill kids,” Moore said. “Everyone agrees now that these folks were wrong.” Tessema said he has concerns over literacy levels of community health workers and their ability to dose RUTFs correctly based on the severity of a child’s case. IRC wants them to treat children based on the size of their upper arm, an anthropometric indication of malnutrition, without needing to weigh them. “We have done MUAC, mid upper arm circumference measurement, only for diagnosis and treatment … We went even further adopting the MUAC not even with numbers but color-coding them, for anyone who [doesn't] have numeric literacy to be able to use for diagnosis,” Tessema said, noting it had been effective with community health workers. In an IRC study, about 90% of children treated with MUAC for diagnosis and discharge using a single product have recovered, which is comparable to the recovery rate of the standard protocol. “It speaks to the simplicity and effectiveness of MUAC based diagnosis and treatment,” Tessema said. Possible manufacturing changes Determining the best course of treatment is incredibly context dependent, according to Allison Daniel, who led the guideline review process for WHO. The way the guidelines are put into practice could vary, she said. “[They] will require country assessments and ministries of health and other implementers will need to assess their context and consider what will work best,” Daniel said. “WHO does provide support to country offices and ministries to be able to implement. But we do know that some of these will be implemented very quickly.” More studies are needed in regions outside sub-Saharan Africa to give WHO confidence that strong findings can be replicated in other contexts, particularly as it relates to formulated foods. For RUTF producers, changes made by implementers to reflect the guidelines will influence how they manufacture the product. One thing new treatment protocols could change is the size of sachets, said Maria Kasparian, executive director of Edesia, a Rhode Island-based RUTF manufacturing nonprofit. Implementers could decide they need them to be different to match a simplified treatment protocol they may adopt. “From the producer side, if there’s a more optimal sachet size that becomes divisible by these new numbers … does it make sense that all the sachets are 90 grams or 100 grams or a certain calorie [amount]?” Kasparian said. “We don’t know if there will be any implication like that, but of course we are open to that if there are ways to facilitate the new protocol to be simpler to program.” UNICEF and the World Food Programme would ultimately have to make the call on whether those changes would be necessary, she said. Living guidelines The guideline process, which began in October 2020, took longer than some implementers liked as they were eager to see WHO reach conclusions that endorse some of the simplified approaches. IRC was frustrated with the pace of the guideline review, Tessema said, hoping for a larger sense of urgency given the global hunger crisis. It’s important WHO is nimble enough to regularly review new evidence on malnutrition treatment and make updates, he said. “WHO does review of drugs and new products and diagnostics every time those are completing their clinical trial. Why not for malnutrition? Why should it be the exception?” Tessema said. There should be process for incorporating new evidence into WHO guidelines on a regular basis, he added. This is exactly the hope, Daniel said. The guidelines are meant to be step one, with operational guidance to come, and are split into two categories: strong and conditional. Strong means that “across all contexts and all situations, implementing a certain intervention outweighs the undesirable consequences.” “In the wasting guideline, many of the recommendations are conditional, and that means a lot of discussion may be required before a certain intervention can be adopted as practice or policy,” Daniel said. A host of conditions must be taken into account to decide which method is best for children, she said, including a child’s family food security. If others in the family regularly don’t get enough to eat, reducing the amount given to a child may not be appropriate, and treatment quantity could be diluted if RUTFs are diverted to other family members to meet their calorie needs. The guidelines are hosted on the MAGICapp platform, which is “dynamic and responsive” and the directives can be revisited when there is new evidence, Daniel said. WHO will release guidelines on the prevention of wasting later this year. The health organization chose to release the treatment portion earlier so implementers could begin using it as soon as possible. Investing in the future Phelan said ALIMA’s future research priorities will be influenced by the guidelines. “It’s super important to reiterate that there needs to be financing for this research,” Phelan said. “It’s important to have the financing follow the recommendations.” More money is also necessary for RUTFs. The Eleanor Crook Foundation calculated that $950 million more per year is needed to fully scale up treatment to reach all kids, but so far there are no plans from any donors to lock in multiyear financing, Moore said. RUTFS are traditionally paid for with humanitarian funding, making it incredibly difficult for manufacturers to have any visibility into their future supply chain. They did get some rare clarity last year, when a half a billion dollars was raised for RUTFs, including pledges from the U.S. Agency for International Development and the Eleanor Crook Foundation. The benefit of having this certainty is already clear in the field, Kasparian said. “We just proved it out in the last year. We had an increased amount of funding and we doubled the amount of RUTF procurement and the implemented programs went up 35%, and they’re on track to go up to double. It’s huge. And we did that in one year,” Kasparian said. “It’s really critical that we keep that momentum and keep that additional funding for this to work. Because when you have a real big shortage of funding then it doesn’t matter how good the protocols are, you’re not going to be able to reach a lot of the kids.”