WHO Essential Medicines List – Presentation to ASTMH 2018

ASTMH Presentation_Ramchandani_Design for Behaviour Change_MG

Our colleague, Rohit Ramchandani, is just back from the Annual Meeting on the American Society of Tropical Medicine and Hygiene (ASTMH) where he’d been invited to give a presentation on “Delivering of the Promise – Co-packaged ORS and Zinc in Zambia & on the Model Essential Medicines List for Children”. This invitation comes as we complete our application to WHO to change the Model Essential Medicines List for children to recommend that ORS and Zinc are co-packaged for the treatment of diarrhoea.

Rohit’s presentation can be downloaded here: PDF format (42 MB) and the transcript is here: Narrative

We thank the ASTMH for giving space for such an important current topic.

[Addendum 31-Jan-2019. We submitted our application to the WHO EML Secretariat on 12-Nov-2018 and it was published on the WHO website on 19-Nov-19. See: Our EML application now open for comments on the WHO website]

[Addendum 9-Jul-2019. Our application was successful. See: Success: WHO adds co-packaged ORS and Zinc to its Essential Medicines List]

Presentation narrative:

Good morning.

My presentation today is entitled: “Delivering on the Promise” and it’ll give us the opportunity to delve into one example of the kind of locally tailored innovation that Felix was referring to earlier by looking at some of our research from Zambia, which we can think of as a “micro” perspective, and then I’ll talk a bit about a collaborative effort we’re working on, under the hospices of the Global Diarrhoea Innovations Group, to influence ORS and Zinc adoption – in the form of normative guidance around co-packaging – Which we can think of as a global or macro level effort.

And so to start, I’d just like to provide a bit of additional context….

Two relatively recent publications – one from the Lancet Series on Childhood Pneumonia & Diarrhoea, and the other from the Global action plan for childhood diarrhea set forth some of the key challenges and priorities in this space

Gill and colleagues note [see slide]

While Zipursky and colleagues identified the #1 theme from the global action plan for Childhood diarrhea as the need to substantially increase the proper use [see slide]

-Now what these findings effectively highlight is that we really need to address both supply and demand side factors simultaneously.

Its not just about getting a product from point A to point B – especially when it comes to medicines. That’s an important part of it. But in our case, ORS and Zinc really can’t be considered “delivered” until that mother, in a rural community, who has a child with diarrhea, both gets access to those products, but also prepares and administers everything to her child correctly.

And so, while our health systems solution really took a broad, multi-pronged approach, addressing both supply and demand side challenges, what I’ll focus on during my twenty minutes today is what we learned from our focus on those demand side factors that supported and interfered with the effective use of these agents – specifically looking at ORS

Now, one of the great things about a vibrant economy is having choice. Yet in many development contexts, one doesn’t often have many choices, let alone ones specifically designed with and for them.

And so, where we started our work in Zambia back in 2011, Was by working with our end users through a design-centred approach, which started with a series of focus group discussions. And we gained a number of very important insights from caregivers of children under 5 living in rural Zambia….. (inaudible)

Let me tell you a little more about this last point, bc it has a number of implications for co-packaged ORS and Zinc products, and for how we measure progress against childhood diarrhea globally.

So when a mother is given ORS at a health centre, she’s typically given an approximately 20g sachet of rehydration salts that are to be mixed with one litre of water. When she gets home to prepare that sachet, there’s typically no standard way of measuring out a litre of water…. And so we wanted to study the implications of this further…

What we found was that approximately forty percent of caregivers who used one litre sachets were preparing them incorrectly, preparing a solution that was either too concentrated, which can cause hypernatremia, making the diarrhea worse, or too diluted, reducing the efficacy of the solution.

And from the images here, taken during our over twenty-four household surveys, when we asked caregivers to show us the containers they used to prepare ORS…Its easy to see why this might be the case, resulting in a wide variety of concentrations…..We have jugs, kettles, bottles, jerry cans, cups, mugs…..all of varying sizes, and filled to varying levels.

Now this also has broader implications for how we measure success against childhood diarrhea at the global level. Our primary indicator of success, in this regard, is coverage.

And how do we measure coverage? Through household level surveys like the DHS and MICS, we simply ask caregivers whose children under five have had diarrhea within the two weeks preceding the survey, whether they were given ORS and Zinc.

What we don’t do is look at the details of that use – or rational use. And so when we see ORS coverage figures of forty-two percent at the global level…we likely need to take that with a grain of salt, pardon the pun. The fact is that we are very likely over-estimating the actual rationale use.

Now under routine data collection systems, it’s not going to be practical to measure observed use, and so we are going to have to continue to rely on reported use. And so in this sense, products that can leverage design to facilitate correct treatment behavior can likely help to provide greater confidence in these kinds of reported figures.

In addition, we know from previous research, that a single child under the age of 5 will typically consume between 200 and 400ml of solution per day. We also found that when caregivers do prepare a litre of solution, they often end up throwing a lot of it away, or trying to save it for use over multiple days, thereby risking contamination.

Despite all of this, on litre sachets are being manufactured the world over. They’re still the standard, and they’ve been the standard since the 1980s, although we are now starting to see more 500ml sachets entering the market.

And these are in contexts where you often have young girls that are travelling 30 min or more to gather the water that their families will use over the next 24 hours for cooking, washing and bathing, etc. So preparing a full litre doesn’t seem to be congruent with the realities of many families.

And so by understanding these pain points of our end user, we were able to redefine the concept of a diarrhoea treatment kit with the creation of the Kit Yamoyo – or “Kit of Life” in the local language.

We worked with partners like PI Global and Amcor – renowned packaging design firms, and our local Zambian pharmaceutical partner, Pharmanova, who has now taken ownership of the product and all of the intellectual property that goes with it, to continually refine and improve the design.

The Kit Yamoyo co-packages ORS and Zinc, ensuring that the fourteen year old WHO UNICEF recommendation for combination therapy, is facilitated.

We added a small bar of hand soap to tie in the message of prevention and make the kit more desirable.

The instructional pamphlet doubles as the branding for the product and can be easily swapped out to accommodate different branding scenarios or be adapted to different contexts, and I’ll show you an example of that application in a moment, the instructions are predominantly pictorial given high levels of illiteracy.

The Zinc is paediatric formulated, meaning it’s dispersible and has a sweet coating, and comes in a blister pack of 10 scored tablets.

The ORS is orange in colour and flavour, making it more attractive and palatable for children.

But perhaps the most important design features, are smaller sachets, and the container’s ability to double as a measurement vessel.

Rather than coming in 1L sachets, the ORS comes in the form of four 200ml sachets, and the packaging measures out that 200ml of water in the perfect concentration.

In addition to being a measuring device, some forms of the Kit packaging can double as a:
a mixing device
a drinking device
and can be re-used later for other purposes.

And finally just to mention from a design perspective, we originally designed the Kit to fit between the empty spaces in crated bottles of Coke.

And the idea there, was that wherever Coca-Cola crates went, so too would these empty spaces between the crated bottles of coke.

Now this hypothesis, of piggybacking on one of the strongest supply chain systems in the world in order to improve delivery and availability to remote areas, eventually proved to be less important than we initially thought it might be.

And while that design feature – what the BBC dubbed the AidPod – won us a lot of awards and recognition at the international level, in practical use, our research showed that only four percent of retailers, that get Coca-Cola and other fast moving consumer goods to the community level for sale in their shops, actually used this nesting functionality.

In fact they would just buy the kits in bulk, and throw that box or bag on the back of their bicycles and take it back to their shops.

…and so what that actually allowed us to do was free us up from that oddly shaped container that was initially being manufactured in the UK….and move toward new formats that were less expensive, and that could be manufactured one-hundred percent locally, while still maintaining the key design features – of co-packaging, water measurement and smaller sachets.

And that resulted in two new configurations or formats – one being a simple screw-top jar, and the other being an even more low-cost flexi-pack.

The pictures in the top right and bottom left here give you an example of how the ability to swap out the branding insert facilitates easy adaptation to different scenarios. The flexi-pack version in the top right corner has the private sector Kit Yamoyo branding, while the one in the bottom left carries the Government of the Republic of Zambia branding.

And the reason why that’s relevant is that in August of this year, after a tendering process, the Ministry of Health in Zambia placed an order for 250,000 kits with the local manufacturer of the commercial Kit Yamoyo, for targeted distribution of a public sector version of the kit, through government health centres.

So just to close off on our Zambia piece, and the importance of design, our findings demonstrated that the odds of correct ORS preparation was 10 times greater in the kit that incorporated smaller sachets and a measurement function, vs. those those that used one litre sachets.

Kit Yamoyo users prepared the ORS in the correct concentration ninety three percent of the time, while non-users prepared it in the correct concentration only sixty percent of the time.

So design really has to be considered as a vital element of delivery. We have to ensure that the current definition or constructs of implementation or delivery sciences give thought to design, whether from a product or from a systems perspective.

And that’s actually a good segway to the next piece of this presentation, which is our effort in collaboration with a number of partners, including PATH and IHME, under the umbrella of the Diarrhoea Innovations Group – and with endorsements from a number of key organizations with expertise in the diarrhea space, to get co-packaged ORS and Zinc listed as a single product on the WHO’s Model Essential Medicines List for Children.

We really believe this proposal could help lead to a potential step change in addressing morbidity and mortality from childhood diarrhea, by influencing access through normative policy change.

This proposed listing would be in addition to the individual listings of both of these products, which are already on the Model EML and EMLc.

But as long as ORS and Zinc are listed separately, they’ll continue to be procured separately, supplied separately, distributed separately and seldom dispensed together.

The latest evidence on global coverage of ORS and Zinc, finds that globally, the median coverage of ORS is forty-two percent and that the median coverage of both ORS and zinc is around seven percent, with zinc typically being the limiting factor.

Here we are almost fifteen years after the WHO and UNICEF recommended the addition of supplementary zinc for the treatment of childhood diarrhea, and we still have a very long way to go.

A single listing for co-packaged ORS and zinc, would provide a number of public health and normative benefits that are likely to ultimately help bring down global mortality and morbidity rates associated with the burden of diarrhea. Let’s take a look at some of the potential benefits.

At a normative level this listing will have 4 types of potential effects.

A cascade effect. Global treatment guidelines and the essential medicines listings serve as important guides for countries in their development of national EMLs and procurement and supply of medicines for donation and local medicine production, as well as training of health care providers. This listing really has the potential to foster an enabling environment for country-level policy work to prioritise access to treatment and incorporate ORS and zinc co-therapy into national health programs.

An awareness effect. That’s likely to lead to an increased recognition and reinforcement among policymakers and health care professionals about existing global normative guidance on the importance of this co-therapy for the treatment of diarrhea.

Health care workers take notice of what’s on the EML. NEMLs, together with standard treatment guidelines, serve as the basis for formal education and in-service training for health care professionals and for education about medication use for the public.

Availability effect. Listing of a co-packaged product can guide the selection, procurement, and supply of medicines in the public sector, schemes that reimburse medicine costs, and medicine donations, from the national level right down to provincial regional and district levels within countries.

And finally,

A manufacturer effect. The listing may catalyse increased demand and spur local medicine production, with manufacturers responding and creating more market competition.

Now in terms of the evidence base for co-packaging, it continues to get stronger. Multiple studies have now shown numerous benefits from co-packaging including:

increased uptake and coverage – both from a combination therapy perspective, as well as from an individual component perspective, although what we really want to see is that combination use rising.

Improved adherence to and preparation of the individual components as a result of improved packaging, as we saw from the Zambia example

Improved dispensing practices by health care workers

Reduced hospitalisations due to diarrhea

Reductions in inappropriate antibiotic prescribing and use

Enhanced satisfaction levels by caregivers of ORS and zinc relative to status quo products as well as enhanced opportunities to develop private-sector, market driven models that leverage value-chain principles to improve availability and access closer to the household level.

This proposal will also achieve harmonisation with the long-standing normative recommendation around the use of both therapies.

Just to close off here, and give you a sense of the timeline we are working on, we are now in the final preparations of submitting our proposal to the WHO EML committee. The deadline for those application is December seventh.

After which, there will be a public review and commentary period. And we would encourage you all to engage with that.

The 22nd meeting of the WHO EML Committee, and their deliberations, will take place from the first to fifth of April, 2019 with decisions being announced in the June/July timeframe.

If we are successful. The Diarrhoea Innovations Group – with PATH leading the process, we’re currently focused on developing plans to really ensure that the new global guidelines around co-packaged ORS and Zinc are widely shared and understood among key global and national stakeholders, and will be looking to support country-led development of policy, guidelines and strategy around co-packaging, including support to potential manufacturers. We will continue to ensure stakeholder consultation and alignment, and also really try to enable knowledge and resource management, including tracking and researching the impact of ORS and Zinc’s inclusion on the Model EML.

And so I’ll stop there and thank you all for your time and attention.