The skiers amongst you will know that there are big risks when going off-piste but the rewards are usually wonderful unless something awful happens. This is the territory we are in right know with the trial.
In our original plan we said we would use ‘off-the-shelf’, pre-approved, over the counter products to make up our ADKs (anti-diarrhoea kits). So these were going to contain:
- 2 x 20g sachets of ORS which each make up one litre of ORS solution
- 1 x blister pack of Zinc supplements
- 1 x small bar of soap
Items 2 and 3 remain unchanged but there are such compelling reasons NOT to include two of the standard ORS sachets that we are not going to do it. Instead we are going to make up our own 4g ORS sachets which will make up just 200ml of solution each. And we will include eight and not two.
So why stick our necks out and run this risk? As mentioned in a previous post the 20g sachets which are generally available were never designed for home use – they were designed for use in hospitals where it makes sense to make up a litre of solution at a time. In the home it makes no sense at all, given that the average consumption is around 400ml in a day and any solution not used after 24 hours of mixing should be thrown away.
So what are the implications of this change of plan? Well, we’ve had to come up with our own artwork for the new, smaller sachets (see the image to the left). We then have to import the packaging (from India) along with new machine parts to deal with the smaller packet size and weight of contents. We then have to run a three-month stability test on the new product and get approval from Zambia’s Pharmaceutical Regulatory Authority (PRA) before the trial starts. Quite a few risks. However, the artwork has been signed off and the machine parts have been ordered, so we are on our way.
What are the benefits of this new approach? The key benefit is that mothers and care-givers won’t have guess the amounts of ORS and water and risk making up a solution that is either too weak to be effective or too strong and cause osmotic diarrhoea. What tends to happen at the moment is that mothers and care-givers know that they do not need a whole litre of solution, so rather than mix up a whole litre and throw most of it away after 24 hours, they tip a part of a sachet into and indeterminate amount of water resulting in an ORS solution that is either too weak or too strong.
With our smaller sachets they will only make up 200ml at a time and they can use the AidPod itself as a measure. The production AidPod has a 200ml mark on it to indicate precisely the amount of water needed. We also think that it will be possible to use the AidPod as a mixer. Tests involving shaking an AidPod full of tea look promising in this regard! See the video below:
So, all in all, we think it’s worth risking it and going off-piste at this point in the trial set-up phase as the potential benefits are wonderful.