Taking an idea to reality

Industry
By
Joshua Hoey
-

The winner of the first PSA Shark Tank is no minnow. SetDose has a $42 billion problem in its sights: medication and dosing errors.

To call medication and dosing errors a signi­ficant problem is an understatement. Globally, medication errors are estimated to cost $42 billion annually; almost one percent of total global health expenditure.1

In Australia, overdoses and omissions are the most common types of reported medication incidents in public hospitals.1 They cost over $680 million annually, while medication-related admissions cost $1.2 billion.1,2 From adverse side effects to allergic reactions, permanent disability, and death, a seemingly small dosing error can have serious ramifications.

It’s figures like these that drove a team of clinicians and researchers, including medical practitioners, pharmacists, nurses, and biomechanical engineers from the University of Sydney, to develop a solution.

‘Really the main person is Rebekah Moles; she’s been doing a lot of work on medication and dosing errors in particular,’ GP and Professor at the University of Sydney Dr Lyndal Travena said.

‘We were trying to identify a good research project that might address this problem, and by talking through the main issues, we came up with SetDose.’

Breaking it down

The SetDose system involves three parts: a software platform, individualised encoded keycards, and a dose metering device that attaches to standard hospital syringes.

‘Pharmacists will be able to double check, through the software, doses and calculations. On the ward, the encoded keycard will be scanned against the patient, the medicine package, and the syringe. And with the syringe device you can’t administer more or less than what is in the program,’ Dr Travena said.

The software is aimed at addressing prescription and calculation errors, the encoded keycards should reduce dispensing errors, while the syringe attachment would prevent administration errors.

‘It clips onto a normal syringe and then you can administer that medicine safely, with much more confidence that the correct dose is being given,’ she said.

The SetDose concept took out first place at the Shark Tank session at the PSA18 annual conference, securing $10,000 in funding to help bring SetDose to market.

Next steps

While the team doesn’t expect to start clinical trials of the system until at least 2020, Dr Travena said the Shark Tank funding will help the team move on to the next stage of development: feasibility and acceptability testing.

‘It’s really important that the prototype is acceptable and looks like it’s something that’s going to be feasible in the workplace.’

Currently, the team has developed two 3D-printed prototypes of the syringe attachment, and the plan is to work with nurses at Sydney’s Royal Prince Alfred Hospital in 2019 to get feedback on the designs from those who will actually be using the device.

‘It’s a fairly clunky prototype, but down the track we hope it’ll become a lot slimmer and easier to use.’

‘Before you can move ahead with development, obviously you’ve got to co-create and co-design it with the people you hope will be using it.’

Reducing medical waste and reusability are becoming increasingly important in the development of medical devices, and so the SetDose team is looking at ways to make the encoded cards reuseable or recyclable.

‘The actual SetDose device that the syringe plugs into doesn’t touch the patient, making it reusable.’

SetDose has also received some additional funding from the University of Sydney, but Dr Travena said they’ll need more as the project moves ahead.

‘We’re really doing this on a shoe string budget. We’ll be looking for interest and partnerships in the industry to help us take it forward when we’ve got a more fully-developed product,’ she said.

Real-world challenges

Re­fining SetDose’s design may be the next step, but the team is also considering challenges with the software concept, particularly when it comes to interoperability.

‘We’d ideally like the software, in a hospital setting, to be able to talk to existing systems.’

It’s shaping up as a signi­ficant challenge for the SetDose team.

Their concept calls for SetDose software to automatically update administered doses in any hospital’s eMeds system. But with different hospitals within even a single state using different electronic systems, developing one SetDose software platform able to interoperate with different hospital systems will be a challenge.

Then there are the many hospitals and aged care facilities that still don’t have electronic systems and rely on paper medication charts and patient records.

‘It may mean that some of the things that we would like SetDose to do will have to wait. We can get something up and working that will do the basics, and then move on to versions two and three as it evolves.’

At the pinpoint

But the main priority, Dr Travena said, is coming up with a solution that is safe and reliable so that patients are safe and clinicians can be con­ dent in dosing.

‘We’ve still got a lot of accuracy testing to do with the device to ensure that what the keycard has tracked into the device is accurate,’ she said.

‘The accuracy of printing and scanning the barcodes on keycards will also need to be tested, as well as testing the accuracy of the syringe attachment across a range of medications.’

If feasibility and acceptability testing goes according to plan, the team expects to move ahead with software development, accuracy testing, and small scale user testing through 2019. With SetDose still in early development, the team is working on costing estimates.

‘It’s going to have to be priced at a point where it’s affordable, but honestly, at this point, I would be plucking a number out of the air.’

While keycards and the syringe attachment should be reusable, subscription to the SetDose software platform is expected to be the major cost.

The team expects hospitals and large aged care facilities will be the key users of the SetDose system, but the plan is to start with paediatric medicine, an area where dosing accuracy is vital and tiny errors can have serious consequences.

‘Children are particularly at risk of dosing errors because of very small values and a lot of liquid medication being administered.’

‘We’ve also had a lot of interest from the neonatal intensive care nursing sector.

‘We’ve only really been working on this for a year and have got SetDose to this early stage, but we’re very encouraged by the positive feedback we’ve received from people at the PSA conference.

‘We feel encouraged, like we’re doing something that appears to have promise and the sector seems to feel will be useful,’ she said.

On track

Currently there is no way to track the supply of dosage administration aid (DAA) packs as they move from pharmacies to aged care facilities and Aboriginal health services. It’s a multi-million-dollar issue, but one that VeriPharm, the winner of the PSA18 Shark Tank People’s Choice Award, plans to solve.

Darwin pharmacist Samuel Keitaanpaa developed VeriPharm as a supply chain tracking system using barcodes and a mobile app. ‘Integrated software at the pharmacy and a mobile application at the health service allow the creation of a shared record of DAA pack contents and their movement between pharmacy and service,’ Mr Keitaanpaa said.

VeriPharm is designed to work with packing software to register each DAA pack with a unique code and the actual number of medications they contain. Packs can be scanned with the mobile app as they move through the supply chain until they are eventually dispensed to a patient. ‘We can identify where an individual DAA was sent and received, and it saves time trying to find missing packs,’ Mr Keitaanpaa said.

The system would also provide data that would highlight where efficiencies in the supply chain could be made. Rather than developing proprietary scanning devices, any mobile device with a camera will be able to use the VeriPharm app to scan and record DAA packs.

Mr Keitaanpaa said the $2,000 in funding will go towards building a demonstration of the software and app to show the functionality of the system. ‘This will allow us to work with industry bodies and government around funding to build the program, as well as engage with stakeholders about other features that would be useful,’ he said.

The biggest challenge to rolling out VeriPharm may come from other similar software vendors. ‘It would be an added level on existing software, similar to MedAdvisor, but given that it’s not a threat to existing software and its potential for inclusion in the Australian Digital Health Strategy, hopefully vendors can see its value,’ Mr Keitaanpaa said.
Skin in the game

For patients undergoing radiotherapy or receiving epidermal growth factor (EGFR) inhibitors, the associated itchy, flaking rash or radiation dermatitis can cause serious discomfort and be debilitating. Topical moisturisers and skincare have been the mainstay of treatment, but there has been increasing interest in oatmeal-based ointments for oncology patients. Melbourne pharmacists Michelle Cassumbhoy and Carson Au have developed their own colloidal oatmeal ointment – M&C’s Cream – and secured $1,000 in funding at the PSA18 Shark Tank event.

‘Colloidal oatmeal on a molecular level acts as an anti-inflammatory due to its beta glucan and avenanthramide content,’ Ms Cassumbhoy said. ‘Our cream contains 10% colloidal oatmeal, more than others on the market, meaning a higher concentration of those active ingredients.’ The cream not only reduces inflammation, but helps retain moisture, essential for healing skin damaged by radiotherapy and EGFR inhibitors.

M&C’s Cream is already available online, and at a retail store and pharmacy in Melbourne. The next step is partnering with oncology departments at hospitals around Australia. ‘We’re in the process of introducing our product to Australian public hospitals, starting with St Vincent’s Hospital oncology in August 2018,’ Ms Cassumbhoy said.

But the pair said the cream has a role beyond oncology departments, and hope to see it available in pharmacies, supermarkets and beauty stores as a treatment for eczema and as a cosmetic moisturiser. The pair have overseen and funded the product’s development themselves, even down to label design, packaging products, and actually hand-manufacturing the cream. They plan to put the funding from PSA18 Shark Tank towards IP rights and trademarking, but will need considerable additional funding as they move forward. ‘If we can overcome the limited funding, we believe M&C’s Cream has a nationwide market in all hospitals with an oncology service, as well as a cosmetic pharmacist formulated product,’ Ms Cassumbhoy said.

References

  1. ‘Medication Without Harm: WHO’s Third Global Patient Safety Challenge. 2017. At www.who.int/mediacentre/news/releases/2017/medicationrelated-errors/en/
  2. Welfare Aloha (2013). Australian Hospital Statistics 2011–2012. Health Services Series no.50.Cat.no.HSE 134. Canberra.

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