A project right here in Ireland, based around open global supply chain standards, offers convincing proof that full traceability is possible all the way through from the supplier to the patient.
The live example comes from the National Centre for Hereditary Coagulatory disorders (NCHCD) at St James’ Hospital and was outlined in some detail at the recent GS1 Healthcare Conference. The project involves a fully traceable supply chain for factor concentrate, the substance used to treat patients with bleeding disorders. The chain starts at the manufacturer level and runs all the way through to the individual patient, whether in hospital or at their own home.
The NCHCD manages patients in Ireland with bleeding or clotting disorders, including all haemophiliacs. There are around 2,000 such people around the country, all treated through the centre. Of these, 60pc receive treatment at home, which is another problem to be solved as the factor concentrate has to be temperature regulated.
As the numbers suggest, haemophilia is a rare condition and it’s lifelong. It’s also expensive, as Dr Barry White, a consultant haematologist by profession and director with the NCHCD, explained. “Our budget for the year is about €40m, which given the size of the population is the largest drug budget per patient in the country,” he said.
In effect, there are two issues at play here: misuse or wastage is obviously a significant problem because of the sums involved and a more efficient supply chain was clearly a desirable outcome. Equally, patient safety was a critical consideration to avoid over-treatment or worse. After all, the present success has its roots in past failures and the project owes its origin to the Lindsay Tribunal report produced in the aftermath of the scandal where HIV and Hepatitis C infiltrated the blood supply.
“Some of the problems in the situation were that products were infected and people knew they were infected but they didn’t know where they were within the supply chain. In Ireland and in other countries there was a small number of people affected by products that were sitting on a shelf and should have been recalled,” White candidly admitted. He didn’t pull punches in describing the situation prior to the Lindsay recommendations. “Part of the problem is, in Ireland as in other countries, the supply chain management is appalling within the hospital system. What goes in retail or animal manufacture is just not here in healthcare.”
The key was serialisation — attaching unique identifiers to every item. “Previously, on the product we had batch number and expiry date and product name but that was really not much use to us,” said White.
“When we started this project, industry couldn’t understand why we wanted to serialise data,” he added. “When we try to do a recall, it’s no good saying we want one of a thousand products. If we’ve released a thousand with the same lot number, that gives us no ability to track them.”
Having consulted the standards body GS1, White and his department began to use a barcoding system that could track and trace the products, as well as ensuring that the patient received the right medication. “What we’re currently using is a linear barcode and what we’re moving on to is a data matrix probably in the next two to three months,” White said. Although industry vendors are promoting radio frequency identification (RFID) as an option for track-and-trace deployments — and White acknowledged that the technology has benefits — the NCHCD won’t take that step just yet. “We’re not moving to RFID at the moment. And we’re going to use data matrix until we bed that down,” he stated.
It soon became clear that the system could help to address other problems such as operational issues. For example, the NCHCD used paper charts and it wasn’t uncommon for a single patient to have around six different charts to describe their condition and various treatments.
“The big problem for us is, with just these paper records, we didn’t know what our patients were getting treatment-wise. On a chart it wasn’t readily available and easily manageable. That causes problems in terms of identifying who’s received at-risk products if you do have a recall. It’s very poor management in terms of how much product you’re using,” said White. The same supply chain system used in the trial also helps to ensure that the factor concentrate is temperature-regulated every step of the way.
To illustrate the patient-centric nature of the new system, White pointed out that not only does every single product get a barcode or data matrix, but every patient has one too. Now, everyone with a bleeding disorder in Ireland has a unique identifier, which allowed the centre to implement track and trace. “Without putting that in place, everything else would fall apart,” said White.
Clintech, an Irish IT supplier, developed an electronic patient record system for the haemophilia patients by modifying a similar software product that had been developed for cancer patients. This record system can be used to assign a diagnosis for a patient and doctors can access the data it holds in real time from any point in the hospital. This master database ties together all of the data such as the patient records and the distribution and movement of blood products.
“This was the bit that eventually got us a lot of the brownie points with the Government. Once this was in place we saw huge gains in terms of product usage and optimum usage and preventing either unnecessary over-treatment or wastage,” he added. The project has generated cost benefits too. “The cost of the service including all the IT technology is less in fact now than when we started, so not alone have we paid for ourselves but we have actually generated savings,” said White. This isn’t small change either — those savings are estimated at around €1m per year.
New elements are being added to the trial all the time. Another element to the project will involve a phone-like device that will be given to people who administer treatments in their own homes. Due to be introduced soon, this will let them send the information back to the centre via the handset and also get verification that they’re using the right blood product. “The key step in this process is simplicity: the less information you’re looking for, the better, and the more likely it is to work,” White said.
Questioned at the end of his presentation, he stressed that good patient experience and not merely saving money was a major outcome of the project. “The quality of care on the medical side was a huge change in how patients get treatment,” White concluded.
By Gordon Smith