The National Centre for Hereditary Coagulation Disorders (NCHCD) at St. James Hospital in Dublin, Ireland is on to something. The Centre’s management was tasked with shoring up the hospital’s management, distribution and administration of home-health hemophilia medications, by making improvements to supply chain, reducing the risk of counterfeits, expediting product recall management, and reducing costs. Then, they went a step further – empowering the patient in the process through the use of smart phones. The results show not only significantly improved efficiencies in management and distribution of cold chain drugs in the program, but a dramatic improvement in the areas of patient compliance, safety and overall improved patient outcomes.

The program initially stemmed from a catastrophic failure in the medication supply chain. In the 1980s, patients suffering from hemophilia, a chronic bleeding disorder caused by a clotting factor deficiency, became infected with HIV/hepatitis due to blood product contamination. The situation was compounded by the fact that infected medication (blood product) remained in the supply chain even after a recall was initiated, leading to further infections and resulting in more than 70 deaths. In Ireland this led to a national Tribunal of enquiry (The Lindsey Tribunal) and acted as a catalyst for procedural change.

Hemophilia affects about 2,000 people in Ireland, 10% of whom are severe enough to require intensive treatment. Seventy-five percent of those patients self-medicate at home. Lack of prompt response can lead to prolonged hospitalization, decreased quality of life, and misuse of expensive plasma and recombinant products.

In order to see how the project management team at St. James’s Hospital was able to empower its hemophiliac patients with smartphone technology for their medication management, it is essential to know how they got there in the first place.

When the NCHCD chose to redesign the supply chain, it began by adopting a commonly used retail track-and-trace model based on GS1 standards and applied data matrix (2D) barcodes to expensive temperature-sensitive hemophilia medications. This enabled integration of the entire supply chain from manufacturer to the patient. This unique code, allocated to each patient, drug product and location, facilitates the automatic capture and linking of data during the supply process, validating each step of the cold chain storage and delivery process in real-time, and ensures that the correct medication is prescribed and delivered to the right patient. It also automatically updates the stock management system so that patient consumption trends can be analyzed.

“The process begins at the cold chain company where the medication from the suppliers is received,” said Feargal Mc Groarty, manager of the National Haemophilia System Project at St. James Hospital in Dublin. “Information on each vial box – product name, expiry date, batch number – is entered into a stock management system. The GS1 standard barcoded Vial Box Serial Number (VBSN) label is generated and applied to each unit of medication. The medication is then stored in validated cold chain conditions. Once a prescription is received for a patient or hospital delivery, all picking, packing and shipping is performed using barcode scanning to track and trace the product as it moves through the supply chain, to either the patient home or the hospital. Within the hospital another software system then takes over the tracking and tracing of the medication as it moves around the premises, again based on barcode scanning.”

The result has been an overwhelming success on a number of fronts. St. James’s Hospital now has total visibility of each unit of hemophilia medication in the supply chain. In the event of a recall, the location of 100% of any selected batch of product can be identified within 10 minutes.

“At-home patients are extremely happy with a cold chain delivery service they can rely on. Product wastage due to failure of cold chain conditions or documentation issues has been virtually eliminated. Since the program has been in place, more than $6.5 million worth of medication has been removed from the supply chain,” continued Mr. Mc Groarty. This is due to the fact that patients no longer “over order” and the fact that patient consumption trends are now visible in real time.

Extending the concept of traceability to drug administration at the bedside and within the patient home is considered the Holy Grail among healthcare providers, regulators and drug manufacturers, and provides the final piece of the supply chain jigsaw. The barcode on the packaging (and the vial) serves as an index key in clinical databases. At the point where medication is administered, barcodes can be used to identify the drug, patient and/or the person administering the drug. This assures a match between the patient and their prescribed medication, and also identifies who is administering it. The system can be linked to software that references information in an Electronic Patient Record (EPR) to comply with the “Five Rights” of patient medication administration: ensuring the right drug is administered at the right time to the right patient in the right dose by the right route. To facilitate this, the technology used needs to be readily available, portable and easy to use.

As part of the Irish initiative, Mr. Mc Groarty and his project team have begun distributing smartphone mobile devices to severe hemophilia patients who require intensive in-home treatment. As well as having standard mobile phone features, the devices are equipped with a software application that allows the patient to maintain records their medication usage by simply scanning the 2D barcode on the medication vial box. A realtime check is then performed against the EPR to ensure that it is their prescribed medication, it is within date and is not subject to a recall. In addition, the application offers the patient the opportunity to record key clinical information relating to why they needed to take the medication. The information – medication taken and reason for treatment – can then be transmitted back to the EPR and form part of the treatment history.

Other significant benefits have also emerged as a result of this application. For example, because information is gathered in real time, caregivers can now identify the time of day that treatment is being administered. “Due to the fact that it has a specific half life, it is recommended that the blood disorder medication should be taken before the patient is most active. But information gathered to date showed that some patients were self-infusing last thing at night. Changing this practice would give improved protection against ‘breakout bleeds’ that can lead to a decrease in quality of life, as well as reducingthe necessity for additional, non-prophylaxis treatment,”Mr. Mc Groarty noted.

He enthusiastically concluded, “Initial feedback from the patients on the program has been overwhelmingly positive. Compliance with medication recording has improved significantly, which in turn helps the caregivers manage the patient’s condition more effectively. Our initiative should help encourage the pharmaceutical and healthcare industries to reach an agreement on a barcode standard for medication [an industry whose reticence to adopt such a standard most find baffling and unsafe]. Once that is achieved and medication packaging contains the barcode, vendors of medication administration applications and EPR systems will begin supporting it. This in turn will lead to wider adoption within the healthcare industry, and hospitals in particular, leading to improved patient safety while simultaneously driving down the cost of healthcare delivery.”

Ireland’s National Hemophilia Systems Project is living proof that the entire healthcare system can work with patients to deliver and track the supply chain of services for wellness, healthcare savings and improved patient outcomes. It’s more than just a vision of the future – it’s attainable.

Kevin O’Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He can be reached at kevin.o’[email protected]. His blog, Where Cooler Heads Prevail, can be found at http://www.coolerheadsblog.com/blog/