Hemophilia is a medical condition in which the ability of the blood to clot is severely reduced, causing the sufferer to bleed severely from even a slight injury. Hemophilia is typically caused by a hereditary condition where the patient has a lack of a coagulation factor, most often factor VIII, also referred to as Hemophilia A. As there are different types of hemophilia disorders there are different treatment options as well. The most severe forms of hemophilia often require human donor plasma for treatment. When a patient has a severe bleed, they will need to infuse the donated plasma supply as quickly as possible. For this reason, many patients have learned to self-infuse at the time of need or as a prophylactic measure.
When human blood and plasma donations are being used for life saving treatments of any condition, concerns over contamination are justified. Rightfully so, and as just one example, in the 1970s and 1980s, 2,400 hemophiliac patients in the U.K. were infected with a tainted blood supply, resulting in many became terminally ill. Of the 1,243 hemophiliacs who were co-infected with both Hepatitis C and HIV, less than 250 remain alive as of 2017. One of the biggest issues stemming from the discovery of the tainted blood, beyond the tragedy of the patients being infected, was implementing a fast and efficient recall. Even after a recall was initiated, patients continued to become infected because there was not a sufficient track and trace system in place.
While most of the issues have been resolved and the donated blood products now undergo rigorous testing procedures throughout the supply chain, there is still room for improvement surrounding the treatment and patient care of hemophiliacs. Moreover, the cost of treatment has risen to meet the testing and preparation standards.
In an effort to create a solution that would address patient safety, improve doctor-patient communication and manage the supply of blood products, mpro5 began working with the National Centre for Hereditary Coagulation Disorders (NCHCD) at St. James’ Hospital based in Dublin, Ireland. NCHCD is world renowned for the treatment of hemophilia.
Patients suffering from the most severe forms of Hemophilia often must self-treat in their own homes. Prompt and appropriate treatment of a hemorrhage is important to prevent long-term complications, disability or even death. NCHCD therefore wanted to implement a track and trace system for factor replacement products being used by patients infusing at home. This would ensure that the highest level of care and safety was available to each patient.
In response to NCHCD’s objectives and specifications, mpro5 developed Europe’s first bar code safety system for blood disorder sufferers in the form of a Smartphone App available across multiple mobile platforms.
A globally unique ID, in QR code format, is assigned to every patient. Each unit of medication is also assigned a global trade item number or GTIN and a global location number or GLN in the supply chain, using the industry standard GS1 track-and-trace bar code system. The smartphone App, developed by mpro5, enables this traceability to extend to the point of patient administration. Integrated in the App is a barcode scanner which allows the patient to capture and verify the unique ID of the product (GTIN, batch/lot number, expiration date and serial number). This ensures that each factor replacement product being infused has not been part of a recall. Further, the application will alert the user if they have a product with an earlier expiration date available to administer and prompt them to use that product first. With the high cost of factor replacement products, it’s imperative that no treatment goes to waste.
After the patient has verification they are administering the most appropriate product they will be prompted to answer several questions. The first question being the reason for the infusion; prophylaxis, immune tolerance therapy or on-demand bleed. If on-demand bleed is chosen the app will prompt you to choose the area of the body the bleed is occurring along with the severity of the bleed. The patient’s treatment center will be sent a special alert if the bleed is severe. The patient will also be prompted to contact emergency services immediately in cases of high risk bleeds recorded within the application.
All patient information is wirelessly synchronized back to the main server where it is stored and made readily accessible for healthcare professionals via a web portal. Since mpro5 applications are also fully offline capable, in the event of poor or no mobile signal coverage, all data is saved securely in an encrypted format on the patient’s device until coverage is restored, where data is then pushed out to the main server.
“The concept of traceability to medication administration 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. Working with Crimson Tide has allowed us to achieve exactly this, and its success can be measured by the global interest in this project from both healthcare providers as well as the Pharma and supply chain industries.”– Feargal McGroarty, NCHCD Project Manager.
Before NCHCD implemented the mpro5 solution, patients had to laboriously complete paper forms with details of medication names, batch numbers and the dates of administrations, which they then posted back to the hospital; these tasks being time consuming, retrospective and highly prone to human error. Since all data from a patient’s smartphone is synchronized wirelessly and automatically back to the main server with a date and time stamp, the transfer of patient information is instantaneous, thus alleviating the need for paperwork and significantly reducing the organization’s administration, paper and post charges.
Healthcare professionals are also able to react immediately to any abnormal bleeds, increasing the level of care being received by their patients. Even more importantly perhaps, patients have given a highly positive response to the service, reporting 100% satisfaction with the convenience and 99% satisfaction with the privacy and confidentiality of the mpro5 system.