A new international track and trace pilot has shown that electronic product codes can be used to make the supply chain more secure
The healthcare sector has demonstrated a complete track and trace system for pharmaceutical products in a live operating, international supply chain environment through a successful pilot.
The pilot tracked 15 different types of drugs through their supply chain journey: from drug manufacturing and packaging plants in Ireland and the Netherlands to their final destination, the pharmacy department at Barts and The London NHS Trust – a large group of clinical academic units that deliver clinical services, education and r&d.
The risk of counterfeit drugs entering the healthcare system is an increasing problem – as shown by the recent criminal investigation into fake Zyprexa for schizophrenia treatment produced in China and sold into the NHS. Thus, the need for technologies that can track drugs and monitor their progress through the entire supply chain has become a priority.
Such technologies could also reduce human error and improve patient safety by cutting the chance of delivering the wrong drug.
Implementing traceability systems that support swift and effective product recalls can also prevent patients from being exposed to sub-standard or dangerous counterfeit drugs. Fourteen major recalls of fake medicines have been ordered by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the past three years, compared with one in the previous decade.
The mass serialisation solution used in the trial meets all current worldwide pharma regulations on authentication and track and trace and also addresses the lack of supply chain visibility of goods shipments in the industry.
The pilot was conducted by a team of technology providers (see below), and included GS1 UK, an independent supply chain standards and solutions body. The pilot formed part of the Building Radio Frequency IDentification solutions for the Global Environment (BRIDGE) project, which is being supported by the EU’s Sixth Framework Programme for Research and Technological Development (FP6) with b7.5m of funding. This is a three-year initiative dedicated to research, development, training and demonstration in the effective use of RFID based on electronic product code (EPC) global standards.
Data carriers, such as GS1 bar codes (data matrix) and EPC/RFID tags, were used in the pilot to enable the full traceability of every single drug product in the supply chain on all levels of packaging and to monitor the progress of transportation lorries.
The project involved the implementation of a data set that included the product code, serial number, expiry date and batch number. This enabled mass serialisation of packaging items that, together with the EPC Information System (EPCIS) necessary for the storage, communication and dissemination of EPC data, delivered the necessary traceability information, which was recorded in and out of each supply chain participants’ custody.Â
All data stored in the EPCIS system provided real-time visibility of the tracked products, such as where the product is, which company has it now and how long have they got it for, as well as historical data.
‘With the ability to fully track and trace the drugs that we order from our suppliers, we can feel confident that the medication we administer to our patients is safe and authentic,’ said Patrick Martin, senior principal pharmacist at Barts and The London NHS Trust.
‘The added benefits of capturing and recording drug expiry dates and batch numbers can also help increase the hospital’s efficiency, enabling improved inventory management and quicker response times to product recalls,’ he added.
‘The success of the pilot demonstrates that the technology required to implement a full international supply chain traceability system using GS1 standards is available today,’ said Gary Lynch, ceo of GS1 UK.
‘The widespread adoption of standardised traceability systems within the healthcare sector will have an incredibly positive impact on improving patient safety, reducing the scourge of counterfeit drugs and improving efficiency within the healthcare sector,’ he added.
More information about BRIDGE and the Pharma Traceability Pilot can be found at www.bridge-project.eu and www.bridgewp6.eu.
BRIDGE Pharma Traceability pilot participants included:
Drug companies: Actavis, Sandoz and Athone Laboratories
Distributors: Kent Pharmaceuticals
Contract packer: Tjoapack
Transport/Logistics services providers: Movianto UK and CPG Logistics
Wholesaler: UniChem
Customer/Recipient: Barts and The London NHS Trust
Equipment and printing solution vendor: Domino Printing Sciences
Technical design and software developers: Melior Solutions
EPCIS services provider: VeriSign Inc
Project management, business consultancy and marketing: JJ Associates
Consultancy of standards and RFID: GS1 UK