Healthcare professionals meet in India for the first time to share traceability and global standards best practices
More than 330 healthcare professionals from 46 countries convened in New Delhi, India for the 36th Global GS1 Healthcare Conference. The conference was especially compelling since India and its healthcare system have been at the forefront of implementing GS1 standards.
During the three-day conference, 43 speakers—regulators, suppliers, wholesalers, hospitals, solution providers—shared updates, experiences and best practices centred on pharmaceutical traceability, hospital transformations, and the status of unique device identification (UDI) regulations globally.
This conference provided an opportunity for participants to engage in lively discussions about the challenges and successes of harmonisation, using GS1 standards. The networking event was a magical and memorable experience for all—featuring India’s rich culture, incredible food and warm hospitality. As the conference ended, a participant described his experience: “Traceability was everywhere!"
Ulrike Kreysa, GS1’s Senior Vice President Healthcare, opened the conference by recognising India as one of the countries leading the way in the adoption of GS1 standards.
Mr. Bhupinder S. Bhalla, President of GS1 India and Ravi Mathur, CEO of GS1 India, welcomed everyone with the call for collaboration during the conference. India is at the heart of global healthcare transformation, with its healthcare sector growing at an accelerated rate. (India’s educational system is producing a staggering number of 50,000 new doctors each year in response to its population needs.) In response, GS1 India is providing strong support to government bodies to enhance the country’s healthcare delivery system.
Special guests included Marianne Timmons, President Industry Engagement & Standards Development with GS1 Global Office, and Dr. Vinod K. Paul, Member of NITI Aayog, a policy think tank organisation in India . Ms. Timmons emphasised the value of GS1 standards in enabling global patient safety. Dr. Paul, who reports directly to India’s Prime Minister, presented the initiative to reform the Indian health insurance system for secondary and tertiary care—thus, reducing out-of-pocket expenses for patients so that even the poorest will have access to the best care possible. Since the system is the largest in the world, Dr. Paul requested that all participants help build consensus and provide recommendations for the efficiency of healthcare.
On day one, manufacturers and regulators highlighted impressive progress in implementing global traceability systems for pharmaceuticals. Tripti Nakhare, Senior General Manager, Regulatory Affairs, FDC Limited in India, shared the manufacturer’s perspective of implementing GS1 standards for pharmaceutical traceability. As a global exporter, FDC has received positive feedback from regulators about its leadership in compliance with regulations like the EU Falsified Medicines Directive and U.S. Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA).
Andreas M. Walter, General Manager, European Medicines Verification Organisation (EMVO), Belgium, announced EMVO’s major achievement in completing its point of dispense verification system in only three years. While challenges remain, the system is expected to continuously improve as all pharmacies, wholesalers and healthcare providers start scanning barcodes and get connected to the system.
Dr. Connie Jung, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity & Recalls, U.S. FDA and Jariwala Jay, Assistant Country Director, with the U.S. FDA in India described implementation of the U.S. FDA’s DSCSA that will ultimately lead to an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States —from manufacturer to patient. They stressed the role of the DSCSA as a tool for ensuring that patients are getting high quality and authentic medicines.
Alexion Pharmaceuticals, Colombia, has put in place an end-to-end traceability system . By implementing GS1 standards, Giovanny Crust, Industrial Engineer, explained that Alexion is now capturing the movement of all its products—within its business and with trading partners as well —and is able to make critical decisions about how to best meet the needs of healthcare providers and patients. Medication dispensing, information management, medication withdrawals, control of expiration dates, medicine duplication control and medication history consultations—these are just some of the applications that GS1 standards support.
Heran Gerba, Director General, Ethiopian Food and Drug Authority, outlined the planned phases of the Ethiopian traceability roadmap, leveraging GS1 standards. Significant progress has been made in developing the Electronic Regulatory Information System—the infrastructure that will capture quality product data and support supply chain traceability. In conclusion, she reminded all participants, “It’s a marathon, not a sprint!” Angiah Santhanaswamy, Public Sector Director, Oracle India Private Limited, shared the exciting outcome of its pilot for a block chain traceability system throughout different states in India. Blockchain transactions transfer product information, captured with GS1 standards, from the manufacturer, distributor and healthcare provider, and then, enable the patient to scan the product to receive traceability information.
Medicine is often effective, yet complex and rather risky. Mistakes happen. During his keynote, Professor Sir Terence Stephenson, Nuffield Professor of Child Health, UCL Great Ormond Street Institute of Child Health, UK, challenged conference participants to think differently about safety practices in hospitals. He explained how mistakes can be “engineered out” of healthcare processes.
It’s not about trying harder—it’s about using technologies and GS1 standards to provide fail-safe healthcare practices. Professor Stephenson was this year’s recipient of the GS1 Healthcare Provider Recognition Award , recognised for his unrelenting contributions to making healthcare safer.
Peter O’Halloran, Chief Information Officer at ACT Health, Canberra, Australia, was also recognised with the GS1 Healthcare Provider Recognition Award. Mr. O’Halloran leads an award winning team that is transforming ACT Health with GS1 standards. He led one of the first programmes globally that used GS1 standards for identification and traceability of manufactured blood products. Mr. O’Halloran encouraged all participants to keep an eye on the real reason for using standards—to improve patient outcomes. “We’re doing simple things that have great outcomes,” said Mr. O’Halloran.
Raghavan Rajagopal, former CEO, Insurance Information Bureau of India, explained that one of the biggest challenges with India’s health insurance industry is collecting data and effectively using it for constructive analytics. In response, the government of India has created the Register of Hospitals in Network of Insurers (ROHINI)—a pan-India registry of hospitals and medical day-care centres in health insurance networks. All in-network hospitals and hospitals involved in cashless reimbursement of health insurance claims must be uniquely identified with a GS1 Global Location Number (GLN) in order to be registered in ROHINI. The ROHINI infrastructure enables ease of doing business with healthcare providers for insurance claims processing, helps prevent fraudulent activities and facilitates fast, reliable analytical reporting on geography-based trends, patterns of disease occurrence, cost patterns and more.
Maryanne Molenaar, Systems Pharmacist, Eastern Health, Australia, shared her experience with closed loop electronic medication management—the use technology and GS1 standards in the medication management process—that aims to minimise manual selection, inputs and transcription. Ms. Molenaar explained how four Australian hospital systems are using GS1 standards in medication management, (one hospital uses GS1 standards on unit dose packaging), to improve patient safety and efficiencies in processes like recalls and stock management. Read the position paper.
Professor Sir Terence Stephenson hosted a panel of professionals from three hospitals in the UK’s National Health Service (NHS) — Dr. Keith Jones, Head & Neck Surgeon, Clinical Director of Surgery, University Hospitals of Derby and Burton NHS Foundation Trust; Lorna Wilkinson, Director of Nursing, Salisbury NHS Foundation Trust; and Dr. David Berridge, Consultant Vascular Surgeon, Deputy Medical Chief Officer, Medical Director of Operations, Leeds Teaching Hospitals NHS Trust.
The panel discussed the critical role of using GS1 standards throughout the patient journey, in the operating theatre and in stock management. Each shared learnings from their implementations—gaining the support of clinicians, ensuring barcode scanning compliance, working with manufacturers and much more. All pointed to the tangible benefits experienced by their hospitals in controlling costs, better managing stock and keeping patients safe.
One participant described the panel: “Bridging the gap between clinical processes and supply chain may seem an alien concept, but leading clinicians from the UK told us how important it is!”
On the last day of the conference, Jay Crowley, Vice President and UDI Practice Lead, USDM Life Sciences and former U.S. FDA Senior Advisor, stressed the importance of using global standards to ensure a globally harmonised approach to UDI. He shared that benefits will be experienced once the UDI and its data attributes are consistently used throughout the device’s lifecycle.
Dr. Rubina Bose, Deputy Drugs Controller, Central Drugs Standard Control Organisation (CDSCO), shared the scope of India’s UDI regulation. This regulation aligns with the International Medical Device Regulators Forum (IMDRF) Guide, released in 2017.
Volker Zeinar, Global Coordination Auto-ID Affairs, B. Braun Medical, explained how the EU Medical Devices Regulation (MDR) is much more than unique device identification. Manufacturers must provide more data as part of the European Database for Medical Devices (EUDAMED), including registration, UDI, certificates, post market surveillance and clinical investigations.
Three hospitals took the stage to discuss the changes and benefits of UDI. In the Netherlands, a National Implant Registry has been created to enable the identification of implants with these unique identifiers referenced in the Electronic Health Records to improve patient safety associated with breast implants. Hennie Mulder, Registered Nurse, Maxima Medical Centre, Netherlands, discussed how barcode scanning for populating the Implant Registry is a critical step in the operating theatre to enable traceability within the hospital and across the country.
Shingo Kasamatsu, Technical Officer of the Faculty of Medical Science, University of Fukui Hospital, Japan, introduced how GS1 standards are supporting the safe and productive use of surgical instruments in the hospital’s operating rooms. Picking errors have decreased from 15 to 1, and each staff member can do more since picking time is shorter, resulting in a reduction of 500 man-hours per year.
Dr. Hajo Reissmann, Head of Medical Supplies Controlling, University Hospital Schleswig-Holstein, Germany, recognised the hard work associated with the acquisition and management of quality product data, yet acknowledged the many benefits for hospitals in the future. He provided insight into the ROI of investing in standards-based processes for data management.
Download day three plenary presentations
Pharmaceutical contract manufacturing is a huge sector with a large number of integrated services. While many market factors are driving growth in contract manufacturing, other factors—supply chain complexity, interoperability issues and the rise of counterfeit medicines—are restraining growth. Learn about the latest traceability initiatives, regulatory actions and challenges being addressed by contract manufacturers and their partners.
Chaired by Jeff Denton, Senior Director, Global Secure Supply Chain Digital Business Solutions, at AmerisourceBergen, panel representatives included Matt Sample, VP Manufacturer Operations, AmerisourceBergen (U.S.), Scott Mooney, VP Distribution Operations Supply Chain Assurance, McKesson (U.S.), Dr. Oliver Nuernberg, Chief Product Owner, SAP Life Sciences, SAP (Germany) and Anand Garg, Senior Director, Head India Supply Chain, Dr. Reddy’s Laboratories (India).
In the U.S., a DSCSA barcode assessment by the top three wholesalers revealed 74.3% of manufacturers’ products scanned had readable 2D GS1 DataMatrix barcodes with all four DSCSA-required data elements—up from only 6.7% in 2017 and 20.7% in 2018. While this is positive news, the need for consistent terminology, standardised requirements across trading partners and markets, and collaboration and data sharing opportunities exist. A key message from SAP: Tracebility is only possible when all are sharing the data.
How are hospitals today redefining healthcare services and the value of care for patients? Dr. Eric Hans Eddes, Chair, Gastrointestinal and Oncological Surgeon, General Director Dutch Institute for Clinical Auditing (DICA), the Netherlands, led a discussion about the challenges faced by hospitals. One challenge is the variation in treatments and outcomes. Based on its audits, DICA is working to reduce these variations for improved outcomes and reduced costs. Hospitals in the Netherlands and Australia also shared initiatives being implemented today that are transforming their hospitals for the future.
Alex van der Putten, Head of Procurement and Supply Chain, advised that being “out of stock is not an option” at the Radboud University Medical Centre, Nijmegen, the Netherlands. The hospital’s Project OVMA is working to create greater transparency in the supply chain with the use of GS1 standards for more efficient use of stock and improvements in inventory management and decision-making based on more and better product data. To date, results are impressive with no out-of-stock situations and a reduction in stock of more than 25%.
Peter O’Halloran, CIO, ACT Health, Australia, discussed the health system’s transition to patient-centred planning coupled with the use of GS1 standards and technologies. Today, the hospital has implemented the full identification of patients, staff, locations, products, assets and documents. Mr. O’Halloran reported that they expect to have full traceability, scanning throughout the supply chain, and full episode costing by 2025.
How are manufacturers and hospitals helping to make patients are safer? Experienced healthcare professionals and pharmacists shared their lessons learned from barcoding unit-level packages for improved medication management. This session was filled with practical information and recommendations about how to make hospitals and pharmacies safer environments for patients.
Sebastien Langlois-Berthelot, Business Capability Analyst, Global Serialisation Operations with Roche, Switzerland, shared Roche’s ongoing journey of applying barcodes—first, on secondary packages and then, evolving to the GS1 DataMatrix barcode on primary packages. He advised that more and more leading hospitals worldwide are introducing requirements for the presence of barcodes for tenders—a strong incentive for manufacturers to get onboard.
A major hospital confirmed, “We are a large purchaser. If the supplier will not comply (by using GS1 standards), then we change supplier .”
Pharmacist Maryanne Molenaar provided additional details about how four hospitals are taking a proactive stance to patient safety by applying barcodes on unit doses of medication. This is part of the Closed Loop Electronic Medication Management (CLEMM) system that aims to minimise manual processes and associated human errors and risks. Robert Moss, President of the Hospital Pharmacy Section, International Pharmaceutical Federation, Netherlands, noted the multiple steps in medication management and where errors are more likely to happen—in prescribing and administering. He stressed how hospital pharmacists should develop quality assurance strategies to detect errors, using GS1 standards-assisted medication administration while calling on drug manufacturers to leverage barcodes on unit dose packages. Medication safety practices are outlined in the International Pharmaceutical Federation’s paper, “The Basel Statements: Statements for the preferred future in Hospital Pharmacy.”
Millions of lives are saved by humanitarian organisations as they deliver essential medicines to people who need them most. These organisations are building safer global supply chains for the distribution of these medicines, with GS1 standards as a common element of their plans, pilots and ongoing efforts.
Mouna Jarmouni, Supply Chain Data and Performance Lead, The Global Fund, Switzerland, described GS1 standards are an important element of the organisation’s strategy to enable end-to-end data visibility for the efficient distribution of safe medicines. The Global Fund, along with other humanitarian organisations like USAID, the Bill & Melinda Gates Foundation, GAVI and UKAID , aligned on a supply chain implementation plan that was tested in five African countries in September.
Ramy Guirguis, Senior Information Technology Advisor, USAID described how GS1 standards are being used in the organisation’s global health supply chain, starting with suppliers’ compliance and current, ongoing product data management efforts. Rachel Smith, Global Standards Technical Specialist, USAID Global Health Supply Chain Programme – Procurement and Supply Management (GHSC-PSM), described GHSC’s goal for a secure and efficient supply chain based on the unique identification of items. The GHSC is supporting USAID by engaging the global health community to build consensus and align requirements between donors and their procurement agents. To date, 59 suppliers have submitted evidence of compliance with the USAID GHSC-PSM Technical Guidelines, with over 2,546 items identified with GS1 GTINs.
Pascal Aulagnet, Senior Manager, Pfizer Digital, Pfizer, France, presented the Vaccines Visibility System where barcodes on tertiary, secondary and primary levels of packaging are scanned throughout the vaccine supply chain for end-to-end inventory management and forecasting. Started in Nicaragua, the VVS has been successfully piloted in Gambia.
Global pharmaceutical manufacturers provided an update about global serialisation regulations in countries around the globe. Based on multiple key drivers of traceability regulation, manufacturers are working to put in place traceability systems that reach beyond their local borders.
Senthil S. Rajaratnam, Affiliate Relations Leader, Global Serialisation Program, Eli Lilly and Company led the panel of Bhaskar Dey, Associate Director, Logistics & Exports at Abbott Healthcare, Scott Mooney with McKesson Pharmaceuticals, and Phill Marley, Product Security Advocacy Lead, AstraZenaca in the UK. A full track-and-trace verification system was outlined to show how the movement of serialised products can be efficiently tracked—from manufacturer to wholesaler and then distributor—and on to the pharmacy for dispensing to patients. These experienced professionals provided best practices for traceability when identifying products and capturing the information via barcodes, using GS1 standards.
Inspirational speaker, Major D. P. Singh, told conference participants about his life-changing injury when a mortar bomb exploded, causing him to lose his leg. Filled with despair, Major Singh chose to fight once again for his life—rebuilding it with promise, hope and determination to grow. He is India’s first blade runner, completing 26 half-marathons. He challenged participants to: “Push yourself and don’t compromise, then you will grow.”
Read more at majordpsingh.com
This conference’s charity was HelpAge India, an organisation that provides aid for disadvantaged elderly. Established 40 years ago, HelpAge supports for the needs of an estimated 106 million elderly people in India as an advocate for universal pension, quality healthcare, action against elder abuse and many more causes at a national, state and local levels.
Learn more at helpageindia.com