Post event summary
More than 290 healthcare industry leaders, regulators and solution providers from 31 countries met in Bogotá, Colombia for the 33nd annual global GS1 Healthcare Conference, from 10-12 April.
Bogotá provided the ideal backdrop for this GS1 Healthcare conference where healthcare providers, manufacturers, distributors and regulators from all parts of the world shared insights about using GS1 standards—and how a simple scan can truly lead to safer, more efficient patient care.
Latin American healthcare providers offer ther perspectives
Healthcare providers representing Colombia, Brazil and Argentina kicked-off the conference by describing how their hospitals are leading the way with the use of GS1 standards across a range of healthcare processes.
The panel was chaired by Carlos Jurado Moncavo, Executive Director of the Health Industry Sector, ANDI, Colombia who described the Latin American healthcare environment, the increasing demands faced by hospitals and how GS1 standards are playing an important role to help address these challenges to drive efficiencies and patient safety.
Nilson Gonçalves Malta, Hospital Automation Manager with the Albert Einstein Hospital, Brazil, shared an overview of the status of private hospitals in Brazil. He discussed the impact of the ANVISA drug traceability law (RDC 157/2017), which has led to GS1 DataMatrix barcodes being applied to secondary packages, each encoded with a Global Trade Item Number® (GTIN®), ANVISA medicine registry number, serial, batch number and expiry date as well as the steps to reporting at the hospital level.
In Argentina, Prof. Dr. Norma Sberna, Head of Pharmacy, Hospital de Pediatria Hospital highlighted recent regulation in Argentina calling for the implementation of traceability systems. The hospital pharmacy is heading towards the implementation of scannings a GTIN plus serial number, batch/lot number and expiry date encoded in a GS1 DataMatrix barcode for each of its pharmaceutical drugs and disposables)—GS1 standards generated and applied by its suppliers. Dr. Sberna concluded by stressing the importance of defining and implementing a traceability system that includes all processes within a pharmacy.
Teresa Tono, CEO, Organización para la Excelencia de la Salud, Colombia, discussed the role of accreditation in the hospital, using the monitoring of diabetes as a model. She highlighted the complementary nature of GS1 standards and the importance of working together with the goal of improved patient safety.
A vision, plan, roadmap and global sharing means successful standards implementations for patient safety
Serious adverse events in the U.S. tripled from 2008 to 2011 for medical devices and medication errors range from 10 to 20% of in-patient admissions in the U.S. and UK. In developing countries, the rate is higher. Statistics like these set the stage for a compelling discussion about traceability and patient safety.
Jean-Michel Descoutures, Hospital Pharmacist with Centre Hospitalier Victor Dupouy, France, introduced the value of GS1 standards in increasing patient safety. A key recommendation for successful implementation of standards includes a bottom-up strategy of creating added value for the hospital combined with a top-down strategy of complying with regulatory requirements.
Tony Scanio, Director Data Management and Business Intelligence, Christus Health, U.S., followed by discussing his healthcare system’s use of GS1 standards that address patient safety concerns—from approval of the product in Christus’ data management systems to receipt and use of the product at the patient bedside or in the operating theatre.
Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Dublin, Ireland described the details of the hospital’s use of GS1 standards to enable traceability in its processes— in procurement, and surgery, and throughout the hospital when tracking patients, for precious samples and assets like wheelchairs. For clinical staff working within their ‘scan for surgery’ program, St. James’s staff now spend just 2 hours per week on stock-related activities compared to 20 hours per week. This means spending more time on patients and their care.
Hennie Mulder, a registered operating room nurse at Maxima Medical Centre, Eindhoven/Veldhoven, the Netherlands, described the labour-intensive, manual process of preparing for a surgical procedure. Now, staff in the operating theatres scan GS1 barcodes for a highly efficient and much safer processes. Ms. Mulder said, “GS1 Barcodes are essential for patient safety. Their development and deployment are important in helping us to overcome difficult situations.”
The benefits and challenges of global UDI harmonisation
With multiple Unique Medical Device Identification (UDI) regulations around the world, how would global harmonisation affect the ease of implementation and adoption for healthcare manufacturers and providers?
Mark Hoyle, Technical Director, UDI, at Teleflex, hosted this panel discussion that explored the benefits of UDI global harmonisation as well as the current challenges of worldwide regulatory requirements.
Jackie Elkin, Global Process Owner, Standard Product Identification, Medtronic explained the latest in UDI regulations spanning the globe while Tom Jones, UDI Program Director with Johnson & Johnson, outlined the key opportunities for harmonisation.
Imagine the benefits for patients and hospitals that would come from harmonised UDI data being exchanged - analysis of patient treatments could be accomplished on a global versus a regional basis. For hospitals, product availability would be easier to share across regions.
Volker Zeinar, Global Coordinator Auto-ID Affairs, B.Braun, wrapped up the discussion by explaining the technical and process-related challenges today and how harmonisation would simplify and accelerate UDI adoption.
Challenges and best practices for identification at point of care
Hosted by Charity Hovey, Project Manager with 3M in the U.S., a panel comprised of a healthcare provider, pharmaceutical manufacturer and medical device manufacturer discussed how they have overcome the unique challenges of implementing identification at point of care.
Whether identifying the patient, location, provider, or medication and device, the audience learned from these pioneers of implementing GS1 identifiers and barcodes. They shared the best practices used to make identification a reality for patient safety, traceability and compliance.
Feargal McGroarty, National Haemophilia System Project Manager, St James’s Hospital in Ireland presented the critical nature of using GS1 standards for unique medicine identification to prevent errors in patient care. Mr. Mc Groarty referenced his extensive work with the haemophilia community, noting how unique patient identification is essential at point of care in the hospital and home as well for recalls, patient electronic health records, stock management and verifiable cold chain delivery.
Tatjana Pathare, Global Supply Chain Management Team, F. Hoffmann La Roche Ltd, Switzerland, provided a detailed analysis of how this global manufacturer applies unique identifiers on vials, syringes and blisters. She shared how Roche has taken a phased approach to implement unique identification on the primary packaging level, solving technical and process-related questions along the way.
Georg Keller, Manager Regulatory Affairs, Labelling Coordinator, B.Braun / Aesculap AG, Germany, concluded with a look at the company’s practices for identifying and marking reusable surgical instruments in compliance with UDI regulations and for improved tracking and management.
Moving products through the supply chain with GS1 standards
AmerisourceBergen, McKesson and DHL form a significant portion of the backbone of the global healthcare supply chain. They are designed to move products efficiently through the global healthcare supply chain to hundreds of thousands healthcare providers around the world. Jeff Denton, Global Secure Supply Chain with AmerisourceBergen, chaired the discussion about their current and future plans for using GS1 standards and technologies for even greater efficiencies.
AmerisourceBergen (ABC) processes hundreds of thousands of transactions with trading partners each business day. Heather Zenk, SVP, Secure Supply Chain & Replenishment Operations, U.S., discussed the impact of the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) and the benefit of using GS1 standards in ABC’s supply chain—not only for compliance, but for interoperability and efficiently moving products to customers. Heather’s vision of a serialized world inspired the audience to see what is possible.
Since 2006, DHL has been a GS1 member. Mike Meakin, VP, Global Quality Regulatory & Compliance, DHL Supply Chain in the UK, discussed how the global supply chain company has undertaken its serialisation journey, leveraging GS1 standards. He discussed the various areas in which DHL is using GS1 standards to enable the efficient and accurate delivery of healthcare products to hospital wards.
Scott Mooney, VP, Distribution Operations, McKesson, U.S., explained how the global distributor is working with manufacturers to comply with regulations in the U.S. and Europe for serialisation of pharmaceutical drugs. Mr. Mooney outlined how McKesson’s warehouses are using GS1 identifiers and barcodes. Recognising the complexity of the McKesson business operations with multiple wholesaler businesses, IT systems and pharmacies in the EU, he discussed the impact of the EU Falsified Medicines Directive (FMD).
Pharmaceutical traceability perspectives from healthcare players across the supply chain
Pharmaceutical traceability enabled by GS1 standards is addressing many of today’s healthcare challenges, particularly those that impact patient safety. It is helping to combat the rise of counterfeit drugs in the global supply chain while reducing prescribing and ordering errors. As the time spent in hospitals by patients is becoming shorter and homecare is becoming more prevalent, the need for traceability is even more critical.
Rigoberto González González, Operations and Logistic Director with Grupo Farmanova Intermed, a large logistics company in Costa Rica, described the company’s use of GS1 standards and the crucial qualitative and quantitative benefits. By using GS1 standards combined with other initiatives, the company has increased efficiencies, decreased picking errors from 6% to .6%, decreased picking time by up to 20% and decreased time spent physically managing inventories by 70%. Examples of other benefits include a significant reduction in re-processing orders, optimising physical storage and ease of compliance with local and international regulations.
In his presentation, Jeff Denton, Global Secure Supply Chain, AmerisourceBergen, stressed that GS1 standards are more important than ever when it comes to blockchain solutions. Providing the needed foundation, GS1 standards assist interoperability and digitalisation.
Balmiro Canedo and Oscar Javier Gomez, security executives from Sanofi, Colombia, presented how high profits and low punishment rates make counterfeit medicines a big issue for the global biopharmaceutical company. They stressed the need for end-to-end traceability of pharmaceutical drugs to combat the consequences of counterfeit drugs, including patient death, no therapeutic effects and loss of trust in the healthcare system.
Maayke Fluitman, PharmD, CEO, Care2create, the Netherlands, discussed the impact of GS1 standards driven by the EU’s Falsified Medicines Directive on processes associated with receiving, fulfilling and dispensing of prescriptions in a retail pharmacy. She believes there are many opportunities to leverage standards for connecting the patient to doctors, pharmacists and other healthcare providers.
Updates from regulators and lessons learned in pharmaceutical traceability
Traceability leveraging unique product serialisation is a powerful strategy for improving patient safety. In collaboration with governments, manufacturers are seizing the opportunity presented by regulations worldwide—the goal to eradicate counterfeits.
Leandro Oliveira, Serialisation and Traceability Leader with Johnson & Johnson (J&J) provided an update on pharmaceutical traceability regulation and pilot in Brazil and Russia. Since 2009 and with the latest valid version more recently in 2017, Brazil’s ANVISA regulation requires the use of a GS1 DataMatrix and relevant GS1 standards for unique medicine identification – including also the ANVISA Registration Number.
J&J is part of the ongoing pilot after which ANVISA will publish more detailed requirements and has defined a number of key milestones to adjust, learn and prepare for the 2022 full-market implementation.
In Russia, a pilot is ongoing with several companies – technical guidelines are available, but there are still constant changes and uncertainty Leandro shared an image of the sample identification in GS1 DataMatrix barcode format as being implemented for the pilot in Russia.
Regulatory updates about the U.S. FDA’s Drug Supply Chain Security Act (DSCSA) and Unique Device Identification (UDI) rule, the European Union’s Falsified Medicines Directive (FMD) and the new European medical device and IVD regulation highlighted progress towards improving supply chain security and achieving traceability of pharmaceuticals and identification of medical devices to increase patient safety.
GDSN in support of regulation and trading partner collaboration
Nazly Chacon, Director of Technological Support, Coopidrogas, Colombia and a panel comprised of MJ Wylie from Johnson & Johnson US, Stéphane Ancel from GAM, a French procurement organisation, and Tony Scanio from Christus Health, a leading healthcare provider in Latin America presented their experiences in sharing accurate and complete product data via the Global Data Synchronisation Network™ or GDSN®. With an eye on collaboration, productivity and patients, each contributor provided his/her view about the journey of data sharing in today’s healthcare world.
MJ Wylie, Global GDSN Strategy & Deployment, Johnson & Johnson Supply Chain (JJSC), U.S. addressed the value of sharing accurate and complete product data with trading partners as well as its many uses throughout the supply chain and operations. J&J uses a tiered approach of strategic partnering, cooperation and collaboration, starting small and celebrating wins along the way.
Stéphane Ancel, CEO of GAM, a healthcare GPO in France, uses the GDSN as a source of data for its electronic catalogue and eProcurement processes with nearly 30% of its suppliers on the system. Mr. Ancel anticipates benefits such as increased productivity, more reliable product data and increased patient safety based on product traceability.
Tony Scanio, Director Data Management and Business Intelligence, Christus Health, U.S., described the healthcare system’s journey to achieving standardised data for its 13 hospitals in Chile, Mexico and Colombia.
Global pharmaceutical manufacturers speak out about pharmaceutical serialisation and traceability
Servier, Bayer and Eli Lilly discussed the lessons learned when implementing pharmaceutical serialisation. Chaired by Scott Mooney, VP Distribution Operations, McKesson, the panel provided updates about their progress and next steps to implement full traceability.
Carole Laloum, Serialisation Distribution Manager Supply Chain with Servier, France presented the changing and complex world of serialisation for the manufacturer, its integration into production and distribution processes, and ultimately as part of verification processes within healthcare provider environments. With more than 2,000 people impacted across the Servier organisation by this important work, internal communication is critical for success.
Stefan Artlich, Director 'Track&Trace', Bayer, Germany, discussed some of the serialisation challenges for manufacturers such as a large number of packaging dimensions and ongoing maintenance of product codes. He advised the first step toward readiness for requirements in a country is to nominate a country project manager. It is important to remember that serialisation implementation takes time. For example, getting a packaging line ready for serialisation or aggregation may take between 12 to 15 months.
Senthil Rajaratnam, Affiliate Serialisation Account Manager, Eli Lilly and Company in the U.S., stressed the need to use GS1 standards as the foundation for serialisation. Without a harmonised approach, manufacturers will waste a substantial amount of time and effort. Education and awareness efforts—first internally and then with other industry members and regulators—will help shape future, globally harmonised regulations aligned with GS1 standards.
Comparing RFID- and GS1 DataMatrix-enabled data capture for pharmaceutical traceability
During this panel discussion, GSK, Roche, Crystal SAS and Pfizer compared RFID tags with GS1 DataMatrix barcodes to better understand the benefits and issues associated with both as tools for standards adoption in healthcare. Every country that has selected a data carrier for medicines traceability in healthcare has opted so far for the GS1 DataMatrix barcode.
Grant Courtney, Manager FMD Project with GSK in the U.S., shared the results from the company’s pilot with RFID tags. One of the lessons learned was that RFID failures were difficult to identify and resolve. Another was that all users of the product did not have RFID readers, so the information would need to be duplicated in barcodes to be useable by the whole supply chain. Finally, there is a patient privacy concern if RFID tags are not “destroyed” upon dispensing.
Sébastien Langlois-Berthelot, Project Manager, Roche, Switzerland, discussed the company’s comparison along with the conclusion that the GS1 DataMatrix barcode is the preferred data capture option for identification, authentication and traceability of medicines. For the past decade, Roche has invested in implementing the GS1 DataMatrix and full aggregation in all of its facilities and contract manufacturing organisations to enable traceability.
Pascal Aulagnet, Senior Manager, Global Serialisation – EMEA Client Partner, Pfizer in France, followed with the company’s analysis of RFID and GS1 DataMatrix with a recommendation for DataMatrix based on its insignificant increase in cost of goods sold, the ability to leverage existing labelling processes and that no additional equipment is needed for the supply chain or healthcare providers.
Camilo Higuita, IT & Innovation Manager, Crystal SAS, an apparel company in Colombia, provided information on the use of RFID tags in production and distribution, and explained the organisation’s experience with non-healthcare products.
Update on UDI guide driving a globally harmonised approach
Jackie Elkin, Global Process Owner Standard Product Identification with Medtronic, U.S., provided an overview of the International Medical Device Regulators Forum (IMDRF) work item - developing a draft UDI Application Guide.
The purpose of the UDI Application Guide is to provide a single source of information to facilitate the implementation of UDI using a globally harmonised approach. This is an extension of the original guidance which was finalised in 2013. The workgroup kicked-off its development effort of the UDI Application Guide in December 2017 and plans to submit the draft guide to the International Medical Device Regulators Forum (IMDRF) management committee in May of this year with a final submission by the end of year or beginning of 2019.
Medical device developments
Medical device traceability in Latin America is advancing with lightning speed. Read how these healthcare stakeholders are learning and creating their own best practices when implementing GS1 standards. Oral care products offer some very unique challenges when it comes to unique identification of the many small products that comprise a portfolio.
Marisol Sanchez Gonzalez, Executive Director, ANDI-CDMIS, Colombia, provided an overview of the medical device market in Colombia and then shared some of the conceptual and regulatory aspects of the standardisation process that is aimed to improve interoperability in the country. All stakeholders are involved in the process of semantic standardisation that will be supported by regulators as well as other stakeholders.
Andrea Rodriguez, Senior Regulatory Affairs & Quality Assurance Manager, Medtronic, Argentina, discussed her company’s very proactive approach to enabling the traceability of medical devices using GS1 standards. Medtronic is taking a phased approach to greatly benefit patients of having a robust system that provides greater certainty when consuming traceable and quality products.
Esteban Lizarazo, President, Amarey Nova Medical, Colombia, presented his findings from research about the complexity of a healthcare supply chain and the importance of GS1 standards for streamlining the management of medical devices within the supply chain.
Labelling oral care products is very challenging. Charity Hovey, Product Manager, 3M, U.S., presented the unique characteristics of the oral care product market along with the technical and storage considerations of its products when labelling them with a UDI.
Global standards and interoperability in Australian healthcare
The Australian Digital Health Agency (the Agency) is a statutory authority, a corporate Commonwealth entity that reports to Australia’s State and Territory Health Ministers through the Council of Australian Governments (COAG) Health Council. It designs and operates national digital health services that give consumers more control of their healthcare when they wish it; connect and empower healthcare professionals; and promote Australia’s global leadership in digital health and innovation.
Dr. Monica Trujillo is the Chief Clinical Information Officer & Executive General Manager – Clinician and Consumer Engagement and Clinical Governance. She shared the agency’s top digital health priorities, designed to keep Australia as a leader in healthcare system performance and efficiencies. GS1 and its standards are an integral part of the agency’s strategy and roadmap.
Top priorities for the Australian Digital Health Agency include My Health Record, an electronic summary of an individual’s health information that is shared securely online. Today, more than 5.5 million consumers and 10,700 healthcare providers participate. Other priorities include improving the quality of healthcare information that can be exchanged securely. To transform Australian healthcare, the agency relies on partnerships including with GS1.
Winning stories of perseverance and passion for patient safety
Mrs. Veronique Jost, Hospital Pharmacist, Dijon University Hospital, France was awarded the GS1 Healthcare Provider Recognition Award for her ongoing championing of implementation of GS1 standards. The Hospital Israelita Albert Einstein, São Paulo, Brazil was awarded GS1 Healthcare Best Provider Case Study Award for an outstanding case study implementation using GS1 standards to advance patient safety.
Their healthcare stories clearly demonstrated how implementations of GS1 standards had a compelling impact on their operations and significant improvements in patient care.
The new Dijon University Hospital optimised its supply chain by implementing GS1 standards throughout its processes—from product receipt to patient care. All hospital floors and rooms are identified with Global Location Numbers (GLN), products in care units are uniquely identified with Global Trade Item Numbers (GTIN), transportation bins with Global Returnable Asset Identifiers (GRAI), and shipments with Serial Shipping Container Codes (SSCC).
As part of this transformation, the integration of new processes in the pharmacy has had a profound impact on the people who work there as well as the patients who rely on the hospital pharmacy safe medication dispensing. With the foundation of GS1 identifiers in place, the hospital and its pharmacy are now well-positioned to take next steps to fully leverage standards for even greater improvements.
Hospital Israelita Albert Einstein opened its doors in 1971 as a non-profit diagnostic and treatment centre, and today has more than 5,000 employees, including more than 500 full-time physicians. With a focus on patient safety, the hospital started using GS1 standards during the process of obtaining its international hospital accreditation. It decided to enhance its dispensing system by leveraging GS1 GTINs encoded in GS1 DataMatrix barcodes that identify medicines at the single unit level—from the pharmacyistist to the point of care.
Representing the hospital, Nilson Gonçalves Malta, Pharmacist and Hospital Automation Manager, described the history of industry partnerships with manufacturers. Today, the hospital has dramatically advanced in its use of GS1 standards. It scans incoming product barcodes from receiving, to distribution, dispensing and administration at the patient bedside.
Mr. Malta closed by saying, “It’s all about patient safety. GS1 standards are one of the most important tools in the hospital supply chain until pharmaceutical drugs reach the patient and point-of-care. When processes are followed, GS1 standards-based barcodes help prevent adverse events from happening—all the time.”