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Healthcare leaders and regulators share track and trace best practices with GS1 standards for access to safe medicines

Addis Ababa, Ethiopia was the chosen venue for the African GS1 Healthcare Conference, from 8-10 May. More than 310 participants from 25 African countries and 13 countries from outside of Africa, met to discuss how GS1 standards can be used to enable track and trace for access to safe medicines, an important issue worldwide.

According to the World Health Organization (WHO), an estimated 1 in 10 medicinal products circulating in low- and middle-income countries is either substandard or falsified. This means that people are taking medications that either fail to treat or prevent disease or could be harmful. Falsified medical products lead to a loss of lives, negatively impact economic growth and erode overall trust in the healthcare system.

Organised by GS1, hosted by the Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) and supported by the United States Agency for International Development (USAID), the African GS1 Healthcare Conference brought together determined and inspired professionals who understand that securing the global healthcare supply chain enabled by GS1 standards is a “marathon, not a sprint.”

 

Yehulu Denekew, Director General, EFMHACA, welcomed all participants to the African GS1 Healthcare Conference with an introduction to Ethiopia as one of the fastest growing nations that has made remarkable strides in economic and social developments in the last decade. “Health is a fundamental human right and medicines are the cornerstone of every healthcare system,” said Mr Denekew.

Studies have shown that gaps exist when it comes to accessibility, quality and affordability of medicines in Ethiopia—an issue that the EFMHACA is working to resolve. About 80 percent of Ethiopia’s USD $500 million demand of medicines and medical devices is imported. In response, Ethiopia has developed a roadmap for pharmaceutical industry development, making huge investments targeted at increasing the local production of pharmaceuticals. Mr Denekew closed by stating the quality and safety of medicines requires the use of GS1 global standards.

Ulrike Kreysa, Senior Vice President Healthcare with GS1, discussed the role of GS1 standards in making the supply chain more secure, which has been recognised by organisations like the Interagency Supply Chain Group (ISG). The ISG is committed to establishing global data standards as part of its procurement requirements and supports country’s acceptance of these standards.

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Tunde Odunlami, CEO, GS1 Nigeria, shared his vision of African healthcare where data would be captured and used at every point in the supply chain for end-to-end visibility and authentication of medicines and recall readiness, coupled with improved regulation by government and resulting in increased patient safety.

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As the guest of honour, Dr Amir Aman, Ethiopia’s Minister of Health, spoke to all participants in the presence of the Ethiopian Minister of Foreign Affairs, the Minister of Industry and the Minister of Trade about the huge threat posed by falsified medications to patient safety and livelihood, especially in Africa. “Trust and credibility in the supply chain has been compromised due to lack of transparency and accountability. Therefore, the implementation of globally harmonised standards is a non-negotiable imperative,” said Dr Aman.

Dr Aman acknowledged that many challenges leading to falsified medicines stem from ineffective supply chain systems and the lack of harmonised traceability systems. He encouraged all conference participants to take a global approach to tackle the counterfeit issue, because the problem is a global one. By developing a platform for the exchange and use of information, efficient and effective communication across stakeholders will prove to be indispensable in the fight against counterfeiting.

 

Leslie Reed, Ethiopia Mission Director, USAID, and Victor Rakoto, Deputy Representative, United Nations Population Fund (UNFPA), delivered the keynote addresses on the Opening Day of the conference.

Ms Reed advised that one of USAID’s top priorities in global health programming is to help developing countries build safe, secure, reliable and sustainable supply chain management systems. For almost 50 years, USAID has been delivering supplies to ensure reproductive rights; In 2017 alone commodities worth over $157 million were procured and delivered to 114 countries, making it the largest public-sector procurer of reproductive health commodities.

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Mr Rakoto recognised the need for trust, commitment and information sharing among supply chain partners as highly critical for advancing supply chains in meeting the need for contraceptives and other reproductive health commodities.

He noted that UNFPA and USAID are collaborating with the Ethiopian government to help tackle the country’s challenge with inventory management and supply chain data visibility by demonstrating real-time track and trace and a dashboard to visualise transactional data. “This effort started with the use of existing barcodes on health commodities to seamlessly capture transactional data in real-time as they moved from one inventory touchpoint to another,” explained Mr Rakoto. “It demonstrated the possibility of end-to-end supply chain data visibility.”

 

Over 48,000 samples were analysed with quality surveys conducted in 88 countries as part of the WHO’s socio-economic study to assess the problem of substandard and falsified medical products. Making the case for attention and investment in this issue, the WHO released its findings and recommendations of the study—results that impact patients who are putting their trust in the effectiveness of medications.

In their presentation, Mick Deats, Group Lead, Substandard and Falsified Medical Products, and Lisa Hedman, Technical Officer, Procurement and Supply Chain Management from the WHO, pointed to three factors leading to substandard and falsified medical products in the supply chain: constrained access to medicines by patients, weak technical capacity and poor governance practices. To overcome these, political will is required to translate policy agreed at the global level to sustainable actions at the local level. The speakers also called on governments to strengthen regulatory capacity and systems and recognised the need for effective, multi-stakeholder engagement for greater transparency.

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Leigh Verbois, Associate Commissioner for International Programs, with the U.S. FDA, provided an update on the implementation of enhanced drug distribution security requirements associated with the Drug Supply Chain Security Act (DSCSA). She described recent stakeholder engagement as part of the FDA’s public meeting series as well as a plan for engaging and educating stakeholders

Ms Verbois described how the DSCSA addresses taking the needed verification steps to identify, quarantine and investigate suspect products, notifying trading partners and the FDA of illegitimate products entering the supply chain, within 24 hours of determination. She advised that the FDA intends to initiate the DSCSA pilot project program this year, coordinating with manufacturers, re-packagers, wholesale distributors and dispensers to explore and evaluate methods for enhanced safety and security of the pharmaceutical distribution supply chain.

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In her presentation, Julia White, Global FP VAN Director, Reproductive Health Supplies Coalition, U.S., outlined how the Global FP VAN is working to ensure continuous availability and choice of family planning products in developing countries.

Ms. White discussed the process and status of developing the Global FP VAN. She stepped through the needed innovations—linkages, data sharing, data management and systems—to aggregate, share and align country demand data with production, procurement and funding to avoid stock imbalances and maximise the use of limited resources. She specifically stressed the importance of high master data and the use of the GS1’s Global Data Synchronisation Network (GDSN) as a means of sharing product data across the supply chain. High quality master data and the GDSN serve as a foundation for traceability.

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One of the clear messages discussed during the conference is that regulations from different countries all require the same basic data elements in the GS1 DataMatrix barcode on pharmaceutical products: product identifier (Global Trade Item Number® or GTIN®), serial number, lot/batch number and expiry date.

During this traceability panel, Ulrike Kreysa, Senior Vice President Healthcare, GS1, outlined the recommendations and learnings from the toolkit of the APEC Roadmap for Global Medical Product Integrity and Supply Chain Security, a multi-year project of the Track & Trace Work Group (TTWG), facilitated by GS1.

Roche and Johnson & Johnson, members of the TTWG, shared their specific experiences, recommendations and best practices about how to get started when creating a traceability system.

 

Françoise Hirth, Serialisation Coordinator for Europe and EEMEA, Roche, Switzerland, outlined how supply chain complexity and lack of control can leave supply chains vulnerable to criminal activities, harming patients and healthcare stakeholders alike. She discussed how industry stakeholders manufacturers, providers, health authorities, logistics providers are working together to implement traceability solutions to improve patient safety.

Dirk Van den Wouwer, EMEA Serialisation & Traceability Leader, Johnson & Johnson Supply Chain, Belgium, clearly outline his company’s approach to serialisation and traceability in support of patient safety and EU Falsified Medicines Directive (FMD) regulation. He specified the seven key deliverables in getting started—from initial communication to process mapping and then to obtaining capital resources. Additional best practices included leveraging existing GS1 standards, driving appropriate communication throughout the internal organisation and engaging closely with other stakeholders.

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The traceability panel discussion continued with GS1’s Ulrike Kreysa and major pharmaceutical manufacturers: Françoise Hirth, Roche, and Dirk Van den Wouwer, JJSC. They addressed important decisions that help drive the decision for a traceability model such as where to collect and hold data in the traceability system and levels of data security.

Turkey’s successful traceability system using a centralised model was reviewed, along with a distributed model that stakeholders in the U.S. are interested in implementing in support of the U.S. FDA’s Drug Supply Chain Security Act. There is broad industry agreement with support from the FDA to leverage the GS1 EPCIS standard as a mechanism for the capture and interoperable sharing of pharmaceutical traceability data as products move through the supply chain.

 

Françoise Hirth outlined Roche’s traceability model based on GS1 codification, serialisation and aggregation. For codification, the company has taken the first step towards traceability by identifying different levels of products and shipments with GS1 identifiers, including the serialisation of secondary packages. By aggregating and sharing the information captured via GS1 barcodes, traceability is then possible; the interoperable exchange of such information between stakeholders is given a boost when these parties leverage EPCIS, a GS1 and ISO open standard geared to enable supply chain visibility.

Dirk Van den Wouwer shared JJSC’s approach to implementing traceability, advising that serialisation was only one part of the implementation process. Another critical element is to establish data repositories and sharing data from manufacturer to pharmacy, at the point of dispensing the medicine. Mr Van den Wouwer described the German National Verification System implementing the European Falsified Medicines Directive that JJSC has been piloting since 2016 to “learn by doing.”

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Day Two of the conference featured speakers from around the world who shared experiences of traceability implementations. Dr Ramy Guirguis, Senior Information Technology Advisor, USAID, U.S., and Thinlay Wangchuk, IT Specialist, UNFPA, Denmark, kicked off the day by discussing the need for data quality, master data management, interoperability and a foundation of GS1 standards for end-to-end supply chain visibility.

Dr Guirguis noted that USAID has adopted the Global Data Synchronisation Network™ (GDSN®) as a source of product information, calling on suppliers to collaborate by submitting quality data for both drug registration processes and supply chain information systems.

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Mr Wangchuk described GS1 standards as a way to address current challenges with the donor supply chain information systems such as financial and resource constraints, the need for accuracy, and business and systems optimisation. There is increasing interest in use of GS1 standards from governments, regulators, manufacturers, NGOs and UN agencies. Currently, UNFPA is conducting an Ethiopian pilot to gain experience by automating the shipment process with GS1 standards and exchange data between suppliers, UNFPA and government systems.

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KEMSA is a medical logistics management organisation under the Ministry of Health in Kenya. Its CEO, Frederick Wanyonyi explained how the organisation started implementing GS1 standards in 2014. With the GS1 system, KEMSA can now identify pharmaceutical drugs, from delivery to the warehouse, while in transit and at the KEMSA facility

Mr Wanyonyi described some of the benefits seen from the use of GS1 standards and barcodes in KEMSA’s business processes: reduced inventory on hand and waste; better control over distribution and storage; and fewer errors when recognising goods, to name a few.

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The Korea Pharmaceutical Information Services (KPIS) was established to collect, investigate, research and provide drug distribution data that encompasses the production, import and consumption of prescribed pharmaceutical and over-the-counter drugs. During her presentation, Hye-Kyoung Kim, Deputy Director, KPIS, Health Insurance Review & Assessment Service, South Korea, discussed how GS1 standards are used in KPIS to uniquely identify drugs and help prevent counterfeit drugs from entering the supply chain.

Ms Kim outlined how drugs—both prescribed pharmaceutical/ethical and over the counter—are identified with the GS1-13 and GS1-128 barcodes, including mandatory serial numbers. With this level of identification plus the according data flow, KPIS can track and trace all drugs from production to consumption.

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Heran Gerba, Deputy Director General, EFMHACA, described the healthcare sector in Ethiopia with about 313 hospitals, 3,200 health centres, 16,000 health posts and 14 local pharmaceutical manufacturers, supplying only about 20 percent of the market needs. Since the vast majority of pharmaceutical drugs are imported, this opens Ethiopia to potential counterfeits and the need for traceability. Ms Gerba advised, “Track and trace will enable local manufacturers to export.”

Established in 2010, EFMHACA is Ethiopia’s federal authority with the mandate to protect the public health and safety of Ethiopia’s 90 million citizens. Describing Ethiopia’s journey to track and trace, Ms Gerba provided an update on what the EFMHACA had done so far with the pilot for the verification of malaria medication.

Ms Gerba then presented the phased roadmap for the implementation of GS1 standards and traceability. Currently, on Phase 1, the EFMHACA is working to strengthen the current environment, including plans to implement the unique identification of medicines with barcodes and sharing the associated master data. Phase 2 is centred on the implementation of batch traceability and Phase 3 on the implementation of traceability based on the serialisation of medicines

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Teddy Berihun, Senior Health Information Systems Adviser, USAID, Ethiopia, presented traceability progress in Ethiopia via different pilots. In 2015, USAID, UNFPA, JSI Research & Training Institute (JSI), and the Pharmaceuticals Fund and Supply Agency (PFSA) collaborated to launch a pilot project in Ethiopia to test the feasibility of using GS1 standards to provide end-to-end visibility of data for emergency contraceptive pills. The pilot provided promising results to help inform broader traceability efforts in Ethiopia’s public health sector. Learn about their progress and efforts since then to ensure traceability for the prevention of fraud.

Another project involved the PFSA that is now using the GS1 Global Document Type Identifier (GDTI) with serialisation to track and authenticate outgoing PFSA official invoices.

Another pilot that Mr Berihun discussed was about the development of a GS1 Verification Platform so that the public can validate the authenticity of malaria medicine. Manufacturers of the ACT (Artemisinin‐based combination therapy)

medicine assign and apply a GS1 GTIN with serial number encoded in DataMatrix barcodes on products shipped to Ethiopia. Using this app, the public can scan the barcode on the package and verify that the product is a genuine ACT-manufactured malaria medicine, imported by PFSA. The team intends to expand the malaria verification pilot learnings to other programs and products

Mr Berihun summarised the value of GS1 standards: “Standardisation of product identification and data exchange provides the basis for the implementation of a traceability system in which visibility in the supply chain can be achieved.”

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Currently in nine countries, the OpenLMIS manages logistics processes for more than 10,000 health facilities across Africa. The OpenLMIS initiative is a collaborative effort of donors such as the Bill and Melinda Gates Foundation, USAID and GAVI as well as implementers and technology partners like PATH, UNFPA, BrowserStack and OpenSRP. OpenLMIS has recently updated their systems to incorporate GS1 standards.

In his presentation, Josh Zamor, Architect, OpenLMIS Community, U.S., shares the OpenLMIS software vision that is standards-based and API-driven to ensure its interoperability with almost any other system, configurable and extensible. Processes supported by OpenLMIS includes order generation and fulfillment, stock management, cold chain equipment tracking, and reporting and analytics.

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Brian Taliesin, Director of Project Management & Knowledge Management, PATH, U.S., described Tanzania’s journey in using GS1 standards and barcodes to identify and manage vaccines.

Mr Taliesin advised that following the development of the WHO recommendation for GS1 standards approximately 85 percent of stock-keeping units of vaccines now have barcodes that capture the GTIN, the lot number and expiration date. Barcode scanning has been adopted by the entire Arusha region in Tanzania, representing approximately 1 million doses per year. Vaccine data are managed via the electronic Logistics Management Information System (LMIS). Significant improvements were recorded, including the monthly physical inventory process that once took 535 minutes and now only takes 90 minutes, an impressive 83 percent reduction.

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Imperial Logistics moves approximately 400 million patient-packs of medicine annually, 90 percent of these throughout Africa. Clinton De Souza, Director, Public Health, Imperial Health Sciences, U.S., described the key elements associated with the chain of custody when preventing counterfeit medicines from entering the healthcare supply chain: serialisation, authentication and blockchain technology.

In its role as wholesaler/manufacturer, Imperial Logistics needs GS1 standards with serial numbers encoded in GS1 DataMatrix barcodes on each of its drug packages. With serialisation, recalls can be easily executed at any point in the supply chain. Products can also be inspected or authenticated, confirming their identity in a rapid scanning process. Mr De Souza shared the company’s current operational projects that include achieving operational visibility, serialisation-as-a-service for its clients, and above-market visibility that includes analysing and managing data to mitigate issues.

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Chuck Biss, Senior Director AIDC Healthcare, GS1, hosted this panel on GS1 identification and barcodes to enable traceability. Ulf Suerig, Head of Global Business Processes, Abbott in Germany, and Pascal Aulagnet, Market Customer Engagement, Pfizer, Europe, discussed how GS1 identifiers and barcodes can help simplify the complexity of today’s regulatory requirements.

Uif Suerig addressed how new regulations worldwide are changing the information, symbols and data sharing requirements at the saleable unit. In order to implement serialisation in support of traceability, he advised that it is wise to focus on the design of the regulation—and the design should be based on GS1 standards. Understanding global standards is key to correctly define the technical specifications of a traceability system for data integrity, data security, and data modelling and reporting.

Pascal Aulagnet, Market Customer Engagement, Pfizer, Europe, also presented the need for, and value of, identification as a foundation for traceability. Mr Aulagnet said, “It’s time to partner together—both governments and pharmaceutical companies—to operationalise and improve technology for the greatest impact.”

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Pete Alvarez, Sr. Director, Identification & Data Strategy, GS1 Healthcare, and Craig Alan Repec, Senior Manager, Supply Chain Visibility, EPCIS & RFID, GS1, provided an overview of GDSN and EPCIS as traceability enablers. Mr Alvarez discussed the challenges faced by manufacturers, healthcare providers and regulators when it comes to master data management. He advised that data quality starts at the source and needs to be maintained throughout the information supply chain. Mr Repec explained the foundational building blocks of EPCIS, and provided insight on designing a future-proof visibility system.

Mr Alvarez discussed how, with the GDSN, data can be easily and systematically maintained and shared between all stakeholders, making accurate and complete data a reality for everyone

Mr Repec followed with an explanation about how EPCIS, a GS1 standard, can support serialisation and provide event-based visibility across the supply chain. GS1’s EPCIS & CBV Implementation Guide provides advice on designing a visibility system based on EPCIS. He gave a high-level overview of the basic steps along with a simplified supply chain example.

Ulf Suerig, Head of Global Business Processes, Abbott in Germany, outlined examples of traceability systems in Turkey, China and Pakistan—their challenges and successes as well as opportunities beyond regulations.

Dirk Van den Wouwer, EMEA Serialisation & Traceability Leader, JJSC, Belgium, discussed how working toward a harmonised identifier would help to simplify the implementation of traceability as well as control costs. He provided an update on the status of identifier harmonisation within the EEA. Mr Van den Wouwer mentioned that critical component of traceability is data sharing via the GDSN and collaborating with customers to improve data accuracy.

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As global healthcare manufacturers with operations in many countries worldwide, B. Braun and Pfizer are impacted by regulations from a growing number of countries and regions—from the U.S. to South Korea, the Middle East and China. This session discussed how they are implementing traceability to address these worldwide regulatory requirements and overcoming challenges along the way.

Pascal Aulagnet, Senior Manager Business Technology, Pfizer, Europe, outlined the company’s global supply chain operations across Africa and its use of GS1 standards to identify pharmaceuticals. The company also shares its product data with trading partners on the GS1 GDSN and leverages GS1 standards in its EDI transactions. Mr Aulagent described how Pfizer was one of the first companies to identify and mark vaccines to ensure that they are getting to the children in need.

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Collins Agoro, Project Manager, Track & Trace, B. Braun in Germany, clarified his company’s commitment to traceability for the predictability, authentication and low risk associated with medicines. Mr Agoro outlined the company’s implementation of trace and trace in response to the EU’s FMD regulation, explaining the relevance to the African continent. He concluded that “we believe that after this conference, we will see increasing requests coming from Africa for serialisation.”

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In 2016, Netcare’s South African operation, consisting of 52 hospitals, embarked on a multi-phased project to scan barcodes of both medicines and surgical devices for increased patient safety. Since 2003, Ireland’s Haemophilia Project has been helping the country’s 5,500 patients with inherited bleeding disorders through the use of GS1 standards. In Ethiopia, hospitals are taking initial steps to lay the foundation of product identification for traceability. These healthcare providers are embracing the positive change that comes with adopting GS1 standards for traceability.

 

Caroline Potgieter, E-commerce Manager, Procurement, Netcare, South Africa, described Netcare’s approach and initial focus on product identification and data capture with GS1 standards for traceability throughout its hospitals. Working closely with suppliers, Netcare continues to address many challenges along the way with decisive actions and collaboration.

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Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Ireland, has been leading Ireland’s Haemophilia Project for more than a decade. By using GS1 identifiers and barcodes, the hospital can validate delivery of products to the patient home.In his presentation, Mr Mc Groarty advised that €5 million worth of medication stock has been removed from the supply chain; in addition, improvements in stock rotation has saved €600,000 worth of stock.

When conducting a mock recall, GS1 standards help IT systems identify the locations of all medication at patient homes and within the hospital in 10 minutes. Mr Mc Groarty concluded, “Standards are the key! Implementing and embedding standards can improve supply chain efficiency, reduce wastage, and help to identify counterfeit medication.”

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Kalkidan G. Tsadik, Operations Manager, Office of Innovative Strategies and Operations, St. Paul’s Hospital Millennium Medical College, Ethiopia, discussed the need to implement GS1 identification standards in Ethiopian hospitals for the traceability of medications as prescriptions are filled, dispensed and administered to patients. Next steps include getting aligned on a strategy and being proactive about this direction.

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The conference concluded with a networking lunch and opportunities to meet with experts from GS1 and industry leaders. Sixty-five very interested healthcare stakeholders attended to get answers to their questions. Topics included how to get started and select a traceability model; how to engage solution providers for support; and how to share traceability information, to name a few.

 

Keith Hummel, USAID, Ethiopia reminded all participants: “As we leave today I would like to remind everyone that your track and trace journey will be much like a desert journey—filled with excitement, worries and doubt. Yet, the outcome will be high-quality medicine.”

Mr Denekew, Director General, EFMHACA, concluded, “Please join us and let us make this initiative be realised in this country and other African countries.”