Verification and Traceability Initiative

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Supporting countries to reduce the urgent risk of falsified and diverted health products in national supply chains with a vision toward national traceability of all vaccines, medicines, and health products.

Addressing falsification and diversion

​​​​​​​Falsified health products put lives at risk by causing harm to patients and failing to treat the diseases for which they were intended. The risk is widespread with a study by the WHO finding that one in ten medical products in Low- and Middle-Income Countries (LMICs) has been reported as being substandard or falsified[1].

Not only do substandard and falsified medical products contribute to antimicrobial resistance and drug-resistant infections, but they also lead to a loss of confidence in medicines, healthcare providers and health systems. Additionally, they represent a large loss of resources, costing around US$ 200 billion globally and US$ 30 billion in LMICs, where the risk of diversion is higher due to limited governance structures, tools, and technical capacity[1]. Current alerts of falsified and substandard medical products as published by the WHO can be viewed here

Investments in verification and traceability can protect beneficiaries from counterfeit health products while strengthening digitally enabled supply chains for public health use cases. 

For health products, we need to be able to tell where the products are coming from and which paths through the supply chain they have taken, including the time between each node of the chain.  

Governments, funders and partners need to have information about health product stock levels and supply chains in order to ensure that the right products are available and can be transported to destinations where they are needed. Inventory data is important to ensure timely supply chain decisions such as forecasting, supply planning and distribution to minimize the risk of shortages or expiration of health products. Recognizing this challenge, a multi-stakeholder initiative called Verification and Traceability Initiative (VTI) was created, composed of national regulatory authorities in Nigeria and Rwanda, The Bill & Melinda Gates Foundation, GAVI, The Global Fund, UNICEF, USAID, and The World Bank. The initiative appointed Vital Wave as the Program Management Unit. The aim of the VTI is to support the development of a system that increases supply chain visibility and decreases the risk of falsified products using GS1 standards, to support the LMICs.

Verification

Enables the identification of counterfeit and diverted health products by validating that a scanned GS1 compliant product pack barcode, is authentic. This helps to remove falsified and diverted products from the supply chain. 

Traceability

The ability to identify the origin and the various stages of product consumption and distribution, and ability to track where a product is at any given time within the distribution system.

 

Introducing TRVST

To realize this goal, the VTI has developed the Traceability & Verification System (TRVST) - a solution designed to allow countries to verify the authenticity of health products and track and trace products through their supply chain. TRVST is a global repository of GS1 compliant information for health products. Manufacturers provide Product Master Data with relevant data attributes for verification and traceability which are encoded on the product pack barcode (e.g. GTINs, Batch/lot, expiry date and serial number) to the system. Client systems can then verify scanned GS1-compliant barcodes against the TRVST which in turn responds indicating whether the details submitted in the request match up with the data that is held in TRVST. TRVST also has a protocol to identify suspect activity (e.g. a high number of scans of the same serial number - especially if scanned in different locations) and sends a response to the user which can be tailored for different needs by national authorities.

3 Step Process

Building the application on the GS1 supply chain standard ensures their interoperability with other GS1-enabled supply chain information systems. This further allows its functionality and scope to be expanded over time to cover other health products and use cases, including traceability, product recall, and supply chain automation and analysis.

Benefits of supply chain visibility

Benefits of SC visibility

TRVST has a set of basic and advanced verification modalities that countries can select from when adopting the system. The goal is to ensure TRVST can work with countries using the most appropriate tools to meet national requirements. Depending on the existing digital health ecosystem within any country, TRVST can be used through two different modalities:

Mobile application

Standalone Mobile Application

Integrated traceability system

Integrated with Traceability System

The simplest and easiest way to deploy TRVST is through an off-the-shelf mobile application that verifies products by scanning barcodes. 

For countries with a national traceability system, their systems can interface with TRVST using an API to verify products registered in the repository.

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Deployments so far and future plans 

The TRVST standalone mobile application (modality A) was successfully trialled in Nigeria and Rwanda in July 2022 at distribution sites where COVID-19 vaccine packs were present. For the trial, secondary pack serial numbers for the J&J COVID-19 vaccine batches in the country were provided by J&J and uploaded to the TRVST repository (666,099 serial numbers). Teams from both countries scanned J&J COVID-19 vaccines in cold stores (193 in Nigeria, 20 in Rwanda), successfully verifying the secondary packs of the batches held by the TRVST repository. Some challenges during the scanning of GS1 2D (two-dimensional) barcodes were identified that were related to damaged barcodes. Failed verifications were also obtained by scanning products whose serial numbers were not in the repository, which allowed the teams to experience the system behaviour in such cases and to test the automatic alert system through emails to country managers.

Participants provided positive feedback on their experiences, noting quick response time, a well-designed workflow to support business processes, and overall excellent usability to accomplish verification of health products. The learnings identified are being used to inform the configuration and development of subsequent verification modalities, and to continue to support Rwanda and Nigeria on their traceability journeys.

The second phase of TRVST will involve the development of version two, with other modalities that can be integrated into country traceability systems through an API becoming available, and the inclusion of additional functionalities of the TRVST repository. Version two will be available in Q4 of 2022 and is currently planned to be integrated into the national systems in Nigeria and Rwanda, plus other countries that have shown interest in deploying TRVST such as Malawi and Nepal. Version two will have track and trace capabilities using the electronic product code information system (EPCIS) and data exchange capabilities. 

 

Getting Involved

The Verification and Traceability Initiative invites active discussion with all country partners on how TRVST can support their journey to traceability. To learn more about the Verification and Traceability Initiative or to get involved as an implementer, please contact the Program Management Unit for the initiative (Vital Wave) on This email address is being protected from spambots. You need JavaScript enabled to view it. or contact a representative of your local development partner organization, The Bill & Melinda Gates Foundation, GAVI, The Global Fund, UNICEF, USAID, and The World Bank. Support for the PMU is provided by PATH. 

 

[1] WHO, A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products, 2017.