[Blog] TRVST system – another huge milestone in the fight against drug counterfeiting
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TRVST is the world’s first global medicines verification system designed to support low and middle-income countries (LMICs) in their ongoing fight to eliminate falsification and diversion of medicinal products.
The WHO estimates that the share of counterfeit and poor-quality drugs on the market ranges from over 10% of total sales in low-income and middle-income countries to 1% in developed countries. Moreover, based on the Systematic Review and Meta-analysis “Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries”* (2018), the results showed that the overall prevalence of poor-quality medicines was 13.6% with a regional prevalence of 18.7% in Africa and 13.7% in Asia. The WHO evaluated that falsifying vaccines and medicines in low- and middle-income countries costs USD 30 billion yearly and over USD 200 billion globally.
The COVID-19 pandemic raised the topic even more, emerging the crucial aspect of vaccine counterfeiting. The WHO has received reports from multiple sources of suspicious offers to sell or supply COVID-19 vaccines to national regulatory authorities or Ministries of Health. In November 2020, fake COVID-19 vaccines (2400 doses of illicit vaccine in 400 ampuls hidden in plastic containers in a refrigerator) were discovered by law enforcement agencies in Johannesburg, South Africa.
However, it doesn`t stop to COVID-19 vaccines. In the research “Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil” (2023)* were pointed out serious issues regarding the safety and authentication of influenza vaccines. The results from the analysis of the vaccine samples, actively distributed at that time on the Brazilian market, showed:
- Evidence of vaccine falsification, handmade packaging, package inserts, and labels;
- Presence of microbial contamination in a sample of seized vaccines;
- Negative results obtained for the potency and identity assays confirmed the absence of pharmacologically active substances;
The volume of this growing phenomenon required global collaborative efforts to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines.
Table of Contents
The role of TRVST
TRVST serves as a global repository that holds product-specific information submitted by the legal manufacturers of medical products. This includes details such as the GS1 Global Trade Item Number (GTIN), the unique product identifier; batch and serial number, and expiry dates.
TRVST is developed under the Verification and Traceability Initiative (VTI), a multi-stakeholder partnership composed of the Bill & Melinda Gates Foundation, the European Commission, Gavi, the Global Fund, UNICEF, USAID, the World Bank, and the national regulatory authorities in Nigeria and Rwanda. These global immunization stakeholders are now working together to develop and Implement TRVST. UNICEF is the legal entity behind TRVST.
TRVST Components
The system is made up of 5 basic elements:
- A standard interface to suppliers (using EPCIS)
- The TRVST repository
- Verification smart phone application and API
- The TRVST dashboard is used for Verification and have a Traceability Administration Portal used to manually upload of Products & location and manage recall batches.
- TRVST API interface to national systems for verification and traceability
TRVST Functionalities
TRVST has three major capabilities for vaccine and pharmaceutical products:
- Verification
- Track & Trace
- End-to-end supply chain visibility
TRVST Traceability Requirements
In order to enable the identification of the unique secondary pack for verification, and traceability of the specific secondary pack through the supply chain, the serialization was underlined.
The track and trace requirements are as follows:
- GS1-barcodes on secondary pack and higher levels, including GTIN, Lot number, expiry date, and serial number
- GS1-barcodes of different packing levels are aggregated
- Data encoded by barcodes is made available to/in TRVST via an automated interface
Notes: Un-serialized products can be verified using just the GTIN, batch/lot identifier, and expiry date.
TRVST in action
In 2022, Rwanda and Nigeria became the first countries to use serialized vaccines and scans at the point of care to improve patient safety. This was a significant milestone for combatting falsified medicines in Africa. 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).
TRVST has received over 300,000 verifications in the past 12 months.
45% of the vaccines procured by UNICEF are now able to use TRVST, which represents around USD 3 billion of products being protected.
Participation Agreements signed by several stakeholders including 8 manufacturers and 18+ vaccine manufacturers ongoing discussions for onboarding.
In the continuation of the article, we will discover more technical details of the TRVST system – onboarding process, verification modalities, key achievements, and more.
Meanwhile, our experts are available to answer your questions in a free consultation – do not hesitate to reach >> communication@softgroup.eu
Sources:
https://www.unicef.org/supply/traceability-and-verification-system-trvst
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10339189/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8881974/
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2696509
