TRAPS (Transparent Pharmaceutical Supply Chains)

TRAPS can transform antimicrobial supply chains through blockchain-powered transparency, intelligence and integration. Combining track and trace, inventory management and malicious practice identification it mitigates misuse, identifies substandard medicines, shortages and stockpiling, ensuring antimicrobials are safe, available and effective. TRAPS -an investment in equitable antimicrobial care for everyone. 

Kamran Najeebullah is the solution lead at CSIRO within the AMR Missions Team. The team is supported by extensive capability within CSIROs Data61, Product development and Commercialisation teams. 

The significant public health issue arising from AMR is primarily due to the use, overuse, and misuse of antimicrobials. Mitigating AMR requires effective management of medicine procurement and inventory control across the fragmented supply chain plagued by poor visibility, lack of standardised reporting, and data interoperability issues.

TRAPS bridges these gaps, enabling informed decision-making and AMR management. While bringing innovation and aiding integration, TRAPS' ability to drive a sustainable shift at the Implementation level will derive the greatest impact.   It provides powerful surveillance and governance capabilities, offering macro and micro visibility, near-real-time decision support, and equipping authorities to intervene against malicious behavior like counterfeiting and stockpiling.

TRAPS directly addresses key One Health crisis areas: developing new forms of community AMR surveillance by involving consumers in reporting and reconciling activity data, countering the dissemination of substandard/falsified antimicrobials through integrated supply chain monitoring for early intervention, and informing AMR policy decision-making by enabling strategies like pooled procurement, incentive modeling, and hotspot identification.

Recognising the unique pharmaceutical distribution landscape in developing regions and LMIC's involving multi-role 'agents', TRAPS allows global, national, subnational, and local visibility/configurability, ensuring contextually relevant and actionable data to tackle distinct challenges.

Initially, TRAPS targeted use cases that assist locally in Australia and Asia Pacific region. As one of the highest per capita antibiotic users globally, Australia faces challenges including shortages, access, Asia-Pacific LMIC region requirements, and a significant lack of local manufacturing and supply capacity.

Through the OnPrime accelerator program, the TRAPS team conducted customer discovery interviews to understand the drivers of antibiotic supply shortages and projected challenges. They interviewed clinicians, pharmacists, regulatory bodies, manufacturers, supply chain organisations, policymakers, and community members to grasp the multi-level challenge and its manifestations across the supply chain. 

The team is exploring pilot scopes and prototypes with potential user groups to 'field test' TRAPS in customer/industry settings, expanding beyond Australia into Asia-Pacific and African LMIC contexts where its potential public health value is significant. These groups range from macro policy organisations to potential collaborations with SECURE, MSupply, Pharmacy Guilds/Associations.

For example, Australia's new PBS Medicines Supply Security Guarantee requires manufacturers stockpile certain medicines, including antimicrobials, to counter shortages. However, stockpiling can negatively impact neighboring LMIC countries with fragile supply chains. The team is exploring collaborations forTRAPS in this context, understand vulnerabilities, test capabilities, and assess data collection and participant motivation assumptions to inform product development.

The TRAPS platform will ultimately develop with tiered features and offerings in both a commercial and not-for-profit model. 

Through the Trinity Challenge, the TRAPS team is seeking to develop a not-for-profit pathway/model where we can collaborate with LMICs to understand and solve challenges not previously addressable.  This collaboration would enable a 'for purpose' use case/pilot (country, region, community) to have both service and product available thereafter on a non-exclusive basis. Ultimately once developed, our strategy is to offer a public health packaged product suite, as well as specialised products/version under commercial terms. 

The TRAPS platform enables participants like manufacturers, distributors, retailers, healthcare providers, and government agencies to maintain and validate a shared, transparent, and tamper-proof record of transactions in a decentralized manner. It facilitates secure exchange of diverse information, including ownership changes, product verification, and time-stamped sensor data like temperature and location.

At the community level, this materially impacts equity of access and quality assurance. In the Asia Pacific, where access is improving, high levels of dilution or incorrect formulation render medicines ineffective. In Africa and online retailing, significant counterfeit and unregulated medicine proliferation occurs (up to 95% of online pharmacies). By providing a single source of truth from source to consumption, TRAPS allows agencies, governments, and industry bodies to identify malicious practices, supply chain imbalances, and intervention needs in near-real-time.

TRAPS ensures visibility and provenance throughout the supply chain, enabling surveillance, audits, forecasting, and deterring falsified or substandard products. It provides an audit trail for investigating antimicrobial product origins in case of suspected resistance outbreaks or adverse events. By monitoring goods flow, TRAPS can detect anomalies and events impacting consumer access to effective medication, including quality degradation, shortages, and stockpiling. Furthermore, TRAPS enhances stakeholder collaboration by establishing common data format, interoperability, and security protocol standards.

Note: given TRAPS is at Proof of Concept stage, the scale strategy is indicative and may evolve as product development and customer feedback progresses. 

The development plan for TRAPS over the next 12-18mths will run parallel workstreams of platform development and customer MVPs. By working with customers across the block chain, rapid develop-test-learn cycles can occur enabling validation and assumption testing during development.  

In addition to this bottom up development approach, the team will also seek funding for a ‘top down’ customer engagement to demonstrate the capability of the system at a macro level. Testing the need for incentivising or mandating participation at key points will be important to the overall success of the product in achieving its aims. 

The intention is to raise through philanthropic or grant funding sufficient funds to  offer sponsored trials to reduce barriers to participation and accelerate market testing. Upon securing funds, the team will seek demonstration partners in key objective areas (policy making, national/subnational modelling, inventory/stockpile management, anti-counterfeitting) to run in-field applications of TRAPS with real data against real challenges. Through this approach, TRAPS will earn trust with key customers and partners and drive uptake.   

TRAPS is at a Proof of Concept level and is not yet in use generating impact. The impact metrics at this stage have been to confirm through perfomance validation, that the system is effective in identifying misuse, capable of being robust to invalid data or manipulation, and that it reconciles where it should at an inventory level.  

For the pilot phase, the team will co-design impact metrics with user groups across each segment of the block chain. The impact metrics will cover both the ability to identify issues, as well as the ability to act upon them (and the impact of those actions). 

The primary barrier in the next year is financial.  The product validation in multiple customer settings (across the areas of the blockchain and at a macro-orchestration level) is essential for market and assumption testing and ultimately adoption.  This requires funding to progress software development to an MVP.  The team has strong support internally and with commitment to co-fund further development once external funding is secured.    

Another barrier is the gap in knowing the challenge and being ready to move on solving it.  Positive engagements with several international organisations are underway, however there is a mismatch in timing for implementation. While organisations are considering how they will respond to the challenges of AMR, there is a 12-24mth delay in funding to procure solutions or look to implement change. We are seeking to self-fund early projects to bridge this gap and demonstrate capability.  

There are also gaps in ambition and policy whereby the required performance of participants in the antimicrobial supply chain are not governed or reporting mandated.We are working in an Australian context to motivate change such that the technologies can be effective in driving the change they are capable of. 

The TRAPS team has an aspiration to achieve maximum impact through its technology.  While commercial success can be achieved with individual companies who seek to gain competitive advantage through use of technologies like TRAPS, or by regulators in high income countries, the core motivation for the team is to be achieve system-level change, in the areas of greatest need.  

The solution is highly applicable to LMIC contexts and the Trinity Challenge provides an opportunity for secure funding and network to enable application of TRAPS via a Pilot(s) in a direct community setting.  The product roadmap is well understood 'top down' however the critical value assumption of consumer participation is to be further developed.  This challenge focusing on the power of citizen data and implementation across supply chain stakeholders would be invaluable to the project.  It would accelerate our in-field validation and product development and would enable collaborations with policy makers that we have yet to be able to achieve. 

Of great motivation is the ability to leverage this support to achieve greater impact in regions outside Australia.

The network of collaborators and mentors available through the Trinity Challenge would provide immense value to the TRAPS team.  Specifically access to the International Pharmaceutical Management Association in Geneva, an opportunity to collaborate with the African Pharmaceutical Distributors Association, and the African CDC to explore potential for pooled procurement for Vaccines initiative and how this could relate to antimicrobials.

Understanding the status and contacts for supply chain monitoring and policy change as part of the WHO People Centred Program would also be invaluable