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MEDICINE VERIFICATION AND TRACEABILITY



SAFER MEDICINES FOR THE WORLD

We are the global leaders in the design and provision of software to support medicine verification and traceability. Every day, our systems check the authenticity of millions of packs of medicine before they are supplied to members of the public, detecting falsified and substandard products, combatting medicine diversion and preventing harm to patients.


TRVST - THE GLOBAL SOLUTION

Governments around the world work tirelessly to protect their citizens from the scourge of falsified medicinal products. This illicit industry is worth tens of billions of dollars annually and, according to the WHO, affects one in ten medicinal products in developing countries.

Emerging from the international response to the Covid-19 pandemic, TRVST is the world’s first global medicines verification system. Falsified drugs contribute to treatment failure, adverse drug reactions and increased drug resistance, especially in the case of vaccine, antiretroviral, antimalarial and antibiotic medications in low- and middle-income countries. TRVST combines verification with traceability to increase visibility across the pre-country pharmaceutical supply chain and promote authentication at the national level. It supports the needs of governments, medicine regulatory authorities, law enforcement agencies and healthcare providers. It promotes the adoption of regulatory standards and best practices and builds public confidence in medicine safety and healthcare programs.

TRVST is the brainchild of the Verification and Traceability Initiative (VTI) set up by stakeholders including UNICEF, Gavi, the Bill & Melinda Gates Foundation, the Global Fund, USAID and the World Bank. Working in partnership with national medicine regulatory authorities in Nigeria and Rwanda, the VTI commissioned Solidsoft Reply to apply their expertise and experience to deliver a system that is simple to use, broad in scope and effective in detecting falsification and diversion, wherever it occurs.

EMVS – PROTECTING A CONTINENT

The European Union promotes the highest standards of medicine safety for its 450 million citizens. Every year, its population consumes 10 billion packs of prescribed medicines supplied by 1,800 pharmaceutical manufacturers across 27 countries. Every pack is individually scanned and inspected at the point of dispense by an authorised pharmacist or dispensing doctor to ensure it authenticity before it is supplied to a member of the public. These checks are carried out at 130,000 dispensing locations across the EU, with additional verification performed by wholesalers within the supply chain. Every scan is checked against trusted data in the European Medicines Verification System (EMVS).

How do you successfully build, deploy and manage a system on this scale in such a challenging and diverse landscape? The secret is strong industry support for a stakeholder model endorsed by national and EU authorities, excellent collaborative leadership across all participating countries and the selection of IT partners with the skills and capacity to deliver systems on this scale.

The stakeholders selected Solidsoft Reply to build the EMVS Hub and a ‘blueprint’ national system. The Hub allows every manufacturer of prescription medicines to securely upload billions of serial numbers which are then distributed to national systems. Our national systems are used by fourteen countries across Europe to support verification and pack decommissioning within their territory, protecting their citizens from falsification, promoting confidence in medicines and ensuring that the European supply chain remains trustworthy and clean.


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  • WHAT IS MEDICINES VERIFICATION?

    Pharmaceutical manufacturers around the world increasingly serialise their medicinal products. They provide unique identifiers for each pack of medicine that they place in the market. These identifiers are printed as two-dimensional barcodes, often following GS1 healthcare standards.


    By uploading their serial numbers to a trusted repository, manufacturers enable pack verification at any location throughout the supply chain or beyond, including the point of dispense, in healthcare institutions or even in the patient’s own home.


    By scanning the barcode, clinicians and patients increase their confidence in the authenticity of each pack of medicine. If a unique identifier fails the test, alerts help manufacturers identify potential falsification or diversion and provide visibility to regulatory authorities. If the pack has expired, or if the batch has been recalled, this is immediately reported to the user, ensuring that substandard products are never used.


    The unique identifier creates a ‘digital twin’ for each commissioned pack, allowing it to be tracked across the supply chain until it is supplied or decommissioned. This allows the provenance of each pack to be determined and helps to detect unusual movements or events that may signify falsification or diversion. By integrating with other systems, the verification system can support other needs such as closed-loop medicine management in healthcare institutions, national pharmacovigilance and detection of reimbursement fraud.

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GS1 STANDARDS

We are committed to interoperability across the pharmaceutical and healthcare sectors. We are proud partners of GS1 and support their standards in all we do.

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GS1 shares our passion for patient safety in healthcare and provides the barcode specifications that power modern medicine verification approaches, together with the track and trace standards that enable supply chain visibility and automation around the world.

The innovation never stops. In recent years, GS1 has introduced Digital Link technology to extend their identifiers across the web, enable new scenarios and streamline transactions across the supply chain. Solidsoft Reply provides Digital Link resolution services alongside our other verification and traceability systems to support electronic patient information and other uses.

VERIFICATION APPLICATIONS

We run the big systems behind medicine verification, but what about the people who actually scan the barcodes? Pharmacists, clinicians, wholesalers and members of the public need applications that are easy to use, provide reliable results and give clear information about the authenticity of the pack.

We provide a range of verification applications to meet the needs of end users. Our browser-based VeriLite application is a cloud-based solution that allows users to connect easily to the verification system using off-the-shelf barcode scanners. We also provide mobile device applications that can be customised to the needs of users or branded as enterprise-level or national verification applications

For more information on VeriLite, see our dedicated VeriLite web site at verilite.eu.

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    WHAT ABOUT TRACEABILITY?

    We think about medicine verification at two levels. The first is simple authentication of each medicinal pack based on a unique identifier. Pharmacists and clinicians scan a barcode to check We think about medicine verification at two levels. The first is simple authentication of each medicinal pack based on a unique identifier. Pharmacists and clinicians scan a barcode to check that the pack is genuine before supplying it to a member of the public. This is great model. It provides significant assurance to clinicians and patients with minimal investment.


    The second level goes much deeper. Falsification and diversion occur anywhere within the pharmaceutical supply chain, and may bypass the legitimate supply chain altogether. Traceability adds an additional dimension that provides much richer insight into the provenance and pedigree of each pack. It does this by recording the journey of the pack from manufacture to the point of supply, building a history of the lifetime of commissioned products to provide greater assurance and better intelligence when falsification or diversion are detected.


    We support traceability of medicinal products through the application of modern industry standards including GS1 EPCIS and related specifications. Traceability provides a deeper level of visibility and insight, and aligns our systems with evolving regulatory requirements around the world.

Electronic Product Information

When it comes to safe use of medicines, verifying the authenticity of medicinal packs is just one part of the puzzle. Another part is the provision of accurate and up-to-date product and patient information in the user’s language.

We make it easy for clinicians and members of the public to obtain this information electronically. By scanning the same barcode used to verify the authenticity of the pack, users download the correct product or patient information in the language of their choice and view it directly on their device.

We use GS1 Digital Links to enable this. Digital Links connect each physical pack of medicine to the wider web, making it easy to get the right information and services to the clinician or patient at the press of a button, helping them to use medicines effectively and safely.

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    SOLIDSOFT REPLY

    Working in medicine verification since 2012, we build and operate large, scalable and reliable systems to meet the pharmaceutical industry’s regulatory requirements and extend the highest standards of medicine safety across the world. We also design and implement applications to keep members of the public safe and provide clinicians with the services they need to manage medicines effectively.


    We are part of the Reply group – a global network of IT companies that bring together their distinctive areas of expertise to meet the demands of industry for digital transformation and innovation. We are a global award-winning Microsoft certified partner, using the power of the Microsoft Azure platform to build systems at global and national levels.


    www.solidsoftreply.eu

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