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Media Contact:
Devendra Mishra
Executive Director
Phone: 818-224-1552
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The Security Challenges of Global Distribution of COVID-19 VACCINES
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Insights from Grant Courtney, Principal Consultant of Be4ward
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March 16, 2021, Calabasas, CA, USA — The Bio Supply Management Alliance (BSMA) has had a missionary initiative to advance the integrity and safety of the supply chain of Life Sciences. In view of the demand for COVID-19 vaccines exceeding the supply and the regional disparity between production and patient vaccination needs, the supply chain is being severely taxed. Devendra Mishra, the Executive Director of BSMA, had the unique opportunity to interview Grant Courtney, the Principal Consultant at Be4ward, to understand how significant risks could be mitigated.
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Grant Courtney is a recognized expert on digital brand protection and product packaging. During his prior 24-year career at GlaxoSmithKline in manufacturing, supply chain and commercial positions, Grant pioneered product coding, serialization, traceability and pack management. Grant has advised EFPIA in defining the industry’s advocacy and strategic approach to anti-counterfeiting and product traceability in Europe. He was an elected member of the GS1 global healthcare leadership team where he drove adoption of standards to increase patient safety and lower healthcare costs globally. Grant has been recognized through several industry awards, including the Institute for Safe Medication Practices Award, for preventing the spread of counterfeits in Nigeria, and the Best Pharmacy Initiative - Falsified Medicines Directive anti-counterfeiting model. He has a degree in Business Studies, a Lean Sigma Green Belt and is accredited by the Chartered Institute of Marketing. Grant is based in the UK.
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HIGHLIGHTS OF THE INTERVIEW
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MISHRA: How do you assess the onerous challenges in the global distribution of COVID-19 vaccines?
GRANT: We have the conditions for the perfect storm, high value vaccines with high demand and low supply. This is a recipe for falsified products which will be distributed through both physical and online channels. Unfortunately, we have already seen criminals profiting from the pandemic. Initially this was PPE items and some therapeutics, but there are now reports of criminal gangs gearing up to supply fake vaccines. In February 2021 authorities in China arrested over 80 people and 3,000 doses of fake COVID-19 vaccines were confiscated.
Very few countries in the world have currently implemented traceability systems across their end-to-end supply chain. Turkey was the first and perhaps the most comprehensive system currently in operation designed to prevent falsified products, reimbursement fraud, product diversion, and promotes the safe use of drugs. To achieve this, GS1 Standards have been implemented to allow the identification of items such as a pack, case or pallet and locations. Traceability events are then captured as the medicines move through the supply chain from manufacturing to the patient. The central traceability system was financed by the Turkish Medicines and Medical Devices Agency (TİTCK), affiliated with the Turkish Ministry of Health. After four years, the project was completed in 2012 with 42,000 stakeholders connected, including 408 manufacturers, 592 wholesalers and over 25,000 pharmacies.
Another significant example of implementation of serialization is the European Medicines Verification System (EMVS) which was set up in response to the EU Falsified Medicines Directive. The primary purpose of the EMVS is to verify every pack prior to dispense.
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MISHRA: Is the initiative for ensuring integrity of the distribution of COVID-19 vaccination a precursor for all drugs?
GRANT: Many of the challenges for the distribution of a COVID-19 vaccine are going to be the same as any other product, such as the need for common identification of an item, standard barcodes, accurate product master data and supply chain partners who share data and transact through common processes. Common standards, processes and interoperable systems drive benefits when establishing a traceability system. Utilizing common barcodes at all levels of the packaging from the vial up to the pallet would allow items to be scanned and the data captured for Logistic and Clinical purposes. Product Master is made available to all stakeholders so that systems can be populated. Transitions based on global protocols and standards ensures there is more interoperability of processes and systems. These are all factors that enable any supply chain to operate with Global Standards very much the DNA of any highly efficient and effective supply chain.
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MISHRA: How can serialization of product help achieve greater integrity in the supply chain?
GRANT: Although serialization and traceability are not the primary factors in operating efficient supply chains, they deliver benefits. Knowing where inventory is at each stage of the supply chain makes for a safe and efficient supply chain. The benefits go further than just manufacture and distribution, all the way to administration of the drug and pharmacovigilance.
By giving each product a unique identifier, we know it is a legitimate vaccine, we know the vaccine type and how many doses are contained in a vial. We also know the location of each vial at all times. This full visibility aids redistribution, recall and the integrity of supply chain before we even consider the big benefits of preventing product falsification and diversion. As we collect more data on these vaccines, shelf life can be extended. Traceability and digital data stored at vial level allows us to update information held without having to recall or waste product. Similarly, there are benefits relating to electronic patient information. Much of this product is going out in common packaging across all countries, in a single language on the packaging. Barcodes can be used to scan and access leaflets in different languages. Due to the acceleration of manufacture with these vaccines, extra vigilance is required relating to, for example, side effects. Robust, reliable product data is essential here with product code and batch code linked to patient records for pharmacovigilance purposes.
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MISHRA: With the desire to foster international travel, what is a Healthcare Passport for travelers?
GRANT: A Healthcare Passport for the vaccinated would extend beyond just travel, it could mean individuals being able to work, attend a conference, or visit a care home. Methods of proving vaccination in a failsafe way is a huge challenge. These ‘passports’ are going to be really important to get some industries safely back up and running, such as travel, leisure and entertainment.
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MISHRA: How can IoT enhance the potential business value of Traceability?
GRANT: Web enabling packs, where every pack can be treated as a unique thing with a unique identifier, can bring about huge benefits. This means you can leverage track and trace, but also can provide additional information about each specific thing by scanning. For example, a leaflet in a different language, or the new expiry date, can be revealed.
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MISHRA: How would you quantify the economic value of an investment in VISIBILITY?
GRANT: The two main benefits of patient safety and supply chain efficiencies are hard to quantify. Patient safety, the safe product correctly administered, means less stress on the healthcare systems. Unsafe product could result in legal action, people being removed from the workplace, damaged healthcare systems, reduced staffing and additional treatments, all at huge cost to society. Improving the efficiencies of your supply chain presents great economic value too. With COVID-19, the global economic cost has been extreme. A stronger, more visible supply chain for the vaccines will help us reopen societies and begin our recovery.
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FINAL NOTE: The COVOID-19 pandemic has compelled further deployment of Track and Trace in the supply chain to reduce the current vulnerabilities in healthcare.
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For a decade, Be4Ward has been an international consulting company dedicated to improving and enhancing healthcare product lifecycles, from packaging through to patient. The focus of the enterprise is statutory, regulatory and standards bodies for shaping public policy in pharmaceutical, biotech, medical device and consumer healthcare companies. Specialty areas consist of Secondary Packaging and Distribution Supply Chain Design; Pharmaceutical Product Launch and Portfolio Management; Product Complexity Management, Late Customisation and Postponement; Finished Goods Supply Chain Process Development; and Product Traceability, Serialization and Anti-Counterfeiting; and, Packaging Design, Labelling and Artwork Management.
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BSMA - Driving Innovation in the Life Sciences Supply Chain
Since its inception in 2007, BSMA is a global organization that fosters Innovation and Adoption of disruptive technologies within the end-to-end supply chain of the Life Sciences industry. With offices in California (USA), Brussels (Belgium) and Mumbai (India), BSMA promotes collaboration and networking between professionals of the biotech, pharmaceutical, academic and medical diagnostics enterprises. The Alliance partners with industry, academia, foundations, suppliers, technology enablers, research institutions, trade organizations and the government to improve productivity, quality, product and service integrity, risk mitigation, managerial talent development and patient care globally. It is also the home of start-up companies engaged in business development and scale up.
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