< PreviousSECURITY 20 Pharma Business International www.pbiforum.net © Shutterstock /SPF Securing the 20-23.qxp_Layout 1 08/04/2021 12:17 Page 1Pharma Business International 21 www.pbiforum.net SECURITY In the wake of the coronavirus pandemic, well-publicised scandals surrounding fake COVID-19 tests, counterfeit vaccines, difficulty verifying products, and theft have heightened concerns over the pharmaceutical industry’s supply chain. At the same time, its increasing complexity - with a globalised market, more exchange points, more stringent regulation, et al. - continues to challenge the pharmaceutical supply chain to become more secure, and all actors within it to be vigilant to risks. The past year has seen criminals home in on high-value COVID-19-related products. In the UK, arrests were made after thieves targeted a truck of lateral flow testing kits worth more than £100,000, while vaccines have been found on the dark net, and a number of counterfeiting organisations have recently been broken up. For example, Chinese police seized over 3,000 saline- filled vials that were being sold as authentic vaccines. Despite these instances of counterfeiting being uncovered, it is not clear how many false vaccines had already been manufactured and shipped. Each step in the supply chain presents a chance for tampering, therefore full insight into the journey of products - end to end visibility - is critical. With lives at stake, slow, inefficient methods must be dropped in favour of tools that allow teams to actively monitor goods, easily report incidents, and analyse data across locations for proactive and swift reactive moves to be made. Companies must also be able to demonstrate supply chains are being managed properly. Track and trace systems have been highlighted as an essential component in bolstering security and authentication in the pharmaceutical supply chain. They have been taken up widely in the US and Europe while continuing to grow in use in other markets. There are a variety of solutions enhancing tracking through supply chains, from more complex temperature monitoring systems and tracking software integrated in supply chain The security of pharmaceutical supply chains has been thrust into the spotlight during the COVID-19 pandemic, while regulation is clamping down on counterfeit drugs and promoting better traceability. 22 Á 20-23.qxp_Layout 1 08/04/2021 12:17 Page 2SECURITY 22 Pharma Business International www.pbiforum.net © Shutterstock /Shidlovski transport management systems to boost visibility and avoid loss and tampering, to chain of custody solutions, unified command and control centres, cloud, Internet of Things (IoT) technology, and smart systems facilitating real-time shipment tracking and programmed with AI to take action when a step in the supply chain does not meet standard operating procedures and send alerts that a shipment has been tampered with or stolen. The evolution of traceability regulations is pushing adoption of drug traceability systems across the globe, such as the US Drug Supply Chain Security Act (DSCSA), which was passed in 2013 and comes fully into effect in 2023. In brief, the aim of the DSCSA is to push the pharmaceutical industry to track products to prevent counterfeits entering the market and provide visibility for recalls and other issues. It requires pharma supply chains to create an electric, interoperable system for this and lot-level traceability. Following this, a piece of legislation was passed by the EU in 2019 (the EU Falsified Medicines Directive, or FMD) and all prescription medicines in the EU must now come with a security feature enabling drug dispensers to verify their authenticity, while further regulation has been passed around the world, from Russia to India. Effective serialisation, and its associated hardware and software, is a key focus in these regulations, to combat and uncover counterfeiting and improve product safety and visibility, identifying 20-23.qxp_Layout 1 08/04/2021 12:17 Page 3Pharma Business International 23 www.pbiforum.net SECURITY products down to the item level. Companies need to serialise individual medicines (assign and affix unique numbers to products) so they can be tracked and authenticated. Serialisation comes with its challenges, of course, including hardware set up and updates to manufacture labels, barcodes, and seals, the potential for a slowed down production line as you get used to the process, especially in packaging, the costs of hardware and software involved, and ensuring all partners in the supply chain participate in tracking. With fake drugs accounting for approximately ten per cent of medical products in developing countries, according to WHO, and a report by PricewaterhouseCoopers valuing the counterfeit drug market at $163 billion to $217 billion per year, there is a clear challenge that needs addressing with this. Serialisation regulations are requiring manufacturers, distributors and 3PLs to acquire proper licences and accreditations in countries mandating serialisation. They are also requiring changes in packaging, marking, and labelling, with packaging being redesigned to include new barcodes, serial numbers, as well as anti-tampering features, and other regulated data elements. At every exchange point, companies will need to track, trace and document shipments using identification numbers linked to items, usually applied as barcodes, but also in RFID tags, which devices can read to then report item status to a back-end system. Meanwhile, blockchain is being touted as the future for ensuring the security of pharmaceutical products, to which serialised packages can feed information. The tech - a shared, permanent ledger - is growing as various approaches to traceability are being taken around the world, raising interoperability concerns. With the shared platform, collaboration is enabled to raise drug safety without sharing sensitive information and blockchain enables permanent and unalterable documentation of a product’s chain of custody and legitimacy. Support for blockchain can be seen in the US Food and Drug Administration’s (FDA) commitment to the technology in a pilot programme with IBM, involving pharmaceutical firm Merck amongst other companies, supporting the US DSCSA which addressed requirements to identify, track and trace prescription medicines and vaccines distributed within the US. The programme, deemed successful, aimed to demonstrate blockchain’s ability to connect systems and organisations to record a common view of product traceability. It additionally illustrated how it could improve patient safety by minimising the time it takes to alert the supply chain of a product recall from days to seconds. In the programme an IBM blockchain system and Merck’s serialisation system were connected. Pilot participants were able to incorporate blockchain to determine product quality and origins of the product, and results show a product’s status can be verified in seconds. With supply chain security currently under more intense threat and public scrutiny, sophisticated supply chain management and enhanced product traceability are vitally important. 20-23.qxp_Layout 1 08/04/2021 12:17 Page 424 Pharma Business International www.pbiforum.net © Shutterstock /Dmitry Kalinovsky 24-27.qxp_Layout 1 08/04/2021 12:18 Page 1PACKAGING Pharma Business International 25 www.pbiforum.net Packaging has a key role to play in battling counterfeit medicines, with manufacturers increasingly relying on track and trace systems. Packaging plays a profound role in impeding counterfeit pharmaceutical products, the presence of which can spell economic damage to manufacturers and pose health risks for patients and consumers. Track and trace technology has emerged as one of the biggest advances in the battle against counterfeit products and as a means of strengthening the supply chain. A track and trace system works by printing a unique identification code onto each product after it has been packaged, which allows the individual product to be tracked from production to end consumer. This process shares more than a passing resemblance to blockchain, however blockchain is still very much in its infancy and is far from commonplace. Track and trace, on the other hand, is already offering manufacturers a robust and reliable means of following their products through the supply chain and ensuring their validity at all times. 26 Á The future of pharma packaging 24-27.qxp_Layout 1 08/04/2021 12:18 Page 2PACKAGING 26 Pharma Business International www.pbiforum.net Together, the two technologies could well create one of the securest supply chains, which the pharmaceutical industry is in need of. Currently, counterfeits are rife, putting drug makers out of pocket and patients at risk. One of the biggest advantages of track and trace technology is that it can be easily integrated into a product supply chain, offering a means for companies of all sizes to sure up their supply chain. For this reason, it’s entirely understandable why a system of this kind is gaining an increasingly large presence in the marketplace, with growth only tipped to grow in the future. In fact, it will be worth $3.93 billion by 2023. The biggest driver behind this growth, other than the obvious outlined above, is that there is an increasing awareness for secure and reliable products from consumers and patients. A similar state of affairs is being seen in the food industry, where consumers are better informed than they have ever been. Thanks in part to the internet – especially social media – consumers are actively engaging with the supply chain and taking a deeper, keener interest in the products and services they use and by. Elsewhere, technological evolution and the more widespread deployment of packaging equipment and machinery is enabling smaller companies to integrate 24-27.qxp_Layout 1 08/04/2021 12:18 Page 3Pharma Business International 27 www.pbiforum.net PACKAGING © Shutterstock /Bukhta Yurii track and trace systems into their supply chain. Then, of course, there are government regulations to consider. Unsurprisingly, governments the world over are keen to end the scourge of counterfeit goods, especially when it comes to food and medicines. Legislation and new regulations will increasingly prioritise track and trace systems, if not make them a legal requirement going forward. There are some hindrances to future growth, however, with hesitation among manufacturers regarding the security features of track and trace packaging chief among them. There’s also a reticence over the high cost involved in implementing a new system, with many companies struggling to justify the expenditure for an issue that may not have affected them directly. Counterfeit drugs and other medical products continue to plague the pharmaceutical sector and put patients at risk. The financial damage can also be significant, and so a reliable solution needs to be implementing in order to eradicate this illegal trade. Track and trace has frequently proven its ability to strengthen the supply chain, prove effective for manufacturers and keep patients safe from unregulated and potentially harmful products. It proves that packaging will remain critical going forward, as track and trace systems become more commonplace. 24-27.qxp_Layout 1 08/04/2021 12:18 Page 4MANUFACTURING 28 Pharma Business International www.pbiforum.net © Shutterstock /ADragan 28-31.qxp_Layout 1 08/04/2021 12:18 Page 1Pharma Business International 29 www.pbiforum.net MANUFACTURING Despite regulators only approving the United States’ first 3D printed prescription drug product in 2016, the proliferation of advanced and additive manufacturing techniques have since come on in leaps and bounds. As with personalised medicine and artificial intelligence, additive manufacturing (or 3D printing) offers a new production avenue for drug makers and a new means of innovating for the healthcare sector. For example, the aforementioned prescription drug – Aprecia Pharmaceuticals’ epilepsy treatment Spritam – was purposefully formulated to disintegrate in the mouth with just a sip of water, making it an ideal option for patients that struggle to take medicine. The precision of 3D printing offers manufacturers absolute control over a product, from texture and ingredient behaviour, to specific size and shapes. As drug makers realise the production possibilities of this technology, combining multiple treatments and doses into a single pill is becoming a more tangible reality. The process of 3D printing – in which a product is built up layer by layer – means producers can have complete control over structure, ingredients and components. The impact this could have on the healthcare sector and the pharmaceutical industry at large is nothing short of disruptive, something regulators have taken notice of. In order to eliminate drug fraud, make medicines more efficient and meet increasing demand, drug production needs to be brought into the modern epoch of manufacturing. This means the widespread adoption of continuous manufacturing, 3D printing and other means of automation. Now the US Food and Drug Administration (FDA) is spearheading a push Printing pills Pharma Business International explores the proliferation of 3D printing in drug manufacturing, what’s driving the growth and what challenges still remain to overcome. 30 Á 28-31.qxp_Layout 1 08/04/2021 12:18 Page 2Next >