Tracing The Tracks of the Drug and Medical Device Trail
As the threat of counterfeiting continues to torment industry stakeholders and patients, more strategic approaches to serialization and traceability are forming.
With more mail order pharmacies, the need for a trusted supply chain and distribution network is more key than ever.
Getty images, Andrzej Rostek
Key Takeaways:
· Counterfeit medications are estimated to make up 10.5% of today’s global medicine supply.
· One continuously developing tactic to prevent and detect counterfeits and other types of fraud is the ability to track and trace products through serialization.
· By linking the drug code, filling batch, timestamps, and other relevant data with a CUID, full container traceability is achieved.
The world’s most commonly counterfeited products have become an eclectic who’s who, spanning everything from trendy novelties to life’s truest necessities. Moving higher up this unflattering list today are pharmaceuticals and medical devices. As more patients become more likely to be tricked into making transactions that can be just as unsafe as they are illegal, more members of the global healthcare community are taking notice.
Counterfeit medications are estimated to make up 10.5% of today’s global medicine supply while approximately 8% of all medical devices currently in use are said to be fraudulent, according to the World Health Organization (WHO). Additionally, at least one in 10 medicines in low- and middle-income countries is said to be substandard or falsified, WHO officials have found. Countries spend an estimated $30.5 billion per year on substandard and falsified medical products, which are often sold online or through informal markets.
As the cost of drugs and devices presumably continue to increase, there doesn’t seem to be any imminent incentive for those who commit fraud to retreat or those who are susceptible to fraud to avoid traps. Despite the presence of robust regulations and education awareness to help prevent fraud, legal assistance to help guide patients who have experienced fraud, and rapid response measures to help mitigate the overall impact of fraud, there’s more work needed to protect patients from these dangers. “It feels like a footrace between staying one step ahead and one step behind,” says Kevin Webb, chief operating officer at API Innovation Center, a 501(c)(3) nonprofit that seeks to, among other initiatives, convene networks of strategic partners throughout industry to bring back the development and the manufacturing of drugs to the United States.
One continuously developing tactic to prevent and detect counterfeits and other types of fraud is the ability to track and trace products through serialization. Various innovative and more sophisticated approaches are becoming more prevalent throughout industry, including among stakeholders who are forming partnerships and other collaborative efforts.
“To the untrained individual, there’s no awareness that a drug is now counterfeit or is no longer safe to potential contamination,” said Webb. “Traceability takes the willingness of supply chain partners to embrace it and be part of it.”
Curbing Counterfeiting Collaboratively
As the president of BD Medical – Pharmaceutical Systems, one of the largest global medical technology companies that develops innovative technologies, services, and solutions to help advance clinical therapies and processes for patients and providers, Patrick Jeukenne, says the conversation about counterfeiting is unending.
“We’re hearing about it every day all over the world, especially with high-end expensive drugs, including oral drugs and injectables,” he said. “Today, we still have a lot of people going to the pharmacy, but as we have more people being diagnosed with chronic diseases, people are also more often having their drugs delivered by mail by specialized distributors. If you don’t have contact anymore with a trusted pharmacist, you need to be able to trust your distributor and the postal system.”
To help strengthen that sense of trust by facilitating advanced protocols for traceability, Jeukenne and BD have formed a partnership with ten23 health,® an organization that develops safe injectable treatment options for patients, for a new radio frequency identification (RFID)-based traceability solution that’s being piloted and is expected to improve the fill-and-finish process and distribution of prefillable syringes.
This solution will benefit ten23 health and its customers by ensuring a higher traceability throughout both the manufacturing process and the supply chain.BDThe BD iDFill™ Individual Prefillable Syringe Identification method equips each syringe with an RFID tag that’s encoded with a serial number known as a “container unique identifier” (CUID). Each CUID can be scanned at various stages of the manufacturing process, from filling to secondary packaging or any further assembly. This enables precise tracking without line-of-sight limitations and allows belt scanning at strategic points throughout manufacturing, said Jeukenne.
Customers can decide when and where they want to track their prefilled syringes and the units. By linking the drug code, filling batch, timestamps, and other relevant data with a CUID, full container traceability is achieved, and multiple applications are enabled, including automated reconciliation, mix-up prevention, and investigation management. The system also helps to quickly identify and trace individual units during production and beyond, Jeukenne said.
“It’s a novel approach that’s going to provide precise segregation at the unit level and significantly speed up investigation and root-cause analysis,” he said. “It allows full traceability from our production to ten23 operations, and it links each container to critical processes through drug data, enhances transparency, and facilitates immediate, accurate investigations when we’re having quality issues.”
Described as an alternative to manually documenting and reconciling product in batches, the RFID technology has been proven to reduce documentation by 85% during an initial pilot run by ten23 health. “With a scan of the individual unit, it’s basically a single-unit traceability,” said Hans-Christian Mahler, chief executive officer of ten23 health. It’s really about the consistent use across the manufacturing processes and providing that additional leverage for customers/users from a security and compliance perspective.”
Dressed Up and In Line
As one who has close to 20 years of industry experience, Caylin Cuillier, senior vice president of quality and operations at Western Botanicals, doesn’t see any means of totally escaping the risks associated with intentional adulteration of drugs and devices today. “We talk a lot about secondary sellers and markets, people who will intentionally purchase bottles and mark them up to portray that they’re actually selling products that they are not selling,” said Cuillier, who manages a staff of 150 employees at the contract manufacturer, which specializes in producing capsules, powders, and liquids for premium dietary supplements, vitamins, minerals, and other nutritional products. “There are too many nefarious people and groups out there looking for an edge to economically adulterate materials to try to make their money, as opposed to manufacturing the correct way.”
Among the types of equipment utilized at his plant that have helped to improve traceability measures is the PharmafillTM (Deitz Company Inc.), a bottomless conveyor designed to sit above laser marking devices, inkjet printers, and other coding systems within a packaging line to print lot codes without disrupting flow. Bottles and containers are placed onto an infeed conveyor, the bottom of which drops away as dual-side belts gently grip the bottles/containers and exposes their bottom portions to a printer. Once printed, the bottles continue downstream for packaging. In conjunction with the recent installation of two new filling and packaging linesto accommodate the company's rapid growth, the conveyor continues to allow for versatile, high volumes of serialization that have allowed the company to keep up with the evolving mandates and requirements (see sidebar) that govern the space, Cuillier said.
“Regardless of what type of material is being packaged, we use the conveyors alongside inkjet printers to print lot codes, expiration dates, and most recently quick response (QR) codes, as well as other information that allows us to have traceability back to the single-bottle level,” he said. “This also allows us to give consumers information about their lot number and expiration date without having it placed on the label itself, where it could rub off or become compromised in some other way.”
The conveyor also establishes a more permanent solution from a safety and regulatory standpoint. “We rely on these conveyers and printers for every unit that we produce,” said Cuillier. “It provides a much stronger solution that the industry definitely needed as we continue to grow.”
The two newly implemented identical filling and packaging lines at Western Botanicals have been integrated with both the fully automated and semi-automated Pharmafill machinery to meet requirements for speed, reliability, and versatility. The lines begin by feeding empty bottles from a turntable or bottle unscrambler onto the conveyor. The Pharmafill PackserterTM inserts a desiccant and the Pharmafill CS1 cottoner inserts cotton before a second rotary turntable accumulates bottles if needed. After capping and labeling, the bottomless conveyor suspends the bottles over the printer and bottles are discharged downstream after their information has been printed. The Pharmafill NB1 neck bander applies tamper-evident shrink bands and the Pharmafill HT6B heat tunnel seals the bands. At the end of the line, a third rotary turntable accumulates bottles for cartoning.
“This all fits in seamlessly so that we can increase our throughput to meet customer demand without needing manual labor for placing stickers on bottles or something else that is removable,” Cuillier explained. “Having the traceability as a consumer, understanding where products are manufactured from, and being able to identify each lot number can help us to shut down these secondary sellers from online distribution sites. We know that when something leaves our facility there’s tamper-evident sealing, lot coding expiration dating, and QR coding on the bottom of bottles to help ensure consumer safety as well as indicating that the product should not be used if there’s concerns about tampering.”
Next-Generation Product Protections
At Isometric Micro Molding, a NISSHA Medical Technologies Company that’s one of the largest medical-focused micro molders in the United States, the products that are most likely to be serialized are next-generation models, that are more expensive and primarily implantables, according to Brent Hahn, senior vice president.“We’re seeing serialization being requested more for next-generation products compared to existing products because customers want to make sure their investments are protected,” he said. “There’s an increase in the conversations for it with innovative new products that are coming to release.”
An organization that works with clients ranging from startups to the largest of medical device and drug-delivery companies, Isometric Micro Molding offers a variety of sterilization options, the most prevalent of which that involve permanent marks on molded components are pad printing and laser etching, says Hahn. “We talk about cost-effective approaches and locations to support the customer’s needs,” he said. “With design for manufacturing, we’re looking at every single input so that we can create a sustainable and scalable solution to support our customers’ initial needs, which are typically lower volume initially. And we are able to scale to hundreds of millions of parts if need be.”
Regardless of the product size and type or the methods utilized, Kevin Webb, chief operating officer at API Innovation Center said that his organization values the benefits that traceability provides to the industry and patients as well as the potential for its future. “In a world where there’s drug shortages, inevitably you’re going to have a situation where you’re going to have counterfeit drugs and you’re going to have contaminated drugs that fall outside the control of the supply chain,” he said. “The bad actors are professionals. These are million-dollar industries of fraud and abuse. We as a healthcare community cannot dismiss them as amateurs. It’s incumbent upon us to stay one step ahead.”
FDA’s Influence on Serialization and Traceability
Steps to achieve an interoperable and electronic method to identify and trace certain prescription drugs at the package level as they move through the supply chain are outlined by the Drug Supply Chain Security Act (DSCSA) as established by Congress to be managed by the U.S. Food and Drug Administration (FDA). The mandates are intended to help prevent harmful drugs from entering the U.S. drug supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response to remove harmful drugs from the supply chain to protect patients.
“Since the start of my career, we have seen the evolution of federal and state requirements for traceability for several different reasons – to protect consumer safety during recalls all the way down to ensuring that the materials you’re using through the supply chain are globally sourced, safe for use, and is exactly what it’s supposed to be,” said Caylin Cuillier, senior vice president of quality and operations at Western Botanicals. “Traceability is a very strict requirement and at our facility we utilize it often to ensure that we’re meeting the various regulations and producing good, quality products that are safe for consumers.”
An overview of various other mandates from regulatory agencies around the world is available and illustrates the challenges that come along with trying to strengthen supply chain security.
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