EU Automation: digital technologies in the supply chain
Errors in the pharmaceutical supply chain can lead to late delivery, increased costs and poor-quality products, which can have a detrimental impact on consumers. Here, Jonathan Wilkins, director at EU Automation, explains how organizations can use digital technologies to improve the pharmaceutical supply chain and minimize the risk of errors.
In 2009, consumers of the pain reliever Tylenol reported a musty odor, requiring Johnson & Johnson to make numerous large recalls. The pallets used for shipment had been treated with a fungicide that had decayed into a chemical that was causing the odor, as well as gastrointestinal adverse effects. The recall cost Johnson & Johnson $900 million and the damage to the Tylenol brand will never be fully repaired.
There are four trends making it increasingly challenging for pharmaceutical organizations to prevent supply chain errors like that of the Tylenol scandal. However, organizations can implement digital technologies to improve supply chain operations and ensure consumers receive a high standard of healthcare.
The pharmaceutical industry has been much slower to globalize than other industries, with high-income countries still dominating production and consumption. However, with many clinical trials now operating globally, including in developing countries, and many developing countries increasing their healthcare budgets, pharmaceutical supply chains are gradually globalizing.
Often, a drug’s active pharmaceutical ingredient (API) will be manufactured by one contract manufacturing organization (CMO), incorporated into the final dosage form by a second CMO and packaged by a third. It is becoming increasingly common for these CMOs to be in different countries.
Despite the increasing costs and complications caused by the globalization of pharmaceutical supply chains, customers are expecting faster deliveries than ever before. Therefore, efficient transport, effective tracking and stringent quality control are becoming even more important.
According to a recent report by the Access to Medicine Foundation, one of the major causes of antibiotic shortages is a lack of visibility in the supply chain. Organizations can increase supply chain visibility using cloud technology to ensure real-time sharing of secure data. The cloud can be accessed by any authorized person, regardless of their location, so geographical boundaries are not a hindrance.
It takes an average of three years from submitting a drug to the Food and Drug Administration (FDA) or European Medicines Agency (EMA), to the drug reaching a patient. This is not fast enough for personalized medicine — patients with serious illnesses often cannot wait three years for a suitable drug. Therefore, the supply chain for personalized medicine must be rapid.
Investments in automation systems will be vital for speeding up the supply chain for personalized medicines, while ensuring the level of precision required for patient safety is achieved consistently. At Hannover Messe in 2017, Siemens demonstrated how automation can be used to design a manufacturing environment that makes personalized medicine more commercially viable. To help automation technology find its way into the personalized medicine industry, Innovate UK has up to £6 million to invest in technology that will help businesses to understand and meet the challenges involved in developing personalized medicines.
However, a fully digitalized factory is a big shift for most manufacturers, requiring rapid change. To make the process more cost-effective, manufacturers can make existing equipment smarter by retrofitting, as well as implementing new equipment.
The stability of biologics is complex because they are made from living organisms or contain components of living organisms. They often degrade by multiple pathways and these pathways may vary at different stages of shelf life. Also, many biologic drugs contain proteins, which can undergo slight structural changes in response to stresses such as temperature excursions. To make sure biologics are safe for consumption, the supply chain must be fast and physical conditions along the supply chain must be tightly and consistently controlled.
Generally, temperature control is greater at earlier stages of the supply chain. Every drug has a label claim, which provides stability information. As drugs begin their journey through the supply chain, the manufacturer ships full trailers of products with the same label claim. However, when the products reach wholesalers, pallets are broken up and products are comingled, meaning label claims become mixed. To make sure supply chains are temperature controlled in their entirety, the industry should pay close attention to improvements at the wholesaler stage.
There are also biochemical technologies that could improve the biologics supply chain. A collaboration between StoneStable, a start-up in Oregon, US, and Portland State University is investigating improved ways to transport vaccines, a type of biologic drug comprised of viruses. The team is experimenting with coating viruses in silica, which renders them inert and resistant to hot and cold temperatures, and then returning them to their original state prior to consumption. This would allow vaccines to be transported at room temperature safely, which would reduce supply chain costs and the number of products discarded due to temperature excursions.
The World Health Organization (WHO) recently estimated that one third of all medicines sold worldwide are counterfeits. As well as damaging the reputation of pharmaceutical companies and causing them a loss of revenue, counterfeit medicines can cause considerable harm to consumers. This has been demonstrated in Sub-Saharan Africa, where counterfeit malaria pills have been responsible for an estimated 116,000 deaths a year.
The prevalence of counterfeit drugs is expected to increase as global costs for healthcare increase and technological advancements make it easier to make exact copies of drugs and their packaging. Fortunately, there are several technologies that can help protect pharmaceutical products against counterfeiting. A common approach is to package drugs with a barrier to entry. Examples include film wrappers, shrinkable seals and bands, breakable caps, tape seals and blister packs. The disadvantage of this approach is that the barriers are easy to mimic.
More advanced technology can provide greater protection against counterfeiting. For example, holograms can combine three layers of security features that show a product is legitimate. Embedded images, digital watermarks and invisible printing are also effective, because they require regulatory approval so are challenging to replicate. Also, chemical and biological tags can offer highly secure authentication, but are more expensive than other options and more challenging to implement.
The FDA recommends pharmaceutical manufacturers use multiple, periodically changing authentication measures on a product specific basis, to provide the best possible protection against counterfeiting.
Since 2009, the capabilities of technology have increased dramatically. This has given companies like Johnson & Johnson the opportunity to improve their supply chains, so that crises like that of the Tylenol brand do not happen again.
Giving efficiency the full throttle at NASCAR
The NASCAR organization has long been synonymous with speed, agility and innovation. And so by extension, partnerships at NASCAR hold a similar reputation. One such partner for the organization has been CDW – a leading multi-brand provider of information technology solutions to businesses, government, education and healthcare customers in the United States, the United Kingdom and Canada. CDW provides a broad array of products and services ranging from hardware and software to integrated IT solutions such as security cloud hybrid infrastructure and digital experience. Customer need is the driving force at CDW, and the company helps clients by delivering integrated services solutions that maximize their technology investment. So how does CDW help their customers achieve their business goals? Troy Okerberg, Field Sales Manager - North Florida at CDW adds “We strive to provide our customers with full stack expertise, helping them design, orchestrate and manage technologies that drive their business outcomes.”
NASCAR acquired International Speedway Corporation (ISC) in 2019, merging its operations into one, new company moving forward. The merger represents an important step forward for NASCAR as the sport creates a unified vision to embrace its long history of exciting, family-oriented racing experiences while developing strategic growth initiatives that will drive the passion of core fans and attract the next generation of race fans. CDW has been instrumental in bringing the two technology environments together to enable collaboration and efficiency as one organization. Starting with a comprehensive analysis of all of NASCAR’s vendors, CDW created a uniform data platform for the data center environment across the NASCAR-ISC organization. The IT partner has also successfully merged the two native infrastructure systems together, while analyzing, consulting and providing an opportunity to merge Microsoft software licenses as well.
2020 turned into a tactical year for both organizations with the onset of the pandemic and CDW has had to react quickly to the changing scenario. Most of the initial change included building efficiencies around logistics, like equipment needing to be delivered into the hands of end users who switched to a virtual working environment almost overnight. CDW’s distribution team worked tirelessly to ensure that all customers could still access the products that they were purchasing and needed for their organizations throughout the COVID timeframe. Okerberg adds that today, CDW continues to optimize their offering by hyper-localizing resources as well as providing need-based support based on the size and complexity of their accounts. Although CDW still operates remotely, the company commits to adapting to the changing needs of their clients, NASCAR in particular. Apart from the challenges that COVID-19 brought to the organization, another task that CDW had been handed was to identify gaps and duplicates in vendor agreements that the two former single-entity organizations had in place and align them based on services offered. CDW further helps identify and provide the best solution from a consolidation standpoint of both hardware and software clients so that the new merged organization is equipped with the best of what the industry has to offer.