Home Health Care Streamlining vaccine supply chains – it’s all about the label

Streamlining vaccine supply chains – it’s all about the label

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Vaccine supply chains are fast changing, complex and vitally important to society, and nowhere is this more evident than with Covid-19.

While a great deal of attention has been given to streamlining supply chains – and ensuring vaccines reach healthcare providers and their patients around the world – one of the most critical components is also the most overlooked: the label.

Think about it. Before a vaccine can be distributed, every label must be pre-approved based on critical info like warnings, instructions and other precautionary data. And every time FDA and global regulations or customer requirements change – whether it’s renaming a vaccine, approving use for a new age group, disclosing new potential side effects, or the issuing of booster shots – the label must change as well.

I say it’s time we give labels the recognition they deserve, as organizations of all sizes can benefit from taking a closer look at their own labeling practices and how modern technologies can improve their operations and supply chains.

And to better understand just how big of an impact a small label can make, we must first consider the unique challenges vaccine supply chains face today.

The unique challenges and demands for vaccine labeling

While labels play a pivotal role in any supply chain, there are many challenges vaccine supply chains face that only become amplified when distributing on a global scale. Here are just a few to consider, which have become increasingly pertinent in response to Covid-19:

    • Label content and regulations change rapidly: Every country, customer and brand has unique regulations, specific mandated information and approval processes, requiring countless label variations – all of which keep changing.
    • Redistributing to other countries: As vaccines are shared across borders, they must be rapidly relabeled. This requires overlabeling or postponement labeling, and any errors or inconsistencies can lead to slowdowns, recalls or worse.
    • Delays from pre-printing: Many vaccine manufacturers and co-packers rely on label stock that is pre-printed with product info, dosage, and other data. This means delays if an update is needed. When speed is a huge consideration, this can be a major problem.
    • Cold chain & unique handling requirements: Cold storage requirements mean any label-based delays in manufacturing facilities, warehouses, shipping containers and healthcare facilities can result in spoilage. This pertinent information must also be clearly identified via the label to ensure proper handling and care.
    • Track and trace is imperative: From pallets down to individual unit dose labels, it is of the utmost importance to ensure clear and complete visibility into where vaccines have been, where they are going and at what time. This insight is essential for protecting patients – especially if a recall occurs – and could even help to verify proof of vaccination.  It is also vital to prevent unauthorized counterfeiting, tampering and gray market vaccine distribution, as well as the growing requirements companies must follow to prevent this.

Of course, addressing these challenges becomes much more difficult when dated, legacy approaches to labeling are holding organizations back.

The problem with dated, legacy labeling

With vaccine labels, there exists a web of pharmaceutical corporations, subcontractors and other firms that must create, print and distribute the proper labels, sub inserts and other needed informational materials. In this network, it may be the case that big brands can design compliant labels with critical info, but they’ll likely rely on a host of secondary facilities and third parties that will need to package and distribute vaccines with their exact standards. This means the ability to share information with different facilities and suppliers quickly is essential.

Adding to the urgency, fast-changing vaccine requirements mean capabilities like on-demand label creation can be the difference between a successful vaccine rollout or a discarded batch. Legacy approaches, like pre-printing label stock, can be too slow and unreliable in today’s fast-moving, global supply chains.

Manual and disparate labeling practices are also an all-too-common problem for labeling vaccines. Different production facilities and distribution centers often manage labeling in isolation, with different software applications, manually inputted data or continuously changing “as-needed” solutions.

Siloed processes make scaling operations harder, add costs to support multiple applications, and delay responses to changing regulations and customer requirements. And, more critically, siloed workflows also increase the risks of non-compliance fines and consumer health dangers if products are mislabeled.

Additionally, when labeling is not organized in a holistic manner, it can be difficult for all parties involved to access the same consistent, approved content for labels. Or it can be hard to readily extend label information to suppliers, potentially leading to delays and wasted vaccines.

And in today’s world of rapidly proliferating data, developing a single source of truth should be part of every organization’s approach to label management. But all too often, labeling issues, like incorrect or missing data, occur when manufacturers in different locations must maintain varying labeling solutions. These disparate solutions might not have connectivity to ensure key data is accurate, and this can quickly lead to a hazard during vaccine distribution.

Ensuring speed, agility and flexibility with enterprise labeling

The label is more than just a sticker on a vial and must be considered from a multi-faceted, holistic perspective. After all, if the label contains inaccurate info or data, the consequences can be catastrophic, ranging from large fines and financial damage, to recalls that put the health and safety of the public in jeopardy.

Ensuring labeling is done efficiently and safely requires coordinating different locations and organizations as well as a variety of data sources that must be in sync. Additionally, labeling on vials, cartons or other parts of a vaccine’s packaging may need to be featured in several different mediums, such as peel offs, direct marking and a plethora of others. Rapid updates to the various labels may also be needed if new contraindications, allergic reactions or other safety issues are found throughout clinical trials or after vaccines have been distributed.

To ensure interconnectedness and a single source of truth, Enterprise Labeling enables organizations to standardize and integrate labeling with business processes and across business lines and geographies. Therefore, with the right solution, labeling can be easily integrated with business applications, like a manufacturing execution (MES), enterprise resource planning (ERP) or product lifecycle management (PLM) system.

Once labeling is integrated with an enterprise’s verified data sources, label makers can gain many advantages, like the ability to anticipate new label changes based on early clinical trials or the ability to rapidly incorporate feedback from vaccines that were sent out under emergency authorizations. These capabilities speed the creation of essential updates, such as temperature-dependent expiry dates, dosage info, side effects warnings or other data that must be rapidly applied to future labels.

Once these updates are made in an Enterprise Labeling solution, organizations can ensure the same updated label data is accessed securely by everyone and tracked reliably. Enterprise Labeling can also enable advanced logic, automation and other features to instantaneously ensure the most updated info is widely available for different labels. Additionally, business users can help quickly design or update labels for any printer or model, without coding. This unburdens IT and reduces bottlenecks.

The value of cloud-based solutions

One of the best methods of deploying an Enterprise Labeling system or extending it to partners is to use a cloud-based solution. With cloud-based labeling, organizations can quickly connect a new site with an enterprise’s corporate data and brand look as well as the pertinent product and client information. This means if a vaccine manufacturer is working with a third-party supplier, they could readily extend compliant, controlled labeling to their operations for seamless remote collaboration. Or organizations could extend labeling quickly to a new location if another is shut down or must be quarantined.

By using a cloud-based Enterprise Labeling solution, users can also collaborate much more effectively and benefit from on-demand and remote printing capabilities, regardless of geography. This eliminates extra costs and delays associated with regularly shipping pre-printed labels to remote sites.

Upgrading for the future

By breaking down siloed processes and addressing label management on an enterprise-wide level, organizations can ensure vaccine labels are commonly accessible and accurate, with a single source of truth for label data. Additionally, Enterprise Labeling can also prepare organizations for future crises by making it easier to scale and extend the proper label data to different locations and partners.

As the world moves forward and supply chains become increasingly global, modernizing labeling will only become more imperative as the regulations around it become more complex. If there’s one thing we’ve learned from Covid-19, it’s that disruption can happen in the blink of an eye and ensuring supply chain resiliency requires planning ahead – not just for the challenges of today, but also for tomorrow.

So, if your supply chain doesn’t include Enterprise Labeling now, can you really afford to wait until the next crisis to upgrade?

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