Serialization in the Pharmaceutical: Improving Track and Trace

AT A GLANCE

Worldwide, pharmaceutical companies are dealing with drug counterfeiting, adulterations, supply chain thefts, and packaging glitches. Serialization has become the need of the hour, and it is much more than just applying barcodes to personalized medicines.
This age of fast-paced digitization calls for modifications and improvements in the serialization techniques. To better strengthen the supply chain loopholes need to be identified and transparency to be maintained not just at the batch level, but for each strip or bottle of the drug.
Pharmaceutical companies and their supply chain vendors will need to make use of Advanced Analytics, Cloud, and Internet of Things (IoT) to get a grip on the modern-day serialization techniques.

Traceability being a mandate globally, and the laws changing across borders, major pharmaceutical companies are working towards improving the tracking and tracing process in the supply chain for better compliance. To that effect, pharmaceutical companies are developing and implementing serialization techniques. Supply chain security, counterfeiting drug theft, better product traceability, mitigation of drug contaminations, and overall cost-savings are different facets that are considered.

Reports suggest that by 2023, globally, more than 90% of drug supply will be scrutinized under track and trace regulations to enhance patient safety measures by combating drug counterfeiting.

The need for serialization is no longer restricted to global mandates compliance but accounted for various other factors. Over the years, pharmaceutical companies have struggled to maintain transparency, accountability, and integrity in the supply chain. The product lifecycle from manufacturer to supplier, distributor, and ultimately the consumer has had various loopholes at different levels – package damage, drug theft, manual errors, and so on. To seal these gaps and improve overall supply chain, serialization is proving to be a useful technique even surpassing the shortcomings of other solutions such as sturdy packaging and traceable 3D hologram models.

FIGURE 1:Common Loopholes in the Pharmaceutical Supply Chain

Innovation is the key to improving trace and track in any supply chain model, and the pharmaceutical supply chain is no exception to this. Companies worldwide are investing millions of dollars in maintaining the integrity of their product throughout its lifecycle from the lab to the patient. To overcome manipulation in product quality and quantity, assigning either a unique identification number or a barcode to the individual items (such as a strip of tablets of a bottle of medicine) for computerized serialization and tracking proves to be a fortified supply chain solution.

This article discusses the newer innovations and latest trends in serialization in the pharmaceutical supply chain.

01.Data Encryption and Data Security

The primary aim of pharmaceutical supply chain serialization is to make sure that the ultimate consumer gets the right drug at the right price. At the same time, companies can easily trace and track their products. This calls for stringent data management and security. The inefficiencies are arising in life sciences companies’ supply chain due to data errors or data leakage causing massive financial debt.

According to Interactive Data Corporation (IDC), the pharmaceutical industry loses on average 4.5% of its potential revenue because of supply chain inefficiencies.

The upcoming trend in serialization will place extra emphasis on data encryption to maintain security and thus the integrity of the product throughout its lifecycle.

02.Recalling Made Possible for Individual Product

The pharmaceutical industry is highly susceptible to product recalls in cases of insufficient packaging or a risk-inducing drug. Earlier, these recalls were made at batch-levels, causing companies massive revenue leakage and disturbing the supply chain on a larger scale. Narrowing down traceability to the individual unit makes it possible for companies to in-turn, narrow down the recalls to different products. Serialization also allows in knowing exactly when and where the product quality was compromised.

FIGURE 2:Serialization to Improve Track and Trace

03.Use of Advanced Analytics

The life sciences companies and their collaborative research branches are looking to better gauge the consumer pattern to cater better to the demands. The use of advanced analytics applications like Microsoft Power BI for visualized, cutting-edge business intelligence reports for serialization will help in learning this pattern. Power BI can enable the end-users in creating their customized dashboards, thus helping with predictive analysis. This can also help in preempting the demand for a particular drug so that pharmaceutical manufacturers can alter their supply chain accordingly to meet the requirements.

04.Enhanced Visibility at Every Level of Pharmaceutical Supply Chain

Apart from ensuring better accountability and compliance, companies are also making use of serialization to enhance visibility and improve monitoring at every level of the pharmaceutical supply chain. This will aid in avoiding stock-outs, monitoring packaging, improving the distribution process, and making sure that the drug is supplied per requirement across the market.

05.Barcoding & Labeling

This time-tested method is one of the most-used for a reason- it makes serialization a lot more streamlined and can help in advanced tracking. The latest digital barcoding techniques and advanced label-making capabilities can help the pharmaceutical industry in taking serialization in the supply chain, a level up.

10%

of the global pharma drug supply is counterfeit, which costs up to $200 billion annually. Additionally, the Interpol calculation reveals that this volume of counterfeit drugs takes a toll of 1 million people every year.

Source: WHO

How will Serialization Impact the Face of Pharmaceutical Companies in the Near Future?

Globally various countries like the USA, UK, Italy, Turkey, and India have taken up serialization of their pharmaceutical supply chain to some extent or the other. Speaking specifically of the United States, serialization of all the drugs at the sealable unit and case level has become a mandate since November of 2017 under the Drug Supply Chain Security Act (DSCSA). This will impact the pharmaceutical companies and their supply chain vendors in the following ways:
In the near future, manufacturers will need to serialize all their drugs at an individual level with barcodes for better track and trace.
There will also be a change in the ways in which manufacturers supply their drugs. Thanks to serialization, they will get better visibility of the market, down to individual drug demand. This will help in better drug distribution.
Warehouses and inventories will be equipped with better visibility and a fortified drug distribution plan.
There will be a better understanding and communication among cross-functional teams. As serialization has an inflow and outflow of information at the production-floor level and at inventory-level, life sciences researchers, packaging personnel, IT experts, and distributors will all be on the same page with regards to the data available for a particular drug.

Challenges in Serialization Faced by Pharmaceutical Companies

Like any other change across the supply chain, serialization has its own set of challenges for the pharmaceutical companies. Here is a look into some of the potential challenging areas when it comes to implementing serialization:

Hardware Setup and Updates: Companies will need to make sure they have highly functioning hardware to manufacture labels, barcodes, and seals that are essential for serialization.
Steady Flow of the Production Line: Sticking to the process of serialization and making your skill base acquainted with this process might slow down the production line. The use of labels for individual units will also significantly slow down the packaging process.
Overall Cost Inflation: Cost inflation is a given when it comes to serialization, given the costs involved in hardware and software. However, this can be negated via pooled-investments and sustainable applications of the hardware and software.
Skilled Personnel Shortage: Newer, digitized ways of serialization would require a skill base that is well acquainted with the technicalities and details of these techniques. Currently, companies are facing a lack of a skilled employee base that is technically sound enough to implement their serialization strategies seamlessly.
Technical Glitches: Serialization is a process that requires minimal human intervention, and while that can be beneficial to avoid manual error, there is also a possibility of technical glitches in the process leading to incorrect tagging and compromised track and trace.

Key Benefits of Serialization Implementation in Operations:

End-to-end implementation across the supply chain for drugs in a hassle-free way
Seamlessly sealing the supply chain loopholes to combat drug counterfeiting and warehouse packaging glitches
Minimal human intervention needed, making serialization a full-proof, effective way to ensure brand authenticity and mitigate batch recalls
Total compliance with the US traceability regulation.

With all the challenges and benefits in mind, every pharmaceutical company will need to keep working towards an advanced, digitally-adept, full-proof serialization process for their supply chain to counterfeit the proliferation of drugs and avoid compromising with drug quality.

Key Takeaways

Serialization in pharmaceutical supply chain plays a significant role in avoiding drug theft, counterfeiting, batch recall and plausible hazard to the patient’s health; Newer trends in serialization are making use of advanced analytics for better drug distribution and fewer stock-outs.
No two pharmaceutical companies will have the same blueprint for their supply chain, and thus they will need to devise unique serialization processes to suit their requirements.
As the serialization of drugs has become a mandate in the USA, it is imperative for pharmaceutical companies and their supply chain vendors to understand and master the technical details of implementing serialization at batch and case levels.
The pharmaceutical companies will need to prepare themselves to overcome the potential challenges in implementing adept serialization to fortify their supply chain and enhance visibility for better drug track and trace.