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By David Lefkowitz, SENIOR DIRECTOR OF MARKET STRATEGY

Over the next thirty years, the number of elderly people aged 65 or over is projected to double globally to more than 1.5 billion people. As the aging population grows, so do chronic conditions and patients often suffer from more than one. (World Population Ageing 2019, United Nations 2020)

This development is exacerbated by the growing middle-class and increasing adoption of sedentary lifestyles, leading to obesity, diabetes, and other chronic health conditions.  

In China, the second largest pharmaceutical market globally, the 60 years and over segment of the population will increase to 28% in 2040 (from 12.4% in 2010). By 2030, chronic disease prevalence such as heart disease or cancer are expected to increase by at least 40% and to account for almost 80% of all deaths in people aged 60 years or over. (China Country Assessment Report on Ageing and Health, World Health Organization 2015)

With the growth of an aging population along with the rise of sedentary lifestyles and associated health conditions, the need for enhanced healthcare, better medications, and innovative solutions is growing worldwide. 

Within this context, new therapeutic approaches have the potential to not only treat, but ultimately cure diseases.  Specialty medications originated decades ago, designed to serve patients who needed specific therapies for serious health conditions.  The recent growth of this sector, a direct result of pharmaceutical innovation fueled by financial investment and R&D, has led to more effective therapies.  The upside is that these new treatments will help us live longer, with the downside being that these drugs are very expensive and quite complex to distribute. 

Specialty medication, also known as specialty pharma, refers to high-cost, high-complexity, and high-touch therapies often used to treat chronic illnesses such as cancer, rheumatoid arthritis, multiple sclerosis, and many others.   

These specialty drugs are fueling the spending growth in the United States and in developed markets abroad.  This upward trend has continued over the last few years, and it’s estimated to reach more than half of the overall pharma spend in the U.S. by 2024. 

"Of these products, it’s estimated that close to $300 billion will need refrigerated storage and transport over the next five years and this segment alone is projected to see a growth rate of more than twice that of non-cold chain products."

While these medications offer great hope for many life-threatening diseases, they can be extremely expensive, and many require special handling and storage for effective temperature management throughout the supply chain.  

Of these products, it’s estimated that close to $300 billion will need refrigerated storage and transport over the next five years and this segment alone is projected to see a growth rate of more than twice that of non-cold chain products.   

This trend is showing no signs of slowing as specialty medications account for the majority of the approximately 7,000 prescription drugs currently in the development pipeline.  By 2024 it’s estimated that five of the top ten best-selling drugs will require refrigerated storage and handling, and more than half of all new drugs awaiting FDA approval will be specialty medications, of which many will require strict 2˚ C and 8˚ C refrigerated storage and transportation.   

As specialty meds continue to grow and cold chain logistics increase in both significance and complexity, it’s important to ensure that your organization is ready.   

Simply put, RFID can save healthcare organizations time and money by providing real-time visibility and traceability, expiration management, temperature control, and location data for high dollar inventory, including specialty drugs.  

RFID enclosures can also play a major role when it comes to tracking, tracing, and storing pharmaceuticals, especially those deemed high security risks or drugs that have special controls as to who can access the medication. 

In many cases today, the check-in and check-out of these drugs is documented manually. RFID-enabled enclosures that track who checked out a drug, and when, can provide secure and documented access to high-risk drugs. Using secure access, each inventory transaction is automatically captured and processed in real-time. The resulting data can be analyzed to track product usage, improve workflows, and make better business decisions going forward.

"While many stand-alone solutions exist for managing specialty drugs, a fully connected, smart inventory management system, working in unison with the DSCSA regulations, presents the most complete and proactive solution for automating the inventory management of these high-value products."

Regarding enhanced security, the final part of the Drug Supply Chain Security Act (DSCSA) will take effect on November 27, 2023.  The DSCSA outlines steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the U.S. This will help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the healthcare supply chain. 

As defined by the DSCSA, all information regarding product and shipment throughout the supply chain must be conducted electronically. Secondly, additional information must be added to the label at the individual product level.  The serialization efforts that began in 2013 have tightened the supply chain and made counterfeiting more difficult, but counterfeit products are still entering the supply chain.  

The enhanced requirements that take effect in 2023 aim to prevent such occurrences by requiring entities to conduct business only with authorized trading partners. 

While many stand-alone solutions exist for managing specialty drugs, a fully connected, smart inventory management system, working in unison with the DSCSA regulations, presents the most complete and proactive solution for automating the inventory management of these high-value products.  

Connecting assets using cloud-based technology enables pharmaceutical manufacturers, distributors, and hospitals real-time information throughout the supply chain, thus improving patient safety, meeting regulatory compliance standards, and accurately monitoring temperature and expiration dates. All resulting in better outcomes for manufacturers, distributors, providers…and most importantly, patients.   

Interested in our cold chain solutions?

Related Links

Events
The Evolution and Growth of Specialty Pharma
the impact of staff shortages and vaccine deadlines on the healthcare supply chain: how RFID can help
Technology
The Impact of Staff Shortages & Vaccine Deadlines
RFID is being used in clinical trials to track and trace drugs automatically.
Whitepaper
RFID In Clinical Trials