For the pharmaceutical and healthcare industries, the digitalization of commerce has rapidly changed how people buy products. This has created new challenges for manufacturers and in particular logistics firms. Today, supply chain management is considered one of the most important strategic components of modern businesses.
Companies must now search for ways to improve delivery supply chain efficiency to decrease their costs while ensuring on-time delivery. In addition, organizations need to enhance their global supply chain visibility, comply with new laws and regulations, and effectively monitor and secure their shipments.
Based on data from the IQVIA Institute for Human Data Science, the global pharmaceutical market will exceed $1.5 trillion by 2023. Spending on medicines in the U.S. is expected to reach over $600 billion on an invoice basis in 2023, including spending in all channels (e.g., retail pharmacies, hospitals, doctors’ offices), and on all product types (e.g., small molecules, biologics, brands, generics, biosimilars).
Realizing the entireness of these challenges in conjunction with the November 27, 2023, Drug Supply Chain Security Act requirements, in this week’s blog we will review how TydenBrooks helps the pharmaceutical industry implement multi-layered security seal, indicators, and advanced tracking and monitoring solutions.
DSCSA Compliance
According to the FDA, the (DSCSA) Drug Supply Chain Security Act is a federal standard that outlines steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States. In 2023, it will not only be manufacturing that must meet these requirements. Shippers and distributors will have to comply with regulations under the (DSCSA), which requires secure, efficient movement, and “traceability” of prescription pharmaceuticals through the supply chain at the unit-level.
A key source of generic drugs prescribed to Americans are manufacturers in India and China. With approximately 80% of active pharmaceutical ingredients and 40% of the finished drug product shipped into the U.S. from overseas, this is a considerable undertaking.
Pharmaceutical Supply Chain Security
While theft and pilferage continue to be serious problems in the pharmaceutical industry, counterfeit drugs, contraband, product damage, drug shortages, and disposal of out-of-date products are all significant concerns. The Pharmaceutical Security Institute (PSI) details a steady upswing of incidents since 2017 on their website. There were 5,987 pharmaceutical crime incidents in CY 2021 which was a thirty-eight percent (+38%) increase from CY 2020.
Fentanyl has become the leading cause of death for Americans ages 18 to 45, and there was a four thousand percent (4,000%) increase in fentanyl seizures across the US-Mexico border. In total, there was 10,000 lbs. of fentanyl seized in 2021, and with fewer than 5 % of the vehicles typically screened by U.S. Customs and Border Protection (CBP) and their powerful high-energy scanners, cross-border pharmaceutical shipment security is critical.
Depending on your companies’ capabilities and the scope of your operations, we have solutions for all business sizes to address these security issues. Today, we will focus on multi-layered supply chain security solutions, so you can take immediate action or reach out to a regional manager for an on-site consultation.
Tamper-Evident Indicative and Barrier Solutions
Begin at the package and case level. Packaging is a critical tool to ensure pharmaceutical product safety. Using our tamper evident VOID tapes and labels on your products and packaging helps prevent theft or diversion, and the introduction of counterfeit products. A tamper evident VOID security label or strip of tape can be applied across the closure of a carton, lid of a bottle, seal of a container. Through customization, you can incorporate security messages in QR codes or Holograms to enhance your brand authentication.
Also consider adding indicators to cardboard cartons or plastic totes. Our WarmMark family of temperature indicators are single-use devices that provide accurate, irreversible evidence of any above temperature deviation allowing you to make smarter decisions across the cold chain. The WarmMark are ascending time-temperature indicator alerts users of exposure to unacceptably high temperature conditions and the cumulative amount of time of the exposure.
The ColdMark descending temperature indicators are single-use devices that provide accurate, irreversible evidence of a below-temperature deviation allowing you to make smarter decisions across the cold chain. The ColdMark turns from clear to violet when the temperature goes below a predetermined threshold.
For your plastic tote bins, be sure to apply a plastic indicative security seal on the lids to prevent pilferage and the risk of contraband being introduced. Maximize your chain of custody by bar coding the plastic seals. Whether its 1D, 2D, or a QR code, bar coding protects your brands authenticity, speeds processing, and confirms the accuracy of the unique numbering that tracks every shipment.
Lastly, secure your mode of transport. Whether it’s over-the-road by truck or piggy-backed by rail, and/or shipped by ocean container, an ISO 17712 high-security bolt or cable seal is a definite must as it provides a barrier from your high-value or high-risk pharmaceutical shipments. Again, utilize bar coding to reduce human error of the unique numbering on bill of ladings, and to add an additional layer of shipment traceability.
Advanced Tracking and Monitoring
Our complete line of advanced tracking and monitoring security solutions utilizes the tracking device or tags data with advanced analytics and automations to monitor your pharmaceutical shipments on our customizable TrackSecure platform.
The TydenTrackers can use a variety of communications including 4G, Bluetooth and WIFI Technologies. The trackers monitor and report fluctuations or changes in temperature, light, moisture, movements, and shock impacts that your cargo may endure, as it moves through the supply chains.
Once the trackers setup is complete, users can securely monitor parameters 24/7, control alarms remotely, view data logging history, run reports in real time, and give access to other team members. No local software is required to use our cloud-based data interface. Mobile push notifications, emails, or texts for out-of-range conditions come standard.
Our leading supply chain, asset tracking for over-the-road, rail, air, or ocean as well as various under roof applications from our connected products line is the TB-HGR4 and the TB-HGD4 tracker. For your pharmaceutical shipments, the TB-HGR4 tracker is a rechargeable device designed for use in multiple supply chain and asset monitoring applications. The device is capable of reporting location, temperature, light, movement, and shock levels.
The TB-HGD4 tracker offers the same reporting but is a non-rechargeable battery-operated device that reports while moving at 15-minute intervals, and 1 hour during stationary. The TB-HGD4 will operate for 60 days. Included in our connected product line are tracking devices which are installed using constant power. TB-HGA4 connects to 12/24 V power with the TB-HFR4 connecting to the building power (120-220V).
Rounding out the product line are our Bluetooth tags, the TB-E4B and TB-E4BL which are designed to work with the TydenTrackers to check and report temperature, humidity, and proximity at preset intervals. We also offer a GPS ISO 17712 bolt seal, the GeoBolt which is a rechargeable overt device that is applied to the truck or sea container door hinge. The GeoBolt monitors location and the “real-time” status of bolt seal.
Our Commitment
All TydenBrooks products, solutions, and strategies go a long way in protecting the public, which in turn protects a company’s brand reputation and increases their value. Our pharmaceutical solutions also improve a company’s bottom line by preventing loss and damaged product claims.
These solutions help protect and streamline processes that will improve on-time deliveries to wholesalers, distributors, hospitals, and patients. In the end, hospitals and healthcare providers need to rely on receiving medicines and treatments on-time and uncontaminated from the unit-level to meet the demands of the (DSCSA) Drug Supply Chain Security Act.
We look forward to helping you prevent theft, pilferage, and tampering while ensuring the secure movement of finished goods and raw materials by your company and partners. For more information or to discuss your unique pharmaceutical security needs and challenges, contact us at 1-800-458-7325 (SEAL) or via email at [email protected].
