There is an increasing need for global medicinal shipments ranging from disaster relief supplies to experimental, personalized treatments. Companies want to ensure their product remains viable, as well as safe, when it reaches consumers. However, governments and organizations add another layer of complexity because they want to guarantee the same things but through regulation.
- International Good Distribution Practices (GDP) help determine how pharmaceutical products should be shipped safely
- Drug Supply Chain Security Act (DSCSA) outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. It will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities to report licensure and other information to FDA annually.
These directives illustrate the emphasis on preventing loss, contamination and spoilage rather than merely responding to it. Another goal is to reduce the risk of fake ingredients getting into the system. The burden falls to the supply chain to improve visibility and documentation from origin to destination. New solutions enable streamlined and automated processes to make compliance easier. IoT technology is part of the answer because smart options provide insight into not only the location of every shipment, but its environmental conditions. This monitoring down to the package level helps companies manage quality, compliance and security better across all transit modes.
Pharmaceutical Shipping Challenges
From vaccines to samples to antibiotics, pharmaceutical products have various temperature requirements that make precise control critical during transport. For example, most vaccines must remain between 35°F-46°F (2°C-8°C); it can take as little as an hour outside this range to damage them. According to the Centers for Disease Control and Prevention (CDC)1, 7% - 37% of providers expose vaccines to improper temperatures1. Other medicines, treatments and biologics are often sensitive to changes in humidity, light and vibration.
The objective of the World Health Organization’s GDP is “to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process.” Smart IoT technology solutions offer this specialized cold chain a more efficient way to monitor the quality of their shipments. It also provides a record of the chain of custody and command when in-transit.
It is estimated that pharmaceutical products that require temperature controlled storage and transport are worth approximately $283 billion, and they are expected to rise by 70% between 2015 and 2021. Many drug companies are now moving into the large-molecule treatments, which require much more rigorous shipping solutions that meet exacting requirements. These medications are typically more temperature sensitive and have a shorter efficacy, resulting in the need for specialized handling and tracking.
For example, together with CalAmp, Cryoport is exploring an advanced visibility service for its supply chain that will monitor, in real-time, environmental readings for regenerative medicine product shipments using Bluetooth® sensor technology. If successful, the combination of the Cryoport Express® Shippers and the Cryoportal® Logistics Management Platform, coupled with CalAmp's Tag™ Bluetooth sensor technology and application, would allow Cryoport to offer another advanced logistics solution that would pro-actively manage supply chain visibility across multi-mode global shipping routes.
Tracking location, proper chain of custody and control, and environmental conditions manually is an investment in time and money. There is also the risk of human error from keying or during an upload of data. Therefore, the supply chain must move towards digitizing processes and information capture in order to comply with regulations and industry standards. These smart technology solutions also provide a competitive edge by continuously logging shipment condition data and transmitting it to the cloud for easy retrieval and compliance reporting. Having access to the information can keep regulators and customers satisfied with your performance.
There are new economical solutions on the market, such as the low-powered Bluetooth-equipped (BLE) sensor tags, that adhere to containers, pallets or even individual packages carrying pharmaceuticals to provide detailed, real-time information about shipping conditions. These sensors continuously log temperature and humidity throughout the journey. They transmit this data, when in range of a wireless gateway, along with proximity data to a cloud application that keeps stakeholders informed. If anything deviates from preset parameters—a temperature threshold is exceeded, there is a light exception or cargo strays from its scheduled route—alert notifications automatically send by text or email to authorized personnel so they can make any necessary changes.
As companies migrate away from 2G and 3G, they are finding more 4G LTE technology options, such as LTE Cat M. It is considered to be the second generation of LTE for connectivity and offers a longer battery life (up to 10 years) for connected devices that don’t require a high bandwidth to transmit. This IoT technology is also suited for applications that cover a wide area on a low-power network. These conditions provide for reliable connectivity, such as in multi-mode supply chain environments. CalAmp’s Trak™ SC1204 is a new wireless gateway that communicates with up to 30 Bluetooth tags at once. The solution works well for transport and storage applications because it offers an economical, low-power LTE Cat-M cellular option that has multi-country support with 2G fallback. Paring these two smart technologies together provides companies with a reliable, cost-effective way to gain or improve visibility into their sensitive shipments from warehouse to destination. To discover how you can reduce risk to your pharmaceutical shipments, visit our Cold Chain Solutions page.
1 Centers for Disease Control and Prevention. Vaccine Storage and Handling Toolkit. Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, and Office of Workforce and Career Development; 2007