In its simplest form, the goal of logistics is to move freight and goods from point A to B. While thousands of miles of roadways, flight paths, and ocean shipping routes make that possible, equally as important is what fuels successful freight transport: data. Collecting and analyzing data has never been more important, especially when it comes to pharmaceutical supply chains. With more than 107 million Americans being fully vaccinated for COVID-19 as of May 4, drug tracking data integrity, quality assurance, and issue detection are keys to safe and effective distribution. Logistics providers serving the global supply chain have a critical job—managing pharmaceutical shipment movements and storage, as well as the thousands of data points that ensure their efficacy.
The Drug Supply Chain Security Act Data Requirements
The Drug Supply Chain Security Act (DSCSA) applies to all pharmaceuticals entering or exiting the United States. The law pertains to drug manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers.
DSCSA outlines the steps for an electronic, interoperable system for identifying and tracing prescription drugs to minimize counterfeit, stolen, contaminated, or harmful products from reaching consumers. The law also establishes national licensure standards for wholesale distributors and logistics providers through the Food and Drug Administration (FDA).
DSCSA includes six major provisions:
- Product identification – manufacturers and repackagers must include a unique identifier on certain prescription drug packages.
- Product tracing – manufacturers, repackagers, distributors, and dispensers must provide information on who handled a drug each time it is sold in the U.S.
- Product verification – establishes a process for verifying the product identifier on prescription drug packages.
- Detection and response – requires parties within the supply chain quarantine and investigate suspicious drugs.
- Notification – creates processes for notifying the FDA and other stakeholders when counterfeit or harmful drugs are found.
- Wholesaler and 3PL licensing – requires distributors and logistics providers obtain and report on state and federal licensure.
While all parties legally hold responsibility for ensuring the safe transport, storage and distribution of pharmaceuticals, logistics providers—and the data they provide—fill a unique role.
From the moment a 3PL takes possession of a drug, it must provide data on the past and present locations of the shipment. This means tracking cargo movements by the minute and documenting to the person, vehicle, and storage unit involved in that movement . Drugs manufactured outside the United States may travel by ship, airplane, and truck before reaching their final destination. This creates multiple touchpoints as the cargo changes hands. The 3PL maintains responsibility for tracing the drug throughout the journey.
This level of location intelligence also requires external data integration. Explanations must accompany all route variances to ensure the drug remained safe and uncompromised during transport or storage. Weather data, road conditions and restrictions, and site-specific information proactively mitigate delays that could compromise drug quality. Failure to provide accurate and timely tracing data can lead to opportunities for adulteration in the drug supply chain.
According to the International Air Transportation Association (IATA), drug temperature excursions cost the industry nearly $35 billion annually. This staggering number reflects product losses, replacement costs, wasted logistics costs, and lost labor time. Not included is the toll on human life resulting from delays and shortages. DSCSA mandates reporting on drug quality data because the practice represents the best way for preventing temperature excursions and isolating impacted products when they occur.
Fluctuations of even a few degrees can compromise drug efficacy. Federal regulations require logistics providers track temperatures using digital monitoring devices and daily physical checks. Data is stored for at least three years and should be available for on-demand digital download. Warehouses must supply detailed records of their operating environments. Documentation includes stability data, geographical and climatic zone data, and shipping and storage conditions such as temperature, humidity and light exposure.
Logistics providers also integrate receiver data when planning pharmaceutical shipment schedules. Knowing cold storage availability at destinations is important. Many drugs dictate both temperature and spacing requirements. Shipping to facilities without room or long-term storage equipment like ultra-low temperature freezers could mean drugs go to waste.
Issue Detection and Response
DSCSA mandates that logistics providers have systems in place allowing for the quarantine and investigation of potentially compromised drugs. Standard procedure involves checking for signs of damage, accurate inventory and quantities, expiration dates, and transport temperatures. Drugs get isolated when variances warrant an efficacy analysis.
By tracking shipment data throughout the supply chain, 3PLs can easily identify and remove potentially compromised products, quickly. The law requires that trade partners notify the manufacturer within 24 hours of discovering potentially harmful products. The manufacturer and FDA then determine next steps based on the information provided. Logistics providers represent a powerful weapon in stopping compromised drugs from reaching consumers—all because of the data they manage.
Langham Logistics: Data Delivered
Langham Logistics meets all State Boards of Pharmacy requirements for 3PL’s and our processes for managing drug product storage and distribution have been inspected and certified for compliance with DSCSA regulations. We utilize sophisticated technology for tracking drug cargo to the minute for location, temperature, and security. Our transport, storage, and documentation processes ensure every pharmaceutical shipment complies with strict FDA guidelines and reaches consumers safely.
Learn why Langham Logistics is a go-to trade partner for global pharmaceutical manufacturers and how we are playing a major role in helping vaccinate the world against COVID-19.