On October 1, the U.S. Food and Drug Administration (FDA) announced another extension of the Drug Supply Chain Security Act (DSCSA) compliance deadline, particularly concerning Waivers and Exemptions Beyond the Stabilization Period.
This extension underscores the complexities of compliance and the limited number of comprehensive solution providers available to assist health systems in achieving full compliance. While the delay offers healthcare organizations additional time, it also presents an opportunity to thoroughly evaluate solution providers that can help them meet the new deadline without compromising patient safety.
Understanding the key components of the DSCSA is crucial, as it significantly impacts the pharmaceutical industry and healthcare providers. The legislation was designed to bolster the FDA’s ability to protect consumers from counterfeit, stolen, or contaminated prescription drugs.
Here are the top 10 things you need to know about the DSCSA, its implications, and how you can ensure your healthcare facility is compliant:
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Why was DSCSA created?
The DSCSA aims to enhance drug safety and protect consumers from counterfeit, stolen, or contaminated medications. By requiring greater transparency and accountability, the regulations will help combat significant challenges in the drug supply chain, including counterfeiting, drug shortages, contamination, and diversion.
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Who is impacted?
DSCSA affects drug manufacturers, wholesalers, healthcare providers, hospitals, pharmacies, and patients. Compliance will require the entire pharmaceutical supply chain to track and trace medications electronically, ensuring accountability from production to patient delivery.
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Electronic tracking of drugs
A primary mandate of the DSCSA is the electronic tracking and tracing of prescription drugs as they move through the supply chain. This ensures transparency at every stage, from the manufacturer to the patient.
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Minimum standards for tracking
To comply with DSCSA regulations, companies and healthcare providers must upgrade their medication tracking systems. Standardized identification and product information must be represented on the lowest saleable unit, allowing drugs to be traced more easily.
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The role of drug identification
Embedded directly in product labels via serialization or Radio Frequency Identification (RFID) tags, plays a crucial role in preventing counterfeiting and tampering. In the event of a recall, healthcare providers can use the serialized data to track down affected medications and identify patients who may have received the recalled product.
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RFID technology for compliance
Technology is becoming the gold standard for meeting and exceeding DSCSA requirements. RFID tagging enables the real-time tracking of medications, enhancing drug security and unlocking new efficiencies in medication management across the supply chain.
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Automation to reduce errors
Automated systems reduce human error in data entry, minimize labor costs for distribution, and streamline inventory management. These systems ensure medications are replenished when necessary, improving efficiency and reducing the risk of stockouts.
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Electronic Tracing: The Future of Medication Management
The Future of Medication Management RFID-enabled automation creates a synchronized and interoperable supply chain, tracking pharmaceutical products at every stage. This ensures accuracy, accountability, and improved medication management, much like modern retail supply chains.
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Cross-departmental collaboration
Hospitals and health systems need to collaborate across departments and with manufacturers and distributors. This interoperability will integrate medication-tracking data into electronic health records (EHRs), improving data aggregation and streamlining operations to enhance patient care.
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Data analytics and inventory tagging
The adoption of advanced technologies, such as RFID tagging and real-time data analytics, is revolutionizing medication tracking. These systems increase visibility, improve inventory management, and help resolve challenges like product recalls more efficiently. Hospitals that have already adopted these systems are experiencing substantial benefits, including enhanced end-to-end visibility for medications.
As the next DSCSA deadline approaches in May, the pharmaceutical industry must prepare for this transformative change. Ultimately they will need to comply with the DSCSA but also unlock new opportunities for excellence in medication management.
