CASP Module 9: Introduction to Logistics, Cold Chain & Supply Chain Integrity
CASP Certification Program

Module 9: Logistics, Cold Chain & Supply Chain Integrity

Ensuring the Integrity of High-Value Therapies from Manufacturer to Patient.

From Warehouse Freezer to Patient’s Vein: Mastering the Specialty Supply Chain

In your community pharmacy practice, managing inventory and logistics is a critical skill. You are adept at forecasting demand for common medications, managing returns, ensuring proper storage for refrigerated items like insulin, and complying with basic pedigree requirements. You understand the importance of getting the right drug to the right place efficiently.

This module elevates those foundational skills to an entirely new level of complexity and consequence. Specialty pharmacy logistics isn’t just about efficiency; it’s about maintaining the absolute integrity of therapies that can cost tens, or even hundreds, of thousands of dollars per dose and often require sub-zero storage temperatures. A single error in cold chain management doesn’t just result in financial loss; it can render a life-saving therapy ineffective or even harmful. Furthermore, the regulatory landscape surrounding drug traceability (DSCSA) imposes rigorous demands that require sophisticated tracking and vendor management.

We will transition your thinking from managing shelves of ambient bottles to orchestrating a high-stakes, temperature-controlled, fully traceable journey for biologically complex molecules. This module dissects the entire specialty supply chain, from forecasting multi-million dollar inventory buys and validating ultra-cold packaging, to mastering serialization requirements and planning for disruptions like hurricanes or power outages. By mastering these logistical complexities, you ensure that the clinical promise of these advanced therapies is actually delivered, intact and effective, to the patient.

Navigating the Complexities of Specialty Logistics

This module provides the essential knowledge to manage the physical and regulatory journey of specialty medications.

9.1 Handling and Packaging for Temperature-Sensitive Products

A masterclass in cold chain management, covering storage requirements (refrigerated, frozen, ultra-cold), validated packaging solutions, temperature monitoring devices, and excursion protocols.

9.2 Procurement and Forecasting of Specialty Inventory

Exploring the unique challenges of purchasing high-cost, limited-distribution drugs, including demand forecasting, Group Purchasing Organizations (GPOs), wholesaler relationships, and managing short-dated inventory.

9.3 Chain-of-Custody Controls and Serialization

A deep dive into the Drug Supply Chain Security Act (DSCSA), understanding requirements for tracing transaction information (TI), transaction history (TH), and transaction statements (TS), and implementing robust chain-of-custody protocols.

9.4 Disaster Recovery and Continuity Planning

Developing robust plans to ensure medication access and supply chain integrity during emergencies like power outages, natural disasters, or cyberattacks, including backup power, redundant systems, and communication strategies.

9.5 Vendor Qualification and DSCSA Compliance

Establishing processes for vetting and approving suppliers (wholesalers, manufacturers, packaging vendors) to ensure they meet quality standards and DSCSA requirements for Authorized Trading Partners (ATPs).