(Vietnam Logistics Review) New regulations ensuring the integrity of the pharma supply chain are nearing the finish line. While some companies have taken an early lead to compliance, others are late getting out of the gate. Which team are you on?
Tracking the global path of a pharmaceutical product from raw material to end consumer is complicated and risky. When done right, strategic chain of custody solutions can leverage brand reputation. But persistent vulnerabilities-poor visibility, and tainted, expired, or counterfeit drugs-can lead to numerous outcomes far more costly than a damaged reputation. Bad deliverables can be the difference between life and death.
Major pharmaceutical companies are susceptible to grim setbacks when weak points infiltrate the chain of custody. Some of these setbacks have become highly publicized cases that resulted in federal criminal charges.
One infamous example occurred in March 2015, when McNeil-PPC Inc., a wholly owned subsidiary of Johnson & Johnson, pled guilty in Federal District Court in connection with adulterated infants and childrens over-the-counter (OTC) liquid drugs. The ruling came five years after the Tylenol maker announced mass recalls of OTC medications including infants and childrens Tylenol and infants and childrens Motrin. In a 2010 press release, McNeil revealed that some of the unexpired recalled medications might have contained "tiny particles." Those foreign specks were later identified as metal-nickel/chromium-rich inclusions that were not intended ingredients of the medications.
Prepping for Change
Managing a balanced chain of custody is integral to adhering to all elements of the The FDAs Drug Supply Chain Security Act (DSCSA) as other requirements take effect within the next decade. Key strategies-and potential missteps-can either help synchronize or disrupt the flow of all parties involved in the chain of custody process.
Good companies sometimes make bad decisions when attempting to expedite steps within the chain of custody. "Every business faces a time when it needs to run with a snap decision, but complex processes such as chain of custody do not fall into that realm," contends Tom Wengrowski, executive vice president at TRIOSE, a Wyomissing, Pa.-based logistics management firm specializing in managed solutions for the healthcare industry.
From his experience working with healthcare companies, Wengrowski cites two detriments to the chain of custody process: poor planning horizon and resourcing. "For example, companies know that they will be required to report a piece of information by a certain date in two years," he says. "But instead of developing a plan early, companies procrastinate due to a lack of resources." The result: serious time compression.
Companies must also dedicate time to understanding the projects definition and requirements. "Even great companies sometimes dont take the time to apply the right resources to defining the requirements," he explains. "Jumping into a solution is a common mistake."
Strengthening the Chain
"Shipping pharmaceuticals via air is complicated because some nationalized airport operators have a closed system that limits visibility to what is happening to a package," explains Jon Edgcombe, software group leader at Boston-based Cambridge Consultants, a product design and development firm that provides cold-chain solutions for the healthcare industry. He adds that the process inevitably involves handovers-where drugs come out of a well-controlled plane environment, then sit on the tarmac, only to be placed into a well-controlled environment for the rest of their journey-and is where end-to-end monitoring comes into its own.
Edgcombe also notes that the current chain of custody system-specifically relevant to a shipments last mile-is often subject to a lack of responsibility, authority, and accountability.
"One way to strengthen the chain of custody process is for the organization that ultimately carries the liability to deploy a solid track-and-trace system by using one core identifier that carries through from manufacture to dispense or point of care," he says. The identifier can be associated with GS1 and logistics track-and-trace numbers to tie to existing expiry date and batch code systems with minimal system modification.
Top 10 Health Supply Chain Issues
Recent research published in the academic journal Operations Research for Health Care titled Top Ten Global Health Supply Chain Issues provides insight into the leading challenges across the pharmaceutical supply chain. Through surveys and interviews with 22 industry stakeholders with roles in the global health and pharmaceutical supply chain-ranging from manufacturer to individual facility, the researchers identified key global health pharmaceutical delivery challenges ranked in order of most critical:
1. Lack of coordination; 2. Inventory management; 3. Absent demand information; 4. Human resource dependency; 5. Order management; 6. Shortage avoidance; 7. Expiration; 8. Warehouse management; 9. Temperature control; 10. Shipment visibility.
The authors, who restricted the survey to the delivery of pharmaceutical products in developing regions instead of the "broader overall delivery or health services and products throughout the globe," conclude that they are hopeful that the findings "will drive future actions, policies, and research that can ultimately improve pharmaceutical delivery in developing regions and save lives."
Đăng Khoa: Source: inboundlogistics.com
.png "From production capacity to market positioning: WEPACK 2026 as Vietnam packaging's moment to move beyond contract manufacturing")