 ![]()
 Email
for more information
Email
to a colleague
Printer
friendly format
|
|
The State of the Pharmaceutical Supply Chain Safety and Security
Vigilence and technology are the order of the dayBy Andy Macaleer
Director of Pharmaceutical Solutions
Acsis, Inc.
According to the World Health Organization, counterfeit medicines are a $32 billion global business and the Food and Drug Administration said it conducted 54 investigations in 2006 - almost double the number in 2005. The largest prescription drug recall in U.S. history occurred in 2003 after Pfizer discovered tens of thousands of bottles of counterfeit Lipitor, the top-selling cholesterol medicine. In the short time from discovery to recall, the fake medications had spread to 15 U.S. states.
In addition to monitoring counterfeits, these organizations have to closely manage product expiration. The leading reason for the return of prescription drugs is due to products sitting in the supply chain too long and expiring before they can be dispensed. The Healthcare Distribution Management Association reports that the pharmaceutical industry incurs $2 billion a year in returns and product losses and incurs another $2 billion annually in the costs associated with processing returns, expirations and recalls.
The public as well as Congress are trying to understand the extent of the problem and want a process in place to ensure a safe and secure supply chain for prescription drugs and to know that that counterfeiting is minimized to the fullest extent. The U.S. Congress passed the Prescription Drug Marketing Act in 1988, which includes a “pedigree” rule mandating a detailed record of a drug‘s movement through the supply chain from the manufacturer to the point of dispensing, in order to help combat drug diversion and counterfeiting. In addition, Department of Defense suppliers are required to use active and passive RFID tags on shipments to the military.
How are drug companies supposed to know and keep track of where their product is at any time? How can they know exactly which drug, from which batch, has been counterfeited, needs to be recalled or has expired? How can they pinpoint exactly which pharmacies, hospitals, or stores the tainted product has been shipped to at any given time? The processes involved with creating a product, from raw material through packaging and shipping, are vast and complex. The ease with which goods move throughout the supply chain permits counterfeits produced in one region to be moved to another without notice at very high profit and with very little risk.
The current situation
Currently, most companies manage finished product at the batch or lot level. If a counterfeit or defect is uncovered that necessitates a recall, the only prudent way to recall the product is to recall the entire lot of batch - potentially making the recall wider in scope than may be necessary. This means added cost for the manufacturer and the retailer in lost inventory, as well as a reduction in consumer confidence.
Further, with the widespread use of contract manufacturing in the industry, much of the drug product is manufactured in one location by one company, shipped elsewhere for packaging, and shipped once again to the owner of the brand for distribution to retail. The more times a product changes hands, the easier it is to introduce counterfeits into the system. Businesses need the ability to trace movement of product not only within their own operations, but at 3rd party partners for manufacturing and distribution, and downstream in the supply chain to the point of dispensing. Instead of trying to recall an entire batch, a company needs to be able to identify down to the individual unit of sale (i.e., pill bottle, blister pack) which items have been impacted by counterfeiting or expiration, and to whom the product has been shipped and where currently resides.
Technological developments
Four years after the discovery of counterfeit Lipitor, the world’s top pharmaceutical companies are devoting millions of dollars to experimenting with new technologies to battle the rising tide of phony drugs that are making their way into patients’ hands. Manufacturers have realized they need to find more and better technologies and capabilities, such as overt packaging techniques, serialization and pedigree, to keep counterfeiting from thriving.
These technologies are imperative for gaining visibility into the prescription drug supply chain. According to a recent industry analyst reports, track and trace technologies have the potential to deliver positive ROI across the entire supply chain. While many businesses were motivated to implement track and trace technology for operational efficiency, research suggests that manufacturers may realize even greater benefits from visibility into the supply chain by reducing the impact of returns processing and product recalls and curbing counterfeiting.
Track and trace capability orchestrates, automates and tracks intra- and inter-enterprise movement and storage of finished goods through the use of barcoding and RFID tags - internally from receipt into and out of inventory to the picking, packing and shipping processes. Track and trace capability facilitates greater control over product recalls and product quality, and most importantly, pedigree and serialization capabilities can be implemented to be technology agnostic and customized as standards issues are resolved and associated changes to the solution need to be made.
Serialization is the process of printing a serialized barcode or applying an RFID tag directly to the product so that it can be monitored throughout the distribution process. RFID can be implemented to both compliment barcode and to automate processes that are not already automated by barcoding, both of which providing additional operational efficiency. The benefit of RFID is to automate a process or transactions that can be done “headless” or without human intervention. Most companies today have automated their inventory management and pick, pack and ship processes with existing technologies, but all requiring human intervention.
Companies can now facilitate the authentication of serialized drug product by distributors or retailers, which provides manufacturers with real-time visibility to where its product physically resides at that time in the downstream supply chain. This visibility and data facilitates the ability to recognize counterfeit situations, identify expired product and perform targeted recalls. As an added measure, retailers could provide access to or sell the pedigree back to manufacturers, which would give the manufacturers not only visibility to where the product physically resides, but also the specific path it took to get there through the supply chain. Like the data the manufacturers are provided by the distributors in fee-for-service agreements, the pedigree data is invaluable to a manufacturer.
For example, when Boston Scientific faced a voluntary recall of one of its stent delivery systems, the company was able to pull the units in question and resupply the market within 48 hours with virtually no back orders. The prompt and effective response helped to greatly minimize bad publicity. This was due in large part to the company’s commitment to supply chain optimization. This type of efficiency and responsiveness impacts more than the bottom line. The reality is that faster, more accurate recalls improve patient safety.
Speed is paramount
When it comes to identifying counterfeits and recalling product, manufacturers need to do it swiftly. Moreover, through the use of serialization, they’ll be able to identify with pinpoint accuracy exactly which items are affected - minimizing the number of units involved in the recall. Comprehensive track and trace solutions that integrate the entire shop floor may be deployed under pressure from regulators or retailers, but businesses are seeing a significant return on investment and recoup the cost of implementation of these systems by improving distribution process and operational efficiency, minimizing product recalls, enhancing consumer confidence in product quality and ensuring their continued loyalty to the brand.
|
