Trace Elements

All inventory is important, but when it comes to products that can actually affect a person’s health, authenticity and safety are especially critical.

This is particularly true in the pharmaceutical industry, which is in the midst of a sea change toward a serialized supply chain.

In 2003, Shabbir Dahod, chairman and founder of Woburn, Mass.-based SupplyScape, put his background in software/application development to use by creating the ePedigree solution that is currently being used or tested by seven of the top 10 pharmaceutical and biotech companies, 80 percent of the specialty distributors, many of the leading pharmacy chains and a leading third-party logistics provider.

ePedigree functions in a fairly straightforward manner. Much like the title of an automobile, it seamlessly shows the history of a product’s previous owners, following it through all levels of distribution. “We were working to generate patient safety enhancements,” Dahod says. “But we ended up creating enhancements for all of the network.”

The FDA established the Prescription Drug Marketing Act (PDMA), which required pedigrees to be associated with products, in 1987. This national pedigree requirement was supposed to have taken effect by the end of 2006, but it ended up being blocked by court order.

In the interim, at least 35 states have passed pedigree laws of their own, and federal legislation is once again being considered.

It’s not that counterfeit problems are rife within the United States; it’s the fact that, in an increasingly global economy, opportunities for fraudulent transactions are greater than ever. According to the FDA, counterfeit drugs account for 7 to 10 percent of the global pharmaceutical market, with theft and other losses totaling more than $40 billion annually.

Looming large on the horizon is Jan. 1, 2011, the hard date for compliance in California; it’s a deadline that Dahod sees as a “galvanizing date for the industry.

“What we find is that companies are moving forward now because they realize the amount of time they will have to comply is very short,” he says. “As you can imagine, to serialize all of your products, to update all of your receiving, and manage all of your shipping operations, that all has to be done with great attention to detail.”

Within the next decade, Dahod predicts, “it will be quite expected that when we buy and sell any food or drug, it will come with a pedigree so that we will know exactly where it’s been, and who had it when, so we can rest assured that it has traveled a safe path.”

Around the same time that ePedigree was being developed, multi-billion-dollar pharmaceutical supplier H.D. Smith was looking for answers of its own. In 2005 it entered into a pilot program with SupplyScape and Stamford, Conn.-based Purdue Pharma to test the ePedigree solution before Florida’s rules went into effect “and it met our expectations and more,” says Robert Kashmer, vice president of IT for H.D. Smith.

“We were easily able to integrate it into our existing warehouse management system. One of the pieces we were looking at was how hard it would be to interface this software. But we were very pleased, at every level, at how easy it was to use and how fast we could bring it to a full production phase.”

Depending on the facility or the requirements of a particular state, H.D. Smith “can track at the item level or from the manufacturer, at the serial level, down to the individual bottle,” Kashmer says. “We can then track the product through the distribution center to the customer, so the customer can look at the pedigree if needed.”

Rx for product recalls
Next up for SupplyScape, Dahod says, will be solutions for dealing with pharmaceutical recalls.

“Companies should be able to know precisely whether any product they have or ever have had is on a recall list,” he says. Currently, when there’s a pharmaceutical recall, manufacturers “send out faxes to those they have sold the product to, or call them. But that process takes forever.”

Some multi-national companies, Dahod says, “actually use sticky notes on their shelves with the numbers being recalled, and then pick up the bottles and say, ‘Oh, is that one of them or not?’

“Either that, or they may try to sweep the shelves. That causes disruption in the ability of the patient to receive his medications, a loss of revenue and a loss of efficiency.”