Pharmaceutical pedigree requirements have been in flux for many years. State governments, federal agencies, and industry have battled over the most secure and efficient method to reduce counterfeiting and diversion by tracking the movement of drug product through the supply chain.
FDA's recall classification system includes Class I recalls, in which the product can cause serious injury or death; Class II recalls, in which the product can cause a temporary or slightly serious health problem; and Class III recalls, which violate manufacturing or labeling laws but do not pose a serious health risk. In one case, the recall of 100,000 bottles of counterfeit cholesterol medicine cost a major North American pharmaceutical manufacturer $55 million (1).The methodologies used by counterfeiters are also improving. Not only are there more and more low-cost and illegal pharmacies proliferating on the Internet (many based in Canada and Mexico), but there is an ever-growing number of offshore manufacturers pushing unlicensed generic drugs into the US pharmaceutical supply chain.
Industry and government recognize that pedigree information needs to be electronically recorded to better secure patient safety. Yet there is no agreement on the best way to make it happen.
The federal government has been working for years to develop a standard for a secure electronic version of the chain-of-custody requirement (ePedigree), but it has stalled because of technical and legal challenges. Although initiatives remain to create a national ePedigree standard by as early as 2011, many states have enacted their own requirements for firms doing business within their borders.
Taking ePedigree in a new direction, California is the first state to require that companies create a unique serial number for each saleable unit. The use of serialization in conjunction with a pedigree can help authenticate a drug, ensuring that it does not negatively impact patient safety and security. Serialization refers to a numerical system that assigns a unique number or identification code to each packaging unit. A serialization scheme is built around a code structure that typically identifies the manufacturer, the product type, and each specific item unit.
Today, most drugs are not serialized at the item, case, or pallet level. A lot number and expiration date is stamped on each saleable unit (e.g., the box or inner-pack) of a pharmaceutical product. But very soon, each of these retail units sold within California will need to have its own unique serial number to distinguish it from other saleable units within the same manufacturing lot.
This serial number, which is the key piece of data that enables the recording of every step in the chain of custody along the supply chain, must be created and maintained in an interoperable electronic system, along with the ePedigree. Implementing such a serialization solution creates a fresh set of challenges for enterprises working within the pharmaceutical supply chain. Because the vast majority of pharmaceutical manufacturers conduct business in California, organizations will be forced to comply. As a result, some believe that California's mandates will soon become the national standard.