WHY WE DID THIS STUDY
Drug diversion, counterfeiting, and the importation of unapproved drugs may result in potentially dangerous drugs entering the drug supply chain, posing a threat to public health and safety. To enhance the security of this supply chain, the Drug Supply Chain Security Act (DSCSA) requires trading partners in the drug supply chain to create a record of each drug product transaction. FDA can use these records to investigate and identify potentially harmful drug products, prevent further distribution, and facilitate efficient recalls.
This is the third OIG study about the security of the drug supply chain. The previous two studies found that overall, selected wholesale distributors and dispensers were moving toward full implementation of DSCSA requirements for drug product tracing, although we found that some tracing documents were missing required information.
HOW WE DID THIS STUDY
We used drug product tracing information to trace-backwards through the drug supply chain, from the dispenser to the manufacturer-44 high-risk drug products billed to Medicare Part D by high-risk dispensers. We reviewed trading partners’ tracing documents to determine whether information necessary to trace drugs was present and accurate. We also surveyed wholesale distributors and manufacturers to obtain information about their documents and interviewed FDA to understand how our results impact its investigations and the safety of drugs in the supply chain.
WHAT WE FOUND
We found that the ownership of 37 of 44 selected drug products could be traced through the supply chain using drug product tracing information that the DSCSA requires. Seven selected drug products could not be completely traced to manufacturers. Typically, this was because tracing documents exchanged between the wholesale distributor and manufacturer were missing or had mismatched tracing information. In one instance, a wholesale distributor refused to provide tracing documents. When tracing information is missing or mismatched, a complete tracing record for a drug product may not always be available to support investigations of suspect or illegitimate drug products in the supply chain, which could delay investigators. Indeed, staff at FDA reported that accurate tracing information is critical to identifying a drug product quickly in the event of a recall or when removing an illegitimate drug product from the supply chain.
Additionally, for 21 of 44 selected drug products, we found that-unlike with their ownership-we could not trace their physical movement through the supply chain using tracing information. We could not identify the shipping locations of trading partners (e.g., manufacturers, wholesale distributors, and dispensers) or of third-party logistics providers that shipped or stored the drugs on behalf of the trading partners. Although the DSCSA does not require this information, should FDA not have access to this information in case of a drug safety emergency, FDA and other investigators would need to request additional documents, which could delay investigations and hamper FDA’s ability to identify sources of potentially harmful drugs in a timely manner.
WHAT WE RECOMMEND
We recommend that FDA follow up with the wholesale distributor that did not provide tracing information. We also recommend that FDA offer educational outreach to trading partners about required drug product tracing information and data standardization guidelines. Lastly, we recommend that FDA seek legislative authority to require information about a drug product’s complete physical path through the supply chain on tracing information. FDA concurred with all of our recommendations.