Nearly 48 percent of high-risk drugs could not be traced through the entire drug supply chain, a report from the Office of the Inspector General found.
The OIG traced 44 drugs it determined were high-risk from manufacturer to wholesaler to pharmacy. It determined the drugs were high-risk based on cost, demand and prior evidence of diversion, counterfeiting or theft. Examples included Gilead's HIV drug, Truvada, and AbbVie's rheumatoid arthritis drug, Humira.
The physical movement of 21 of the 44 drugs could not be traced all the way through the supply chain, the report said.
The OIG reviewed Medicare Part D claims billed between January and May 2018 and focused on claims handled by high-risk pharmacies, meaning those that dispense drugs in combinations that could lead to severe adverse reactions in patients.
"Not being able to trace a drug’s physical movement delays FDA and other investigators and makes it more difficult to ensure that potentially harmful drugs do not enter the supply chain," the report said.
The OIG recommended the FDA better educate companies about paperwork requirements as well as seek legislation to require information about a drug product’s complete physical path through the supply chain.
The report comes amid rising fears of the safety of the global drug supply chain during the coronavirus outbreak, as well as efforts from the Trump administration to allow importation of prescription drugs from Canada.
Read the full report here.