With reports that Covid-19 vaccines are being stolen and sold on the black market, Tom Knight, CEO of Atlanta-based inventory visibility and analytics firm Invistics, says he saw this coming back in April 2020.
He was far from alone: “Nearly everyone familiar with drug diversion, or the illegal transfer and theft of controlled substances, knew that such a valuable product, with such a high profit opportunity, was likely to be stolen,” he says.
While the vast majority of healthcare workers do the right thing, he adds, and vaccine manufacturers should be applauded for their security efforts so far, this is not a new problem: High-value controlled substances, particularly opioids, as well as non-controlled substances such as high-priced oncology drugs, are regularly stolen and resold across a huge black market. In 2019, the Joint Commission, the nation’s oldest and largest healthcare accreditor, issued an advisory urging healthcare systems to detect and prevent the diversion of controlled substances by employees. And according to the CDC, drug diversion through opioid tampering has even led to infectious outbreaks in hospitals around the U.S.
Anyone familiar with the scope of drug diversion would realize early on that “these Covid-19 vaccines will likely be some of the most diverted medications in the history of mankind,” says Knight.
Security Challenges Across Complex Healthcare Supply Chains
Covid-19 vaccine security vulnerabilities create massive challenges for healthcare supply chains, with risk of diversion at every link along the way, from the manufacturer to the distribution channel and the courier.
“The closer you get to the patient, the greater the risk of diversion,” says Knight. A manufacturing facility may have huge pallets coming off a production line, but it can be heavily secured, including with gated fences. But for each step a drug moves closer to the patient, the fewer resources there typically are to protect it.
“In most cases, Covid-19 doses for nursing homes are being shipped to retail pharmacy stores and walked through the front door, and then taken in a personal vehicle to the long-term facility,” says Knight. In hospitals, he points out, the need for extra-cold storage of Covid-19 vaccines means that they might not be stored in the most-secure locations (a vault in an interior room, for example, which is where narcotics would traditionally be stored).
“Sadly, the short supply, financial incentive and people desperate for the vaccine can lead to legitimate doses being diverted,” he says.
Drug Diversion Programs Help Shore Up Security
For years, the CDC has urged healthcare organizations to implement drug diversion programs in their facilities to prevent, detect and properly report instances of diversion. And since 2017, Invistics has received NIH research grants from the National Institute on Drug Abuse (NIDA) to tackle drug diversion detection in healthcare facilities. Knight also helped found a nonprofit which offers a national database for drug diversion in healthcare facilities.
It’s a tall mountain to climb: A 2020 survey by Porter Research found that only 36% of respondents were confident in their current drug diversion programs.
The key to success is for healthcare facilities to view their inventory through the lens of data-driven supply chain issues, rather than clinical workflows, says Knight.
“Our technology uses AI and machine learning to pull in data that healthcare already has but may not look at for this purpose,” he explains. For example, rather than only examining data from locked cabinets with controlled substances, organizations should connect and analyze other data points including electronic health records, the time of day drugs are administered, patient pain scales and other alerts.
The good news for Covid-19 vaccine security is that they are reportedly being put into vials specially-made by Corning embedded with identifiers under black light to prevent counterfeits — which will likely be an even greater threat than theft, Knight says. In addition, he adds, the federal government’s public-private partnership, Operation Warp Speed, has implemented significant security efforts to protect the vaccines.
Finally, simple approaches such as buddy systems during vaccine transport can help: “Two people, one serving as a witness, greatly reduces the likelihood of diversion,” he says.