Pharmaceutical counterfeiting is a serious, pervasive threat; according to the World Health Organization, fake drugs drain the global economy of as much as $200b in lost profits annually. Considering the risk to patient safety, it is an issue with potentially deadly consequences.
Michael Bartholomeusz, TruTag CEO, told Outsourcing-Pharma that the pharmaceutical industry is highly focused on finding ways to defeat counterfeiters.
“Pharmaceutical companies and the industry at large are acutely aware of the problem of counterfeit and diversion and have expended enormous effort, resources and money around grappling with the problem,” he said. “A lot of the pharma industry’s efforts have been a result of the 2013 track-and-trace bill passed by the US Congress.”
To date, he commented, much of the work by pharma companies, their production and packaging partners, and other stakeholders has been centered on packaging solutions.
“The entire pharmaceutical supply chain — from manufacturers to distributors, wholesalers and retailers — presently uses packaging level serialization to fight counterfeit and diversion, as mandated in the 2013 track and trace legislation,” he said.
However, Bartholomeusz surmised, spending so much time, attention and effort on thwarting counterfeiters via packaging techniques falls short.
“The problem with serialization and other packaging level measures is that once tablets and capsules are removed from the packaging or containers, all bets are off,” he told OSP. “Fake products can be easily substituted into genuine packaging, and the supply chain is none the wiser.”
To help step up the fight against fakery, Bartholomeusz said, pharmaceutical companies are beginning to explore on-dose track-and-trace technology. His firm has partnered with tablet coatings firm Colorcon on SoteriaRX, a line that empowers pharmaceutical firms to transform their tablets to “seamlessly enable” on-dose track and trace.
“Pills must be protected on the on-dose/item level to ensure that the genuine product is in genuine packaging and that counterfeits are unable to quietly enter the supply chain,” he said. “The certainty that on-dose authentication offers is crucial; it enables pharma to fully protect the health and safety of the end-patient, as well as mitigate the tremendous cost burden fake pharma imposes on the global health care system.”
Other anti-counterfeit technology the industry might see in use in the near future, Bartholomeusz said, involves an app that enables a user to point their smartphone at a tablet, scan and verify.
While pharmaceutical counterfeiting might never be completely eradicated, he said, the challenge is worth taking on.
“There will always be counterfeits in the supply chain—however, that doesn't mean that patients need to be exposed to them. That's why it's essential that we identify counterfeit pharma before they get to consumers, he said.”
“To do this, we need to empower every patient to be able to authenticate their medicines. Fortunately, the technology exists to do this today in a cost-effective manner,” Bartholomeusz remarked.