Drug companies, distributors, and pharmacies are all racing to comply with federal pharmaceutical identification requirements ahead of a November deadline.
Contract pharmaceutical manufacturers face a unique set of challenges under the Drug Supply Chain Security Act.
Ashley Umberger, the manager of engineering at Virginia-based Afton Scientific, told Pharmaceutical Processing that her company went above and beyond the serialization required this year in an effort to accommodate a wide range of partner companies.
Afton’s Charlottesville manufacturing plant provides automated aseptic filling of liquid drugs, as well as pre-sterilized and packaged components, under the names Afton Scientific and AnovaFill.
Explosion of Counterfeit Drugs
Although Afton is a relatively small CMO, Umberger said, it provides services to companies worldwide — from small drug makers to industry giants Pfizer, Johnson & Johnson and Takeda.
“The serialization needs for a company like mine … are definitely going to be a little bit different,” said Umberger, who is scheduled to participate in a panel discussion on serialization at INTERPHEX.
As counterfeit medications became increasingly prevalent, the DSCSA — or Title II of the Drug Quality and Security Act — was signed into law in 2013 with the goal of enabling the tracking of drugs through the entire pharmaceutical supply chain within 10 years.
The DQSA was crafted in response to a deadly meningitis outbreak stemming from a Massachusetts compounding pharmacy in 2012, but the law also included measures designed to crack down on the growing problem of counterfeit drugs.
Some estimates indicate that more than 10 percent of all pharmaceuticals in the global supply chain are counterfeit. The number varies from country to country — the percentage in the U.S. is much lower, while the share of counterfeit drugs in other countries could be as high as 70 percent — but the proliferation of online pharmacies facilitated their growth worldwide.
One analysis blamed ineffective or toxic counterfeit drugs for up to 1 million deaths each year, and the problem could compromise any company’s supply chain if it diverted into unauthorized channels.
Implementation of DSCSA
The first phase of the DSCSA, implemented in 2015, required manufacturers, distributors and pharmacies to share identifying information and transaction histories.
The next phase — which will take effect in November — requires companies to create a unique identifier for the smallest sales unit of each pharmaceutical. The serial number, commonly known as a 2D barcode, will eventually enable individual drug sales to be traced from production to the pharmacy counter.
A subsequent phase of the law, called aggregation, would also require companies to mark larger containers of drugs for shipment. Umberger said that stipulation would not take effect until 2023, but that Afton invested in aggregation in order to accommodate clients that already implemented those systems.
“It just made sense to kind of streamline that,” said Umberger, who helped lead the serialization efforts at Afton beginning in the late summer and early fall of 2016.
Umberger said that the primary challenge to implementing serialization stemmed from Afton’s demands for flexibility.
Many larger generic companies have internal serialization practices, while smaller clients would likely ask Afton to provide its own tracking information for those medications.
Umberger said that Afton’s serialization software would need to handle everything from organizing huge files of serial numbers to generating new numbers altogether.
“We really needed something that was going to allow us to make one [production] line work for multiple products,” she said.
Calls for Clarity
Umberger said that contract manufacturers hope that the Food and Drug Administration will define more clearly where CMOs fit on the supply chain between the drug company and the pharmacy.
The industry is also concerned about how distributors will handle different levels of tracking. Some drug makers, like Afton, are already implementing aggregation, while others are simply complying with the minimum requirements through 2017.
In addition, Umberger said that pharmacists are accustomed to deriving information about drugs from their bottles – and that they likely hope to add more than just an alpha-numeric code to serialized pharmaceuticals.
Overall, however, Umberger said that the industry appears prepared to meet the November 2017 deadline.
Analysts indicated last year that most pharmaceutical firms were well on their way to finalizing their equipment and software purchases and, moving forward, would need to continue to install, test, and evaluate their systems in coming months.
Afton Scientific, for one, is ready.
“I think that a lot of people have been able to get the serialization portion down,” Umberger said.