Supply Chain Security: 3 Visions To Prevent Fraud And Safeguard The Patient
By Trisha Gladd, Editor, Life Science Connect
The vulnerability of the pharmaceutical industry’s supply chain has been talked about in great depth, especially since the passing of the Drug Quality and Security Act (DQSA) last November. Millions of stolen, counterfeit, and illegal medications infiltrate pharma’s shipping lanes every year, and despite all of the buzz, experts are pumping out viable solutions at a much slower rate than criminals are distributing contaminated and/or fake drugs.
The FDA remains vigilant in its efforts to secure the global supply chain, but it is only one governing body in a world full of consumers. In the U.S. alone, it was estimated last year that 70 percent of Americans take at least one prescription drug. This statistic is staggering when you consider how many people in a population of over 315 million are in danger. With increasingly sophisticated threats putting these patients at risk, what can we do to protect them? Where do we go from here?
While the DQSA has promise, its plan of putting together an electronic, interoperable system to identify and trace prescription drugs is scheduled to take nine more years and still only brings the industry to the back door of the pharmacy, where many experts believe our greatest risks exist. These experts are skeptical that, even after the time and cost companies will put into preparing for the regulation, the DQSA will not have a major impact on the exploding need for stronger supply chain security.
In this edition of Pharmaceutical Online E-Magazine, we offer the insight of three industry experts who have their own ideas of what we can do to protect our drugs as well as the patients who depend on them. In the first article, Walter Berghahn, executive director of the Healthcare Compliance Packaging Council (HCPC), offers a provocative take on pharmaceutical packaging and discusses the astounding fact that, while the supply chain is indeed at risk, we have ignored an obvious security issue. This is the fact that the bottle holding the medicine we have spent millions to manufacture, transport, and protect is the same antiquated design used for over 60 years. He also addresses the lack of focus the DQSA has at the pharmacy level and presents some confounding facts about how susceptible to illness and even death this misstep leaves our loved ones.
At the ISPE-FDA cGMP conference in June of this year, Illisa Bernstein presented the audience with an overview of what the FDA has done so far to address security needs and what the future plans are, specifically regarding the FDA’s recent decision to revisit its supply chain strategy. In an article written by Ed Miseta, executive editor of Pharmaceutical Online E-magazine, Bernstein reminds readers that the FDA can do only so much, and it will be not only its actions but also the actions of everyone in the industry that will help prevent illegitimate drugs from entering the marketplace.
Finally, Jim Murphy, president and managing director of Almac Clinical Technologies, discusses the concept of connectivity in pharma and how optimizing production and distribution requires a coordinated oversight of the entire supply chain, a feat he believes can be accomplished using interactive response technologies (IRTs). Through real-time patient information and drug-related activities throughout the life of the study, Murphy says it is more than possible for a company to improve supply efficiencies, which is yet another way to protect the product and the patient.
As always, it is our continued effort at Pharmaceutical Online to advance the industry through valuable and actionable information, and we believe that is exactly what you’ll find in this issue. I can’t promise these solutions will undoubtedly protect the supply chain, but as my mom has always said, “You don’t know unless you try.”