Your Drug Is Only as Good as the Information Attached to It

By January 27, 2016 April 30th, 2018 DSCSA, Serialization, Toolkits

A long and complex drug supply chain is rife with vulnerabilities. A recent recall shows why serialization is creating a safer and more transparent worldwide system for drug manufacturing and distribution.

A customer reported that the package of Hospira injectable magnesium sulfate was mislabeled on the primary container, which identified the package as Heparin sodium 2000. It’s a small mistake: The product itself was perfectly safe, the name on both the container and the overwrap were correct, and the barcode on the overwrap was also correct. But it’s a mistake that requires Hospira to recall an entire lot of the drug. And, fairly or not, it will probably give healthcare workers and patients pause when encountering any Hospira product in the near future.

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It could have been worse. Let’s say you may manufacture a highly regarded and top-selling drug. But one day it’s discovered that the information linked to just a single package of that drug – identifying its serial number, origin, shelf life, and batch number – is unreliable. That medication is now a suspect and potentially dangerous substance, both in the eyes of the regulatory world, and with patients, who quickly turn their backs on your company. The result is catastrophic, for your company’s reputation and its bottom line. And, as you know, one misstep, even by an industry leader, opens the door for smaller, more innovative companies to step in and conquer a corner of the drug market.

Coming Soon: Serialization Compliance

Thanks to serialization, traceability, and the Drug Supply Chain Security Act (DSCSA), by 2017, issues like those above will be identified long before the drug lands in a patient’s hands.

The DSCSA was put into place to create a more connected and safer supply chain and overcome these four challenges:

  • Counterfeiting: Fake or inferior copies of legitimate pharmaceutical products
  • “Gray” Marketing: Unauthorized marketing or distribution of branded products
  • Complex Regulations: A global web of rules that leave gaps in reporting and tracking
  • Product Mistakes: Mislabeled or tainted drugs sent into the market

With many deadlines on the horizon, pharma companies need to lay out their route to DSCSA compliance, preferably with the help of a partner who can ease them through the process and help them stay on budget.

LSPediA Serialization Toolkit: Compliance, Patient Safety, and Process Improvement  

Built on industry best practices and deployable as a customizable template, LSPediA’s Serialization Toolkit is helping pharma manufacturers, packagers, and distributors implement a comprehensive serialization process into their organizations. Watch some of our customer testimonials to see how some of those companies are lowering serialization spending, shortening project timelines, and onboarding teams faster – all while maintaining complete control over the process. And, to learn how LSPediA can help you achieve the same results, contact me today.