Integrating Digital Solutions to Enhance Traceability and Safety in Drug Administration

Drug labeling has become a key issue in the pharmaceutical industry. Mislabeling has frequently led to providers prescribing the wrong medications to their patients. In an interview with Pharm Exec, Laura Johnson, senior director, sales, life sciences, Loftware, discussed key challenges of drug labeling, ensuring that labels are easily understood, unclear labeling, and the role of digital passports.

PE: How can integrating digital solutions, like digital passports, enhance traceability and safety in drug administration?

Johnson: I think conceptually, having this digital passport is going to allow for more visibility to where that product has traveled within the supply chain. If it’s something that's counterfeit or off market, there can be some legal trafficking or identification back to where the original source was coming from so we can educate the general population that they shouldn't be taking it or using it. There’s always the side of it that we touched on earlier in the conversation about the different regulatory requirements. I would imagine that digital passports are also going to link back to what was the original, intended use and approved use for these different pharmaceuticals. Having that depository of what's been approved in the United States by the FDA or potentially in Europe by the different medicine agencies, I think the regulatory compliance side of things is certainly something that would be a benefit of a digital passport. I mentioned serialization earlier. Back in the day, I had some experience with RFID technology, and that was a way to have a higher level of security. I feel like in digital passport, it’s kind of this two-step authentication. It’s not just this identifier on the product, but it's also that verification behind the scenes. So, anything with a high level of security is definitely a benefit.

Full Interview Summary: The pharmaceutical industry faces significant challenges regarding drug labeling, with mislabeling or misunderstood labeling potentially leading to serious consequences, such as injuries or hospitalizations. One key issue is patient comprehension, especially for those with low health literacy. Many patients may not fully understand the purpose of their prescriptions, potential interactions, or adverse effects, especially when dealing with multiple medications. This highlights the importance of clear, comprehensive labeling that goes beyond the physical bottle to include all necessary prescribing information, warnings, and adverse effect details. However, this information is often overlooked, leading to gaps in patient understanding and safety. A major challenge arises from the disconnect between manufacturer labeling and what patients receive at pharmacies, particularly when medications are repackaged. Inconsistent transfer of important information, such as expiration dates or allergens, can cause confusion and even lead to medications being discarded, as happened with certain COVID-19 vaccines during the pandemic. Innovations in labeling, such as electronic labeling (e-labeling), present opportunities to improve patient outcomes. With technologies like barcodes or QR codes, patients and caregivers can access detailed information online, which ensures the most up-to-date data is available. Additionally, digital passports are seen as a promising tool for tracking a drug's lifecycle, ensuring compliance, and preventing counterfeit medications. While the implementation of such digital solutions is still evolving, their potential to enhance traceability and safety in drug administration is substantial, particularly in regulatory compliance and security.