The Role of Digital Passports in Preventing Off-Label Usage

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 do you see the role of digital passports evolving in preventing off-label usage and ensuring patients receive the correct medication?

Johnson: From what I do know, it's really a means of tracking the product from conception or production all the way through. Obviously, it will help to support compliance standpoint of the patient taking the pharmaceutical medication, while also helping doctors and caregivers through the fact that it is being prescribed as intended. What's not clear to me is who's tracking all of that. I think that whole digital passport concept is another step in the right direction, after years of focusing on serialization and having serialization be a way to track the product, but I'm not as clear on the steps and how it will be managed and who would have access to that information at this point in time.

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.