Challenges of Unclear Product Labeling on Patient Outcomes

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: Can you share an example where unclear labeling led to challenges in the market or patient outcomes?

Johnson: The one that resonated with me was that during covid, with all of the emergency approvals that were taking place for the vaccines, it was a very unique situation where lots of manufacturers were trying to just get the vaccines out as quickly as they could. We heard a number of reports on some labels and some products going out without expiry dates on them, and the different aid personnel in remote locations who potentially didn't speak English or understand the different symbols or understand the format of those labels. I had heard that there was a large portion that were discarded because they just didn't know if the product was still valid for use.

The example that I heard was that it had a manufacturer's date on it, but it didn't have an expiry or used by date. I think that goes to the fact that right now, manufactures say that while there are a number of things that have to happen before a product is approved, those efforts are to make sure that the product label has he information that's needed, it’s clearly written, and people can quickly understand exactly the intent of it.

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.