Since the start of the COVID-19 pandemic, pharmacies have been exceptionally overwhelmed, overburdened and understaffed. The outbreak caused pharmacies to become the frontline of public health, handling COVID-19 testing and vaccinations, and distributing critical medicines, all while maintaining regular prescription services.
This surge in demand, which was needed during the pandemic, has not let up. Leading to staff shortages, increased workloads and disrupted supply chains, the situation was exacerbated by stress for pharmacists. Those additional responsibilities took time away from the one-on-one time millions of Americans were used to getting with their pharmacists to ask questions about their medications.
More and more, Americans are relying on printed patient medication information (PMI), the insert included with their prescription, for information about side effects, drug interactions and instructions. With face-to-face time with their pharmacists dwindling, Americans know how important it is to ensure the PMI is understandable and accessible.
Last year, the Food and Drug Administration released a plan to standardize and improve PMI because Americans are receiving different types of PMI. The FDA is correct, we need to standardize PMI. However, after looking at the proposed PMI, I think the FDA has missed the mark. Not only that, but its proposed PMI would make matters worse. The version is hard to read and hard to understand, and it incentivizes using PMI in a digital format only. The rule creates an unfunded mandate on already overwhelmed pharmacies, costing pharmacies $1.6 billion and requiring 71 million more staff hours annually.
A newly released survey of consumers nationwide found that 92 percent of respondents prefer the easy-to-read, color-coded PMI format designed and tested at Duke University Medical Cognition Laboratory. This isn’t surprising, considering the FDA’s version wasn’t designed using cognitive science.
The FDA’s push to go digital is also a problem. Digital PMI may be accessible for those with smartphones, technology skills and consistent internet access, but many older, rural and low-income populations lack that access. The same survey found that 64 percent of consumers would have difficulty accessing PMI if it’s distributed electronically instead of print. This would only exacerbate healthcare disparities between the haves and the have-nots. Keeping PMI printed is the only way to ensure that every patient — regardless of age, location or income — has access to this sometimes life-saving information.
The data prove that the FDA must reconsider how it designs and distributes PMI. The goal of standardizing PMI is to ensure patients have clear, concise and accessible information about their prescription drugs. We can’t achieve that if Americans don’t understand it, don’t retain it, discard it immediately, or lose access because it’s stuck behind a QR code.
While the FDA’s intentions are correct, its first attempt fell flat. We can’t afford to get this wrong, and public health is at risk. The FDA should re-evaluate its proposed PMI to ensure it is designed using cognitive research and printed.