Patients need access to critical medication information. A new FDA rule would limit it

Medical professionals know that sharing clear and accurate health information with patients empowers them to make wise decisions that set them on a path to healthier living. Educating patients about their prescription medications is especially important. Since millions of Americans rely on prescription medication, effective patient medication information (PMI) is more important than ever. 

PMI is the pamphlet dispensed with prescriptions at the pharmacy that includes critical details like side effects, directions for use and common mistakes to avoid. Receiving PMI at the pharmacy allows patients to engage with their pharmacist, ask questions and review the information about taking their medications correctly. For patients with complex prescription regimes, having this information on hand can be the difference between staying healthy and ending up in the emergency room.

As a former regulator who worked at the Food and Drug Administration (FDA), I am baffled that the FDA recently proposed a rule that would likely limit access to this critical information. It seems like the FDA is attempting to shift PMI exclusively to a digital format. And while this seems to be a good-faith effort, PMI doesn’t have to be either digital or print — it should be both. 

In addition to being a practicing doctor who regularly treats patients, I serve as the chief medical officer at WebMD, the nation’s leading online health education platform. I would not work with WebMD if I did not believe in the value of digital tools in educating patients.

But that doesn’t mean all information must be entirely online. There’s a reason some of the most important documents in our lives are physical — from birth certificates to car titles — and why printed books still vastly outsell e-books. For many people, a printed format simply works better at conveying information, which is why it makes little sense that the FDA would rip life-saving printed information from patients’ hands. At a time of rampant misinformation for which the FDA expressed an explicit priority to combat, the FDA should be making it easier for patients to learn about their medications, not harder.

It’s a general principle of medical practice that when educating patients, it’s important to meet them where they are. While some may be comfortable using an online link to access their PMI, many elderly or poor patients lack the technological skills necessary to do so.

Also, if a patient is taking multiple medications simultaneously, cross-referencing can be quite difficult electronically. Merely handing patients a digital link to use later ignores that health care information is best communicated at the point of care, when patients are most likely to be interested and engaged. The FDA is all but ensuring that many patients will struggle to access that information. 

The FDA tried to account for this by requiring pharmacists to print PMI upon request. But this is flawed thinking that is impractical and unrealistic. Most patients will not know or remember to ask their pharmacist for PMI anyway. In fact, asking for PMI shouldn’t be the patient’s responsibility at all. As a health care community, it’s our collective duty to provide patients with everything they need to stay healthy — not create new barriers to life-saving information.

The FDA’s own calculations about this rule show that requiring pharmacists to print PMI would pile on an additional 81 million hours of labor and cost pharmacies an extra $1.6 billion annually. Given that pharmacists are already overworked, this added burden would seriously jeopardize pharmacy care and patients’ lives. We say we are committed to addressing burnout — how does adding more work address that?

There’s another issue with the FDA’s rule, and that is the format of PMI itself. Currently, there’s no standard for formatting PMI, which means much of it is confusing, bloated, too small to read and too complicated to understand. While the FDA is standardizing PMI format in this rule, it never once tested the new format on patients to gauge whether it will be an effective educational tool.

This is odd given the importance of this information and given that in other areas, the FDA’s Office of Prescription Drug Promotion extensively studied how patients respond to pharmaceutical advertising. It is deeply troubling that they aren’t allocating similar resources to understanding patient education. 

This issue may seem trivial, but make no mistake: It will impact thousands, if not millions, of people. Already, 1 in 4 hospitalizations and more than 125,000 deaths each year are the result of medication errors or adverse drug interactions. By limiting access to critical medication information, the FDA may inadvertently push these numbers higher.

Everyone at the FDA, including Commissioner Robert Califf, does incredible work to make our nation safer and healthier. But the recently proposed rule is seriously out of touch because it lacks a fundamental understanding of the process for when patients receive medications and their interactions with the pharmacy.

The FDA’s mission is to put patients first, but this new rule abandons that mission by limiting patient access to critical information. The FDA should protect printed medication information for every patient in America.

John Whyte, MD, MPH, is chief medical officer at WebMD.