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Drug Labeling Trends: Making Medical Language Accessible to Patients

Drug Labeling Trends: Making Medical Language Accessible to Patients

Patient medical literacy remains a challenge for healthcare providers and pharmacists.

Certainly, many people are turning to the internet to inform themselves about conditions and potential treatments, but many other patients struggle with things like treatment adherence when the directions that come with a prescription drug appear incomprehensible.

The solution, then, is for packaging, drug labeling and prescription instructions to contain more meaningful information. This is easier said than done, however. As multiple studies have shown, there are ways to present drug information more clearly to consumers, but there are systemic hurdles, as well.

Below is an overview of how patient-facing drug information is evolving to support health outcomes.

Accessibility Means Tackling Health Literacy

An important aspect of patient-centricity in clinical trial and care delivery is information accessibility. When treatment plans or instructions lean too heavily on clinical terms or medical jargon, this presents an accessibility challenge for patients who lack that medical literacy.

That’s the majority of patients, too. F. Randy Vogenberg, Ph.D., the editor of the Glossary of Common Drug Related Terms and Acronyms, writes in Managed Healthcare Executive that nine in 10 adults lack the medical comprehension necessary to manage their conditions and treatments.

“For most people this is not due to a lack of intellect, but rather a lack of familiarity with common terminology,” he writes. “This means that those who interface with members—from physicians to customer service representatives—must use the clearest form of language over acronyms and jargon whenever possible.”

This difficulty extends to over-the-counter medications. As researchers Jesse R. Catlin and Eric P. Brass write in a 2018 paper for MDPI’s journal Pharmacy, drug facts labels (DFL) are limited by their static nature. “[I]t is clear from prior research that the DFL falls short in some areas, most notably in the ability to tailor the communication to an individual user’s specific situation (i.e., other medications, literacy level, language ability, age, pre-existing beliefs/attitudes, etc.) or when more complex decision algorithms are required (e.g., statins).”

Catlin and Brass suggest deploying more interactive technologies and empowering pharmacists to help cover this understanding gap. More on that in a moment.

First, though, it’s worth exploring what information gaps can be closed simply via better labeling.

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What Better Printed Labeling Could Fix

Simply editing and formatting the instructions that accompany drugs can be a major help for patients.

In a 2015 article for Drug Safety, researchers Lauren McCormack, et al., presented findings from a survey of more than 1200 consumers. Half of the group was given an unedited FDA Drug Safety Communication for an anonymized drug, and the other half were given a DSC that had been edited. The edited version

  • was written in active voice,
  • rephrased behavioral recommendations to be “more action oriented,”
  • simplified the language,
  • broke up the text with paragraph breaks and subheadings,
  • and took care to contextualize and explain relevant data.

The result? The latter group’s members reported their DSC was more informative and easier to comprehend. “This study provides quantifiable evidence that incorporating clear communication and health literacy principles into risk communication information can significantly increase consumers’ understanding of drug safety information,” the researchers conclude.

“This suggests that greater effort should be made to apply such modifications to highly technical scientific and regulatory topics, especially when safety issues are involved.”

Three years later, a literature review by a team of researchers in Chicago arrived at similar conclusions. Rebecca J. Mullen from Northwestern’s Feinberg School of Medicine was the first author on the paper, which reviewed 49 articles to identify the best practices for label design and formatting.

Among the best practices identified were the “use of plain language principles, typographic cues, quantitative descriptors, and standardized formats, when applicable.”

Around the same time, Wisconsin Health Literacy led a group of collaborators in designing a better prescription drug label. That design focused on the formatting of the information as well as the phrasing of the information. For example, one of the designs, for an inhaler, instructed the user to “Take 2 puffs by mouth 10 minutes before exercise.” This is similar to the change from the McCormack, et al., study that rephrased directions to be more action-oriented.

The lesson from each of these research groups is that small changes can have a big impact on bridging the comprehension gap that so many patients face.

Systemic Challenges That Remain

As mentioned earlier, however, change is easier said than done.

For one thing, the in-pharmacy experience can vary widely for patients, and this includes what information they receive at the point of prescription fulfillment (or at the point of purchase for OTC drugs).

Michelle Llamas at Drugwatch has an excellent overview of some of this. Llamas writes that many pharmacists will apply their own sticker labels to a medication’s packaging (e.g. a blue “For Oral Use Only” sticker), but how those stickers are applied and what information they contain are at the pharmacist’s discretion.

Further, Llamas notes how FDA-approved medication guides can come with filled prescriptions, but those may or may not get handed out.

Weak federal regulations are partly to blame for this disparity among pharmacies. Federal law requires pharmacies to make reasonable efforts to provide translation services for prescription instructions, but they’re often very limited,” Christina Ianzito at AARP writes. “California is one of a handful of states with firmer regulations, requiring pharmacies to offer instructions in Spanish, Chinese, Vietnamese, Korean or Russian on request.”

Therefore, the patient’s choice of pharmacy impacts how much information that patient receives about a given medicine.

This isn’t the only systemic challenge, though. FDA comprehension studies also contribute to the fact that many drug labels are so incomprehensible for many people. These studies are required at various stages in a drug’s lifecycle, researchers Morris S. Whitcup and Keith LaMattina write.

When a drug is newly introduced, when there are formulation changes or when the drug moves to OTC, for example, the FDA can require the manufacturer to conduct a study into how well consumers understand the drug’s labeling.

Whitcup and LaMattina write that one potential point of failure in these comprehension studies is when the drug company doesn’t adequately specify the label’s primary and secondary communication objectives. And when you set your objectives too high, you create a higher risk for failing that study. This creates an incentive to make a drug’s labeling minimally comprehensible, but not terribly useful.

Finally, pharmacies have a software limitation. Katie Gerhards, content marketing manager at the University of Wisconsin-Madison School of Pharmacy, writes how some pharmacy software only allows for printouts in certain font sizes and certain styles. Therefore, any attempts to roll out industry-wide label redesigns will run into problems when a pharmacist’s printer can only produce all-caps labels in an 8-point font.

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Digital Solutions for Patient-Centered Labeling 

Digital technologies could solve some of the systemic challenges outlined above.

For example, digital labels aren’t restricted by space or by what font the software can print. They’re also much more responsive than paper labels, writes Amy Loerch, former managing editor at the International Society for Pharmaceutical Engineering. “[W]hen expiry data change—an especially frequent occurrence with biopharmaceuticals—each package must be manually relabeled, a costly and time-consuming process.”

A digital label (sometimes “eLabel”) could simply be a bar code, QR code or an NFC tag that consumers could scan with their phones. Having the person’s phone be the interface for information receipt opens up a world of new possibilities.

For example, Arne Rehm at Schreiner MediPharm suggests storing explanatory video and audio files on an NFC tag. These, he writes, “are particularly helpful in the case of pens and autoinjectors because using them properly often requires several steps in the correct sequence and the handling of such injection aids is not always intuitive.”

Of course, these changes too are easier said than done. The industry would have to standardize what kind of digital labeling would be used, for example, and how that information would be regulated. But for the sake of patient outcomes and human health, change must be a priority.

This is the conclusion by a team of researchers writing in Therapeutic Innovation & Regulatory Science. Jodi Smith-Gick is the first author of that article. “eLabels are not a futuristic dream,” Smith-Gick and co-authors write. “Its time has come as the pharmaceutical industry strives to focus on the patients. There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling.

“... The industry must start now to build the foundation to enable a fully connected, patient-centric experience. Patients are waiting on us.”

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