There have been so many great discussions during this health literacy month that we want to keep the conversations about health literacy going. And more importantly, we want to make health literacy a part of every patient touch point. For those who are new to the discussion, we use the Department of Health and Human Services (HHS) definition of health literacy—the ability to obtain, process, and act appropriately on health information (HHS, 2000).
As the US population continues to become more culturally diverse, health literacy is becoming more important. Studies have found that only 12 percent of adults have proficient health literacy. (Kutner, Greenberg, Jin & Paulsen, 2006). In other words, most adults lack the skills they need to effectively manage their health.
A timely new study, Health Literacy Knowledge Among Direct-to-Consumer (DTC) Pharmaceutical Advertising Professionals (Mackert, 2011) addresses the issue of health literacy in pharmaceutical ads. It reports findings from interviews with advertising professionals. And it offers great insight on how pharmaceutical advertising professionals view health literacy and its role in DTC ads. Based on these findings, we interviewed our own Clear By Design™ health literacy team of experts—Bradley Aufderheide, Lisa Hunt, Julia Olff, Kevin Purcell, Ken Thorlton, and Luanne Koper—who address this topic from a variety of perspectives.
You’ve all read Dr. Mackert’s study and how those interviewed look at the use of health literacy principles in a DTC ad. What does your experience tell you are the key challenges to incorporating health literacy into a DTC ad? And how do you handle those challenges?
From an account management perspective, the most important challenge is ensuring that clients understand exactly what the principles of health literacy are and how, when applied appropriately, those principles can have a powerful and positive impact on educating and informing consumers.
Typically, our health literacy training seminars, such as those for Clear By Design™, are given to both core and extended brand teams. We help them understand and embrace health literacy by showing them why it’s in the brand’s best interest, how it can help with initiating patients on treatment, and, more importantly, how health literacy helps improve adherence to treatment, brand success, and patient outcomes.
The limited format of a print ad can be difficult to effectively educate patients and address all barriers. The best ads drive the patients to a Web site or an 800 number to learn more. For an ad to be effective, it needs to quickly tell a story visually and through minimal copy. Applying health literacy principles to an ad helps patients gain awareness, internalize, learn, and act on the information they've gleaned about a brand. In ads that try to explain a disease state, the challenge is to create messages that meet the needs of their intended audience. Often, a client’s med-legal team may require language that is pulled directly from the PI, which is not written in a patient-friendly manner. Unless an ad is designed with health literacy in mind, the audience may not understand medical terminology used in the ad.
With DTC ads, we always strive to develop materials that balance health literacy with presenting safety information in a way that meets regulatory requirements. The challenge here is that safety information is often written at a high reading level, using complex medical terminology. And it is frequently not written to support or drive action. It can also have the effect of raising concern instead of informing. As part of health literacy, we encourage pharmaceutical clients to revise their safety language using patient-friendly words, and to reduce the amount of data presented whenever possible. We also try to use graphics and illustrations to reduce the numeracy burden for patients and make it easier for them to understand and apply survival or risk data to their situation.
Ken and Kevin, you you are responsible for the design and copywriting of DTC ads despite all these constraints. How do you approach these challenges?
From a design perspective, it’s all about adequate white space. So finding the right balance between exciting visual concepts and clinical content provides a unique challenge—not to mention the FDA’s requirement to make the size and placement of safety and risk information more prominent. The goal is to ensure that readers don’t get overwhelmed and move on to another page before they have a full understanding of the intended message. One way to solve this problem is to create a double-page spread ad. But if scope and budget do not allow this, be sure to work with your creative copywriters from the very beginning to ensure messages are succinct and don’t take up too much space.
From the content perspective, our key challenges include the space limitations Ken mentioned balanced by health literacy principles, which often lead to increased content length because you have to define terms and provide context for new information. I believe health literacy and creativity can absolutely coexist; however, we must work that much harder to ensure that they do. Fortunately, some clients work with us to develop their fair balance so that it meets health literacy standards.
In my experience, more and more med-reg departments are inclined to consider (and even request) that fair balance language and disclaimers be created to meet the needs of their intended audience by adhering to health literacy principles. After all, if consumers can understand it, then the pharma company has done a better job of meeting the latest FDA requirements.
One of the key findings of this study is that because of business concerns, educational messages need to be tied directly to an advertised medicine and its benefits. How can we do this to still produce materials that follow health literacy guidelines?
At HealthEd, we don’t necessarily see these needs as being in conflict. Patients benefit from well-designed materials that provide balanced information about the medicines that are available to them. The application of health literacy guidelines is one of the ways we can foster quality education within marketing.
As the FDA and pharmaceutical companies’ interpretation of guidelines evolve, our clients are becoming more aware of and interested in educating the patient audience as opposed to only driving brand awareness. We have seen many clients investing in longer-form content channels such as digital, direct mail, and telephonic support to address these needs. In those venues, health literate communications are crucial to achieving measurable behavior change.
Here, the challenge we face is ensuring that any communication has an appropriate balance of risk and benefit. The goal of any communication should be to present the benefit and risk information in a balanced way. To me, consumers must be able to understand the information. And the information must include both the benefit and risk about the treatment. When health literacy principles are followed, consumers and potential patients will be able to make truly informed decisions about their health.
Finally, how do we help the pharma and healthcare industries understand how important health literacy will be moving forward--especially now that the FDA is setting new standards that demand it?
Last year, in the notice of violation letters that the FDA sent to pharma, the FDA increasingly cited that the presentation of safety and risk information was not as simply and clearly stated as the benefit information in patient pieces. For the FDA, this violates the idea of fairly balancing claims. By letting our pharma clients know how often this violation gets cited, we may increase their interest in the importance of using health literacy principles to craft language that is readily understood by people with low literacy.
Also, DDMAC, the Division of Drug Marketing, Advertising and Communication, has been elevated from a government division to a government office called the Office of Prescription Drug Promotion, or OPDP. Within OPDP, they have made 2 divisions: one for professional promotion oversight and one for DTC promotion. I believe having an office that specializes in DTC will mean more resources will be devoted to reviewing materials. This will lead to more notices of violation to pharma companies. And that will get their attention.
As advertising has evolved and federal regulations have become stricter, it has presented an opportunity for the patient to be more involved in every aspect of their treatment. Fair balance in television commercials today seems laughable, but the fact that the consumer is now aware of all the side effects as well as the benefits is information that was not always easy to discern in the past. Moving forward, patients will be even more involved in their treatment and the tools that help them to do so will become more personalized and mobile. Pharmaceutical companies that understand this will have a much better chance at raising their messages to the “top of the heap.”
Between the FDA’s new risks and benefits standards for communicating, and the HHS’s National Action Plan to Improve Health Literacy, we have a strong case for universal health-literate communications. As a health educator, I help determine and recommend health literacy requirements for specific patient audience. When making educational recommendations to clients, we highlight how government health literacy initiatives can be applied to improve patient and consumer communications that meet regulatory requirements. One of the most effective ways of demonstrating the value of health literacy principles is to measure the impact of the educational interventions on patient satisfaction and behavior. To this end, we have developed Return on Education™—an analytical framework to measure the effectiveness of patient education and marketing efforts to enhance patient outcomes.
It’s important to point out that there is a difference in quality between health literacy that is designed to meet FDA regulations and health literacy that is designed to truly help patients and caregivers. That’s where being able to show a financial Return On Education™ comes into play. The better we help clients use and implement health literacy principles, the greater the potential for a measurable financial return—and the greater the likelihood that the pharma industry will embrace the kind of work we do here at HealthEd.
I want to thank our expert panel for weighing in on this issue today. I think one of the key themes to emerge is that true health literacy is more than just literacy. It must be considered by everyone who has a stake in creating patient-facing content. Defining and understanding health literacy is key. And we need to understand that health literacy is not a hindrance. It actually can help brands achieve their objectives.
Manager, Health Education
SVP, Strategic Services
SVP, Group Account Director
Vice President, Editorial Services
SVP, Creative Director
Kutner, M., Greenberg, E., Jin,Y., and Paulsen, C. (2006). The Health Literacy of America’s Adults: Results From the 2003 National Assessment of Adult Literacy (NCES 2006–483).U.S.Department of Education.Washington, DC: National Center for Education Statistics. Retrieved from: https://nces.ed.gov/pubsearch/pubsinfo.asp?pubid=2006483
Mackert, M. (2011). Health literacy knowledge among direct-to-consumer pharmaceutical advertising professionals. Health Communication, 26, 525-533. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/21469006
U.S. Department of Health and Human Services. 2000. Healthy People 2010. Washington, DC: U.S. Government Printing Office. Retrieved from: https://www.healthypeople.gov/2010/