Prescription Drug Labels and Communication about Medications: An Issue of Health Literacy

William Shrank, M.D.

Brigham and Women's Hospital, Harvard Medical School

Dr. Will Shrank has been actively involved in evaluating how to improve prescription drug labels. His goal is to improve prescription literacy by helping patients read and understand the information about their prescription drugs. In a 2006 study published in the Archives of Internal Medicine, it was noted that physicians and pharmacists do not communicate sufficiently with their patients about medications:

·        Only 74% of doctors stated the name of the medication

·        Only 58% of the time was the frequency or timing of the dosage explained.

·        55% explained the number of pills to take

·        35% addressed the adverse side effects

·        34% explained how long to take the medication

According to Dr. Shrank, "Federal law mandates that a pharmacist discuss the medication with the patient. But when you sign for your medications, you are actually signing a waiver that the pharmacist doesn’t need to speak with you." Pharmacists didn't fair much better in the study, with only about 63% of pharmacists discussing medication instructions.

Dr. Shrank believes that improving labels will enhance patient adherence to medications, improve quality and decrease medication/dosage errors. He stated that patients who have chronic conditions are only 50% adherent in taking their medications, and are non-compliant usually because they have not been fully educated on how to take the medications properly. They don’t fully understand their disease, why the medication is important, what side effects the medication might have and they have poor communication with their physician.

In the United States, drug-related morbidity accounts for more than $77 billion annually, with 17% of older Americans hospitalized from medication errors. Research finds that labeling problems contribute to these medication errors 33% of the time.

"There are no regulations in formatting of labels," said Dr. Shrank. "I would argue that there should be consistent formatting on labels. It’s interesting to note that the FDA has done this for everything else—your food, over the counter drugs—but with prescription drugs no effort has been made to come up with a set of standards to make it easier for patients to read and understand medication." Since 1979, he said the FDA has made an effort to standardize labeling on medication in the United States but little improvement has been made.

In a current study by Dr. Shrank et al, four drugs were filled at six pharmacies in four major cities across the country, totaling 96 prescriptions. Of the 96, 11 were filled using over-the-counter products, which left 85 labels to compare. Dr. Shrank: "What’s most interesting is the variation of the warning labels." Anywhere from 5-10 different warning labels were used by different pharmacies for the same medication.

Canada and Europe are ahead in the area of medication labeling, requiring that patient literature be clear and understandable along with the information being reviewed by the government. One of the problems with labeling in the United States is that the consumer medication information (CMI) label is provided by two private companies that give more information about the drug which is aimed at doctors, not patients, and has advertising.

"We need to focus on labels aimed at patients," said Dr. Shrank. He shared results of a literature review showed that patients prefer clear directions with no vague terminology, benefits of the medication explained, and warning and side effects of the medication clearly stated. Patients also want suggested responses to side effects such as when to call a doctor or discontinue the medication, and duration of the therapy. "The elderly have a much harder time reading and understanding icons," noted Dr. Shrank, "so we need to develop a coherent system that works together."

Along with the standardized labeling, Dr. .Shrank conducted another study on doctor-patient awareness of drug costs. Many doctors are not aware of the out-of pocket costs to a patient when a medication is prescribed, nor do they feel it is their job to be aware of this. Many patients are also unaware of their co-pay requirements, which can lead to non-compliance in taking the medication when the patient is faced with the cost of the drug. If the doctor was aware of the costs, they might consider prescribing a generic drug, which has an average adherence rate of 58.8% by the patient - 6.2% higher adherence than when a patient is prescribed a non-preferred drug.

Improving Health Promotion Counseling for Patients with Limited Literacy Skills

Hilary K. Seligman, M.D.

San Francisco General Hospital and University of California, San Francisco

Dr. Hilary Seligman is an assistant professor of medicine at UC San Francisco and has a clinical practice at San Francisco General Hospital. Dr. Seligman has been involved in many studies on the clinical impact of limited literacy skills, and her research focuses on socioeconomic disparities in health promotion behaviors.

Dr. Seligman feels that all patients will benefit from improved health promotion counseling, but that patients with limited health literacy may preferentially benefit from certain counseling techniques. "It is not clear that 'screening’ patients for limited health literacy in the clinical setting improves patient outcomes. I don’t screen my patients for health literacy; I counsel all of my patients using these techniques," she said.

These techniques include counseling about behaviors that improve health, such as diet, physical activity, medication compliance and management, and depression/stress management. Those with a chronic disease and limited health literacy are affected by their lack of knowledge. Many studies have shown that they have a higher prevalence of poor health status and diabetes, poorer knowledge about their disease and how to treat it, less compliance with self-care, and more complications and hospitalizations.

The patient’s self-management in regard to their chronic disease has changed the way the condition is treated, explained Dr. Seligman. "In the old paradigm, you go to a doctor’s office when you are sick, take antibiotics and are done. With chronic diseases, the vast amount of care happens in patients’ homes and workplaces.

"We must strive to provide better health promotion counseling to all patients, but particularly to those with limited health literacy." In an unpublished study by Dr. Seligman, 61% of limited health literacy patients had difficulty achieving physical recommendations and 46% had trouble with diet recommendations. This is 18% and 14% higher, respectively, than for patients with adequate health literacy.

The study also showed that with high-quality counseling, these numbers improve dramatically. "We have to help our patients move beyond knowledge. A lot of health education materials focus on knowledge. Patients have difficulty moving from knowledge to what they need to know to change behaviors," said Dr. Seligman. "Long-term behavioral change requires confidence in the patient’s ability to be successful."

In a focus group conducted by Dr. Seligman, more than 100 participants demonstrated that patients, particularly those with limited health literacy, want clinicians to provide the need-to-do, not just the need-to-know. Dr. Seligman uses action plans to achieve patient success. "Action plans are highly-specific, easily achievable, short-term activities a patient agrees to do to help them reach a long-term goal," she explained.

She provided an example: If the long-term goal is for the patient to lose weight, the action plan might be having the patient agree to walk around the block before sitting down to watch TV after dinner, at least three times during the next seven days. "Doing so will improve a patient’s confidence in their ability to identify and achieve short-term goals, creating a course of action to increase behavior change. Action plans also teach problem-solving skills," she said.

"What we should be doing is spending time to help patients enact behavior changes," said Dr. Seligman. "Patient-generated behavior changes are best." The action plan has three critical components. It has to be:

·        patient generated (self-managed),

·        easily achievable (increases confidence), and

·        highly specific (what, how much, when, how often).

A study assessing clinician satisfaction with action plans showed clinicians rated 75% of the talks with patients more satisfying or equally satisfying than previous talks. The majority of clinicians - over 80% - said they would continue having discussions about action plans with their patients even after the study concluded. Many of the clinicians in the study also agreed that primary care clinicians should be trained in using action plans.

Dr. Seligman noted that action plans have a very high success rate overall - 83% of patients will complete them. Three weeks after starting an action plan, 79% recall making the plan, while more than half recalled the details and made behavior changes consistent with that plan.

According to Dr. Seligman, well-designed health education materials can augment the action plan discussion. "I don’t think giving written materials to a patient with low health literacy will cause them to have behavioral changes. Written materials should be given with behavior action plans," she said.

Action plan lessons can be incorporated into traditional counseling strategies (called "Action Plans Lite" by Dr. Seligman) by assessing patient barriers to self-management (pain, depression, etc.), offering practical health literacy appropriate strategies for overcoming those barriers (portion reduction size vs. carbohydrate counting), and telling the patient what they need to do, not just what they need to know.

"Achieving small goals is much more effective than not achieving large goals," said Dr. Seligman. "Particularly for patients with limited health literacy, use high quality health education materials that augment, rather than replace, your counseling."

Clinical Problem-Solving with Professional Health Literacy Skills

Mary Jane Tremethick, Ph.D., R.N.

Patricia Hogan, Ph.D.

Northern Michigan University

                        Dr. Mary Jane Tremethick is a registered nurse currently teaching in Community Health Education at Northern Michigan University. Dr. Patricia Hogan is a former National Health/Fitness Director for the National Board YWCA, is a health, fitness and education consultant, and currently teaches at Northern Michigan University.

The purpose of their talk was to educate attendees on how to identify and frame health care issues, access and evaluate health information relevant to the problem, and to apply valid information to address health care issues.

Dr. Tremethick started the session by posing some questions to the audience: "How were you taught at school? Did you learn by listening? My mom would say you are book smart but you have no common sense. Sometimes people get it and sometimes they don’t get it. Today we are going to talk about how people get it."

There is a difference between what is taught in educational settings and what is needed in a professional setting. "Teaching is talking, learning is listening," commented Dr. Tremethick. Dr. Hogan added, "The educational model is about empowerment. Education involves behavior change. The concept of literacy is an educational principle."

"We need to understand behavior change," noted Dr. Hogan. She told the story of the TV program about woman who was a smoker, begging people to bring her cigarettes and refusing to stop smoking. Then one day she picked up her 3 year old grandson and blew smoke in his face. He wrinkled his nose and made a face. She stopped smoking that day.

"We can’t just look at individuals, we have to look at family life, and keep looking at the bigger picture of world events and how that is affecting the individual, said Hogan.

Health literacy is summarized as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. Critical thinking is central to professional health literacy, creating a disciplined form of inquiry engaged to determine appropriate courses of action. With critical thinkers, they raise questions and concerns, they think clearly and reflectively, they question assumptions, and explore alternate solutions to a problem.

Dr. Hogan said, "Patients may understand the information, but getting insight into something requires motivation. You can train someone against their will, but you can’t educate them against their will." Patients need to acquire Problem Based Learning (PBL) skills. PBL is more of a mental activity with initial task/skill/knowledge acquisition; it centers on contextual-based learning, and focuses on higher order thinking skills.

Many studies have shown that long-term testing scores higher with PBL, people have better competencies with interpersonal skills, problem solving, self directed learning, information gathering and have the ability to work and plan efficiently.

You Built It But They Didn’t Come: Improving Program Attendance

Leslie Deane

FirstHealth of the Carolinas

  Leslie Deane has more than 25 years of experience as an administrator and marketing director for many profit and non-profits, planning and marketing effective healthcare education programs.

"Learn from the mistakes of others. You can’t live long enough to make them all yourself" is a quote from Martin Van Bee with which Deane opened the session, along with her own admission that, "I’m proud to bring these mistakes to you today."

Deane’s first example of a good program that almost failed is FirstGarden. This program, sponsored by a grant from Robert Wood Johnson Foundation, was conceived to encourage healthy eating and exercise among children. The grant partnered Deane’s employer, FirstHealth, the Boys & Girls Club, and other local groups with master gardeners to teach the children how to garden and prepare healthy foods.

The first mistake was the flyer used to recruit the master gardeners. Volunteer sign ups were very low because the flyer was confusing and unclear. The headline of the flyer didn’t tell the reader what to do or learn, the use of the word "you" was not used in the first 40 words, and much of the text was "grantspeak."  

"The real problem," said Deane, "was that there was no person to call. Just calling an organization is a problem and causes 'what ifs’ in a person’s mind."

The recruiting piece for the kids was also a failure. The name of the project, FirstGarden, was named after the company, but had no meaning for the audience they were trying to bring in. Plus, the wording in the flyer telling kids they will "have fun and learn new things" isn’t compelling enough. "Kids are very skeptical and we need to offer proof. Have pictures or something to back it up."

There were other problems with the flyer that hadn’t been researched as well. "We presume that kids care about fruits and vegetables. What really failed with this flyer is that kids have to bring this home to get permission. A lot of parents can’t read and kids lose papers before they get home," said Deane.

Over a year it became evident that fewer children were showing up and the program partners became involved in heated debates. The problems boiled down to communication. "It’s a story of building it to our needs instead of theirs. We want to communicate messages to people, but if they are not interested in the message, then they may not care at all," commented Deane. "The moral of the story is: Build it to their specifications, not ours."

Plans for a "Second" Garden are under way, this time taking into consideration all aspects of the project - the program partners/sponsors, the children, the volunteers, and the parents.

Many of these costly mistakes could have been avoided if the audience had been researched prior to creating the program. "Assess audience needs before moving forward with a project," says Deane. "When you are in a meeting, planning a project, ask yourself: 'Who is the audience?’ If the phrase is coming up 'I think’, ask yourself, 'how do I know?’ We don’t know unless we go out and ask. Take time to research your audience."

When you research your audience, you will know their needs and wants, you can translate your features into their benefits, you can identify and remove their barriers, and you can test your plan with your target audience.

Deane’s second example was the prostate cancer screening event or what she likes to call, "The Little Robot That Couldn’t." The goal of the project was to generate prostatectomies and increase awareness of the advantages of a robotic prostatectomy, all prostate cancer treatment options, and prostate cancer signs and symptoms.

The first graphic generated for the advertising campaign was too busy and was rejected. "You don’t have to spend a lot of money if your message is on target," says Deane, "Don’t be afraid to reject things." With a new flyer approved, free prostate screenings were set up in mobile health vans in four locations on four separate dates. One van was set up at a Lowe’s Hardware and the other three at local banks. Announcements were mailed to over 4,200 men between the ages of 55-75.

The results were completely underwhelming. Of the 50 tests that were performed, 44 were done at the Lowe’s location and only 6 attended the free lecture. "The moral of this story: Free may not be cheap enough. Men are a difficult group to get to come to screenings. Success was being at the hardware store where the men are at," said Deane.

The truth about things that are "free" is that they are not free if they are hard to attain or that just because it’s free, it doesn’t have a value or cost. You will need to encourage direct mail responses by giving something away, but keep in mind that time is more precious than money to many people.

Deane firmly believes that you need to build where the audience already is located and subscribes to the "Carpenter’s Law." Says Deane, "Ask enough questions from people so that the carpenter knows how to build the building. He will lay out the walkway after the building is constructed. Until people are already using paths, you don’t know where people want to walk." In other words, don’t reinvent the wheel, just harness existing behavior and tap into that existing demand.

Deane’s third example, and a success story, was a heart disease screening. The goal of this project was to set up free fasting total cholesterol tests at five locations. A direct mailing was sent out to women ages 45-64, and those who responded to the mailing would get a free first aid kit. Lastly, test results could be picked up at a lecture at one of three local hospitals.

Unlike the prostate screening event, the results for this event were overwhelming. Over 500 tests were performed with over 650 attendees showing up for the lectures. Of the women tested, 65 did show elevated levels and within one year of the campaign, two heart procedures were completed.

One of the key differences with the success of this event was the research done. The direct mail copy was tested and then revised before being sent out, focus groups were used and the event planners did not presume that they knew all the answers.

The second key difference was that this event was directed toward women. Heart disease in women is a very current, timely topic and women are the health care decision makers of the family. Women also tend to bring someone with them to events, such as a friend or spouse and women are also the ones who do the purchasing in the household and respond at much higher rates than men for "free" gifts.

The Robotic Prostatectomy Newsprint Ads are another example of an ad campaign that almost didn’t make it. The physicians wanted to show off their new "toy", the robot, and explain how the robot made them better surgeons. Test readers showed that they did not want to see the robot. The readers’ main concerns were not addressed - incontinence and loss of sexual function.

Says Deane, "We used a man in a new ad with pictures of the doctors with headings noting the biggest concerns of the audience as found with our research. I got approval for the ad because of the research that proved men loved the ad.

"Don’t just look at attendance as a measurement of success. Education gets the word out," said Deane. She also says to measure all results, to encourage other "purchases" beyond attendance and to develop a mailing list from each campaign. Dean also suggests, "Put a way for people to respond so that you can collect data and develop mailing lists. That means you can reach them again."

What Patients With Chronic Illnesses Told Us They Need: Lessons from Canada

Judy King, Ph.D.

University of Ottawa

    Judy King, Ph.D is a physiotherapist and part time professor at the University of Ottawa. Dr. King has been practicing as a physiotherapist for nearly 20 years in a diversity of clinical, research, and administrative roles along with teaching as an invited professor at both McGill University and Dalhousie University. Dr. King’s topic for the session is also her Ph.D. dissertation.

Dr. King cited five Canadian literacy and health projects (including her own) that support her theory on patient education for adults living with limited literacy and chronic illness. The first project is at the Centre for Literacy of Quebec, an ongoing multi-phased project began in 1999 to study the complex combination of factors involved with literacy and health, along with attempting to identify how various barriers to patient communication can be recognized and addressed.

Phase one found that written documents were not directly useful to a patient. Patients and health care providers had different perceptions of the health education needs, and family members wanted different information than patients.

Phase two set out to implement and evaluate recommendations from phase one. Health educators chose key health messages and created brochures with multiple versions to identify the most effective one. It was concluded that there must be a clearer understanding of who compromises the "hard-to-reach" before different means of communication is developed. "Hard to reach was something health care workers said as an excuse," said King, "everyone gets the same pamphlet."

Phase three of the study reviewed all alternative medical and educational literature such as audiotapes, videotapes, interactive media, etc. Most evaluative studies exclude non-English speaking patients, patients who could not read, and had other physical and/or cognitive deficits. In other words, the marginalized groups that the study had set out to help were being excluded.

The second study was done by Gillis and Quigley, professors at St. Francis of Xavier University in Antigonish, Nova Scotia. Their goal was to explore factors that influence the ways adults with limited literacy access and act upon health information and services.

The study was conducted on rural, small communities in Nova Scotia. Four themes emerged from the data:

·        social isolation

·        lack of transportation

·        limited opportunities for employment, recreation, health care, education, and social services, and

·        accessibility of affordable health care.

These findings were so powerful they have been used to help build cases for improving policies, programs, and practices to enhance the health of adults who face literacy as a barrier to good health.

The Canadian Public Health Association (CPHA) had a Literacy and Health Conference in 2004. According to Dr. King, they put together a Learner’s Gallery - stories from adult literacy learners from across Canada were posted all over the walls. These stories talked about the problems patients with limited literacy and disease had when dealing with a complicated health system. The CPHA also conducted a study on increasing the understanding of the impact of low health literacy on chronic disease prevention.

The study found that health information comes from a variety of sources. People with chronic illness are getting information that is not consistent and, at times, contradictory. The study also discovered that the "bigger picture" needs to be kept in focus when dealing with a person of limited literacy. They may understand the need to eat fresh fruit every day, but they may not be able to afford it or, due to their remote location, not be able to buy it at all.

Dr. King also conducted a study into the meaning of patient education experiences for adults with limited literacy and a chronic illness. She worked with 14 adults living with a variety of chronic illnesses, mainly women between the ages of 24-68, and English was not the first language for over half the participants.

Her study revealed that there were many barriers to receiving health information. The health care provider and patient differ in how they view health education, with the patient feeling that it is the health care provider’s role to teach them. Language is a big concern since it’s a problem if the patient doesn’t understand what the health provider is telling them. Mismatched expectations were also noted, with the patient wanting respect and consideration of time from the health care provider. Patients also felt powerless if they could not read or write. Patients feel as if they were inferior and not worthy of respect.

Dr. King has some sound advice for health care providers: "Just telling people to do something doesn’t work, otherwise every one of us in this room would be a size 6 and run a marathon.

"Use common words, not medical jargon, and take your time when talking, because you will save time in the long run. Give people enough details about their disease." Patient education is crucial to integrating chronic illness information into their lives. Dr. King also recommends that healthcare workers ask the patient what they know about their condition and make sure the information is accurate - not just something they found on the Web.