Making drug labels say what they mean
From the April ACP Observer, copyright © 2007 by the American College of Physicians.
By Stacey Butterfield
Take two tablets twice daily. Swallow whole. Take with plenty of water.
Internists provide these instructions multiple times a day without a second thought, but new studies indicate that a significant number of patients may not be getting the message.
In a study published last year in the Annals of Internal Medicine, Terry C. Davis, PhD, and colleagues asked patients at three primary care clinics to demonstrate their understanding of five common prescription labels. "Almost half of the people misinterpreted one of the five labels. Labels are seemingly simple and short but what we found is that they're not clear to many people," said Dr. Davis.
Even when patients could read the labels, researchers found that they often didn't really understand the instructions. Among low literacy patients (sixth grade reading level or below), 71% could read aloud "Take 2 tablets by mouth twice daily." Yet when the same participants were asked to demonstrate how many pills they would take in a day, only 35% took four pills from the bottle.
Michael Wolf, PhD, MPH, holds an actual prescription showed to him by a patient. The labels read: "Do not chew or crush"; "Swallow whole or sprinkle capsule contents on small amount of food"; and "Take on an empty stomach at least one hour before or at least one hour after a meal."
Patients also confused tablespoons with teaspoons and were less likely to understand instructions with multiple numbers (such as "Take 1 tablet by mouth twice daily for 7 days").
The study's findings highlight a serious problem with current medication practices, according to Ruth M. Parker, FACP, one of the study authors. "If you can't understand the use and the dose, you're really in trouble."
Also problematic was the finding that the more medications a patient takes, the more likely they are to misunderstand usage and dose instructions. "You might say, 'Well gosh, if you're taking four or five meds you must sort of learn what it is you need to do. We didn't find that," said Dr. Parker. "That's kind of scary."
And the brightly colored warning labels on the side of the bottle? Researchers in this and prior studies found that patients pay little attention to those labels, and when they do look at the warnings, they often get vague, or even opposite, messages than what was intended.
Patients often attribute meaning to the labels' color, which is completely random. "Patients see red and think danger, but the color is meaningless," said Dr. Davis. The graphics on warning labels, presumably intended to help with comprehension, often only confuse the situation. The image accompanying "For External Use Only," for example, conveyed to surveyed patients anything from "Medicine will make you dizzy" to "Take only if you need it."
Michael S. Wolf, PhD, MPH, an author of the Annals study, also studied patients' understanding of the common label "Do not chew or crush. Swallow whole." The results were concerning, he said. "A large proportion of the patients not only misinterpreted it; they thought that they could actually chew it up or sprinkle it on food. If you were to do that with an extended-release tablet for a hypertensive drug, you could cause acute hypotension."
"Take with plenty of water—how much is plenty? The labels need to be written clearly and in a way that is evidence-based"
—Ruth M. Parker, FACP
The simplest sounding instructions can actually be the most confusing, noted Dr. Parker. "Take with plenty of water—-how much is plenty? The labels need to be written clearly and in a way that is evidence-based," she said.
Confuse patients less'
The ACP Foundation (ACPF) has taken up the challenge of exploring evidenced-based ways to improve medication labels for patients. In 2003, the Foundation adopted a general focus on issues of health literacy and a panel of expert advisers later selected prescription bottle labeling as a particular target.
"The first focus is to really look at use and dosage instructions. We think that's the most important thing," said Dr. Parker, who chairs the ACPF's advisory committee. "Our focus at the Foundation has been, 'How can we confuse patients less?'"
Toward that goal, the Foundation has commissioned research, convened conferences and gathered stakeholders to discuss prescription labeling. Experts from the field, the pharmaceutical industry and government agencies have come together under the direction of the ACPF.
Developing a consensus among the many, many stakeholders is going to be the biggest challenge, said Jean Krause, CEO of ACPF. Unlike over-the-counter medication, which is regulated by the FDA, prescription bottle labels are regulated by 50 different state pharmacy boards.
Besides the state-to-state differences, much of the label design is left up to individual pharmacies or even pharmacists. There is no regulation of warning labels, for example, said Dr. Wolf. "It's up to the pharmacist to choose what warnings to place on the bottle, because there may be many associated with a drug," he said.
Currently, the decisions about what information to emphasize on the label are not made in a patient-centered way. "Often the name and the logo of the pharmacy are highlighted in the brightest colors and biggest print," said Dr. Davis. Then, there is the wording of those instructions, made on an individual basis by physicians, which the researchers have some suggestions for improving.
Make sure your patients get the message
Changing the design of prescription bottle labels to improve patient comprehension is a long process, but practicing physicians can have an immediate impact on individual patients' understanding. Here are some tips on how to talk with your patients so that they are more likely to take their medications correctly:
Start talking. Just bringing up the subject of how to take medication is a good start, said Dr. Wolf. "We know from surveys that a lot of physicians and pharmacists are missing opportunities to adequately counsel patients on how to take prescribed regimens. Just beginning that dialogue would be a strong step forward to ensuring medication safety."
Be specific. Label researchers found "take twice daily" to be one of the most confusing instructions to patients. "I am aware now that it's much better for my patients if I put on the bottle what 'twice' actually means—for example, take one at breakfast and one at dinnertime," said Dr. Parker. Prescriptions with specific times, such as "take at 8 a.m. and 8 p.m.," also tested well among patients.
Sometimes it's necessary to get even more specific about when to take medication, said Isabel V. Hoverman, MACP, an internist in Austin, Texas. "With diabetes meds, people seem to be regularly creative about when to take it. If you say take it with breakfast, they'll take it an hour after breakfast." If the medication needs to be taken before a meal, be sure to specify that, Dr. Hoverman said.
Standardize. Once you pick a format for your prescriptions, stick with it. Patients who take multiple medications can be confused by differently worded prescriptions that actually mean the same thing, like "twice daily" and "take at 8 a.m. and 8 p.m." "You don't want multiple bottles with different instructions," said Dr. Parker.
Ask, don't tell. The best way to know whether patients understand and are willing to follow the instructions is to ask them. With current meds, ask patients how they are taking them. "People will kind of hint to you if there are times that they're not taking the medication, especially when they say, 'I'm supposed to take it … ,'" said Dr. Hoverman. When prescribing a new medication, explain the dosing and then review. "Ideally, the physician should not only go over it with the patient, but have the patient tell them back how they're going to take the medicine," said Terry C. Davis, PhD, a label researcher.
Check their meds. At least once a year, have patients bring in the actual bottles of all their medications. "I've had patients who end up taking both brand and generic versions of the same drug because they think they are two different drugs," said Dr. Hoverman. Insist on the actual bottles instead of a list to make sure the information is up to date, she said. "It's almost as hard to get people to bring in their medication as it is to get them to quit driving. The reason there are so many errors or near misses is because people assume they know what they're doing."
Watch refills. You can tell if patients are taking medication properly by tracking when they need a refill. "Every time I get a request for a refill, I write down the last fill date. We can see at least for the last month how many tablets they are taking in a month," said Dr. Hoverman. Unfortunately, this strategy doesn't work as well with mail-order pharmacies, she noted.
Delegate when necessary. Implementing these strategies can be somewhat time-consuming and time is already short in most office visits, the experts acknowledged. Medication discussions can be conducted by a nurse or other staff instead of a physician. "If a doctor can't do it, make sure someone in the office can," said Dr. Parker.
A half-million adverse events
Affecting change within this well-established system is a massive undertaking, experts acknowledged. It will require action on the part of physicians, pharmacy boards, pharmacies, and label software companies, among other groups.
The ACPF hopes to be a catalyst for change, inspiring the stakeholders to work on the issue, said Ms. Krause. "What we're finding exciting is that there is a lot of interest in this," said Dr. Parker. Recent reports from the Institute of Medicine and the Joint Commission have highlighted the problem of health literacy and specifically mentioned the issue of prescription bottle labeling.
Although there seems to be a consensus about the existence of the problem, the development of solutions is still in the early stages. The IOM report asked the FDA to create guidelines for the packaging and labeling of pharmaceuticals. Dr. Parker noted that federal regulations like those adding the "Drug Facts" to OTC medications may be a model for changes.
Meanwhile, Dr. Wolf is lead author for the Foundation on a white paper that pulls together the best practices uncovered in health literacy research and creates a proposed list of standards for the industry.
Dr. Davis and others are at work on an ideal label for prescription bottles. She is planning a study to test patients' comprehension of an enhanced label, after which researchers will begin using the label on a test group of actual patients' medications. "We want to find out if this is a better mousetrap that makes a difference in patients' reading and understanding labels," said Dr. Davis.
"We know that there are 500,000 adverse events with medicine in outpatient settings every year," said Dr. Davis. If changes to prescription labels can reduce that number, it will benefit everyone involved.
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