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The Safe Use Initiative and Health Literacy: Workshop Summary 6 How Can the Lessons of Health Literacy Be Used to Build Patient-Centered Outcomes for Safe Use? Isham framed the final discussion. How can the lessons of health literacy be used to build patient-centered outcomes for safe use? The Food and Drug Administration (FDA) is looking for specific areas of preventable medication risk through its Safe Use Initiative. One way to approach this is as the Center for Disease Control and Prevention’s (CDC’s) Budnitz suggested, by focusing on three drugs—warfarin, insulin, and aspirin. Every group that spoke at the workshop has looked at the issue of preventable medication risk. Different stakeholders approach the issue differently. For example, government agencies may promote education, while the FDA uses regulation as a tool, and health plans talk about case management and their tools. Isham suggested a collaborative be formed to develop an opportunity map regarding warfarin, for example. Where are the opportunities to add value and help individuals—under a variety of socioeconomic situations, educational levels, health literacy levels—understand safe use of warfarin? That would be the analytic phase, before educational campaigns are launched or regulations set. Start from a common understanding across stakeholders. Then ask each stakeholder what it can bring to the table to close gaps and add value. First there needs to be consensus on best practices for some of the medications discussed. For example, after hip surgery, warfarin is prescribed for some patients for weeks, others for days. If there is no literature on the subject, doctors could be encouraged to do real-time trials to figure out how to avoid needless exposure to a drug or underuse. Then,
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The Safe Use Initiative and Health Literacy: Workshop Summary once the medication is prescribed, how well do people consistently adhere to the instructions? There are drug-labeling issues. What can pharmaceutical companies do in labeling and information? An opportunity map can be created for each participant. Since this is a health literacy meeting, what contribution can health literacy make in partnership with others? Who should be at the table? Ruth Parker expressed concern about going one drug at a time, versus a more cross-cutting approach. The data exist about the top three drugs, but it might not get the process far enough. She advocated looking at all levels, all the points—labeling, dispensing containers, communication, follow-up—but from a patient-centered view. What is going to make the consumer most likely able to do what he or she needs to do safely and effectively? Wolf said perhaps singling out the three drugs with the highest rates of adverse drug reactions could be a first step for dealing with specific things in the health care system—things such as pulling someone off a medication or not prescribing it when it is not called for—quality control issues that are not in the patient’s hands, but rather the hands of the systems or providers. It is important to remember that it is unlikely the patient is taking only one medication. Budnitz weighed in on the debate over targeting high-risk medications, or situations that data show cause lots of harm, versus a more systematic change. The challenge is finding winnable battles, places where it is possible to demonstrate effect. There is the concern about building interventions in silos. The PROTECT Initiative, which focused on medication overdoses in children, is an example of what can be done. It began with over-the-counter (OTC) medications because that was the opportunity to get stakeholders together to implement some change. The hope is those changes will be transferred to prescription medications in the future, and to how volume measures go on all liquid medications. In other words, there are some lessons that can be applied to other medications. There is a way to think about the big picture, but start somewhere with a concrete effort. If we try to start fixing everything at once, there are a lot of ways to go wrong. Where can this group carry out some concrete, high-impact interventions that can be a model for a system-wide effort later? The FDA’s Weiss liked the idea of doing both: go vertical and horizontal. She noted that Sharfstein said pick low-hanging fruit, test the idea and see how it works, then show tangible results and apply elsewhere. And do not forget the people who will be newly insured under health care reform, who haven’t been plugged into the health care system. How will they be reached? Yin pointed out that everyone is talking about a systematic approach
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The Safe Use Initiative and Health Literacy: Workshop Summary versus doing one medicine at a time. Looking ahead, using the acetaminophen example, active ingredients can be explained and icons used, but what about other active ingredients? What other icons can a label hold? Would it increase confusion? A systematic approach is important, Yin said. McEvoy asked about focusing on the black box warnings. Hundreds of drugs have black box warnings, which indicate the FDA considers they carry some of the highest risks of any drugs. This could be the place to start. Dissect black box warnings, which are incredibly complex, and see what impact they are having on risk and benefit decision making. Communication is not sufficiently valued, Schwartzberg said. There is good legal precedent that the patient has a right to understand. It is bigger than the newest technology, the electronic health record: we are not able to find a way to really communicate well to patients so they can understand. Communication needs to be valued as much as diagnosis and treatment. Isham encouraged the FDA to look at specific initiatives, include broader initiatives that are more systems initiatives, and categorize the list of activities both ways. Dreyer agreed, adding that the FDA has a central role to play that has not been expressed clearly yet. With labeling, for example, there should be two or three main messages patients get from the box. Right now, the FDA requires too much additional information on the label. Some of those requirements need to be removed. The FDA needs to be a central player, not looking on. Weiss replied that the FDA’s regulatory role is central to its mission, as authorized by Congress. The FDA does not see itself in the driver’s seat, but in a joining-in role, seeing how it can help with other’s initiatives, lending support as needed. The FDA has regulatory authority over medications, for example, requiring REMS1 for certain classes of medications. Then there are other entities, the health plans and professional societies that the FDA does not have authority over but would like to voluntarily bring together to work on these issues. McEvoy used consumer medical information (CMI) as an example of how regulation can cause problems. A set of guidelines was developed in 1996, then reinforced with an FDA guidance document in 2006. Because CMI was set up around the measurement of defined goals, the 1 Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), FDA has the authority to require persons submitting certain drug approval applications to submit a proposed REMS as part of the application. FDA may require a REMS when necessary to ensure that the benefits of a drug outweigh its risks. FDAAA also authorizes FDA to require holders of certain drug applications approved without a REMS to submit a proposed REMS if the agency becomes aware of new safety information and makes a determination that a REMS is necessary to ensure the benefits of the drug outweigh its risks.
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The Safe Use Initiative and Health Literacy: Workshop Summary ultimate consequence was stifled innovation. Publishers were prevented from coming up with effective ways of communicating with patients because the focus was on meeting criteria for content and format rather than educating patients in a manner than they understood. The nitroglycerin example is relevant. A drug interaction exists that can result in death and yet 12 years later, very little has changed in the labeling and the CMI. That is because of the way the agency has enforced its regulations. The FDA does not have the freedom to identify all 25 drugs that a given precaution might apply to and instantaneously apply it to those drugs. Each case must be negotiated with the sponsor of that drug to modify their label except in unusual circumstances. The FDA is inhibited from working more effectively and more systematically in bringing about those sorts of changes. The FDA is asking for input to do something that is not within its traditional legislative role, Budnitz noted. He went on to say that this might be an opportunity for the roundtable to pick the number one priority and maybe number two, and get them done. Maybe systematic change is number one for the Roundtable on Health Literacy. If that can be clearly defined and backed up with data on actual harm, that would be quite useful, and the FDA and other federal agencies could act on it. Isham encouraged the group to continue with this line of thinking and take this opportunity to offer its ideas to the FDA. Schwartzberg said the issue is communication to patients and what the patient understands. Working with the Drug Facts and redoing their structure based on the criteria that the USP has just developed is aimed at making things clear and easy. Take what is already being worked on and bring it to the next level so that information will be easier for patients to understand. Johnson noted the benefit of consumer advocates working with the FDA and suggested the agency continue to open its doors to input from consumers and consumer advocates. McEvoy suggested a need for presenting more balanced benefit/risk information. Under ARRA (American Recovery and Reinvestment Act), money is going into funding comparative effectiveness research. But there is a disconnection between the research and what the FDA can say about a drug. To make informed choices about health care and about medication use, patients have to consider risk in the context of benefit. The focus has been almost entirely on risk, especially what comes out of the FDA, in both professional and consumer labeling. Bullman asked that work move toward a useful, actionable written adjunctive information sheet to be provided at the point of prescribing a medication, culminating in the development of something that takes into account high risk. This would apply to med guide messages and safe use and benefit as well; messages that could be made available across
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The Safe Use Initiative and Health Literacy: Workshop Summary the spectrum of medicine users, not just in English or poorly translated Spanish. Yin pointed to the very concerning 99 percent inconsistency between dosing information on the label and the dosing device. What would it take to get rid of this high level of inconsistency and variability? The voluntary guidance by the FDA was a great first step (FDA, 2006). But there needs to be continued monitoring of the situation to look for progress and improvement. Barrett would go further, asking that the FDA require accountability. If a company creates a drug, it should provide specific dosage devices that are equated to the directions on the bottle, going beyond monitoring for a simple win-win. Isham suggested that warfarin/Coumadin be used as a probe to figure out how health literacy can contribute to developing a multistakeholder solution to improving use of that drug. Debussey would like to see basic work on how patients understand and interpret risk, benefit, and key words such as active ingredient. It is important to not focus just on terms as has been done with content and format, but actually develop the language that makes sense to patients, not just for written materials, but across the board for how we speak about a drug, write about it, and what patients hear on the radio. Would it help to organize activities by disease rather than drug, Griffiths asked. We know the primary issues around safety, medication adherence, and health literacy. But do we know what patients need in order to understand what those issues are? Looking by disease rather than drug, can we ask, what are the touch points that the health plans, the pharmacies, and the pharmaceutical companies can get involved in? What can be done so that when a patient and pharmacist interact, the patient gets exactly the information needed to walk out of the pharmacy and take the drug with confidence and accuracy? Isham agreed. In the real world, no drug is taken in isolation, and they are often taken in the context of a chronic disease. Pisano turned the question to the FDA: What are the two or three big problems that lend themselves to solutions? She also said she would take a broader approach than that of focusing on one area or problem for discussion. She would focus on all the touch points that contribute to a patient’s understanding of a disease and how to take a medication properly. Media coverage of research from the medical community can be problematic as well. The media are left to translate research results and sometimes it detracts rather than helps. McNeil’s Kuffner advocated for acetaminophen being part of the Safe Use Initiative. It is a medication that is OTC and prescription, so it allows issues to be addressed on both sides. It is one of the most commonly used medications and most commonly prescribed by health care providers. To
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The Safe Use Initiative and Health Literacy: Workshop Summary learn how to tackle this issue, acetaminophen would be a good test. Acetaminophen is the low-hanging fruit: thousands of patients went into U.S. pharmacies today and picked up prescriptions that were labeled APAP and had no idea that the medicine actually contains acetaminophen. The medication administration section of OTC drugs is very unclear for reasons discussed earlier, Dreyer said. We give better instructions for building a bicycle than for taking medicines that can kill you. First, the Drug Facts need to be better. Second, patients need to know what the active ingredient is. Third, FDA rules are very rigid on limited English proficiency. Those rules need to be loosened to put other languages on OTC drugs. Amy Wilson-Stronks with the Joint Commission spoke as a consumer. If somebody she cares about is taking a drug, she doesn’t want them to die or be maimed or hurt. The most important piece is whatever the FDA can do to promote effective education to both providers so they know what to tell their patients about risks involved with the drugs and off-label use of drugs, as well as providing education directly to the patient. Even people who are physicians are not free from risk of adverse events such as toxicities and drug interactions. Ratzan reminded the group about the National Action Plan on Health Literacy that is about to be released.2 The draft plan was developed over years of surgeon general’s workshops around the country. There was one specific statement dealing with OTC safe use. If there is a way to get that funded and linked with this FDA Safe Use Initiative, that’s an opportunity, Ratzan said. Ratzan then focused on aspirin use, one of the three top drugs on Budnitz’s list. As a public health issue, 10,000 deaths a year could be averted by appropriate low-dose aspirin use. Ratzan challenged others to pick up a low-dose aspirin bottle and determine what the appropriate dosage is and what aspirin use is for. Fixing low-dose aspirin would be another piece to move on. Isham agreed that one of the biggest opportunities the United States has for intervention is appropriate aspirin use. Barrett reminded the group that patients are not all the same; there are different levels of understanding. It is important to take into consideration the hard-to-reach populations and those who have low literacy. Most patients don’t know that patient information leaflets (PIL) exists. It is not written in a patient friendly or health literate way, even with the new PIL format. Loveland suggests that patients must realize the PIL is there, and it must look more attractive and appealing to them. 2 The National Action Plan to Improve Health Literacy was released May 27, 2010. It was presented to the public at an IOM Roundtable on Health Literacy workshop on that date. A summary of that workshop is in preparation and will be released in 2010.
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The Safe Use Initiative and Health Literacy: Workshop Summary Budnitz and Parker’s recommendations for an evaluation of a sentinel drug that enables a systematic review made sense to Ross. The important thing, he said, is to develop a way for physicians to interact with patients, identify medications, and use electronic medical records to track adherence. This may mean charging a task force to develop that approach. NLM’s Logan asked what else, in addition to better information, influences medication understanding and adherence. The literature suggests caregivers play a big role. A couple of years ago a JAMA study showed a great medication adherence problem in a particular community. The researchers asked all the patients to designate a caregiver. That caregiver could be a health care provider or a friend. The result was that adherence and understanding went up geometrically. From a communication theory perspective this study makes a great deal of sense because the process of communication is often as influential as the content of communication. In a simple step, they shifted a vertical process to a horizontal process. More research is needed about what motivates people beyond good information, Logan said. Martha Gragg with the Missouri Foundation for Health is a nurse and a hospital CEO. Because medications are being taken by patients themselves or given by a parent or caretaker, she said, it is crucial that labeling be readable and understandable by all who handle that medication. The devices must match. She stated her opinion that the problem seemed simple to solve. Parker offered a wording preference. The FDA, in charge of drug safety for the public, should consider changing the title of this initiative to Patient-Centered Safe Use, thereby making the patient-centered focus a priority in all efforts. Brach said a culture change is in order. The FDA’s orientation is to pharmaceutical companies as its clients, those who pay the agency to approve their drugs. Doing some internal education on health literacy throughout the FDA could be the single most powerful way of starting to address this issue. There are a lot of people at the FDA who do not have a consumer or patient focus. The FDA’s Weiss was offered a chance to close. She welcomed the input from consumer groups and other stakeholders. She thanked participants for giving the FDA the opportunity to receive feedback on this very important aspect of medication safety.
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