Identifying Activities Around Which to Build Partnerships for Patient-Centered Drug Safety


Sandra DeBussey


Health literacy and better patient understanding about their medications have an important safety aspect but also relate to overall patient outcomes. “Health literacy can be difficult to assess, however, as it is not only a measure of an individuals’ understanding of health information at various points in time but also a measure of how well various health care systems have been organized” (IOM, 2009).

The research shows that simple is not always clear (Table 5-1). People with low literacy have more trouble than those with higher health literacy

TABLE 5-1 Understanding Label Information

Common Rx Bottle

Warning Labels

Percent Voicing Understanding

Lowest Level Readers

Basic Level Readers

Take with food



Medication should be taken with plenty of water



Refrigerate, shake well, discard after (date)



SOURCE: Adapted from Wolf et al., 2006.

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5 Identifying Activities Around Which to Build Partnerships for Patient-Centered Drug Safety PHARMACEUTICAL COMPANY Sandra DeBussey GlaxoSmithKline Health literacy and better patient understanding about their medica - tions have an important safety aspect but also relate to overall patient outcomes. “Health literacy can be difficult to assess, however, as it is not only a measure of an individuals’ understanding of health information at various points in time but also a measure of how well various health care systems have been organized” (IOM, 2009). The research shows that simple is not always clear (Table 5-1). People with low literacy have more trouble than those with higher health literacy TABLE 5-1 Understanding Label Information Percent Voicing Understanding Common Rx Bottle Warning Labels Lowest Level Readers Basic Level Readers Take with food 61 89 Medication should be taken with 14 52 plenty of water Refrigerate, shake well, discard 0 13 after (date) SOURCE: Adapted from Wolf et al., 2006. 

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY TABLE 5-2 Voicing Understanding vs. Taking Correct Action When Asked to Demonstrate the Instruction “Take Two Tablets by Mouth Twice Daily” Reading Level Voiced Understanding Demonstrated Correctly Low 71% 35% Marginal 84% 63% Adequate 89% 80% SOURCE: Adapted from Davis et al., 2006. understanding label information. But even people with good reading skills have poor comprehension when labels include information that is not relevant or does not go together. If too much information is on the label, or if it is too cryptic, people will not be able to perform the actions necessary to take their medications correctly. There is a difference between people saying they can understand a statement and being able to take the correct action. The gap widens as literacy decreases (Table 5-2). It is important to foster more discussion so that the words we use are actionable by the patients. Visuals add to people’s comprehension and to their willingness to look at information (Delp and Jones, 1996). But if visuals are not good or if they are not well tested, they may not make a difference. GlaxoSmithKline has made a concerted effort to foster internal aware- ness of health literacy principles and facilitated application of those prin - ciples to patient- and consumer-directed materials. The company devel- oped standardized health literacy training that is available across the organization including the marketing departments, patient recruitment and product labeling teams, and research and development staff. Medica- tions are complicated and needs vary, but giving staff good tools—review checklists, a style guide, internal and external expert review support— makes implementation easier. The company is seeing a difference. Depending on the medication, patient information is available in sev- eral forms: med guide, patient package insert (PPI), patient information leaflet (PIL) and consumer medicine information (CMI) (Table 5-3). GlaxoSmithKline has conducted consumer testing to improve con- sumer medication information, taking such standard information and putting it into a more patient friendly format in a type of drug fact box found on over-the-counter (OTC) labels. As expected, consumers found it easier to correctly find and restate information from simplified formats: adequate print size and print quality, spacing between lines, informa- tion presented in tables with gridlines, bolding of important words and phrases, and easy-to-understand language with actionable information. There were also surprises. Participants had clear opinions on what kinds

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 BUILD PARTneRSHIPS FoR PATIenT-CenTeReD DRUG SAFeTY TABLE 5-3 Types of Patient Information Leaflets Type of Patient Information Mandatory? Who Is Involved? Yes Written by drug MedGuide Certain Rx meds with serious and company significant public health concerns FDA approved as decided by the FDA—currently 180+ Yes Written by drug Patient Package Insert (PPI) Oral contraceptives and medicines company with estrogen FDA approved No Written by drug Patient Information company Leaflet (PIL) FDA approved No Consumer Medication Information Provided voluntarily Written by private (CMI) Rx medicines filled for the 1st time by Pharmacies vendors of information they wanted and how it should be presented. They wanted to know, first, what action they needed to take. For example, go to the hos- pital if …, followed by the list of side effects, rather than providing a long list of effects and the action afterwards. DeBussey said that GlaxoSmith - Kline plans to publish this in the Drug Information Journal later in 2010. PHARMACY Gerald Mcevoy, Pharm.D. American Society of Health-System Pharmacists The American Society of Health-System Pharmacists (ASHP) is a national professional and scientific society of 35,000 members practic - ing in hospitals and organized health systems. Quality and safety is an advocacy priority for the ASHP. Pharmacists play a key role in manag - ing medication risk and reducing preventable harm. The Food and Drug Administration’s (FDA’s) Safe Use Initiative acknowledges the role of ASHP and its members in terms of medication orders screening, benefit/ risk communication to patients and caregivers, medication histories and

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY medication reconciliation,1 therapy monitoring, medication therapy man- agement, and collaborative practice models. Another key area for phar- macist involvement is in using technology to improve medication use processes and building the safety nets to catch problems. Three collaborative opportunities involving pharmacy are specific to health literacy: prescription container labeling, patient counseling, and consumer medication information (CMI). The prescription container label is the most widely used means for communicating medication use information, yet there is confusion among patients about dosing instruc- tions, auxiliary information, and intended use. McEvoy is co-chair of U.S. Pharmacopiea’s (USP’s) Health Literacy and Prescription Container Advisory Panel, the work of which Schwartzberg summarized earlier (see pages 20-22). The USP is developing standards for content and format of the limited piece of real estate that is the label (USP, 2010). The second opportunity in health literacy is in patient counseling. Time constraints are a reality among healthcare providers, at the phar- macy where the prescription is filled, in the physician’s office where it is prescribed, and in the hospital where the nurses do not have enough time to discuss a medication plan with the patients. The third health literacy opportunity is in the CMI, the most widely used supplemental means for communicating medication use informa- tion. ASHP is a commercial provider of a database of CMI. In its current state, CMI is focused on risk information, with very little benefit informa - tion provided. Lack of health literacy is a barrier to understanding the CMI in the context of safe medication use. CMI has also been criticized because current standards for its production focus on content and format rather than on the effects the CMI has on patient understanding and actions. The standards were established in 1996 (Steering Committee, 1996) and clarified by an FDA-issued guidance in 2006 (FDA, 2006). That document recommended testing in patients and consumers, but testing never occurred. The FDA has determined that CMI documents do not meet the agen - cy’s criteria for containing useful and relevant information for patients. The Safe Use Initiative identifies CMI as a key opportunity for collabora - tion. Many stakeholders favor replacement of several existing documents (CMI, med guides, and PPIs) with a single document. Two FDA-commis - sioned studies in 2001 and in 2008 examined this issue. The 2001 study 1 Reconciliation is the process of comparing a patient’s medication orders to all of the medications that the patient has been taking in order to avoid medication er- rors such as omissions, duplications, dosing errors, or drug interactions. This is a re - quirement of the Joint Commission within hospitals (http://www.jointcommission. org/sentinelevents/sentineleventalert/sea_35.ht m).

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 BUILD PARTneRSHIPS FoR PATIenT-CenTeReD DRUG SAFeTY showed about half of all CMI met the definition of usefulness; the 2008 study showed a higher percentage, 64 percent to 75 percent, met the definition of usefulness. McEvoy noted, however, that the criteria used exceeded criteria set out in the Keystone Guidelines (Steering Committee, 1996), which are incredibly flexible in what can or should be included. In the 2006 FDA guidance, clarifications were made. The guidance states, for example, that information about the effectiveness of treatment should be limited to physical reactions that a patient can detect. Yet roughly half of the criteria set forth for one of the drugs, Lisinopril, dealt with laboratory tests that had nothing to do with physical reactions. A detailed analysis by the ASHP looked at nitroglycerin patient informa - tion. There is a very serious adverse effect of the drug interaction between Viagra and nitrates, but none of the CMI that was tested 5 years after the contraindication included any information on the drug interaction dangers. Even today, 12 years after the contraindication appeared in the Viagra labeling, only one piece of FDA-approved CMI actually includes this life-threatening contraindication. Dr. McEvoy concluded by saying that the ASHP has several recom- mendations regarding CMI. They are: • Involve stakeholders to improve the quality, consistency, and sim- plicity of CMI. • Pursue a single, comprehensible document. • Create evidence-based models and standards for CMI and develop detailed guidance. • Validate CMI models in actual-use studies in relevant patient populations. • Clearly establish what is most important to communicate with consumers, how, and at what points of care. • Work with state boards of pharmacy to ensure down-stream com- pliance with FDA-established standards for content, format, and distribution at point of dispensing. • Engage existing infrastructure for content development and deployment; investigate private-public partnerships. • Explore certification process for publishers of CMI. • Implement only change that has sound, supportive evidence and economic- and workflow-impact considerations.

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY INSURER Jill Griffiths Aetna Research with Aetna members ages 18-64 clearly indicates that mem - bers with lower literacy are desperately in need of education and informa- tion (Table 5-4). They are much less likely than those with moderate health literacy or higher health literacy to strongly agree that they actively seek information to improve their health and well-being, that they are aware of all the tests and screenings that are recommended for their age group and gender, and that they have a good understanding of how to use their health insurance plan. The layers in health care—medical, pharmaceuti- cal, behavioral health, and health insurance systems—are all trying to individually communicate to people about what they should be doing. And it is not being done very well. This research also reveals that low health literacy and moderate health literacy are problems, not only with health, but also with how people experience their health insurance plan, in this case, Aetna. 2 Only 28 percent of members with low literacy strongly agree that it is easy to find out what is covered and what is not by their health plan (Table 5-5). That means the other 72 percent are not maximizing their health insur- ance coverage or their pharmaceutical coverage. So not only is labeling a problem, but patients do not even know whether they can obtain a drug at the pharmacy. Aetna asked members what it can do to improve their experience and more than one in four of the lower health literacy members asked for better or more communication and explanations. They asked for more explanation of coverage, simpler language, and updated information. If people understand the health plan better, if things are clearer, their satis - faction will go up, and their relationship will be better. Most of Aetna’s patient safety and medication adherence programs— alerts to pharmacists about drug interactions or drug-to-disease interac - tions and messaging to physicians about gaps in care—are not visible to members. Because members do not understand their benefits, Aetna is moving to go directly to members and physicians with simpler informa- tion. Staff pharmacists at Aetna provide the opportunity to engage in more data sharing of medications, lab tests, and information regarding patient visits to a doctor, so that care is coordinated among the patient, physicians, and caregivers. 2 To define low health literacy, medium health literacy, and higher health literacy, Aetna pulled data from a variety of research sources to set these definitions, however no additional information was provided by the speaker.

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TABLE 5-4 Lower Health Literacy Members Are in Need of Education and Information Lower Mod Higher General Health and Insurance Attitudinals Health Lit Health Lit Health Lit (percentage who strongly agree among 18-64-year-old (n = 95) (n = 47) (n = 66) commercial members; n = 207) (A) (B) (C) I am sure I’m always taking my prescription medicines 89% 83% 94% 96%A correctly I am comfortable filling out medical forms by myself 77% 59% 83%A 97%AB I know how much I’m going to pay out of pocket when I visit 66% 41% 80%A 91%A a doctor* I have a good understanding of how to use my health 63% 36% 76%A 95%AB insurance plan* I am aware of all the tests and screenings that are 60% 42% 73%A 78%A recommended for my age group and gender* I actively seek information to improve my health and well- 55% 44% 63% 66%A being NOTE: *Questions included in the DSS health literacy algorithm. Statistically significant differences denoted by ABC (95% confidence level). 

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0 TABLE 5-5 Discrepancy in Scores Between Highly Literate and Lower Literate Members Continues to Exist on Elements Related to the Actual Insurance Experience Lower Moderate Higher Insurance Attitudinals Health Lit Health Lit Health Lit (percentage who strongly agree among 18-64-year-old (n = 95) (n = 47) (n = 66) commercial members; n = 207) (A) (B) (C) I know how to contact Aetna if I have a question or concern 79% 69% 83% 91%A about my plan* I am comfortable contacting Aetna if I have a question or 74% 66% 75% 86%A concern It is easy to find out if a doctor or hospital is in my health 68% 55% 71% 84%A plan’s network It is easy to reach a live person at Aetna 57% 48% 65% 66% I am confident that it will be easy to get Aetna to answer or 55% 40% 58% 73%A address my questions and concerns Aetna provides access to the information I need to make 55% 42% 52% 77%AB informed decisions about my health care* It is easy to find out what’s covered and what’s not by my 46% 28% 48%A 71%AB health plan NOTES: *Questions included in the DSS health literacy algorithm. Statistically significant differences denoted by ABC (95% confidence level). SOURCE: Griffiths, 2010.

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 BUILD PARTneRSHIPS FoR PATIenT-CenTeReD DRUG SAFeTY Aetna has been involved in three clinical studies in recent years. The Aetna Foundation funded studies at University of Pennsylvania and Brigham and Women’s Hospital on warfarin use and myocardial infarc - tion to understand the effect of removing financial barriers on medication adherence. An asthma outcomes study demonstrated that plain language intervention decreased use of rescue medication and increased use of controller medications. A study on migraine was conducted to evaluate whether technology, plain language, and a case worker can provide mea - surable improvement in discharge instruction compliance, quality of life, and decreased emergency room use. In 2004, Aetna launched a public health education program on health benefits literacy and financial literacy to show people how to maximize their benefits.3 The company started a working group in 2005 that has begun an awareness campaign for employees, established criteria and requirements for communication with constituents, and that continues to provide stakeholders with training and tools to address health literacy. Aetna is working to simplify communication efforts at every patient touch point in the system to improve their experience. Griffiths concluded her presentation by saying that opportunities to partner include patient safety collaborations to help patients understand, safely use, and adhere to medication protocols; personal health records as vehicles for educational outreach; formulary simplification and education; and data sharing among the care team to improve patient understanding and confidence. HEALTH PLANS Susan Pisano America’s Health Insurance Plans The community of health plans is eager to collaborate to promote safe use of medications; it is the right thing to do, said Pisano. America’s Health Insurance Plans (AHIP), representing nearly 1,300 member com - panies, has several established vehicles for partnerships among member companies, including the AHIP Health Literacy Task Force (chaired by Jill Griffiths, Vice President, Thought Leadership Clinical and Provider Rela- tions, Aetna), the Addressing Disparities in Health Work Group, and the National Health Plan Collaborative. Several AHIP Health Literacy Task Force members are at this workshop. The task force’s focus is recruiting more member companies to become involved, providing them with tools 3 See www.PlanforYourHealth.com.

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY to get started and advance progress, and sharing information so that no one has to reinvent the wheel (AHIP, 2010). AHIP member programs to address compliance and safety around medication use are often framed as quality/adherence rather than health literacy, though they have elements of health literacy within them. There are programs to avoid hospital admissions, prevent avoidable readmis- sions, and prevent avoidable emergency room use. They often involve intensive one-on-one interactions between a case manager and a patient and a pharmacist. Does the patient know how to take the medications? Is the patient taking the medications properly? The results of these pro- grams suggest that the one-on-one interaction is important and is having an impact. AHIP is not involved with labeling issues, but it has relationships with mail order pharmacies that would be helpful. There are opportuni- ties for AHIP to participate in general education campaigns, for example, through personal health records. Most AHIP members offer personal health records to their members. AHIP has a tradition of providing gen- eral information, such as what screening tests are important at what age and gender, but the decision making happens between the patient and the provider. AHIP could play a similar role in campaigns regarding safe use of OTC drugs; safe use of frequently used drugs such as aspirin, acet- aminophen, and antibiotics; as well as how to read the prescription label or what questions to ask your pharmacist. Finally, AHIP’s work on health literacy is integrated with its work in health disparities and cultural competency. Since these programs are in place to address specific populations, they offer additional opportunities for partnerships to address the safe use of medications. NATIONAL CONSUMERS LEAGUE Mimi Johnson national Consumers League The National Consumers League (NCL) is the nation’s oldest con- sumer advocacy organization, founded in 1899 to protect and promote social and economic justice for consumers and workers in the United States and abroad. Health issues, including food safety and drug safety, have been a big part of the NCL’s mission. The NCL sees great value in public-private partnerships to leverage resources and work together toward a common goal. The NCL has entered partnerships to survey consumers regarding gaps in understanding about certain health issues. A project on acetaminophen safe use, geared toward teenagers, is in place now. The NCL is gearing up for a project examining health literacy around

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 BUILD PARTneRSHIPS FoR PATIenT-CenTeReD DRUG SAFeTY vaccines. Do people understand what a vaccine is, its risks and benefits? Do they understand what immunity is? What are the risks of complica- tions from the vaccine versus contracting the actual disease? The NCL is working with AHRQ on a national multimedia cam- paign to improve public health by raising consumer awareness of the importance of good medication adherence.4 The campaign involves a broad cross-section of public and private stakeholders. Nearly three out of four Americans report that they do not always take their medications as directed (NCPA, 2006). Average adherence rates are around 50 to 60 percent. It is a big problem. Among the top barriers to adherence is that patients are not often convinced of the need, or they do not understand what the drug is doing for them; they do not understand the active ingredient. It is an exciting opportunity to make adherence a concept that the everyday consumer knows about. The NCL will test messages and con- cepts that resonate with consumers. Different cultural, socioeconomic, and linguistic groups will receive targeted outreach. Stronger partner- ships on these issues with everyone at the table means there will be a uni- fied message. Drug companies are excited about coordinating unbranded dissemination to health care practitioners. In the NCL’s experience, health care practitioners need to be prepared for the launch of a national campaign to educate consumers. If consumers are engaged and ready to ask questions, the health care practitioners need to be prepared for the dialogue. A wide range of stakeholders are involved in the NCL’s adherence campaign. Three workgroups are focusing on chronic condition outreach, health care practitioner outreach, and evalua- tions. Stakeholders will have tool kits for their constituents so that all will use the common messages and themes. The project must be consensus driven to succeed. Everyone needs to be at the table from the beginning to find what can be agreed upon and advanced. It requires an up-front conversation between patient and physician about treatment options, considering the patient’s lifestyle and what he or she can do to adhere. The NCL values and has a history of welcoming all parties to the table, Johnson said. Such partnerships bring varied perspectives and experience to the problem at hand, extend a campaign’s reach beyond that of one group, and provide an opportunity for complimentary efforts. 4 See http://www.nclnet.org/health/106-prescription-drugs/234-ncls-medication- adherence-campaign.

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY DISCUSSION William Ross, a nephrologist, began by describing practical issues he hears from his patients. They ask him why taking medications has to be so complicated. Who can take medications three or four times a day? It is not realistic. Why not simplify the process, make one pill for everything? Patients do not understand drug interactions or therapeutic concentra - tions of drugs. His patients also bring their medications to him, dump them on the counter, maybe five different medications—a blue pill, red pill, green pill—and expect him to know what they are. He thinks icons could help with medication identification, as well as using electronic medical records. Johnson described what the NCL learned from focus groups with newly diagnosed patients and those who have been living with a chronic condition. Some people set up systems to help them take medications properly; others had jobs or lifestyles that did not allow them to adhere to the prescription. But they all valued their relationship with their doctor above all. Debussey agreed that health care organizations have taken on narrow pieces of the puzzle, but they have not connected across all the organiza - tions to see how to solve some of the complicated issues. The electronic medical records and personal health records offer an opportunity to make some information more easily available to patients. For example, there could be tools to print out an icon of the different medications to show a patient and explain why they are taking the drug. The tools could also explain to patients why they have to take a drug three times a day and another only once a day. Robert Logan, National Library of Medicine (NLM), noted that NLM has a website called Pillbox that shows photographs of medications and explains what they are.5 It is in beta testing and should be more compre- hensive in the coming years. A separate NLM website called Daily Med6 provides similar drug information. Griffiths pointed out the disturbing number of medications at differ- ent dosages that look the same. McEvoy responded that most states now require that the prescription container label carry the identifying marks that are on the dose form. Unfortunately, that information is hard to find among all the other information on the label. And it is only useful if the patient keeps the container. Wong asked the panel to comment on patient-centered meaningful use and the electronic health record (EHR). Aetna is doing a lot of work 5 See http://pillbox.nlm.nih.gov/index.html. 6 See http://dailymed.nlm.nih.gov/dailymed/about.cfm.

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 BUILD PARTneRSHIPS FoR PATIenT-CenTeReD DRUG SAFeTY on meaningful use, but it still focuses on health care professional users. There is a tremendous opportunity, Griffith said, to determine where to connect patients and physicians and health plans. McEvoy responded that ASHP is participating in the meaningful use debate as it relates to computerized physician order entry systems. ASHP is focusing on such things as drug interaction alerts and maximum dose alerts. The NCL is part of the consumer partnership for e-health and has been weighing in on Capitol Hill with meaningful-use definitions throughout the process, Johnson said. There are exciting opportunities to talk about that which is beyond health information technology: how to collect and use data in a way that will lead to better health outcomes for patients, especially underserved populations. According to Brach, when the Centers for Medicare & Medicaid Ser- vices (CMS) issued their meaningful-use initial regulations at the end of December (CMS, 2009), it specifically said it wanted to include aspects of patient education, cultural competence, and literacy. But that has not yet happened. AHRQ’s Brach said she hopes to see some guidance on those issues soon. AHRQ is soliciting proposals to address how to improve patient education in electronic health records from the perspective of the physician users. For meaningful use, they want to see patient education options, including printable handouts for patients, or on-screen tools. The desire is to learn more about how to use technology tools to help people with limited literacy catch up, rather than letting this technology leave them further behind. Johnson & Johnson’s Scott Ratzan pointed out that with health liter- acy integrated into health care reform, there are opportunities to increase efforts in this area, perhaps through funding for research. He sees oppor- tunities in public-private partnerships to speed diffusion of safe use and health literacy and strategic health communications. Programs can not be vertical, he said. We need horizontal programs to strengthen systems with pharmacists, prescribers, and individuals. We also need to look beyond best practices to next practices. One thing to explore is the use of new communication technologies such as mobile phones. Ratzan worked with Text4Baby,7 a mobile health project with the White House, Healthy Mothers/Healthy Babies, and 60 or so partners all focused on getting health literate messages to women during pregnancy. All the groups came together because the White House convened the meeting and said it was important. There is great work out there, and the key is to find it and dif- fuse it for others to be successful, Ratzan said. Cocotas said coordination between the physical and mental health sectors is challenging within the health care sector. Interesting medical 7 See http://www.text4baby.org/.

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 THe SAFe USe InITIATIVe AnD HeALTH LITeRACY and legal challenges arise around accountability. Although tools finally exist to coordinate care, she sees people stepping back from taking on the responsibility. Case managers are flooded with new information. Who is responsible, who communicates with the consumer about what they need to do, who will communicate what messages to consumers? Griffith added that in the health information exchanges there is not enough clar- ity about who is to do what. AHIP, insurers, pharmaceutical companies, pharmacies, and the government are all interested in methods to com - municate with patients. Is there something different that has to happen to have all the stakeholders communicate more effectively? Brach pointed to a study by Schillinger and colleagues (2006). In a sample of patients taking warfarin, there was 50 percent discordance between what the patients thought they were supposed to be taking and what the doctors thought they had told the patients to take. More than 30 percent admitted to missing a dose; they were not adhering to the medi - cation regime. Yet physicians and pharmacists frequently say they do not have time to go over the information on how to take the medicine during their short visits. Can reimbursement be restructured to get better results and avoid more costly mistakes, such as emergency room (ER) visits? AHIP’s Pisano said several models are being tested with different kinds of payments. It is important to ask if these concepts include a component of health literacy. People need to make sure the patient has demonstrated understanding. There is a lot of experimentation going on that assumes physicians will spend more time with the patient given the correct payment incentive. Using electronic health records, doctors can be given standardized, simple language about a drug to talk with the patient, Wolf said. He explained that Debra Roter at Johns Hopkins University is working on a plain language dictionary of complex medical terms. It is not an opti - mal tool for patients, but it gives providers the language to take a very complex term and explain it. It helps them know what they need to tell a patient about warfarin during prescribing, for example. Wolf has shown with time motion studies that it adds only one second to a doctor’s visit. Using the EHR platform, doctors can be more efficient. There has been provider resistance because providers think they will have to do more in their 20 minutes, but by leveraging these tools, providers can be more effective. The next few years will be about health reform, said Griffiths, but also about finding ways to look at reimbursement models with hospitals, health plans, and providers, looking for quality improvement and cost control. She questioned, however, whether the problem is a reimburse - ment issue. Is it that the health plan is not paying enough, or are there

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 BUILD PARTneRSHIPS FoR PATIenT-CenTeReD DRUG SAFeTY other encumbrances on the doctors’ time? Health plans are working on standardized accreditation processes and procedures to see how to make some of the work easier so that doctors can spend more of their time on patient care. Bullman said that about 2 years ago NCPIE ran focus groups with consumers who were taking medications for acute self-limiting problems and patients taking medicines for which there is a required a medication guide. Of the second group, none were familiar with the medication guide, but once they worked through the guide and talked through what they had learned from the med guides, they consistently felt it was the kind of infor- mation they should talk about with their doctors. They wanted to receive it at the time the medicine was being prescribed, as part of a discussion about treatment options. They wanted to get it again at the pharmacy to be clear on risks from the medication. The bottom line is, consumers who are exposed to high-risk medications want to know about the medication as soon as possible during the opportunity for dialogue.

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