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3 Federal Agency Reaction to Prescription Use Instruction Standardization CINDy bRACH, M.P.P. Agency for Healthcare Research and Quality The evidence is clear that patients do not understand current drug labels, that there are medication adherence problems, and that there are ambulatory medication errors. The presumption is that there is a correla- tion between understanding and adherence. What is less clear is what should be placed on drug labels to remedy the problems, despite some good best practices from the health literacy research literature as well as specific testing of different labeling approaches. There is some information about how to improve labels, yet more research is needed to determine what changes to make. Furthermore, there is no strong evidence to demonstrate that changing the label and increasing understanding will lead to better adherence, fewer adverse consequences, or better patient outcomes. More research is needed on these issues. It is also important to address the issue of language barriers in patient understanding of medication information. The American College of Physicians (ACP) Foundation white paper suggested that a regulatory approach could be used to achieve standard- ization. There is no good evidence to suggest that regulation is the best approach. However, research about other kinds of medication information shows that voluntary approaches have not been highly successful. Several questions need to be addressed: What are the mechanisms by which standardization can be achieved? What would the process look 

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0 stAndARdizing MediCAtion lABels like? What are the costs of standardizing? What level of evidence is needed to introduce a best practice? One may be willing to adopt what looks to be an improvement, even without the highest bar of evidence, if the cost is low. However, if there is a high cost, then more evidence is required. The benefits of standardization have been well presented. The main risk may relate to the energy required to implement a standardized drug label. That is, those efforts might detract from other efforts that are needed to address the problems of low adherence and medication errors. The Agency for Healthcare Research and Quality (AHRQ) is engaged in a number of activities related to drug labeling and patient understand- ing. For example, AHRQ has been working with the National Council for Prescription Drug Programs on a program related to standardization in ePrescribing.1 It is important to examine whether the standardized message the pharmacist receives from the physician is actually a good message to put on the pill label. AHRQ has also been working on the opportunities for counseling about medications. There are opportunities in inpatient care for discharge education and counseling. A number of projects have been funded in this area, and some of them have developed pictorial graphic pill calendars for patients that display the schedule for their medications. Another project has developed a pill card that is currently being tested. When a patient fills a new prescription at the pharmacy, he or she will receive a pill card with a list of all the medications that have been filled at that pharmacy and instructions for how to take them. The pill card uses various icons such as the sun to indicate morning and the moon to indicate night. The project has also developed a health literacy assessment guide. The guide is used by pharmacies to determine how well they are doing in commu- nicating with their patients and addressing variable health literacy. AHRQ is also involved in a project called “Questions Are the Answer.” Research has shown that patients who leave a provider’s office with ques- tions are more likely to have a patient safety event. Thus, a website that aids patients in constructing a list of pertinent questions to ask their doc- tors has been developed for patients to use before their appointments. The project has also developed a musical public service announcement. And AHRQ is developing a health literacy assessment of patients’ experiences, including a question about how easy it was to understand the medication instructions given by the physician. 1 ePrescribing is defined as “the transmission, using electronic media, of prescription or prescription-related information, between a prescriber, dispenser, PBM, or health plan, ei- ther directly or through an intermediary, including an ePrescribing network. E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the dispenser” (Federal Register, 2005).

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 FedeRAl AgenCY ReACtion Brach concluded that there will always be some people who do not understand instructions, no matter how carefully the label is written. Therefore, drug labeling needs to be part of an overall strategy to improve medication adherence and reduce medication errors. NANCy OSTROvE, Ph.D. Food and drug Administration The Food and Drug Administration (FDA) supports evidence-based standardization as a baseline for information accessibility as demonstrated through FDA regulations that require nutrition-facts panels on foods and drug-facts labels for over-the-counter products. Consistently placed information assists the targeted audience in finding information, read the information, and, it is hoped, apply the information. Standardization may be particularly important for populations with limited literacy. The majority of the findings in the ACP Foundation white paper are well supported by the literature. A major strength of the white paper lies in its proposal for standardization of dosing instructions to the degree to which the implementation of those standards is evidence based. The ques- tion is, What specific standard for dosing information will improve under- standing and appropriate use of prescription medications, especially for those with lower literacy and health literacy skills? Unfortunately, there is a risk that the desire to rapidly achieve standardization could undermine appropriate research. For many years, FDA has deferred to state regulations and state boards of pharmacy in determining what information should appear on prescription drug container labels. In fact, there are many who believe that prescription medications are exempted from the Federal Food, Drug and Cosmetic Act requirements for providing adequate directions for use. For the FDA to establish a requirement or set a standard concerning drug labels would be viewed as interfering with the practice of pharmacy. Once a drug is approved for marketing, prescribers are free to prescribe it con- sistent with their clinical judgment. The FDA does not have the authority to dictate to prescribers how they should write their prescriptions. Information surrounding the container label (i.e., patient package inserts) is regulated by the FDA. In response to the Institute of Medicine (IOM) report on the future of drug safety (IOM, 2007) and with informa- tion obtained from public meetings, the FDA Center for Drug Evaluation and Research is putting together a strategic risk communication plan that will include an examination of all the tools currently used by FDA for communicating drug information. Furthermore, even though consumer medication information sheets are not regulated by the FDA, Congress

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 stAndARdizing MediCAtion lABels has mandated that FDA assess the program’s success and has defined suc- cess as 95 percent of patients in the year 2006 who received new prescrip- tions also having received useful information with their prescriptions. FDA has also recently established a Risk Communication Advi- sory Committee that will provide a forum for discussion of issues and approaches to improving how FDA is communicating with its targeted audiences—both patients and health care providers. The committee will not be addressing specific drug issues or specific device issues but rather will focus on broader issues, such as health literacy and how to appro- priately communicate both the risks and benefits of the products FDA regulates from foods through biologics, drugs, and medical devices. The FDA agrees that standardization is a good idea and that imple- mentation should be evidence based. Implementation could occur through the National Association of Boards of Pharmacy (NABP) and the state boards of pharmacy. The NABP has, for example, a set of model laws that could incorporate standards for prescription container labels. Finally, the FDA does not perceive that existing federal regulations would interfere with implementing standardization. vIRgINIA TORRISE, Pharm.D. department of veterans Affairs As a comprehensive health care system, the Department of Veterans Affairs (VA) may face challenges that differ slightly from those encoun- tered in the private sector. The VA serves approximately 5 million veteran patients and dispenses approximately 120 million prescriptions a year. It serves an aging population, the average age of which is approximately 65 years old. Understanding the instructions through the health care process is challenging. The VA has ePrescribing, it has treatment guidelines, and it will be developing more robust decision support systems. Currently the VA is examining standardization of nomenclature as part of its ePrescribing, a result of an initiative that merged the prescription portion of VA’s elec- tronic medical record information system with that of the Department of Defense. Phase II of the merger will examine laboratory information. The VA is also building a personal health record that not only provides infor- mation about medications, but will also provide such things as reminders to patients of appointments and upcoming laboratory work. Additionally, if individual patients agree, community providers can include information in the records and patients can list over-the-counter items they purchase. The VA system integrates the prescribing and filling of prescriptions with an examination of patient understanding and adherence. An impor-

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 FedeRAl AgenCY ReACtion tant component of proper prescription use is communication from the provider to the pharmacist about the purpose of the prescribed medica- tion. There may also be future opportunities to provide the pharmacist with additional information that will allow him or her to assess, for example, whether a laboratory goal has been met or if there have been risks occurring with certain medications. Pharmacists in the VA work with medical teams, often in clinic settings, where they review the appropriate- ness of the medication on a medical record, counsel patients, and check to see if patients understand instructions. One approach includes shared appointments, where patients meet with several providers (e.g., physi- cian, nurse, nutritionist, pharmacist) at the same time who communicate with the patient about his or her health and treatment. The VA shares the commitment to improve health literacy and sup- ports the need for medication label changes but believes such changes should be just one part of a larger approach that must include accessible, verbal communication. DISCuSSION An audience member asked if, without considering whether it is the correct thing to do, it would it be possible to write federal legislation or regulations that would mandate standardized drug labeling. Brach stated that the Medicare Prescription Drug, Improvement and Modern- ization Act of 2003 actually mandates the adoption of standards for inter- operability for ePrescribing so that from the prescriber to the pharmacist, there will be a standard. One might say, therefore, that standardization has a legislative basis. Ostrove responded that it is probably possible, but one then must ask whether it would be the most appropriate approach. Given the historical deferment to the states, the practicality of federal regulation is probably fairly limited. There would most likely be objections about interference with the practice of pharmacy and the practice of medicine. Panelists were asked, if everyone seems to agree that standardizing the drug label is a good idea, how can this be accomplished without an accompanying policy change? How will these standards be enforced? For example, current evidence shows that despite extremely detailed guidance on the development of FDA medication guides, this guidance is not followed. Should standards be developed and merely circulated with the hope that they will be adopted? Should there be a model practice act developed that is similar to the new California law? While some best practices have been identified, there is no real incentive for their adop- tion. One can travel through each of the 50 states in the United States and know what a stop sign looks like, but there is no consistency about what

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 stAndARdizing MediCAtion lABels a “no food” symbol on a prescription bottle looks like. What will cause the situation to change? Ostrove responded that these are issues of implementation and raise the overall question of whether the introduction of standards should be a grassroots approach or whether it should be through legislation and regulation. Even if one were to implement regulations, it does not mean that practice will conform, as seen from research that shows mandated medication guides are not distributed. Brach responded that from the perspective of a non-regulatory federal agency, there are options short of regulation, such as working with relevant associations and organizations. If there is sufficient evidence to support standardization, then one could bring relevant groups together to develop an implementation strategy. Such groups might include the Department of Health and Human Ser- vices, private-sector partners from relevant associations (e.g., from phar- macy and medicine), and the IOM Roundtable on Health Literacy. The panel was then asked whether the expanding use of electronic medical records presents any additional regulatory or legislative possibili- ties or issues. Brach responded that, to her knowledge, there are no pro- hibitions to such legislation or regulation. Currently there are a number of systems operating. The Department of Health and Human Services is engaged in trying to reach a consensus about interoperability among the many vendors of the systems that do exist, but it is not pursuing regula- tion in this area. Torrise agreed that there is probably nothing that would prevent such regulation, but there are disincentives. Panelists were then asked if each would state who should take lead- ership on moving forward on the issue of drug label standardization. Torrise stated that since the VA is, in effect, its own state board of phar- macy, it can write the necessary policies for its system. Furthermore, the VA will be closely examining the issue of standardization to determine how to move forward in this area. Brach suggested that the implementa- tion issues are beyond the purview of one federal agency and, instead, require the cooperation of all those involved. From the AHRQ perspec- tive, Brach stated, one needs to determine how drug label standardization would be integrated into the overall strategies of improving other pieces of the system, such as patient counseling, since merely standardizing drug labeling would not fix the problems of medication safety and adherence. Ostrove agreed with Brach and further pointed out that there is as yet no information on the impact of such standardization on patient adher- ence. Until that is available, the best that can be done is to develop a theoretical marketing plan for the idea. Groups that could be instrumental in moving forward with this include the IOM, working very closely with the pharmacy industry and the NABP.