5
Other Stakeholder Reaction to Prescription Use Instruction Standardization: Physicians and Patients

WILLIAM DOLAN, M.D.

American Medical Association


The Institute of Medicine Roundtable on Health Literacy and the American College of Physicians (ACP) Foundation are to be commended for their work in the area of standardizing drug labels. There is a crisis. One in seven people in the United States is without health insurance, but about one in three (90 million people) cannot read their prescription labels and are uninformed about the treatment they are receiving. While there may be disagreements with some portions of the ACP Foundation white paper, the American Medical Association (AMA) supports the exploration of a standard medication label format.

There are many causes of the problems that face us, including, for example, the poor reading skills of many American citizens. However, addressing the labeling problems is a proper place to begin our efforts to improve patient understanding. Drug labeling changes might be implemented on a state-by-state basis, as is occurring with attempts to provide health insurance to the uninsured. States have the capacity to make changes. Chain stores such as Wal-Mart and Target are other places to begin change efforts.

Changing the format in which physicians write prescriptions is probably not the best approach. Using Latin to inform the pharmacist has worked well. Furthermore, states have their own requirements. New York, for instance, has recently developed a tamper-proof prescription pad that



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5 Other Stakeholder Reaction to Prescription Use Instruction Standardization: Physicians and Patients WILLIAM DOLAN, M.D. American Medical Association The Institute of Medicine Roundtable on Health Literacy and the American College of Physicians (ACP) Foundation are to be commended for their work in the area of standardizing drug labels. There is a crisis. One in seven people in the United States is without health insurance, but about one in three (90 million people) cannot read their prescription labels and are uninformed about the treatment they are receiving. While there may be disagreements with some portions of the ACP Foundation white paper, the American Medical Association (AMA) supports the exploration of a standard medication label format. There are many causes of the problems that face us, including, for example, the poor reading skills of many American citizens. However, addressing the labeling problems is a proper place to begin our efforts to improve patient understanding. Drug labeling changes might be imple- mented on a state-by-state basis, as is occurring with attempts to pro- vide health insurance to the uninsured. States have the capacity to make changes. Chain stores such as Wal-Mart and Target are other places to begin change efforts. Changing the format in which physicians write prescriptions is prob- ably not the best approach. Using Latin to inform the pharmacist has worked well. Furthermore, states have their own requirements. New York, for instance, has recently developed a tamper-proof prescription pad that 

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 stAndARdizing MediCAtion lABels every physician is required to use. Mandating a uniform prescription pad across all states would require legislation. Congress has been considering legislation that would require all Medicaid prescriptions be tamper proof, but it is currently on hold because of numerous problems. Widespread use of electronic medical records may lead to prescription format changes. However, only 10 percent of physicians currently have electronic medical records. They are very costly—about $30,000 to $50,000 per physician per setup, with a $1,000 monthly maintenance fee. Further- more, because there are between 100 and 300 providers of the software for electronic medical records, interoperability is a problem. Improving patient understanding requires better physician counsel- ing. The AMA has a large literacy program with workbooks for clinicians and others, as well as patient handouts. There are also movies about health literacy available on the AMA website. The AMA supports efforts aimed at improving patient understand- ing and will work with others to accomplish this. In response to a ques- tion from the audience, Dolan agreed that there should be a convening organization—perhaps the National Patient Safety Foundation, the IOM, or the AMA—to bring together interested stakeholders. There should also be broad collaboration of all stakeholders in the effort. ALbERT Wu, M.D., M.P.H. Bloomberg school of Public Health, Johns Hopkins Uniersity There is enough evidence available to show that something must be done to address problems with patient understanding and use of medi- cations. The question is, What should be done? To answer this question, evidence tables are needed that delineate the level of evidence available for each of the recommendations made in the white paper and for the specific proposal for standardization. A research agenda to evaluate the effectiveness of different strategies is needed as well. There are several challenges that will be encountered as one moves forward with standardizing medication container labels. One of the chal- lenges of standardization is that there must be room for exceptions. All guidelines are applicable in 80 percent or 90 percent of the cases, but they must be written to allow room for improvisation because there are always nonstandard orders that need to be written. Another challenge is the writ- ing of prescriptions. Handwriting as a method for getting prescriptions into the medication system is one of the root causes of variability and should be eliminated. It is important to take action before ePrescribing is in widespread use so that the systems will be interoperable. A third challenge is that the business case for standardization has not been made. What will

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 otHeR stAkeHoldeR ReACtion: PHYsiCiAns And PAtients standardization cost? Yet another challenge is that there is not, at present, sufficient outrage about the problems of the current system of medication drug labeling. How many people really think there is a problem in pre- scription writing and dispensing? The issues need to be well publicized. There is also tension between innovation and standardization. There is an opportunity for research given the innovations that organizations such as Pfizer, Target, Wal-Mart, and the Department of Veterans Affairs are undertaking in this area. At the same time there is the proposal for standardization put forth by Wood at this conference and the approach being taken in California. Studies are needed to compare the effective- ness of various approaches, using logic models to examine outcomes. Such outcomes include understanding, adherence, medication errors, and injuries. However, it is important to remember that when something new is implemented, it is very likely that performance will become slightly worse before improvements are made. As efforts are evaluated, this must be kept in mind. Policy change is needed. There are local policy changes in systems that cover millions of people (e.g., California, Veterans Affairs, Wal-Mart). However, more evidence is needed before national policy can be devel- oped. National policy is necessary to compel practice change. To lead this effort a convener is needed. The IOM, by virtue of hav- ing assembled such an impressive group of people at this conference, has begun the process. Perhaps the National Quality Forum could play a major role. Constituents from across the medication use spectrum are needed in the effort, not just those from health literacy, but from a much broader base. WILLIAM buLLMAN, M.A.M. national Council on Patient information and education The expertise that has been brought to bear on the production of the white paper and the organization of this conference is tremendous. The ACP Foundation and the IOM Roundtable on Health Literacy are to be commended. The white paper is comprehensive. The presentation regard- ing the universal medication schedule was fascinating. What, then, are the next steps needed? The call for regulation may be premature. The experience of the National Council on Patient Information and Education (NCPIE) might be brought to bear in an examination of this issue. The NCPIE has been involved in attempting to stimulate quality improvements in written drug information, both in the clinical content and the design layout and readability of the consumer medical information sheets. Furthermore, it has convened

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 stAndARdizing MediCAtion lABels groups to discuss with the FDA issues related to the medication guide and the concept of the electronic medication guide. Efforts in this area call into question the idea that regulation is a panacea, and caution is urged in pursuing the regulatory avenue. The NCPIE was formed in 1982 with a mission to stimulate and improve communication of information on appropriate medicine use. The operating philosophy is that oral counseling, supported by appropriately designed written information as adjunctive information, is the way to achieve a more informed patient or caregiver. An examination of data from about 1992 to 2004 will show that con- sumers are not routinely receiving information about instructions for use, precautions and warnings, side effects, and refills. Only about 60 percent to 64 percent of patients report receiving information in the physician’s office—primarily about refills and side effects—and the figures are even lower for pharmacies. At the same time, patients have failed to ask for information. Increasing these percentages requires behavioral change, an extremely difficult challenge. We are not without tools. The AMA has guidelines for counseling patients in the ambulatory care setting. There are counseling guidelines for pharmacy and nursing guidelines about appropriate medication com- munication. These have not, however, undergone any kind of rigorous research program to determine if they are effective or to learn how to make them better. Addressing the issue of drug label standardization, the United States Pharmacopeia might be a very good place to move this initiative for- ward. It has a committee on safe medication use and is involved with the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). Furthermore, it has a multidisciplinary mem- bership that includes federal agencies. LINDA WEISS, Ph.D. new York Academy of Medicine The ACP Foundation white paper advocates standardization of pre- scription drug container labels. Standardization would also facilitate translation of instructions into other languages. As Wood reported, the instruction “take 1 pill a day,” was written in 44 different ways. Translat- ing the instruction once, from a standard format, is reasonable; expecting pharmacists to provide 44 translations is likely to cause a number of problems. The white paper concluded that improvements are also needed in other sources of consumer medication information. These improvements

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 otHeR stAkeHoldeR ReACtion: PHYsiCiAns And PAtients should include, for example, standardized translation of medication labels and other information provided during the pharmacy’s medica- tion counseling. The New York Academy of Medicine has been working in the area of translated medication information for patients who do not speak English well. Results of a study on access to translated medication labels were used by the Academy to develop a continuing education curriculum for pharmacists as well as other interventions for use in New York City. Work is being undertaken collaboratively with physicians, nurses, pharmacists, health educators, and immigrant advocates. New York City is home to 2.9 million foreign-born people. Almost half of New York City residents speak a language at home other than English. More than one in four adults say they do not speak English well, and about half of those are in homes where no one speaks English well. Increasingly, limited English proficiency is a national issue. Between 1990 and 2000, 45 states saw growth in their immigrant populations, some by 300 percent or 400 percent. In the country as a whole, some 21 million people say they are limited English proficient, a growth rate of 50 percent over the past decade. Research suggests that patients who do not speak English well have poor knowledge of medication and dosing instructions as well as significantly greater problems with medication adherence and that providing oral and written medication information in their language is linked to improved health outcomes. The New York Academy of Medicine conducted a random sample telephone survey of 200 pharmacies. The survey found that 88 percent reported that they served patients daily who did not speak English well. Eighty percent stated that they could translate labels into at least one lan- guage. But of those with daily limited English proficiency patients, fewer than 40 percent translated daily, while almost 25 percent never translated. Some 88.5 percent of the 200 pharmacies employed bilingual staff, but less than half of these staff were pharmacists or pharmacy interns. It was found that in many of these pharmacies, counseling was being provided by store cashiers or by another customer in the store. The study and follow-up discussions identified a number of factors associated with limited access to the use of translated medication informa- tion. One factor is capacity. Dispensing software may not have translation capacity or the capacity to translate into needed languages. A related factor is concern about the accuracy and reliability of translations that are provided. Some systems are better than others. Pharmacists reported that they have often identified errors in their English labels and therefore expect that such errors also exist in the translations. Pharmacists who do not speak the language are concerned that the instructions and other information might not be correct.

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 stAndARdizing MediCAtion lABels Another concern is that many software systems can print in one lan- guage only. If the label is translated, then it is entirely in the translated language and may not comply with regulations. For pharmacists who can- not read the translated label, there is again concern that the information on the translation might not be correct. Pharmacists were also concerned about the time and the cost of providing translated written materials as well as translated telephone services. A number of pharmacies had such telephone services, but they were not used. For those who need a translated label, it appears that the mechanics of translation would be facilitated by standardization. Furthermore, to the extent that research will be conducted on label standardization, it makes sense that such research also examine translation of labels. Whatever format is ultimately chosen, provision should be made for translation of that format. Furthermore, there should be a broad collaborative effort involving all the different professions as well as the patient perspective in moving forward with the idea of standardization. MARA yOuDELMAN, J.D., L.L.M. national Health law Program Of the more than 21 million people in the United States who are limited English proficient (LEP), slightly over 2 million are individuals over age 65. Given what we know about problems in understanding med- ication instructions among people over 65 who are proficient in English, it is certain that the problems must be worse for those people over 65 who are LEP. One study conducted in hospitals in the Boston area showed that 27 percent of patients who needed but did not have interpreters left the hospital not knowing how to take their prescription drugs. For those who either did not need an interpreter or for whom interpretations were sup- plied, only 2 percent did not understand how to take their medications. While the problem for LEP patients cannot be eliminated simply by modi- fying the medication labels, changing the labels will help significantly. In addition to the problems that pharmacists face, clinicians also are struggling with how to meet the needs of their LEP patients. The National Health Law Program (NHLP) has surveyed this issue. One such survey conducted with the American Hospital Association found that 81 percent of hospitals are treating LEP individuals at least monthly. Sixty-three per- cent of these hospitals are seeing LEP patients daily or weekly. The NHLP also conducted a survey with the American College of Physicians that found that about 65 percent of all internists have active patients with LEP

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 otHeR stAkeHoldeR ReACtion: PHYsiCiAns And PAtients and that 81 percent of these physicians are treating LEP patients monthly. Therefore, when we are discussing the issues of understanding and com- pliance with prescription drug instructions, we must examine not only what happens in pharmacies, but also in the broader medical system. Legally, standardization would be of great assistance because any cli- nician who accepts federal funds in the United States is subject to Title VI of the Civil Rights Act of 1964, which states that one cannot discriminate on the basis of national origin. The Supreme Court and the federal agen- cies have said that language can be a proxy for national origin. There- fore, clinicians treating Medicare, Medicaid, and state children’s health insurance program patients have an affirmative expectation to provide language services to meet the needs of their LEP patients. Having a standard medication label in place eases the ability to trans- late these labels and therefore will be of great assistance to clinicians and pharmacists in meeting their existing obligations under Title VI. There is nothing in the federal laws that prohibits translation; rather there appears to be a more permissive approach that allows inclusion of other languages in a prescription label. Some states, such as New York, have provided affirmative support for translation. One of the state pharmacy laws in New York talks about misbranded drugs and says that any word, statement, or other informa- tion required to appear on the label must be in terms likely to be read and understood by the ordinary individual. In New York City, as is the case in more and more cities across the country, an ordinary individual would very likely include an LEP individual. Therefore, pharmacists might not be in compliance with state law or might be found to have misbranded a drug if they are not providing the translation. There is significant support in existing law at both the federal civil rights level and in some states to encourage standardization to ease the way for compliance with these laws. Standardization is essential to ensur- ing that LEP individuals have the access to the health care system that is guaranteed under federal law. Furthermore, with standardization there would be only one way to write “take one pill a day,” and that phrase could be translated by one software company or every software company into the top languages needed, thus easing the burden on pharmacies and pharmacists for multiple translations. Moving forward with standardization should be a collaborative effort, but who leads that effort depends on which organizations have the relevant expertise, clout, commitment, and interest to bring all the stakeholders together.

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 stAndARdizing MediCAtion lABels DISCuSSION One audience member stated that an evidence-based standardized format for writing prescriptions would make the job of the physician much easier. With such a standardized form, even if it were translated into another language, the prescriber would know exactly where and how to fill in the instructions for use. Therefore, moving forward with testing of a standardized prescription format appears to be a very good idea. Another participant raised concerns about samples. In many cases, particularly with vulnerable populations who cannot afford medications and who are seen in community health centers and other settings, physi- cians often give samples and provide instructions for their use. Provid- ing such samples may be of great concern, particularly when they are given to patients with low levels of literacy or language barriers. Wu responded that the IOM report on preventing medication errors (2007) was quite critical about the use of samples because samples provide many opportunities for bypassing safety checks that otherwise exist. However, if such samples were dispensed in unit-of-use packages, this might be an opportunity to provide more information in an attractive package and might offset some of the potential risks caused by the relatively unfettered distribution of samples. Bullman stated that the NCC MERP is examining the use of samples. Dolan emphasized the need for counseling and educa- tion of patients about proper medication use.