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What Would It Take to Move Toward Prescription Use Instruction Standardization?

ROGER WILLIAMS, M.D.

United States Pharmacopeia


The United States Pharmacopeia (USP) is a standard-setting body. There are about 500 standard-setting bodies in the United States. Three hundred or so are accredited by the American National Standard Institute (ANSI), which is a professional association that watches over all the U.S. standard-setting bodies. At the global level there is the International Standards Organization (ISO) in Geneva, Switzerland.

Standards can be either documentary or physical. The USP sells physical reference materials, as does the National Institute of Standards in Technology (NIST). Documentary standards include such things as best practices, guidelines, guidance, regulations, and laws. From this perspective, the patient package insert is a standard.

Standards can be voluntary or mandatory. Additionally, there are different kinds of standard-setting bodies. For example, there are voluntary consensus standard-setting bodies where individuals affected by the standards participate in developing them. Government is a very strong standard-setting body, but that is a different model.

The USP is a convention of about 450 associations, and it is a practitioner-based body. There are about 40 pharmacopeias worldwide, but the only one of them that is nongovernmental is the USP. The USP was started in 1820 by practitioners who desired good standards and good names for the medicines they used.



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7 What Would It Take to Move Toward Prescription Use Instruction Standardization? ROgER WILLIAMS, M.D. United states Pharmacopeia The United States Pharmacopeia (USP) is a standard-setting body. There are about 500 standard-setting bodies in the United States. Three hundred or so are accredited by the American National Standard Insti- tute (ANSI), which is a professional association that watches over all the U.S. standard-setting bodies. At the global level there is the International Standards Organization (ISO) in Geneva, Switzerland. Standards can be either documentary or physical. The USP sells phys- ical reference materials, as does the National Institute of Standards in Technology (NIST). Documentary standards include such things as best practices, guidelines, guidance, regulations, and laws. From this perspec- tive, the patient package insert is a standard. Standards can be voluntary or mandatory. Additionally, there are different kinds of standard-setting bodies. For example, there are volun- tary consensus standard-setting bodies where individuals affected by the standards participate in developing them. Government is a very strong standard-setting body, but that is a different model. The USP is a convention of about 450 associations, and it is a practitioner-based body. There are about 40 pharmacopeias worldwide, but the only one of them that is nongovernmental is the USP. The USP was started in 1820 by practitioners who desired good standards and good names for the medicines they used. 

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 stAndARdizing MediCAtion lABels Good pharmaceutical care involves a long process that begins with drug discovery at one end of the process and moves through many steps until it ends with the patient properly using the drug. In considering how to improve patient outcomes, one can look at any of the component steps in this process, but standardizing prescription medication labels is an issue that deserves consideration and that would have a major impact. Williams stated that the United States had a gross domestic product of more than $13 trillion in 2006 (Geographic.org, 2007). U.S. health care expenditures are expected to exceed $4 trillion by 2016 (AAOS, 2007). As of 2005, the annual expenditure on prescription drugs alone was more than $200 billion (KFF, 2007), and it is likely the drug bill will move much higher. About half the total value of drugs sold worldwide are sold in the United States, and of those, generics account for about 10 percent of the total cost. Generics are approaching 60 percent of all prescriptions, and it is likely that percentage will increase. Given the value of the prescription drug market, even minor improvements could have a large effect in terms of dollar value. The Hazard Analysis and Critical Control Points is a food safety sys- tem used by the Food and Drug Administration (FDA). One could use a similar approach to examine the process whereby medicine moves from the practitioner’s office to the patient’s home and to determine where the greatest improvement might be achieved. Another way to think about this is using the Situation Target Proposal. The specific proposal offered here is to use one of USP’s expert committees, perhaps the Safe Medication and Use Committee, to start working on a format standard for the prescrip- tion bottle label. USP is willing to invite representatives of the Institute of Medicine Roundtable on Health Literacy and the American College of Physicians (ACP) Foundation to its next meeting to discuss possibilities. There has clearly been tremendous progress on standardizing the label, including examples from Pfizer and some of the major chain drug stores. The USP has well-evolved procedures and processes for how a standard-setting activity should proceed. There is a public notice or com- ment called Pharmacopeial Forum. All stakeholders could participate in this activity in one way or another. One might use the National Coordinat- ing Council for Medication Errors Reporting and Prevention as a staging area to talk about the various issues related to standardization. It should be possible to come forth with a reasonable, voluntary standard in a fairly short amount of time. It is important to emphasize that the USP is not an enforcing body. It would be up to other bodies—for example, the FDA or state boards of pharmacy—to adopt the standard if they wished to do so. A standard does not have much meaning unless there is also a conformity-assessment activity for the standard. This is something that the USP could offer. At

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 wHAt woUld it tAke? a minimum, the USP would like to participate in the effort. If medica- tion care can be improved, there is the potential to save a great deal of money—for example, by reducing hospitalizations due to improper use of medications. DARREN k. TOWNZEN, R.Ph., M.b.A. national Council for Prescription drug Programs Why is a standardized label needed? Clearly, one reason is to increase patient understanding. Another reason is because of the inconsistency across states in the information on the prescription drug label. Beyond the label itself are the problematic auxiliary labels. While they serve a purpose, they are difficult to read and understand. There was discussion earlier about the pharmacist interpreting the prescription. Rarely is it the case that the pharmacist enters that informa- tion into the system. Usually it is a technician, although the pharmacist makes sure the printed label is correct. It seems it would be efficient to have a standardized prescription pad as well as a standardized label. Stan- dardization through ePrescribing is preferable. However, if prescriptions are written on paper, a standardized prescription format could increase the level of understanding and reduce errors. SuSAN JOHNSON, Pharm.D., Ph.D. Food and drug Administration Drug facts labeling for over-the-counter (OTC) products was devel- oped largely because the printing on the products was ghastly. The label- ing had become illegible, and there was no standardization in formatting, presentation, or order of idea. Patients were unable to read the labels. While a great improvement over the previous condition, drug facts label- ing does have its limitations as a model to use for standardizing prescrip- tion drug labels. For instance, the instruction language did not change, so instructions still read “take one every six to eight hours as needed.” Perhaps what California develops will prove a more useful model. An issue of importance is the attitude of the patient toward the medi- cation. There is the perception that OTC medications cannot cause harm. Patients also often believe that if the physician prescribed the medication, it is safe. People lose sight of the risks. This is of particular concern with specific drugs that have narrow therapeutic windows or with specific populations. For example, medication misuse in infant populations can lead to very serious outcomes. An OTC label states that for children under

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 stAndARdizing MediCAtion lABels 2 years, the product should be used at the discretion of the physician. Infants should not be dosed by parents or other health care practitioners. However, that is what is occurring, and there are medication errors made because of such things as the dropper used or the markings on the dropper or dosage cup. All of these concerns are outside the realm of the prescrip- tion instruction or other label component. They are beyond the control of the dispensing process. However, they are major factors in how a patient actually uses the medication. Some have suggested that the FDA has placed limitations on the way in which drug labels can be changed or improved. In reality, the FDA has no interest in limiting innovations. Some of the newest moves from a prescription to an OTC drug are good examples of ways in which manu- facturers have created innovations to provide patients with extensive con- sumer information and extensive packaging to increase comprehension. Such innovations would be welcome in the prescription realm as well. The people attending this conference have the ideas that can move standardization forward. Looking at high-impact changes, as suggested by Williams, is a good place to start for introducing standards, particu- larly if one is going to propose federal regulation. As FDA lawyers say, show me the proof this works, show me the proof it does not have a down side, show me that people will not object to it, and show me that it does not make things worse. Such things have high impact and are the things that would most quickly and easily become federal standards. vANESSA CAJINA, M.P.A. latino Coalition for a Healthy California The need to standardize prescription drug labels has been well out- lined. On October 11, 2007, California became the first state in the United States to pass legislation adopting standardized prescription drug label- ing. The Latino Coalition for a Healthy California (LCHC) has been active in the passage of this legislation, particularly since 20 percent of those living in California speak some language other than English at home. These individuals have poor health outcomes and great health disparities, partially due to an inability to understand the content on prescription drug labels. LCHC paired with two senior citizen advocacy organizations, the Senior Action Network and the Grey Panthers of California, to investigate the need for standardizing prescription drug labels. Given that research results indicated that the standardized label was more comprehensible, LCHC and its partners worked for passage of legislation to create such a standard label. There are certainly a number of points at which commu-

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 wHAt woUld it tAke? nication about medication can and should occur, including when physi- cians and pharmacists counsel patients. Labeling, however, is the primary method of communication with a patient and the easiest to legislate. Legislation was introduced about a year ago by State Senator Ellen Corbett. Initially, many pharmacy associations expressed concern. The LCHC and its partners worked with the associations and with the Califor- nia State Board of Pharmacy, and in the end these organizations became supporters of the bill, working with the LCHC and its partners to rewrite language and develop a solution to standardizing prescription drug labels. The new law requires the California Board of Pharmacy to adopt a standardized prescription label by January 1, 2011. The label must take into account input from public meetings and medical literacy research regarding comprehension of labels. The label must have improved direc- tions for use and improved font types and sizes. It must also have patient- centered information placement. The needs of LEP patients, the needs of senior citizens, and technology requirements necessary to implement the standards must be considered. The LCHC and its partners will begin holding stakeholder meetings in January 2008 to develop recommenda- tions for the Board of Pharmacy. DISCuSSION One participant stated that it is important to support more research on standardization and that the universal medication system proposed by Wood should be part of any such study. In response, Williams stated that if one waits for all the evidence one wants, there will never be a standard. There are things that can be done now. Another participant suggested that now is a good time to conduct research and evaluation in California, given passage of the law requiring development of a standard drug label. One audience member asked whether there was a list of preferred ways to provide medication instructions. In response, it was stated that the USP does have available pictograms, allied with standard word- ing, that were developed several years ago. These have been broadly accepted, even internationally. Currently, the USP is entering into a research agreement with the International Pharmaceutical Federation to test these pictograms as well as some others that have been developed outside the country. As one thinks about changing auxiliary labels, one might consider how to integrate pictograms for better understanding by the patient.

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