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Reaction from the Pharmacy Field to Prescription Use Instruction Standardization

ALAN GOLDHAMMER, Ph.D.

Pharmaceutical Research and Manufacturers of America


For the issues under discussion, the pharmaceutical industry role is primarily limited to packaging pharmaceuticals and moving them into the supply chain, where they are shipped to pharmacies and dispensed. Everything done by the industry is regulated by the Food and Drug Administration (FDA), down to the letters used on the drug label. Unless a pharmaceutical manufacturer is supplying items in unit-of-use packaging (e.g., oral contraceptive pills), the drugs are usually shipped in large bottles that are then repackaged by the pharmacist in smaller containers with medication labels affixed at that point. However, what the industry does in unit-of-use packaging is done effectively and probably addresses a number of the issues under discussion.

Physicians, pharmacists, and patients all have responsibilities in ensuring appropriate medication use. Patients have the responsibility to request information from their physicians and, if they need additional information, from their pharmacists. Furthermore, patients should have a written medication record, that is, a record of all the medicines they are taking. Pharmacists have a responsibility to counsel patients. However, given that pharmacists are frequently overworked, there is insufficient time to provide the kind of counseling needed. What pharmacists can do is dispense consumer medication information leaflets and draw patients’ attention to the information. Physicians need to learn to write



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4 Reaction from the Pharmacy Field to Prescription Use Instruction Standardization ALAN gOLDHAMMER, Ph.D. Pharmaceutical Research and Manufacturers of America For the issues under discussion, the pharmaceutical industry role is primarily limited to packaging pharmaceuticals and moving them into the supply chain, where they are shipped to pharmacies and dispensed. Everything done by the industry is regulated by the Food and Drug Administration (FDA), down to the letters used on the drug label. Unless a pharmaceutical manufacturer is supplying items in unit-of-use packag- ing (e.g., oral contraceptive pills), the drugs are usually shipped in large bottles that are then repackaged by the pharmacist in smaller containers with medication labels affixed at that point. However, what the industry does in unit-of-use packaging is done effectively and probably addresses a number of the issues under discussion. Physicians, pharmacists, and patients all have responsibilities in ensuring appropriate medication use. Patients have the responsibility to request information from their physicians and, if they need additional information, from their pharmacists. Furthermore, patients should have a written medication record, that is, a record of all the medicines they are taking. Pharmacists have a responsibility to counsel patients. How- ever, given that pharmacists are frequently overworked, there is insuf- ficient time to provide the kind of counseling needed. What pharmacists can do is dispense consumer medication information leaflets and draw patients’ attention to the information. Physicians need to learn to write 

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 stAndARdizing MediCAtion lABels prescriptions clearly and to ensure that appropriate information is given to patients; ultimately, these are skills that should be included in the medi- cal school curriculum. Drug labels need to be made much simpler. An important partner in determining how to move forward in this process is the National Associa- tion of Boards of Pharmacy. DARREN k. TOWNZEN, R.Ph., M.b.A. director of Pharmacy systems, wal-Mart An expected benefit of standardization is consistency. Clearly there is now great inconsistency across pharmacies. As Wolf stated when describ- ing the 31 different label styles developed in response to state regulations, there is great disparity in minimal requirements. It is to the benefit of a chain such as Wal-Mart that as much information as possible is presented in a consistent manner. However, there are barriers and limitations to standardization. One barrier is the opportunity costs of standardization. That is, if improvement efforts are focused on standardization, it could result in not implementing other approaches to reducing medication errors that might have a bigger effect on consumer health and well-being. Another concern relates to adopting a standard that requires placing the indication for the medica- tion on the label. Some patients may not wish such information displayed on the label—for example, patients who are being treated for depression or erectile dysfunction. In determining the information that should appear on a label, the patient’s perspective should be considered. There are some advantages to unit-of-use packaging such as the Z-Pak (Zithromax®) developed by Pfizer. For example, regardless of what the physician writes on the prescription or what the pharmacy provides the patient when it dispenses the medication, necessary information is consistently presented on the Z-Pak itself, including what the medication is for and how to take it. The packaging also includes the lot number and expiration date, which would be of great value if a Class I recall was issued. Wal-Mart is examining the possibility of placing generic medication in a package similar to that of the Z-Pak, always being cognizant of cur- rent FDA restrictions, and is working with the generic manufacturers to accomplish this. The approach was tested with Warfarin. Consumers were presented with the medication in what is called consumerized prescrip- tion packaging. The responses were very positive. An examination of the current evidence seems to support stan- dardization of drug labels as a mechanism for increasing patient com-

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 ReACtion FRoM tHe PHARMACY Field prehension. However, increasing comprehension is not the same as increasing adherence. It is likely that even with inventive approaches to increasing patient understanding, many patients will not take their medication as directed. Therefore, a variety of approaches are needed to solve current problems. gERALD McEvOy, Pharm.D. American society of Health-system Pharmacists As a professional practice association that represents pharmacists, the American Society of Health-System Pharmacists (ASHP) is very support- ive of the recommendations of the ACP Foundation white paper and the need for standardization. There is clear evidence documenting problems, and the ASHP believes that medication labeling standards are one part of the solution. While best practices are described here and in the white paper (e.g., simplified statements and formatting issues), evidence to sup- port a particular approach is lacking. Furthermore, the ultimate outcome of suggested changes has not yet been established, either for medication safety or for patient adherence. The use of regulation as a solution is of great concern. For instance, medication guides are an example of how the FDA has regulated a phar- macy practice issue. These guides have not been a success for many reasons, one of which is the FDA’s failure to understand the basic dispens- ing function. While there are well-established standards for content and format of these guides, many of them have become focused on a single risk without any description of benefit and without incorporating all the standards for content and format. Following a regulatory approach could result in a very long wait for gains to be realized. The ASHP is involved in many initiatives that address the issues dis- cussed here and in the ACP Foundation white paper. It has an extensive and well-established policy development process with key groups that include the Section on Pharmacy, Informatics, and Technology, the Coun- cil of Therapeutics, and a center on patient safety. Key guidelines have been developed for patient education and counseling that include the core recognition that pharmacists have a responsibility to provide counseling, not just to offer it. Furthermore, the ASHP is a publisher of consumer medication information (CMI), is a resource used by the National Library of Medicine’s Medline Plus, has a working relationship with Consumer Reports that can be used to educate consumers, and operates the website SafeMedications.com. Several difficulties must be considered when designing solutions to the problems associated with drug container labeling. One question raised

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 stAndARdizing MediCAtion lABels earlier related to the costs estimated for implementing changes. Given the number of systems in place that would be affected, such as legacy (old) computer systems, the costs could be considerable. Furthermore, the evidence required to substantiate a large investment in a particular approach to standardized labels is lacking. Another difficulty is changing long-standing professional practice, both in medicine and pharmacy. For pharmacists in hospital settings, times for administration of medi- cation are driven by when nurses typically make rounds to distribute med- ications. In the ambulatory setting this is not the case, which complicates the standardization process. Medication reconciliation,1 required by the Joint Commission on Accreditation of Healthcare Organizations, is another key issue that will affect attempts at standardization, as will computerized physician order entry (CPOE) systems. Each CPOE vendor can indepen- dently develop the dosage instructions available through the CPOE. For standardization to work in both the hospital and the ambulatory settings, there must be some effort to bring concordance to these systems. Currently, the National Council for Prescription Drug Programs (NCPDP) is focusing on standards for communication between the pre- scriber and the pharmacist. It also has a strong international influence. However, the Department of Veterans Affairs principally uses standards from HL7.2 There are efforts under way to ensure the standards are in agreement, which is very important, but one must also take into account issues related to how international recommendations would relate to the U.S. model of health care. Finally, one must address issues surrounding the use of legacy systems as well as physician and pharmacist behaviors. Medication safety is a professional practice issue. It involves the pro- fessions of pharmacy and medicine as well as other health care providers involved in counseling patients about safe and effective medication use. The ASHP does not believe that regulation, at least as an initial approach, is the appropriate avenue to follow. Rather, the focus should be on devel- oping best practices that are evidence based and have a broad base of stakeholder input. 1 Reconciliation is the process of comparing what medication the patient is taking at the time of admission or entry to a new setting or level of care with what the organization is providing (admission or new medication orders) in order to avoid errors such as conflicts or unintentional omissions (AAP, 2005). 2 Health Level 7 (HL7) refers both to an organization involved in setting international health care standards and to some of the specific standards it has developed. HL7 are “ANSI-accredited standards for electronically defining clinical and administrative data in the healthcare industry. HL7 is one of several Standards Developing Organizations in healthcare. The ‘7’ comes from application layer 7 in the OSI model, which is the highest level where programs talk to each other” (PC Magazine, 2007).

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 ReACtion FRoM tHe PHARMACY Field The ASHP does support a broadly based stakeholder process for inves- tigating the problems and the best means for establishing needed stan- dards. Organizations that should participate in this process include the National Association of Boards of Pharmacy (NABP), the NCPDP, HL7, the Joint Commission, the United States Pharmacopeia (USP), and, given the emergence of ePrescribing models and other informatics initiatives, the American Medical Informatics Association (AMIA). WILLIAM ELLIS, R.Ph., M.S. American Pharmacists Association Foundation The IOM Roundtable on Health Literacy and the ACP Foundation are to be commended for convening this group and undertaking the task of examining problems and solutions for the issues surrounding medication container labeling. There is certainly evidence to support standardization of medication labeling. The time is right in health care, and more specifi- cally in pharmacy practice, to begin discussing needed changes, since there is a great deal of discussion occurring about changing the basic model of pharmacy practice and moving to a more patient-centered approach. Medications are among our most powerful tools in the fight against disease. Yet medications are frequently viewed as simple commodities. When that occurs, one begins to lose the ability to differentiate among them. Patients assume all medications have been approved by the FDA and that they are therefore safe and effective. Furthermore, patients often believe that over-the-counter medications cannot cause harm. It is impor- tant that pharmacists and physicians communicate that medications, whether over-the-counter products or prescription medications, must be used respectfully. While it is important from a quality improvement perspective to address prescription labeling, it is also important not to lose sight of the larger picture in which health care is delivered, a picture that includes interactions between patients, pharmacists, physicians, and other health care providers. Labeling must be examined against this broader system, and an important tool in this examination is practice-based research. The American Pharmacist Association (APhA) Foundation conducts practice-based research related to improving outcomes in chronic disease through a variety of initiatives such as the Diabetes Ten City Challenge,3 3 The Diabetes Ten City Challenge is a program for use by employers and communities to address diabetes and reduce health care costs through implementation of the APhA Foundation’s Patient Self-Management Program. Using incentives, employer groups in 10 communities, with the help of pharmacist coaches, physicians, and community health resources, encourage people to manage their diabetes (APhA, 2007).

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0 stAndARdizing MediCAtion lABels which is a highly collaborative effort involving teams of physicians, pharma- cists, nurses, diabetes educators, and patients. Such research will help iden- tify best practices, which are to be preferred over a regulatory approach. While regulation is not favored as the primary approach to solve drug labeling problems, there may be some role for regulation. For example, the NABP plays an important role in developing model regulations for review and use by the 50 state boards of pharmacy. In moving forward to address the kinds of issues raised here, thought could be given to a national collaboration that would examine how to implement some of the best practices we know exist. There are numerous stakeholders that should participate in such an effort, many of whom have already been identified. Although it is important to hold discussions of how to proceed, action is also necessary. DISCuSSION One participant asked, since those on the panel appear to favor moving forward with standardization and the recommendations in the ACP Foundation white paper, who should lead that effort? Goldhammer responded that the leader should come from the field of pharmacy. Townzen suggested that the NCPDP would be an appropriate leader. That organization has been identified by the Consolidated Health Initia- tive as an appropriate group for establishing standards. Furthermore, the NCPDP has devised a standardized prescription card to address some of the variation in state requirements. McEvoy agreed that the NCPDP is a key participant and reiterated what he stated during his presentation, that is, that the other groups that should be involved include the AMIA, USP, the Joint Commission, HL7, and the IOM. McEvoy also suggested that one might wish to have a neutral convener for this effort, perhaps a new consortium of groups. Ellis responded that medicine and pharmacy practitioner organizations should begin the process but that other stake- holders should be involved. Panelists were asked whether there are business or competitive issues (other than costs of implementation) to consider that might create barriers to implementation if efforts to standardize labels resulted in minimiz- ing pharmacy logos. Ellis and Townzen agreed that the effect of mini- mizing the pharmacy logo is probably minimal and should not impede implementation. Another questioner asked whether clinical trials could be designed around a standard medication administration schedule and, if so, whether pharmaceutical manufacturers could take the lead on that restructuring. Goldhammer responded that it seems possible to structure clinical trials to include standardized administration and that it would be appropriate for the pharmaceutical industry to investigate this.