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 system 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 prescription 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 comment called Pharmacopeial Forum. All stakeholders could participate in this activity in one way or another. One might use the National Coordinating 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