In Pursuit of a Patient-Centered VA Prescription Label
July/August 2011
In Pursuit of a Patient-Centered VA Prescription Label
The patient-centered prescription label movement has roots in primary research studies by notable health literacy proponents (Davis et al., 2006; Davis et al., 2008; Shrank et al., 2007; Sharnk, Avorn et al., 2007). This foundational work paved the way for setting standards for prescription label formats, content, lexicon, and numeracy interpretation. As the data mounted, consensus recommendations emerged in publications from the American College of Physicians Foundation (ACPF)(2007), United States Pharmacopeia (USP)(2010, 2011), National Association of Boards of Pharmacy (NABP)(2009), American Foundation for the Blind (AFB)(American Society of Consultant Pharmacists Foundation/AFB, 2008), and the Institute for Safe Medication Practices (ISMP)(2010), to name a few.
Each organization has played a critical role in the understanding of what it means to deliver a patient-centered prescription label. It is to these consensus guidelines that the VA, through a joint venture between the VA National Center for Patient Safety (NCPS) and VA Pharmacy Benefits Management (PBM), has turned in evaluating, redesigning, and testing potential standardized outpatient prescription labels. It is, to say the least, a considerable task, considering the VA serves more than 4 million individuals through both local VA medical center outpatient pharmacies and Consolidated Mail Outpatient Pharmacies (CMOPs)(Aspinall et al., 2009). Though the VA’s seven CMOPs provide mail-order prescriptions to veterans via highly automated distribution systems at strategic locations throughout the country, they lack a standardized label.
Implementing a consistent label format and style, therefore, could significantly improve the reliability of information transfer between the healthcare team and the patient by promoting a “shared mental model.” The concept of the shared mental model reaches across high-reliability industries and uses standardization to achieve the goal of error reduction (Sculli & Sine, 2011). Medication self-administration errors can be mitigated by:
- delivering information in a consistent, patient-centered fashion (i.e., medication names are enlarged while pharmacy logos are minimized),
- clearly communicating the prescribed task to the patient (i.e., how many tablets to take per day—a component of prescription numeracy), and
- promoting safe usage (i.e., patient can readily confirm the bottle is his or hers—an example of error trapping) (FDA, 2009).
Standardization, however, should not be so rigid as to disregard other safety vulnerabilities. It is important to recognize that some variation might need to exist at a local level to account for region-specific or other factors. This is absolutely important in healthcare as individual facilities take into account their resources—human, financial, technology, etc.—and facility complexity when making quality improvements. This is why, as the largest healthcare provider in the United States, the VA had to approach the idea of a redesigned prescription label from a “glocal” (global-local) strategy. The glocal strategy concept is relevant in this situation because national policy not only influences local action, but can also be influenced and crafted by local and individual needs.
Standardizing the VA’s national prescription labeling program globally, without giving up the ability to meet the needs of veterans with varying circumstances—whether those needs are based on geographic regional differences, language, or cultural differences—can help to ensure the greatest adoption and the most sustainable change.
In late 2008, VA’s efforts were about to take a giant step forward, as a local quality improvement initiative begun at the VA Medical Center, Amarillo, Texas, converged with the emergence of national consensus recommendations.
The Local Effect
The Amarillo VA Medical Center recognized that VA prescription labels were not always user-friendly. One problem noted was that the name of a medication could appear in different locations on separate prescription labels. For example, labels on prescription labels mailed from a CMOP may not match those on prescriptions picked up from a local VA outpatient pharmacy. A veteran might inadvertently take pills from both bottles, unaware that the two bottles contained the same medication, despite bearing the medication name on each label. Rather than reducing the dose as a provider might intend with a new prescription, a veteran could nearly double the amount of medication taken because of the inconsistency of the labeling.
In 2007, Amarillo was awarded a grant through the NCPS Patient Safety Initiative (PSI) program to evaluate medication label design. The program was established to stimulate creative approaches to complex patient safety issues.
After NCPS awarded the Amarillo team funding for their PSI, the team quickly set out to determine veterans’ acceptance and comprehension of various label designs. The first step was to explore which attributes made a label more or less useful to the user. The team used current literature and examples from industry leaders to create two novel label designs. The new designs incorporated recommendations on the placement of patient-centric components, the use of highlighting, and differing font types and sizes.
The team then reached out to veterans, asking them to volunteer to provide comments on the new and old label formats. After about a week, more than 100 veterans had provided comments. While most veterans were able to correctly identify the drug name and directions for use on all three label types, a preference emerged for one of the new labels—one that gave higher prominence to fields such as the drug name than to non-patient-centric components, such as the prescriber’s name. This preference was particularly evident in comments from individuals with lower levels of health literacy. The team was not surprised to find the current standard VA prescription label was the least preferred design.
The preliminary findings of the PSI were shared with program managers from NCPS in February 2008, followed by a formal project summary in March. The talk of a patient-centric label became a topic of conversation among attendees at a VA Patient Safety Leadership training held in Phoenix, Ariz., later that year. Concurrently, representatives from the PBM were serving on roundtables and consensus groups providing their expertise on the subject.
In August 2009, the National Association of Boards of Pharmacy adopted language in its Model Act, defining minimum standards for prescription labeling, thus heightening the urgency for the VA to meet the charge and address this issue head-on nationally (National Association of Boards of Pharmacy, 2009).
Global Considerations
The hunt was then on to determine how best to serve the VA’s 4.4 million pharmacy users through the redesign of the label affixed to nearly 122 million prescriptions dispensed each year (Aspinall et al., 2009). Several factors were at play, most specifically the diversity of age, education level, language, and cultures of those served by the VA. All of these factors affect the underlying health literacy level of the veterans who use VA pharmacies.
It became apparent from the work done at Amarillo that additional research on the impact of culture and age in the veteran population on healthcare literacy was needed with respect to prescription labeling.
Fortunately, the VA was in an excellent position to provide support for research to identify “best practices” for prescription drug labeling for a VA-specific population (Wolf et al., 2011). To define the path to take, recommendations available from expert panels and advisory boards regarding the subject were systematically collated. (To view a cross-walk of the various consensus guidelines with links, please visit www.patientsafety.gov.)
Some of the recommendations—such as those offered by ACPF, NABP, USP, and the California Board of Pharmacy report—provided a pictorial representation of what a “compliant” label would look like. There was, however, no single, perfect model. For example, the California State Board of Pharmacy (2010; n.d.) reiterated the critical elements as defined by patients, but compliant labels (proposed by the SB 472 Medication Label Subcommittee) still showed some interspersing of these critical data elements among other less critical elements. Pharmacy name and logo continued to receive high prominence on the label.
The VA faced two major challenges. First, the VA has over 150 unique outpatient pharmacies and seven CMOPs. If the VA were to make recommendations to all of its pharmacies to deliver a more patient-centric label, it was imperative that the label used be standardized so that veterans receiving prescriptions from more than one VA pharmacy (a frequent phenomenon) would see only one label format. How would the VA settle on just one label format when several options seemed to be equally appropriate based on the consensus guidelines?
Second, the technology currently used in each of the VA pharmacies places certain parameter limits on label format possibilities. This is compounded by the fact that VA pharmacies are not standardized on a specific brand of dispensing technology. Target®, one of the front-runners in the patient-centered prescription label movement, had the benefit of influencing the technology used to print the label (ISMP, 2005). The VA recognized that it must address or work within the constraints of current technology—a local variable. The VA acknowledged that capital expense was a large inhibiting factor for standardization; however, rather than delaying action, a question was asked, Is there something we can do now to put us one step closer? The answer was a resounding, “Yes.” So, NCPS and PBM set out to research the subject further at the user-interface.
Taking it to the Next Level
The Patient-Centered VA Prescription Label (PC-VARx) study design was influenced by a health-literacy study that included a “user-centered” iterative design model to develop and improve health communication guidebooks (Neuhauser et al., 2009). Following a comprehensive literature and consensus guideline review, the PC-VARx study team, led by Principal Investigator Keith Trettin, R.Ph., developed an advisory panel of key stakeholders within the VA. Supported by a grant from the VA’s Innovation Funding for the Advancement of a Patient-Centered Care Culture, 10 VA facilities were recruited to host veteran surveys based upon their representation of various sub-populations of veterans—geographic/regional, language, and cultural.
The goal was to integrate veteran feedback on preference and usability of proposed labels. Pharmacy staff members were invited to participate in a parallel survey. The purpose of the comparator survey was to inform the study team about any potential untoward consequences to the medication dispensing node of the medication-use process through a prescription label redesign (FDA, 2009). The VA’s Institutional Review Board and labor management approval was obtained for both the veteran and pharmacy staff involvement. As this publication goes to press, veterans have been surveyed at each of the 10 separate VA facility locations and data aggregation is in progress. The pharmacy staff surveys, delivered via an online survey tool, were still ongoing. The results of the study will be used to inform the final decisions on a standardized prescription label and published in a peer-reviewed journal so that the information adds to the collective knowledge on user preferences with respect to prescription labels.
Delivering Quality, Achieving Safety
The VA’s Universal Services Task Force’s April 2009 report charged the VA community to:
• systematize the coordination, continuity, and integration of care;
• solicit and respect the veteran’s values, preferences, and needs;
• empower veterans through information and education; and
• enhance the quality of human interactions and therapeutic alliances (Tuchschmidt, 2009).
The PC-VARx study’s systematic approach, focused at the level of the veteran, aims to provide the scientific rigor required to ensure that the decisions made during the redesign are supported by sound principles. The empowerment of veterans to influence the redesign of what will become a new national VA prescription label readily allows for the incorporation of both their collective and individual values, preferences, and needs into the final product. Such a patient-centered step forward helps us to realize the veteran’s expectation of safe, high-quality care, while helping to build on and contribute to the foundational work of our colleagues.
Erin Narus is a licensed pharmacist with the VA National Center for Patient Safety in addition to PharmaCare Services at St. Elias Specialty Hospital in Anchorage, Alaska. She received her doctor of pharmacy degree from the University of Wisconsin Madison after completing a bachelor of science in chemistry from the University of Alaska Fairbanks. She completed a geriatric pharmacy residency at the Boise VA Medical Center. She has been with the VA since 2001 and served in various capacities at three different VA medical centers. She served as the study coordinator on the Patient Centered VA Prescription Label (PC-VARx) project prior to relocating to Anchorage in spring 2011. She may be contacted at Erin.Narus@va.gov.
Joe Youngblood is the patient safety officer for VISN 18. He has more than 25 years of experience in pharmacy practice. Youngblood is a graduate of Southwestern Oklahoma State University and has worked in retail pharmacy, nuclear pharmacy, and hospital pharmacy, as well as consulting in long-term care and mental health facilities. He is a licensed pharmacist in Texas. He may be contacted at Joe.Youngblood@va.gov.
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