The Problem
Adverse drug events (ADEs) are prevalent in outpatient settings. Approximately 4.5 million ambulatory visits related to ADEs occur each year, the majority of these in outpatient office practices. Medication non-adherence is also common and has well-established significant clinical consequences. The high prevalence of both ADEs and non-adherence often stem from challenges inherent to accurately taking daily medications for patients with chronic conditions.
In order to take medications correctly, patients in ambulatory care must master several complex tasks. First, they must have an accurate understanding of medications and their proper dosing. Second, they must consolidate their regimen into an efficient daily schedule, and be able to problem solve around regimen design as their medications change. Third, they must maintain a daily behavior over time. Finally, they must recognize symptoms that could be a result of medication use. Studies have repeatedly documented that many patients have problems performing these routine tasks. Patients with limited health literacy, limited English proficiency, the elderly, and those taking many medications are at especially high risk for misunderstanding medication instructions.
Our Proposed Solution
Universal Medication Schedule
One approach to improving medication safety is by redesigning medication instructions. In 2007, a research team at Northwestern University devised the Universal Medication Schedule (UMS), a plain-language approach to standardizing and simplifying medication instructions to support safe and effective prescription drug use. The Institute of Medicine's 2008 report, Standardizing Medication Labels, called for setting labeling standards, such as those in the UMS, to help patients easily understand prescription directions. This approach can help patients not only self-administer medications correctly, but also organize complex medication regimens so as to minimize the number of pill-taking episodes per day.
The effectiveness of the UMS label has been tested in multiple settings. A randomized trial of diverse, low-income patients found that patients were 33% more likely to correctly interpret UMS instructions compared to the current standard, with overall comprehension rates of the UMS instructions exceeding 90%. A second study found that patients with limited health literacy were more likely to correctly interpret UMS instructions compared to standard label instructions and that UMS outperformed the standard for more complex medication regimes. Plain-language translated instructions, known as ConcordantRx, were similarly validated through combined efforts by Northwestern and UCSF investigators.
Rates of correct interpretation by literacy level for standard prescriptions and patient-centered label (PCL) instructions. PCL orders information on the label according to the patient's perspective and organizes medications around four standard time periods (morning, noon, evening, and bedtime).
Our Approach
Despite the multiple lines of evidence suggesting the effectiveness of UMS and ConcordantRx labeling, systemic adoption has been slow to absent. Because the characteristics of our patient population align with those most at risk for misunderstanding their medication instructions, we consider the SFHN an ideal site for the adoption of the UMS framework, as well as to study implementation challenges, solutions, and impacts to inform dissemination to other public delivery systems.
Our goal is to improve medication comprehension and adherence through plain-language instructions as outlined by the UMS framework. We hope to not only promote adherence, but also facilitate the management of multiple and complex medical conditions as well as prevent ADEs.
The specific project aims include:
- Conduct problem analysis with the goal of UMS/ConcordantRX prescribing becoming the standard of care for patients' care within the San Francisco Health Network.
- Design and develop an HIT platform and a provider workflow which will support an effort to make UMS/ConcordantRx insturctions the new standard across all the electronic prescribing platforms in the San Francisco Health Network.
- Implement the UMS/ConcordantRx via electronic prescribing throughout the San Francisco Health Network and evaluate from patient, provider, and pharmacy perspectives.
Michael Wolf's study tested comprehension for standard, UMS, and UMS with graphic aid instructions with 500 primary care patients in an efficacy trial at four clinics in two sites. Findings revealed that 91% of patients correctly interpreted UMS instructions, with the strongest benefits associated with patients with low literacy and more complex regimens.