Although institutional and policy level changes have been implemented to improve medication adherence, [21–24] less attention has been placed on elderly consumers' ability to understand medication labels to reduce medication misuse at home . The development of an easily implementable tool such as the TCOM labeling system offers pharmacies and health care providers the potential to decrease medication errors among adults 65 years of age and older, a population that is more likely to be on multiple medications and is more vulnerable to adverse drug events than the general population [25, 26]. The TCOM system can empower older adults with an accessible system to enhance correct use of medications in the home and potentially decrease adverse events associated with medication misuse or incorrect use.
Qualitative responses by study participants confirmed the need for clear label formatting, explicit instructions on dosage, and supported the idea of adding an easily identifiable visual aid to existing medication labels . Hwang and colleagues found that commonly used illustrations that are currently used on medication labels do not increase patients' ability to identify their medications, and in some cases, may be ambiguous or misleading . Although further refinement of our TCOM label system may be necessary to ensure the clarity of the colors and symbols used, our pilot study implemented a focus group phase to foster input into the development of a set of symbols that would be easily identifiable by the target population. Pre-post medication identification test results show that the TCOM label system did in fact improve patients' ability to correctly identify their medications from a distance of two feet, and approached significance when placed directly in front of study participants. These results suggest that the proposed labeling system has the potential to be a helpful visual addition to current medication bottle labels, since visual aids currently used on bottle labels may not be effective.
Although participants were able to more accurately identify their medications at a distance of two feet after the addition of the TCOM label, the small effect size may call into question the clinical relevance of study results. However, the incorrect use of even one medication can result in adverse events, including hospitalizations or deaths, and/or suboptimal treatment of a medical condition. Therefore, even small improvements in medication identification have the potential to reduce the incidence of preventable adverse drug events and improve medical outcomes. Care must also be taken in the interpretation of study results due to the small sample size. Results are specific to patients 65 and older from a member clinic of the North Texas Primary Care Practice-Based Research Network and may not be generalizable to other populations. Recall bias may have occurred during the implementation of the pre-post test assessments. Participants may have remembered the purpose of their medications more clearly after the addition of the TCOM label since they were asked to recall the purpose of their medicines prior to the addition of the label. However, participants were not informed whether or not they had matched their medication to the correct indication during the assessment process, and they were expected to already be familiar with their medications. Participants were not asked to learn a set of new indications, but rather were required to be currently taking a minimum of five prescription medications in at least three medication classes in order to qualify for the study.
It is difficult to assess the impact of recall bias on study results due to lack of a comparison group and randomized study design. To address this issue, further study is recommended to determine the utility of a visual system of labeling in real-world settings to assess the comparative effectiveness of the proposed labeling system to current bottle labels. Studies have shown that adults 65 years of age and older have the lowest average literacy rate among all age groups and that literacy can have a significant impact on a patient's ability to recognize medications [9, 28]. Further study is needed in home, pharmacy, and community settings to determine how social factors outside of a research setting impact the suitability and effectiveness of the TCOM labeling system.