Evaluation of the design and structure of electronic medication labels to improve patient health knowledge and safety: a systematic review

Abstract

Introduction

Patient misunderstanding of instructions on medication labels is a common cause of medication errors and can result in ineffective treatment. One way to better improve patient comprehension of medication labels is by optimizing the content and display of the information.

Objectives

To review comparative studies that have evaluated the design of a medication label to improve patient knowledge or safety.

Methods

Studies were selected from systematic computerized literature searches performed in PubMed, Embase (Elsevier), Cochrane Central (EBSCO), Cumulative Index to Nursing and Allied Health Literature-CINAHL (EBSCO), and Web of Science (Thomson Reuters). Eligible studies included comparative studies that evaluated the design of a medication label to improve patient knowledge or safety.

Results

Of the 246 articles identified in the primary literature search, 14 studies were selected for data abstraction. Thirteen of these studies significantly impacted the patient understanding of medication labels. Three studies included a measure of patient safety in terms of medication adherence and dosing errors. The utilization of patient-centered language, pictograms/graphics, color/white space, or font optimization was seen to have the most impact on patient comprehension.

Conclusion

It is essential to present medication information in an optimal manner for patients. This can be done by standardizing the content, display, and format of medication labels to improve understanding and medication usage. Evidence-based design principles can, therefore, be used to facilitate the standardization of the structure of label content for both print and electronic devices. However, more research needs to be done on validating the implications of label content display to measure its impact on patient safety.

Systemic review registration

PROSPERO CRD42022347510 (http://www.crd.york.ac.uk/prospero/).

Key points for decision-makers

• This study aims to review comparative evaluation studies on how medication label design can be optimized to improve patient understanding of medications and patient safety.

• It also discusses possible requirements for a new medication e-label standard to enhance the dissemination of tailored content via web and mobile apps.

• It revealed the importance of standardizing label content and display structure to incorporate into print and electronic formats.

Introduction

Medication labels provide vital health information about the investigational drug product, its preparation, dispensing, storage, and use. Although these labels are designed to assist patients’ understanding of their medications, over 50% of medication use errors, in terms of dosing, intervals, route of administration, etc., were seen to have occurred due to label miscomprehension by patients and their caregivers [1, 2]. According to the Institute of Medicine (IOM) report, inadequate labeling was cited as a significant cause of medication errors and adverse events due to improper understanding of instructions by the patient [3, 4]. Ultimately, instructions on these labels are increasingly important, especially if patients do not receive oral or written instructions from their providers on how to manage their medications appropriately. Patients with limited health literacy skills and managing multiple medication regimens are also at greater risk of experiencing medication errors due to misinterpretation of label instructions [4].

Additionally, revisions and updates to the approved labels occur quite often with about 400 to 500 product label changes occurring every year. Since drug labels are an essential tool to convey information about a medication’s indication, dosage, pharmacology, or adverse effects, it is important for patients to be made aware regarding any new information about a drug [5]. Disseminating these updates to patients can, ultimately, be time-consuming and, if not read, can lead to a potential risk to patient safety.

Variability in drug labeling can adversely affect a patient’s understanding of medication instructions [6, 7]. Previous studies have recommended some best practices, such as using plain language, improved formatting, and more explicit instructions for conveying prescription medication information to patients to improve patient safety [4, 6, 8,9,10]. Most recently, a study in 2018 reviewed the design of prescription drug labeling and educational materials. While it presented evidence supporting the best practices for prescription medication information, it did not evaluate how the design practices would impact patient outcomes and safety [10].

Currently, the US Food and Drug Administration (FDA) has developed a standard to regulate labeling content to meet better the prescribing practitioners’ needs (Physicians’ Labeling Rule, PLR) [11]. The PLR was designed to improve how health care practitioners access, read, and use medication labels by including specific sections, such as Highlights of Prescribing Information (Highlights), a Table of Contents (Contents), and the Full Prescribing Information (FPI) [12]. The central goal of the PLR is to provide structured labeling information that is easy to access, read, and use by both the FDA and the public to enhance the consistency in drug labeling [13]. Despite this, research has shown that patients still experience a lack of knowledge about the drugs prescribed to them and that increased adverse events can occur due to this lack of knowledge [8, 11].

One possible way to improve the dissemination of patient medication information is through an electronic medication label, also known as an “e-label.” This e-label will be geared towards patients to enhance patient utilization and increase patient safety. The e-label can be accessed via electronic means, such as through a machine-readable QR code, barcode, or URL on the medication product itself (Fig. 1) [14].

Fig. 1

Electronic labeling—technology preview [14]

The FDA does currently have a standard for drug information in electronic form using the HL7 standard Structured Product Labeling (SPL) [8]. This standard defines the content of human prescription drug labeling in an XML format [15]. SPL documents contain the content of labeling (all text, tables, and figures) for a product and additional computer-processable drug knowledge [15]. While the current SPL standard defines the content of human prescription drug labeling, it does not represent the optimal display format [11]. Effectively disseminating e-labels with content beyond text, such as graphics and video, will require standardization. The standard would describe both the structure of the content and display standards such as font size, language, typography, and other user interface standards for optimal display across electronic devices. This study, therefore, aims to systematically review comparative evaluation studies on how medication label design can be optimized to improve patient understanding of medications and patient safety. It also discusses possible requirements for a new medication e-label standard to enhance the dissemination of tailored content via web and mobile apps.

Methods

This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting systematic reviews [16] (CRD42022347510; http://www.crd.york.ac.uk/prospero/).

Systematic computerized literature searches were performed in PubMed, Embase (Elsevier), Cochrane Central (EBSCO), CINAHL (EBSCO), and Web of Science (Thomson Reuters). The search was designed to identify studies that evaluated medication label design and how improvements in drug labeling can enhance patient knowledge. No date or language limits were applied, and no gray literature sources were examined. The search was performed on July 20, 2022. The search terms are listed in Appendix 1.

Inclusion criteria are English language articles that evaluate how the medication label design can be optimized to improve patient understanding of medications and safety. Studies to be included need comparative evaluations such as clinical study, comparative study, evaluation study, validation study, retrospective cohort study, prospective cohort study, randomized, controlled trial (RCT), cohort study, before-and-after study, or multicenter study. Articles that did not include a measure of health knowledge were excluded. Two blinded study authors independently reviewed the titles and abstracts of each article identified by the search. A consensus of all the authors settled any study selection disputes regarding whether studies obtained from the literature search met the inclusion/exclusion criteria to be included in this review.

Two blinded authors independently conducted the quality assessment and data extraction. The Covidence screening and data extraction tool for authors was used [17]. The quality assessment was conducted based on the recommendations of the Cochrane Risk of Bias Comparison: sequence generation, allocation concealment, blinding of participants, blinding of outcome assessors, incomplete outcome data, selective outcome, and other sources of bias. The following data were extracted: study identification, methods, population, intervention, and outcome variables. p values < 0.05 were considered statistically significant. A third author adjudicated disagreements between the two blinded authors.

Results

Of the 246 articles identified in the primary literature search, 212 were included in the title and abstract screening after removing duplicate articles. Of the 212 articles, 176 were excluded due to ineligibility. Following the exclusion, 33 articles were selected for the full-text review. Of those 33 articles, 19 studies were excluded due to not meeting the inclusion criteria. This resulted in 14 eligible studies identified for data abstraction, as presented in Fig. 2.

Fig. 2

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram of the article search and review process

In this systematic review, the studies included were published from the years 1997 up to 2019. Nine of the studies were conducted in the USA, and one study was conducted in each of the following countries: Ireland, Australia, Hong Kong, Singapore, and South Africa. The included studies consisted of seven randomized control trials, three cross-sectional studies, one experimental study, one cohort study, one comparative study, and one structured interview design. These studies were all conducted via convenience, voluntary sampling, surveys, or clinic patients. The participants recruited from each of the studies consisted of the patient population, except for one study that also included participants involving physicians and pharmacists (Table 1). Of the included studies, 11 of them focused specifically on prescription medication labels while only 3 of the studies [18,19,20] focused only on over the counter (OTC) medication labels.

Table 1 Background information of included studies

Across the 14 included studies, the utilization of patient-centered language, in terms of the usage of explicit, deconstructed instructions, simplified text, numeric characters instead of words, the addition of pictograms/graphics and color/white space, or font optimization, were seen to have the most impact on patient comprehension (Table 2).

Table 2 Summary of studies: label design recommendations

Of the eight studies that utilized patient-centered language, it was found that including explicit, deconstructed instructions and simplified text and numeric characters on prescription drug label instructions can improve patient comprehension [23, 24]. Specific features that were implemented to improve readability included using simple language for directions intended for 5th-grade reading skills (age range 10–11 years), inserting a table for times of administration, adding indications to the instructions, or adding a box for warnings and precautions. These features were incorporated to improve the convenience of finding information on the label [26].

Of the six studies that utilized pictograms/graphics for medication labels, it was found that for the pictograms to be effective, they should have direct connections with familiar aspects encountered in daily life. It was recommended that pharmaceutical pictograms be designed considering the following five features: familiarity, concreteness, complexity, meaningfulness, and semantic distance [21]. Further, in a population with limited reading skills, the inclusion of pictograms on medicine labels was found to positively influence the understanding of instructions and adherence [27]. Including pictograms on the labels was particularly valuable in communicating instructions on how to take medicine and in emphasizing the necessity of completing the course [27]. Furthermore, one study noted that patients found it most useful when the actual administration times were drawn in for each patient on a clock face diagram to avoid prolonged intervals between doses. Patients actively welcomed this pictogram as they found it to be instrumental in clarifying one of the most difficult features of taking multiple daily doses [27]. Including pictographic dosing diagrams was found to be especially helpful in preventing significant dosing errors [28].

In terms of layout, six studies recommended improving content layout via the utilization of color, white space, and font size optimization. Color backgrounds and white space were manipulated to improve the cosmetic appearance of the label. Recommendations also included using a bigger font size (larger font used for patient name, medication name, and dosage and directions in comparison to other components of the label) [26].

In terms of outcome measures, thirteen studies were found to directly measure the impact of patient understanding of their medication labels, and three studies were found to include a measure of patient safety in terms of medication adherence and dosing errors. All three studies correlated patient safety positively with the redesigned labels (Table 3). Of the included studies that evaluated how label reformatting impacted patient comprehension, 13 of the studies had structured interview assessments. In contrast, one study utilized the Short Test of Functional Health Literacy in Adults (STOFHLA) and Modified LaRue Tool (MLT) scores (Table 4). Most of the included studies utilized previous research efforts, patient feedback, and pilot testing methods to redesign medication labels in a more patient-centric format. Of the two studies that redesigned labels by utilizing pictograms to depict how to take medication, they obtained pharmaceutical pictograms from the US Pharmacopeia or the International Pharmaceutical Federation (FIP) (Table 4).

Table 3 Patient comprehension and safety

Table 4 Label table design process and evaluation

Only one study evaluated the impact of language choice on label comprehension. This study assessed the use of bilingual text on patient comprehension and found that adding bilingual text on prescription medication labels considerably improved understanding of the labels, especially among non-English speakers [30].

In terms of how to best communicate prescription label information to patients, only one study was found to discuss this topic. This study assessed how adding pharmacist counseling could improve patients’ comprehension of the medication label. This study found that incorporating a label highlighting critical educational components and a pharmacist-led education counseling session on the medication showed improved Rx label comprehension and functional health knowledge [25]. The label design was enough to solve the patient’s comprehension problem.

In terms of the quality of the studies, the quality assessment scores of the included studies are provided in Appendix 2.

Bias assessment

The Cochrane method was used to evaluate bias and is summarized in Fig. 3. Seven of the studies reviewed were deemed under the low-risk category for performance bias. The other seven of the studies had an unclear risk for performance bias as proper blinding of the personnel was not always guaranteed.

Fig. 3

Bias evaluation

All the studies were deemed to be at low risk for attrition bias. A significant factor in determining the risk of bias was the inadequate reasoning for missing data. Nine reviewed studies were deemed low risk for detection bias, two at high risk, and three at unclear risk. Reporting bias was also considered to be at low risk across all studies. Three studies contained other potential sources of bias. These studies noted that some of the participants recruited work in healthcare [21], that most of the participants were young and had undergraduate or above education level [17], and that the majority of participants were female (93%) [27]. This was determined to meet the criteria for a high risk of bias due to the potential of increased health literacy and the low variability of the recruited participants. None of the studies were evaluated as having a high risk of bias due to a lack of information regarding funding sources or conflicts of interest.

Discussion

This review evaluated how medication label content and display formats impact patient understanding and safety. It was found that incorporating specific design elements, such as adding visual aids, optimizing font or color, or patient-centered language, can improve label comprehension. Ultimately, specific format changes need to be addressed in order to ensure the proper identification of key information necessary for the safe and appropriate use of medications [31].

Due to contributing factors such as complex labeling language, confusing layout, or small font sizes, many patients may struggle to read and understand their medication labels. These may, in particular, impact populations such as the elderly, patients with low reading and health literacy, and patients with poor English proficiency [26]. According to previous studies, prescription labels that had been redesigned in a patient centric format were seen to be preferred over the current labels. Patients were, overall, found to favor labels that specifically highlighted the medication name, dosage, and directions, utilized increased font size, and color and white space optimization [19, 26, 28,29,30,31]. In regard to the usage of pictograms/graphics, previous studies found that graphics can improve comprehension if the illustrations and text are well-matched to each other and are appropriate and/or familiar to the background of the user [20,21,22, 27, 28, 30, 32]. Furthermore, among bilingual patients, it was reported that when provided with medication information in their native language, they had increased levels of understanding of their medications [30]. As a whole, these findings correlate with the results of this review in that the utilization of patient-centered language, pictograms/graphics, color/white space, or font optimization are seen to have the most impact on patient comprehension.

Therefore, it is of particular importance to pay attention to label layout and how to emphasize critical medication information to improve label readability. One way this can be done is through the utilization of e-labels. For, with e-labels, an adaptive used interface could be used. This interface could change the elements or layout on an electronic label to match the preferences of the individual user in terms of changing the font size or language. It could also provide label content in different formats, such as through low-language level text, pictograms, or video explanations.

For example, patients’ preferences for more graphical styles could display content using pictograms to users preferentially. Providing label content in these different formats can help improve label understanding by appealing to patients across all literacy levels.

Furthermore, label content could be tagged with medical terminology codes such that medication warnings could be more easily integrated into electronic medication reminder applications and drug-drug interaction warnings to patients. This tagging of alternative content descriptions could also be provided in graphical formats which could be used to improve the dissemination of tailored content to lower literacy or older adults via web or mobile apps.

Evidence-based recommendations on optimal content and display formats will, however, be necessary for new electronically encoded medication labels that go beyond the current SPL standard [33]. Furthermore, integrating standards beyond the healthcare field, such as IEEE (Institute of Electrical and Electronics Engineers), ISO (International Organization for Standardization), or ITU (International Telecommunication Union), could help with the interoperability of other applications, such as smart home monitoring, which could connect with healthcare provider apps and services [34, 35].

Certain challenges, however, should be noted with the utilization of electronically encoded medication labels. Limitations includes patient lack of access to a reliable electronic device or connectivity issues such as having access to Wi-Fi internet services to be able to access the label. Additionally, applying a new electronic standard will be a significant challenge to ensure that compliance with labeling accuracy, consistency, and traceability are met.

Key policy makers, such as the FDA and pharmaceutical industries, should, therefore, take note to consider how the above factors can impact patients and work to create standardized format and content practices for e-labels to provide patients with clear, concise, and accessible medication information. For developing a new electronic standard could improve connectivity and provider-to-patient communication, leading to better comprehension, safety, and patient experience.

In addition to formatting label display, the process of patient engagement should also be looked at to improve patient medication comprehension. A better process is needed to better engage with consumers to communicate medication information and improve label comprehension beyond the initial visit to a pharmacy. While the “teach-back” method, in which patients are asked to repeat instructions to demonstrate their understanding, is the currently recommended technique used to assess patient understanding of their medication label, it may not be enough for identifying potential errors in medication administration. Previous studies documented a gap between a patient’s ability to correctly state instructions and their ability to correctly demonstrate the correct number of pills to be taken daily. An enhanced approach is, therefore, needed to verify that patients can accurately describe and demonstrate how to take their medications [36,37,38]. However, more definitive studies are needed to inform practice standards on communicating medication information to consumers.

Furthermore, it is also important to consider how the content of information in a label can impact the benefit/risk perception of a drug regimen as this can affect a patient’s compliance with their drug therapy. Patients may perceive that the risk of the drug, such as in terms of side effects, is much more detrimental than the benefit of the drug. In that case, they may take the medication intermittently or stop taking it altogether, which can reduce the overall beneficial effect of the drug. Therefore, the way information is placed in a label, such as through more explicit or deconstructed text, is important as this can directly impact the patient’s perception of the drug and, in turn, their compliance/adherence to their regimen. A patient’s ability to understand the risk–benefit ratio may influence their medication adherence, and clinical trials may influence their choice to enroll in the study. There are particular problems in enrolling low-literacy patients in clinical trials [39, 40].

In order to provide patients with a balanced benefit/risk perception of their medication, it would be important to consider adding a section on benefits information to the label. This section will include more details on how the drug works, the relationship between the mechanism of action and the disease, and how the effects can be monitored [41, 42]. Adding this information on a label can provide patients with more information not only on the drug’s risks but also on its benefits and how it works to help them. This can lead to increased medication knowledge, ultimately influencing patient adherence/compliance [41].

One can, further, consider using human factors approaches to address problems for reducing medication errors, such as through label misinterpretation [43, 44]. Rather than reacting to medical errors, human factors analysis can consider processes, environments, interactions, and other resources to prevent them before they occur proactively. By incorporating human factors approaches in the designing process of medication labels, the labels can be designed in a way that is tailored specifically for patients, allowing the labels to be more patient centered. Ultimately, placing more emphasis on user-centered design can improve patient care and safety by providing another way that can be utilized to make labels more patient centric and improve their understating of label.

Certain limitations of this review should be noted. While an extensive search strategy was used, articles may have been missed using the previously described search methods. The scope of this review was also limited to only include articles utilizing a comparative design to assess an intervention’s effectiveness and articles written only in English. The keywords that were utilized in the literature search were not truncated, possibly resulting in the limitation of potentially relevant articles from other English-speaking countries.

Furthermore, sampling bias may have occurred in the 4 studies that utilized convenience sampling techniques rather than the gold standard of a randomized control trial as the study design. This may indicate that the results of these studies may not be generalizable to the greater population.

Conclusion

This paper summarizes comparative studies that evaluated the design of a medication label to improve patient knowledge and safety. Most studies focused on usability and content, and few evaluated patient safety. This review further revealed the importance of standardizing label content and display structure to incorporate into print and electronic formats. It is essential to present medication information optimally for patients to improve understanding and medication usage. Evidence-based design principles can be used to standardize the structure of label content for both print and electronic devices. However, more research needs to be done on validating the implications of label content and display formats. The findings from this review reveal the importance of further assessment of the impact of label content and display, specifically on patient safety, and evaluation and validation of the label content display.