Consumers’ Medication Schema for Package Inserts

1.1. Package inserts in Korea

Package inserts are one of the important sources for drug information, where consumers or patients can obtain such information on their own. However, the readability and comprehensibility of the inserts printed in Korea are in doubt. The report by the Consumer Safety Center (2008) in Korea revealed that 99.2% out of 123 leaflets examined used a font size smaller than 8 point, which is the recommended font by the guideline of KFDA (Korea Food & Drug Administration); moreover, 66.1% used a font size smaller than 6 point and 91.8% used more than one difficult technical term. In addition, the dosage instructions were occasionally given inappropriately. In some drugs, the recommended dosage was expressed in ‘mg’ even when the drugs were in the form of a tablet or a capsule, which makes it difficult for consumers to take the exact amount. Problems of how Korean consumers perceived the package inserts surfaced through this investigation; small font size, difficult terms and texts leveled at medical specialists were mentioned as the primary issues (Song, Lee, Kim & Lee, 2008).

As Figure 1 shows, a large amount of content is written in small font and moreover, the items are not structured based on item importance or frequency of use, engendering low readability and accessibility. In another study, consumer competency of information on medication was examined by using ‘the label reading survey’, which was adjusted to fit Korean consumers (Marietta, Welshimer & Anderson, 1999; Nam & Yoo, 2010). Information on the three best selling OTC drugs, analgesic, antacid and anti-diarrhea, was tested. One thousand consumers participated in the survey and the results revealed that respondents correctly answered 3.82 questions, on average, out of 10 questions, which indicates an overall low knowledge level.

Figure 1

An illustration of a package insert and packages printed in Korea (http://blog.daum.net/moge-family/534)

The guideline by KFDA on how to present the information of drugs in containers, packages and package inserts suggests eighteen items and their presentation order (Table 1). Compared to the other countries, eighteen items are a high figure. For example, the U.S. FDA suggested eight items, such as active ingredients, purposes, uses, warnings, directions, other information, inactive ingredients and questions. The FDA recommends companies to provide the drug facts in the listed order and to be easily read and understood. In England, five items, such as name of the medicine, strength, route of administration, posology and warnings, are regarded as the most vital drug facts. They need be presented in the same page without the interruption of logo or graphics and should be printed in a font as large as possible; further, there should be enough space between letters and lines for readability.

In addition to the large number of items, texts are written in a small font size and are tightly spaced, which discourages consumers from reading the inserts. There are difficult Sino-Korean¹ words and the suggested order does not reflect the importance of information with regards to medication and the frequency consumers consult the information. The most important and useful information, such as efficacy and effects, warnings, directions and doses, were usually provided in the middle of package inserts without any emphasis or highlights (Song et al., 2008). There must be reasons as to why such a great deal of information is provided. Possible reasons may be protecting consumer rights to know the information, preventing consumers from misusing or abusing drugs by providing enough information, or defending manufacturers or sellers against the responsibility for misuse or abuse. However, too much information is not useful and only reduces the readability and comprehensibility if it is not organized in a way such that consumers can easily process the information.

Table 1

Items to be included in the package inserts in the order provided by KFDA

1.2. Medication schema

In cognitive psychology, there is a concept called schema, which refers to how knowledge is represented in our memory. As experiences of objects, events, situations or actions are repeated, some generalization or abstraction occurs and a mental structure called schema is formed (Rumelhart & Ortony, 1977). Schema helps us understand, memorize and make inferences, allowing for efficient information processing. There can be various kinds of schema; according to Morrow and colleagues, people come to structure their medication knowledge through repeated medication experiences and this organized knowledge structure is called as medication schema. The instructions compatible with their schema help people understand and remember medication information and thereby increase adherence (Morrow, Leirer, Altieri & Tanke, 1991; Morrow, Leirer, Andrassy, Tanke & Stine-Morrow, 1996).

Morrow et al. (1991) examined medical instructions and asked older adults to indicate how 10 items should be ordered in the instructions. The ten items were identified as important factors in a previous study (Morrow, Leirer & Sheikh, 1988). The results revealed that the general schema was shared. The items were grouped into three categories: general information (doctor name, medication name and purpose), intake (dose, schedule, duration and warnings) and possible outcomes (mild and severe side effects, emergency information). In another study, they examined younger and older adults and demonstrated that they shared a similar schema with the 10 items, which were divided into two groups: description of medication and intake, and the potential problems associated with taking the medicine and what to do if complications occur (Morrow et al., 1996). They first demonstrated the medication schema and then conveyed that participants recalled medication instructions better when the instructions were designed to be compatible with their schema.

Maat and Lentz (2010) also demonstrated that when information leaflets were structured according to readers' pre-existing schema, accessing and comprehending the information improved. When people read functional or informational text, they do not simply read it from the beginning to the end. Instead, they navigate through it by skimming, searching and re-reading it (Hartley, 2004; Wright, 1999). Therefore, it is important to structure the text in a way that people can easily access information that they want to read. In order to enhance accessibility, they changed the structure of the side effects, which was grouped by organ systems, to the structure grouped in terms of frequency of information use and severity of the effects.

Similarly, Gray, Cantrill and Noyce (2002) suggested a concept called ‘health repertories’. It refers to the schema people have for selfmedication of minor ailments. Based on the data from focus group interviews, structured interviews and depth interviews of young adults in the U.K., they demonstrated that young adults developed schema for the management of minor ailments. The schema included description/ labeling of symptoms, one or more self-medication strategies and contingency plans in case the strategies failed. Gray et al. (2002) also suggested that this schema is developed through a consumer socialization process and personal illness episodes, and it is dynamic because it keeps changing with new experiences.

The previous studies clearly show that Korean package inserts are not user friendly both perceptually and cognitively. Based on the research on medication schema, the present study aims to investigate the medication schema that Korean consumers have regarding package inserts and to suggest ways to design instruction information so that the accessibility and utilization of the package inserts can be improved.

2.1. Participants

One hundred forty five undergraduate students participated in this study (male: 58, female: 79, no answer: 8). They were from two universities in Seoul. Their mean age was 27.52 (SD=10.24).

2.2. Procedure and questionnaire

Questionnaires were distributed at the beginning of the class and students filled them out for approximately ten minutes. For the questionnaire, we sampled package inserts from the ten best selling OTC drugs in Korea. Despite the KFDA guideline, we wanted to gather the medication information presented to the consumers in the market. From this sampling, twelve items were gathered and they were presented in the questionnaire (Table 2). We did not include the letter of “over-the-counter drug” because all of the sampled package inserts showed this letter either at the right or left heading separately from the other content.

Table 2

Twelve items and their importance order (1: the most important)

Based on the study by Morrow et al. (1996), the participants were first asked to order the twelve items according to their importance (order task) and then to categorize the twelve items into groups (sort task). They could make any number of groups as they thought necessary. In addition to the main tasks, the participants were asked to indicate the items they did not know the meaning of and the unincluded items they wished to have included. Further, they were asked as to how often they read package inserts; five options were provided: (1) never read, (2) sometimes read, (3) often read, (4) always read, or (5) read for the first time. Finally, questions regarding sex and age were asked.

2.3. Statistical analysis

To extract the schema, hierarchical cluster analyses were carried out on the data from the order and sort tasks. For the order task, a 12×12 matrix with a distance between every pair of items was created for each participant, and the mean distance matrix across the participants was analyzed. For the sort task, a 12×12 matrix with the number of participants who put each pair of items into the same group was created and analyzed. Because the order and the sort tasks provide different information, different matrices were created. A distance matrix was created for the order task, while a frequency matrix was created for the sort task (Morrow et al., 1996). In the hierarchical cluster analysis, Ward’s method was used, which is known as more informative than other methods because it is less influenced by the overlapping clusters (Aldendorfer & Blashfield, 1984).

For the data analysis, SPSS 12.0 was used. For the other questions, descriptive statistics were reported.

3.1. Descriptive statistics

Regarding the frequency of reading package inserts, the results indicated that 35.2% of the respondents read them sometimes, 22.8% of them read them only at the first time, and 9.7% of them never read it. These results indicate that half of them do not often consult thepackage inserts when they take medicine (Table 3).

Table 3

Frequency of reading package inserts

The results of the order task are presented in Table 2. Information related medicine intake (effects, warnings & dosage) turned out as important, whereas details about drugs, such as shape, package unit and name of tar color, turned out to be less important. After the order task, we asked the participants to write down the items that they did not know the exact meaning of. Some participants listed more than one item; in total, one hundred fifty six items were mentioned as being difficult to understand. ‘Description of drugs’ was the most often mentioned item (Table 4).

Table 4

Items difficult to understand

The reason that this item was chosen seems to be attributed to the fact that the words are in Sino-Korean. Although the Chinese characters of the word are not difficult to comprehend, the Korean word displayed is not an often used one, making it difficult to understand. Furthermore, the names of tar color and preservatives seem to be overly detailed with specialized information.There were thirty eight items as the unincluded items they wished to have included. However, fifteen of them (39.5%) were items already in the package inserts, such as side effects and contraindications. This well demonstrates that people have difficulty in finding the information they need. Fourteen of them (36.8%) were about the alternative presentation of the items already in the package inserts, such as dosage according to age, dosage indication such as prescription drugs (e.g., how many or much to take in the morning, afternoon and night), and easier presentation of the effects and side effects. Only four (10.5%) were new items, such as providing the probability of side effects, daily practices inducing the effects of drugs, how to dispose drugs and symptoms of misuse or abuse.

3.2. Hierarchical cluster analysis

Figure 2 and Table 5 show the graphical and numerical summaries of the cluster solution of the order task. Figure 2 shows that two clusters are formed at the distance of 20~25 and Table 5 also shows that change between coefficients was the largest from stage 10 to 11, which suggests a two-cluster solution. The three most important items, efficacy & effects, warning, and directions and doses, were grouped together and the remaining items were grouped into one group as well.

Figure 2

Dendrogram using the Ward method: order task2

Table 5

Agglomeration schedule: order task

For the sort task, the average number of categories that the participants created was 3.55 (SD=0.69). Out of 145 participants, eighty eight (60.7%) created four categories, thirty eight (26.2%) created three, nine (6.2%) created two, two (1.4%) created one, and eight (5.5%) did not answer. The results conveyed that the twelve items were divided into two categories.

Figure 3 and Table 6 show the graphical and numerical summaries of the cluster solution of the sort task. Figure 3 shows that two clusters are formed at the distance of 20~25 and Table 6 also shows that change between coefficients was the largest from stage 10 to 11, which suggests a two-cluster solution. One group included information on medication intake and specific accounts on the drug, such as efficacy & effects, warnings, directions & doses, letter of “misuse/abuse concerns,” names and quantity of active ingredients, methods of storing, names and quantity of preservatives, description of drugs and the names of tar color. This information is usually what consumers need and use for medication. The other group included general information about drug and pharmaceutical companies, such as the product name, company name and address, and package unit.

Figure 3

Dendrogram using the Ward method: sort task3

Table 6

Agglomeration schedule: sort task