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Associate Professor, Departments of Clinical Pharmacy and Family Medicine, College of Pharmacy and Graduate School of Medicine, University of Tennessee, Knoxville, TN
Assistant Professor, Departments of Clinical Pharmacy and Family Medicine, College of Pharmacy and Graduate School of Medicine, University of Tennessee
Associate Professor, Department of Family Medicine, Graduate School of Medicine, University of Tennessee
Associate Professor, Department of Family Medicine, Graduate School of Medicine, University of Tennessee
Professor, Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ
Reprints: Dr. Franks, Departments of Clinical Pharmacy and Family Medicine, College of Pharmacy and Graduate School of Medicine, 1924 Alcoa Highway, Box 117, Knoxville, TN 37920, fax 865/974-2022, afranks{at}utmem.edu
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Abstract |
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OBJECTIVE: To evaluate readability and formatting characteristics of CMI included with nonsolid (ie, topical cream/lotion, inhalation, transdermal) drug samples.
METHODS: We collected a convenience sample of nonsolid dosage sample medications (N = 55) from several different private and university-affiliated primary care and specialty physician practices at a large academic medical center in the southeastern US. We noted whether CMI was present and, if it was, we assessed it for instruction presentation, reading level, text size, format/layout, and comprehensibility.
RESULTS: Most (43 of 55) products included CMI, either as a separate leaflet or directly on the packaging. Reading level of CMI leaflets ranged from the 6th- to 14th-grade level, with just 4 (16.0%) written at the recommended 6th-grade level. Text font point size was 9.48 ± 2.14 (mean ± SD; range 5–12). Text printed directly on sample packaging averaged 6.61 point ± 2.62 (4–11) font size. Ninety-two percent of CMI leaflets included a combination of text and pictures; only 11.1% of CMI printed directly on the packaging used pictorial aids.
CONCLUSIONS: Most CMI accompanying nonsolid medication samples is written at a reading level that exceeds that of many consumers and does not meet recommended standards for readability and comprehensibility of patient education material.
Key Words: drug information, drug samples, health literacy
Published Online, December 17, 2008. www.theannals.com, DOI 10.1345/aph.1L362
According to the Department of Education's 2003 National Assessment of Adult Literacy conducted by the US Department of Education and the National Center for Education Statistics, more than one-third of American adults (90 million people) have deficient literacy skills.4 Adults over the age of 65 years, who use disproportionately more medications than the remainder of the population does, have rates of limited health literacy that exceed 50–60%.4
Studies have assessed readability of CMI for prescription and nonprescription drugs.5-10 All of these studies found that CMI is generally unsuitable for patients with limited literacy skills because the readability of the CMI often exceeds the reading skills of the average American. Studies of prescription drug labels11-13 and Food and Drug Administration medication guides had similar findings.14 The high reading demand of CMI and drug labels has important implications for patient safety, as an Institute of Medicine report estimated that 1.5 million medication errors occur annually in the US,15 and poor labeling is a primary cause of many of these errors.15,16
Research has shown that the practice of dispensing pharmaceutical company–provided samples has medication safety issues related to storage, handling, record keeping, and labeling.17 Samples are often dispensed without clear patient instructions or appropriate patient-specific labeling.17,18 Even if the clinician provides verbal information during the encounter, patients often do not remember details and will depend on written information provided with the sample regarding instructions about how to take the medication.18,19 With drug samples, the company-produced information may be the only information that the patient receives.
Although the shortcomings of CMI accompanying medication samples in solid dosage forms (tablets and capsules) have been described,10 to our knowledge, no studies have examined CMI that comes with nonsolid drug sample products. Therefore, the objective of this study was to characterize and evaluate the formatting and readability of CMI included with nonsolid (eg, creams, inhalers, transdermal products) medication samples with various formulations and administration routes.
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Methods |
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PACKAGING ASSESSED
We assessed sample packaging according to the following criteria: (1) Did
the packaging specify the indication(s) for use? (2) Was space available on
the packaging for the provider to apply a label or to write dosing
instructions? (3) Was there a toll-free number or Web site from which patients
could obtain additional information, if desired?
ASSESSING CMI
We assessed CMI by first noting whether or not it was included with the
product. If CMI was included, we then noted whether it was printed (1)
directly on the packaging or (2) on a separate package insert included inside
the packaging or attached to the outside. We then used previously reported
techniques6-10
to evaluate readability and formatting characteristics for CMI in each of the
2 categories (ie, on the packaging or in a separate insert) according to the
following 4 criteria: presentation type, instruction layout, text point size,
reading grade level, and comprehensibility.
PRESENTATION TYPE AND LAYOUT
We evaluated presentation type by first assessing whether patient
instructions were included. If provided, we noted whether the instructions
were part of a package insert intended for healthcare providers or whether
they were included as a separate enclosure directed to patients. The
instruction layout was classified as containing all text, all pictures, or
both text and pictures.
COMPREHENSIBILITY AND LEGIBILITY
We then used criteria created by Svarstad et
al.20 to
evaluate comprehensibility and legibility. The first criterion notes the
presence of important warning information and, if provided, whether it is
either highlighted in a box or printed in boldface type. The second criterion
specifies whether text is presented in a normal font, rather than in ornate
fonts or italics, and whether the text is presented in both upper and lower
case letters, as opposed to all capital letters. The third criterion assesses
the appropriate placement of headings (placed on separate lines vs on the same
line as text) and the use of bullets to enhance readability. The final
criterion specifies the presence of adequate space between lines (>2.2 mm
recommended) and sufficient contrast between the colors of the ink and
paper.
To determine the text point size of the most prominent font in the patient instructions section of CMI, we measured the distance from the ascent line (top of the capital letters) to the descent line (bottom-most descender, eg, lowest portion of the lower case letter p or y) with a C-Thru Ruler (C-Thru Ruler Co., Bloomfield, CT). Standard recommendations for text point size of package inserts (leaflets) is at least 10 points.21-24
READABILITY
We assessed readability of patient instructions sections of CMI using the
Fry
formula.25
(Complete Fry formula instructions and accompanying graph are available at
www.rctresources.com/downloads/curriculum/fry.pdf.)
This method involves an assessment of the number of sentences and syllables
from 100-word passages selected from the beginning, middle, and end of the
text. The average number of sentences and syllables in each of the 3 passages
is then calculated. Finally, the average number of sentences per 100 words and
average number of syllables per 100 words are plotted on a graph. This graph
is used to estimate reading grade level. The reading level recommended for
patient education information is at or below grade level 5 or
6.23,24
ASSESSMENT RELIABILITY AND DATA ANALYSIS
Two authors (ASF, LSW) independently evaluated each patient instruction CMI
using the criteria described. Investigators scored the criteria as not met (0
points), partially met (1 point), or fully met (2 points). Interrater
reliability (agreement) for each of these 7 criteria was calculated using
Cohen's 
, which ranged from 0.88 to 1.0. The same authors reviewed and
discussed the independent scores that were inconsistent between raters. Both
investigators then arrived at consensus, and the final score was recorded.
All data were entered into and analyzed using the Statistical Package for the Social Sciences (SPSS+, SPSS Inc., Chicago, IL) for Windows, version 14.0. We calculated descriptive statistics (percentages, frequencies, modes, medians, means, standard deviations) to assess readability and formatting characteristics of prescription medication sample packaging and accompanying CMI.
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Results |
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Twelve (21.8%) of the 55 sample medication products evaluated had no CMI. Table 2 describes the packaging characteristics of 43 prescription drug samples containing CMI. CMI was either provided as a separate package insert (n = 25) or printed directly on the packaging (n = 18).
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Of the 25 products that included drug information as part of a separate package insert, 7 (28.0%) included CMI as part of prescribing information intended for healthcare professionals. CMI was printed on a separate sheet of paper with the heading "Information for the Patient" or "Patient Instructions" in 18 (72.0%) of the samples that included CMI as a separate package insert. Four (16.0%) separate package inserts were written at the 6th-grade level, while 6 (24.0%) were at the 10th-grade or higher level (Figure 1). Text point size averaged 9.48 ± 2.14 (range 5–12).
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Discussion |
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Encouraging findings of our study were that more than two-thirds of CMI
included a clear indication for use and that, overall, these nonsolid products
were more likely to include CMI (72%) than has been reported for oral tablets
or capsules
(50%).10
However, the mean text size for separate CMI leaflets on these products was
still small (similar to that accompanying oral
samples)10
and text printed directly on the packaging was much smaller (approximately
6-point font), well below the recommended font size of 10–12
points.21-24
The reading level of most CMI of the products reviewed in our study was higher
than the recommended 6th grade or lower, although lower than the level that is
found with CMI for oral tablet and capsule sample products (
10th
grade).10
Instructional formatting that includes illustrations in CMI has been shown to improve patient recall, comprehension, and satisfaction, as well as medication adherence.27-29 Although more than 90% of the CMI in our study included as separate leaflets contained pictures, only about 10% of the information printed directly on the packaging included pictorial aids. Compared with oral products, these dosage forms were more likely to include pictures to complement the text. Interestingly, while more space was provided in the separate leaflets, oral tablet and capsule sample products with CMI printed directly on the packaging had more frequent use of pictures for CMI printed directly on the package (28%) than did separate CMI leaflets (10%).10
LIMITATIONS
A primary limitation of this study is the method by which medication
samples were obtained. They were not collected randomly, but as a convenience
sample from primary care and specialty physician offices. So, there is a
possibility that we may have somehow collected a nonrepresentative sample of
products. Because manufacturers provide samples of newly marketed products,
the products evaluated may be newer and would be expected to have better CMI
compared with older products.
Secondly, we did not evaluate patient comprehension or understanding of CMI or the effect that it had on adherence or other medication-taking behaviors. We did, however, assess characteristics of formatting and readability that have been shown to affect patient comprehension.
Finally, due to the brevity of the text included directly on the product packaging, we were unable to calculate the reading level for that particular information. We did, however, describe the limited information, small text size, and lack of source for additional information contained in packaging labels.
CMI accompanying samples of nonsolid medication is not consistent with recommended standards for legibility and comprehensibility, resulting in a significant disparity between patient literacy and suitability of CMI. Overall, formatting and readability do not facilitate patient understanding or appropriate medication-taking behavior. Most CMI is written at a higher than recommended reading level and printed in font size that is too small.
The dosage forms described in this study require more intensive patient education for appropriate administration. Because the distribution of medication samples excludes pharmacists who may provide verbal education regarding administration and safety, prescribers should dispense samples attentively and should provide individual verbal patient education to complement the limited written CMI.
To promote safe and effective use of medications, minimal standards of readability and comprehensibility should be required for all CMI, including written information provided with drug samples. Medication sample CMI should be redesigned to be consistent with patient safety standards and should be comprehensible by patients with varying levels of health literacy. Further research should focus on testing patient understanding of CMI accompanying medication samples and determining whether better instructions lead to more positive health-related outcomes.
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