Consumer confusion between prescription drug precautions and side effects
Introduction
Consumers in developed countries around the world increasingly seek health information online, with information about prescription drugs—including drug side effects—being one of the most commonly sought topics [1], [2], [3], [4], [5], [6], [7]. Although large government and commercial websites (e.g., NIH.gov, WebMD.com) are the most popular sources of online drug information [6], brand-name drug websites (i.e., DrugName.com) are also a leading and frequently visited source [5], [6], [8], [9]. This is true even in countries that ban direct-to-consumer marketing of prescription drugs, because the Internet enables consumers in these countries to access brand-name drug websites [10]. More than two-thirds of search engine results for prescription drugs contain at least one link directing individuals to brand-name drug websites regardless of geographic location [11].
Brand-name drug websites typically contain the same information provided in hard-copy package inserts, and they are designed both to educate consumers about the drug as well as promote it [12], [13]. However, evaluation of brand-name drug websites suggests that many sites do not present information in a balanced manner, often presenting information about benefits higher on the site and in larger font and placing risk information in less conspicuous locations [14], [15], [16], [17]. Beyond brand-name drug websites, online health information in general has many limitations: Information is typically written at a high reading level and consumers scan information rapidly, with the average website visit lasting less than one minute [18], [19].
Although little research has been conducted on consumers’ understanding of the information presented on brand-name drug websites, previous research suggests that most consumers have difficulty comprehending this same information when it is presented in package inserts. Specifically, consumers struggle to interpret multiple elements of package inserts, including dosage, indication, method of administration, instructions for use, and warnings and contraindications [20], [21], [22]. This is especially true when consumers are older, take multiple medications, have lower literacy skills, and have limited English proficiency and when labels include medical terminology, multistep instructions, and distracting content (e.g., unrelated visuals) [22], [23], [24], [25], [26], [27], [28], [29].
More alarmingly, few consumers know the potential side effects and warnings of their current prescription drugs, especially consumers who are older, take multiple medications, and have lower health literacy [30], [31], [32], [33]. Even when presented with educational materials, such as medication guides or brief summary pages—which are designed to improve knowledge of drug risks—consumers have difficulty recalling risk information [34], [35], [36].
Given consumers’ difficulty understanding and recalling risk information, one important area of concern is their potential confusion between drug precautions and drug side effects [37]. Precautions and side effects are often presented together in a drug’s detailed risk information, yet they contain very different messages. Precautions are a type of drug warning that directs consumers to tell their healthcare provider if they have a certain pre-existing health condition so that the dosage can be adjusted or contraindications can be avoided (e.g., tell your doctor if you have hypertension as your dosage may need to be adjusted). Conversely, side effects alert consumers to potential adverse events that might result from taking a medication (e.g., the drug may cause hypertension). Consumers who misinterpret precautions as side effects may be at greater risk for serious adverse reactions, incorrect dosing, and insufficient monitoring. Consumers who misinterpret side effects as precautions may unnecessarily avoid a medication, leading to poor illness management or less effective treatment. Despite these implications, no research has examined how likely consumers are to confuse these two types of risk information or how such confusion might affect consumer risk perceptions and behavior.
The purpose of this exploratory study was to examine whether consumers can distinguish between drug precautions and drug side effects presented on brand-name drug websites. We presented consumers with one of four brand-name drug websites for fictitious prescription drugs, which contained information on both drug side effects and drug precautions. We then assessed consumer recall and interpretation of drug risk information. The ability of consumers to distinguish between drug precautions and drug side effects has important implications for treatment decision-making and patient safety. Specifically, we examined three research questions:
- (1)
How likely are consumers to confuse drug precautions and drug side effects?
- (2)
What types of individuals are most likely to confuse these concepts?
- (3)
Does confusion between precautions and side effects influence drug risk perceptions?
Section snippets
Study design
This study was nested within a set of larger experimental studies that examined how exposure to brand-name drug websites influences consumer knowledge as well as perceptions and behaviors related to prescription drugs. For the larger studies, we created websites for five fictitious prescription drugs indicated to treat seasonal allergies, high cholesterol, high blood pressure, acid reflux, and depression; and we tailored those websites for various experimental conditions that manipulated the
Participant characteristics and precaution recall
We enrolled a total of 873 participants in the experimental conditions examined in this study. Of those enrolled, 134 participants (15.3%) mentioned at least one precaution when asked to report drug side effects and negative outcomes. The remaining participants either did not mention any precautions (n = 655; 75.0%) or skipped the question asking about drug risks (n = 84; 9.6%).
Most study participants were female, White, older than 60 years of age, and had obtained a college degree (Table 2).
Discussion
This study addresses a critical gap in the literature by providing an exploratory look at how consumers interpret drug precautions on brand-name drug websites, and the findings suggest that at least some consumers are likely to misinterpret precautions as potential side effects produced by the drug. Precaution recall was generally low in the overall sample, which was not surprising given that the question we asked focused on side effects. However, the 8%–23% (depending on illness population) of
Conflicts of interest
The authors have no conflicts of interest to report.
Funding
This research was funded by a contract from the U.S. Food and Drug Administration (FDA), Office of Prescription Drug Promotion.
Patient identifying information
We confirm that all patient/personal identifiers have been removed or disguised so that the patient(s)/person(s) described are not identifiable and cannot be identified through the details of the article.
Statement of Authorship/Contributions
All authors meet the requirements for authorship and submission. JA assisted with stimuli development, collected data, analyzed results, and led the writing of the manuscript. DR conceptualized the study; oversaw stimuli development, data collection, and analysis; and wrote sections of the manuscript. HS and AO helped refine the study design, oversaw data collection and analysis, and provided substantial input on the manuscript. HS also conducted analyses for this manuscript. All authors have
Acknowledgements
We would like to thank Kathryn Aikin of the U.S. Food and Drug Administration for her thoughtful input on the study design and the manuscript. We also thank the following employees of RTI International for their assistance: Kayla Gray, Scott Boggs, Elizabeth Robbins, and Maria Ashbaugh (stimuli development) and Jennifer Gard Read, Bridget Kelly, and Rebecca Moultrie (questionnaire development and cognitive interviews). We also wish to thank Suzanne West and Katherine Treiman for their thorough
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