Original Research
Factors associated with intention to engage in self-protective behavior: The case of over-the-counter acetaminophen products

https://doi.org/10.1016/j.sapharm.2015.06.005Get rights and content

Abstract

Background

Inappropriate use of acetaminophen products is a concern due to the severe liver damage associated with intentional or accidental overdose of these products. In 2009, the U.S. Food and Drug Administration (FDA) issued more severe organ-specific warnings for the acetaminophen Drug Facts label to improve protective behavior among patients. However, it is not clear how patients react to such interventions by the FDA.

Objective

The objective of this study was to evaluate the factors influencing patients' intention to engage in protective behavior while using acetaminophen products after reading the Drug Facts label. The study specifically looked at the relationship between four Protection Motivation Theory-based risk cognition factors and the intention to engage in protective behavior.

Methods

An experimental, cross-sectional, field study was conducted using self-administered questionnaires at four community pharmacies in Houston, TX. Two hundred surveys were collected from adults visiting the selected pharmacy stores. Participants were exposed to a simulated label (i.e. Drug Facts label) containing organ-specific warnings for over-the-counter (OTC) acetaminophen products. Risk cognition measures (i.e. measures of perceived severity, perceived vulnerability, response efficacy, and self-efficacy) and measures of intention to engage in protective behavior (always reading warnings, using products with more caution, and consulting a pharmacist/physician) were recorded. Pearson correlation and multiple linear regression analyses, controlling for demographic and behavioral characteristics of the participants, were performed.

Results

Bivariate analyses indicated that an increase in perceived severity, perceived vulnerability and response efficacy were associated with a higher intention to engage in protective behavior. Findings from the multiple regression indicated that increase in perceived severity of liver damage, belonging to a non-healthcare occupation, no history of acetaminophen use and no history of alcohol consumption were associated with a higher intention to engage in protective behavior.

Conclusion

Higher risk cognition of liver damage associated with inappropriate use of OTC acetaminophen products leads to greater intention to engage in protective behavior while using such products. Developing interventions targeted towards improving reading and adhering to the Drug Facts label could improve risk cognition, and thus improve patients' intention to engage in protective behavior. Regular acetaminophen users, heavy alcohol consumers and healthcare professionals might need other interventions apart from the Drug Facts label to improve their likelihood to engage in protective behavior.

Introduction

Over the past few decades increasing efforts are being made to educate patients in healthy behavior, self-care, and preventive care. The earlier practice of unilateral style of health care has shifted over time to increased level of patient involvement in day-to-day management of health. However, a major challenge with the increased participation of a patient in his or her own healthcare is ensuring the use of appropriate healthcare practices and self-protective behavior. Messages and warnings promoting protective behavior such as healthy-eating, adhering to different treatment regimens, methods for avoiding adverse events, and following provider's instructions are expressed routinely to patients via media, at doctors' offices, and at pharmacies. Despite these ubiquitous messages and warnings, patients are often found to engage in potentially harmful or negligent behavior.1 The ineffectiveness of these healthcare messages and warnings indicate an inability to identify the most effective modes of communicating these messages to the patients. The pathway through which these healthcare messages and warnings affect patients' cognition of the importance of these messages, and patients' intention to eventually engage in the recommended protective behavior is poorly studied in most healthcare situations. This study aims to address this gap, and examine one such pathway of patients' risk cognition when exposed to warning messages, and the effect of this risk cognition on the intention to engage in protective behavior.

Negligent patient behavior is particularly common in the use of over-the-counter (OTC) products, which do not require provider prescriptions or instructions, and are freely available in supermarkets and convenience stores.2 The ready availability of the OTC products leads to an erroneous perception of their being safe. Although OTC medications help save an average of $102 billion annually by aiding self-care for commonly occurring conditions,3 inappropriate use of such medications often lead to high rates of drug-related emergency department visits and hospitalizations. Since the OTC products do not usually involve prescriptive directions from providers, the Drug Facts label on these products play an important role in providing usage directions and warnings to the patients. However, patients might rely on their own judgment and their prior experience with these OTC products, which might lead to inappropriate product use and associated adverse events.4 According to an estimate by the Institute of Medicine, 90 million adults in the United States may have difficulty understanding the health information presented to them on the Drug Facts labels.5 The Food and Drug Administration (FDA) plays an important role in making sure that the information on these Drug Facts labels is easy to comprehend, and conveys important warning messages about these OTC products. This study for the first time uses the case of exposure to the warnings on OTC acetaminophen Drug Facts label to study the effect of risk cognition on the intention to engage in protective behavior.

The case of acetaminophen was particularly picked for this study because it is the most commonly used and “misused” OTC medication among the US adult population.4, 6 Furthermore, the severity of acetaminophen-related side-effects make the drug a suitable case for studying patient risk cognition and intention to engage in protective behavior. An average of about 42,329 emergency department visits per year during the years 2000–2006 were attributable to acetaminophen overdose, of which 51% were unintentional injuries.6 The average annual projected number of acetaminophen overdose-related hospitalizations was reported to be approximately 37,000 during 2005–2006.6

Acetaminophen is also associated with acute liver failure (ALF). In a study conducted by Larson et al7 on ALFs in 22 tertiary care centers in the United States, about 42% of the ALFs were determined to result from acetaminophen-related liver damage. In the same study, the annual percentage of acetaminophen-related ALF was reported to have risen from 28% in 1998 to 51% in 2003. These adverse events associated with acetaminophen use may indicate patients' inability to recognize the risk associated with acetaminophen products and make appropriate decisions while consuming these products. Previous literature has reported that patients' use and comprehension of acetaminophen drug information was inadequate, especially from the Drug Facts label.8

As stated previously the FDA has time and again made efforts to improve the quality of information provided on the Drug Facts label. In April 2009 the FDA issued new organ-specific warnings for the Drug Facts label for OTC acetaminophen products.9 The anticipated effectiveness of the new acetaminophen warnings was demonstrated in a previously reported study.10 The study found that the new warnings were associated with increased cognition of the risk of liver damage and improved intention to engage in protective behavior when using acetaminophen drugs as compared to the older Drug Facts label without these warnings. Although that study established the potential of the new warnings in improving patient behavior, it did not examine the underlying cognitive factors which guide patients' risk perception, and their effect on the motivation or intention to engage in protective behavior. An understanding of these cognitive factors, and their effect on the intention to engage in protective behavior, could help in future development of better warnings for the Drug Facts labels. In the domain of self-medication, very little data exists on the effect of risk cognition on patients' intention to engage in protective behavior. Furthermore, no data exist on such a relationship in the context of exposure to OTC Drug Facts label warnings.

Several theories, such as the Health Belief Model (HBM),11 the Theory of Reasoned Action (TRA),12 the Subjective Expected Utility Theory (SEU),13 and the Protection Motivation Theory (PMT)14 have been used to explain and predict protective behavior. These theories suggest that an individual's recognition of the risk of an event, his/her beliefs, attitude, and several other cognitive factors mediate the intention to engage in a particular behavior and, perhaps, a protective behavior (such as appropriate use of medications). Previous studies in healthcare behavior research that have employed these theories indicate, in general, a positive association between cognition of risk of a harmful event and intention to engage in protective behavior.15, 16 However, this association has not been studied in the context of OTC product use. In order to reduce, or possibly eliminate the likelihood of an adverse outcome, the first step is to identify whether recognition of acetaminophen-related risk of liver damage can influence the intention to engage in protective behavior. The aim of the current study was therefore to investigate risk cognitive factors that potentially influence the intention to engage in protective behavior, in order to reduce the risk of severe liver damage among patients using OTC acetaminophen products.

Weinstein performed a literature review of the four key theories explaining protective behavior (TRA, SEU, HBM and PMT).17 Among the four theories, PMT is the only model that includes self-efficacy as a separate component. Research on self-efficacy has indicated that self-efficacy is an important factor in motivational, cognitive, and affective processes.18Self-efficacy is particularly relevant in the context of OTC medication use because these medications involve personal decision making and self-medication. Hence this study used PMT as its theoretical framework for examining the effect of risk cognition on the intention to engage in protective behavior. The PMT was originally proposed by Rogers in 1975 and was further revised in 1983 to generalize the theory towards persuasive communication.14, 19 The PMT postulates that the two constructs measuring risk cognition are threat appraisal and coping appraisal (Fig. 1). These two measures characterize the cognitive mediational processes in risky situations and motivate an individual to engage in protective behavior. Threat appraisal involves an individual's perception of how threatened he/she feels about a harmful event. Variables that capture threat appraisal are perceived severity and perceived vulnerability. Perceived severity indicates how severe an individual perceives the risk of an event (liver damage) to be. Perceived vulnerability indicates an individuals' perception of their own vulnerability to the event (liver damage). Coping appraisal involves the individual's assessment of coping responses recommended for preventing the event (liver damage). Variables that explain coping appraisal are self-efficacy and response efficacy. Self-efficacy refers to the belief that one can successfully enact the recommended behavior (reading the warnings carefully, using acetaminophen products with caution and consulting a pharmacist/physician before using OTC acetaminophen products) to avoid the event or reduce the risk of the event (liver damage). Response-efficacy refers to beliefs about the effectiveness of the recommended behavior in removing or reducing the risk of the event (liver damage). Sub-optimal threat appraisal or coping appraisal may undermine the intention to engage in a protective behavior.20

The objective of this study was to assess the effect of the four risk cognition measures, as defined in the PMT, on the intention to engage in protective behavior when using OTC acetaminophen-containing products, in the context of exposure to the warnings on the Drug Facts label required by the FDA.

Section snippets

Study design and data collection

An experimental, cross-sectional, field study was conducted using a self-administered questionnaire. Four community pharmacy retail stores were selected for data collection based on proximity to the researchers after obtaining consent from the pharmacies. Data was collected during May 2010 to June 2010. Every individual visiting the OTC section of the pharmacy was approached by a data collector and requested to participate by reciting a communique. Participants were required to be

Results

Table 2 provides information regarding the participant characteristics. The mean participant age was 43 years with a somewhat balanced distribution by gender (51.5% women). Majority of the participants were non-Hispanic whites (52%), and most had some college education or higher (84%). The sample had a relatively higher proportion (35%) of individuals with graduate degrees. With respect to occupation, 61.5% of the participants belonged to a non-healthcare profession. With respect to the history

Discussion

This study aimed to identify factors influencing the intention to engage in protective behavior in order to minimize the risk of unintentional liver damage associated with the use of OTC acetaminophen drug products. The study found that certain factors in the PMT framework explained the intention to engage in protective behavior. Specifically, an increase in perceived severity of liver damage associated with inappropriate use of OTC acetaminophen products, belonging to a non-healthcare

Limitations

The findings of this study should be viewed in the context of certain limitations. First, since the study was conducted at selected community retail pharmacies in Houston and limited to English-speaking adults, it is not generalizable nationally. Second, although the study participants did not differ from the non-respondents with respect to gender and ethnicity, differences in other characteristics such as education, reading comprehension, and income were not captured. Third, the Drug Facts

Conclusion

Patients with higher risk cognition of liver damage exhibited greater intention to engage in protective behavior when using OTC acetaminophen products. Other significant factors affecting the intention to engage in protective behavior were lack of history of acetaminophen product use, lower alcohol consumption, and belonging to a non-healthcare occupation. Developing interventions targeted towards improving reading and adhering to the Drug Facts label could improve risk cognition, and thus

References (28)

  • A.M. Larson et al.

    Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study

    Hepatology

    (2005)
  • Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final monograph. Final rule

    Fed Regist

    (2009)
  • R. Goyal et al.

    Effectiveness of FDA's new over-the-counter acetaminophen warning label in improving consumer risk perception of liver damage

    J Clin Pharm Ther

    (2012)
  • V.J. Strecher et al.

    The Health Belief Model. Cambridge Handbook of Psychology, Health and Medicine

    (1997)
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