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

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.

Hepatocellular carcinoma surveillance rates in commercially insured patients with noncirrhotic chronic hepatitis B.

American association for the study of liver diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines recommend biannual hepatocellular carcinoma (HCC) screening for noncirrhotic patients with chronic hepatitis B infection (HBV), yet there are no data estimating surveillance rates or factors associated with surveillance. We performed a retrospective cohort study of US patients using the Truven Health Analytics databases from 2006 to 2010 and identified patients with noncirrhotic chronic HBV. Surveillance patterns were characterized using categorical and continuous outcomes, with the continuous measure of the proportion of time 'up to date' with surveillance (PUTDS), with the 6-month interval following each ultrasound categorized as 'up to date'. During a median follow-up of 26.0 (IQR: 16.2-40.0) months among 4576 noncirrhotic patients with chronic HBV (median age: 44 years, IQR: 36-52), only 306 (6.7%) had complete surveillance (one ultrasound every 6-month interval), 2727 (59.6%) incomplete (≥1 ultrasound) and 1543 (33.7%) none. The mean PUTDS was 0.34 ± 0.29, and the median was 0.32 (IQR: 0.03-0.52). In multinomial logistic regression models, patients diagnosed by a nongastroenterologist were significantly less likely to have complete surveillance (P < 0.001), as were those coinfected with HBV/HIV (P < 0.001). In linear regression models, nongastroenterologist provider, health insurance subtype, HBV/HIV coinfection, rural status and metabolic syndrome were independently associated with decreased surveillance. Patients with HIV had an absolute decrease in the PUTDS of 0.24, while patients in less populated rural areas had an absolute decrease of 0.10. HCC surveillance rates in noncirrhotic patients with chronic HBV in the United States are poor and lower than reported rates of HCC surveillance in cirrhotic patients.

Predictors of smoking among male college students in Saudi Arabia.

Identifying the predictors of smoking in one of the top cigarette-consuming countries in the world is a vital step in smoking prevention. A cross-sectional study assessed the predictors of smoking in a cohort of male students in 3 universities in Saudi Arabia. A pre-tested, validated questionnaire was used to determine sociodemographic characteristics, academic performance, peers' smoking, and presence of a smoker within the family. Of the 337 participants, 30.9% were current smokers (smoked 1 or more cigarettes within the last 30 days). Lower academic performance (OR = 2.29, 95% CI: 1.02-5.17), peer smoking (OR = 4.14, 95% CI: 1.53-11.3) and presence of other smokers in the family (OR = 2.77, 95% CI: 1.37-5.64) were the significant predictors of smoking status identified using multiple logistic regression analysis. These findings highlight the influence of family and peer pressure in initiating cigarette use among the youth of Saudi Arabia.

Predictors of smoking among male college students in Saudi Arabia

Identifying the predictors of smoking in one of the top cigarette-consuming countries in the world is a vital step in smoking prevention. A cross-sectional study assessed the predictors of smoking in a cohort of male students in 3 universities in Saudi Arabia. A pre-tested, validated questionnaire was used to determine sociodemographic characteristics, academic performance, peers' smoking, and presence of a smoker within the family. Of the 337 participants, 30.9% were current smokers [smoked 1 or more cigarettes within the last 30 days]. Lower academic performance [OR = 2.29, 95% CI: 1.02-5.17], peer smoking [OR = 4.14, 95% CI: 1.53-11.3] and presence of other smokers in the family [OR = 2.77, 95% CI: 1.37-5.64] were the significant predictors of smoking status identified using multiple logistic regression analysis. These findings highlight the influence of family and peer pressure in initiating cigarette use among the youth of Saudi Arabia

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

WHAT IS KNOWN AND OBJECTIVES: The Food and Drug Administration (FDA) issued new organ-specific warning label requirements for over-the-counter (OTC) analgesic products in order to make consumers aware of the risk of liver damage when using acetaminophen. However, awareness of a health risk alone cannot ensure consumers' engagement in safe and preventive behaviour. In this study, we attempted to: (i) measure consumer risk perception of liver damage due to the OTC acetaminophen products and (ii) analyse the effectiveness of the new organ-specific warning label in improving consumer risk perception of liver damage and intention to perform protective behaviours while using OTC acetaminophen products. METHODS: This within-subject experimental study used a convenience sample of English-speaking adults visiting OTC segments of selected pharmacy stores in Houston. Participants were randomly exposed to the old and new warning labels and their respective risk perception (measured on a visual analogue scale, 0%, no risk, to 100%, extreme risk) and behavioural intention (measured on a 7-point Likert scale) were recorded using a validated, self-administered questionnaire. Descriptive statistics and non-parametric Wilcoxon signed-rank tests were performed using sas statistical software (v 9.2) at a priori significance level of 0.05. RESULTS AND DISCUSSION: Majority of participants (74.4%) were not aware of the new warnings; however, majority (67.8%) had prior knowledge of the risk. The mean risk perception score for the new warning label was found to be significantly higher (72.2% vs. 65.9%, P < 0.0001) than the old warning label. Similarly, the average intention score for the new warning label was significantly higher (5.06 vs. 4.86, P < 0.0001) than the old warning label. WHAT IS NEW AND CONCLUSION: The new warning label mandated by FDA is effective in improving consumer risk perception of potential liver damage and may encourage protective behaviour. However, future studies are essential to assess the impact of the new label on actual changes in consumer behaviour and subsequent reduction in acetaminophen-related morbidity and mortality.

Consumer involvement: effects on information processing from over-the-counter medication labels.

The objective of this study was to evaluate the effects of consumer involvement on information processing from over-the-counter (OTC) medication labels. A sample of 256 students evaluated simulated OTC product labels for two product categories (headache and cold) in random order. Each participant evaluated labels after reading a scenario to simulate high and low involvement respectively. A questionnaire was used to collect data on variables such as label comprehension, attitude-towards-product label, product evaluation, and purchase intention. The results indicate that when consumers are involved in their purchase of OTC medications they are significantly more likely to understand information from the label and evaluate it accordingly. However, involvement does not affect attitude-towards-product label nor does it enhance purchase intention.

Accuracy of information on printed over-the-counter drug advertisements.

Direct-to-consumer drug advertising is a useful medium for educating people and disseminating product information. Consumers make product purchase decisions based on the information gained from advertisements. If advertisements are misleading, consumers may not have adequate drug knowledge to detect this misinformation. The objective of this study was to evaluate print advertisements for over-the-counter (OTC) products. Five clinical pharmacists evaluated print advertisements appearing in three consumer periodicals. Advertisements were selected over a nine month period beginning January 1994. Accuracy of information on OTC advertisements was determined based on federal guidelines. Additionally, reviewers identified deficiencies in advertisements that may mislead consumers. According to reviewers, around 50% of advertisements lacked accurate statements. Side effects were indicated on only one advertisement. All advertisements were indicated by reviewers to be more promotional than educational. Reviewers indicated that more than 50% of advertisements lacked information essential for consumers to make an informed choice during self-medication decisions. This study indicates that OTC drug advertisements lack information necessary for consumers to make informed purchase decisions. Inaccurate information and lack of information on side effects could mislead consumers causing harmful adverse events.

Readability of over-the-counter medication labels.

OBJECTIVE: This study evaluated information on over-the-counter (OTC) medication labels. Brand-name OTC products were examined to determine compliance with the Label Readability Guidelines recommended by the Nonprescription Drug Manufacturers Association (NDMA). Additionally, the use of pictures on OTC medication labels was assessed. The effect of pictures on other aspects of label design that may affect comprehension was also evaluated. DESIGN: We evaluated 100 OTC medication labels (20 analgesics and 80 cold/cough products). Assessment of label content was based on certain aspects of label design, such as package size, font size of written information, format of information on warnings and indications, use of pictures, and use of advertising claims on product labels. RESULTS: Many products evaluated did not meet NDMA guidelines. Even when font size of product name increased with increase in package size, font size on warnings and indications remained constant at 6 points. Lack of boldface (63%), use of all uppercase font (30%), use of hyphenation (49%), lack of paragraph breaks (19%), and the small font size of 6 points or less (98%) could reduce readability. Packages containing pictures were significantly larger than packages without pictures. Several packages (30%) contained pictures in the indications section. Many products contained advertising claims that were classified as "green" or "quality" (41%) and "free" (38%). Additionally, 43 different advertising claims were identified; some of these may be difficult for patients to interpret. CONCLUSIONS: The findings may help FDA develop specific regulations to improve label readability. Pharmacists who recommend OTC products to consumers should be aware of these issues and evaluate requests by consumers regarding OTC drugs accordingly.

An investigative model evaluating how consumers process pictorial information on nonprescription medication labels.

Currently, marketed over-the-counter (OTC) medication labels were simulated and tested in a controlled environment to understand consumer evaluation of OTC label information. Two factors, consumers' age (younger and older adults) and label designs (picture-only, verbal-only, congruent picture-verbal, and noncongruent picture-verbal) were controlled and tested to evaluate consumer information processing. The effects exerted by the independent variables, namely, comprehension of label information (understanding) and product evaluations (satisfaction, certainty, and perceived confusion) were evaluated on the dependent variable purchase intention. Intention measured as purchase recommendation was significantly related to product evaluations and affected by the factor label design. Participants' level of perceived confusion was more important than actual understanding of information on OTC medication labels. A Label Evaluation Process Model was developed which could be used for future testing of OTC medication labels.

How the elderly and young adults differ in the decision making process of nonprescription medication purchases.

The study compared elderly and young adults in their behavior and involvement in the decision making process of over-the-counter (OTC) medication purchases. Elderly subjects were more involved in the decision making process to purchase OTC medications compared to young adults. The elderly not only purchase and spend more money on medications but also read OTC labels completely. They requested help from the pharmacist more frequently than young adults. Needs of the elderly in making an OTC medication purchase were different compared to young adults. The two age groups differed on importance rating for several attributes regarding OTC medications, such as; ease of opening the package, child resistant package, side effects of medicine, manufacturer of medicine, print size on package labels, and greater choice of medicine.