This article was downloaded by: [University of California-Irvine ]On: 03 April 2012, At: 07:33Publisher: RoutledgeInforma Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House,37-41 Mortimer Street, London W1T 3JH, UK

Health CommunicationPublication details, including instructions for authors and subscription information:http://www.tandfonline.com/loi/hhth20

The Influence of Need for Cognition and PrincipalDisplay Panel Factors on Over-the-Counter Drug FactsLabel ComprehensionJesse R. Catlin a , Cornelia Pechmann a & Eric P. Brass b ca The Paul Merage School of Business, University of California, Irvine, USAb David Geffen School of Medicine at UCLAc Harbor-UCLA Medical Center

Available online: 07 Sep 2011

To cite this article: Jesse R. Catlin, Cornelia Pechmann & Eric P. Brass (2012): The Influence of Need for Cognition andPrincipal Display Panel Factors on Over-the-Counter Drug Facts Label Comprehension, Health Communication, 27:3, 264-272

To link to this article: http://dx.doi.org/10.1080/10410236.2011.578335

PLEASE SCROLL DOWN FOR ARTICLE

Full terms and conditions of use: http://www.tandfonline.com/page/terms-and-conditions

This article may be used for research, teaching, and private study purposes. Any substantial or systematicreproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form toanyone is expressly forbidden.

The publisher does not give any warranty express or implied or make any representation that the contentswill be complete or accurate or up to date. The accuracy of any instructions, formulae, and drug doses shouldbe independently verified with primary sources. The publisher shall not be liable for any loss, actions, claims,proceedings, demand, or costs or damages whatsoever or howsoever caused arising directly or indirectly inconnection with or arising out of the use of this material.

Health Communication, 27: 264–272, 2012Copyright © Taylor & Francis Group, LLCISSN: 1041-0236 print / 1532-7027 onlineDOI: 10.1080/10410236.2011.578335

The Influence of Need for Cognition and Principal DisplayPanel Factors on Over-the-Counter Drug Facts

Label Comprehension

Jesse R. Catlin and Cornelia PechmannThe Paul Merage School of Business

University of California, Irvine

Eric P. BrassDavid Geffen School of Medicine at UCLA and

Harbor-UCLA Medical Center

Nearly all work aimed at optimizing the ability of labeling to communicate over-the-counter(OTC) drug information has focused on back-of-the-package characteristics, such as the DrugFacts label. The effects of front of the package, or principal display panel (PDP) factors, havelargely been neglected by researchers. Similarly, heterogeneity in consumers’ approach to newinformation has received scant attention in the context of OTC drugs. This preliminary studytested the hypothesis that display of a drug’s brand name on the PDP and individuals’ needfor cognition influence comprehension of Drug Facts label information. University students(n = 212) that had experienced heartburn but not used the drug class being studied constitutedthe primary analysis cohort. Students were randomly assigned to review one of two PDPs(brand name or generic), followed by a Drug Facts label and a series of questions related toselection and usage of the drug. Participants with low need for cognition were influenced bythe brand name PDP, as those exposed to a PDP featuring a brand (vs. generic) spent less timereading the Drug Facts label and demonstrated lower comprehension of the label informationon proper drug selection. These findings suggest that further research is needed to understandthe impact of PDP contents and cognitive characteristics of consumers on the communicationof OTC drug information. Health care providers should consider communication strategiesthat account for the challenges patients face in using OTC drugs properly.

Drug labels are the primary means of communication withconsumers in the over-the-counter (OTC) drug market andthus play a vital role in ensuring safe medication usage.Today, more than 700 OTC products contain active ingre-dients or dosages that were previously available only by pre-scription (Consumer Healthcare Product Association, 2001).The increasing number and complexity of drugs under con-sideration for OTC approval make it imperative to betterunderstand how to effectively communicate health informa-tion via OTC labeling (Hong et al. 2005). This informationincludes not only directions for use, but information on who

Correspondence should be addressed to Jesse R. Catlin, The PaulMerage School of Business, University of California, Irvine, CA 92697-3125. E-mail: jcatlin@uci.edu

should and should not use the drug as well as warningsto consumers as to when additional medical care may beneeded.

Before a drug can be switched from prescription to OTCstatus, the manufacturer must demonstrate to the Food andDrug Administration (FDA) that consumers can use the druglabel to determine whether the drug is appropriate for themand subsequently use the product as directed (Brass, 2001;Brass & Weintraub, 2003; Harrington & Sheppard, 2002;Nguyen, Cook, & Bero, 2006). In partial fulfillment of thisrequirement, drug manufacturers conduct empirical studiesto assess label comprehension. Though used to make regula-tory decisions by the Food and Drug Administration, scien-tific design of label comprehension and self-selection studiesappears to be a recent phenomenon (Brass & Weintraub,

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

NEED FOR COGNITION AND PDP INFLUENCE COMPREHENSION 265

2003; Leonard-Segal et al., 2009) and the study data arenot routinely made publicly available (Morris, Lechter,Weintraub, & Bowen, 1998). Consequently, public knowl-edge of study results is limited to those presented at publicmeetings or published in medical journals (e.g., Brass, 2004;Brass et al., 2008; Raymond, Dalebout, & Camp, 2002;Schwartz, Bansal, Hale, Rossi, & Engle, 2008). Thus, ourinsights into the influences on label communication acrossthe diverse population and strategies for improvement arelimited.

Historically, research and policy efforts have focused onoptimizing the presentation of detailed drug information onthe back of the package. For example, to standardize detailedinformation on the back of the package, the FDA devel-oped the Drug Facts label, which is currently mandatoryfor all OTC drug products (OTC Drug Facts Label, 2009).Meanwhile, the front of the retail package labeling, com-monly referred to as the principal display panel (PDP), hasreceived substantially less attention, and restrictions on thisaspect of labeling are far fewer than for the Drug Factslabel on the back of the package (Labeling Requirements forOver-the-Counter Devices, 2009). The perceived importanceof the PDP as a communication tool is increasingly evidentthrough recent FDA policies mandating that certain classesof OTC medicines include additional information (e.g.,active ingredient names) on the front of the package (Organ-Specific Warnings, 2009). However, to date, there has beenalmost no empirical research designed to systematicallyinvestigate the ways in which PDP information (e.g., brandnames) may impact consumer comprehension of OTC druginformation.

Under current policy, once a particular drug type hasbeen approved for OTC use and any exclusive sales periodsgranted by the FDA have lapsed, generic and other manufac-turers of pharmacologically equivalent versions of the drugcan bring their products to market without conducting labelcomprehension studies. While the Drug Facts labels on theback of the packages may contain similar information, thePDPs of these generic or store-branded products will likelycontain different branding, logos, and other information.

Health literacy is recognized to influence consumercomprehension of Drug Facts information and the FDArequests that sponsors recruit participants with varyinglevels of literacy when conducting label comprehensionstudies to ensure that comprehension is adequate in thissubgroup. However, little research has considered otherindividual-level trait variables that may affect how bothhigh- and low-literacy individuals acquire drug labelinformation.

To begin addressing these deficiencies in our understand-ing of communication to OTC consumers, an exploratorystudy was conducted to test the hypothesis that PDP fac-tors (e.g., brands) and individual differences (e.g., needfor cognition) influence consumer comprehension of labelinformation.

CONCEPTUAL FRAMEWORK

A variety of studies have explored pharmaceutical labelingissues including design factors such as print size (Wolf et al.,2010), organization of information and language (Wolf et al.,2007), the impact of low literacy (Davis et al., 2006), andeven perceived label importance (Hanoch, Katsikopoulos,Gummerum, & Brass, 2007). However, aside from a fewstudies, the impacts of PDP factors such as branding haverarely been considered with respect to OTC pharmaceuticals.Among this limited work is an eye-tracking study showingthat consumers spend more time looking at brand names thanat warnings (Bix, Bello, Auras, Ranger, & Lapinski, 2009).Another study highlighting the importance of PDP factorsfound that many parents inappropriately suggested a drugfor a child under 2 years of age when the PDP containedgraphics associated with infants (e.g., teddy bears) (Lokkeret al., 2009). Much of the academic literature on brands andOTC drugs has concentrated on the effects of advertisingon product category demand (e.g., Ling, Berndt, & Kyle,2002); little attention has been given to how brand informa-tion affects consumer processing of other drug information.However, in making predictions about how the presence ofa brand may impact processing of label information, it isuseful to consider previous research on branding in generalconsumer contexts.

Branding

A wealth of literature exists that highlights the impor-tance of branding in general consumer purchase decisions.Comparing a variety of marketing mix variables such asbrand, price, and retailer reputation, Dawar and Parker(1994) found brand to be the most important signal usedby consumers to evaluate product quality. Moreover, a studyby Maheswaran, Mackie, and Chaiken (1992) used theheuristic-systematic processing model and found that brand-ing can be used by consumers as a heuristic cue to simplifydecision making. Given these previous findings, we examinewhether the presence of a popular brand may function as aheuristic cue that consumers use to infer product attributesand limit Drug Facts label search.

Need for Cognition

Need for cognition is defined as “the tendency for an indi-vidual to engage in and enjoy thinking” (Cacioppo & Petty,1982, p. 119). Individuals with high need for cognitionare found to evaluate information in a more effortful man-ner, rather than rely on heuristic cues such as branding(Cacioppo, Petty, & Morris, 1983). A study by Schmidt andSpreng (1996) builds on this by proposing that consumerswith high need for cognition exhibit increased motivation tosearch for product information. Moreover, individuals withlow need for cognition have been shown to use cognitive

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

266 CATLIN, PECHMANN, AND BRASS

shortcuts or heuristics when evaluating products (Haugtvedt,Petty, & Cacioppo, 1992; Verplanken, 1993). Combinedwith prior work suggesting the differing effectiveness ofhealth messages depending on level of need for cogni-tion (e.g., Williams-Piehota, Schneider, Pizarro, Mowad,& Salovey, 2003; Williams-Piehota, Silvera, Mowad, &Salovey, 2006), it seems reasonable that consumers’ needfor cognition levels may influence ability to acquire DrugFacts label information and could impact the degree to whichthey are influenced by PDP characteristics such as brand-ing. Need for cognition is a commonly used variable instudies of student populations and it has been shown to sig-nificantly affect their processing of other health messages(Cacioppo, Petty, Feinstein, & Jarvis, 1996), so it seemsimportant to consider the impact of need for cognition inlabel comprehension studies.

In the following study, we study the impacts of brandingand need for cognition on consumer attention to, and com-prehension of, Drug Facts label information. We hypothesizethat participants with low need for cognition will be influ-enced more by PDP characteristics, specifically brands, thanthose with high need for cognition.

METHOD

A two-factor (brand vs. generic) between-subjects designwas used to assess the potential effect of branding onlabel comprehension. Need for cognition was measured afterparticipants completed the comprehension tasks.

Participants

Participants were undergraduate university students whoreceived course credit for participating (n=614). The OTCdrug was a heartburn remedy. To identify a cohort mostclosely mimicking an OTC-purchase group, a primary analy-sis cohort (n=212) was identified as those participants witha history of heartburn but no prior use of the branded testdrug, Prilosec OTC.1 Fifteen participants had previouslyused Prilosec OTC and were excluded from the primaryanalysis cohort on this basis.

Materials and procedure. The study was web-basedand used PDP images based on the label of the chronic heart-burn reliever, Prilosec OTC. The branded condition featuredthe retail PDP for Prilosec OTC, while the generic condi-tion featured the same PDP image but with the brand namereplaced with the drug’s commonly used generic name,omeprazole (see Figure 1). The same Drug Facts label, taken

1All analyses that are reported here are based on the primary analysiscohort, but analyses of the secondary cohort are available upon request fromthe authors.

FIGURE 1 Example of a branded principal display panel (PDP).

directly from the retail Prilosec OTC package, was used forboth conditions (see Figure 2).

This research was approved by the university’s institu-tional review board and participants were recruited from theuniversity’s human subject pool. Potential participants weredirected to a website indicating they would be participatingin a study about consumer perceptions of pharmaceuticalpackage labels. A link was provided for participants whodesired, before starting, to complete the study later. Thewebsite was configured such that participants completed thequestionnaire in an uninterrupted session (i.e., no savingand resuming). Individuals consenting to participate weredirected to an instructions page indicating that they wouldbe exposed to a series of product label images followed by aquestionnaire. They were told to review each label image foras long as they deemed necessary as if planning to purchaseand use the medication. Upon advancing to the next web-page, the participants were randomly exposed to one of thetwo PDP label images (Prilosec OTC or omeprazole). Whenparticipants felt they had reviewed the PDP label sufficiently,they could move on to the next page, containing the DrugFacts label. The pages following this image contained thequestionnaire items, including dependent measures of labelcomprehension, manipulation checks, the need for cognitionscale, and demographic questions.

One difference from most industry-sponsored label com-prehension studies was that participants did not have theability to refer back to the label images or previous ques-tions. This made it possible to more clearly isolate the impactthat the PDP label cues have on Drug Facts label infor-mation acquisition and comprehension, but also introducedsome effects of memory. Although memory has been linkedto comprehension and compliance (e.g., Berry, Michas, &Rosis 1998; Ley, 1988), the typical assumption is that con-sumers in real consumption situations will have full accessto labeling and therefore this access should not be impeded

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

NEED FOR COGNITION AND PDP INFLUENCE COMPREHENSION 267

FIGURE 2 Example of a drug facts label.

in comprehension tests. However, given research findings onthe prevalence of time-saving heuristic information process-ing (e.g., Chen & Chaiken, 1999) and the general character-ization of consumers as reducing cognitive effort wheneverpossible (e.g., Payne, 1982), it is also plausible that allowingconsumers to access the label during the questionnaire mayunduly prompt them to refer back to the label more than theywould otherwise and artificially inflate comprehension.

Measures

The four focal measures of interest in this study were: (1)Drug Facts label comprehension, (2) time spent readingthe Drug Facts label, (3) need for cognition, and (4) brandpopularity.

Drug Facts label comprehension. The Drug Factslabel comprehension-dependent measures were divided intotwo parts. The first involved participants’ understanding ofselection information, or whether a drug should be pur-chased and used for a particular condition. This was assessedusing a seven-item list of conditions and two hypotheti-cal scenarios. The list featured seven medical conditions,and participants were asked to indicate whether the med-ication was appropriate to treat each malady by choosingyes or no. Participants were also shown two hypotheticalscenarios that contained descriptions of a situation with adecision regarding drug selection, and were asked whether

the decision was correct (yes or no) based on the Drug Factslabel (Table 1). Blank answers were scored as incorrect. Thetotal number of correct answers to both sets of questions (outof nine) was used as the measure of selection informationcomprehension.

TABLE 1Items Used to Measure Comprehension of Selection Information

Condition ListBased on the package label, is this medication intended to be used to treat

the following conditions? (Yes/No)1. Stomach ulcers2. Chest pain3. Heartburn 2 or more times per week4. Stomach pain5. Nausea/vomiting6. Heartburn 1 time per week7. Irritable bowel syndrome

Hypothetical ScenariosBased on the package label, is this a correct way to use this medication?

(Yes/No)8. Alice has noticed that she always gets heartburn after once-weekly

dinners at an Italian restaurant with her husband. She purchases thismedication and now takes it the morning of the days she plans to eatat the Italian restaurant. She has not had heartburn since.

9. Sarah has had mild heartburn twice a week for quite some time(about 3 months), typically after eating spicy food. She purchases thisproduct to help and takes a pill a day for 2 weeks, after which shestops using the medication.

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

268 CATLIN, PECHMANN, AND BRASS

The second measure of label comprehension involvedparticipants’ understanding of usage information or how touse the drug once purchased. This included understandingof dosage directions, warnings related to when to stop using,etc. Usage information comprehension was assessed using12 hypothetical scenarios involving concepts such as thenumber of pills to take at a time and the length of time to takethe medication. Participants were asked to indicate whether,based on the Drug Facts label, they believed the scenariodescribed an appropriate use of the medication (yes or no).Questions were balanced with an equal number of correctyes and no answers and were presented one-by-one in ran-dom order. The number of correct answers (out of 12) wasused as the measure of usage information comprehension.

Time spent reading Drug Facts label. The timeparticipants spent on the page containing the Drug Factslabel image was measured as a proxy for attention to theDrug Facts label. Although some individuals may read morerapidly than others, research shows that time spent readingand comprehension of detailed information are correlated(Just, Carpenter, & Woolley, 1982). Preliminary examinationof the data did not reveal any extreme values, but to limit theinfluence of outliers and unequal variance, the natural loga-rithm of the number of seconds spent on the page containingthe Drug Facts label image was used as the dependent mea-sure in the analysis (Keene, 1995). Note that the mean timespent reading the Drug Facts label (M = 79.84 seconds) andthe good comprehension scores reported later in this arti-cle indicate that participants were sufficiently engaged in thestudy task.

Need for cognition. Need for cognition was measuredusing Cacioppo, Petty, and Kao’s (1984) 18-item, 7-pointLikert scale (1 = strongly disagree and 7 = strongly agree)featuring statements concerning cognitive activity prefer-ences (e.g., “I only think as hard as I have to”). Items weresummed and a median split was used to create the high andlow need for cognition groups (! = .86).

Brand popularity. To measure the degree to which thebrand manipulation was successful, we used Mishra, Umesh,and Stem’s (1993) four-item, 7-point semantic differentialscale measuring the perceived popularity of a particularbrand. Items were summed (! = .93).

RESULTS

Two-way omnibus analyses of variance (ANOVAs) wereconducted to test the effects of branding and need for cog-nition on each of the dependent measures.2 If the two-way

2Based on prior research suggesting the importance of consumer knowl-edge in product evaluation (e.g., Alba & Hutchinson, 1987), participants’self-rated knowledge of OTC medications was measured. Inclusion of this

interaction was significant, follow-up pairwise comparisonsor t-tests were adjusted using the Dunn–Sidak method tomaintain a type I error rate of .05. In addition, for signifi-cant results, effect sizes were calculated based on the pointbiserial correlation coefficient, also referred to as the propor-tion of explained variance (r2

pbs) (Sawyer & Ball, 1981). Theeffect sizes ranged from 2% to 8% (or “small” to “medium”),which is common for behavioral science research (Cohen,1977; Sawyer & Ball, 1981).

The primary analysis cohort consisted of 212 participantswho indicated a history of heartburn, but no prior use ofthe brand. This cohort was young and Asians and femaleswere overrepresented, but there were no significant differ-ences between the primary analysis cohort and the otherparticipants in terms of gender ("2(1, N = 614) = 1.18,p = .278), ethnicity ("2(4, N = 614) = 7.20, p = .126), orneed for cognition level (t(612) = 1.53, p = .126).3 Hence,the primary analysis cohort seems to be representative of theoverall sample.

Manipulation Check

A two-way omnibus ANOVA with the brand popularityscore as the dependent variable revealed that the PrilosecOTC (branded) PDP scored higher (M = 21.29, SD = 5.19)on the popularity scale than the omeprazole (generic) PDP(M = 18.48, SD = 4.71), F(1, 208) = 16.54, p < .001,r2

pbs = 8%, which is consistent with the effect of previousexposure of the cohort to the branded drug. Though the sizeof this effect can be classified as “medium” (Sawyer & Ball,1981), this is reasonable since participants in the primaryanalysis cohort had not previously used the brand and theonly difference in the PDP packaging was the brand name(i.e., the colors, fonts, etc. remained the same).

Time Spent Reading Drug Facts Label

Results from a two-way ANOVA indicated a main effect forneed for cognition. Participants with low need for cognitionspent less time reading the label (M = 4.20, SD = .98, in logseconds) than those with high need for cognition (M = 4.56,SD = .67), F(1, 208) = 10.82, p = .001, r2

pbs = 4%. Themain effect for brand was also significant, with participantsexposed to the branded PDP spending less time reading theDrug Facts label (M = 4.26, SD = .93) than those exposedto the generic, F(1, 208) = 4.67, p = .032, r2

pbs = 2%.There was also a significant interaction between the brandand need for cognition factors, F(1, 208) = 8.03, p = .005.The decrease in time spent reading the Drug Facts label forthe PDP featuring a brand only occurred among participants

variable did not significantly influence results, so we report the ANOVAresults without the covariate for simplicity.

3A full summary of participant demographic information is availableupon request from the corresponding author.

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

NEED FOR COGNITION AND PDP INFLUENCE COMPREHENSION 269

with low need for cognition, such that those exposed to thebranded PDP spent less time reading the label (M = 3.90,SD = .99) than those exposed to the generic PDP (M = 4.47,SD = .89), t(99) = !3.58, p < .001, r2

pbs = 8%.

Comprehension of Selection Information

Consistent with the results for time spent reading the DrugFacts label, a two-way ANOVA yielded a main effect ofneed for cognition, F(1, 208) = 6.50, p = .012, r2

pbs = 3%,such that participants with low need for cognition exhibiteddecreased levels of selection information comprehension(M = 8.10, SD = .97) compared to those with high needfor cognition (M = 7.69, SD = 1.43; maximum score = 9).The main effect for brand was nonsignificant, F(1, 208) =2.15, p = .145. A significant brand by need for cognitioninteraction, F(1, 208) = 4.38, p = .038, and pairwise testsshow that the effect of the branded PDP is significant onlyamong low need for cognition participants, t(107) = 2.54,p = .012, r2

pbs = 4%. Low need for cognition participants inthe brand condition performed significantly worse on ques-tions about selection information (M = 7.37, SD = 1.56)compared to those in the generic condition (M = 7.96, SD =1.24). There was no significant effect for brand among highneed for cognition participants on these questions.

Further consideration of the individual questions used tocreate the composite measure of comprehension of selectioninformation demonstrated that some of the more difficultor nuanced questions were more discriminating in termsof identifying differences in comprehension across groups.For instance, the largest difference can be seen in the caseof the question about whether the drug should be used forheartburn that occurs one time per week (selection informa-tion question 6; see Table 1). Note that the stimulus drugis only indicated for chronic heartburn occurring two ormore times per week. Among participants with low needfor cognition there was a sizeable difference, with 61% cor-rect in the brand versus 79% correct in the generic condition("2(1, N = 108) = 4.26, p = .039). Questions that wereless effective in identifying comprehension differences wereeasier to answer, e.g., whether the drug should be used totreat nausea/vomiting (selection information question 5; seeTable 1). Among participants with low need for cognitionthere was no statistical difference between groups for thisnausea-related question, with 94% in the brand conditionversus 93% in the generic condition answering this questioncorrectly (p = 1.000, Fisher’s exact test).

Mediation analysis. Using the method suggested byBaron and Kenny (1986), we tested whether the effects ofbranding and need for cognition on comprehension of selec-tion information were mediated by the time spent readingthe Drug Facts label. For mediation to occur, three con-ditions must be satisfied. First, the independent variables

(branding and need for cognition) must affect the media-tor (time spent reading the Drug Facts label). Second, themediator must have an impact on the dependent variable(comprehension of selection information). Third, effects ofthe independent variables on the dependent variable must bediminished when the mediator is included as a covariate inthe full model (Baron & Kenny, 1986). The first requirementwas met by the previously presented significant interactiveeffect of brand and need for cognition on time spent readingthe Drug Facts label. Condition two was satisfied by a sig-nificant effect of time spent reading the Drug Facts label oncomprehension of selection information, F(1, 210) = 20.48,p < .001. The final condition was met by the nonsignificantbrand by need for cognition interaction in a model includingtime spent reading the Drug Facts label, F(1, 207) = 2.02,p = .157. Taken together, it appears that the effects of brandand need for cognition on comprehension of selection infor-mation manifest through differences in time spent readingthe Drug Facts label.

Comprehension of Usage Information

For the label comprehension measure involving usage infor-mation, the main effect for the brand was not significant,F(1, 208) = 0.49, p = .485, while there was a signifi-cant main effect of need for cognition, F(1, 208) = 11.67,p = .001, r2

pbs = 5%. Participants with high need forcognition consistently performed better (M = 9.06, SD =1.75) than those with low need for cognition (M = 8.22,SD = 1.85; maximum score = 12). However, there weretwo relatively difficult questions that exhibited consistentresults with the selection information, including the questionregarding whether the medication should be crushed prior toadministration (usage information question 3; see Table 2)and whether an individual taking anxiety medication neededto consult a doctor prior to use (usage information question8; see Table 2). In the first question about tablet admin-istration, 67% of participants with low need for cognitionin the brand condition versus 93% in the generic conditionanswered this question correctly ("2(1, N = 108) = 11.90,p = .001). For the second question regarding doctor con-sultation, 71% of participants with low need for cognitionin the brand condition versus 88% in the generic conditionanswered this question correctly ("2(1, N = 108) = 4.87,p = .027).

DISCUSSION

The current results are consistent with the hypothesis thatPDP characteristics, such as branding, and trait variables,such as need for cognition, can impact attention to and com-prehension of Drug Facts label information. Lower levelsof need for cognition were associated with less time spentreading the Drug Facts label and lower comprehension of all

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

270 CATLIN, PECHMANN, AND BRASS

TABLE 2Items Used to Measure Comprehension of Usage Information

Hypothetical ScenariosBased on the package label, is this a correct way to use this medication?

(Yes/No)1. Dave uses this product to treat frequent heartburn by taking 1 pill a

day for 14 days. Two months later, he begins having frequentheartburn again so he again takes 1 pill a day for 14 days.

2. After a month of experiencing heartburn 4 times per week, Bobdecides to use this medication. He takes 1 pill a day for 3 days andhis heartburn is gone. Despite the relief, he continues taking a singlepill each day for 11 days.

3. Gina is helping her 80-year-old grandmother who often has frequentheartburn. Because her grandmother has difficulty taking pills, Ginacrushed one tablet of this medication and gave it to her grandmotherwith a glass of water every day for two weeks.

4. Julie has taken this medication for one week. Even though previousmedications she used to treat her heartburn required chewing thetablets before swallowing, she does not like the taste of thismedication and so she swallows a tablet whole once a day. She plansto do this for another 7 days.

5. Tom has been taking this medication every morning for five days totreat his frequent heartburn. Monday morning he was running late forwork and forgot to take a pill. Tuesday morning he takes 2 pills tomake up for the missed dose.

6. Jim recently purchased this medication at a local pharmacy to treatthe heartburn he was experiencing several times a week during thepast month. Even though he never eats breakfast, he takes a single pillin the morning with a cup of water and will continue this for twoweeks.

7. Brad, who has frequently experienced heartburn over the past month,takes this product for 1 day and feels a little better but still hasheartburn. He decides to contact his doctor.

8. James, who takes diazepam (a medication that helps control hisanxiety) and suffers from frequent heartburn, thinks this heartburnmedication will help him. He purchases this heartburn medication,but decides to contact his doctor prior to use.

9. Janet, who has been very uncomfortable due to heartburn many timesin the past month or so, purchases this product. Because she normallygets heartburn after dinner, she takes one pill each night before goingto bed for two weeks.

10. Amanda has recently started eating healthier and working out. Shehas lost 10 pounds over the course of a month. She has experiencedfrequent heartburn for a few weeks and so she purchases thismedication. For the next 14 days, she takes 1 pill and drinks a bottleof water on her way to the gym each morning.

11. Diana has suffered from frequent heartburn recently, especially aftermeals. She used this medication for a couple of weeks about a yearago and it helped her feel much better. Her wedding is tonight andshe wants to be sure she is not uncomfortable so she just takes 1 pillbefore breakfast and she will do the same for 13 more days.

12. Many members of Brandon’s family have experienced issues withheartburn. At the suggestion of a doctor, Brandon’s brother took thismedication at a dose of 2 pills per day for two weeks and says hefeels much better. Based on his experience, Brandon’s brother advisesBrandon to take 2 pills in the morning each day for two weeks.

types of Drug Facts information. Further, among participantswith low need for cognition, the presence of a brand nameon the PDP (vs. generic) resulted in less time spent read-ing the Drug Facts label, which led to lower comprehensionof information, particularly related to appropriate selection

of the drug (i.e., whether the drug should be purchasedto treat a particular condition). In general, comprehensionwas impeded for the more difficult questions regarding drugselection and use. As the complexity of drugs submitted forOTC approval increases, some of the more difficult ques-tions may be of higher clinical concern due to the higherlikelihood of consumer confusion and error. Therefore, labelcomprehension questions probably should not be weightedequally by the FDA (Brass, Shay, & Leonard-Segal, 2009).

These results complement research on health literacydemonstrating an impact on a wide variety of outcomes,including comprehension of prescription and OTC drugwarnings (Davis et al., 2006). In line with previous research(e.g., Williams-Piehota et al., 2003, 2006), the current worksuggests a broader range of individual differences (e.g., needfor cognition) that may influence the effectiveness of healthcare communication strategies, even among high literacypopulations.

When evaluating these findings, it is important to con-sider the sample population: young, highly educated uni-versity students. Based on past studies (Cacioppo, Petty,Feinstein, & Jarvis, 1996), it is likely that the general level ofneed for cognition in our sample was higher than in the gen-eral population. Therefore, the findings of this study could beconservative in that effect sizes could be more pronounced ifparticipants are drawn from the general population. Further,our manipulation check reveals a relatively modest percep-tion of strength for the brand we used, so it is possible thateffects would be stronger for more well-known brands.

Limitations

This study may not have realistically simulated an OTCpurchase or use situation and could have been seen by par-ticipants as a low-stakes task or artificial context. The cohortof university students was one of convenience and is notrepresentative of the OTC consumer population. As uni-versity students have been shown to exhibit relatively lowinvolvement with OTC products (Sansgiry & Cady, 1996),we constrained the primary analysis cohort to participantswho had previously experienced heartburn and thereforeshould have found the heartburn drug label more personallyrelevant. While the time spent in label review and the overallhigh levels of comprehension support that the students wereengaged participants, their degree of motivation may affectwhether the results are generalizable.

To prevent undue cued scrutiny of the label, participantswere not permitted to return to the label while answeringthe questions. This may limit the applicability of the resultsto other contexts, as it is no longer a pure comprehensionexercise but also includes a memory component. However,given other research suggesting the importance of memoryin comprehension and compliance (e.g., Berry, Michas, &Rosis 1998; Ley, 1988), a fruitful opportunity for futureresearch may be to further examine how consumers rely on

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

NEED FOR COGNITION AND PDP INFLUENCE COMPREHENSION 271

memory (vs. referring to the label multiple times) in usingOTC medications.

Lastly, our comprehension questions were adapted fromand similar to those used in industry-sponsored label com-prehension studies, but other questions might have produceddifferent results. Further, we did not assess actual medica-tion use, so it is unclear whether the effects we observed forcomprehension would manifest behaviorally.

Implications

These findings demonstrate that PDP factors such as brandmay influence label comprehension in ways not previouslyexplicitly considered by the FDA or researchers. Moreover,the construct of need for cognition is identified as a factorthat impacts comprehension level on its own and may alsoinfluence the degree to which PDP characteristics have aneffect on Drug Facts label comprehension. These prelimi-nary results suggest the potential value of additional researchinto how PDP characteristics affect consumers’ perceptionsand comprehension.

While the FDA currently recognizes low literacy as animportant determinant of label comprehension and sug-gests that label comprehension studies include low-literacyconsumers (FDA, 2010), the present study suggests theimportance of further research on how other individual dif-ference variables such as need for cognition may impactlabel comprehension. Integration of these types of individualdifference variables into industry label comprehension stud-ies can help pharmaceutical manufacturers design packagingthat helps improve consumer comprehension and mitigatesthe use of heuristics that lower comprehension.

The results also raise the possible need to consider thestatus of brand at the time of application for prescriptionto OTC switch, as well as the brand’s potential develop-ment post-approval. For instance, a brand that is relativelyunknown to consumers at the time of switch application(and label comprehension study) may make significant gainsin brand popularity once on the market, thus enhancing itsperceived validity as a heuristic cue in consumer decision-making. In fact, previous research has indicated that mostdrug switches are accompanied by significant amounts ofadvertising to help increase awareness and differentiatebrands from competitors (Macheca 2006). If comprehensionestimates are obtained from label comprehension studiesconducted prior to these gains in brand strength, compre-hension may be overestimated compared to after the drughas been on the market for an extended period.

Lastly, for health care providers who recommend OTCdrugs to patients, the study highlights the possibility that theinstructions given should go beyond simply recommendingthe drug and assuming the label will provide all the rest ofthe information. Provision of more detailed information orinstructions may be beneficial to patients in some cases. Inparticular, to mitigate the adverse impact of PDP factors such

as branding, it may be useful to specifically communicatedifficult label information to patients.

REFERENCES

Alba, J. W., & Hutchinson, J. W. (1987). Dimensions of consumer expertise.Journal of Consumer Research, 13, 411–454. doi: 10.1086/209080

Baron, R. M., & Kenny, D. A. (1986). The moderator-mediator variabledistinction in social psychological research: Conceptual, strategic, andstatistical considerations. Journal of Personality and Social Psychology,51, 1173–1182. doi: 10.1037/0022-3514.51.6.1173

Berry, D. C., Michas, I. C., & de Rosis, F. (1998). Evaluating explanationsabout drug prescriptions: Effects of varying the nature of informationabout side effects and its relative position in explanations. Psychologyand Health, 13, 767–784. doi: 10.1080/08870449808407431

Bix, L., Bello, N. M., Auras, R., Ranger, J., & Lapinski, M. K. (2009).Examining the conspicuousness and prominence of two required warn-ings on OTC pain relievers. Proceedings of the National Academyof Sciences of the United States of America, 106, 6550–6555.doi:10.1073/pnas.0810665106

Brass, E. P., Shay, L., & Leonard-Segal, A. (2009). Analysis of mul-tiple end points in consumer research in support of switching drugsfrom prescription to over-the-counter status: The concept of end-point hierarchies. Clinical Pharmacology & Therapeutics, 85, 369–374.doi:10.1038/clpt.2008.254

Brass, E. P. (2001). Changing the status of drugs from prescription to over-the-counter availability. New England Journal of Medicine, 345, 810–816. doi: 10.1056/NEJMra011080

Brass, E. P. (2004). Consumer behavior in the setting of over-the-counter statin availability: Lessons from the consumer use studyof OTC Mevacor. American Journal of Cardiology, 94, 22–29.doi:10.1016/j.amjcard.2004.07.051

Brass, E. P., Vassil, T., Replogle, A., Hwang, P., Rusche, S., Shiffman, S.,& Levine, J. G. (2008). Can consumers self-select for appropriate use ofan over-the-counter statin? The self evaluation of Lovastatin to enhancecholesterol treatment study. American Journal of Cardiology, 101, 1448–1455. doi: 10.1016/j.amjcard.2008.01.020

Brass, E. P., & Weintraub, M. (2003). Label development and the label com-prehension study for over-the-counter drugs. Clinical Pharmacology &Therapeutics, 74, 406–412. doi: 10.1016/S0009-9236(03)00239-X

Cacioppo, J. T., & Petty, R. E. (1982). The need for cognition. Journalof Personality and Social Psychology. 42, 116–131. doi: 10.1037/0022-3514.42.1.116

Cacioppo, J. T., Petty, R. E., Feinstein, J. A., & Jarvis, W. B. G. (1996).Dispositional differences in cognitive motivation: The life and times ofindividuals varying in need for cognition. Psychological Bulletin, 119,197–253. doi: 10.1037/0033-2909.119.2.197

Cacioppo, J. T., Petty, R. E., & Morris, K. J. (1983). Effects of needfor cognition on message evaluation, recall, and persuasion. Journal ofPersonality and Social Psychology, 45, 805–818. doi: 10.1037/0022-3514.45.4.805

Cacioppo, J. T., Petty, R. E., & Kao, C. F. (1984). The efficient assessmentof need for cognition. Journal of Personality Assessment, 48, 306–307.doi:10.1207/s15327752jpa4803_13

Chen, S., & Chaiken, S. (1999). The heuristic-systematic model in itsbroader context. In S. Chaiken & Y. Trope (Eds.), Dual process theoriesin social psychology (pp. 73–96). New York: Guilford Press.

Cohen, J. (1977). Statistical power analysis for the behavioral sciences.New York: Academic Press.

Consumer Healthcare Products Association. (2001) OTC facts andfigures. Retrieved from http://www.chpa-info.org/pressroom/otc_factsfigures.aspx

Davis, T. C., Wolf, M. S., Bass, P. F., Thompson, J. A., Tilson, H. H.,Neuberger, M., . . . Parker, R.M. (2006). Literacy and misunderstanding

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12

272 CATLIN, PECHMANN, AND BRASS

prescription drug labels. Annals of Internal Medicine, 145, 887–894.Retrieved from http://www.annals.org

Dawar, N., & Parker, P. (1994). Marketing universals: Consumers’ useof brand name, price, physical appearance, and retailer reputationas signals of product quality. Journal of Marketing, 58, 81–95. doi:10.2307/1252271

FDA Center for Drug Evaluation and Research. (2010). Guidance forindustry label comprehension studies for nonprescription drug prod-ucts. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Hanoch, Y., Katsikopoulos, K. V., Gummerum, M., & Brass, E. P. (2007).American and German students’ knowledge, perceptions, and behaviorswith respect to over-the-counter pain relievers. Health Psychology, 26,802–806. doi: 10.1037/0278-6133.26.6.802

Harrington, P., & Shepherd, M. D. (2002). Analysis of the movementof prescription drugs to over-the-counter status. Journal of ManagedCare Pharmacy, 8, 499–508. Retrieved from http://www.amcp.org/amcp.ark?c=jmcp&sc=archives

Haugtvedt, C. P., Petty, R. E., & Cacioppo, J. T. (1992). Need for cogni-tion and advertising: Understanding the role of personality variables inconsumer behavior. Journal of Consumer Psychology, 1, 239–260. doi:10.1016/S1057-7408(08)80038-1

Hong, S. H., Spadaro, D., West, D., & Tak, S. (2005). Patient valuationof pharmacist services for self care with OTC medications. Journal ofClinical Pharmacy and Therapeutics, 30, 193–199. doi: 10.1111/j.1365-2710.2005.00625.x

Just, M. A., Carpenter, P. A., & Woolley, J. D. (1982). Paradigms and pro-cesses in reading comprehension. Journal of Experimental Psychology:General, 111, 228–238. doi: 10.1037/0096-3445.111.2.228

Keene, O. N. (1995). The log transformation is special. Statistics inMedicine, 14, 811–819. doi: 10.1002/sim.4780140810

Labeling requirements for over-the-counter devices. (2009) 21 CFR pt.801.61-2. Available at: http://www.law.cornell.edu/cfr/

Leonard-Segal, A., Shay, L. E., Shetty, D., & Schiffenbauer, J. (2009).Unique role of consumer studies in nonprescription drug development.Journal of the American Pharmacists Association, 49, 670–673. doi:10.1331/JAPhA.2009.08068

Ley, P. (1988). Communicating with patients. London: Croom Held.Ling, D. C., Berndt, E. R., & Kyle, M. K. (2002). Deregulating direct-to-

consumer marketing of prescription drugs: Effects on prescription andover-the-counter product sales. Journal of Law & Economics, 45, 691–723. doi: 10.1086/368004

Lokker, N., Sanders, L., Perrin, E. M., Kumar, D., Finkle, J., Franco, V.,. . . Rothman, R.L. (2009). Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics, 123,1464–1471. doi: 10.1542/peds.2008-0854

Mahecha, L. A. (2006). Rx-to-OTC switches: Trends and factors under-lying success. Nature Reviews Drug Discovery, 5, 380–386. doi:10.1038/nrd2028

Maheswaran, D., Mackie, D. M., & Chaiken, S. (1992). Brand name as aheuristic cue: The effects of task importance and expectancy confirmationon consumer judgments. Journal of Consumer Psychology, 1, 317–336.doi: 10.1016/S1057-7408(08)80058-7

Mishra, S., Umesh, U. N., & Stem, D. E. (1993). Antecedents of the attrac-tion effect: An information-processing approach. Journal of MarketingResearch, 30, 331–349. doi: 10.2307/3172885

Morris, L. A., Lechter, K., Weintraub, M., & Bowen, D. (1998).Comprehension testing for OTC drug labels: Goals, methods, target pop-ulation, and testing environment. Journal of Public Policy & Marketing,17, 86–96. Retrieved from http://www.jstor.org

Nguyen, N. T., Cook, D. M., & Bero, L. A. (2006). The decision-making process of U.S. Food and Drug Administration advisory com-mittees on switches from prescription to over-the-counter status: Acomparative case study. Clinical Therapeutics, 28, 1231–1243. doi:10.1016/j.clinthera.2006.08.007

Organ-specific warnings; Internal analgesic, antipyretic, and antirheumaticdrug products for over-the-counter human use; Final monograph. (2009).Fed. Reg. 74, 19385. (To be codified at 21 C.F.R. pt. 201)

OTC Drug Facts label. (2009). Retrieved from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143551.htm

Payne, J. W. (1982). Contingent decision behavior. Psychological Bulletin,92, 382–402.

Raymond, E. G., Dalebout, S. M., & Camp, S. I. (2002). Comprehensionof a prototype over-the-counter label for an emergency contraceptive pillproduct. Obstetrics & Gynecology, 100, 342–349. doi: 10.1016/S0029-7844(02)02086-0

Sansgiry, S. S., & Cady, P. S. (1996). How the elderly and young adults dif-fer in the decision making process of OTC medication purchases. HealthMarketing Quarterly 14, 3–21. doi: 10.1300/J026v14n01_02

Schmidt, J. B., & Spreng, R. A. (1996). A proposed model of external con-sumer information search. Journal of the Academy of Marketing Science,24, 246–256. doi: 10.1177/0092070396243005

Schwartz, S. M., Bansal, V. P., Hale, C., Rossi, M., & Engle, J. P. (2008).Compliance, behavior change, and weight loss with Orlistat in an over-the-counter setting. Obesity, 16, 623–639. doi: 10.1038/oby.2007.96

Sawyer, A. G., & Ball, A. D. (1981). Statistical power and effect size inmarketing research. Journal of Marketing Research, 18, 275–290.

Verplanken, B. (1993). Need for cognition and external information search:Responses to time pressure during decision-making. Journal of Researchin Personality, 27, 238–252. doi: 10.1006/jrpe.1993.1017

Wolf, M. S., Davis, T. C., Bass, P. F., Curtis, L. M., Lindquist, L. A., Webb,J. A., . . . Parker, R.M. (2010). Improving prescription drug warningsto promote patient comprehension. Archives of Internal Medicine, 170,50–56. Retrieved from http://www.archinternmed.com

Wolf, M. S., Davis, T. C., Shrank, W., Rapp, D. N., Bass, P. F., Connor,U. M., . . . Parker, R.M. (2007). To err is human: Patient misinterpre-tations of prescription drug label instructions. Patient Education andCounseling, 67, 293–300. doi: 10.1016/j.pec.2007.03.024

Williams-Piehota, P., Pizarro, J., Silvera, S. A. N., Mowad, L., & Salovey,P. (2006). Need for cognition and message complexity in motivating fruitand vegetable intake among callers to the cancer information service.Health Communication, 19, 75–84. doi: 10.1207/s15327027hc1901

Williams-Piehota, P., Schneider, T. R., Pizarro, J., Mowad, L., &Salovey, P. (2003). Matching health messages to information-processingstyles: Need for cognition and mammography utilization. HealthCommunication, 15, 375–392. doi: 10.1207/S15327027HC1504

Dow

nloa

ded

by [U

nive

rsity

of C

alifo

rnia

-Irv

ine

] at 0

7:33

03

Apr

il 20

12