An assessment of older adults' selection of over‐the‐counter medication: What information are they utilizing during the selection process?

Herein, we investigate the information older adults use when selecting over‐the‐counter (OTC) medications. Two specific objectives framed our work: (1) determine what information older adults believe to be important when selecting an OTC and (2) determine what information they believe to be important when assessing an OTC product's appropriateness for use. Five focus groups comprised of OTC users aged 65+ (total n = 24) were led using a moderator guide which incorporated surveys, individual activities and guide group discussions in support of these objectives. Complete transcripts of group discussions were coded into emergent themes and analysed in conjunction with survey results. Four broad themes were identified: price, search for advice, perception of efficacy and perception of safety. While we framed our study specific to labelling information, expecting older consumers to use a deliberative decision‐making process, typical of products that carry risk, what emerged was the fact that they utilized a habit‐based process that was largely driven by price comparisons and previous success with products. The specific, intensive information from the Drug Facts Label (DFL) required by the US Food and Drug Administration (FDA), which we had designed our questions around, was not the information discussed intently by our participants. Data suggests that they rely on simple heuristics available through other aspects of the packaging.


| INTRODUCTION
Convenient access, independence and flexibility are among the benefits offered by self-care which utilizes over-the-counter (OTC) medications.Further enhancing the appeal of this approach is the fact that it has been suggested that for every $1 (USD) spent on OTCs, $6-7 is saved in lieu of more expensive care (e.g., doctor visits). 1 OTCs are a particularly important component of US healthcare, which is high in cost and lacks a universal, government-funded insurance system.These benefits, combined with an ever-increasing range of readily available products used to treat varied conditions, as well as commercial advertisements focused primarily on symptom relief, have, undoubtedly, led to the growing popularity of OTC use.US sales of OTC medicines have more than doubled in recent years, from $14.7 billion in 2000 to $34.3 billion in 2017. 2 Information included in OTC labelling is primarily dictated by regulations promulgated by two agencies in the United States, the Fair Trade Commission (FTC) and the Food and Drug Administration (FDA).The FTC controls information related to marketing, while information related to safe and effective use of products is regulated by the FDA.The FTC has the mission of 'protecting the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education'.Meanwhile, the FDA mission relates to 'protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and products that emit radiation'.
Although we were interested in information related to general decision-making specific to packaging, we focused our study questions on the FDA-regulated information related to the safe and effective use of products.
One of the risks associated with escalating use of medications (both Rx and OTC) are adverse drug reactions (ADRs).ADRs are defined as 'appreciably harmful or unpleasant reaction[s] resulting from an intervention related to the use of a medicinal product'.
(Edwards and Aronson, 3 p.1255) ADRs have been indicated to significantly contribute to mortality, morbidity, extended hospital stays and increased healthcare costs.A retrospective study of reports from 2011 to 2020 4 indicates that approximately 54% of ADRs are preventable and that their severity is significantly correlated with age and engagement in polypharmacy.
Parsing the precise cause of an ADR and the role of OTCs can be difficult as ADRs can happen to patients under the care of a doctor or can be the result of self-medication practice which may (or may not) include OTC use.Results of a prospective study utilizing multiple centres focused on long-term care suggested that, for cases involving self-medicating patients, 53.8% of ADRs were due to OTC drugs.Many of these were the result of drug-drug interactions occurring between the OTC and prescription medication. 5It has been postulated that the ease of access consumers have to OTC products signals relative harmlessness to consumers, potentially encouraging a cavalier attitude regarding their use and encouraging regular consumption. 6,7Additionally, others suggest that consumers perceive a product that can be purchased alongside relatively harmless products (e.g., groceries) as less dangerous than a product purchased with something they perceive as more dangerous (e.g., prescription drugs). 8der adults are about four times more likely to suffer an ADR than their younger counterparts, and it has been suggested that ADRs are responsible for between 9% and 20% of hospital admissions in geriatric units. 9Increased prevalence of ADRs occurs in older adults for a variety of reasons, including a tendency to engage in polypharmacy 10 ; changes in pharmacokinetics, pharmacodynamics, limitations in perception and cognition associated with normal aging; lower rates of health literacy relative to other segments of the population [11][12][13][14] ; and inappropriate prescribing and monitoring practices compared to other demographics. 9,15,16spite the increased risk older adults face and the indication that OTCs play a role in ADRs, research regarding the decision-making processes employed by older adults when choosing and using an OTC is limited. 17,18Work by Carpenter and Yoon, investigating decisionmaking by older adults that focuses on decisions related to general consumer products, suggests they are less likely than younger adults to undertake cognitively demanding information search processes; specifically, older adults are more likely to use simple heuristics when making purchase decisions than their younger counterparts. 19,20This leads the authors to conclude that older consumers make better purchasing decisions when fewer choices are available in the consideration set and are more likely to prefer established brands. 19,20[23] Work conducted by Holden et al. supports this notion; their work suggests a habit-based process for making purchase decisions related to OTCs rather than a deliberative process. 24In light of all of these factors, strategies which encourage informed decision-making and selection of OTCs by older adults are a worthy pursuit.A common approach to promote the safe and effective use of OTCs focuses on packaging and labelling as a vehicle for transferring information. 25For OTCs sold in US commerce, labelling requirements from the FDA mandate the content and formatting of a 'Drug Facts Label' (DFL).
The DFL provides comprehensive, drug-specific information related to the safe and effective use of most drugs sold in the United States and is generally displayed to the right side of the Principal Display Panel (PDP-the face customarily displayed during retail).
The saliency of varied packaging attributes has been investigated for effects on consumer choice of OTCs.8][29] Further, studies suggest that consumers are poorly informed regarding the active ingredients present in the OTCs that they take, with only 41% indicating that they always look for the active ingredient when purchasing OTCs. 28Other surveys report 78% of respondents use symptom relief to guide purchase decisions, 54% brand name and 47% look for sale products. 27Lacking in these studies is how older consumers perceive the importance of, and interact with, information relating to safety (contraindications and other warnings) during selection.
A limited number of studies suggest that age-related differences exist regarding interactions with OTC labelling.A 2015 survey reports that adults over age 70 were significantly less likely to report reading the label as important when reusing an OTC product as compared to adults aged 18-34. 30This finding suggests that, despite the increased risk for ADRs in older consumers, they are less likely to access the information included on the DFL that could mitigate the occurrence of such events.
In response to trends and data such as these, the Consumer Healthcare Products Association (CHPA) and the Gerontological Society of America (GSA) assembled a panel of experts with the goal of identifying critical gaps in the relatively neglected area of OTC use among older adults in order to promote safe and effective use of the same. 31focus group methodology was utilized to enable participants to build on each other's verbal responses and allow the research team opportunity to follow-up with participants to clarify intended meanings related to responses.Ultimately, it was because of this method that we were able to draw the conclusions that we did, which were much different than we anticipated when designing our study.
To better understand older adults perception of the importance of varied pieces of information on OTC labels and identify congruence (they perceived it to be important and utilized it) or incongruence (they perceived it to be important but did not utilize it), we conducted a series of focus groups with individual activities imbedded within them to address the following objectives.

| OBJECTIVES
Specific goals of the work were to 2.1 determine what label information older adults believe to be important when selecting an OTC and 2.2 determine what label information they believe to be important to assess when determining a product's appropriateness for use.

| METHODS
Data were collected during five focus groups.Focus groups utilized a moderator guide; this guide not only allowed for uniform facilitation of discussion but also enabled a single member of the research team to consistently conduct a series of individualized tasks where participants regrouped upon completion to discuss individual responses collectively.Methods were approved as part of Michigan State University (MSU) IRB # x17-922eD exemption category 8; i054087.

| Recruitment, screening and consent
Participants were recruited via the SONA system.SONA is an experiment management system used for the scheduling and management of research involving human subjects that is maintained and overseen by the College of Communication Arts and Sciences at MSU.The system is used to maintain a pool of interested community participants to assist research teams with identifying, scheduling, screening and contacting members of the surrounding community who have expressed interest in research and are eligible for a particular study.
Additionally, word of mouth communication and distribution of recruitment fliers to participants with the intention of providing recruitment information to eligible friends and family members was also utilized.
A purposeful, selective sampling technique was employed, where eligible participants were age 65 and older, had purchased and used an OTC medication within the preceding 12 months, had transportation to the research site and expressed willingness to be video and audio recorded.Sampling was decided a priori, informed by Guest et al., whose work suggests that 90% of all themes are identified within the first four focus groups of a study 32 ; the small group sizes employed were supported by Masadeh's review of focus group methodologies, which identified increased per capita participation, and a lesser likelihood of competition between members for speaking time as benefits of smaller group sizes. 33ter informed, written consent was obtained, participants privately filled out their demographics and OTC purchase behaviours while other participants gathered.

| Focus groups
The focus groups, which incorporated a series of individual activities/ worksheets throughout, were guided by a single researcher using standard focus group protocol (for a review of this methodology, see Krueger and Casey 34 and Wilkinson 35 ).See Table 1 for a summary of the moderator guide and the Supporting Information for a copy of both the moderator guide and data collection instruments related to individualized activities.

| Independent activities embedded within focus groups
During individual activities (see Table 1), participants privately responded using worksheets corresponding to the activity (see supplemental materials for copies of these instruments).After a few moments of reflection and the chance to record answers privately, the group reconvened to share and discuss responses or participate in the moderator-led activity.All interactions were audio and video recorded, and members of the research team took notes that could be used to clarify unclear moments in recordings.Discussions from the focus groups were manually transcribed, verbatim, by a single researcher (the moderator of all focus groups) who reviewed the recordings at reduced speeds in conjunction with notes taken by research assistants.

| Data analysis
Analysis of the transcripts for themes adapted a technique outlined by Krueger 36 ; specifically, we employed the use of a spreadsheet to identify and group thought units.Each of the transcribed focus groups was assigned to a column within a spreadsheet, and each isolated statement was provided its own cell.Researchers reviewed data to identify common words/phrases that appeared (e.g., sale, price and value to identify thought units related to thought units that cantered T A B L E 1 Summary of the moderator guide.

Activity
Individual activity-Information from the Principle Display Panel (PDP) and headings from the Drug Facts Label (DFL) were broken into individual components and participants were asked to rate them on a 5-point Likert scale for the question how frequently they used this information (Never-Rarely-Sometimes-Often-Always)

Activity
Individual activity-Participants were asked to indicate yes, no or not sure, to whether or not they had a variety of conditions that are commonly contraindicated with OTC drug products.Characterize conditions likely to be contraindicated.

Activity
Individual activity-Participants were asked to indicate yes, no or not sure to whether or not they had taken a list of drug commonly contraindicated with OTC medications within the past week.Characterize other medications taken by participants likely to be contraindicated.

Activity
Individual activity-Information from the PDP and headings from the DFL were broken into individual components and participants were asked to rate them on a 5-point Likert scale for the question how important each piece of information was when making a decision related to use for themselves (not at all, low, neutral, moderately and very).
on price); the search function of the software was employed to identify similar thought units which were colour coded into a consistent theme to allow for grouping and enumeration.While Krueger advocates writing thought units contributed by individuals on cards and sorting along themes, we electronically adapted the original methodology.
Data analysis and coding of quotations was conducted by a single researcher, and the analysis of the data was reviewed by a second member of the research team to verify the qualitative identification of the emergent themes.

| Participant characterization
Twenty-four participants took part in focus groups conducted for the purpose of assessing information older adults deemed important during product selection to compare this with information that they deemed important during product use.Group size ranged from four to six participants; Table 2 presents sample characteristics for the group in aggregate and broken down by individual focus group.
Following the collection of basic, demographic information, a section of the documentation attempted to characterize broad motivations for and patterns of purchase related to OTC products.
All (24) participants had purchased at least one OTC medication within the last year, with 37.5% of participants reporting they purchased OTC medications at least once a month and 8% indicating that they purchased OTCs two to three times per month.Twenty-one claimed they were primary purchaser of OTC medication for their household (87.5%) while three indicated that they shared the responsibility with a spouse or partner (12.5%).
When surveyed about their health histories, 12 (50%) participants reported having high blood pressure, five (20.8%) reported having diabetes, four (16.6%) reported having any thyroid condition, three (12.5%) reported having heart surgery previously, two (8.3%) reported stomach bleeding problems or ulcers and one (4.1%)participant reported either three or more alcoholic drinks per day, trouble swallowing food or kidney disease.Although these conditions are not typically treated with OTC drugs, they are contraindicated with the use of them, and label warnings on OTCs were used to inform the data that we collected in an attempt to characterize the risks associated with OTC use among our study population.

| Motivations for purchase
Participants were provided with a list of possible reasons motivating purchase of OTCs (see Table 3) and provided an open-ended opportunity to add their own.They were asked to indicate/list all that applied and allocate the percentage of times that a given reason was a motivator (i.e., participants were instructed that the total of the reasons from the list needed to add to 100%).The data from a single participant health food stores and convenience stores) all received two or less participants reporting.One reason the purchase location was of interest is the context of the display and sale of the product has the potential to influence perception of the product.Literature from the field of risk perception suggests consumers to be more likely to perceive a product they were able to purchase alongside relatively harmless products (e.g., groceries) as less dangerous than a product purchased with something perceived as more dangerous (e.g., prescription drugs); specifically, that purchase context influences risk perception. 372 | Four themes identified by content analysis

| Price
Of the four emergent themes the content analysis identified as information used during product selection, price was the most prominently featured, with 14/24 (58.3%) of participants expressing price as a consideration in the worksheet activity and EVERY participant indicating it as a consideration during the discussion (24/24).

| Advice
Although participants did report seeking formal medical advice by providing information about OTCs at a check-up or asking doctor for advice related to OTCs used for recurrent ailments, a prevalent theme during selection was to seek informal advice from a family member or friend.This has the potential to lead to decision-making based on incomplete information relating to medication behaviours, health conditions or medical history; studies of people caring for loved ones with chronic illness suggest, 'families have poor knowledge of OTC medication side effects and risks'. 38Since many participants also expressed surprise related to the depth of information of OTC warnings, it is evident that researchers should not assume that consumers are aware of the information present on the DFL.
The idea that people don't utilize information in the DFL to make decisions about these products is not new.Empirical work investigating how the formatting of varied pieces of information on the PDP influence attentional allocation when older adults viewed OTCs found that 63.4% of the test population did not use the DFL to make the decision about a product's appropriateness for their use, 27,29,30 instead solely relying on the PDP.

| Perception of OTC safety and efficacy
The final two trends that emerged from the data relate to the phenomenon of repeat use of the same product: perceived safety and perceived efficacy are similar, but distinct.These trends are alike in that they are informed by participants' prior experience taking a particular medication but differ in how participants reported the influence of each on purchase behaviour.Perceived safety was an overarching concept, with participants indicating that OTC is inherently safe.As mentioned previously, it has been postulated that the purchase location (e.g., a grocery store, where products low in risk are purchased) can influence consumer perception of risk 37 ; this could be a mediating factor influencing this finding.
The theme related to therapeutic efficacy differed from the theme of safety in that it was informed by a history of previous use and appeared to pertain to specific products that participants had used previously with success.In both cases, heuristic cues such as package colour or other indicators of trade dress were utilized to identify products previously used successfully or identify store brands that would provide equivalent effects at a lower price point, residing at the intersection of two trends.

| Objective 1: Determine which label information older adults use when selecting an OTC
The moderator guided participants through discussion which intended to identify label information older adults deemed to be important when making a purchase decision related to OTC products.Review of the transcribed discussions suggest most of the information older adults mentioned using when making a purchase decision appear on the PDP (the face customarily displayed at retail  39,40 If reduction of ADRs is a priority for this vulnerable population, a strategy worthy of further consideration is moving information critical to safe selection to the front of the package, where a consumer would be more likely to encounter it.

| DISCUSSION
While study questions were written to encourage discussion about older consumers' use of labelling information when selecting an OTC product (Objective 1) or assessing its appropriateness for their own use (Objective 2), analysis of the group discussions revealed labelling was not used in the way that we anticipated it would be.The study was designed to investigate a deliberative decision-making process, assuming that information from the DFL would weigh heavily into focus group themes.Instead, we found older consumers relied heavily on other types of information, such as prior knowledge, experience, or advice, rather than information related to the safe and effective use for OTCs conveyed on the packaging and labelling.
Packaging and labelling seemed to be used as a means to identify products the participants had used successfully on previous occasions in order to initially identify the product or make comparisons to identify a more affordable substitute.Specific information related to price included using net content information to calculate the price per dose or the use of colour or other components of trade dress to locate and compare store versus name brands.
The very design of the system seems to support this type of processing.The PDP typically contains information necessary to make price comparisons (net contents, dosage form, etc.) and branding information (trade dress and brand names).Conversely, by definition, information required for the safe and effective use of a product is located on faces not customarily displayed at retail.It can be construed that the physical configuration of the package, in combination with the graphics, actually encourages the use of simple heuristic cues during decision-making.In other words, that the very design facilitates cross-product comparisons and price comparisons (information regulated by the FTC, not the FDA).While it can be argued that this is an appropriate strategy for products with no risk of adverse health consequences, it has the potential to lead to inappropriate choices for products that have risks associated with inappropriate or improper use.
This combines with other themes that emerge from the data, like a tendency to repurchase products previously used successfully (from the perspective of both safety and efficacy), to reinforce a habit-based purchase process.In a habit-based process, routine purchases are made without consideration of possible adverse events because there is a low perception of risk.More deliberative processes would engage more involvement with possible adverse events and lead consumers to weighing risks and benefits.

| LIMITATIONS
We chose the focus group method to develop a preliminary sense of how older consumers utilize information when conducting decisionmaking and selection for OTC products.While we enumerated the number of participants who shared points of view to illustrate the magnitude of the findings, these results are not generalizable to the population.
The primary limitations of this study lie within the self-reporting aspects of the focus group technique and the relative uniformity of our sample.According to Ecks, people tend to report idealized behaviours when reporting them publicly. 41Additionally, although subjects were characterized using basic demographic information (Table 2), major health conditions and purchase behaviours, we did not control the groups for the heterogenous realities (i.e., separate those who were frequent purchasers/users from those who were not and, therefore, constructing their opinions from different experience sets).Additionally, the groups that we recruited were relatively homogeneous in racial, socio-economic and educational background; as such, readers are cautioned against generalizing the findings widely.

| CONCLUSIONS
These findings, coupled with research that suggests that people do not turn beyond the PDP when making OTC decisions, 29 further support a call for more research investigating what content should be included on the PDP of OTC drugs. 42If reduction of ADRs is a priority for this vulnerable population, a strategy worthy of further consideration is moving information critical to safe selection to the front of the package, where a consumer would be more likely to encounter it.Further research into information designs that garner the attention of older adults at the point of purchase should also be conducted, particularly for OTC medications on the Beers List.
Begin the discussion of the topic model sharing and hear all participant voices • Round robin sharing from demographic sheet regarding places OTCs have been purchased within the last year, # of purchases per household and typical usage statistics T A B L E 2 Demographic characteristics by focus group and in aggregate.
a One participant failed to report their age.T A B L E 3 Self-reported reasons for purchase.® , reported by 6/24 participants as outlets for purchase (25%).A small number of participants 3/24 (12.5%) reported purchasing OTC medication online.Other retail environments (vending machines, airports, gas stations, hotel lobbies, hospital pharmacies, ). Examples include the form of the medication (tablet, capsule, caplet, etc.), the number of pills in the container and the brand name or trade dress (e.g., colour associated with brand).Where regulated, this information is governed by the FTC, whose mission is to prevent unfair trade practices.Very