Laura Bix

Quantifying age-related differences in information processing behaviors when viewing prescription drug labels

Adverse drug events (ADEs) are a significant problem in health care. While effective warnings have the potential to reduce the prevalence of ADEs, little is known about how patients access and use prescription labeling. We investigated the effectiveness of prescription warning labels (PWLs, small, colorful stickers applied at the pharmacy) in conveying warning information to two groups of patients (young adults and those 50+). We evaluated the early stages of information processing by tracking eye movements while participants interacted with prescription vials that had PWLs affixed to them. We later tested participants’ recognition memory for the PWLs. During viewing, participants often failed to attend to the PWLs; this effect was more pronounced for older than younger participants. Older participants also performed worse on the subsequent memory test. However, when memory performance was conditionalized on whether or not the participant had fixated the PWL, these age-related differences in memory were no longer significant, suggesting that the difference in memory performance between groups was attributable to differences in attention rather than differences in memory encoding or recall. This is important because older adults are recognized to be at greater risk for ADEs. These data provide a compelling case that understanding consumers’ attentive behavior is crucial to developing an effective labeling standard for prescription drugs.

Examining the conspicuousness and prominence of two required warnings on OTC pain relievers

The labeling of over-the-counter (OTC) drugs is critical to their safe and effective use, and certain warnings are meant to be read at the point of purchase (POP). Examples include (i) warnings that alert consumers to the fact that the package is not child-resistant and (ii) warnings that alert consumers to potential product tampering. U.S. law mandates these warnings be “conspicuous” and “prominent” so that it is likely that consumers will read them before leaving the store. Our objective was to quantify the relative prominence and conspicuousness of these warnings. Sixty-one participants reviewed the packages of 5 commercially available analgesics to evaluate the prominence and conspicuousness of these warnings. Evaluated data included (i) the time spent examining the warnings compared with other areas of the label (using a bright pupil eye tracker), (ii) the ability to recall information from the OTCs viewed, and (iii) the legibility of the warnings relative to other elements of the labels (as measured by ASTM D7298-06). Eye-tracking data indicated that warnings were viewed by fewer participants and for less time than other elements of the packages. Recall and legibility data also indicated that the warning statements compared unfavorably with other elements of the labels tested. Evidence presented in this study suggests that 2 required warnings on 5 different OTCs are not prominent or conspicuous when compared with other elements of tested labels.

Biomechanical Analysis of Opening Glass Jars: Using Kinematics

The research theorizes that there are three styles of hand movement when removing a lug closure from a glass jar; lid hand movement alone, jar hand movement alone, or the movement of both hands. However, it is hypothesized that experimental set up will significantly impact how participants move as they remove jar lids; that an unrestrained subject will move differently from one restrained for ease of experimental set up. Each study participant will open glass jars with lug style closures in two fashions: restrained, so that the test jar remains on the table, and unrestrained.

Promoting safe and effective use of OTC medications: CHPA-GSA National Summit.

Research on the ways older people use prescription medications (Rx) is a mainstay of the gerontological literature because use of Rx medications is common, and appropriate use is central to effective management of chronic disease. But older adults are also major consumers of over-the-counter (OTC) medications, which can be equally significant for self-care. Nearly half of older adults aged 75-85, for example, are regular users of an OTC product. Ensuring that consumers safely and effectively use OTC products is critical in order to minimize potential drug-drug interactions and unintentional misuse. Yet we know surprisingly little about the ways older adults select OTC medications and decide when to start or stop use, how older people actually take these medications, or how involved clinicians and family members are in older adult OTC behavior. Research in this area is critical for developing interventions to help ensure safe and appropriate OTC use. For this reason, The Gerontological Society of America (GSA), in partnership with the Consumer Healthcare Products Association (CHPA), convened a summit of experts to set an agenda for research in OTC behaviors among older adults. The panel suggested a need for research in 5 key areas: Health literacy and OTC behavior, decision making and OTC use, the role of clinicians in OTC medication behavior, older adult OTC behavior and family care, and technologies to promote optimal use of OTC medications.

Is the test of senior friendly/child resistant packaging ethical?

Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the ‘senior friendliness’ of CR designs that are used throughout the world disallow people with ‘overt or obvious’ disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision.

To See or Not to See: Do Front of Pack Nutrition Labels Affect Attention to Overall Nutrition Information?

Background Front of pack (FOP) nutrition labels are concise labels located on the front of food packages that provide truncated nutrition information. These labels are rapidly gaining prominence worldwide, presumably because they attract attention and their simplified formats enable rapid comparisons of nutritional value. Methods Eye tracking was conducted as US consumers interacted with actual packages with and without FOP labels to (1) assess if the presence of an FOP label increases attention to nutrition information when viewers are not specifically tasked with nutrition-related goals; and (2) study the effect of FOP presence on consumer use of more comprehensive, traditional nutrition information presented in the Nutritional Facts Panel (NFP), a mandatory label for most packaged foods in the US. Results Our results indicate that colored FOP labels enhanced the probability that any nutrition information was attended, and resulted in faster detection and longer viewing of nutrition information. However, for cereal packages, these benefits were at the expense of attention to the more comprehensive NFP. Our results are consistent with a potential short cut effect of FOP labels, such that if an FOP was present, participants spent less time attending the more comprehensive NFP. For crackers, FOP labels increased time spent attending to nutrition information, but we found no evidence that their presence reduced the time spent on the nutrition information in the NFP. Conclusions The finding that FOP labels increased attention to overall nutrition information by people who did not have an explicit nutritional goal suggests that these labels may have an advantage in conveying nutrition information to a wide segment of the population. However, for some food types this benefit may come with a short-cut effect; that is, decreased attention to more comprehensive nutrition information. These results have implications for policy and warrant further research into the mechanisms by which FOP labels impact use of nutrition information by consumers for different foods.

User-pack interaction: Insights for designing inclusive child-resistant packaging

Drug packages protect and deliver prescription and over-the-counter (OTC) drugs, as well as communicating necessary warnings and directions to people, enabling the therapeutic benefit of their contents. Despite the fact that people with disabilities and older adults represent a significant portion of the pharmaceutical market, protocols across the world for testing child-resistant (CR) packaging (ISO, 2003), exclude people with any obvious or overt disabilities from the senior-related portion of the test (Bix et al., 2009) (Figure 9.1). These regulations have a critical impact on the level of inclusivity of commercially available CR packaging currently on the market.

A New Methodology for Whole-Package Microbial Challenge Testing for Medical Device Trays

It is critical that packages containing sterile medical devices maintain a sterile barrier until the device is used. In 1995, a study conducted by the Health Industry Manufacturers Association (HIMA) compared a whole-package microbial challenge test to physical integrity testing [1]; published results indicated the superiority of physical tests. This paper discusses the problems with the classic approach to whole-package microbial challenge, outlines a new whole-package microbial challenge test, and details the work done to begin to illustrate its effectiveness. The project aim is the creation of a new methodology for microbial challenge testing of medical device packages that reduces the chance of false positives that were commonly observed with the previous technique. The proposed method involves aseptically filling sterile, sealed packages with growth media, challenging them with microbes, incubating the package, and then conducting colony counts to determine package contamination. Results suggest that the proposed technique does not have the false positives that were associated with historical microbial challenge testing. False positives are a serious problem, as they indicate that a package has not maintained its sterile barrier when, indeed, it has. This can lead manufacturers to false assumptions about production and the package, potentially resulting in increased costs for healthcare providers and patients. Research presented here represents the first step in creating a standardized methodology for whole-package microbial challenge testing. Currently, such a test does not exist. While there are numerous physical integrity tests that a manufacturer of medical devices can employ to verify the integrity of packages before release to the market, a need exists for a standardized whole-package microbial challenge test that overcomes the difficulties associated with those of the past.

Mapping kinematic functional abilities of the hand to three dimensional shapes for inclusive design

Loss of hand function can have adverse effects on an individuals ability to maintain independence. The ability to perform daily activities, such as food preparation and medication delivery, is dependent on the hands ability to grasp and manipulate objects. Therefore, the goal of this research was to demonstrate that three dimensional (3D) modeling of hand function can be used to improve the accessibility of handheld objects for individuals with reduced functionality through informed design. Individual models of hand functionality were created for 43 participants and group models were developed for groups of individuals without (Healthy) and with reduced functionality due to arthritis (RFA) of the hand. Cylindrical models representative of auto-injectors of varying diameters were analyzed in 3D space relative to hand function. The individual model mappings showed the cylinder diameter with the highest mapped functional values varied depending on the type of functional weighting chosen: kinematic redundancy of fingertip pad positional placement, fingertip pad orientation, or finger force directionality. The group mappings showed that for a cylinder to be grasped in a power grasp by at least 75% of the Healthy or RFA groups, a diameter of 40mm was required. This research utilizes a new hand model to objectively compare design parameters across three different kinematic factors of hand function and across groups with different functional abilities. The ability to conduct these comparisons enables the creation of designs that are universal to all - including accommodation of individuals with limits in their functional abilities.

The role of packaging size on contamination rates during simulated presentation to a sterile field.

Objective The objective of this study was to assess the impact of package size on the contact between medical devices and non-sterile surfaces (i.e. the hands of the practitioner and the outside of the package) during aseptic presentation to a simulated sterile field. Rationale for this objective stems from the decades-long problem of hospital-acquired infections. This work approaches the problem from a unique perspective, namely packaging size. Design Randomized complete block design with subsampling. Setting Research study conducted at professional conferences for surgical technologists and nursing professionals. Participants Ninety-seven healthcare providers, primarily surgical technologists and nurses. Methods Participants were gloved and asked to present the contents of six pouches of three different sizes to a simulated sterile field. The exterior of pouches and gloves of participants were coated with a simulated contaminant prior to each opening trial. After presentation to the simulated sterile field, the presence of the contaminant on package contents was recorded as indicative of contact with non-sterile surfaces and analyzed in a binary fashion using a generalized linear mixed model. Results Recruited subjects were 26–64 years of age (81 females, 16 males), with 2.5–44 years of professional experience. Results indicated a significant main effect of pouch size on contact rate of package contents (P = 0.0108), whereby larger pouches induced greater rates of contact than smaller pouches (estimates±SEM: 14.7±2.9% vs. 6.0±1.7%, respectively). Discussion and Conclusion This study utilized novel methodologies which simulate contamination in aseptic presentation. Results of this work indicate that increased contamination rates are associated with larger pouches when compared to smaller pouches. The results add to a growing body of research which investigate packagings role in serving as a pathway for product contamination during aseptic presentation. Future work should investigate other packaging design factors (e.g. material, rigidity, and closure systems) and their role in contamination.