Improving over-the-counter medication safety for older adults: A study protocol for a demonstration and dissemination study

Abstract

Background Adverse drug events (ADEs) associated with over-the-counter (OTC) medications cause 178,000 hospitalizations each year. Older adults, aged 65 and older, are particularly vulnerable to ADEs. Of the 2.2 million older adults considered at risk for a major ADE, more than 50% are at risk due to concurrent use of an OTC and prescription medication. Objectives To refine the intervention and implementation strategy through diagnostic and formative evaluation; to evaluate the effectiveness of the intervention for preventing misuse of high-risk OTC medications by older adults; and to evaluate the implementation of the intervention in community pharmacies. Methods A system redesign intervention to decrease high-risk OTC medication misuse will be tested to reduce misuse by improving communication between older adults and community pharmacists via the following features: a redesign of the physical environment to sensitize older adults to high-risk OTC medications, and the implementation of a clinical decision tool to support the pharmacist when critically evaluating the older adult’s health status. The study will be conducted in three phases: a participatory design phase, a beta phase, and a test phase. The test phase will be conducted in three mass-merchandise stores. A total of 144 older adults will be recruited. A pre (control)/post (intervention) test will determine the effectiveness of the intervention. The primary outcome will be a comparison of proportion of older adults who misuse OTC medication from baseline to post-intervention. The process of implementation in the community pharmacy setting will be evaluated using the taxonomy proposed Proctor et al. The participatory design phase has been approved by the institution’s IRB (2016-0743). Projected Impact We anticipate that this project, which focuses on achieving systems-based improvement in an underemphasized area of the medication use process, will reduce ADEs associated with inappropriate OTC medication use in older adults.

Understanding the Factors Influencing Older Adults’ Decision-Making about Their Use of Over-The-Counter Medications—A Scenario-Based Approach

“…The Senior Section’s OTC medication inventory consists of products that are carefully selected using the Beers Criteria [ 30 ]—an evidence-based clinical practice guideline used as a source of older-adult OTC safety information—that have lower risk profiles for the treatment of allergies, coughs/colds, sleep, or pain [ 31 ]. As a component of a multifaceted pilot project examining the implementation of the Senior Section and its effectiveness at reducing unsafe medication use, pharmacy customers participated in a scenario-based semi-structured interview regarding their planned use of OTC medications [ 32 ]. This data collection process allowed for the evaluation of patients’ feedback about the way that they would use an OTC product that they selected, as well as the factors that they considered could lead either to safe or potentially harmful use.…”

“…Although this analysis is specific to patients’ medication use information, the overall study examining Senior Section implementation has so far generated multiple publications describing different aspects and effects of the intervention. These publications have covered such distinct methods or topics as the explanation of the participatory design influence [ 31 ], description of the study protocol [ 32 ], descriptive analysis of patient/pharmacist encounters defined through a study data collection form, mixed-methods analysis of patient/pharmacist encounters [ 33 ], and qualitative assessment of pharmacy staff reactions to the Senior Section [ 34 ]. In addition to these publications, manuscripts currently are being prepared to address the following topics: a methods paper describing the task simulation and situational interviewing approach used to capture participants’ decisions when selecting and using OTC medications; a methods paper describing the process of classifying types of misuse and operationalizing these misuse constructs; a quantitative analysis of the Senior Section’s effect on the occurrence of standardized medication misuse classifications [ 35 ]; a qualitative analysis classifying types of OTC selection processes for older adults, including the results from a latent semantic analysis of older adults’ interviews; an industrial engineering analytic method to conceptually diagram older adults’ cognitive decision-making process while considering and selecting an OTC medication.…”

Analysis of spontaneous reporting of suspected adverse drug reactions for non-analgesic over-the-counter drugs from 2008 to 2017

“…In the present study, the age group most susceptible to ADRs of OTC drugs were patients aged above 70 years of age. One of the reasons why older adults are in need of improvement in their knowledge of OTC drug safety could be their misuse of OTC drugs [43, 44]. Furthermore, polypharmacy observed especially in this subgroup could also be a cause of ADRs.…”

Understanding older adults' medication decision making and behavior: A study on over-the-counter (OTC) anticholinergic medications

“…The simulation session followed a published protocol for OTC shopping research from a similar study that was conducted in retail pharmacies. 30,38 Per that protocol, participants were instructed to select one or more medications to treat hypothetical sleep disturbance and pain symptoms. While participants made their selections, they were instructed to think-aloud, meaning to articulate their thoughts contemporaneously.…”

“…27 Other studies have developed educational board games, 28 OTC product labeling, 29 and consumer-facing interventions in OTC retail stores. 30 A key aspect of medication-related consumer-oriented interventions is not only changing behavior, but also influencing upstream consumer factors such as awareness, perceptions, education, and empowerment. 26,28,31…”