No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
A Field Study: Partnering with Pharmacists to Develop a Tool for Evaluating Misuse of Over-the-Counter Medications among Older Adults in the Community Pharmacy
Abstract
Safe over the counter (OTC) medication use by older adults (OAs, aged 65+) is difficult to achieve because of age-related physiologic complexities, and millions of OAs in the US who are at risk of experiencing a major adverse drug event linked to an OTC medication. Our interdisciplinary team studies how we can improve OTC safety in OAs by developing human factors-based, community pharmacy interventions. Testing the effectiveness of our interventions on improving OTC safety necessitated the development of a framework that captures the ways OTC medication misuse can occur and designing and implementing a tool that can be used to evaluate for potential misuse, which can be used by researchers and healthcare professionals to understand misuse in OAs. This paper shares the results of our efforts and discusses the implications of our work for other HF practitioners that may be interested applying our approach to their research.
Background: Over the past 20 years or so, the drug misuse scenario has seen the emergence of both prescription-only and over-the-counter (OTC) medications being reported as ingested for recreational purposes. OTC drugs such as antihistamines, cough/cold medications, and decongestants are reportedly the most popular in being diverted and misused.
Objective: While the current related knowledge is limited, the aim here was to examine the published clinical data on OTC misuse, focusing on antihistamines (e.g., diphenhydramine, promethazine, chlorpheniramine, and dimenhydrinate), dextromethorphan (DXM)- and codeine-based cough medicines, and the nasal decongestant pseudoephedrine.
Methods: A systematic literature review was carried out with the help of Scopus, Web of Science databases, and the related gray literature. For data gathering purposes, both the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and PROSPERO guidelines were followed (PROSPERO identification code CRD42020209261).
Results: After completion of the selection, eligibility, and screening phases, some 92 articles were here taken into consideration; case reports, surveys, and retrospective case series analyses were included. Findings were organized according to the specific OTC recorded. Most articles focused here on DXM (n = 54) and diphenhydramine (n = 12). When specified, dosages, route(s) of administration, toxicity symptoms (including both physical and psychiatric ones), and outcomes were here reported.
Conclusion: Results from the systematic review showed that the OTC misusing issues are both widespread worldwide and popular; vulnerable categories include adolescents and young adults, although real prevalence figures remain unknown, due to a lack of appropriate monitoring systems. Considering the potential, and at times serious, adverse effects associated with OTC misusing issues, healthcare professionals should be vigilant, and ad hoc preventative actions should be designed and implemented.
The potential risks of over-the-counter (OTC) medications are often aggravated in vulnerable populations, such as older adults. The elevated patterns of older-adult OTC medication use do not necessarily translate into a greater understanding of these medications or their safety implications. The objective of this study was to assess how older adults' knowledge, beliefs, and attitudes inform their decision-making regarding OTC use. Situational interviews were conducted in three community pharmacies with 87 older-adult participants to capture how they intended to use an OTC medication. The interviews were transcribed and qualitatively analyzed, generating seven key themes: (1) medication use concerns; (2) following label instructions; (3) wait time until medication effect; (4) responses to medication not working; (5) decision to stop medication; (6) sources of information; and (7) safety implications. This study shows substantial variations in older-adult OTC medication use while providing insight on factors that influence older adults' appropriate OTC medication use and, in some cases, the potential for harmful effects.
Background
Adults aged 65+ (older adults) disproportionately consume 30% of over-the-counter (OTC) medications and are largely responsible for making OTC treatment decisions because providers lack awareness of their consumption. These treatment decisions are complex: older adults must navigate age-related body/cognitive changes, developed comorbidities, and complex medication regimens when selecting the right OTC. Yet little is known about how older adults make such decisions.
Objectives
This study characterizes older adults' cognitive decision-making process when seeking to self-medicate with OTCs from their community pharmacy, and demonstrates how hierarchical task analysis (HTA) can be used to evaluate a pharmacy intervention's impact on their decision-making.
Methods
A pre-/post-implementation approach, using a think-aloud interview process, was conducted with older adults within a community pharmacy setting as they completed a hypothetical scenario to treat either pain, sleep, or cough/cold/allergy symptoms. HTA developed a conceptualization of older adult decision-making regarding OTC selection and use before/after Senior Section implementation.
Results
An HTA constructed from 12 purposefully-selected interviews (pre-n = 9/post-n = 3), consisting of 8 goals/15 sub-goals. While selecting an OTC, older adults considered quantity, cost, form, regimen, safety, strength, appropriateness of OTC safety, generic/name-brand, past experiences, and ingredients. The intervention reduced by half the number of factors considered.
Implications
Older adult decision-making is more complex than just selecting OTC medication from a pharmacy shelf. HTA-informed decision profiles can provide pharmacists critical insights into safety issues that older adults may not be considering (e.g., factors related to safety, strength, or appropriateness of OTC for symptoms) so that pharmacists can support their decision-making.
Background
No interventions have attempted to decrease misuse of over-the-counter (OTC) medications for adults older than 65 (older adults) by addressing system barriers. An innovative structural pharmacy redesign (the Senior SectionTM) was conceptualized to increase awareness of higher-risk OTC medications. The Senior Section contains a curated selection of OTC medications and is close to the prescription department to facilitate pharmacy staff/patient engagement to reduce misuse.
Objective
This pilot study examines the Senior Section’s effectiveness at influencing OTC medication misuse in older adults.
Methods
A pretest-posttest non-equivalent groups design was used to recruit 87 older adults from three pharmacies. Using a hypothetical scenario, participants selected an OTC medication, which was compared to their medication list and health conditions, and their reported use was compared against the product labeling. Misuse outcomes comprised Drug/Drug, Drug/Disease, Drug/Age, and Drug/Label with five sub-types. Patient characteristics were compiled into a propensity-score matching logistic-regression model to estimate their effects on the Senior Section’s association with misuse at pre-/post-implementation.
Results
Patient characteristic were uniform between pre-/post-implementation and, once entered into a propensity-score matching model, Drug/Label Misuse (Exceeds Daily-Dosage) significantly lessened over time (z=-2.42, p=0.015). In addition, the Senior Section reduced Drug/Label Misuse (Exceeds Single-Dosage) for both the raw score model (z=-6.38, p=0.011) or for the model in which the patient characteristics propensity score was added (z=-5.82, p=0.011). Despite these limited statistical effects, misuse was found to decrease after implementation for 7 of 11 comparisons.
Conclusions
These nascent outcomes begin providing an evidence base to support a well-conceived pharmacy-based OTC aisles redesign for reducing older adult OTC medication misuse. The Senior Section, when broadly implemented, creates permanent structures and processes to assist older adults to access risk information when selecting safer OTC medications.
Background:
Stakeholder engagement is an important component of the research process for improving the use and uptake of patient-centered health care innovations. Participatory design (PD), a method that utilizes the involvement of patients and other stakeholders, is well-suited for the design of multifaceted interventions in complex work systems, such as community pharmacies, that have diverse and dynamic end-users.
Objective:
The objective is to describe a blueprint for how to use PD when designing a community pharmacy intervention. This paper outlines the steps of PD and highlights the advantages and disadvantages of this method.
Methods:
PD is explained step-wise to underscore the considerations required of researchers unfamiliar with PD. This includes the development of a tailored PD approach, PD session preparatory work, data collection, and intervention development and evaluation. The stakeholders recruited for the community pharmacy intervention were pharmacy staff and older adult patients who received prescriptions at the pharmacy corporation in which the intervention was being implemented. The PD process was a series of six adaptive sessions: (1) problem identification, (2) solution generation, (3) convergence, (4) prototyping, (5) initial evaluation, and (6) formative evaluation.
Results:
A description of the PD process to design a community pharmacy intervention is provided. The process led to the development of a patient-centered prototype. The advantages of using PD included the opportunity to clarify problems faced by stakeholders, generation of novel solutions to incorporate into the intervention, and the ability to vet and fine-tune stakeholder design ideas in an iterative fashion. The insight gained was unprecedented and invaluable to the researchers. The biggest challenge of employing PD was the time-sensitive and time-intensive nature of developing each session, collecting data, and reflecting on the results in order to design subsequent sessions.
Conclusions:
The PD process led to the development of a patient-centered prototype. PD enabled stakeholders to generate creative solutions and provide unique insight on addressing issues faced in healthcare redesign research and specifically in community pharmacies.
Community pharmacies are unique healthcare settings characterized by extended hours and access to a pharmacist who can provide free OTC guidance. Our hypothesis is that older adults who are more aware of OTC risks and can more easily determine if that risk pertains to their own health by speaking with a community pharmacist, will safely select and not misuse OTC medications. The National Academy of Science has called for using a systems approach to improving patient safety, which considers how multiple elements operate together when caring for patients. Accordingly, our lab developed and tested a multi-component intervention that redesigned a mass-merchandise store’s physical environment in order to support the safe selection of OTCs by older adults. The intervention is a senior section proximal to the prescription department. It includes consultation space, lighted magnifying glasses, warning signage, and a curated list of OTC medications that was selected by geriatric pharmacy experts.
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:
It is anticipated 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.
Background:
Older adults are the largest consumers of over the counter (OTC) medications. Of the older adults who are at risk of a major adverse drug event, more than 50% of these events involve an OTC medication.
Objective:
To explore how older adults select and hypothetically use OTC medications and if the selected medications would be considered safe for use.
Methods:
Walking interviews were conducted with 20 community-dwelling older adults in a community pharmacy. Each participant selected an OTC medication for a hypothetical pain and sleep scenario. Data were analyzed for four types of misuse: drug-drug interaction, drug-disease interaction, drug-age interaction, and excess usage.
Results:
At least one instance of potential misuse was found in 95% of participants. For sleep medications, drug-drug interactions and drug-age interactions were more common, affecting 50% and 65% of participants respectively. The most common type of misuse noted in the pain products selected was that of drug-drug interaction, with a total of 39 occurrences, affecting 60% of the participants.
Conclusions:
OTC misuse is common among older adults, and it is important for older adults to seek out resources, such as a pharmacist, to help them make safe OTC decisions.
Background:
The abuse and misuse of prescription and nonprescription or the so-called Over-The-Counter (OTC) drugs is a serious and growing public health problem worldwide. The increased availability of these drugs has contributed to a dramatic rise of inappropriate use.
Objectives:
The aim of this study was to investigate abuse/misuse of prescription and non-prescription drugs in community pharmacies in Aden city-Yemen and to gather information about suspected drug abusers in the community.
Methods:
A cross-sectional survey using a structured questionnaire randomly distributed to 200 community pharmacies (June-September 2013). Data were coded and analyzed using SPSS Results: A total of 170 pharmacists completed the questionnaire (85.0% response rate), more than half of which (57.7%) suspected drug abuse/misuse in their pharmacies. The top four suspected medications of abuse were Alprazolam, Ketoprofen, Tramadol, and antibiotics. Most participating pharmacists in this study (83.3%) noticed an increasing pattern of abuse/misuse. The majority of suspects of prescription and non-prescription drug abuse (64.1%) were either chewing Khat or carrying it while buying the drug from the pharmacists.
Conclusion:
Abuse/misuse of prescription and nonprescription drugs is present in community pharmacies in Aden and it is linked to the recreational use of Khat. Current methods for controlling the problem are ineffective, and better methods should be developed.
The 2015 American Geriatrics Society (AGS) Beers Criteria are presented. Like the 2012 AGS Beers Criteria, they include lists of potentially inappropriate medications to be avoided in older adults. New to the criteria are lists of select drugs that should be avoided or have their dose adjusted based on the individual's kidney function and select drug-drug interactions documented to be associated with harms in older adults. The specific aim was to have a 13-member interdisciplinary panel of experts in geriatric care and pharmacotherapy update the 2012 AGS Beers Criteria using a modified Delphi method to systematically review and grade the evidence and reach a consensus on each existing and new criterion. The process followed an evidence-based approach using Institute of Medicine standards. The 2015 AGS Beers Criteria are applicable to all older adults with the exclusion of those in palliative and hospice care. Careful application of the criteria by health professionals, consumers, payors, and health systems should lead to closer monitoring of drug use in older adults.
Potentially inappropriate medications (PIMs) continue to be prescribed and used as first-line treatment for the most vulnerable of older adults, despite evidence of poor outcomes from the use of PIMs in older adults. PIMs now form an integral part of policy and practice and are incorporated into several quality measures. The specific aim of this project was to update the previous Beers Criteria using a comprehensive, systematic review and grading of the evidence on drug-related problems and adverse drug events (ADEs) in older adults. This was accomplished through the support of The American Geriatrics Society (AGS) and the work of an interdisciplinary panel of 11 experts in geriatric care and pharmacotherapy who applied a modified Delphi method to the systematic review and grading to reach consensus on the updated 2012 AGS Beers Criteria. Fifty-three medications or medication classes encompass the final updated Criteria, which are divided into three categories: potentially inappropriate medications and classes to avoid in older adults, potentially inappropriate medications and classes to avoid in older adults with certain diseases and syndromes that the drugs listed can exacerbate, and finally medications to be used with caution in older adults. This update has much strength, including the use of an evidence-based approach using the Institute of Medicine standards and the development of a partnership to regularly update the Criteria. Thoughtful application of the Criteria will allow for (a) closer monitoring of drug use, (b) application of real-time e-prescribing and interventions to decrease ADEs in older adults, and (c) better patient outcomes.
LABEL: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated
- Dailymed
Evidence-Based Drug Referential Solutions
- Lexicomp
The Over-the-Counter Medicine Label: Take a Look
- C Us Fda